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The Cochrane Database of Systematic Reviews logoLink to The Cochrane Database of Systematic Reviews
. 2021 Apr 4;2021(4):CD010829. doi: 10.1002/14651858.CD010829.pub2

Interventions for increasing solid organ donor registration

Alvin H Li 1,, Marcus Lo 2, Jacob E Crawshaw 3, Alexie J Dunnett 4, Kyla L Naylor 2, Amit X Garg 5, Justin Presseau 3
Editor: Cochrane Kidney and Transplant Group
PMCID: PMC8164549  PMID: 35608942

Abstract

Background

A solution for increasing the number of available organs for transplantation is to encourage more individuals to register a commitment for deceased organ donation. However, the percentage of the population registered for organ donation remains low in many countries.

Objectives

To evaluate the benefits and harms of various interventions used to increase deceased organ donor registration.

Search methods

We searched the Cochrane Kidney and Transplant Register of Studies up to 11 August 2020 through contact with an Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register Search Portal and ClinicalTrials.gov.

Selection criteria

We included all randomised controlled trials (RCTs), cluster RCTs and quasi‐RCTs of interventions to promote deceased organ donor registration. We included studies if they measured self‐reported or verified donor registration, intention to donate, intention to register a decision or number of individuals signing donor cards as outcomes.

Data collection and analysis

Two authors independently assessed retrieved studies and extracted data from included studies. We assessed studies for risk of bias. We obtained summary estimates of effect using a random‐effects model and expressed results as risk ratios (RR) (95% confidence intervals; CI) for dichotomous outcomes and mean difference (MD; 95% CI) or standardised mean difference (SMD; 95% CI) for continuous outcomes. In multi‐arm trials, data were pooled to create single pair‐wise comparisons. Analyses were stratified by specific intervention setting where available.

Main results

Our search strategy identified 46 studies (47 primary articles, including one abstract) comprising 24 parallel RCTs, 19 cluster RCTs and 3 quasi‐RCTs. Sample sizes ranged from 138 to 1,085,292 (median = 514). A total of 16 studies measured registration behaviour, 27 measured intention to register/donate and three studies measured both registration behaviour and intention to register.

Interventions were delivered in a variety of different settings: schools (14 studies), driver’s motor vehicle (DMV) centres (5), mail‐outs (4), primary care centres (3), workplaces (1), community settings (7) and general public (12). Interventions were highly varied in terms of their content and included strategies such as educational sessions and videos, leveraging peer leaders, staff training, message framing, and priming. Most studies were rated as having high or unclear risk of bias for random sequence generation and allocation concealment and low risk for the remainder of the domains.

Data from 34/46 studies (74%) were available for meta‐analysis. Low certainty evidence showed organ donation registration interventions had a small overall effect on improving registration behaviour (16 studies, 1,294,065 participants: RR 1.30, 95% CI 1.19 to 1.43, I2 = 84%), intention to register/donate (dichotomous) (10 studies, 10,838 participants: RR 1.21, 95% CI 1.03 to 1.42, I2 = 91%) and intention to register/donate (continuous) (9 studies, 3572 participants: SMD 0.23, 95% CI 0.11 to 0.36, I2 = 67%).

Classroom‐based interventions delivered in a lecture format by individuals from the transplant community may be effective at increasing intention to register/donate (3 studies, 675 participants: RR 1.33, 95% CI 1.15 to 1.55, I² = 0%). Community interventions targeting specific ethnic groups were generally effective at increasing registration rates (k = 5, n = 4186; RR 2.14, 95% CI 1.35 to 3.40, I² = 85%), although heterogeneity was high. In particular, interventions delivered in the community by trained peer‐leaders appear to be effective (3 studies, 3819 participant: RR 2.09, 95% CI 1.08 to 4.06, I² = 87%), although again, the data lacked robustness. There was some evidence that framing messages (e.g. anticipated regret) and priming individuals (e.g. reciprocity) in a certain way may increase intention to register/donate, however, few studies measured this effect on actual registration.

Overall, the studies varied significantly in terms of design, setting, content and delivery. Selection bias was evident and a quarter of the studies could not be included in the meta‐analysis due to incomplete outcome data reporting. No adverse events were reported.

Authors' conclusions

In our review, we identified a variety of approaches used to increase organ donor registration including school‐based educational sessions and videos, leveraging peer leaders in the community, DMV staff training, targeted messaging and priming. The variability in outcome measures used and incompleteness in reporting meant that most data could not be combined for analysis. When data were combined, overall effect sizes were small in favour of intervention groups over controls, however, there was significant variability in the data. There was some evidence that leveraging peer‐leaders in the community to deliver organ donation education may improve registration rates and classroom‐based education from credible individuals (i.e. members of the transplant community) may improve intention to register/donate, however, there is no clear evidence favouring any particular approach. There was mixed evidence for simple, low‐intensity interventions utilising message framing and priming. However, it is likely that interest in these strategies will persist due to their reach and scalability. Further research is therefore required to adequately address the question of the most effective interventions for increasing deceased organ donor registration.

Plain language summary

Interventions for increasing solid organ donor registration

What is the issue?

There is a global need to increase the number of available organs for transplantation. One possible strategy is to encourage more individuals to register as organ donors.

What did we do?

To address this, we identified 46 studies that tested various strategies to encourage people to register as an organ donor. Sixteen of these studies measured actual registration, 27 studies measured people’s intention to register/donate and three studies measured both.

What did we find?

Studies were conducted in widely different settings including schools, driver motor vehicle (DMV) centres, primary care and in the local community. Studies also used widely different strategies to increase registration such as education, training peer‐leaders, training DMV or primary care staff, and framing information about organ donation in certain ways.

We found that studies had a small overall effect on people’s intention to register/donate along with actual registration rates, however, no particular strategy stood out as being more effective than the rest. There was encouraging evidence that training peer‐leaders in the community to deliver organ donation education may improve registration rates and classroom‐based education from members of the transplant community may improve intention to register/donate. There was also some evidence that framing organ donation information in certain ways may help increase people’s intention to register/donate but further studies are needed.

Conclusions

In summary, strategies to increase organ donation registration have some benefit but vary considerably in terms of the setting in which they are delivered, who they target and how they are delivered.

Summary of findings

Background

Description of the condition

Many patients worldwide are dying on the transplant waiting list due to the shortage of available organs (Aubrey 2008; Santiago‐Delpin 1997; Van Gelder 2008; Wolfe 2010). One potential solution for increasing the number of available organs for transplantation is to develop interventions to support and encourage individuals to register a commitment for deceased organ donation through a registry (Rosenblum 2012). Despite support for donor registries from the public and national organisations, many countries have modest registration rates (< 40% of the population registered) (Rosenblum 2012). Thus, while establishing the donor registry infrastructure is necessary, it is not a sufficient intervention for ensuring that individuals actually register their donation wishes.

Description of the intervention

As of 2012, 19 countries operated deceased organ donor registries where the stated goal is to maximise the total number of affirmative registrants (Rosenblum 2012). These registries are used to communicate an individual’s wish regarding organ donation after death to their next‐of‐kin. Registration choices differ among nations, and can include “yes” only, “yes and no” and “yes, no and unsure”. In addition, some countries also allow individuals to clarify which organs and tissues they wish to donate. Past studies have found that families are more likely to consent to organ donation if their loved ones had previously expressed a willingness to donate (e.g. on a donor card or driver’s license) (Lawlor 2006; Siminoff 2002).

How the intervention might work

Many interventions can effectively increase knowledge, attitude and prompt family discussion about organ donation (Li 2013a). These interventions can include mass media campaigns and classroom educational programs. Such interventions have been shown to benefit other public health issues such as drinking and driving (Elder 2004) and smoking (Bala 2017). However, it is unclear which interventions have actually demonstrated an increase in the number of individuals registering a commitment to organ donation (Li 2013a; Thornton 2012). Surveys have further found that while a majority of respondents were willing to be donors, many had not registered (Lee 2010; Yeung 2000). The gap between willingness to be a donor and actual registration may be due to a lack of awareness of the registry, uncertainty about the registration process or perceived ineligibility as a donor amongst other things (Li 2017; Siegel 2005; Yeung 2000).

Why it is important to do this review

The need for interventions that go beyond merely increasing support for organ donation, but increase actual affirmative registration values, prompted the present review. Moreover, there is a need to identify the best quality evidence (e.g. randomised controlled trials (RCTs)) which was a limitation of previous reviews in this area (Golding 2017; Jones 2017; Li 2013a; Li 2015). This systematic review synthesises the best evidence currently available from studies evaluating various interventions to increase affirmative organ donor registrants. This review aims to guide the design and use of further interventions to fill organ donor registries. The focus of this review is on solid organ donations after death. Interventions may benefit society if an increased number of organ donor registrants directly translates to an increased number of deceased donors. However, it is important to keep in mind that these interventions may also be detrimental to society or individual participants if they unintentionally discourage registration for deceased organ donation.

Objectives

This review aims to look at the benefits and harms of various interventions used to increase deceased organ donor registration.

Methods

Criteria for considering studies for this review

Types of studies

We included all RCTs, quasi‐RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods), and cluster RCTs that evaluated interventions to promote deceased organ donor registration. We had planned to include controlled before‐after studies, but we subsequently decided to focus on RCTs because of their lower risk of bias. We excluded studies from countries that do not comply with the Declaration of Istanbul.

Types of participants

Inclusion criteria

All participants eligible to make a commitment for deceased organ donation in their respective jurisdiction.

Exclusion criteria

Participants who are not eligible to register for deceased organ donation in their respective jurisdiction (e.g. under the minimum age required).

We excluded studies that examined consent for organ donation from relatives of patients declared deceased and eligible for organ donation. We also excluded studies focusing on increasing living organ donation.

Types of interventions

We considered any interventions and methods of delivering an intervention used to increase organ donor registration including classroom educational program, brochures, interactive computer program, videos, and multi‐component interventions. The comparison group could be an inactive control intervention (e.g. no intervention) or an active intervention (e.g. different variant of an educational program). We excluded interventions solely focusing on tissue or blood donation.

Types of outcome measures

Characteristics of joining an organ donor registry vary among countries. We included studies that measured consent to deceased organ donation through registration in an organ donor registry, signed donor cards or verification of organ donation registration as shown on a driver’s licence or identification card. For this reason, we expected that identified studies would stem from countries with an explicit consent or "opt‐in" system. Registration choices may also be measured and may include "yes" (the participant declares that they would like to be a deceased organ donor in the advent of death), "no" and "unsure". We also included studies that measured self‐reported intention or willingness to become an organ donor. Furthermore, we extracted any adverse events reported in any studies. Adverse events may include discomfort or dissatisfaction with the intervention.

Primary outcomes
  1. Registration in an organ donor registry (yes/no) and registration choices ("yes" to being a donor, "no" or "unsure")

  2. Signed donor cards (yes/no)

  3. Verification of organ donation as shown on driver's licence or identification card (yes/no)

  4. Any adverse events. (e.g. discomfort with the intervention)

Secondary outcomes
  1. Self‐reported intention to register as a donor (e.g. Do you intend to register as a donor?)

  2. Self‐reported willingness to donation (e.g. Would you be willing to donate your organs?)

These can be either reported as yes/no or on a scale (e.g. yes/no/maybe, fully agree to fully disagree).

Search methods for identification of studies

Electronic searches

We searched the Cochrane Kidney and Transplant Register of Studies up to 11 August 2020 through contact with the Information Specialist using search terms relevant to this review. The Register contains studies identified from the following sources:

  1. Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL)

  2. Weekly searches of MEDLINE OVID SP

  3. Hand searching of kidney‐related journals and the proceedings of major kidney conferences

  4. Searching of the current year of EMBASE OVID SP

  5. Weekly current awareness alerts for selected kidney and transplant journals

  6. Searches of the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov

Studies contained in the Register of Studies are identified through search strategies for CENTRAL, MEDLINE, and EMBASE based on the scope of Cochrane Kidney and Transplant. Details of these strategies, as well as a list of hand‐searched journals, conference proceedings, and current awareness alerts, are available in the Specialised Register section of information about Cochrane Kidney and Transplant.

See Appendix 1 for search terms used in strategies for this review.

Searching other resources

  • Reference lists of review articles, relevant studies, and clinical practice guideline

Data collection and analysis

Selection of studies

The search strategy described was used to obtain titles and abstracts of studies that may be relevant to the review. The titles and abstracts were screened independently by two authors, who discarded studies that clearly did not meet our inclusion criteria; studies and reviews that might include relevant data or information on studies were retained for full‐text screening.

Data extraction and management

Data extraction was carried out independently by two authors using data extraction forms. Where more than one publication of one study existed, we grouped reports together and the publication with the most complete data was extracted. For each study, we extracted relevant background information to provide context regarding its country's organ donor legislation.

Assessment of risk of bias in included studies

The following items were independently assessed by two authors using the risk of bias assessment tool (Higgins 2011) (see Appendix 2).

  • Was there adequate sequence generation (selection bias)?

  • Was allocation adequately concealed (selection bias)?

  • Was knowledge of the allocated interventions adequately prevented during the study (detection bias)?

    • Participants and personnel

    • Outcome assessors

  • Were incomplete outcome data adequately addressed (attrition bias)?

  • Are reports of the study free of suggestion of selective outcome reporting (reporting bias)?

  • Was the study apparently free of other problems that could put it at a risk of bias?

Measures of treatment effect

For dichotomous outcomes (e.g. donor registration status; yes/no) we expressed results as a risk ratio (RR) with 95% confidence intervals (CI). Where continuous scales of measurement are used to assess the effects of treatment (e.g. a scale of willingness to register as a donor), the mean difference (MD) was used, or the standardised mean difference (SMD) in the case of different scales being used.

Unit of analysis issues

We handled issues with non‐standard designs such as cluster RCTs as recommended by the Cochrane Handbook for Systematic Interventions (Higgins 2011). We estimated the effective sample size by dividing the original sample size by the design effect (1 + (Average Cluster Size ‐1) * intraclass correlation coefficient). We used the ICC reported in the study where available. If not reported, we used an intraclass coefficient (ICC) estimate of 0.07 based on a previous study (Li 2017). For dichotomous outcomes, both numbers of participants and numbers of participants registered for organ donation were divided by the design effect.

Dealing with missing data

If needed, any further information from the original author was requested by written correspondence (e.g. emailing or writing to corresponding author) and any relevant information obtained in this manner was included in the review. Attrition rates due to drop‐outs, losses to follow‐up, and withdrawals were investigated. Issues of missing data and imputation methods (e.g. last‐observation‐carried‐forward) were critically appraised (Higgins 2011).

Assessment of heterogeneity

Where applicable, we assessed heterogeneity using a Chi² test on N‐1 degrees of freedom, with an alpha of 0.05 used for statistical significance and with the I² test (Higgins 2003). I² values of 25%, 50% and 75% correspond to low, medium, and high levels of heterogeneity.

Assessment of reporting biases

If applicable, we used funnel plots to explore the potential existence of small study bias due to the large heterogeneity of the interventions (Higgins 2011).

Data synthesis

We pooled data using the random‐effects model and used the fixed‐effect model to ensure robustness of the model chosen and susceptibility to outliers where possible. In studies with multiple intervention groups, groups were combined to create a single pair‐wise comparison to ensure that no data were lost. For dichotomous outcomes, both the sample sizes and the number of people with events (registered/intended to register) were summed across groups. For continuous outcomes, pooled sample sizes, means and standard deviations were calculated.

Subgroup analysis and investigation of heterogeneity

We planned a subgroup analysis to explore possible sources of heterogeneity (e.g. participants, interventions and study quality). Heterogeneity among participants could be related to age, gender, educational level, or ethnicity. Heterogeneity in organ donor interventions may be related to the personnel delivering the intervention (e.g. volunteers, health care workers or transplant recipients), duration and method of delivery of the intervention (e.g. educational program, videos). We described any adverse effects that were reported by the authors. Adverse events may include discomfort or dissatisfaction with the intervention. Where possible, the risk difference with 95% CI was calculated for each adverse effect, either compared to no intervention or to another intervention. Due to the low number of studies identified comparing the same intervention and control, we were unable to perform subgroup analysis to explore possible sources of heterogeneity.

Sensitivity analysis

We planned to perform the following sensitivity analyses in order to explore the influence of the following factors on effect size.

  1. Repeating the analysis excluding unpublished studies

  2. Repeating the analysis taking account of risk of bias

  3. Repeating the analysis excluding any very long or large studies to establish how much they dominate the results

  4. Repeating the analysis excluding studies using the following filters: diagnostic criteria, language of publication, source of funding (industry versus other), and country

However, due to the wide variety of interventions, these were not possible.

Summary of findings and assessment of the certainty of the evidence

We produced Summary of Findings tables to determine the pooled effect of organ donation registration interventions on our primary (registration behaviour) and secondary outcomes (intention to register/donate). Separate analyses were done for dichotomous and continuous outcomes. Certainty of the evidence was assessed using GRADE.

Results

Description of studies

Results of the search

Our search strategy identified 115 potentially relevant records (see Figure 1). Six records were identified as ongoing studies/abstract only. After full text review from our search strategy, we included 47 records describing 46 RCTs that met our inclusion criteria. One study was included but no full text publication was available (Dobbels 2009). The six ongoing studies will be incorporated in a future update of this review (ACTRN12614000690651; Andrews 2012a; iDecide 2010; NCT02318849; RegisterNow‐1 2017; Yee 2014).

1.

1

Flow chart showing study selection

Included studies

See Characteristics of included studies table.

We included 24 parallel RCTs (52%), 19 cluster RCTs(41%), and 3 quasi‐RCTs (6.7%). Most studies had 2 arms (29 studies; 63%), followed by 4 arms (8 studies; 17%), 3 arms (7 studies, 15%), one study with 6 arms, and one study had 8 arms. The number of clusters in the 19 cluster RCTs ranged from 9 to 121. Four (21%) cluster RCTs did not report the number of clusters included in their study. The sample size of participants for all included studies ranged from 138 to 1,085,292 (median: 514). Four studies did not report a total sample size (Alvaro 2011a; Alvaro 2011b; Rodrigue 2012; Rodrigue 2015).

Studies were conducted in the USA (23 studies; 50%), the UK (8 studies; 17%), and the Netherlands (6 studies; 13%). One international study was conducted in Australia, Belgium, Brazil, Ireland, Spain, and Taiwan.

Outcomes measured

A total of 16 studies measured registration behaviour (Alvaro 2011a; Alvaro 2011b; Andrews 2012; Bidigare 2000; Degenholtz 2015; Degenholtz 2019; Loughery 2017; INORDAR 2012; Quick 2012; Quick 2015; Resnicow 2010; Rodrigue 2012; Rodrigue 2015; Sallis 2018; Thornton 2012; Thornton 2016), 27 studies measured intention to register/donate (Alarcon 2008; Blazek 2018; Cardenas 2010; Chien 2015; Dobbels 2009; Doherty 2017; Doyle 2019a; Doyle 2019b; Hirai 2020; O'Carroll 2011a; O'Carroll 2011b; O'Carroll 2017a; O'Carroll 2017b; O'Carroll 2019; Project ACTS I 2010; Project ACTS II 2013; Quinn 2006; Reubsaet 2003; Reubsaet 2004a; Reubsaet 2004b; Reubsaet 2005; Riccetto 2019; Siegel 2016; Skumanich 1996; Smits 2006; Steenaart 2018; Thornton 2019) and three studies measured both registration behaviour and intention to register (Hyde 2013; Murakami 2016; Rodrigue 2019).

A total of 14 studies reported actual registration rates as verified by the donor registry (Andrews 2012; Degenholtz 2015; Degenholtz 2019; Loughery 2017; INORDAR 2012; Quick 2012; Quick 2015; Resnicow 2010; Rodrigue 2012; Rodrigue 2015; Rodrigue 2019; Sallis 2018; Thornton 2012; Thornton 2016). Five studies reported either the number of signed cards or forms returned (Alvaro 2011a; Alvaro 2011b), self‐reported registration (Hyde 2013; Murakami 2016) or self‐reported making a decision to donate (Bidigare 2000).

Among studies measuring intention, 18 studies measured intention to register to donate (e.g. do you intend to register as a donor?) as the outcome measure (Blazek 2018; Chien 2015; Dobbels 2009; Doyle 2019a; Doyle 2019b; Hirai 2020; Hyde 2013; Quinn 2006; Reubsaet 2003; Reubsaet 2004a; Reubsaet 2004b; Reubsaet 2005; Riccetto 2019; Rodrigue 2019; Siegel 2016; Skumanich 1996; Steenaart 2018; Thornton 2019). Eight studies measured intention to donate (e.g. do you intend to donate your organs?) as the outcome measure (Alarcon 2008; Doherty 2017; Murakami 2016; O'Carroll 2011a; O'Carroll 2011b; O'Carroll 2017a; O'Carroll 2017b; O'Carroll 2019). Two studies measured participants readiness to express donation intentions via a driver’s license, donor card and/or discussions with family members (Project ACTS I 2010, Project ACTS II 2013). Two studies measured willingness to donate (e.g. would you be willing to be a donor?) without asking any questions focusing on registering for donation (Cardenas 2010; Smits 2006).

Excluded studies

We excluded 34 studies from our review (see Characteristics of excluded studies). Studies were excluded for being unrelated to deceased organ donation (23 studies) or they focused on general attitudes towards organ donation and did not measure organ donor registration behaviours (11 studies).

Risk of bias in included studies

See Characteristics of included studies table for an assessment of the risk of bias of the included studies (see Figure 2; Figure 3). Overall, the majority of studies were rated as having high or unclear risk of bias.

2.

2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

3.

3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Allocation

Random sequence generation

Twenty‐one studies (43%) did not report their method of sequence generation. Among those studies with a low risk of bias (22; 48%), the random sequence generation methods included: online randomisation tool (Project ACTS II 2013), coin flip (Alvaro 2011a, Cardenas 2010; Degenholtz 2015), computer‐generated sequence (Doherty 2017; Hyde 2013; Murakami 2016; Thornton 2016; Steenaart 2018), random number table (Thornton 2012), and a third‐party company to perform the simple randomisation (INORDAR 2012; Thornton 2019).

Allocation concealment

Twenty‐nine studies did not report their method of allocation concealment or had a high risk bias (63%). Among the 13 studies with low risk of bias, the method of allocation concealment included using sealed envelopes (Thornton 2012; Thornton 2016; Rodrigue 2019).

Blinding

Performance bias

Twenty‐one studies (46%) were reported as having a low risk of performance bias. Blinding of participants and study personnel was not addressed in many studies. However, due to the nature of the study design of some of these studies (e.g. cluster randomisation at the classroom level), participants may likely have been aware of which groups (intervention or control) they were assigned, to which may have caused them to respond to the intervention accordingly.

Detection bias

Forty‐four studies (93%) were assessed as low risk of bias, given that the outcome (e.g. intention to register for organ donation) was either measured via self‐report or through actual registration rates. We judged two studies that reported using a non‐blinded interviewer to ask participants about their intention to register to be at high risk of bias (Doherty 2017; Doyle 2019a).

Incomplete outcome data

Four studies (9%) were judged to be at high risk of attrition bias because they reported high loss to follow‐up rates, and stated that those who completed the study had different characteristics than those that were lost to follow‐up (Project ACTS II 2013; Hyde 2013; Loughery 2017; Quinn 2006).

Selective reporting

Thirty‐six studies (78%) were deemed to be at low risk of reporting bias. Ten studies (22%) were assessed as high risk of bias. These studies did not report a numerator or denominator for the outcomes considered in this review (Alarcon 2008; Bidigare 2000; Dobbels 2009; Hyde 2013; Project ACTS II 2013; Reubsaet 2004a; Reubsaet 2004b; Rodrigue 2012; Rodrigue 2015; Skumanich 1996).

Other potential sources of bias

Nineteen studies (41%) were deemed to be at unclear or high risk of other bias. The most common source of other bias were biases associated were not reporting baseline differences.

Effects of interventions

See: Table 1; Table 2; Table 3

Summary of findings 1. Summary of Findings Table ‐ Interventions for increasing solid organ donation registration (dichotomous outcome).

Interventions for increasing solid organ donation registration (dichotomous outcome)
Patient or population: increasing solid organ donation registration Setting: Intervention: intervention Comparison: control
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) № of participants 
(studies) Certainty of the evidence
(GRADE) Comments
Risk with control Risk with intervention
Registration behaviour: ICC adjusted (dichotomous) 40 per 1,000 52 per 1,000
(47 to 57) RR 1.30
(1.19 to 1.43) 1294065
(16 RCTs) ⊕⊕⊝⊝
LOW a,b,c  
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). 

CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_416986025065372155.

a. Despite being randomised, most studies were rated as having unclear or high risk of bias
b. There was substantial heterogeneity between trials regarding setting, type of interventions and measured outcomes
c. Potential publication bias may be an issue. Other studies may exist but have not been submitted or accepted for publication and therefore were not identified through our search strategy

Summary of findings 2. Summary of Findings Table ‐ Interventions for increasing solid organ donation registration intention (dichotomous outcome).

Interventions for increasing solid organ donation registration intention (dichotomous outcome)
Patient or population: increasing solid organ donation registration intention Setting: Intervention: interventions Comparison: control
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) № of participants 
(studies) Certainty of the evidence
(GRADE) Comments
Risk with control Risk with interventions
Registration intention (dichotomous) 385 per 1,000 466 per 1,000
(397 to 547) RR 1.21
(1.03 to 1.42) 10838
(10 RCTs) ⊕⊕⊝⊝
LOW a,b,c  
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). 

CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_416986147679296079.

a. Despite being randomised, most studies were rated as having unclear or high risk of bias
b. There was substantial heterogeneity between trials regarding setting, type of interventions and measured outcomes
c. Potential publication bias may be an issue. Other studies may exist but have not been submitted or accepted for publication and therefore were not identified through our search strategy

Summary of findings 3. Summary of Findings Table ‐ Interventions for increasing solid organ donor registration (continuous outcome).

Interventions for increasing solid organ donor registration (continuous outcome)
Patient or population: increasing solid organ donor registration Setting: Intervention: intervention Comparison: control
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) № of participants 
(studies) Certainty of the evidence
(GRADE) Comments
Risk with control Risk with intervention
Registration intention: ICC adjusted (continuous) The mean registration intention: ICC adjusted (continuous) was 0 SD MD 0.38 SD higher
(0.18 higher to 0.59 higher) 3572
(9 RCTs) ⊕⊕⊝⊝
LOW a,b,c  
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). 

CI: Confidence interval; MD: Mean difference
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_417077169819443221.

a. Despite being randomised, most studies were rated as having unclear or high risk of bias
b. There was medium heterogeneity between trials regarding setting, type of interventions and measured outcomes
c. Potential publication bias may be an issue. Other studies may exist but have not been submitted or accepted for publication and therefore were not identified through our search strategy

We described an overview of the intervention for each study in the Characteristics of included studies table. We describe the included studies below, grouped primarily by the setting in which the intervention took place in. We also provide an overview of the intervention strategies in Table 4.

1. Categories of strategies included in the interventions.

Study In‐person Ed Video Ed Web Ed Framing Peer leaders Priming S.I.M Staff training Planning/rehearsal
Alarcon 2008 X X
Alvaro 2011a X
Alvaro 2011b X X
Andrews 2012 X X X
Bidigare 2000 X
Blazek 2018 X
Cardenas 2010 X X
Chien 2015 X
Degenholtz 2015 X X
Degenholtz 2019 X X X
Dobbels 2009 X
Doherty 2017 X
Doyle 2019a X
Doyle 2019b X
Hirai 2020 X
Hyde 2013 X X
INORDAR 2012 X
Loughery 2017 X X X
Murakami 2016 X
O'Carroll 2011a X
O'Carroll 2011b X
O'Carroll 2017a X X
O'Carroll 2017b X X
O'Carroll 2019 X X
Project ACTS 1 2010 X
Project ACTS II 2013 X X
Quick 2012 X
Quick 2015 X
Quinn 2006 X
Resnicow 2010 X X
Reubsaet 2003 X
Reubsaet 2004a X X
Reubsaet 2004b X
Reubsaet 2005 X X X
Riccetto 2019 X
Rodrigue 2012 X X
Rodrigue 2015 X
Rodrigue 2019 X
Sallis 2018 X
Siegel 2016 X
Skumanich 1996 X
Smits 2006 X
Steenaart 2019 X X X
Thornton 2012 X
Thornton 2016 X
Thornton 2019 X
Total 18 13 6 6 4 5 9 3 4

Ed ‐ education; S.I.M ‐ Survey Item Manipulation

Overall effects

Three meta‐analyses were conducted to compare the overall effect of the included interventions on organ donor registration compared to control on 1) registration behaviour (dichotomous), 2) intention to register/donate (dichotomous) and 3) intention to register/donate (continuous). Data were not available for all studies, primarily due to inadequate reporting of outcome data needed for our analysis (Blazek 2018; Cardenas 2010; Chien 2015; Degenholtz 2015; Dobbels 2009; Hyde 2013Project ACTS II 2013;  Reubsaet 2004a; Reubsaet 2004b; Rodrigue 2012; Rodrigue 2015; Rodrigue 2019; Siegel 2016; Skumanich 1996). 

Each outcome had similar effect sizes. 

  • Organ donor registration interventions had a small effect on improving registration behaviour (dichotomous) with high heterogeneity (Analysis 1.1 (16 studies, 1,294,065 participants): RR 1.30, 95% CI 1.19 to 1.43; I2 = 84%; low certainty evidence).

  • Interventions had a small effect on increasing the intention to register/donate (dichotomous) with high heterogeneity (Analysis 2.1 (10 studies, 10,838 participants): RR 1.21, 95% CI 1.03 to 1.42; I2 = 91%; low certainty evidence).

  • Interventions had a small effect on increasing the intention to register/donate (continuous) with medium heterogeneity (Analysis 3.1 (9 studies, 3572 participants): SMD 0.23, 95% CI 0.11 to 0.36; I2 = 67%; low certainty evidence).​

1.1. Analysis.

1.1

Comparison 1: Registration behaviour: dichotomous, Outcome 1: Registration behaviour: ICC adjusted (dichotomous)

2.1. Analysis.

2.1

Comparison 2: Registration intention: dichotomous, Outcome 1: Registration intention: ICC adjusted (dichotomous)

3.1. Analysis.

3.1

Comparison 3: Registration intention: continuous, Outcome 1: Registration intention: ICC adjusted (continuous)

School‐based setting (14 studies)

Fourteen studies were conducted within a school‐based setting and compared the effects of an educational program (Alarcon 2008; Cardenas 2010; Chien 2015Dobbels 2009Murakami 2016; Reubsaet 2003; Reubsaet 2004a; Reubsaet 2004b; Reubsaet 2005Rodrigue 2019Skumanich 1996; Smits 2006Steenaart 2018; Thornton 2019). Nine studies were conducted in high schools (Alarcon 2008Cardenas 2010Dobbels 2009Reubsaet 2003; Reubsaet 2004a; Reubsaet 2004b; Reubsaet 2005; Smits 2006; Steenaart 2018), four targeted university students (Chien 2015; Murakami 2016; Skumanich 1996; Thornton 2019), and one was delivered in a driving school setting (Rodrigue 2019). Ten studies compared a classroom‐based educational intervention to a control (e.g. lecture on another health topic). All of the studies had a minimum of one session with students, with up to a maximum of four sessions with the same group (Alarcon 2008). All of the studies included a measure of intention to register/donate and two studies measured both intention to register/donate and registration rates (Murakami 2016Rodrigue 2019). A subgroup analysis revealed that school‐based interventions had a small effect on increasing the intention to register/donate versus control (Analysis 2.2 (6 studies, 6272 participants): RR 1.34, 95% CI 1.27 to 1.42; I² = 0%).

2.2. Analysis.

2.2

Comparison 2: Registration intention: dichotomous, Outcome 2: Registration intention (dichotomous): school setting (ICC adjusted)

Lectures with a member of the transplant community (4 studies)

Four studies incorporated members of the transplant community to give presentations to students on the topic of organ donation (Alarcon 2008; Cardenas 2010; Murakami 2016; Smits 2006). Three studies used transplant recipients (Cardenas 2010; Murakami 2016; Smits 2006). Murakami 2016 also included the presence of a transplant nephrologist, and Alarcon 2008 included a youth on the transplant wait list. Compared to control, students who received a presentation with a member of the transplant community had stronger intention to register (Analysis 4.1 (3 studies, 675 participants): RR 1.33, 95% CI 1.15 to 1.55; I² = 0%). Murakami 2016 also measured rates of self‐reported registration and found that 7/102 in the intervention group registered compared to 1/101 in the control group (RR 6.93, 95% CI 0.87 to 55.32). 

4.1. Analysis.

4.1

Comparison 4: Lecture with member of transplant community versus control, Outcome 1: Intention to register

Cardenas 2010 measured changes in willingness to donate (4‐point scale: 1) Would like to be an organ donor; 2) Considering it; 3) Undecided; 4) Do not want to be an organ donor). Cardenas 2010 reported that 31% (24/78) in the intervention group moved in a positive direction compared to 7% (5/75) control group. Cardenas 2010 found that 14% (11/78) of the intervention group moved 1‐point in negative direction compared to 7% (6/75) in the control group (adverse event).

Classroom computer delivered  (1 study)

Reubsaet 2004b compared the effects of an interactive, tailored, computer‐based intervention that taught adolescents about organ donation and how to register (intervention group) with a brochure on organ donation (control group) on intention to register for organ donation. They reported that the intervention did not have a statistically significant impact on the primary outcome being tested (OR 1.11, 95% CI 0.39 to 3.19).

Video‐component (6 studies)

Five of the school‐based studies incorporated a video‐based education program with their lectures to educate students and promote organ donation (Alarcon 2008; Cardenas 2010; Reubsaet 2004a; Reubsaet 2005; Steenaart 2018). Alarcon 2008 and Cardenas 2010’s video lasted 10 minutes, while Reubsaet 2004a and Reubsaet 2005 were both 20 minutes. Steenaart 2018 incorporated video fragments into discussions about organ donation along with practising completing an organ donation registration form. ​​​​Reubsaet 2005 also included an interactive, tailored, computer‐based intervention (see Reubsaet 2004a). Lectures with video were more effective than control at increasing rates of self‐reported registration among students (Analysis 5.1 (3 studies, 3493 participants): RR 1.26, 95% CI 1.08 to 1.46, I² = 56%).

5.1. Analysis.

5.1

Comparison 5: Lecture with video versus control, Outcome 1: Self‐reported registration

Thornton 2019 undertook a 3‐arm RCT to test the effect of web‐based educational videos (no lecture) on organ donation intention among university students. In one of the conditions, students received a 5‐minute animated video explaining the donation/transplantation process and donor registration process. In another condition, students received a 5‐minute live‐action video with an emotional appeal addressing common concerns regarding the donation process. Students in the control group visited a website unrelated to organ donation. Students in both the animated (30/753, 4.0%) and live‐action (30/755, 4.0%) video conditions were more likely agree to register for donation compared to control (21/753, 2.8%) (P < 0.001 for both comparisons). 

Message framing delivered within school (1 study)

Chien 2015 compared the effects of gain/loss framed and statistical/exemplar messages on college students intention to register as organ donors. A “gain‐framed” message is a positive message that emphasises the benefits of a certain action by either underscoring the potential gains to an action, or emphasising the disadvantages that could be avoided by taking an action. A “loss‐framed” message is a negative message with an emphasis on the disadvantages that could result from taking an action, or from not taking an action. An “exemplar” message was one that focused on qualitative evidence that revolves around exemplar characters, in the context of narratives and personal anecdotes. A “statistical” message is one that focuses on the statistics regarding an issue. While no significant difference was found between using gain‐ versus loss‐framed messages, a significant difference was observed between the statistical versus exemplar messages (mean = 4.77, SD = 0.89) in the exemplar group, compared to the statistical group (mean = 4.15, SD = 1.19).

Integrated model of behavioural prediction (1 study)

Dobbels 2009 compared the effects of a tailored, theory‐based intervention program on intention to register among high‐school students. Only an abstract is available and there was insufficient information about the intervention and methods. They reported that the intention to register as a donor increased to 40% in the intervention group while control group remained similar at one‐year follow‐up (25%) (RR 1.98, 95% CI 1.5 to 2.7).

In‐school driver's education classes (1 study)

Rodrigue 2019 compared the effects of providing organ donation messaging to adolescents attending driver's education classes (3 types: testimonial, informational, and blended) compared to historical controls. They reported that a higher proportion of study adolescents registered as donors (60%, 340/567) compared with the historical comparison group (50%, 789/1575; P < 0.001). They reported that the testimonial (64%) and blended (65%) were more effective than the informational group (51%). 

Drivers motor vehicle (DMV) centre setting (5 studies)

Five studies compared the effects of testing an intervention implemented in DMV centres (Degenholtz 2015Hirai 2020Rodrigue 2012; Rodrigue 2015; Thornton 2012).

Staff training (2 studies)

Two studies (Degenholtz 2015; Rodrigue 2012) evaluated the effects of providing organ donation training to DMV staff. Degenholtz 2015 reported that customers seen by staff who received a web‐based training program on organ donation were more likely to register as organ donors (OR 1.08, 95% CI 1.06 to 1.09). Rodrigue 2012 reported that during the intervention phase, where DMV staff received in‐person training that emphasised the importance of organ donation and the role that DMV offices play in enrolling potential donors, DMV offices receiving the intervention had a higher donor designation rate than the usual care group (36% compared to 29%; denominator not reported). There were no statistically significant differences between the intervention group and usual care group during the follow‐up phase, when the intervention was no longer provided.

Video‐based (2 studies)

The other two studies (Rodrigue 2015; Thornton 2012) focused on exposing organ donation material via video directly to DMV customers. Thornton 2012 used research assistants to recruit and show participants in the intervention group a 5‐minute iPod video that addressed concerns about organ donation. They reported that 84% (372/443) of those shown the video registered, compared to 72% (369/509) who did not view the video (OR 2.05, 95% CI 1.49 to 2.81). Rodrigue 2015 displayed subtitled videos with no audio in DMV offices. Compared to the usual standard of care (posters, and brochures displayed in the waiting area), DMV offices displaying the video intervention had a lower aggregate monthly donor designation rate during the intervention phase (48.0% in the intervention group, compared to 50.5% in the usual care group). There was no longer a significant difference in monthly donor designation rates during the follow‐up phase, when the intervention video was no longer shown.

Message framing delivered by DMV (1 study)

Hirai 2020 compared different types of message framing in a DMV setting.  The intervention consisted of reading a leaflet with different messages that prompted organ donation registration. There were 5 types of frames for the messages: “peer”, “gain”, “loss”, “reciprocity”, and “peer + reciprocity”. The control condition involved a leaflet without a prompt message. In an adjusted analysis, the reciprocity‐framed message was a significant predictor for increase readiness to register (OR 1.60, P = 0.041) compared to control.

Mail‐outs (4 studies)

Three studies (INORDAR 2012; Quick 2012; Quick 2015) assessed the effects of different messaging strategies embedded within large mail‐out campaigns to members of the general public and another study provided web‐based education to university students (Riccetto 2019).

Message framing delivered by mail‐out (3 studies)

Three studies (INORDAR 2012; Quick 2012; Quick 2015) compared different messaging strategies by mail.

Quick 2012 compared the effects of receiving a letter from an authoritative source (i.e. a Secretary of State; SoS) versus an information brochure from the SoS versus a combination of the letter and brochure. The authors reported that 2668/42789 (6.2%) of those who received a SoS letter registered compared to 1534/46624 (3.3%) who received the SoS brochure and 2706/43001 (6.3%) who received both a letter and brochure.

Quick 2015 compared the effects of messaging strategies from donors, transplant recipients, and patients on the wait list. They reported that a brochure featuring a combination of donors, transplant recipients and patients on the wait‐list had the largest effect on organ donor registrations (7.7%; 1102/14265), whereas each of the three categories individually had comparably lower registration rates: organ donor (5.6%; 803/14324); transplant recipient (5.9%; 847/14265); and waiting list individuals (5.9%; 831/14207).

INORDAR 2012 tested the effects of anticipated regret on participants likelihood to register as organ donors via questionnaires, by asking participants to think about whether they would regret not registering as an organ donor. They found that participants in the anticipated regret group (4.5%; 104/2308) were less likely to register compared to the control group (6.4%; 149/2330). This study will be discussed further in the anticipated regret section below.

Web‐based education (1 study)

 Riccetto 2019 tested whether web‐based educational material promoting organ donation increased intention to donate among university students recruited via a mail‐out. The control group did not receive any intervention components. Donation intention was measured using a single‐item (“do you intend to donate your organs after death?”, yes/no). There was no significant difference in those who intended to donate between the intervention (297/347, 85.6%) and control groups (353/392, 90.1%).

Primary care setting (3 studies)

Three studies (Bidigare 2000Degenholtz 2019Thornton 2016) evaluated an intervention implemented within a primary care setting. A subgroup analysis revealed that primary care‐based interventions probably did not increase rates of registration versus control (Analysis 1.2 (3 studies, 3829 participants): RR 1.13, 95% CI 0.79 to 1.61, I² = 63%).

1.2. Analysis.

1.2

Comparison 1: Registration behaviour: dichotomous, Outcome 2: Registration behaviour (dichotomous): primary care setting (ICC adjusted)

Written materials and brief discussion with primary care physician (1 study)

Bidigare 2000 compared the effectiveness of providing written materials and a brief discussion about organ donation with a primary care physician (intervention group) with providing written materials only (control group). There was no statistically significant difference in commitment to organ donation in the intervention group (12/40, 30%) versus control (53/125; 42%).

Video‐based (1 study)

Thornton 2016 compared the effectiveness of viewing a 5‐minute video addressing concerns about organ donation, along with cueing patients to ask one question about organ donation with their primary care physician (intervention group) with a standard usual visit (control group). They reported that 22% (100/456) of those who received the intervention registered for organ donation, compared to 15% (71/459) of the control group.

Distributing registration form upon check‐in (1 study)

Degenholtz 2019 compared the effectiveness of  providing clinic staff with organ donation training material and providing a one‐page registration form to patients (intervention group) compared with to only having posters and brochures placed in the waiting room (control group).  They reported that 761 (8.1%) of 9428 people who were not already registered completed the designation form to be organ donors and no new donor designations in the control group. 

Workplace setting (1 study)

Quinn 2006 compared the effects of an enhanced educational session (intervention group 1), basic educational session (intervention group 2) and control group implemented within a workplace environment. Worksites were recruited from various financial, insurance, manufacturing, hospitality, and service industries. The basic educational session was grounded in the Transtheoretical Model and consisted of a ‘Lunch and Learn’ with a presentation on the need and value of organ donation followed by a testimony from a transplant recipient and family member of a posthumous organ donor. The enhanced session involved the same components along with encouragement of the employees to persuade their family members to register for organ donation. The control intervention provided participants with brochures on multiple health related topics including organ donation. Among participants who completed the 1‐month follow‐up questionnaire, more participants (110/172, 64%) from the basic intervention, and more participants (122/179, 68%) from the enhanced intervention reported to have signed donor cards compared to those in the control group (81/137, 59%).

Local community setting (7 studies)

Seven studies utilised community settings (e.g. churches, hair salons, town hall meetings) targeting particular groups of individuals (e.g. African‐American population, Hispanic population) (Alvaro 2011a; Alvaro 2011b; Andrews 2012; Project ACTS I 2010; Project ACTS II 2013; Loughery 2017; Resnicow 2010). A subgroup analysis revealed that interventions delivered within a targeted community setting (all cluster RCTs) increased rates of registration compared to control (Analysis 1.3 (5 studies, 4186 participants): RR 2.14, 95% CI 1.35 to 3.40, I² = 85%).

1.3. Analysis.

1.3

Comparison 1: Registration behaviour: dichotomous, Outcome 3: Registration behaviour (dichotomous): community setting (ICC adjusted)

Leveraging peer leaders (3 studies)

Three studies compared the effects of training peer leaders to provide organ donation education to a primarily African‐American population. These studies targeted Church members, alumni members of sorority/fraternities, and salon patrons. Andrews 2012 tested the effects of training peer leaders as health advisors to educate church members about organ donation (intervention group) compared to health advisors that did not discuss organ donation, but instead focused on fruit and vegetable consumption (control group). Resnicow 2010 compared the effectiveness of training hair stylists to provide a brief motivational intervention for organ donation (intervention group) compared to a basic health‐based education unrelated to organ donation (control group). In both groups, hair stylists were asked to conduct four brief health chats with each client. Loughery 2017 compared the effects of training members of sororities and fraternities to deliver organ donation content (adapted from Andrews 2012) to a chronic disease education program. Participants from the intervention chapters also received two tailored newsletters, based on the participants’ responses to knowledge and misconception deficits on their baseline survey. These newsletters also featured stories about affected individuals from organ donation. Training peer leaders to deliver organ donation related material was more effective in increasing verified donor registration rate compared to non‐organ donation related material (Analysis 6.1 (3 studies, 3819  participants): RR 2.09, 95% CI 1.08 to 4.06, I² = 87%).

6.1. Analysis.

6.1

Comparison 6: Leveraging peer leaders versus control, Outcome 1: Verified registration

Immediate versus delayed registration opportunity (2 studies)

Alvaro 2011a and Alvaro 2011b recruited participants from 'town hall' meetings and  a 'flea market', respectively, to test the effects of providing an immediate and complete registration opportunity (intervention group) versus a delayed opportunity (control group). In the Alvaro 2011a study, all town hall attendees received a 1‐hour expert presentation before exposure to the immediate or delayed registration conditions. Alvaro 2011b focused on the effects of an awareness campaign (a manned organ donation information booth) that promoted an immediate and complete opportunity to register in a Spanish‐dominant Hispanic population. The authors reported that the intervention was more effective compared to control in both studies. However, our combined results showed that the CI was wide and imprecise (Analysis 7.1 (2 studies, 314 participants): RR: 2.24, 95% CI: 0.76 to 6.60; I² = 90%).

7.1. Analysis.

7.1

Comparison 7: Immediate versus delayed registration opportunity, Outcome 1: Signed donor cards or forms

Culturally‐sensitive  (2 studies)

Project ACTS I 2010 recruited 425 participants to compare the effects of delivering a Project ACTS (About Choices in Transplantation and Sharing) health package to a control health package (i.e. pamphlets and videotapes on health topics that are currently available to participants) to churches. The Project ACTS health package (intervention group) was tailored to the African‐American community and featured a video, educational pamphlet, donor card and other promotional items (e.g. pendants, pens). They found that participants in the intervention group were more likely to have discussed organ donation with family members compared to the control group (OR 1.64, P = 0.04). However, they reported no significant effect of intervention in terms of donor designation status on a donor card or driver’s license.

Project ACTS II 2013 recruited 585 participants from the community to test the effects of the differences between two intervention packages (Project ACTS I versus Project ACTS II), both including a DVD and educational booklet or pamphlet, as well assessing mode of delivery (reviewing the material in a group setting versus take‐home) on an “expression of donation wishes” (score range from 3 to 15, with a higher score indicating stronger willingness to be recognised as an organ donor). ACTS II was revised to include a new host with a personal connection to donation, a youth’s perspective on donation, a physician’s presence, shortened family discussion and information about living donation. Project ACTS II 2013 reported no difference between intervention package. However, participants in the group‐setting condition (baseline = 7.6, follow‐up = 8.9) had a larger increase in expression of donation wishes from baseline (baseline = 7.6, follow‐up = 8.1) compared to participants in the take‐home condition.

General public setting; message framing (12 studies)

The remaining studies focused on recruiting participants from the general public and did not focus on testing their intervention in a particular setting or target population. Instead, these studies tested a specific strategy such as framing or priming to increase registration/donation intention or actual behaviour. Studies used a variety of methods to recruit participants including shopping centres/town centres (Doherty 2017; Doyle 2019a; O'Carroll 2011a; O'Carroll 2011b), university campuses (Doyle 2019a; O'Carroll 2017a), local workplaces (O'Carroll 2017a) and/or online methods (Blazek 2018Doyle 2019bHyde 2013O'Carroll 2017a; O'Carroll 2017bO'Carroll 2019Sallis 2018; Siegel 2016). 

Omitting affective attitude questions (3 studies)

Three studies (Doherty 2017; Doyle 2019a; Doyle 2019b) used similar methods to test the effects of including or removing certain questions that may influence a person’s attitude about organ donation on their intention to register as organ donors (measured on a 7‐point scale). All three studies adopted a 3‐arm RCT design with participants completing either a full questionnaire (Group 1, control), a questionnaire omitting affective attitude items (Group 2) or a questionnaire omitting negatively worded affective attitude items (Group 3). A combined analysis revealed that omitting negatively worded affective attitude items (Group 3) versus control (Group 1) probably did not increase intention to donate across studies (Analysis 10.1 (3 studies, 1306 participants): MD 0.09, 95% CI ‐0.23 to 0.40, I² = 65%). In two of the studies (Doherty 2017; Doyle 2019a), the authors also measured the number of participants who accepted a donor card upon completing the study questionnaires. A combined analysis revealed that there was probably little or no difference between omitting negatively worded affective attitude items (Group 3) and control (Group 1) groups (Analysis 10.2 (2 studies, 896 participants): RR 1.12, 95 % CI 0.99 to 1.26, I² = 0%).

10.1. Analysis.

10.1

Comparison 10: Omitting affective attitude questions versus control, Outcome 1: Intention to register

10.2. Analysis.

10.2

Comparison 10: Omitting affective attitude questions versus control, Outcome 2: Accepting donor card

Anticipated regret (3 studies)

Three studies by O’Carroll and colleagues (O'Carroll 2011a; O'Carroll 2011b; INORDAR 2012) tested whether simply asking people to rate the extent to which they anticipate feeling regret for not registering as a deceased organ donor increased their intention to register (O'Carroll 2011a; O'Carroll 2011b) or actual registration rates (INORDAR 2012). The intervention consisted of participants completing two additional questions about anticipated regret on a questionnaire. The findings from O'Carroll 2011a and O'Carroll 2011b revealed that non‐donor participants exposed to the anticipated regret condition may have higher intention to register scores compared to control (Analysis 8.1 (2 studies, 284 participants): MD 0.73, 95% CI 0.16 to 1.30, I² = 39%). However in a subsequent study, INORDAR 2012 found that participants allocated to the anticipated regret condition (104/2308; 4.5%) were less likely to register compared to the control group (149/2330; 6.4%) (Analysis 8.2; 1 study, 4638 participants): RR 0.70, 95% CI 0.55 to 0.90). Of note, the authors stressed that there may be other factors, such as exposure to negative items in the intervention group, that may have caused the lower registration rate, and that the “findings do not indicate that anticipated regret interventions are likely to be unsuccessful”.

8.1. Analysis.

8.1

Comparison 8: Anticipated regret versus control, Outcome 1: Intention to register

8.2. Analysis.

8.2

Comparison 8: Anticipated regret versus control, Outcome 2: Verified registration

Reciprocity prime (3 studies)

Three further studies by O’Carroll and colleagues (O'Carroll 2017a; O'Carroll 2017b and O'Carroll 2019) decided to test whether a different type of priming, this time focusing on reciprocity, could increase organ donation intentions and behaviour among non‐donors. The reciprocity prime consisted of a single statement ("I would accept an organ from a deceased donor in order to save my own life") and was compared to a neutral filler statement (control). In all three studies, the reciprocity prime condition was probably more effective in increasing intention to donate for organ donation versus control (Analysis 9.1; 3 studies, 1078 participants): MD 0.51, 95% CI 0.27 to 0.74, I² = 28%). However, no group differences were found among those taking an organ donation information leaflet or clicking a link to register for donation which were included as proxy measures of registration behaviour (O'Carroll 2017b; O'Carroll 2019).

9.1. Analysis.

9.1

Comparison 9: Reciprocity prime versus control, Outcome 1: Intention to donate

Sallis 2018 conducted a large pragmatic online study comparing the effects of seven different messaging strategies (social norms, social norms plus logo, social norms plus image, loss frame, gain frame, reciprocity, and cognitive dissonance) with control on completed donor sign‐ups (i.e. study did not differentiate whether sign‐ups included new registrations or people who sign up more than once). In the most effective arm, Sallis 2018 reported that reciprocity prime was more likely than control to sign up for donor registration (Analysis 9.2; 1 study, 271,574 participants): RR 1.37, 95% CI 1.31 to 1.43). When intervention groups were combined versus control, a similar effect size was found (RR 1.23, 95% CI 1.19 to 1.28).

9.2. Analysis.

9.2

Comparison 9: Reciprocity prime versus control, Outcome 2: Verified registration

Positive versus negative affect (1 study)

Blazek 2018 conducted a study to examine the effects of “positive” affect compared to “negative” affect by randomising participants to either a positive or negative affect autobiographical recall task. Blazek 2018 reported no significant difference between the conditions in increasing registration intention, however, the positive affect condition did increase positive attitudes towards organ donor registration (MD 2.07, 95% CI 1.83 to 2.31).

Motivational/volitional (1 study)

Hyde 2013 compared the effects of 1) motivational intervention (strengthening the intention to register by attitudes, subjective norms, control, moral norms, and identity) 2) volitional intervention (strengthening the intention to register by using action and coping plans), 3) a combined motivational and volitional intervention, and 4) a control condition. Hyde 2013 found that a combined condition (41.9%, 13/35) had a higher self‐reported registration rate compared to the combination of all other conditions (17.6%, 19/108).

Recalling DMV experience (1 study)

Siegel 2016 recruited 163 online participants and reported that reading about a person’s frustrating DMV experience and then recalling a frustrating DMV experience will result in a significantly lower intention to register (measured on a 100‐point scale) (mean = 39.3, SD = 33.9) when compared to not recalling a negative experience (control group; mean = 50.0, SD = 29.4).

Discussion

Summary of main results

This review summarises 46 RCTs of interventions to increase registration for organ donation from a wide variety of settings. The most common settings in which interventions were delivered was in schools to target adolescents. Other settings included DMV centres, mail‐out campaigns and primary care. A number of studies were also delivered in local community settings targeting specific ethnic groups (e.g. African‐American, Hispanic populations). Interventions were highly varied in terms of their content and included strategies such as educational sessions and videos, leveraging peer leaders, staff training, message framing, and priming. Many interventions were single session and reporting of the intervention strategies (i.e. ‘active ingredients’) being tested was often poor. Just 40% of studies measured actual registration whilst the rest measured intention to register/donate. Risks of bias among studies were often rated as unclear or high. Incomplete outcome data reporting meant that a 25% of studies could not be synthesised for meta‐analysis.

Our meta‐analysis revealed that organ donation registration interventions may improve the intention to register/donate and actual registration, with medium to high heterogeneity, respectively. There was some evidence that leveraging peer‐leaders in the community to deliver organ donation education may improve registration rates and classroom‐based education from credible individuals (i.e. members of the transplant community) may improve intention to register/donate, however, there is no clear evidence favouring any particular approach. There was mixed evidence for simple, low intensity interventions utilising message framing and priming, however, it is likely that interest in these methods will persist due to their reach and scalability which may appeal to program planners aiming to maximise the number of registrants at the lowest cost.

There is a need for further research in this area and for better reporting of trial data. Most studies did not include a measure of actual registration, rather the willingness or intention to donate. Whilst it is important to target individual’s intention to donate (Li 2015), there is a pressing need to find ways to translate good intentions into action, termed the ‘intention‐behaviour gap’ (Sheeran 2002), to fill organ donation registries. As such, future studies should explore this space to identify strategies to encourage individuals who are inclined to donate but have not yet registered.

Overall completeness and applicability of evidence

The data on the most effective intervention remains incomplete. This review summaries a body of research that varied considerably in the design, setting, content and to an extent, the definition of donor registration. As such, there remain many further questions regarding the optimal content, mode of delivery and setting of interventions to increase donor registration. For stakeholders seeking guidance on which strategies may work best in their particular jurisdiction/setting, the situation remains unclear. There was some evidence that complex interventions leveraging credible (e.g. members of the transplant community) or trusted (e.g. peer‐leaders in the community) individuals to provide information about organ donation may increase registration intention and behaviour, respectively, however, further testing is required.

Although cost‐effectiveness was not a focus of this review, only a few studies reported the costs involved with implementation or development of their interventions, which could be useful for program planners when selecting which intervention to adopt (Degenholtz 2015; Quick 2012; Quick 2015; Quinn 2006). For example, Quick 2012 reported the production and mailing cost as well as total cost for their trial, and reported that their total cost per registration was 8.21USD per registrant. Many of the included studies in our review adopted multi‐arm designs and undertook head‐to‐head comparisons of interventions, which would have been conducive to some sort of cost‐based analysis.

Quality of the evidence

The strength of this review is that we focused on RCTs and emphasised verified donor registrations. That being said, the certainty of evidence detailed in the Summary of Findings tables was rated as ‘low’ due to studies having high or unclear risk of bias, substantial heterogeneity and risk of publication bias. Specifically, many of the studies included in this review were judged to be at high or unclear risk of bias for random sequence generation and allocation concealment, often due to inadequate reporting.

Potential biases in the review process

This review has some limitations which may have affected bias. First, there was considerable heterogeneity among interventions and comparisons, which limited our ability to synthesise our findings and explore whether certain strategies were more effective than others. Second, data incompleteness was an issue and prevented data from 25% of studies being included in the meta‐analysis. This was particularly an issue among the studies measuring intention to register/donate that did not report key data needed for pooled analysis (e.g. sample sizes, means, SDs). Third, many studies differed on their definition of “registration for organ donation”. Some studies asked participants if they were willing to consent to organ donation or if they were intending to be organ donors. This is an important distinction because while some individual may be willing to be organ donors, there may be other barriers to registering for organ donation such as the fear of putting their name in a large database (Siegel 2005). Fourth, it is possible that there was publication bias in the studies we considered for this review, as many of them reported positive findings for their intervention. The results of the funnel plots suggest publication bias for the effects of donor registration on mean change in registration intention (Figure 4) and registration behaviour (yes/no) (Figure 5) while the results of the funnel plot for registration intention (intend to register/do not intend to register) suggest no publication bias (Figure 6.) Finally, 80% of the studies were conducted in three countries – the USA, UK, and Netherlands – therefore generalisability to other countries may be problematic.

4.

4

5.

5

6.

6

Agreements and disagreements with other studies or reviews

We found other reviews in which their findings or topic overlap with this review (Golding 2017; Jones 2017; Li 2013a; Li 2015). Broadly, our review agrees with other reviews that implementing an intervention to increase donor registration is more effective compared to no intervention. However, it remains unclear what particular strategy or setting is more effective. Li 2015 reported that anticipated regret was effective at improving the community willingness to be a deceased donor, but their review was published prior to the larger, subsequent study by INORDAR 2012 which found that anticipated regret was less effective in registering for organ donation compared to control. Our review agrees with Golding 2017 that targeting DMV offices may be an effective method of increasing registration by accessing large parts of population. Our review agrees with Jones 2017 and Li 2013a that additional higher quality studies are needed before firm conclusions can be made regarding whether primary care office or school‐based interventions can increase organ donation registration, , given that there may be unique implementation barriers in these particular settings.

Authors' conclusions

Implications for practice.

There is currently insufficient evidence to determine the best strategy to increase donor registration. The interventions varied considerably in terms of content, complexity and intensity which has time, cost and resource implications for stakeholders. There was some evidence that complex interventions leveraging credible (e.g. members of the transplant community) or trusted (e.g. peer‐leaders in the community) individuals to provide information about organ donation may increase registration intention and behaviour, respectively. As such, stakeholders should consider identifying credible and or trusted individuals in their jurisdiction/setting to deliver interventions to increase organ donation registration. There was mixed evidence for simple, low intensity interventions utilising message framing and priming, however, it is likely that interest in these methods will persist due to their affordability, reach and scalability. It may be that a trade‐off in acceptable sizes of effect are necessary if such interventions can be delivered cheaply and at the population level.

Implications for research.

Our review provides an up‐to‐date summary of evidence for randomised studies of interventions to increase organ donor registration. Despite identifying 46 studies, we conclude that further studies are warranted. There were no reports of adverse events among studies, meaning that further work in the area is acceptable. There was considerable methodological heterogeneity in terms of the design, setting and content which made pooling effects for meta‐analysis somewhat difficult. Authors should consider better data reporting in line with the Template for Intervention Description and Replication (TIDiER) (Hoffmann 2014) because incomplete outcome data reporting meant that a quarter of studies could not be synthesised for meta‐analysis. Moreover, we recommend that studies use appropriate reporting tools to better describe their intervention to help identify the 'active ingredients' that are being tested to foster a more cumulative evidence base. In addition, we recommend the testing of specific behaviour change techniques to increase donation registration as opposed to only focusing on testing the setting of delivery and source of delivery. We also recommend that future studies should focus on verified donor registration rather than or in addition to intention to register. There is potential for the interplay between intention and actual registration behaviour to be explored and to leverage strategies that facilitate translating intention into action.

History

Protocol first published: Issue 11, 2013
Review first published: Issue 3, 2021

Acknowledgements

The authors are grateful to the following peer reviewers for their time and comments: James Neuberger (Liver Unit, Queen Elizabeth Hospital, Birmingham, UK); Laura A Siminoff, PhD (Temple University College of Public Health, Philadelphia, PA USA), and also to the one peer reviewer who wishes to remain anonymous.

Dr. Li was supported by a Kidney Foundation Scholarship, CIHR Doctoral Scholarship and a CIHR Fellowship Scholarship. Dr. Naylor was supported by Osteoporosis Canada’s Canadian Multicentre Osteoporosis Study (CaMos) Fellowship and a CIHR Fellowship Scholarship.

Appendices

Appendix 1. Electronic search strategies

Database Search terms
CENTRAL
  1. MeSH descriptor: [Tissue and Organ Procurement] this term only

  2. ((tissue or organ or organs) next donor*):ti,ab,kw

  3. ((tissue or organ or organs) near donat*):ti,ab,kw

  4. (deceased next donor*):ti,ab,kw

  5. {or #1‐#4}

  6. (register or registers):ti,ab,kw

  7. (registry or registries):ti,ab,kw

  8. registrant*:ti,ab,kw

  9. registration:ti,ab,kw

  10. "Attitude to health":kw

  11. ((willingness or intention or opinion or opinions or attitude*) near (donat* or donor*)):ti,ab

  12. (donor designation):ti,ab,kw

  13. {or #6‐#12}

  14. {and #5, #13}

MEDLINE
  1. Tissue Donors/

  2. "Tissue and Organ Procurement"/

  3. Organ Transplantation/

  4. (organ donor* or tissue donor*).tw.

  5. ((organ or organs or tissue) adj3 donat*).tw.

  6. deceased donor*.tw.

  7. or/1‐6

  8. Registries/

  9. (register or registers).tw.

  10. (registry or registries).tw.

  11. registrant*.tw.

  12. registration.tw.

  13. "Attitude to Health"/

  14. ((willingness or intention or opinion or opinions or attitude*) adj10 (donat* or donor*)).tw.

  15. donor designation.tw.

  16. or/8‐15

  17. and/7,16

EMBASE
  1. organ donor/

  2. directed tissue donation/

  3. organ transplantation/

  4. (organ donor* or tissue donor*).tw.

  5. ((organ or organs or tissue) adj3 donat*).tw.

  6. deceased donor*.tw.

  7. or/1‐6

  8. registry/

  9. registration/

  10. (register or registers).tw.

  11. (registry or registries).tw.

  12. registrant*.tw.

  13. registration.tw.

  14. "attitude to health"/

  15. ((willingness or intention or opinion or opinions or attitude*) adj10 (donat* or donor*)).tw.

  16. donor designation.tw.

  17. or/8‐16

  18. and/7,17

CINAHL
  1. (MH "Tissue and Organ Harvesting+")

  2. (MH "Living Donors")

  3. (MH "Organ Transplantation+")

  4. (MH "Organ Procurement+")

  5. TI organ donor*

  6. AB organ donor*

  7. TI tissue donor*

  8. AB tissue donor*

  9. TI deceased donor*

  10. AB deceased donor*

  11. (MH "Organ Procurement+")

  12. OR/1‐11

  13. (MM "Organ Donor Cards")

  14. TI register*

  15. AB register*

  16. TI registry

  17. AB registry

  18. TI registries

  19. AB registries

  20. TI registrant*

  21. AB registrant*

  22. TI registration*

  23. AB registration*

  24. (MM "Health Beliefs")

  25. (MM "Attitude to Health")

  26. TI donor designation

  27. AB donor designation

  28. willingness N5 (donor* or donat*)

  29. intention N5 (donor* or donat*)

  30. attitude N5 (donor* or donat*)

  31. opinion* N5 (donor* or donat*)

  32. OR/13‐31

  33. AND/12,32

Appendix 2. Risk of bias assessment tool

Potential source of bias Assessment criteria
Random sequence generation
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Low risk of bias: Random number table; computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random).
High risk of bias: Sequence generated by odd or even date of birth; date (or day) of admission; sequence generated by hospital or clinic record number; allocation by judgement of the clinician; by preference of the participant; based on the results of a laboratory test or a series of tests; by availability of the intervention.
Unclear: Insufficient information about the sequence generation process to permit judgement.
Allocation concealment
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Low risk of bias: Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study (e.g. central allocation, including telephone, web‐based, and pharmacy‐controlled, randomisation; sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes).
High risk of bias: Using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
Unclear: Randomisation stated but no information on method used is available.
Blinding of participants and personnel
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Low risk of bias: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
High risk of bias: No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding.
Unclear: Insufficient information to permit judgement
Blinding of outcome assessment
Detection bias due to knowledge of the allocated interventions by outcome assessors.
Low risk of bias: No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding; blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
High risk of bias: No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding.
Unclear: Insufficient information to permit judgement
Incomplete outcome data
Attrition bias due to amount, nature or handling of incomplete outcome data.
Low risk of bias: No missing outcome data; reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; missing data have been imputed using appropriate methods.
High risk of bias: Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; ‘as‐treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation; potentially inappropriate application of simple imputation.
Unclear: Insufficient information to permit judgement
Selective reporting
Reporting bias due to selective outcome reporting
Low risk of bias: The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way; the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon).
High risk of bias: Not all of the study’s pre‐specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre‐specified; one or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Unclear: Insufficient information to permit judgement
Other bias
Bias due to problems not covered elsewhere in the table
Low risk of bias: The study appears to be free of other sources of bias.
High risk of bias: Had a potential source of bias related to the specific study design used; stopped early due to some data‐dependent process (including a formal‐stopping rule); had extreme baseline imbalance; has been claimed to have been fraudulent; had some other problem.
Unclear: Insufficient information to assess whether an important risk of bias exists; insufficient rationale or evidence that an identified problem will introduce bias.

Data and analyses

Comparison 1. Registration behaviour: dichotomous.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1.1 Registration behaviour: ICC adjusted (dichotomous) 16 1.294065E6 Risk Ratio (M‐H, Random, 95% CI) 1.30 [1.19, 1.43]
1.2 Registration behaviour (dichotomous): primary care setting (ICC adjusted) 3 3829 Risk Ratio (M‐H, Random, 95% CI) 1.13 [0.79, 1.61]
1.3 Registration behaviour (dichotomous): community setting (ICC adjusted) 5 4186 Risk Ratio (M‐H, Random, 95% CI) 2.14 [1.35, 3.40]

Comparison 2. Registration intention: dichotomous.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
2.1 Registration intention: ICC adjusted (dichotomous) 10 10838 Risk Ratio (M‐H, Random, 95% CI) 1.21 [1.03, 1.42]
2.2 Registration intention (dichotomous): school setting (ICC adjusted) 6 6272 Risk Ratio (M‐H, Random, 95% CI) 1.34 [1.27, 1.42]

Comparison 3. Registration intention: continuous.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
3.1 Registration intention: ICC adjusted (continuous) 9 3572 Mean Difference (IV, Random, 95% CI) 0.38 [0.18, 0.59]

Comparison 4. Lecture with member of transplant community versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
4.1 Intention to register 3 675 Risk Ratio (M‐H, Random, 95% CI) 1.33 [1.15, 1.55]

Comparison 5. Lecture with video versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
5.1 Self‐reported registration 3 3493 Risk Ratio (M‐H, Random, 95% CI) 1.26 [1.08, 1.46]

Comparison 6. Leveraging peer leaders versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
6.1 Verified registration 3 3819 Risk Ratio (M‐H, Random, 95% CI) 2.09 [1.08, 4.06]

Comparison 7. Immediate versus delayed registration opportunity.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
7.1 Signed donor cards or forms 2 314 Risk Ratio (M‐H, Random, 95% CI) 2.24 [0.76, 6.60]

Comparison 8. Anticipated regret versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
8.1 Intention to register 2 284 Mean Difference (IV, Random, 95% CI) 0.73 [0.16, 1.30]
8.2 Verified registration 1 4638 Risk Ratio (M‐H, Random, 95% CI) 0.70 [0.55, 0.90]

Comparison 9. Reciprocity prime versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
9.1 Intention to donate 3 1078 Mean Difference (IV, Random, 95% CI) 0.51 [0.27, 0.74]
9.2 Verified registration 1 271574 Risk Ratio (M‐H, Random, 95% CI) 1.37 [1.31, 1.43]

Comparison 10. Omitting affective attitude questions versus control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
10.1 Intention to register 3 1306 Mean Difference (IV, Random, 95% CI) 0.09 [‐0.23, 0.40]
10.2 Accepting donor card 2 896 Risk Ratio (M‐H, Random, 95% CI) 1.12 [0.99, 1.26]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Alarcon 2008.

Study characteristics
Methods Study design: cluster‐RCT with a pre/post‐test (two arms)
Study duration: not reported
Study follow‐up period: not reported
Participants Country: Spain
Setting: Classroom
Number: treatment group (109); control group (48)
Mean age ± SD (years): 15.36 ± 0.72 (mean age was calculated for the entire sample, not by group)
Sex (M/F): Treatment group (56/53); control group (20/28)
Interventions Intervention group
The intervention consisted of 4 sessions. In session 1, students were given a pretest and had a discussion about previous awareness regarding organ donation. In session 2, students viewed the video "Seeing to Donate." In addition, students debated their values and attitudes, and discussed awareness of attitudes in the family setting. In session 3, students talked about the results of the home discussion, and the researcher and transplant coordinator gave an explanation of the donation‐extraction‐transplant process in Malaga. In addition, a young undergraduate on the kidney transplant waiting list gave a testimony. Finally, in session 4, students designed a slogan as a group, and received the post‐test
Control group
No description given
Outcomes Primary outcome
Intention to donate own organs (measured via self‐completed questionnaire)
  • Intervention group: (91/109) 83.5% stated they would donate their own organs

  • Control group: (27/48) 56.3% stated they would donate their own organs


Adverse events were reported
Other outcomes
Awareness about donation‐extraction‐transplant process (percent of participants reporting having none, low, high, and very high level of information)
  • Intervention group: 0%, 3.4%, 72.5%, 23.9%

  • Control group: 18.7%, 50%, 29.2%, 2.1%n


Intention to donate organs from relatives:
  • Intervention group: 77.1% stated they would donate a relative's organs

  • Control group: 50% stated they would donate a relative's organs


Family discussion
  • Intervention group: 78.9% stated they had spoken about the subject in the time between pretest and post‐test

  • Control group: 20.8% stated they had spoken about the subject in the time between pre and post‐test

Notes Funding source: not reported
Study author contact: blamen@uma.es (Prof Maria Jose Blanca)
Classes were randomly divided into a control or intervention group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about randomisation scheme
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation method
Blinding of participants and personnel (performance bias)
All outcomes High risk Insufficient detail about whether there was blinding of participants/personnel. Seems likely that participants may be aware of class allocation and thus, there may be a risk of performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient detail about handling of incomplete outcome data
Selective reporting (reporting bias) High risk Important detail re: numerator/denominator/confidence intervals/P values missing
Other bias Unclear risk Contamination can be an issue with classroom education and authors did not discuss this issue

Alvaro 2011a.

Study characteristics
Methods Study design: cluster‐RCT
Study duration: not reported
Study follow‐up period: not reported
Participants Country: USA (Chicago, Phoenix, Miami)
Setting: "Town halls" (churches in Chicago, universities in Phoenix, local organisations in Miami)
Number: not reported; ranged from 15‐59 participants at each town hall
Mean age (years)
  • Chicago: intervention group (51.7); control group (47.5)

  • Phoenix: intervention group (32.4); control group (22.0)

  • Miami: intervention group (43.5); control group (56.2)


Sex (% female)
  • Chicago: intervention group (64.5%); control group (73.0%)

  • Phoenix: intervention group (64.1%; control group (61.0%)

  • Miami: intervention group (69.4%); control group (78.7%)

Interventions Two “town halls” were implemented in each city. Donor registration forms were provided to participants following a 1‐hour presentation by an organ donor expert panel (e.g. donor recipient, donor family member, an OPO health educator, and a physician/clinician). Following the presentation and approximately 15 minutes before the completion of the meeting, surveys and donor registration forms were distributed among audience members. Town halls within each of the three cities were randomly assigned to either an intervention (immediacy condition) or control group (non‐immediacy condition)
Intervention (immediacy condition)
  • Participants were told to complete the donor registration forms and drop them, along with the survey in a collection box prior to leaving the meeting


Control (non‐immediacy condition)
  • Participants were given a self‐addressed stamped envelope before leaving and asked to mail in their donor registration forms on their own time

Outcomes Primary outcome
Completed and submitted an organ donation registration form
  • Intervention group: 42/104 registered

  • Control group: 11/107 registered


No adverse events were reported
Notes Study author contact: Eusebio.Alvaro@cgu.edu
Registration rates varied across the cities. In Chicago, Phoenix and Miami saw participants register in the intervention group at a rate of 27%, 67% and 41% respectively. None of the participants from the control group in both Chicago and Phoenix completed and submitted a donor registration form. In Miami, 23.4% of those in the control group mailed in a completed donor registration form
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about randomisation scheme
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation method
Blinding of participants and personnel (performance bias)
All outcomes Low risk Insufficient detail about blinding however, blinding of personnel unlikely to affect outcome
Blinding of outcome assessment (detection bias)
All outcomes Low risk Registration in a donor registry is unlikely to be affected by detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Minimal loss to follow up
Selective reporting (reporting bias) Low risk Outcome measures reported
Other bias High risk Each site could recruit their own participants

Alvaro 2011b.

Study characteristics
Methods Study design: cluster‐RCT
Study duration: 8 weekends, beginning in Spring 2009
Study follow‐up period: not reported
Participants Country: USA (Arizona)
Setting: Flea market
Number: intervention group (87); control group (69)
Mean age ± SD (years): not reported
Sex: not reported
Interventions An organ donation information booth featuring Arizona Organ Donor Registry brochures and registration forms, along with two field workers associated with the Donor Network of Arizona, were present for eight weekends consecutively at the flea market. The workers were made available to answer any questions related to the registration process in Arizona, explaining the nature of the process, and offering visitors the opportunity to complete a registration form on the spot. Intervention versus control weekends order was determined using a coin flip method
Intervention group (immediacy)
  • During intervention weekends banners featuring either the phrase “Register Here!” or “Register Now!”were displayed to visitors


Control group (non‐immediacy)
  • During control weekends banners featuring the phrase “Done Vida!” were displayed to visitors

Outcomes Primary outcome
Completed paper registry forms on‐site by the flea market attendees (participants)
  • Intervention group: 67/87 (86%) participants registered

  • Control group: 37/69 (54%) participants registered


No adverse events were reported
Notes Study author contact: Eusebio.Alvaro@cgu.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Authors used coin flip to determine randomisation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation method
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Registration in a donor registry is unlikely to be affected by detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Minimal loss to follow up
Selective reporting (reporting bias) Low risk Outcome measures reported
Other bias High risk Each site could recruit their own participants

Andrews 2012.

Study characteristics
Methods Study design: cluster RCT with a pre/post‐test (two arms)
Study duration: June 2008 to March 2009
Study follow‐up period: not reported
Participants Country: USA
Setting: Churches (22 sites)
Number: intervention group (622); control group (632)
Mean age (years): intervention group (50.30); control group (50.18)
Sex (% female): intervention group (70.53%); control group (70.63%)
Interventions Churches were assigned to either an intervention or control. Researchers provided a 4‐hour long training session to 100 peer leaders from the 22 churches
Intervention group
  • Peer‐led motivational discussion on organ donation plus a video viewing. Peer leaders received training on how to complete informed consent documents and administer baseline questionnaires, overview of study design, program components and expectations, basic information about diabetes, hypertension, chronic kidney disease, nutrition. The 32‐minute video "living on through love" featured a local African American donor family, organ recipients, nephrologist, transplant surgeon and pastor. Participants were also provided information on the different religious views on organ donation


Control group
  • Received only information on how to complete consent documents, administer baseline questionnaires and overview of study design, program components and expectations. Additionally received content on a fruit and vegetable program

Outcomes Primary outcome
Verified registration in state's donor registry. Outcome was provided by State Organ procurement agency
Study was only able to reach 923/1254 (74%) participants at the 12‐month follow‐up period. The intervention group had 622 participants and the control group had 632 participants who completed the baseline questionnaire, where a total of 211 registrations from participating churches were verified
  • Intervention group: 163/622 registered

  • Control group: 48/632 registered


Intention to donate (mean score from 1 to 10) among those not registered at post‐test were 5.8/10 in intervention group compared to 5.2/10 in control group (P = 0.38)
Notes Funding source: Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation
Study author contact: Ann M. Andrews (aandrews@nkfm.org)
Churches were pair‐matched by average income and size prior to randomisation
*Study authors noted that only 192/211 of the registrants completed the baseline questionnaire
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about randomisation scheme
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation method
Blinding of participants and personnel (performance bias)
All outcomes High risk Insufficient detail about whether there was blinding of participants/personnel. Seems likely that participants may be aware of class allocation and thus, there may be a risk of performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Verified registration in donor registry not affected by blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk 26% of baseline participants did not provide follow‐up questionnaire. Authors reported no difference from those that dropped out of the study to those who completed follow‐up
Selective reporting (reporting bias) Low risk Outcome measures reported
Other bias High risk Baseline groups not equal. For verified registrations, most did not complete a baseline questionnaire

Bidigare 2000.

Study characteristics
Methods Study design: quasi‐RCT with a pre/post‐test (2 arms)
Study duration: not reported
Study follow‐up period: not reported
Participants Country: USA
Setting: Family physician office
Number: intervention group (40); control group (125)
Mean age: not reported(all participants were 18 years of age or older)
Sex: not reported
Interventions Patients being seen were assigned to one of two intervention groups (every 4th patient was assigned to the experimental group). Patients completed a baseline questionnaire at the time of visit, and then received a pamphlet (the pamphlet answered commonly asked questions regarding organ donation) and an organ donation sticker. After the visit, patients were given the second questionnaire regarding their decision to commit to organ donation, what was their decision, and whether they discussed this choice with family members
Intervention group
  • Received informational material + brief word of encouragement from treating physician


Control group
  • Received informational material only

Outcomes Primary outcome
Self‐reported commitment to organ donation registration (yes/no). The authors report between‐group comparisons for 165 participants: intervention group (40); control group (125)
  • Intervention group: 12/40 (30%) self‐reported making the decision to donate after the intervention

  • Control group: 53/125 (42%) self‐reported making the decision to donate after the intervention


Secondary outcome
Knowledge scores regarding organ donation (scores for the knowledge variables were summed for pretest and post‐test, with a total of 10 questions. A significant increase in knowledge regarding organ donation was found between pretest and post‐test (7.9 and 9.2, P < 0.01)
No adverse effects were reported
Notes Funding source: not reported
Study author contact: Susan Bidigare (sbidigar@med.wayne.edu)
Denominator/numerator for intervention and control group were not reported
Every 4th patient assigned to intervention (informational material + brief word of encouragement from treating physician)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Non‐random component in the sequence generation process ("every 4th patient assigned to intervention")
Allocation concealment (selection bias) High risk Physician could potentially foresee allocation assignment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about whether there was blinding of participants/personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient detail about missing data or lost to follow up
Selective reporting (reporting bias) High risk Outcomes of interest not reported completely (proportions only)
Other bias High risk Study did not report baseline differences

Blazek 2018.

Study characteristics
Methods Study design: RCT
Study duration: not reported
Study follow‐up: not reported
Participants Country: USA
Setting: online (Amazon's MTurk)
Number: positive affect (261); negative affect (242)
*statistics regarding age and sex were only provided for the entire cohort (503)
Mean age ± SD: 33.59 ± 11.31 years
Sex (% female): 42%
Interventions Participants were randomly assigned to either a positive or negative affect condition, involving an autobiographical recall task. Participants were asked to recall a time when they felt positive or negative (the task did not mention any specific emotions). Participants then completed the post‐test questionnaire
Positive affect condition
  • Participants were asked to recall a time when they felt particularly positive


Negative affect condition
  • Participants were asked to recall a time when they felt particularly negative

Outcomes Those in the positive affect condition reported significantly higher scores on the general positive affect scale
Primaryoutcome
Attitudes towards organ donation registration, registration intention
  • Attitudes (measured on 7‐point scale): 4.31 positive affect versus 4.01 negative affect, there was a significant difference between the positive and negative affect conditions in attitudes towards organ donor registration

  • Intention to register (7‐point scale): 3.80 positive affect versus 3.83 negative affect, no significant difference was found between positive and negative affective conditions


Secondary outcome
Registration behaviour proxy (question: would you like to register as a donor?) Authors reported no significant effect of affect condition on registration behaviour was found. (B = ‐0.14, SE = 0.34, Wald v2 (1) = 0.16, P = 0.690)
Notes Funding source: grant number R39OT26990
Contact: Danielle Blazek, danielle.blazek@cgu.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Low risk Insufficient detail about allocation concealment but study was administered via Amazon mTurk and participants unlikely affected by selection bias
Blinding of participants and personnel (performance bias)
All outcomes Low risk Online nature of study unlikely to affect performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcomes measured via self‐reported questionnaire
Incomplete outcome data (attrition bias)
All outcomes Low risk Study states "no cases of missing data were identified"
Selective reporting (reporting bias) Low risk All data appear to be fully reported
Other bias Low risk No other major biases

Cardenas 2010.

Study characteristics
Methods Study design: cluster‐RCT with pre/post‐test (two arms)
Study duration: not reported
Study follow‐up period: not reported
Participants Country: USA
Setting: classroom
Number: intervention group (96); control group (91)
Mean age ± SD (years): intervention group (15.9 ± 1.3); control group (16.6 ± 1.4)
Sex (% males): intervention group (62.5%); control group (67.0%)
Interventions All students received a baseline questionnaire and then within two weeks, the classes were assigned to either an experimental or a control group
Intervention group
  • A single 40‐minute classroom session moderated by an African American or Asian American representative from a local community health agency. A transplant surgeon delivered current medical information and a 10‐minute video featuring ethnically‐diverse teenagers discussing organ donation and a Q/A period. Completed the second questionnaire AFTER receiving the education session


Control group
  • No intervention. Students completed the second questionnaire BEFORE receiving the educational session

Outcomes Primary outcome
Willingness to donate organ
Intervention group had 78 participants and control group had 75 participants; 153 pairs of completed questionnaires (completed and responded to opinion question on baseline and second questionnaire completed)
  • Intervention group: 31% (24/78) of experimental participants changed their opinions in a positive direction, 14% (11/78) in a negative direction and 55% (43/78) remained unchanged

  • Control group: 7% (5/75) changed opinions positively, 8% (6/75) negatively and 85% (64/75) were without change


OR of 7.14 positive change in willingness to donate (P < 0.0001) Referent = intervention
OR of 2.272 moving down the willingness scale (P = 0.065) Referent = intervention
Adverse events: more participants in the intervention group changed their attitudes in a negative direction, (14% versus 8%)
Notes Funding source: National Institute of Allergy and Infectious Disease grant R18AI40674
Study author contact: Margaret D. Allen (mallen@benaroyaresearch.org)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation conducted by a coin toss
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation method
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants in both groups aware that they will receive an educational session, thus unlikely that they were aware of group allocation
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias.
Incomplete outcome data (attrition bias)
All outcomes Low risk No students were excluded and limited missing data.
Selective reporting (reporting bias) Low risk Appropriate outcomes measured
Other bias High risk Baseline groups not similar; different in age, and ethnicity (more Europeans in control group).

Chien 2015.

Study characteristics
Methods Study design: factorial RCT; 2 x 2 between‐subjects factorial design (4 arms; loss/gain x exemplar/statistical message)
Study duration: not reported
Study follow‐up period: not reported
Participants Country: Taiwan
Setting: classroom
Number: 189 college students (authors did not specify how many in each of the 4 groups)
Mean age ± SD: 21.6 ± 2.9 years
Sex (M/F): 81/108
Interventions Participants completed a baseline questionnaire on demographic characteristics. After completion, participants were randomly assigned to read 1 of 4 versions of an organ donation promotional message (messages contained in Table 1)
Statistical messages emphasised numbers, while exemplar messages depicted an individual's story. Gain‐framed messages conveyed that patients would survive due to organ donation, while loss‐framed messages conveyed that patients would die if organs were not available. Final questionnaire answered after reading of the respective message
Group 1
  • Gain‐statistical message


Group 2
  • Loss‐statistical message


Group 3
  • Gain‐exemplar message


Group 4
  • Loss‐exemplar message

Outcomes Primary outcome
Intention to register as an organ donor, intention to discuss decision with relevant individuals. Both items were rated on a scale 7 point scale (strongly disagree to strongly agree), and the ratings of the 2 items were summed to create an intention scale
  • No significant main effect of gain (4.58 ± 1.00) compared to loss‐framed (4.33 ± 1.19) messages on intention scores

  • Significant main effect of statistical/exemplar messages found (P < 0.05). Participants exposed to exemplar message (4.77 ± 0.89) were significantly more likely to express behavioural intention to become an organ donor, compared to the statistical message (4.15 ± 1.19)

  • Significant interaction between conditions also found. Loss‐exemplar appeal more effective than loss‐statistical appeal (P < 0.01)


No adverse effects were reported in this study
Notes Funding source: financial support provided by the Ministry of Science and Technology of the Republic of China under Project MOST 101‐2410‐H‐003‐045‐MY2
Study author contact: Yu‐Hung Chien (roland.chien@ntnu.edu.tw)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about randomisation scheme
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about whether there was blinding of participants/personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Study completed in a single session so unlikely risk of attrition bias
Selective reporting (reporting bias) Low risk Outcome measures reported
Other bias High risk Did not report baseline differences

Degenholtz 2015.

Study characteristics
Methods Study design: cluster‐RCT
Study duration: July 2009 to December 2011
Study follow‐up period: not reported
Participants Country: USA
Setting: Department of Motor Vehicle (DMV) centres (19 centres)
Number: treatment group (423,786); control group (267,904)
Mean age (years): intervention group (40.60); control group (40.24)
Sex (% female): intervention group (50.20%); control group (50.66%)
Interventions A web‐based training program was delivered to DMV customer service representatives. Development of the intervention was based on a literature review of organ donation issues, with input from staff at four DMV offices in the state (not included in the 19 DMV offices used in the study)
Intervention group
  • Web‐based training system hosted on a dedicated computer away from the front desk area. Training required customer service representatives to click on every link and every page of every screen, and answer 5 multiple choice questions at the end. Customer service representatives had to view every page, every pop‐up, and answer all 5 questions correctly to be considered trained


Control group
  • Received the web‐based training one year after the experimental centres

Outcomes Primary outcome
DMV customers registration as organ donors
Total of 1,042,697/1,118,577 DMV transactions had complete data
  • Intervention group: 7.5% increase in the proportion of customers who registered as organ donors when seen by trained customer service representatives (OR 1.075; 95 CI 1.063 to 1.086)

  • Control group: N/A


No adverse events were reported in this study
Notes Funding source: Grant number R390T10580 from Division of Transplantation, Health Resources and Services Administration, US Department of Health and Human Services
Study author contact: Howard Degenholtz (degen@pitt.edu)
The two groups were made comparable using county population, median household income, and high school graduation rate
Web‐based training was implemented at 10 treatment group centres in April 2010, and at 9 control centres 1 year later (state‐wide phase)
Note: Had a pilot group of 351,007
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation conducted by a coin toss
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Outcome (donor registration) not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Donor registration rates likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Less than 10% missing data
Selective reporting (reporting bias) Low risk All outcome measures reported
Other bias Low risk No other foreseeable biases

Degenholtz 2019.

Study characteristics
Methods Study design: cluster RCT (3‐arm)
Study duration: not reported
Study follow‐up period: 6 months
Participants Country: USA (Western Pennsylvania and Western Virginia)
Setting: primary care clinics
Sample size
  • Distinct local offices (121)

    • In‐person: 47 offices

    • Web‐based: 33 offices

    • Control: 41 offices

  • A total of 1521 clinic staff were trained, and surveys were returned from 66.4% of staff (1011)

    • In‐person: 442

    • Web‐based: 369

    • Control: 200

  • Patients not previously designated (10,007)

    • In‐person: 6245

    • Web‐based: 3183

    • Control: 579


Age (years)
  • Overall: 73.2

  • In‐person: 18 to 64 (72.2%); 65+ (27.8%)

  • Web‐based: 18 to 64 (74.8%); 65+ (25.2%)

  • Control: 18 to 64 (69.3%); 65+ (30.7%)


Sex
  • Overall: 57.7% female

  • In‐person: 57.1% female

  • Web‐based: 58.5% female

  • Control: 61.9% female

Interventions Intervention included a 1‐hour training session (in‐person or web‐based) regarding organ/tissue donation, in addition to the availability of donor designation forms at check‐in that were given to all patients as they check in. Control consisted of a standard brochure only (no training or donor designation forms)
In‐person
  • A trained interventionist delivered a 1‐hour course explaining the organ donation process and implementation of the program in primary care offices. There was an opportunity for interactive discussion and for members of the research team to help front desk staff to set up the donor designation forms


Web‐based
  • Materials were mailed to the office with instructions to access the content online. The online content consisted of the same material that were delivered in‐person, but in a web‐based format. The interventionist contacted office managers within 1 week to check compliance with training. A member of the research team dropped off the donor designation forms and other materials


Intervention
  • Staff at the primary care offices received a 1‐hour training session regarding organ donation, and were also provided with donor designation forms to give to all patients at check‐in


Control
  • Primary care offices received standard organ donation brochures

Outcomes Primary outcome
Actual registration rates as verified by the donor registry
The main outcome was the proportion of patients who had not previously been registered as organ donors that completed the donor designation part of the PSL (Patients Save Lives) form
  • Intervention groups: the intervention groups had a higher rate of previously undesignated patients choosing to designate themselves as organ/tissue donors than the control group. The in‐person arm had a slightly higher rate of new donor designations than the web‐based group (8.6% versus 7.1%; P = 0.011)

    • In‐person: 536/6245 (8.6%)

    • Web‐based: 225/3183 (7.1%)

  • Control group: 0/579 (0%)


Secondary outcomes
Staff self‐report surveys captured staff knowledge and attitudes about organ donation
  • Intervention groups

    • Knowledge: staff in the intervention groups were more informed about organ donation than control. Participants scored 67% in the in‐person group, and 68% in the web‐based group, compared to only 57% correct in the control group (F = 49.46; P < 0.0000)

    • Attitude: More positive attitudes towards organ donation were noted for the in‐person group (4.51), followed by the web‐based group (4.40), followed by the control group (4.28) (F = 13.03; P = 0.00)

  • Control group

    • Knowledge: 57%

    • Attitude: 4.28

Notes Funding source: Grant No. R39OT29881 from the Health Resources and Services Administration’s Division of Transplantation (HRSA/DoT), U.S. Department of Health and Human Services
Study author contact: degen@pitt.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study authors state that physicians were randomised into 1 of 3 study arms
Allocation concealment (selection bias) Unclear risk No information provided regarding allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Based on the nature of the intervention, it is unlikely that the primary care physicians would be unaware of their treatment allocation. Thus, high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Primary outcome was donor designation status. Measurement of this outcome is unlikely to be impacted by bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Organ procurement organisations sent back all donor designation forms to study team. Thus, low risk of attrition bias
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Unclear risk Intervention was a one‐off session, staff data were collected shortly after delivery; 33.6% of staff who were trained did not return the self‐report survey

Dobbels 2009.

Study characteristics
Methods Study design: cluster RCT
Study duration: 5 hours
Study follow‐up period: 1 year
Participants Country: Belgium
Setting: High School
Number: 1328; 6 control schools, 6 intervention schools
Age: +17 years
Sex: not reported
Interventions Intervention consisted of a young patient's witness, letter of a mother of a young donor, targeted information, explanation of the law and information on how one can register for organ donor
Outcomes Primary outcome
Intention to register
  • Authors reported intention to register as a donor increased to 40% in intervention group, while control group remained steady at 25% (RR 1.98, 95% CI: 1.5 to 2.7)

Notes Author contacted back in 2013 and they reported that they have not published. Author followed up in 2019
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information (abstract only)
Allocation concealment (selection bias) Unclear risk Insufficient information (abstract only)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information (abstract only)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information (abstract only)
Selective reporting (reporting bias) High risk Numerator denominator not reported for intention to register
Other bias High risk Only abstract included

Doherty 2017.

Study characteristics
Methods Study design: multi‐arm RCT (3 arms)
Study duration: not reported
Study follow‐up period: not reported
Participants Country: Ireland
Setting: shopping centre
Number: group 1 (113); group 2 (119); group 3 (117)
Mean age ± SD (years): group 1 (40.2 ± 17.8); group 2 (42.8 ± 16.8); group 3 (40.6 ± 17.5)
Sex (% female): group 1 (46.4%); group 2 (44.5%); group 3 (48.7%)
Interventions Participants were randomly assigned to 1 of 3 groups based on a computer generation program. All subjects participated in interviews from research staff
Group 1 (replication group)
  • Participants completed the questionnaire in its entirety


Group 2 (omitting affective attitudes)
  • Participants completed a version of the questionnaire with 16 affective attitude items omitted


Group 3 (omitting negatively‐worded affective attitudes)
  • This group completed the questionnaire, but with 12 negatively‐worded affective attitude items omitted

Outcomes Primary outcome
Intention to donate (Ireland does not have a registry, so participants were asked about their intention to sign up to be a donor).
  • Mean intention scores: group 1 (4.43 ± 1.89); group 2 (4.95 ± 1.64); group 3 (4.88 ± 1.81)

  • Group 2 had a statistically significant higher mean intention score than Group 1. Group 3 had a larger mean intention score to Group 1, but did not reach statistical significance


Secondary outcome
Taking a donor card after the interview
  • Individuals in group 2 were marginally more likely to accept a donor card than Group 1 (OR 1.4, 95% CI 0.94 to 2.07)

  • Group 3 individuals were not more likely to accept a donor card than Group 1 (OR 1.1, 95% CI 0.69 to 1.75)

Notes Funding source: RSCI Summer Research School (grant to two authors)
Study author contact: Sally Doherty (sallydoherty@rcsi.ie)
Defined willingness to donate as meeting any of the following four conditions: 1) carrying a signed donor card 2) indicating donation status on drivers license 3) providing information on an organ donation app; and 4) discussing one's wishes with family members
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants randomly assigned using a computer generation program
Allocation concealment (selection bias) High risk Interviewers were aware of which group the next person they approached was randomised
Blinding of participants and personnel (performance bias)
All outcomes High risk Single‐blinded study. However, likely that lack of blinding of personnel may affect performance bias given that evaluators interviewed the participants
Blinding of outcome assessment (detection bias)
All outcomes High risk Single blinded study. However, intention to register as an outcome may be influenced by lack of blinding since participants were interviewed by evaluators
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session with no loss to follow up
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No other major biases identified

Doyle 2019a.

Study characteristics
Methods Study design: RCT (3‐arm)
Study duration: study start date: February 2016; primary completion date: December 2017, Study completion date: April 2018
Study follow‐up period: no follow‐up
Participants Country: international; Ireland, Malaysia, India (countries that do not have an organ donation registry) & UK (does have a register) sample
Setting: community; participants were recruited in‐person from community (shopping centres, libraries, university campuses)
Sample size: 1007 non‐donors
Mean age ± SD: 34.4 ± 18.1 years
Gender: 54.0% female
Interventions Overview: In India, Ireland, and Malaysia, one of three questionnaires were verbally delivered to participants. Interviewers approached potential participants, and delivered the questionnaire face‐face. Researchers filled in the questionnaires for the participants. In the UK, questionnaires were given to participants to be self‐completed in the library, which were then returned to the researchers.
After provision of a study information leaflet and consenting to participate, participants provided demographic information and then answered 27 questions about organ donation beliefs. Affective attitudes (ick factor; jinx factor; medical mistrust; perceived benefits; bodily integrity). Anticipated regret (2 items). Theory of planned behaviour (cognitive attitudes; perceived behavioural control; subjective norms; dummy items).
Intervention group
  • Omitted affective attitudes: all 16 questions on affective attitudes were deleted, with dummy questions (e.g., about politics) substituted for these deleted questions (as in the INORDAR trial).

  • Omitted negatively‐worded affective attitudes only: omitted 12 negatively‐worded affective attitudes only, which were substituted with the same questions as other intervention group.


Control group
  • No‐intervention replication group: completed the entire questionnaire (similar to the anticipated regret group from INORDAR), replicating methods of O’Carroll et al. 2011)

Outcomes Primary outcome
Self‐reported intention to register as a donor: intention to donate, assessed by 2 items on a 7‐point scale (e.g., “I will definitely sign up for organ donation and discuss this with my family in the next few months”)
  • Intervention groups

    • Omitted affective attitudes: 4.30 ± 1.57) (n = 323)

    • Omitted negatively‐worded affective attitudes only: 4.47 ± 1.56 (n = 343)

    • There were no significant group differences seen in intention to donate

  • Control group

    • No‐intervention replication group: 4.44 ± 1.66 (n = 341)


Secondary outcomes
The secondary outcome (where applicable) was taking a donor card after the interview (study 1; yes/no)
  • Intervention groups

    • Omitted affective attitudes: 51.6%

    • Omitted negatively‐worded affective attitudes only: 48.4%

    • There were no significant group differences seen in those who took a donor card

  • Control group

    • No‐intervention replication group: 46.3%

Notes Funding source: This research was supported by the RCSI Research Summer School and the RCSI Student Selected Component, who had no role in recruitment, data analysis or interpretation.
Study author contact: fdoyle4@rcsi.ie
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were block‐randomised using the ralloc command for Stata 13.0, and Excel sheets with the order of participant recruitment needed was sent to researchers
Allocation concealment (selection bias) High risk Group allocation was centrally and pre‐determined, interviewers were aware of group allocation
Blinding of participants and personnel (performance bias)
All outcomes High risk Study personnel were not blinded to treatment condition, and approached participants themselves and delivered the questionnaire as well. The lack of blinding thus leaves potential for performance bias
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcomes were all reported on a 7‐point Likert scale, and answers were solicited by interviewers who were not blinded to treatment condition. Thus, there is potential for detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Outcome data was unavailable for some participants, but no reasoning is provided for this loss‐to‐follow‐up. There is insufficient information to judge risk of bias
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other bias identified

Doyle 2019b.

Study characteristics
Methods Study design: RCT (3‐arm)
Study duration: digital survey accessible September to October 2017
Study follow‐up period: no follow‐up
Participants Country: UK sample (England and Scotland)
Setting: Online
Participants (aged 18+) from England and Scotland who had never previously donated an organ and were not registered as organ donors were asked to take part in a digital survey
Sample size: 612 non‐donors
Mean age ± SD: 50.4 ± 15.6 years
Sex: 50.3% female
Interventions Overview: participants completed online questionnaires administered by the Qualtrics digital platform. Prompted to answer 27 questions about organ donation beliefs. Affective attitudes ('ick' factor; jinx factor; medical mistrust; perceived benefits; bodily integrity). Anticipated regret (2 items). Theory of planned behaviour (cognitive attitudes; perceived behavioural control; subjective norms; dummy items).
Intervention group
  • Omitted affective attitudes: All 16 questions on affective attitudes were deleted, with dummy questions (e.g. about politics) substituted for these deleted questions (as in the INORDAR trial)

  • Omitted negatively‐worded affective attitudes only: omitted 12 negatively‐worded affective attitudes only, which were substituted with the same questions as other intervention group


Control group
  • No‐intervention replication group: completed the entire questionnaire (similar to anticipated‐regret group from the INORDAR trial by O’Carroll et al. 2011)

Outcomes Primary outcome
Self‐reported intention to register as a donor
Intention to donate, assessed by 2 items on a 7‐point scale (e.g., “I will definitely sign up for organ donation and discuss this with my family in the next few months”)
  • Intervention groups

    • Omitted affective attitudes: 3.19 ± 1.56 (n = 208)

    • Omitted negatively‐worded affective attitudes only: 3.44 ± 1.56) (n = 195)

    • There were no significant group differences seen in intention to donate

  • Control group

    • No‐intervention replication group: 3.13 ± 1.49 (n = 209)


Secondary outcomes
The secondary outcome (where applicable) was asking participants if they would like to be taken to the organ donor registry website (study 2; yes/no)
  • Intervention groups

    • Omitted affective attitudes: 6.25%

    • Omitted negatively‐worded affective attitudes only: 8.72%

    • There were no significant group differences seen in those who agreed to be taken to the organ donor registry website

  • Control group

    • No‐intervention replication group: 6.22%

Notes Funding source: this research was supported by the RCSI Research Summer School and the RCSI Student Selected Component, who had no role in recruitment, data analysis or interpretation.
Study author contact: fdoyle4@rcsi.ie
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Qualtrics software automatically randomised online participants into 1/3 conditions using simple randomisation
Allocation concealment (selection bias) Low risk Allocation was done completely online
Blinding of participants and personnel (performance bias)
All outcomes Low risk Questionnaires were delivered online and the study was double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcomes were all self‐completed by participants who were blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome data was available for all participants
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other bias identified

Hirai 2020.

Study characteristics
Methods Study design: RCT (6‐arm)
Study duration: February to March 2018
Study follow‐up period: no follow‐up
Participants Country: Japan
Setting: Driver’s license centre
Sample size: 3224
Mean age ± SD: 44.39 ± 12.74 years
Sex: 59.2% male
Interventions Three investigators randomly distributed leaflets, which included the study questionnaire, before the driver training started at the license renewal centre
Intervention consisted of reading a leaflet with different messages that prompted organ donation registration. There were 5 types of frames for the messages: “peer”, “gain”, “loss”, “reciprocity”, and “peer + reciprocity”. The control condition involved a leaflet without a prompt message. On all 6 types of leaflets, the method of registering for organ donation was described on the opposite side
Intervention groups
  • Peer: “many people have already expressed their intention to donate their organs”

  • Gain: “your intention could make it possible to save the life of 6 people”

  • Loss: “5 people die every week because enough donors are not available”

  • Reciprocity: “You may also need to receive an organ from other donors"

  • Peer + reciprocity: “many people have already expressed their intention to donate organs. It may be necessary for you to receive organs from other people as well


Control group
  • The control leaflet did not contain any prompting messages. It included a general description about organ transplantation.

Outcomes Primary outcome
Self‐reported readiness to register as a donor
  • Intervention groups: 2670 participants had not registered previously

    • Peer: 33/526

    • Gain: 42/556

    • Loss: 41/527

    • Reciprocity: 58/552

    • Peer + reciprocity: 36/530

    • In adjusted analysis, reciprocity‐framed was significant predictor for increase in the “immediate decision” response (OR ‐1,596, P = 0.041) compared to control

  • Control group: 36/553

Notes Funding source: This work was supported in part by Health and Labour Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare, and the Behavioral Economics Research Center at the Institute of Social and Economic Research of Osaka University.
Study author contact: khirai@grappo.jp
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “Three investigators randomly distributed leaflets, which included the study questionnaire” No further detail provided
Allocation concealment (selection bias) Unclear risk “Three investigators randomly distributed leaflets, which included the study questionnaire” No further detail provided
Blinding of participants and personnel (performance bias)
All outcomes High risk Investigators distributed the leaflets prior to the driver training
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by lack of outcome assessment blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Single intervention, data was complete
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major biases identified

Hyde 2013.

Study characteristics
Methods Study design: factorial and multi‐arm (4 arms)
Study duration: not reported
Study follow‐up period: 1 month
Participants Location: Australia
Setting: Online (web‐based survey)
Number: motivational (42); volitional (36); combined (38); control (61)
Mean age ± SD (years): motivational (46.90 ± 14.95); volitional (46.49 ± 16.42); combined (46.19 ± 15.46); control (48.79 ± 13.83)
Sex (M/F): motivational (19/23); volitional (15/21); combined (15/23); control (24/37)
Interventions Each participant was randomly assigned to one of four arms. Both the motivational and volitional interventions were derived from a previous study.
Intervention groups
  • Motivational: designed to strengthen people's intentions to communicate by encouraging supportive attitudes and norms

  • Volitional: participants created both action and coping plans to strengthen behaviour. For action planning, participants filled in the blanks in a statement for registering and discussing which specified when, where and how communication of their donation wishes would occur. For coping planning, participants listed three obstacles that may interfere with their plans and suggested three solutions they could use to successfully overcome the identified barriers

  • Combined: both the motivational and volitional arms


Control group
  • No description given

Outcomes Primary outcome
Self‐reported registration in the Australian Organ Donor Register and self‐reported discussion of organ donation preference with relevant individuals
  • Self‐reported registration behaviour

    • Motivational: 5/35 registered (14.3%)

    • Volitional: 7/28 registered (25.0%)

    • Combined: 13/31 registered (41.9%)

    • Control: 7/45 registered (15.6%)

  • Self‐reported intention to register also measured (143): not all groups compared

    • Motivational: 5.08 ± 1.84 (67)

    • Volitional: 4.27 ± 1.94 (76)

  • Discussing organ donation preference (88 discussed in total)

    • Motivational: 6/19 (31.6%) discussed

    • Volitional: 4/20 (20%) discussed

    • Combined: 6/18 (33.3%) discussed

    • Control: 11/31 (35.5%) discussed


No adverse effects were reported in this study
Notes Funding source: Queensland University of Technology, Vice Chancellor's Postdoctoral Research Fellowship Support Grant
Study author contact: Melissa Hyde (melissa.hyde@griffith.edu.au)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation conducted by a computer generated sequence
Allocation concealment (selection bias) Low risk Used computer to allocate
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes High risk Did not provide demographic information on those who only completed baseline questionnaire (loss to follow‐up) and they had different scores on attitudes and moral norm towards organ donation
Selective reporting (reporting bias) High risk All outcomes reported appropriately
Other bias Low risk No other biases

INORDAR 2012.

Study characteristics
Methods Study design: multi‐arm RCT (4 arms)
Study duration: April to October 2012
Study follow‐up period: registry checked 6 months later
Participants Country: Scotland
Setting: mailing campaign
Number: NQC (2330); QC (2257); TPB (2313); AR (2308)
Mean age ± SD (years): NQC (41.28 ± 11.70); QC (40.81 ± 11.65); TPB (41.32 ± 11.95); AR (40.65 ± 11.83)
Sex (% male): NQC (43.79%); QC (44.53%); TPB (43.47%); AR (43.35%)
Interventions Participants were randomly assigned to one of four arms, using simple randomisation in a 1:1:1:1 ratio. A market research company did the randomisation sequence and participant enrolment/assignment, to which all participants were blind to the experimental arm
No questionnaire control (NQC)
  • Participants completed a survey collecting their demographic information, whether or not they were a registered donor, if they knew of anyone who had received an organ transplant, if they knew anyone who had donated an organ, if they knew anyone who needed an organ, whether or not they had ever donated an organ and whether or not they had ever donated blood


Questionnaire control (QC)
  • Participants completed the same questionnaire that was given to the NQC group, with the addition of 16 extra items. Additional items measured their non‐cognitive affective attitudes towards organ donation (i.e. bodily integrity, medical mistrust, 'ick' factor, jinx, perceived benefits). All items were rated on a 7‐point scale from 1 "strongly disagree" to 7 "strongly agree." Participants also rated their intention to register as an organ donor on a 2‐item scale. Nine of the survey items were filler items to ensure that the number of items in the QC arm were identical to the TPB/AR arms


Theory of planned behaviour questionnaire (TPB)
  • Questionnaire had the same affective and intention items as the QC questionnaire, plus an additional 7 items. Additional items measured attitude, subjective norm and perceived control. Two additional filler items were included to ensure the total number of items was equal to that of the AR arm


Anticipated regret questionnaire (AR)
  • Questionnaire contained the same affective, intention and TPB items as the TPB arm, plus an additional 2 items that measured the extent to which the participant would anticipate regret for not registering as an organ donor

Outcomes Primary outcome
Verified registration of participants in the UK organ donor registry (a total of 497/9208 (5.4%) participants registered as a verified organ donor)
  • NQC: 149/2330 participants registered

  • QC: 119/2257 participants registered

  • TPB: 125/2313 participants registered

  • AR: 104/2308 participants registered


Participants in the NQC group were more likely than the AR group to register in the UK organ donor registry (P = 0.042)
No adverse events were reported
Notes Funding source: grant from The Scottish Government Chief Scientist's Office (Ref. CZH/4/686)
Study author contact: Ronan E. O'Carroll (reo1@stir.ac.uk)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Market research company performed the randomisation using simple randomisation
Allocation concealment (selection bias) Low risk Mail‐out study unlikely to be affected by lack of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were blinded to the experimental arm
Blinding of outcome assessment (detection bias)
All outcomes Low risk Unlikely that donor registration in the registry is affected by lack of blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major biases identified

Loughery 2017.

Study characteristics
Methods Study design: cluster‐RCT with a pre/post‐test
Study duration: February 2010 to February 2011
Study follow‐up period: 9 to 12 months
Participants Country: USA
Setting: African‐American alumni sorority and fraternity chapter (25 sites)
Number: treatment group (501); control (397)
Age > 45 years: intervention group (56%) control group (44%)
Sex (% female): intervention group (69.06%); control group (77.83%)
Interventions The chapters were randomized to either an experimental or control group, and were pair matched based on both size (less than 100 members, or 100 and more members) and gender (sorority or fraternity)
Peer leaders of the control group were trained during a 2‐hour session, covering topics such as basic information about diabetes, hypertension, chronic kidney disease, nutrition, physical activity, communication techniques based on motivational interviewing and group facilitation techniques. The peer leaders of the intervention group received the same training as control, with the addition of education on organ and tissue donation through a viewing of a short film titled “Living on Through Love.”
Intervention group
  • Received at least one organ donation presentation discussing the need for organ donors among the African American community, the benefits of donation (to refute common misconceptions), and instructions for signing up on the state donor registry. Participants also received two tailored newsletters about organ donation (one 3‐4 months post‐baseline questionnaire, and one at the 7‐8 month period) that focused on common misconceptions and knowledge, which were based on responses received through the baseline survey


Control group
  • Received a chronic disease education program that was integrated into regularly scheduled events, with the addition of supplementary chronic disease education materials. At least one presentation regarding diabetes, hypertension, and chronic kidney disease was delivered to chapter members of the control group

Outcomes Primary outcome
Donor designation registration on Michigan Organ Donor Registry (a total of 471/898 participants completed the follow‐up survey)
  • Intervention group: 108/501

  • Control group: 76/397


No adverse effects were reported in this study
Notes Funding source: Health Resources and Services Administration of the US Department of Health and Human Services grant #R39OT15494
Study author contact: Caitlin Loughery (cbuechley@nkfm.org)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding was not addressed. Unclear if participants or personnel were blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding unlikely to affect the primary outcome (donor registration)
Incomplete outcome data (attrition bias)
All outcomes High risk Attrition was high (48% lost to follow up)
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major biases identified

Murakami 2016.

Study characteristics
Methods Study design: RCT
Study duration: 25 August 2014 to 3 October 2014
Study follow‐up period: 39 days
Participants Country: Japan
Setting: nursing university
Number: intervention group (102); control group (101)
Median age, IQR (years): intervention group (19, 19 to 20); control group (20, 19 to 20)
Sex (% female): intervention group (89.2%); control group (89.1%)
Interventions Intervention group
  • Participants received a lecture and participated in a small group discussion. The lecture was provided by 2 lecturers: a transplant nephrologist and a kidney transplant recipient. The lectures discussed end‐stage kidney disease, provided an overview of the organ donation system in Japan, and personal experiences (from the transplant recipient) on dialysis therapy and donor kidney transplantation. Participants received an information booklet ("The Gift of Life" at the end, containing a donor card


Control group
  • Participants received 3 information booklets, one of which was the same as the intervention group's ("The Gift of Life"). The other two booklets were "Current Status of Transplantation in Japan" and "Kidney Failure: Treatment Options and Practice"

Outcomes Primary outcome
Self‐reported organ donor designation (any of the following: Internet registration, donor card, driver's license, health insurance card). (203/205 students completed the final questionnaire (n=2 excluded from intervention group for absenteeism))
  • Intervention group: 7/102 (6.9%; Proportion Ratio: 6.93, 95% CI 0.87 to 55.32; P = 0.07) provided consent for organ donation

  • Control group: 1/101 (1.0%) provided consent for organ donation


Secondary outcome
Measured the proportion of students who (i) obtained approval of family to the student's consent to organ donation, (ii) expressed willingness to provide consent for donation, (iii) expressed willingness to donate organs after brain death, (iv) expressed willingness to donate organs after circulatory death, (v) expressed willingness to approve organ removal from a deceased family member with donor designation, (vi) expressed willingness to approve organ removal from deceased family member with unknown donation status, (vii) discussed deceased organ donation with family, (viii) whose family members provided consent for organ donation
  • Expressed willingness to provide consent for donation

    • Intervention group: 56/102 (54.9%)

    • Control group: 40/101 (39.6%)


No adverse events were reported
Notes Funding source: Yukiko Ishibashi Foundation
Study author contact: Professor Shunichi Fukuhara (fukuhara.shunichi.6m@kyoto‐u.ac.jp)
Participants were randomly assigned to intervention or control group, in a 1:1 ratio, using computer‐generated random numbers. Non‐blinded. Authors provided additional details of protocol
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation conducted by a computer generated sequence
Allocation concealment (selection bias) Low risk Allocation conducted by an independent person
Blinding of participants and personnel (performance bias)
All outcomes High risk Likely that participants aware which group they were assigned to which may have caused them to respond accordingly
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Loss to follow up minimal
Selective reporting (reporting bias) Low risk All outcome measures reported
Other bias High risk Contamination occurred in 52.0% of the intervention group and 42.6% in the control group

O'Carroll 2011a.

Study characteristics
Methods Study design: pseudo‐RCT
Duration of study: not reported
Duration of follow‐up: not reported
Participants Country: Scotland
Setting: Shopping mall
Number: 138 total, 91 non‐donors
Age group (1‐5): 3.7 (1.8) for non‐donors
Sex (M/F): 39/52
Interventions Intervention group
  • Anticipated Regret (AR): participants completed the same questionnaire as above, with the addition of two extra questions assessing anticipated regret: "If I didn't register as an organ donor and someone I cared about died that could have been saved, I would feel regret" and "If I don't register as an organ donor I will later wish that I had."


Control group
  • Participants completed a questionnaire assessing five items regarding their attitudes towards organ donation (i.e. bodily integrity, medical mistrust, 'ick' factor, jinx and perceived benefit). They also completed additional questions related to cognitive‐rational factors (three questions to get an overall sense of the participants' attitudes towards the idea of organ donation, five questions to assess their knowledge of organ donation and two questions to measure subjective norm)

Outcomes Primary outcome
Participants intention to become a registered organ donor (measured on a scale from 1 "strongly disagree" to 7 "strongly agree")
  • Intervention (AR): mean intention score: 5.5 (SE 0.28) (SD 1.86) (44)

  • Control group: mean intention score: 4.4 (SE 0.27) (SD 1.85) (47)


The mean intention score for the AR condition was significantly higher compared to that of the control condition (P = 0.008)
Notes Study author contact: Ronan E. O’Carroll (reo1@stir.ac.uk)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Pseudo‐randomisation with equal number of control and experimental condition
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Unlikely that lack of blinding of participant and personnel would affect performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by donor registration status
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session intervention with no loss to follow up
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major biases identified

O'Carroll 2011b.

Study characteristics
Methods Study design: pseudo‐RCT
Duration of study: not reported
Duration of follow‐up: not reported
Participants Country: Scotland
Setting: Shopping mall
Number: 342 total, 193 non‐donors
Age group (1‐5): 3.62 (1.8) for non‐donors
Sex (M/F): 95/98
Interventions Participants were pseudo‐randomly allocated to either a control or an anticipated regret condition, using the same methods as described in O'Carroll 2011a
Intervention group
  • Anticipated regret (AR): participants completed the same questionnaire as the control group, along with two additional anticipated regret questions (described in O'Carroll 2011a)


Control group
  • Participants received the same questionnaire as described in O'Carroll 2011a. They also completed six additional questions that assessed their general superstitious beliefs (three assessing positive beliefs and 3 assessing negative beliefs)

Outcomes Primary outcome
Participants intention to become a registered organ donor (measured on a scale from 1 "strongly disagree" to 7 "strongly agree")
  • Intervention group (AR): mean intention score: 4.6 (SE 0.18) (SD 1.83) (103)

  • Control group: mean intention score: 4.1 (SE 0.19) (SD 1.80) (90)

  • The AR intervention resulted in a significantly higher intention to become a posthumous organ donor (P = 0.036) as compared to the control group


No adverse events were reported in this article
Notes Study author contact: Ronan E. O’Carroll (reo1@stir.ac.uk)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Pseudo‐randomisation with equal number of control and experimental condition
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Unlikely that lack of blinding of participant and personnel would affect performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by donor registration status
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session intervention with no loss to follow up
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major bias identified

O'Carroll 2017a.

Study characteristics
Methods Study design: factorial RCT
Study duration: not reported
Study follow‐up period: not reported
Participants Location: UK
Setting: online or in‐person (at university campus or local workplaces)
Number: intervention group (71); control group (69); face‐to‐face setting (83); online setting (57)
Age: intervention group (predominantly 18‐24 years; 40.8%); control group (predominantly 18‐24 years; 29.0%); face‐to‐face setting (predominantly 18‐24 years; 37.3%); online setting (predominantly 18‐24 years; 31.6%)
Sex (% female): intervention group (52.1%); control group (62.3%); face‐face setting (56.6%); online setting (57.9%)
Interventions Participants who were indicated as non‐donors were randomly assigned to either a reciprocity prime or control condition using an online randomization tool.
Intervention group
  • Reciprocity prime: participants completed a questionnaire beginning with a priming question, followed by two questions regarding their intention to register as an organ donor. The reciprocity prime was based on marketing materials used by the UK NHS Blood and Transplant's organ donation campaign. Participants were required to respond to the question "I would accept an organ from a deceased donor in order to save my own life," evaluated on a 7‐point Likert scale (from "strongly disagree" to "strongly agree")


Control group
  • Participants completed the same questionnaire as the intervention (reciprocity prime) group, but with a neutral 'filler' statement

Outcomes Primary outcome
Participants organ donation registration intention score (evaluated by two questions on a 7‐point Likert scale (i.e. "I strongly intend to donate my organs in the future," "I will definitely donate my organs when I die")). These two questions were averaged to produce one overall intention score (i.e. mean intention score)
  • Prime versus control condition: prime participants scored significantly higher on intention compared to that of the control group

  • Prime condition: 5.64 ± 1.15 (71)

  • Control condition: 4.96 ± 1.44 (69)

  • Face‐to‐face prime condition: 5.54 ± 1.2 (47)

  • Face‐to‐face control condition: 4.85 ± 1.49) (36)

  • Online prime condition: 5.83 ± 1.05 (24)

  • Online control condition: 5.08 ± 1.40 (33)


No adverse events were reported
Notes Funding source: not reported
Study author contact: Ronan E. O'Carroll (reo1@stir.ac.uk)
Participants were non‐donors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online randomisation tool
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were blinded due to nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded due to nature of intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk Unclear why the full sample of subjects were not included (518 recruited, but only 511 subjects included in analysis of organ donation intention and 509 included in analysis of behavioural proxy for organ donation registration)
Selective reporting (reporting bias) Low risk No reporting bias identified
Other bias Low risk No other bias identified

O'Carroll 2017b.

Study characteristics
Methods Study design: factorial RCT
Study duration: not reported
Study follow‐up: not reported
Participants Location: in‐person from Scotland and other online
Setting: online or in‐person (different town/city centres)
Number: intervention group (244); control group (274); face‐to‐face setting (336); online setting (182)
Age: intervention group (predominantly 45 to 54; 27.6%); control group (predominantly 65+; 23.7%); face‐to‐face setting (predominantly 65+; 29.5%); online setting (predominantly 45 to 54; 27.6%)
Sex (% female): intervention group (51.4%); control group (48.2%); face‐to‐face setting (43.9%); online setting (60.4%)
Interventions Intervention group
  • Reciprocity prime: participants completed a questionnaire beginning with a priming question, followed by two questions regarding their intention to register as an organ donor. The reciprocity prime was based on marketing materials used by the UK NHS Blood and Transplant's organ donation campaign. Participants were required to respond to the question "I would accept an organ from a deceased donor in order to save my own life," evaluated on a 7‐point Likert scale (from "strongly disagree" to "strongly agree")


Control group
  • Participants completed the same questionnaire as the intervention (reciprocity prime) group, but with a neutral 'filler' statement

Outcomes Primary outcome
Participants organ donation intention (evaluated the same way as Study 1), their behavioural measure of organ donor registration (yes/no to taking a brochure in the face‐to‐face condition or yes/no to clicking the link in the online condition).
  • Prime condition: 4.94 ± 1.96 (244)

  • Control condition: 4.66 ± 1.92 (274)

  • Face‐to‐face condition: 4.90 ± 2.01 (152)

  • Control condition: 4.90 ± 1.93 (184)

  • Online condition: 4.99 ± 1.90 (92)

  • Control condition: 4.16 ± 1.82 (90)


No adverse events were reported
Notes Funding source: not reported
Study author contact: Ronan E. O'Carroll (reo1@stir.ac.uk)
Participants were non‐donors
There was found to be no difference found between the two modes of delivery (i.e. online versus face‐to‐face)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online randomisation tool
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were blinded due to nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded due to nature of intervention
Incomplete outcome data (attrition bias)
All outcomes Low risk Unclear why the full sample of subjects were not included (518 recruited, but only 511 subjects included in analysis of organ donation intention and 509 included in analysis of behavioural proxy for organ donation registration)
Selective reporting (reporting bias) Low risk No reporting bias identified
Other bias Low risk No other bias identified

O'Carroll 2019.

Study characteristics
Methods Study design: RCT
Study duration: September to October 2017
Study follow‐up period: not reported
Participants Country: England & Scotland
Number: Intervention group (210); control group (210)
Setting: online digital survey (UK Qualtrics participant panel)
Mean age + SD (years): intervention group (52.9 + 15.4); control group (53.9 +15.3)
Sex (% female): intervention group (56%); control group (51%)
Interventions Participants were randomly assigned to either reciprocity prime or control groups, in a 1:1 ratio. After reading their respective statements, participants completed the post‐test questionnaire
Intervention group
  • Reciprocity prime: participants read the reciprocity prime statement ("I would accept an organ from a deceased donor in order to save my own life")


Control group
  • Participants read the control statement ("most of the general public have a good understanding of organ donation")

Outcomes Primary outcome
Intention to donate (assessed with 2 questions: "I strongly intend to donate my organs when I die"; "I will definitely donate my organs when I die", 7‐point scale)
  • Participants in the prime condition had significantly higher intentions towards organ donation (4.3 ± 1.6) (210) compared to control participants (3.7 ± 1.4) (210); F(1,418) = 17.4, P ≤ 0.001 (Welch correction), d = 0.4 (95% CI 0.21 to 0.59)


Secondary outcome
Proxy for organ donation registration behaviour (yes/no to being taken to the U.K. organ donor registration and information page)
There was no significant difference in proxy organ donor registration behaviour between reciprocity prime and control conditions
  • Reciprocity prime: 23/210 agreed to visiting the organ donation information webpage

  • Control: 25/210 agreed to visiting the organ donation information webpage

Notes Funding source: not reported
Author contact: Ronan E. O’Carroll, ronan.ocarroll@stir.ac.uk
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned by block allocation in a 1:1 ratio by third‐party software
Allocation concealment (selection bias) Low risk Allocation concealment was not described but online nature unlikely to be affected by selection bias
Blinding of participants and personnel (performance bias)
All outcomes Low risk Not relevant
Blinding of outcome assessment (detection bias)
All outcomes Low risk self‐reported questionnaire unlikely to be affected by detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk All outcome data appear to be reported
Selective reporting (reporting bias) Low risk All data appear to be fully reported
Other bias Low risk No other foreseeable bias

Project ACTS I 2010.

Study characteristics
Methods Study design: clustered RCT with pre/post‐test (two arms)
Study duration: not reported
Study follow‐up period: 1 year
Participants Country: USA
Setting: Churches (9 sites)
Number: intervention group (175); control group (162)
Mean age (years): intervention group (49.5); control group (52.5)
Sex (% female): intervention (79.4%); control (76.3%)
Interventions Churches were randomly assigned to either an experimental or control intervention
Intervention group
  • Received the Project ACTS intervention package, which consisted of a culturally‐sensitive video, educational pamphlet, donor card, a National Donor Sabbath pendant and other items embossed with the project brand. The video was hosted by a gospel singing group and featured testimonials from individual and family about the organ donation process. The Project ACTS educational pamphlet contained statistics on African Americans waiting list and information on the allocation system


Control group
  • Received standard pamphlets on organ donation with a donor card that is available to all consumers

Outcomes Data was collected at baseline and 1‐year follow‐up. Of 425 participants, 337 (79.3%) completed the follow‐up survey
Primary outcome
Self‐reported willingness to identify as an organ donor on driver's license
  • Intervention group: 46.9% (82/175)

  • Control group: 48.8% 79/162)


Self‐reported willingness to carrying a donor card
  • Intervention group: 24.0% (42/175)

  • Control group: 24.7% (40/162)


Study reported no significant differences between experimental and control group
No adverse events were reported
Notes Funding source: National Institute of Diabetes and Digestive and Kidney Diseases (grant #5 R01 DK62617‐05)
Study author contact: Kimberly Arriola (kjacoba@sph.emory.edu)
Intervention participants were more likely than control participants to review a donation‐related video (56.6% versus 23.6%; chi2 P < 0.001) and written materials (69.1% versus 50.9%; chi2 P < 0.001)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Likely that participants aware which group they were assigned to which caused them to respond accordingly
Blinding of outcome assessment (detection bias)
All outcomes Low risk Donor registration likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Although dropout was high (21.5% intervention, 19.8% control), authors addressed that those lost to follow up had similar characteristics to those who completed the second questionnaire. Authors did not provide any additional information
Selective reporting (reporting bias) Low risk All outcome measures reported appropriately
Other bias High risk Different baseline characteristics among intervention and control. Groups were different in age, educational attainment and income. Authors did not address issue of contamination

Project ACTS II 2013.

Study characteristics
Methods Study design: factorial cluster‐RCT with a pre/post‐test (4 arms)
Study duration: April 2009 to February 2011
Study follow‐up period: 1 year (April 2010 to February 2011)
Participants Country: USA
Setting: group setting or at home
Number: revised intervention (283); original intervention (302); group setting (288); take‐home setting (297)
Mean age (years): revised intervention (46.2); original intervention (46.3); group setting (44.9); take‐home setting (47.6)
Sex (% female): revised intervention (70.7%); original intervention (67.5%); group setting (70.1%); take‐home setting (68.0%)
Interventions Eight focus groups with 5 to 10 individuals (n=59) informed the revision of Project ACTS II materials. Nineteen outreach workers (15 female; 4 male) participated in the intervention delivery. Outreach workers attended one‐on‐one training that described project, study protocol, how to recruit participants, and how to facilitate group discussion. Workers tasked with recruiting up to 32 individuals, and facilitated group discussion
Group 1
  • Revised intervention/group setting: viewed the Project ACTS II DVD and educational booklet in a group setting, followed by group discussion


Group 2
  • Revised intervention/take home: viewed an unrelated DVD (social determinants of health) in a group setting, followed by group discussion, and took Project ACTS II materials home


Group 3
  • Original intervention/group setting: viewed the Project ACTS I DVD and booklet in group setting, followed by group discussion


Group 4
  • Original intervention/take home: viewed an unrelated DVD in group setting, followed by group discussion, and took Project ACTS I intervention materials home

Outcomes Primary outcome
Expression of donation wishes, which was a sum of three behaviours (driver's license, donor card, discussing with family about one's wishes) (scores ranged 3 ‐ 15, higher scores indicate greater willingness to donate)
Authors able to reach 509/585 (87%) of participants at the 1‐year follow‐up period
  • Intervention package: no significant effect of condition on expression of donation wishes

  • Setting: significant effect of condition, where participants in the group condition had a larger increase in expression of donation wishes from baseline to follow‐up (baseline = 7.6, follow‐up = 8.9) compared to take home condition (baseline = 7.6, follow‐up = 8.1)


No adverse effects were reported in this study
Notes Funding source: National Institute of Diabetes and Digestive and Kidney Diseases (Grant #5R01DK079713‐05)
Study author contact: Kimberly Arriola (kjacoba@sph.emory.edu)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used an online randomisation tool
Allocation concealment (selection bias) High risk Outreach workers were aware of group allocation
Blinding of participants and personnel (performance bias)
All outcomes High risk Outreach workers were not blinded and thus, high risk of performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes High risk Those loss to follow‐up had significantly different characteristics than those who completed the study
Selective reporting (reporting bias) High risk Did not report mean score of donation intention for donation intention outcome
Other bias High risk Did not address issue of contamination by outreach worker

Quick 2012.

Study characteristics
Methods Study design: multi‐arm RCT
Study duration: December 2010 to June 2011
Study follow‐up period: not reported
Participants Country: USA
Setting: direct‐mail campaign
Number: letter (42,789); brochure (46,624), letter + brochure (43,001)
Mean age: not reported but mail was sent to 18 year olds
Sex: not reported
Interventions Direct‐mail marking strategy. Participants were assigned to one of three arms
Letter only from the Secretary of State (SoS)
  • Addressed to individual by first name, encouraged residents to become an organ and tissue donor, stated facts and statistics. The letter concluded by telling residents that joining the registry takes 30 seconds and registration can occur via Internet, phone or returning the attached card


Brochure only from the SoS
  • Brochure was informed by multi‐ethnic focus groups. The front featured transplant recipients and facts about organ donation were presented along with a narrative about a family who experienced both recipient and donation side. The brochure described steps to join the organ and tissue donor registry and contained a registration form


Combined Letter and Brochure
  • Receiving both the letter and the brochure from the SoS

Outcomes Primary outcome
Registration in Illinois' First‐Person Consent Registry (to track registrations in the registry, each condition contained a 4‐digit code that participants were told to enter when joining)
  • New registrations: 6908

  • Letter only from the Secretary of State (SoS): 2668/ 42789 (6.2%) (significantly higher compared to brochure only (P < 0.001); no difference compared to combined SoS letter and brochure (P > 0.05)

  • Brochure only from the SoS: 1534/46624 (3.3%)

  • Combined Letter and Brochure: 2706/43001 (6.3%) (P < 0.001 compared to brochure only)

Notes Funding source: Health Resources and Services Administration's Division of Transplantation grant #R39OT15493‐02
Study author contact: Brian L. Quick (bquick@illinois.edu)
Total cost for project was $56 686
Production and mailing cost/cost per registration
Letter only: $0.38
Brochure only: $0.41
Combined: $0.43
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Insufficient detail about blinding but participants receiving mail‐outs are likely to have low risk of being aware which group they were assigned to
Blinding of outcome assessment (detection bias)
All outcomes Low risk Donor registration likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Single intervention and those who were excluded were those who had undeliverable mail
Selective reporting (reporting bias) Low risk All outcome measures reported appropriately
Other bias Low risk No other bias identified

Quick 2015.

Study characteristics
Methods Study design: multi‐arm RCT
Study duration: Summer of 2011
Study follow‐up period: not reported
Participants Country: USA
Setting: direct‐mail campaign
Number: organ donor brochure (14,324); organ recipient brochure (14,265); waiting‐list brochure (14,207); combination brochure (14,265)
Mean age: 18 years (brochures were only sent to individuals who were 18 years of age)
Sex: not report
Interventions Individuals were randomly assigned to receive a personalised letter from the secretary of state, plus 1 of 4 brochures featuring either organ donors, recipients, individuals on the waiting list or a combination of all three.
Intervention
  • SoS Letter Each letter was personally addressed to the individual. Individuals were informed of their eligibility to join the registry, and encouraged to do so. Statistics were presented regarding the shortage of organs, the waiting list (national and state level), and the impact of one donor on multiple recipient lives. Individuals were presented with various methods to register.


Common features to all 4 brochures
  • All brochure covers featured photographs of three children (one African American, one Caucasian, one Hispanic). All covers included identical vital statistics about the organ donation shortage, and the benefit of donation. The left side of the brochure featured facts about organ/tissue donation to counter common misconceptions. A tagline at the bottom of the left side read "Be a Hero. Your Decision can save lives. Join the Illinois Organ/Tissue registry today." Registration form with mailing instructions included in all brochures. Back of all brochures featured information and instructions on how to register


Donor brochure
  • Featured pictures of three children, along with their names, whose family members donated their organs after they died. Introductory sentence under the pictures read: "Thanks to their decision to become organ donors, many Illinois residents' lives were saved and improved." Narrative within brochure featured the story of 9‐year‐old Jazmyne, whose decision to donate improved lives


Recipient brochure
  • Featured pictures of three children, along with their names, who had received life‐saving transplants. Introductory sentence read "These Illinois residents are alive today because someone like you said 'Yes' to become an organ donor.' Narrative within brochure spoke about 6‐year‐old Anna, who received a liver at 5‐months old and is now in Kindergarten


Waiting‐list brochure
  • Featured pictures of three children, along with names, who are currently waiting for an organ transplant. Introductory sentence under pictures read "Jalene, Julio, and Charlie are 3 of over 5000 Illinois residents waiting for an organ transplant." Inside the brochure, a narrative told the story of Penny, a 2‐year‐old girl in need of a new heart


Combination brochure
  • Featured pictures of three children, and identified whether they were a donor, recipient, or waiting for an organ transplant. Introductory statement read "Your decision to become an organ/tissue donor can save and improve the lives of many Illinois residents". Interior narrative told the story of Julie, whose son died and donated his organs, and whose daughter received a transplant

Outcomes Primary outcome
Registration in the Illinois Organ and Tissue Donor Registry, via U.S. postal mail or Internet
A total of 3583 first‐time organ donation registrations resulted from the campaign ‐ 1102 from the combination brochure, 803 from the organ donor brochure, 847 from the recipient brochure, and 831 from the waiting list brochure.
  • Donor brochure: 803/14324 (5.6%)

  • Recipient brochure: 847/14265 (5.9%)

  • Waiting‐list brochure: 831/14207 (5.9%)

  • Combination brochure: 1102/14265 (7.7%); outperformed the donor brochure (OR 1.41, 95% CI 1.28 to 1.55, P < 0.001), the recipient brochure (OR 1.33, 95% CI 1.21 to 1.46, P < 0.001), and waiting list brochure (OR 1.35, 95% CI 1.23 to 1.48, P < 0.001)


No adverse events were reported in this article
Notes Funding source: Health Resources and Services Administration's Division of Transplantation grant #R39OT15493
Study author contact: Brian L. Quick (bquick@illinois.edu)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Insufficient detail about blinding but participants receiving mail‐outs are likely to have low risk of being aware which group they were assigned
Blinding of outcome assessment (detection bias)
All outcomes Low risk Donor registration likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Single intervention and those who were excluded were those who had undeliverable mail
Selective reporting (reporting bias) Low risk All outcome measures reported appropriately
Other bias Low risk No other bias identified

Quinn 2006.

Study characteristics
Methods Study design: clustered‐RCT based upon 1 month post‐intervention (3 arms)
Randomisation occurred at the level of the worksite
Study duration: not reported
Study follow‐up period: 1 month
Participants Country: USA
Setting: worksites (40) through corporations (12)
Number: basic (254); enhanced (288); control (213)
Mean age: basic (40.9 years); enhanced (41.0 years); control (41.3 years)
Sex (% female): basic (77.8%); enhanced (77.4%); control (73.6%)
Interventions Participants were assigned to one of three arms. All interventions were presented during a 1‐hr "lunch‐and‐learn" program
Basic educational
  • Development of intervention was based on the Transtheoretical Model and was a factual presentation designed to raise the worker's awareness of the value of and need for organ donation. The intervention introduced the workers to a trained transplant recipient and a family member of a deceased organ donor and each provided a testimonial. Finally, workers were taught what steps to take to become an organ donor


Enhanced educational intervention
  • Basic educational intervention and advice and encouragement for participants to persuade family members to register for organ donation and informing other family members about their choices. This advice included presenting facts about the need/value of donation, sharing testimonials heard in the program, and outlining one's own personal view of the benefits


Control group
  • Participants were provided brochures on a range of health‐related topics from diabetes and kidney disease to organ donation. A heath educators facilitated the session

Outcomes Primary outcome
Changes in intention to donate (signed donor card), communication with family regarding organ donation intention, change in family member's intention to be donors (signed donor card).
  • Basic educational: 110/172 registered (64%); rate of change: 29%, P < 0.001

  • Enhanced educational intervention: 122/179 (68%); rate of change: 31%, P = 0.002

  • Control group: 81/137 (59%); rate of change, 17%, P = 0.454


Secondary outcome
Self‐reported proportion of family members signed donor card.
  • Basic educational: 115/172 (67%); 9% to 17%, P < 0.001

  • Enhanced educational intervention: 118/179 (66%); 10% to 17%, P < 0.001

  • Control group: 86/137 (63%); 10% to 14%, P = 0.016


No adverse events were reported in the article
Notes Funding source: Health Resources and Services Administration, Office of Special Programs, Division of Transplantation, grant # 1‐H39‐OT‐00086‐01
Study author contact: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Likely that participants aware which group they were assigned to which caused them to respond accordingly
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely to have low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes High risk High loss to follow up (34%). Differences in demographics of those loss to follow up
Selective reporting (reporting bias) Low risk All outcome measures reported appropriately
Other bias Low risk No major biases identified. However, a proportion of participants reported having signed donor card at baseline but subsequently in follow‐up questionnaire did not have signed donor card which should not have been possible

Resnicow 2010.

Study characteristics
Methods Study design: cluster RCT
Study duration: not reported
Study follow‐up period: 4 months
Participants Country: USA
Setting: Hair Salons (52)
Number: treatment group (1370); control group (1419)
Mean age ± SD (years): treatment group (38.3 ± 14.8); control group (42.5 ± 16.5)
Sex (% female): treatment group (73.5%); control group (80.8%)
Interventions Stylists from the salons attended a 1‐day, 4‐hr training session lead by the National Kidney Foundation of Michigan coordinator. The sessions covered information regarding nutrition, exercise, diabetes, and chronic kidney disease, as well as a 30‐minute presentation on organ donation (provided key information, and refuted common myths). After the session, stylists were randomized by salon to control or intervention condition (each salon comprised stylists of only 1 condition).
Intervention group
  • Stylists from intervention group returned for second day of training in Motivational Interviewing techniques to help them deliver organ donation counselling. This training session was 4‐hrs and covered motivational interviewing/communication skills, discussion of ways to integrate organ donation into client interaction, and practising using these skills with health chat demos

  • Stylists were asked to conduct 4 health chats with each client, addressing organ donation during at least 2 of the 4 chats. Clients received a folder containing educational brochures on chronic disease as well as organ donation, and an Organ Donor Registry card was distributed at Chat 1 and Chat 4


Control group
  • Received only the first day of training (mentioned above)

  • Stylists were asked to conduct 4 health chats with each client, discussing goal setting for chronic disease behaviours. They were asked to not discuss organ donation. Clients received a folder containing educational brochures on chronic disease as well as organ donation, and an Organ Donor Registry card was distributed at Chat 1 and Chat 4

Outcomes Primary outcome
Verified registration in Michigan Organ Donor Registry (registry registration cards were numbered so they could be linked to participants, and the registry provided card numbers of participants who mailed their registration cards) (a total of 97 donor cards were returned)
  • Intervention group: 68/1370 (5.0%)

  • Control group: 29/1419 (2.0%)


Intervention group was 4.4x (95% CI 1.3 to 15.3) more likely to submit an enrolment card than control
No adverse events were reported in the article
Notes Funding source: Health Resources and Services Administration grant #R39OT04109
Study author contact: Ken Resnicow (kresnic@umich.edu)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and investigators assessing outcomes were not blinded to group assignment. However, it was likely that the hair stylist was aware of group allocation, which may have caused performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported registration unlikely to be affected by blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Study has minimal loss to follow‐up (< 10%)
Selective reporting (reporting bias) Low risk All outcomes appear to be reported appropriately
Other bias Low risk No other identified major biases

Reubsaet 2003.

Study characteristics
Methods Study design: RCT with pre/post‐test (2arms)
Study duration: not reported
Study follow‐up period: 1 week
Participants Country: Netherlands
Setting: classroom
Number: intervention group (125); control group (117)
*statistics regarding age and sex were only provided for the entire cohort*
Mean age: 15.4 years
Sex(% female): 51%
Interventions Baseline questionnaire was assigned before the intervention. Participants received the follow‐up questionnaire one week post‐intervention
Intervention group
  • Students in the education group were simply invited to practice filling in an invalid but realistic registration form


Control group
  • No intervention, standard classroom activities

Outcomes Primary outcome
Intention to fill out the donor registration form
Mean scores (standard deviation) for intention to donate (range from ‐3 to +3, fully disagree to fully agree). Question asked was: "Do you intend to fill‐in and return the registration form when you reach the age of 18 years?")
The authors reported that the intervention was not significantly associated with registering as a potential deceased organ and tissue donor (OR 1.47; 95% CI 0.67 to 3.25)
  • Intervention group: mean score increased from 0.90 (1.82) to 1.40 (1.59)

  • Control group: mean score increased from 1.00 (1.77) to 1.10 (1.67)

Notes Funding source: Dutch Kidney Foundation, the Dutch Ministry of Health, CZ Health Insurances and NIGZ/SDV
Study author contact: Astrid Reubsaet (a.reubsaet@gvo.unimaas.nl)
Primary outcome measure was intention to fill out the form rather than actually registering a deceased organ donor
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Insufficient detail about blinding. However, it is likely that participants are aware of group allocation and thus, high risk of performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire likely low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session likely to have minimal loss to follow up
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other major identified biases

Reubsaet 2004a.

Study characteristics
Methods Study design: cluster‐RCT
Study duration: not reported
Study follow‐up period: post‐test questionnaire administered immediately following intervention
Participants Country: Netherlands
Setting: classroom
Number: treatment group (126); control group (126)
*statistics regarding age and sex were only provided for entire cohort
Mean age ± SD: 15.88 ± 0.75 years
Sex (% female): 59%
Interventions Intervention group one (E1) and control group one (C1) received a pre‐test questionnaire two weeks prior to the intervention to determine whether or not the questionnaire had a sensitizing effect on the intervention. There was no impact found of pre‐test questionnaire on post‐test measures
Intervention groups (E1 and E2)
  • Students were shown a video on the topic of organ donation and registration. The video consisted of four episodes in which positive and negative outcome expectations regarding organ donation and registration were discussed

  • More specifically, episode one discussed brain death. Episode two explored commonly held beliefs, such as that by registering as an organ donor you could potentially be helping a person in need of an organ. In episode three, the pros and cons of registration and non‐registration of organ donation preference were discussed. Lastly, episode four touched on the importance of registering as an organ donation preference. Finally, after watching the video, students participated in a 50‐minute class discussion to talk about what they had just been presented in the video


Control groups (C1 and C2)
  • Participants in the control group did not receive any intervention

Outcomes Primary outcome
Participants intention to register as an organ donor preference and their intention to register as a posthumous organ donor
  • Participants in the intervention group were more likely than those in the control group to be willing to register their organ donation preference (OR 3.42; 90% CI 1.22 to 9.60).

  • Intention to register as a posthumous donor was found to be higher in the intervention group as compared to the control group (OR 1.85; 90% CI 1.02 to 3.34)

Notes Funding Source: Dutch Kidney Foundation, the Dutch Ministry of Health, CZ Health Insurances and NIGZ/Donorvoorlichting
Study author contact: Astrid Reubsaet (a.reubsaet@gvo.unimaas.nl)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by lack of outcome assessment blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Minimal loss to follow up
Selective reporting (reporting bias) High risk Intention score not fully reported in results
Other bias High risk Groups were imbalanced

Reubsaet 2004b.

Study characteristics
Methods Study design: cluster RCT
Study duration: not reported
Study follow‐up period: post‐test delivered immediately post‐intervention
Participants Country: Netherlands
Setting: computer‐based intervention
Number: intervention group (86); control group (100) (14 classrooms in total were randomly allocated)
*statistics regarding age and sex were only provided for the entire cohort*
Mean age ± SD: 16.02 ± 0.65 years
Sex (% female): 53%
Interventions Intervention group
  • Students received an interactive computer‐based intervention. They first completed a screening questionnaire that included questions on positive/negative outcome expectations, social outcome expectations, anxiety related to organ donation registration and past behaviour and knowledge. Students then received tailored feedback messages that were written for each item in the screening questionnaire (i.e. messages were written by professional health educators, in association with a physician and representatives of the Dutch Foundation of Donor Education). Six topics related to organ donation and registrations were then presented. These included (1) the advantages to organ donation and registration, (2) other people’s perspective of organ donation and registration, (3) whether or not organ donation is scary, (4) what they think about organ donation and registration, (5) an organ donation knowledge test and (6) whether or not they would like to receive more information about organ donation and registration


Control group
  • Students received an 11‐page brochure on the topic of organ donation and registration from the Dutch Foundation of Donor Education.

Outcomes Primary outcome
Participants intention to register as an organ donor preference and their intention to register as a posthumous organ donor. It was found the intervention did not have a significantly stronger impact on intention to register an organ donor preference, nor did it have a statistically significant impact on the intention to register as a posthumous organ donor.
No adverse events were reported in this study.
Notes Funding Source: Dutch Kidney Foundation, the Dutch Ministry of Health, CZ Health Insurances and NIGZ/Donorvoorlichting.
Study author contact: Astrid Reubsaet (a.reubsaet@gvo.unimaas.nl)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail about blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by lack of outcome assessment blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Minimal loss to follow up
Selective reporting (reporting bias) High risk Intention score not fully reported in results
Other bias Unclear risk No information about baseline

Reubsaet 2005.

Study characteristics
Methods Study design: RCT with post‐test (2 arms)
Study duration: N/A
Study follow‐up period: 1 week
Participants Country: Netherlands
Setting: classroom (39)
Number: treatment group (1287); control group (1581)
*statistics regarding age and sex were only provided for the entire cohort (n=2868)
Mean age ±SD: 16.5 ± 6.7 years
Sex (% female): 55%
Interventions Intervention group
  • First of two parts was a 50‐minute program consisting of four 5‐minute video episodes on outcome expectations and misconceptions about organ donation and importance of discussing organ donor registration with family members and group discussion. The video episodes discussed brain death, altruistic benefit of registering as a deceased organ donor, family discussion around organ donation and registration, and the importance of registering an organ donation preference independent of whether one wants to be a donor. Second part consisted of an interactive computer program that provided tailored information about organ donation and registration and an invalid but realistic donor registration form that was meant for practising


Control group
  • No intervention. During the first lesson, students in the control group were brought to another room to complete the evaluation questionnaire. One week later, students in both groups received the interactive computer program and registration training session (second part). One week after the second lesson, students in the experimental group completed the evaluation questionnaire whereas students in the control completed a questionnaire on a subject not related to organ donation and registration (physical activity)

Outcomes Primary outcome
Positive registration intention, registration as a donor, registration as a restricted donor, registration as a non‐donor, leaving the decision to their next of kin and not willing to return the registration form.
  • Intervention group (1287): Positive Registration Intention: 870 (68%); Registration as donor: 355 (28%); Registration as restricted donor: 320 (26%); Registration as non‐donor: 305 (24%); Leave the decision to next of kin: 151 (12%); Not willing to return the registration form: 124 (10%)

  • Control group (1581): Positive Registration Intention: 795 (51%); Registration as donor: 357 (23%); Registration as restricted donor: 366 (24%); Registration as non‐donor: 327 (21%); Leave the decision to next of kin: 246 (16%); Not willing to return the registration form: 250 (16%)


All outcomes significantly different P < 0.001
No adverse events were reported in this study
Notes Funding source: Dutch Kidney Foundation, the Dutch Ministry of Health, CZ Health Insurances, and NIGZ/Donor Education
Study author contact: Astrid Reubsaet (a.reubsaet@gvo.unimaas.nl)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Authors reported using "random numbers"
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Authors did not address blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by lack of blinding outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Information on non‐responder unclear and unknown amount of missing data
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias High risk Baseline groups differed on level of education. Lower response rate in experimental group from loss to follow‐up

Riccetto 2019.

Study characteristics
Methods Study design: RCT (2‐arm)
Study duration: not reported
Study follow‐up period: no follow‐up
Participants Country: Brazil
Setting: emails sent to undergraduate students at two universities
Sample size: 739 students
Mean age (years): intervention group (22.4); control group (21.9)
Sex (% males): intervention (36.6%); control group (31.6%)
Interventions Educational material promoting organ donation was sent to the intervention group before completion of the study questionnaire, while individuals in the control group completed the questionnaire without accessing the material.
Intervention group
  • Participants were sent informative material about organ donation before completion of the study survey. The material was free access, and taken from 2 non‐profit organisations that promote organ donation in Brazil


Control group
  • Participants completed the study questionnaire without receiving the educational material

Outcomes Primary outcome
Self‐reported intention to register as a donor (1‐item): “Do you intend to donate your organs after death?”
  • Intervention group: 297/347 (85.6%)

  • Control group: 353/392 (90.1%)


There were no significant group differences seen in intention to donate
Secondaryoutcome
“Opinion on organ donation had changes in 2 of 7 analyzed questions (p<0.05). Knowledge on the subject had a shift in answer patterns in 4 of 7 questions.” Did not include (assessed multiple items regarding knowledge/opinion that were not clearly defined)
  • Intervention group: opinions (7 items) and knowledge (6 items) about organ donation was also collected.

  • Control group: See above

Notes Funding source: not reported
Study author contact: e.riccetto@gmail.com
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation to group was done via SurveyMonkey software in a 1:1 manner
Allocation concealment (selection bias) Low risk Researchers were blinded to randomisation
Blinding of participants and personnel (performance bias)
All outcomes High risk Although no information is provided regarding blinding of participants, it is likely that upon receiving educational material regarding organ donation that they would be aware of their group allocation. Since the study questionnaire was administered after accessing the educational material, there is potential for performance bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Although there was no blinding for outcome assessment, questionnaire responses were categorical and self‐completed, and thus unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Questionnaires were completed immediately following access to material, and thus there was low attrition
Selective reporting (reporting bias) Low risk Results from all 20 questions included in the survey were fully reported
Other bias Low risk No other major biases identified

Rodrigue 2012.

Study characteristics
Methods Study design: cluster RCT (randomisation was stratified by Florida region, due to variability in population demographics)
Study duration: not reported
Study follow‐up period: 17 months (6 month baseline phase, 3 month intervention phase, 8 month follow‐up phase)
Participants Country: USA
Setting: Department of Motor Vehicles offices
Number: treatment group (15); control group (15)
Mean age: not reported
Sex: not reported
Interventions Intervention group
DMV offices displayed standard organ donation materials, received letter from the state director regarding the importance of organ donation, the role of the DMV in organ donation and the administration's commitment to the study. The experimental group also received staff training led by a Donate Life Florida liaison and a donor family representative and/or transplant recipients. Staff were also provided with Donate Life t‐shirts and label pins. Volunteers also staffed information tables at various points and invited people to visit. In addition, DMV staff had lunch and learn sessions led by organ procurement organisation representatives and included participation by donor family or recipient. These sessions emphasised the need for donation, myths and highlighted the DMV's role in facilitating transplantation. They also encouraged friendly competition among DMV offices assigned in the experimental group and given feedback. The experiment was conducted during a 3‐month period
Control group
  • DMV offices provided a passive display of organ donation materials

Outcomes Primary outcome
Donor registration rates (measured at baseline, during the intervention, and a follow‐up period post‐intervention)
* Of the original 30 DMV offices included in the study, 2 offices in the intervention group closed, and 2 control offices closed, leaving a total of 26/30 (13 for both intervention and control)
  • Intervention group: 36% donor registration rate

  • Control group: 29% donor registration rate


* The experimental group had a significantly higher aggregate monthly donor designation rate compared to the control group (10% vs 1%, p=.02), however, these increases in donor designation rates were not maintained in the months after the DMV‐based intervention was withdrawn (p=.13).
No adverse effects reported in this study
Notes Funding source: Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation, grant no. D71HS08576
Study author contact: James R. Rodrigue (jrrodrig@bidmc.harvard.edu)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Insufficient detail about blinding however, it is unlikely that blinding would affect participants performance
Blinding of outcome assessment (detection bias)
All outcomes Low risk Donor registration not likely affected by detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Less than 10% loss to follow up
Selective reporting (reporting bias) High risk Outcomes not reported completely. (e.g. total number of new registrations)
Other bias Low risk No other major biases identified

Rodrigue 2015.

Study characteristics
Methods Study design: cluster RCT
Study duration: May 2012 to December 2014
Study follow‐up period: 15 months (5 months baseline phase, 5 months intervention phase, 5 months follow‐up phase)
Participants Country: USA
Setting: motor vehicle offices
Number: treatment group (16); control group (12)
Age (mean proportion ± SD): treatment group (male: 45.22 ± 4.76; female: 52.91 ± 5.58); control group (male: 45.28 ± 4.7; female: 54.81 ± 5.01)
Sex (mean proportion of age range ± SD): treatment group (< 30 years: 61.77 ± 8.24; 30 to 55 years: 51.70 ± 5.84; > 55 years: 36.95 ± 4.65); control group (< 30 years: 61.17 ± 6.90; 30 to 55 years: 54.95 ± 5.00; > 55 years: 38.38 ± 4.05)
Interventions Department of Motor Vehicle offices were randomized using a mixed randomization scheme. Ten offices were identified as serving moderate‐high proportions of ethnic/racial minorities, and these offices were randomized first into 2 groups (usual care, usual care + video intervention). A simple randomization scheme was used to allocate the remaining 18 offices into two groups
Intervention group
  • Video intervention (videos ran sequentially on a repetitive loop during all hours of office operation, for 5 consecutive months). A continuous series of 5 video segments were looped sequentially on monitors installed in motor vehicle office waiting areas (1 monitor per intervention office). All videos were displayed without sound, with subtitles. Videos featured local individuals and highlighted the positive impact of organ donation (from the point of view of a 6‐year‐old transplant recipient), the negative impact of organ donor shortage (from the perspective of a 37‐year‐old on the waiting list), the negative impact of not documenting one's donation intentions (from the perspective of a family of a 20‐year‐old who died waiting for a transplant), and the benefit of documenting one's donation intentions (from the family of an 18‐year‐old who died in an automobile accident, and who donated his organs due to his donor designation documentation). In addition, there was an informational video (produced by Health Resources and Services Administration) that emphasises the need for organ donation to facilitate transplants for the thousands of people on the waiting list


Control group
  • A director conducts an annual organ donation awareness workshop for motor vehicle office staff, and ensures that all offices have visible point‐of‐decision organ donation materials (i.e. signing mats, posters, brochures) in waiting areas and transaction counters. In addition, the director ensures that patient and donor family volunteers visit motor vehicle office staff regularly (volunteers periodically staff tables with organ donation information in motor vehicle office waiting rooms, and interact with the staff by describing their personal stories and thanking the staff for their role in introducing the organ donation option to customers

Outcomes Primary outcome
Aggregate monthly donor designation rates
  • Intervention group: 50.5% mean monthly % of registered donors

  • Control group: 48% mean monthly % of registered donors


A significant group effect was observed during the intervention phase (P = 0.1) The usual care group had a significantly higher aggregate monthly donor designation than the intervention group
No adverse events were reported in this study.
Notes Funding source: Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) under grant numbers D71HS22061 and D71HS24204.
Study author contact: James R. Rodrigue (jrrodrig@bidmc.harvard.edu)
912 customers were interviewed following transactions
Percentage of new donor designations: 418/912 (45.8%) reported being a registered donor before visiting the motor vehicle office. Only 207/418 (49.5%) of those previously registered reporting renewing their registration as a donor
Uptake of different organ donation materials: 475/912 (52.1%) reported seeing at least 1 organ donation messaging during their visit. Donation poster was the most commonly seen (307, 33.7%), whereas 18.9% (172) reported watching the organ donation intervention video
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Lack of blinding of participants and personnel unlikely to affect outcome
Blinding of outcome assessment (detection bias)
All outcomes Low risk Verified donor registration status unlikely to be affected by lack of blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No offices closed or withdrew from the study
Selective reporting (reporting bias) High risk Unable to identify the total number of registered donors in each group
Other bias Unclear risk Insufficient detail about baseline differences among the groups

Rodrigue 2019.

Study characteristics
Methods Study design: cluster RCT (4‐arm)
Study duration: July 2015 to February 2018
Study follow‐up period: not reported for primary outcome; 1‐week follow‐up for secondary outcomes only
Participants Country: USA (Massachusetts)
Setting: Driving schools
Number: intervention groups (611); historical comparison group (1575)
Mean age: intervention group (15.9 years); historical comparison group (not reported)
Sex (% females): intervention groups (48%); historical comparison group (not reported)
Interventions All videos were 6 minutes long
Informational video
  • Included information about the supply‐demand problem in transplantation, common reasons for/against donor designation, donation myths, and how to register as a donor (segments taken from Organ Donation and Transplantation: How Does it Work?). No personal testimonials included.


Testimonial video
  • 4 personal testimonials about transplantation/donation. Few facts were included about donation.


Blended video
  • Featured segments from both the informational/testimonial videos.


Intervention group
  • Participants in the intervention group were shown 1 of the 3 videos in class. Three questionnaires were completed immediately before, shortly after, and 1 week following their exposure to the donation engagement, which measured the secondary outcomes of knowledge, attitudes, beliefs, and donor designation likelihood. A fourth questionnaire was mailed to parents afterwards to enquire about their designation status, attitude, and likelihood to follow their adolescent’s donation wishes


Control group
  • The control group was a regionally matched historical comparison group consisting of donor designation data of 1575 adolescents that obtained their driver’s license in the 6 months preceding study enrolment

Outcomes Primary outcome
Donor designation status at the time first driver’s license was issued (yes/no)
  • Informational video: 95/187 (51%)

  • Testimonial video: 124/194 (64%)

  • Blended video: 121/186 (65%)

  • Control group: 789/1575 (50%) of the historical comparison group registered as donors


Donor designation rates were significantly higher for adolescents in the testimonial or blended group than in the informational and historical comparison groups (P = 0.013)
Secondary outcomes
“Questionnaires assessing donation engagement, knowledge, attitude, beliefs, and intention before the intervention, after the intervention, and at 1‐week follow‐up” (pre‐post, 1 week follow‐up)
Participants in the informational group (P < 0.001; d = 0.45) and blended group (P < 0.001; d = 0.69) had more knowledge gains after the intervention than the testimonial group (P = 0.22; d = 0.09)
There was no significant messaging x time interaction effect for donation engagement, attitude, and beliefs or for designation likelihood. However, there was a significant interaction effect for donation knowledge (P = 0.03)
Intention at 1‐week follow‐up
  • Informational: 7.64 (2.7)

  • Testimonial: 8.10 (2.7)

  • Blended: 8.13 (2.3)

  • Control: not reported

Notes Funding source: Grant R39OT26988 from the Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation
Study author contact: jrrodrig@bidmc.harvard.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Group assignment was done in a 1:1:1 ratio, with an equal number of sealed envelopes that were picked at random by classrooms. Thus, low risk of selection bias
Allocation concealment (selection bias) Low risk Group allocation was concealed using sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Classroom instructors/research assistants were not blinded to group assignment. However, primary outcome (donor designation status) is objective and unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Primary outcome of donor designation status was accessed by Department of Transportation staff members who were blinded to study’s purpose and group assignment
Incomplete outcome data (attrition bias)
All outcomes Low risk Primary outcome data was available for 93% of the study participants and 100% of the control participants. 100% of secondary outcome pre/post‐test surveys were collected from participants
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Low risk No other bias identified

Sallis 2018.

Study characteristics
Methods Study design: quasi‐RCT (equal ratio alternate allocation)
Study duration: 24 June 2013 to 19 July 2013
Study follow‐up: N/A
Participants Country: England, Scotland, Wales
Setting: online
Number: social norms (135,537); social norms + image (133,990); social norms + logo (135,471); loss frame (136,528); gain frame (136,963); reciprocity (136,349); cognitive dissonance (135,229); control (135,225)
*since participants were individuals who were renewing their road tax or registering online for a driver's license on a government website, no data is available regarding mean age or sex*
Interventions Participants were quasi‐randomly assigned to one of eight conditions using a JavaScript randomisation code embedded in the government website. Participants read a message specific to the intervention, before being asked to join the National Health Service Organ Donor Register.
Social norm
  • Participants read the message "every day thousands of people who see this page decide to register"


Social norm + logo
  • Participants read the message "every day thousands of people who see this page decide to register (plus logo)"


Social norm + image
  • Participants read the message "every day thousands of people who see this page decide to register (plus image)"


Loss frame
  • Participants read the message "three people die every day because there are not enough organs"


Gain frame
  • Participants read the message "you could save or transform up to 9 lives as an organ donor"


Reciprocity
  • Participants read the message "if you needed an organ transplant would you have one? If so please help others."


Cognitive dissonance
  • Participants read the message "if you support organ donation please turn your support into action"


Control
  • No message

Outcomes Primary outcome
Registration in the organ donor registry Registration was greatest in the reciprocity condition, with individuals 1.38x more likely to register than controls.
  • Social norm: 3858/135,537 registered (2.8%). Individuals were 1.25x more likely to register (95% CI 1.2 to 1.31, P < 0.001)

  • Social norms + image: 2879/133,990 registered (2.1%). Individuals were less likely to register (OR 0.94; 95% CI 0.89 to 0.99, P < 0.05)

  • Social norms + logo: 3911/135,471 registered (2.9%). Individuals were 1.27x more likely to register (95% CI 1.21 to 1.33, P < 0.001)

  • Loss frame: 4119/136,528 registered (3%). Individuals were 1.33x more likely to register (95% CI 1.27 to 1.40, P < 0.001)

  • Gain frame: 3883/136,963 registered (2.8%). Individuals were 1.25x more likely to register (95% CI 1.19 to 1.31, P < 0.001)

  • Reciprocity: 4256/136,349 registered (3.1%). Individuals were 1.38x more likely to register (95% CI 1.32 to 1.45, P < 0.001)

  • Cognitive dissonance: 3781/135,229 registered (2.8%). Individuals were 1.23x more likely to register (95% CI 1.17 to 1.29, P < 0.001)

  • Control: 3085/135,225 registered (2.3%)

Notes Funding source: Study reported that no direct funding was required for this project. The UK Cabinet Office, UK Department of Health, UK GDS and UK NHSBT provided the human resources.
Contact information: Anna Sallis, ku.vog.ehp@sillas.anna
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Although quasi‐RCT, randomisation was computer‐generated embedded as part of the trial
Allocation concealment (selection bias) Low risk Used computer to allocate
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were not aware they were participating in a trial, and research personnel were not directly involved in the data collection procedure.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Measured outcome was registration in an organ donor registry
Incomplete outcome data (attrition bias)
All outcomes Low risk All outcome data appear to be complete
Selective reporting (reporting bias) Low risk All data appear to be reported
Other bias Low risk No other identified source of bias

Siegel 2016.

Study characteristics
Methods Study design: RCT
Study duration: November 2015
Study follow‐up period: N/A
Participants Country: USA
Setting: online (Amazon MTurk)
Number: 163 (number in intervention and control group not reported)
*statistics regarding age and sex were only provided for the entire cohort*
Mean age ± SD: 37.48 ± 13.02 years
Sex (% female): 46%
Interventions Researchers posted a survey on MTurk with no eligibility requirements associated with potential participants donor registration status. Following a series of screening questions, participants who matched the qualification criteria (i.e., non‐registered organ donors and who saw themselves as eligible) were invited to participate in the main study. Participants were assigned to either an intervention (DMV) or control group following their given consent to participate
Intervention group
  • Participants were asked to reflect on their own frustrating DMV experiences following the reading of a vignette (a story of another person’s frustrating (i.e. terrible service, long lines and lost time) DMV experience). Once this was completed, they moved on to the post‐test measures asking for demographics and their intention to register as an organ donor


Control group
  • Completed only the post‐test measure of the study (intention to register as an organ donor and demographic questions)

Outcomes Primary outcome
Intention to register as an organ donor
  • Intervention group: participants had a significantly lower donor registration intention in comparison to the control group (50.04 ± 29.38)

  • Control group: participants had a significantly greater donor registration intention in comparison to the intervention (DMV) group (39.32 ± 33.87)


No adverse events were reported
Notes Funding source: Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number R39OT26990.
Study author contact: Jason T. Siegel (Jason.siegel@cgu.edu)
Description of study abstracted from study 3.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Low risk Insufficient detail about allocation concealment however, online survey administered by MTurk unlikely to be affected by lack of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding of participants and personnel was not addressed. However, unlikely that participants participating in an online survey would be aware of their group assignment
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected self‐reported questionnaire
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data
Selective reporting (reporting bias) Low risk All results appear to be reported
Other bias Low risk No other major biases identified

Skumanich 1996.

Study characteristics
Methods Study design: RCT (2 arms)
Study duration: not reported
Study follow‐up period: N/A
Participants Country: USA
Setting: classroom
Number: 169 (no number provided for intervention and control groups)
*statistics regarding age and sex were only provided for the entire cohort (169)*
Mean age: 20.73 years
Sex (% female): 55%
Interventions During class time, subjects randomly received one of two organ donation brochures with uniform organ donor cards attached to the inside, along with a survey form. They were asked to read through the brochure and answer the survey questions. Upon completing the survey, they handed back the survey and brochure, but were given the option of keeping the organ donor card
Intervention group
  • The intervention brochure contained a combination message, which included positive affirmations about donation and fear refutation statements. The combination message was prefaced by an empathy arousal cue (i.e. narrative statement based on a story of a person undergoing a transplant procedure)


Control group
  • The control brochure contained the combination message only

Outcomes Behavioural intention to sign donor card ‐ ranged from 1 (definitely sign) to 5 (definitely not sign)
Empathy arousal was significantly associated with keeping donor card
Notes Funding source: not reported
Study author contact: not reported
Results per group were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient detail about random sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient detail about allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Unlikely that blinding of participants and personnel would affect outcome
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Minimal loss to follow up
Selective reporting (reporting bias) High risk Results not fully reported. Only effect sizes
Other bias Unclear risk Baseline characteristics not reported

Smits 2006.

Study characteristics
Methods Study design: RCT (2 arms) with a post‐test only
Study duration: not reported
Study follow‐up period: 1 week
Participants Country: Netherlands
Setting: classroom
Number: treatment group (152); control group (163)
*statistics regarding age and sex were only provided for the entire cohort (n = 319)*
Mean age ± SD: 16.5 ± 0.7 years
Sex (% female): 53%
Interventions Intervention group
  • Five kidney patients gave a 45‐minute presentation during school hours to a group of students. All of the educators (2 females and 3 males, between the ages of 44 and 64 years‐old) had suffered from a kidney disease, had undergone dialysis and all carried functioning donor kidneys. The presentation was broken down into three sections, with ten minutes spent presenting basic facts about organ donation and the Dutch registration system, 20 minutes spent with patients discussing their own experiences as a kidney patient and the last 15 minutes allowed for students to ask and discuss any questions/issues about organ donation/transplantation with the patient educators


Control group
  • Participants completed a written questionnaire to measure their feelings/perceptions regarding organ donation and registration. This group received no specific educational information on organ donation

Outcomes Primary outcome
Participants intention to fill out and return the organ donation registration form, intention for registration choice, beliefs and attitudes related to organ donation registration, self‐efficacy and knowledge
  • Intervention group

    • Not sending back the form: 11.8%

    • Leaving the decision to the next of kin: 8.6%

    • Not willing to donate: 28.3%

    • Registering as a donor for specific organs or tissue: 24.3%

    • Registering as a donor without restrictions: 27%

    • Intended to register: 78/152, 51.3%

  • Control group

    • Not sending back the form: 17.2%

    • Leaving the decision to the next of kin: 18.4%

    • Not willing to donate: 21.5%

    • Registering as a donor for specific organs or tissue: 22.7%

    • Registering as a donor without restrictions: 20.2%

    • Intended to register: 70/163, 42.9%


Results were not significantly different. Authors did not report proportion but noted that experimental group were more willing to fill in registration form compared to control (P<0.001). More students from the experimental group reported to be willing to donate organs posthumously. However, a larger proportion of students in the experimental group did not want to donate their organs after death in comparison to the control.
More members of control group would not send back the form and would leave the decision to others (35.6% versus 20.4%)
Notes Funding source: Institute HEALTH, University of Maastricht, The Netherlands.
Study author contact: Bart van den Borne (b.vdborne@gvo.unimaas.nl)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Did not specify random sequence
Allocation concealment (selection bias) Unclear risk Did not specify any methods of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information about blinding of participants
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported questionnaire unlikely to be affected by outcome detection
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient detail about participants loss to follow‐up
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias Unclear risk Was not clear if randomisation was at the student level or classroom. Experimental group had more students living in urban environment

Steenaart 2018.

Study characteristics
Methods Study design: cluster RCT (2‐arm)
Study duration: September 2017 to June 2018
Study follow‐up period: 6 months to 1 year post‐intervention (follow‐up results not included, authors citing high attrition)
Participants Country: Netherlands
Setting: school‐based
Targeting lower education students through schools for Intermediate Vocational Education (IVE)
Sample size: intervention group (45 classes); control group (43 classes); 1170 students
Mean age ± SD (years): intervention group (18.05 ± 1.99); control group (18.04 ± 2.06)
Sex (% male): intervention group (33.8%); control group (29.5%)
Interventions Overview
Effectiveness of the intervention was evaluated in a post‐test only design. Intervention group received the in‐person intervention followed by the study questionnaire. Control group completed the questionnaire prior to receiving the intervention.
Intervention group
  • Two 50‐min lessons addressing 3 elements. First lesson involved watching video fragments, followed by plenary discussion (focused on increasing involvement, encouraging positive beliefs, and counterbalancing negative beliefs). Second lesson involved students receiving tailored feedback on misconceptions they may have had by individually working with 2 quizzes on the study website. Also filled in a simulated organ donation registration form (to enhance self‐efficacy)


Control group
  • Control involved the study questionnaire being administered/completed before the intervention

Outcomes Primary outcome
Self‐reported intention to register as a donor (yes/no/don’t know)
251/1170 had already registered
  • Intervention group: students in intervention group had higher odds of having positive registration intentions (OR 1.81; 95% CI 1.10 to 2.96). After adjusting for sex, age, educational level, migration background, religion, having had education about organ donation before, the finding was still significant (OR 1.74; 95% CI 1.11 to 2.73)


Count data not reported in paper but authors contacted and provided:
  • 899 valid yes/no data points

  • Intervention group: 242/459 (52.7%)

  • Control group: 177/440 (40.2%)


Secondary outcomes
The questionnaire assessed demographics, registration behaviour, registration intention and beliefs regarding organ donation
  • Intervention: no significant effects were found for intention to register as a donor (OR 1.08; 95% CI 0.67 to 1.73)

  • No significant differences in the 11 beliefs measured regarding organ donation were found

  • Control group: see above

Notes N/A
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Authors stated that computer software was used to randomly assign classes to intervention
Allocation concealment (selection bias) Unclear risk No information provided regarding allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Teachers delivered the educational intervention. Thus, blinding was not done in this study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Although researchers were not blinded, questionnaires were completed by participants themselves. Thus, lack of blinding is unlikely to influence outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Protocol is available, and primary and secondary outcomes are fully reported
Selective reporting (reporting bias) Low risk All outcomes appear to be reported
Other bias High risk High dropout “due to problems with planning the lessons or staff turnover”

Thornton 2012.

Study characteristics
Methods Study design: cluster RCT pre/post test (2 arms)
Study duration: July 2008 to December 2009
Study follow‐up period: N/A
Participants Country: USA
Setting: DMV offices (12 offices)
Number: intervention group (443); control group (509)
Mean age ± SD (years): intervention group (24 ± 10); control group (25 ± 12)
Sex (% male): intervention group (48%); control group (46%)
Interventions Participants were randomised to either an intervention or control group using a random‐number table with centralised allocation concealment (sealed envelopes)
Intervention group
  • Participants were asked to watch a 5‐minute video viewed on an iPod with noise‐cancelling headphones. The video addressed 6 concerns: (1) desire not to think about death and subsequent disfigurement, (2) concern that potential donors may not receive adequate medical care if found to be carrying a donor card, (3) distrust of the medical establishment, (4) belief that religion may not support donation, (5) desire to be buried with organs intact, and (6) lack of knowledge about the need for organs. It showed a discussion among an ethnically diverse group of 20 people (i.e. organ donors/recipients, family members of organ donors/recipients, and family members of those who died while waiting for organ transplants). After watching the video, entering/exiting the DMV and being interviewed by study staff, participants were then provided written information on organ donation (by Life‐banc and the Cleveland branch of the Minority Organ Tissue Transplant Education Program)


Control group
  • Participants entered/exited the DMV, were interviewed by study staff and received the same written information as the intervention group (as described above)

Outcomes Primary outcome
Organ donor designation (license, learner's permit, or identification card) (a total of 952/5207 DMV patrons were included in the final analysis (intervention group (443), control group (509))
  • Intervention group: 372/443 (84%) of participants registered for organ donation as verified on the driver's license, permit or identification card. The adjusted OR for consenting to organ donation for the intervention group was 2.05 (95% CI 1.49 to 2.81). Intervention effect was more evident among black participants (76% versus 54%, 22% absolute difference (95% CI 9 to 35))

  • Control group: 369/509 (72%) registered.


No adverse events were reported in this study
Notes Funding source: National Institute on Minority Health and Health Disparities (grant 1‐P60MD002265‐01), National Center for Research Resources (grant UL1RR024989), and Robert Wood Johnson Harold Amos Medical Faculty Development Program.
Study author contact: J. Daryl Thornton (daryl.thornton@case.edu)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Authors used random‐number table to generate random sequence
Allocation concealment (selection bias) Low risk Randomisation schedule was concealed using sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and investigators assessing outcomes were not blinded to group assignment. However, it was likely that DMV staff was blinded to the group assignment of the study participants given that the intervention occurred outside of each DMV branch
Blinding of outcome assessment (detection bias)
All outcomes Low risk Verification of donor registration status on drivers license is likely low risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Minimal people discontinued the intervention or the control. However there was no details about those who withdrew or refused to show their license
Selective reporting (reporting bias) Low risk All outcomes reported appropriately
Other bias Low risk No other major biases identified

Thornton 2016.

Study characteristics
Methods Study design: RCT
Study duration: February 2013 to May 2014
Study follow‐up period: not reported
Participants Country: USA
Setting: primary care clinics
Number: intervention group (456); control group (459)
Mean age ± SD (years): intervention group (51 ± 13); control group (52 ± 12)
Sex (% male): intervention group (32%); control group (34%)
Interventions Intervention group
  • A 5‐minute video (shown on iPads) was presented to participants showing an impromptu discussion among an ethnically diverse group of 20 people of various ages, with various relationships to organ donation/transplantation. In the video, both living and deceased organ donation was discussed. After watching the clip, patients chose one of 12 possible questions regarding barriers to donation that they could discuss with their primary care physician (patients were also given the option to make up their own question if they chose)


Control group
  • Patients met with their primary care physician as per usual (no intervention).

Outcomes Primary outcome
Organ donor designation (on the Ohio electronic donor registry or by donor card)
  • Intervention group: 100/456 (22%) patients consented to organ donation

  • Control group: 71/459 (15%) patients consented to organ donation


* Intervention patients were more likely compared to control to consent to donate organs (adjusted OR 1.5; 95% CI 1.10 to 2.13)
Secondary outcome
Willingness to donate, willingness to donate a kidney while living, frequency of patient discussions with primary care provider, patient satisfaction with time spent with their primary care provider, discussion of living wills
  • Intervention patients were more willing to sign up to be a donor in the near future (adjusted OR 1.38; 95% CI 1.06 to 1.78)


No adverse events were reported in this study
Notes Funding source: grants P60MD002265 and UL1TR000439 from the National Institutes of Health, and grants R39OT22056 and R39OT26989 from the U.S. Department of Health and Human Services Health Resources and Services Administration
Study author contact: J. Daryl Thornton (daryl.thornton@case.edu)
At the beginning of the study, computer‐generated randomized group assignments were created and placed in sealed, consecutively numbered, opaque envelopes (study staff opened these envelopes at the clinic site, revealing the study arm designation). Study staff visited clinics in an order/time determined with computer‐generated random assignment.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomised using computer‐generated randomised group assignments
Allocation concealment (selection bias) Low risk Group assignments were placed in sealed, consecutively numbered, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes High risk Study staff was not blinded to study arm assignment, which could have biased the results given that they asked participants to register for organ donation at the end of the study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Although study staff was not blinded to study arm assignment, it is unlikely that lack of blinding of outcome assessment would affect verified donor registration
Incomplete outcome data (attrition bias)
All outcomes Low risk Single session and low attrition rate
Selective reporting (reporting bias) Low risk All outcomes appeared to be reported
Other bias Low risk No other major biases identified

Thornton 2019.

Study characteristics
Methods Study design: RCT (3‐arm)
Study duration: recruitment occurred via email from September to December 2014
Study follow‐up period: no follow‐up
Participants Country: USA
Setting: Online; students at 3 north‐eastern Ohio universities
Sample size: animated (753); live‐action (755); control (753)
Mean age ± SD (years): animated (24.5 ± 8.4); live‐action (24.9 ± 9.1); control (25.0 ± 8.7)
Sex (% female): animated (57.1%); live‐action (56.5%); control(58.7%)
Interventions Overview
Students viewed content of their treatment arm online, and were then immediately directed to an online questionnaire with an option to access their state’s donor registry website to enrol as a donor.
Intervention groups
  • Animated: a 5 minute animated video (“Organ Donation and Transplantation: How Does It Work?) produced by the US Department of Health and Human Services Division of Transplantation was viewed. The video explains the donation/transplantation process, including the waiting list, the process to become a donor, how organ matching works, etc

  • Live‐action: a 5‐minute video (“Won't you Help?) with an emotional appeal that contained a non‐scripted discussion among an ethnically‐diverse group of 20 people with various relationships with donation/transplantation was viewed. It addressed 6 common concerns regarding the donation process identified by previous research


Control group
  • Control participants visited a website containing information from the Center for Disease Control's (CDC) about health and wellness in adolescents and young adults. The information focused on healthy and preventive behaviours, as well as protective factors to mitigate life stressors

Outcomes Primary outcome
Self‐reported readiness to consent to organ donation (register today; register within next 6 months)
  • Register today

    • Animated: 30/753 (4.0%)

    • Live‐action: 30/755 (4.0%)

    • Control: 21/753 (2.8%)

  • Register within next 6 months

    • Animated: 114/753 (15.2%)

    • Live‐action: 134/755 (17.8%)

    • Control: 73/753 (9.7%)


Secondary outcomes
Agreed to visit state donor registry to consent to donate
  • Animated: 42/753 (5.6%)

  • Live‐action: 64/755 (8.6%)

  • Control: 39/753 (5.2%)

Notes Funding source: National Institute on Minority Health and Health Disparities and the US Department of Health and Human Services Health Resources and Services Administration.
Study author contact: daryl.thornton@case.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online Qualtrics software randomly assigned students to 1 of 3 treatment arms
Allocation concealment (selection bias) Low risk Study personnel were not involved in the randomisation process
Blinding of participants and personnel (performance bias)
All outcomes Low risk Study personnel were blinded to group allocation, as well as participants
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcomes measured were categorical/objective and unlikely to be affected by bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Questionnaire was administered immediately following intervention
Selective reporting (reporting bias) Low risk All outcomes fully reported
Other bias Low risk No other bias identified

M/F ‐ male/female; N/A ‐ not applicable; OR ‐ odds ratio; RCT ‐ randomised controlled trial; RR ‐ relative risk; SD ‐ standard deviation; SE ‐ standard error

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
ACRE 2009 Not relevant to deceased organ donation
Barnieh 2011 Not relevant to deceased organ donation
Bonfiglio 2014 Not relevant to deceased organ donation
Dew 2013 Not relevant to deceased organ donation
Dijker 2019 Donor registration was not the outcome variable
ELITE 2013 Not relevant to deceased organ donation
Gordon 2016 Not relevant to deceased organ donation
Hart 2012 Not relevant to deceased organ donation
HOUSE CALLS 2012 Not relevant to deceased organ donation
KTAH 2012 Not relevant to deceased organ donation
Lin 2014 Study measured intention to advocate organ donation rather than intention to donate
Living ACTS 2014 Not relevant to deceased organ donation
LOVED 2017 Not relevant to deceased organ donation
Mayrhofer 2006 Study measured parent's intention to consent for organ donation for their child rather than themselves
McDonald 2007 Measured willingness to communicate their decision to become an organ donor with their family
McDonald 2013 Not relevant to deceased organ donation
NCT01048437 Not relevant to deceased organ donation
NCT01786525 Not relevant to deceased organ donation
NCT01855438 Not relevant to deceased organ donation
Philpot 2016 Measured reflection of video and not organ donor registration
Piccoli 2004 Did not look at the outcome measures of interest (i.e. assessed opinions on deceased organ donation)
PREPARED 2012 Not relevant to deceased organ donation
Rodrigue 2007 Not relevant to deceased organ donation
Siegel 2015 Not relevant to deceased organ donation
Siminoff 2015 Study measuring family consent to organ donation
Studts 2010 Not relevant to deceased organ donation
Sullivan 2012 Not relevant to deceased organ donation
TALK 2011 Not relevant to deceased organ donation
TALKS 2015 Not relevant to deceased organ donation
Vinokur 2006 Did not look at the outcome measures of interest (i.e. assessed contact with registry but not verified or self‐reported registration)
Wang 2018b Not focused on evaluating the effects of an intervention
Waterman 2015 Focus on living kidney donation / did not measure organ donation registration behaviour
Whisenant 2012 Measured attitudes towards organ donation and did not clearly specify any questions related to organ donation registration behaviour
YPT 2014 Study examined knowledge and small action steps towards donation, but no donation behaviours

Characteristics of ongoing studies [ordered by study ID]

ACTRN12614000690651.

Study name Increasing organ donor registration rates among TAFE students: a cluster randomized controlled trial of brief and enhanced information videos
Methods Three‐arm cluster RCT
Participants Location: Newcastle, Australia
Participants: students who were enrolled in a TAFE class, present on the day of the baseline survey was delivered who can read and understand English and who were over the age of 16 years‐old
Interventions Students will be randomised into one of 3 conditions (brief video, enhanced video or control). All we complete a baseline and one‐month follow‐up survey covering registration status and knowledge and attitudes towards organ donation
Intervention groups will view a video‐based intervention either covering a) a brief informative video about organ donation or b) an enhanced informative video with an interview with an organ donation recipient and relative. They will also be given the opportunity to complete an organ donor registration form
Control: no intervention
Outcomes Primary outcome: number of students registered on the Australian Organ Donor Register measured by self‐report and validated using the number of registration forms returned
Secondary outcome: number of students reporting having had family conversations about organ donation measured using a questionnaire developed by the research team
Starting date 4/08/2014
Contact information Prof Rob Sanson‐Fisher (email: rob.sanson-fisher@newcastle.edu.au)
Notes Recruitment has been completed

Andrews 2012a.

Study name Peer mentoring to increase deceased organ donation among ESRD patients
Methods Cluster RCT
Participants Location: Michigan, USA
Participants: ESRD (92) patients in various dialysis units across Southeast Michigan
Interventions Dialysis units will be randomised into either an intervention or control group
Intervention: patients will be assigned a peer mentor with who they will meet with 7 times over a 4‐month period (via both in‐person and phone contacts). In these discussions they will cover topics such as coping with chronic illness, leaving a legacy through organ donor registration and signing onto the Donor Registry
Control: will receive mailings about organ donation and the Donor Registry
Outcomes Primary outcome: donor registrations through both mail and internet
Secondary outcome: surveys will evaluate feasibility, change in patient’s organ donation knowledge and attitudes, self‐reported donation status, hope and quality of life.
Starting date N/A
Contact information Unknown
Notes Abstract Only

iDecide 2010.

Study name iDecide Study
Methods Parallel RCT
Participants Location: Hawaii
Participants: anyone registered as an undergraduate student at University of Hawaii at Manoa, University of Hawaii at Hilo, or Hawaii Pacific University over the age of 18 years (estimated 4500 participants)
Interventions Experimental: web intervention using an interactive website, social media and ramification (i.e. iDecide Hawaii)
Control: no intervention
Outcomes Primary outcome: donor status (time frame: 2 years); number of subjects who are designated as an organ donor on license/donor registry.
Secondary outcome: talk to peers/family (time frame: 2 years); number of subjects who report talking to family members or peers about their choice to be an organ donor
Starting date November 2014
Contact information 1. Cheryl Albright, PhD, MPH (tel: 808‐956‐9716; email: cherylal@hawaii.edu)
2. James M Kowalski (tel: 808‐956‐4968; email: jamesmk@hawaii.edu)
Notes Ongoing study/abstract only

NCT02318849.

Study name Online Intervention for ANHPI College Students (iDecide)
Methods Parallel RCT
Participants Registered undergraduate student at University of Hawaii at Manoa, University of Hawaii at Hilo, or Hawaii Pacific University; over the age 18 years
Interventions Intervention: Online intervention that uses information, engaging contests, and advocacy drives to encourage college students to become designated organ donor on driver's license
Control: no interaction
Outcomes Donor status: percent of subjects who are designated organ donor on license/donor registry (at 2 years)
Talk to peers/family: percent of subjects who report talking to family or peers about choice be organ donor (at 2 years)
Starting date 20 November 2014
Contact information Cheryl Albright; University of Hawaii
Notes Recruitment completed

RegisterNow‐1 2017.

Study name Promoting Organ Donor Registration in Family Physician Offices
Methods Stepped‐wedge cluster randomized trial.
Participants Location: Ontario, Canada
Participants: Participants are patients that visited a family physician who are at least 16 years‐old with a valid Ontario health card (eligibility criteria to register for organ donation in Ontario).
Interventions Experimental: Reception staff providing handout; Mobile tablet that provides the immediate opportunity for patients to register in the waiting room.
Control: No intervention.
Outcomes Primary outcome: Donor registration status at 7 days (Yes/ No registered).
Secondary outcome: Donor registration status at 14 days; Donor registration status at 30 days
Starting date September 2017
Contact information Alvin Li, PhD (tel: 519‐685‐8500 ext. 58502; email: alvin.li@lhsc.on.ca)
Justin Presseau, PhD (tel: 613‐737‐8899 ext. 73821; email: jpresseau@ohri.ca)
Notes  

Yee 2014.

Study name Comparison of Staff vs Patient Attitudes on Organ and Tissue Donation
Methods Cluster randomized design controlled intervention study.
Participants Location: Michigan, United States
Participants: Staff and dialysis patients at twelve dialysis units in Southeast Michigan.
Interventions Experimental: Staff and dialysis patients at dialysis units completed baseline surveys on knowledge and attitudes about organ donation, as well as intent to donate, prior to receiving organ donation education.
Control: No control group.
Outcomes Primary outcome: Intention to register as an organ donor/donate organs (comparison of dialysis unit staff and patients receiving dialysis treatment).
Secondary outcome: Knowledge and attitudes on organ donation.
Starting date Unknown.
Contact information Unknown.
Notes N/A

ESRD ‐ end‐stage renal disease; RCT ‐ randomised controlled trial

Differences between protocol and review

Controlled before‐after studies were not included; only RCTs were included.

Contributions of authors

  1. Draft the protocol: AHL, KLN

  2. Study selection: AHL, ML, AD, KLN, JC

  3. Extract data from studies: AHL, ML, AD, KLN, JC

  4. Enter data into RevMan: AHL, AD, JC

  5. Carry out the analysis: AHL, JC

  6. Interpret the analysis: AHL, ML, AD, JP, KLN, AXG, JC

  7. Draft the final review: AHL, ML, AD, JP, JC

  8. Disagreement resolution: JP, AXG

  9. Update the review: AHL, ML, JC

Sources of support

Internal sources

  • Nil, Other

External sources

  • No sources of support supplied

Declarations of interest

Alvin H Li has declared that they have no conflict of interest

Marcus Lo has declared that they have no conflict of interest

Jacob E Crawshaw has declared that they have no conflict of interest

Alexie J Dunnett has declared that they have no conflict of interest

Kyla Naylor has received an Astellas Training Award.

Amit Garg received partnership funding from Astellas Canada for a Canadian Institutes of Health Research funded grant to improve the practice of living kidney donation.

Justin Presseau has declared that they have no conflict of interest

New

References

References to studies included in this review

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Thornton 2019 {published data only}

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References to studies excluded from this review

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Living ACTS 2014 {published data only}

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LOVED 2017 {published data only}

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NCT01786525 {published data only}

  1. Rodrigue JR. House calls and web-based decision support: improving access to live donor kidney transplantation. www.clinicaltrials.gov/ct2/show/NCT01786525 (first received 8 February 2013).

NCT01855438 {published data only}

  1. Traino HM. Increasing communication about live donor kidney transplant. www.clinicaltrials.gov/ct2/show/NCT01855438 (first received 16 May 2013).

Philpot 2016 {published data only}

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Piccoli 2004 {published data only}

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PREPARED 2012 {published data only}

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Sullivan 2012 {published data only}

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TALKS 2015 {published data only}

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Vinokur 2006 {published data only}

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YPT 2014 {published data only}

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ACTRN12614000690651 {published data only}

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Andrews 2012a {published data only}

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RegisterNow‐1 2017 {published data only}

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