Interventions for improving health literacy in people with chronic kidney disease

Zoe C Campbell; Jessica K Dawson; Suzanne M Kirkendall; Kirsten J McCaffery; Jesse Jansen; Katrina L Campbell; Vincent WS Lee; Angela C Webster

doi:10.1002/14651858.CD012026.pub2

. 2022 Dec 6;2022(12):CD012026. doi: 10.1002/14651858.CD012026.pub2

Interventions for improving health literacy in people with chronic kidney disease

Zoe C Campbell ^1,^✉, Jessica K Dawson ^2,³, Suzanne M Kirkendall ⁴, Kirsten J McCaffery ¹, Jesse Jansen ^1,^5,⁶, Katrina L Campbell ⁷, Vincent WS Lee ^2,⁸, Angela C Webster ^1,^9,^10,¹¹

Editor: Cochrane Kidney and Transplant Group

PMCID: PMC9724196 PMID: 36472416

Abstract

Background

Low health literacy affects 25% of people with chronic kidney disease (CKD) and is associated with increased morbidity and death. Improving health literacy is a recognised priority, but effective interventions are not clear.

Objectives

This review looked the benefits and harms of interventions for improving health literacy in people with CKD.

Search methods

We searched the Cochrane Kidney and Transplant Register of Studies up to 12 July 2022 through contact with the 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 (ICTRP) Search Portal and ClinicalTrials.gov. We also searched MEDLINE (OVID) and EMBASE (OVID) for non‐randomised studies.

Selection criteria

We included randomised controlled trials (RCTs) and non‐randomised studies that assessed interventions aimed at improving health literacy in people with CKD.

Data collection and analysis

Two authors independently assessed studies for eligibility and performed risk of bias analysis. We classified studies as either interventions aimed at improving aspects of health literacy or interventions targeting a population of people with poor health literacy. The interventions were further sub‐classified in terms of the type of intervention (educational, self‐management training, or educational with self‐management training). Results were expressed as mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CI for dichotomous outcomes.

Main results

We identified 120 studies (21,149 participants) which aimed to improve health literacy. There were 107 RCTs and 13 non‐randomised studies. No studies targeted low literacy populations. For the RCTs, selection bias was low or unclear in 94% of studies, performance bias was high in 86% of studies, detection bias was high in 86% of studies reporting subjective outcomes and low in 93% of studies reporting objective outcomes. Attrition and other biases were low or unclear in 86% and 78% of studies, respectively.

Compared to usual care, low certainty evidence showed educational interventions may increase kidney‐related knowledge (14 RCTs, 2632 participants: SMD 0.99, 95% CI 0.69 to 1.32; I² = 94%). Data for self‐care, self‐efficacy, quality of life (QoL), death, estimated glomerular filtration rate (eGFR) and hospitalisations could not be pooled or was not reported.

Compared to usual care, low‐certainty evidence showed self‐management interventions may improve self‐efficacy (5 RCTs, 417 participants: SMD 0.58, 95% CI 0.13 to 1.03; I² = 74%) and QoL physical component score (3 RCTs, 131 participants: MD 4.02, 95% CI 1.09 to 6.94; I² = 0%). There was moderate‐certainty evidence that self‐management interventions probably did not slow the decline in eGFR after one year (3 RCTs, 855 participants: MD 1.53 mL/min/1.73 m², 95% CI ‐1.41 to 4.46; I² = 33%). Data for knowledge, self‐care behaviour, death and hospitalisations could not be pooled or was not reported.

Compared to usual care, low‐certainty evidence showed educational with self‐management interventions may increase knowledge (15 RCTs, 2185 participants: SMD 0.65, 95% CI 0.36 to 0.93; I² = 90%), improve self‐care behaviour scores (4 RCTs, 913 participants: SMD 0.91, 95% CI 0.00 to 1.82; I² =97%), self‐efficacy (8 RCTs, 687 participants: SMD 0.50, 95% CI 0.10 to 0.89; I² = 82%), improve QoL physical component score (3 RCTs, 2771 participants: MD 2.56, 95% CI 1.73 to 3.38; I² = 0%) and may make little or no difference to slowing the decline of eGFR (4 RCTs, 618 participants: MD 4.28 mL/min/1.73 m², 95% CI ‐0.03 to 8.85; I² = 43%). Moderate‐certainty evidence shows educational with self‐management interventions probably decreases the risk of death (any cause) (4 RCTs, 2801 participants: RR 0.73, 95% CI 0.53 to 1.02; I² = 0%). Data for hospitalisation could not be pooled.

Authors' conclusions

Interventions to improve aspects of health literacy are a very broad category, including educational interventions, self‐management interventions and educational with self‐management interventions. Overall, this type of health literacy intervention is probably beneficial in this cohort however, due to methodological limitations and high heterogeneity in interventions and outcomes, the evidence is of low certainty.

Keywords: Humans; Health Literacy; Renal Insufficiency, Chronic; Renal Insufficiency, Chronic/therapy

Plain language summary

Health literacy interventions in people with chronic kidney disease

What is the issue? The long‐term management of chronic kidney disease (CKD) requires people with the disease to be involved in their own care because it is a complex chronic disease. Many people who have CKD may not understand how to use health information to best support their decisions about treatment and management. This ability or skill is referred to as health literacy. Improving the health literacy of people with CKD may improve their health outcomes and help them to manage their disease and avoid complications.

What did we do? We searched the literature for any studies that included an intervention aimed at improving health literacy in people with CKD. The interventions were divided into educational interventions, self‐management training interventions, and educational with self‐management training interventions.

What did we find? We found 120 studies enrolling 21,149 patients. Compared to usual care, educational interventions may increase kidney‐related knowledge; however, information on self‐care, self‐efficacy, quality of life (QoL), death, kidney function, and hospitalisations could not be analysed or was not reported. Self‐management interventions may improve self‐efficacy and one aspect of QoL (physical component score) but probably did not slow the decline in kidney function after one year. Information on knowledge, self‐care behaviour, death and hospitalisations could not be analysed or was not reported. Educational with self‐management interventions may increase knowledge, improve self‐care behaviour scores, self‐efficacy, one aspect of QoL (physical component score), and probably decreases the risk of death, but may make little or no difference to slowing the decline in kidney function. Data for hospitalisation could not be analysed.

Conclusions

Interventions to improve aspects of health literacy are a very broad category, including educational interventions, self‐management interventions and educational with self‐management interventions. Overall, this type of health literacy intervention is probably beneficial to patients with CKD however, due to limitations with the study methods and high variability in the interventions and outcomes make it difficult to give any recommendations.

Summary of findings

Summary of findings 1. Educational interventions versus usual care for improving health outcomes in people with chronic kidney disease (CKD).

Educational interventions versus usual care for improving health outcomes in people with CKD
Patient or population: Improving health outcomes in people with CKD Setting: any setting Intervention: educational interventions Comparison: usual care
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with usual care	Risk with educational interventions	Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Knowledge: kidney disease‐related knowledge	The SMD was 0.99 higher with education interventions (0.65 higher to 1.32 higher) compared to usual care		‐	2632 (14 RCTs) 99 (2 non‐RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3}	Two non‐RCTs found a significant improvement in knowledge in the intervention group when compared to control
Self‐care behaviour assessed with: Self‐care behaviours for HD scale ‐ 0 to 88 (higher equates to more self‐care behaviours)	The mean self‐care behaviour score was 61 with usual care	The self‐care behaviour score was 5.8 points higher with educational interventions (5.07 higher to 6.53 higher) compared to usual care	‐	60 (1 non‐RCT)	⊕⊕⊝⊝ LOW ^{4 5 6}	‐
Self‐efficacy	Two RCTs reported no difference in self‐efficacy between the educational intervention group and usual care group		‐	579 (2 RCTs) 99 (2 non‐RCTs)	⊕⊝⊝⊝ VERY LOW ^{6 7 8}	One non‐RCT reported self‐efficacy increased in the intervention group when compared to control (P < 0.05), while another reported feelings of powerlessness decreased in the intervention group compared to usual care (P < 0.000)
QoL	1. Physical and psychological domain sections of the WHOQOL‐BREF improved in the intervention group compared with control (P < 0.001) (one study) 2. Overall KDQoL scores improved in the intervention group compared with control (P < 0.001) (one study) 3. No change with educational interventions on the KDQoL or the SF‐36 domains (three studies)		‐	573 (5 RCTs)	⊕⊝⊝⊝ VERY LOW ^{6 9 10}	‐
Death	Two studies reported a reduction in median survival. One study measured this in years (7.96 versus 5.07, P = 0.053), while the other study, which reported survival in months (11.9 versus 11.2, P < 0.001), also reported more patients died in the control group compared to the intervention group (29 versus 5, P < 0.001)		‐	908 (2 RCTs)	⊕⊕⊝⊝ LOW ^{6 10 11}	‐
eGFR: mL/min/1.73 m²	eGFR increased by 0.08 ± 0.14 in the intervention group and decreased by 0.113 ± 0.79 in the control group (P < 0.011)		‐	573 (1 RCT)	⊕⊕⊕⊝ MODERATE ^{6 10}	‐
Duration of hospital stay Time frame: days	One study reported education decreased the time spent in hospital by 8.7 days (13.54 days less to 3.86 days less) compared to control One study reported that the provision of educational materials had no effect on the number of hospital readmissions		‐	621 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^{6 10}	‐
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: Confidence interval; SMD: Standardised mean difference; RCT: Randomised controlled trial; HD: Haemodialysis; QoL: Quality of life; WHOQOL‐BREF: Abbreviated World Health Organization Quality of Life questionnaire; KDQoL: Kidney disease quality of life questionnaire; SF‐36: Short form 36 questionnaire; eGFR: estimated glomerular filtration rate
GRADE Working Group grades of evidence High 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

Self‐management training versus usual care for improving health outcomes in people with CKD
Patient or population: people with CKD Setting: all settings Intervention: self‐management training Comparison: usual care
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with usual care	Risk with self‐management training	Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Knowledge: kidney disease‐related knowledge	The mean knowledge was 97.1 points with usual care	The kidney disease‐related knowledge score was 2.1 points higher with self‐management training (0.15 higher to 4.05 higher) compared to usual care	‐	103 (1 RCT)	⊕⊕⊝⊝ LOW ^{1 2 3}	Two studies not included in the meta‐analysis found increases in knowledge with self‐management training group compared with control
Self‐care behaviour	Self‐management interventions increased self‐reported self‐care behaviours in some domains		‐	497 (4 RCTs)	⊕⊕⊝⊝ LOW ^{3 4 5}	‐
Self‐efficacy	The SMD for self‐efficacy was 0.58 higher with self‐management interventions (0.13 higher to 1.03 higher) compared to usual care		‐	417 (5 RCTs)	⊕⊕⊝⊝ LOW ^{3 6 7}	‐
QoL	The mean SF‐36 physical component score was 4.02 higher with self‐management interventions (1.09 higher to 6.94 higher) compared to usual care. There was no evidence to suggest self‐management interventions improved scores on the KDQoL (effect and burden of kidney disease domains) or the SF‐36 (physical functioning, role physical, mental component score, emotional well‐being and role emotional domains)		‐	1470 (9 RCTs)	⊕⊕⊝⊝ LOW ^{3 8 9}	‐
Death	There was 1 death during the study period; however, the group assignment was not reported		‐	89 (1 RCT)	‐	‐
eGFR	The mean eGFR was 1.53 mL/min/1.73 m² higher with self‐management training (1.41 lower to 4.46 higher) compared to usual care		‐	855 (3 RCTs)	⊕⊝⊝⊝ MODERATE ⁴	Long‐term follow‐up in one large study found the rate of eGFR decline in the self‐management training group was 0.45 mL/min/1.73 m²/year less than the control group (P = 0.01)
Hospitalisation	One study reported self‐management training participants were hospitalised less (57.3% versus 23.9%) and for shorter time periods than the control group; however, they did not report a difference for the emergency department, outpatients, or home healthcare visits One study reported no significant difference in readmission rates between the self‐management training and control groups		‐	285 (2 RCTs)	⊕⊕⊝⊝ LOW ^{3 5}	‐
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: Confidence interval; SMD: Standardised mean difference; RCT: Randomised controlled trial; QoL: Quality of life; KDQoL: Kidney disease quality of life questionnaire; SF‐36: Short form 36 questionnaire; eGFR: estimated glomerular filtration rate
GRADE Working Group grades of evidence High 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

Educational interventions and self‐management training versus usual care/control for improving health outcomes in people with CKD
Patient or population: people with CKD Setting: all settings Intervention: educational interventions and self‐management training Comparison: usual care/control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with usual care/control	Risk with educational interventions and self‐management training	Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)	Comments
Knowledge: kidney disease‐related knowledge	The SMD for kidney disease‐related knowledge was 0.65 higher with education plus self‐management interventions (0.36 higher to 0.93 higher) compared to usual care/control		‐	2185 (15 RCTs) 91 (2 non‐RCTs)	⊕⊕⊝⊝ LOW ^{1 2}	Two non‐RCTs reported an increase in knowledge in the intervention group compared to control
Self‐care behaviours: self‐report questionnaires (higher is better)	The SMD for self‐care behaviours was 0.91 higher with education plus self‐management interventions (0.00 lower to 1.82 higher) compared to usual care/control		‐	913 (4 RCTs) 123 (2 non‐RCTs)	⊕⊕⊝⊝ LOW ^{2 3 4}	One non‐RCT an increase in the self‐care practice scale in the intervention group compared to control One non‐RCT did not provide sufficient data for analysis
Self‐efficacy: self‐report questionnaires (higher is better)	The SMD for self‐efficacy was 0.50 higher with education plus self‐management interventions (0.10 higher to 0.89 higher) compared to usual care/control		‐	687 (8 RCTs) 125 (2 non‐RCTs)	⊕⊕⊝⊝ LOW ^{2 6}	Two non‐RCTs reported an increase in self‐efficacy in the intervention group compared to control
QoL: SF‐12, SF‐36, KDQoL	Educational and self‐management training interventions did not improve QoL in the majority of studies. However, they may improve the physical component score of the SF‐36 measurement tool		‐	3848 (14 RCTs) 129 (2 non‐RCTs)	⊕⊕⊝⊝ LOW ^7 8	Two non‐RCTs found no difference in QoL scores between the intervention and control groups
Death	6 per 100	4 per 100 (3 to 6)	RR 0.73 (0.53 to 1.02)	2801 (4 RCTs) 1938 (1 non‐RCT)	⊕⊕⊕⊝ MODERATE⁴	One non‐RCT reported lower death rates in the intervention group when compared with control
eGFR: mL/min/1.73 m²	The mean eGFR was 4.28 mL/min/1.73 m² higher with educational and self‐management training interventions (0.03 lower to 8.85 higher) compared to usual care/control		‐	618 (4 RCTs) 190 (3 non‐RCTs)	⊕⊕⊝⊝ LOW ^{4 5}	Two non‐RCTs reported no increase in eGFR compared to usual care One non‐RCT did not find a difference in eGFR between the intervention and control groups
Hospitalisations	1) Three studies reported no difference in hospitalisation rates between the intervention and control groups 2) Two studies reported fewer participants were hospitalised in the intervention group when compared with control		‐	3110 (5 RCTs) 2588 (3 non‐RCTs)	⊕⊕⊝⊝ LOW ^{4 10}	Three non‐RCTs reported reductions in hospitalisations for the intervention group compared with control
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: Confidence interval; SMD: Standardised mean difference; RCT: Randomised controlled trial; QoL: Quality of life; SF‐36: Short form 36 questionnaire; eGFR: estimated glomerular filtration rate
GRADE Working Group grades of evidence High 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

Database	Search terms
CENTRAL	MeSH descriptor: [Kidney Diseases] this term only MeSH descriptor: [Renal Replacement Therapy] explode all trees MeSH descriptor: [Renal Insufficiency] this term only MeSH descriptor: [Renal Insufficiency, Chronic] this term only hemodialysis or haemodialysis:ti,ab,kw (Word variations have been searched) hemofiltration or haemofiltration:ti,ab,kw (Word variations have been searched) hemodiafiltration or haemodiafiltration:ti,ab,kw (Word variations have been searched) kidney disease* or renal disease* or kidney failure or renal failure:ti,ab,kw (Word variations have been searched) ESRF or ESKF or ESRD or ESKD:ti,ab,kw (Word variations have been searched) CKF or CKD or CRF or CRD:ti,ab,kw (Word variations have been searched) CAPD or CCPD or APD:ti,ab,kw (Word variations have been searched) predialysis or pre‐dialysis:ti,ab,kw (Word variations have been searched) {or #1‐#12} MeSH descriptor: [Health Literacy] this term only MeSH descriptor: [Health Education] this term only MeSH descriptor: [Consumer Health Information] this term only MeSH descriptor: [Patient Education as Topic] this term only MeSH descriptor: [Health Knowledge, Attitudes, Practice] this term only MeSH descriptor: [Comprehension] this term only MeSH descriptor: [Self Care] explode all trees MeSH descriptor: [Educational Status] this term only literacy or literate:ti,ab,kw (Word variations have been searched) patient education:ti,ab,kw (Word variations have been searched) self‐management or self‐car*:ti,ab,kw (Word variations have been searched) {or #14‐#24} {and #13, #25}
MEDLINE	Health Literacy/ Health Education/ Consumer Health Information/ (literacy or literate).tw. educational status/ Patient Education as Topic/ exp Self Care/ Health Knowledge, Attitudes, Practice/ Comprehension/ patient education.tw. (self‐management or self‐car$).tw. or/1‐11 Kidney Diseases/ exp Renal Replacement Therapy/ Renal Insufficiency/ exp Renal Insufficiency, Chronic/ dialysis.tw. (hemodialysis or haemodialysis).tw. (hemofiltration or haemofiltration).tw. (hemodiafiltration or haemodiafiltration).tw. (kidney disease* or renal disease* or kidney failure or renal failure).tw. (ESRF or ESKF or ESRD or ESKD).tw. (CKF or CKD or CRF or CRD).tw. (CAPD or CCPD or APD).tw. (predialysis or pre‐dialysis).tw. or/13‐25 and/12,26
EMBASE	health education/ health literacy/ health promotion/ psychoeducation/ patient education/ nutrition education/ consumer health information/ exp comprehension/ (literacy or literate).tw. (self‐management or self‐car$).tw. patient education$.tw. or/1‐11 exp renal replacement therapy/ kidney disease/ chronic kidney disease/ kidney failure/ chronic kidney failure/ mild renal impairment/ stage 1 kidney disease/ moderate renal impairment/ severe renal impairment/ end stage renal disease/ renal replacement therapy‐dependent renal disease/ kidney transplantation/ (hemodialysis or haemodialysis).tw. (hemofiltration or haemofiltration).tw. (hemodiafiltration or haemodiafiltration).tw. dialysis.tw. (CAPD or CCPD or APD).tw. (kidney disease* or renal disease* or kidney failure or renal failure).tw. (CKF or CKD or CRF or CRD).tw. (ESRF or ESKF or ESRD or ESKD).tw. (predialysis or pre‐dialysis).tw. ((kidney or renal) adj (transplant* or graft* or allograft*)).tw. or/13‐34 and/12,35

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; minimisation (minimisation 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 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 d 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 standardised difference in means) amongst 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 standardised difference in means) amongst 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. sub‐scales) 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.

(i) Confounding domains listed in the review protocol
Confounding domain	Measured variable(s)	Is there evidence that controlling for this variable was unnecessary?*	Is the confounding domain measured validly and reliably by this variable (or these variables)?	OPTIONAL: Is failure to adjust for this variable (alone) expected to favour the experimental intervention or the comparator?
			Yes / No / No information	Favour experimental / Favour comparator / No information

(ii) Additional confounding domains relevant to the setting of this particular study, or which the study authors identified as important
Confounding domain	Measured variable(s)	Is there evidence that controlling for this variable was unnecessary?*	Is the confounding domain measured validly and reliably by this variable (or these variables)?	OPTIONAL: Is failure to adjust for this variable (alone) expected to favour the experimental intervention or the comparator?
			Yes / No / No information	Favour experimental / Favour comparator / No information

(i) Co‐interventions listed in the review protocol
Co‐intervention	Is there evidence that controlling for this co‐intervention was unnecessary (e.g. because it was not administered)?	Is the presence of this co‐intervention likely to favour outcomes in the experimental intervention or the comparator?
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information

(ii) Additional co‐interventions relevant to the setting of this particular study, or which the study authors identified as important
Co‐intervention	Is there evidence that controlling for this co‐intervention was unnecessary (e.g. because it was not administered)?	Is the presence of this co‐intervention likely to favour outcomes in the experimental intervention or the comparator?
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information
		Favour experimental / Favour comparator / No information

Signalling questions	Description	Response options
Bias due to confounding
1.1 Is there potential for confounding of the effect of intervention in this study? If N/PN to 1.1: the study can be considered to be at low risk of bias due to confounding and no further signalling questions need be considered		Y / PY / PN / N
If Y/PY to 1.1: determine whether there is a need to assess time‐varying confounding:
1.2. Was the analysis based on splitting participants’ follow‐up time according to intervention received? If N/PN, answer questions relating to baseline confounding (1.4 to 1.6) If Y/PY, go to question 1.3.		NA / Y / PY / PN / N / NI
1.3. Were intervention discontinuations or switches likely to be related to factors that are prognostic for the outcome? If N/PN, answer questions relating to baseline confounding (1.4 to 1.6) If Y/PY, answer questions relating to both baseline and time‐varying confounding (1.7 and 1.8)		NA / Y / PY / PN / N / NI

Questions relating to baseline confounding only
1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?	NA / Y / PY / PN / N / NI
1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?	NA / Y / PY / PN / N / NI
1.6. Did the authors control for any post‐intervention variables that could have been affected by the intervention?	NA / Y / PY / PN / N / NI
Questions relating to baseline and time‐varying confounding
1.7. Did the authors use an appropriate analysis method that controlled for all the important confounding domains and for time‐varying confounding?	NA / Y / PY / PN / N / NI
1.8. If Y/PY to 1.7: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?	NA / Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to confounding?	Favours experimental / Favours comparator / Unpredictable

Study ID	Group	Name	Why	What	Who	How	Where	When and how much	Tailoring. modification, adherence and fidelity
Abraham 2012	Education: Individual vs control	A patient counselling intervention	Patient counselling may decrease co‐morbidities and improve QoL	Verbal and written educational material regarding diet, exercise, lifestyle modification and the importance of regular dialysis and follow‐up. Written material	‐	Face‐to‐face	‐	‐	‐
Afrasiabifar 2013	Education: Individual vs control	A nurse‐led education program	Nursing education may increase knowledge about self‐care behaviours, coping with kidney disease, and adaptation to the long‐term dialysis plan	The education plan contained information about kidney function and its role. An educational booklet containing the main points of self‐care for HD patients	Nursing staff	Face‐to‐face	During HD	Eight 1‐hour sessions over 8 weeks before and during HD	If a patient needed expert consultation, he/she was referred to a specialist
Aliasgharpour 2012*	Education and self‐management: Group vs control	Self‐efficacy promotion training for people on HD	A self‐efficacy promotion training program is an applied educational method which has many benefits in chronic disease	Education pertaining to the four components of self‐efficacy: 1.) Performance attainment ‐ anatomy and physiology of the kidney, complications of kidney failure diet, fluid allowance, and drug therapy; 2.) Vicarious experience ‐ group discussion for role modelling and learning from other patients’ experiences; 3.) Verbal persuasion ‐ persuasive strategies such as verbal encouragements and positive feedback; 4.) Physiological feedback ‐ progressive muscle relaxation as a stress‐management strategy. Booklet: summary of the lectures and related pictures	HD nursing staff	Small groups of two or three: Face‐to‐face	During HD	Six 30‐minute sessions before and during HD over 2 weeks	‐
Alikari 2019	Education: Individual vs control	A nurse‐led educational intervention for people on HD	Nurse‐led educational programs have been shown to increase knowledge and adherence in people with HD. This study aims to replicate this in a Greek population	Education session: Education based around the topics in the booklet ‐ anatomy and kidney function, CKD, diet and fluid restrictions, medication, laboratory tests, CKD‐related conditions, transplantation, and peritoneal dialysis. Booklet: Dialysis answers to common questions	Researchers	Individual: face‐to‐face	During HD	One 40‐minute session	The education session was tailored to the individual’s education level, kidney disease knowledge level, and ability to understand the terminology
An 2011*	Education: Materials (email) vs control	An email education program	Stress related to HD can cause non‐compliance. Examining whether education can reduce stress and therefore increase compliance	Email material: Risks of fluid accumulation, sodium accumulation, and hyperkalaemia, how to control fluid, sodium, and potassium, medication regimen, eating out, desirable menu etc	Research assistants	Individual: emails	‐	Twelve emails: 2/week for 6 weeks	Intervention participants could reply to emails with questions
Bahramnezhad 2015	Education ‐ Other: Family group vs individual	Family‐centred education for people on HD	Family members play a role in the care responsibilities of the patient. Examining whether family‐centred education is more beneficial than individual education in controlling of complications of HD (hypotension, muscle cramps)	Educational sessions ‐ First session: Kidney disease Second session: Nutrition and diet Third session: Exercise and medications. Pamphlet on material from each session provided	‐	Face‐to‐face: individual or with a family member present	‐	Three 30 to 45‐ minute sessions	‐
BALANCEWise‐HD 2013	Self‐management: One‐on‐one vs control (with the provision of dietary monitoring device)	Dietary counselling for people on HD	Diet and exercise diary can improve adherence. Examining whether computer‐based self‐monitoring can help manage dietary regime	Intervention: Social cognitive theory‐based behavioural counselling with a focus on building self‐efficacy regarding adherence to the HD diet and dietary counselling. Control: Usual care. PalmOne Tungsten/E2 PDA with BalanceLog software by Micro‐Life. The software allowed 4 meal logs per day and was programmed for individual calorie and nutrient requirements as per the renal dietitian.	Renal dietitian	Face‐to‐face	During HD	HD group: Twice/week for weeks 1 to 6, once/week for weeks 7 to 12, once a fortnight for weeks 13 to 16	The intervention and PDA were tailored for each participant
BALANCEWise‐PD 2011	Self‐management: Individual vs control (with the provision of dietary monitoring device)	Dietary counselling for people on HD	Diet and exercise diary can improve adherence. Examining whether computer‐based self‐monitoring can help manage dietary regime	Intervention: Dietary counselling based on social cognitive theory, paired with PDA‐based dietary self‐monitoring.	Renal dietitian	Face‐to‐face and telephone	HD: On dialysis ward PD: At convenient locations, during clinic appointments or over the phone	HD group: Twice/week for weeks 1 to 6, once/week for weeks 7 to 12, once a fortnight for weeks 13 to 16 PD group: Tried to stick to similar schedule. Interventions lasted 16 weeks	The intervention and PDA were tailored for each participant
Baraz 2010	Education ‐ Other: Video vs oral group	Educational interventions, both video and face‐to‐face	Video education may have some advantages and play a supportive role in teaching procedures	Oral group: Teaching intervention with questions at the end and a workbook to take home. Video group: Video content ‐ ESKD knowledge, dietary management for HD, food and fluid restrictions, reasons for compliance. Workbook and video	Principal investigator: Renal nurse	‐	Oral was in a group setting. Video was individual during dialysis	Both groups: 2 x 30‐minute education sessions	‐
Barnieh 2011	Educational with self‐management: Group vs control	Education about living kidney donation	Formal education may increase the rates of living kidney donation, and studies suggest that combination interventions are better than single interventions	Structured education session followed by written education materials: Advantages of living donor transplantation and information on living donors Second component: Small group interactive session brainstorming advantages of living kidney donation, problem‐based learning surrounding barriers to living kidney donation. Written education materials in the mail	Small group sessions: 3‐5 patients, family members, transplant nephrologist, and a recipient and a donor	Group: face‐to‐face after provision of materials	‐	Phase 1: Written materials two weeks after education session. Phase 2: 2‐hour small group interactive session 2 weeks after written materials received	‐
BRIGHT 2013	Education and self‐management: Materials and phone support vs control	Self‐management education with tailored community access support	CKD is a good exemplar to explore innovative community‐ and network‐focused models of self‐management. Information about self‐management, tailored access to local community resources, and telephone guidance could improve health outcomes for patients with stage 3 CKD	Telephone‐based self‐management from a lay health worker to support the use of the PLANS website. A kidney information guidebook, 'Keeping your kidneys healthy', about changes that could help maintain vascular health in early CKD. Booklet and interactive website 'Patient‐Led Assessment for Networks Support', a needs‐led self‐assessment tool with links to relevant community resources and local support	Lay health workers participated in a three‐hour training session about how to facilitate appropriate referrals to local resources	Telephone support	‐	One phone call one week post‐distribution of the workbook, and one phone call 4 weeks post	The intervention was tailored to each individual
Campbell 2008	Self‐management: Individual vs control	A nutritional counselling intervention	Dietary compliance is increased with self‐management interventions that involve ongoing feedback, monitoring and support	Individual dietary prescription to provide intensive nutritional counselling with regular monitoring guided by the medical nutrition therapy framework from the American Dietetic Association. Individualised self‐management principles: Goal‐setting, menu planning, label reading, and identification of foods containing protein, sodium, etc	Dietitian	Face‐to‐face with follow‐up phone calls	‐	One‐hour consultation followed by 15 to 30‐minute telephone calls; biweekly for the first month, then monthly. Interventions lasted 12 weeks	The intervention was tailored to each individual
Chen 2006b	Self‐management: Individual vs control	Menu suggestions and dietary education	Dietary non‐compliance may be due to poor understanding. Menu suggestions might make it easier for patients to comply with proper diet	Treatment group: Individualised menu suggestions based on their food preferences and education on how to exchange the foods at equivalent amounts according to the exchange list. Both groups got standard education	Dietitian	‐	‐	One‐off intervention	The menu suggestions were based on individual diets
Chen 2011e	Education and self‐management: Group/individual vs control	Self‐management support program	Patient participation and self‐management are vital for proper disease management. Examining whether a structured self‐management support intervention will improve disease progression or morbidity	Health information and education: Individualised lectures on kidney health, nutrition, lifestyle, nephrotoxin avoidance, diet and pharmacological regimens. Weekly telephone calls to enhance CKD self‐management and ensure timely follow‐up. Self‐management support group: Comprised health information, patient education, telephone‐based support, and the aid of a support group	Case management nurse	Patient education: Face‐to‐face. Support group: 5–10 CKD patients	‐	Patient education: Monthly. Telephone‐based support: Weekly. Support group: twice a month	Intervention was tailored and those at the same CKD stage were in the same support groups
Chen 2012g	Education: Individual vs control	Dietary education	‐	Education about dietary protein exchange	Dietitian	Face‐to‐face	‐	‐	‐
Chisholm 2001	Self‐management: Individual vs control	Clinical pharmacist counselling	Clinical pharmacists (pharmacists who have specific training in providing direct patient care in the area of medication therapy) can improve patient compliance to medications	Counselling from the clinical pharmacist after assessment of clinical data and patient understanding. Verbal or written information about medication compliance, instructions about when, how, and the amount of medications to take Was available for questions via telephone	Clinical pharmacist	Face‐to‐face or via telephone	Kidney transplant clinic. The Medical College of Georgia Hospital and Clinics	‐	Individualised advice on medications
Chisholm‐Burns 2013	Self‐management: Individual vs control	Behavioural contract intervention	Behavioural contracting may improve adherence to health‐related behaviours	Intervention group signed a behavioural contract which was then reviewed every 3 months. The participants worked with the study pharmacists to assess barriers to adherence and developed patient‐centred solutions to these barriers. IST adherence contracts followed the following format: Goal‐setting, motivation, social support, memory techniques, problem‐solving, and consequences of non‐adherence. Adherence to educational pamphlets and a pillbox. Toolbox of standardised solutions to adherence barriers as an aid for the contracting process	One clinical pharmacist that was trained by the lead investigator on the contracting process	Face‐to‐face or via telephone	‐	20 to 30 minutes every 3 months for 12 months	‐
Cho 2013a	Self‐management: Individual vs control	Health contract intervention	Health contract intervention aims may improve self‐care behaviour of people with CKD through increasing active patient participation with the nurse	Each session consisted of an introduction, mutual goal‐setting and contracting/recontracting. The self‐care behaviour of the participants was reinforced through praise, encouragement, and support at each time of dialysis. A week prior to each session, participants completed a self‐care log, which covered fistula management, BP and body weight measurement, exercise, and a dietary intake diary. Self‐care log	Researchers	Face‐to‐face	‐	30 to 60‐minute sessions. Once/week for 4 weeks	The intervention was tailored to each individual
Choi 2012*	Self‐management and education: Group and individual vs control	Self‐management program	Increased direct interaction with health care professionals may increase the knowledge, self‐management, and psychological indicators of people with CKD	Pre‐program session to assess baseline characteristics. Education session surrounding understanding and self‐managing CKD, diet management, and types of KRT. Individual consultations. Reinforcement education and follow‐up session	Educators were from the expert panel and included a physician, a nutritionist, and a nurse. Follow‐up was with the coordinating nurse researcher	Face‐to‐face in a small group, then individually	Seminar room in outpatient department of nephrology in a university hospital	90‐minute group session and 20‐minute individual session. One week later, a follow‐up individual session	The individual consultation was tailored to each individual
Chow 2010	Self‐management: Individual vs control	Nurse‐led case management program	Nurse‐led case management care model may have a positive effect on patients with chronic disease	Comprehensive discharge planning protocol: A motivational interview and a standardised 6‐week nurse‐initiated telephone follow‐up regimen. Shared objectives were developed, with a realistic action plan incorporating the patient’s preferences, including exercise regimen, medication, fluid and diet adherence behaviours, technical procedures for home peritoneal dialysis, and avoidance of infection. Education program conducted by the nurse case manager	Nurses that had undertaken a 24‐hour training program and a simulated interview	Face‐to‐face individually or with family present, then via telephone	Pre‐discharge interview in the hospital	Unsure length of pre‐discharge interview. First telephone call 20 to 30 minutes, the remainder varied	The intervention was tailored to each individual
Clark 2010	Self‐management: Individual vs control	Intensive, regular physician‐led education about phosphorous control	Increased education and self‐management training around phosphate control may help to lower phosphate levels in patients with hyperphosphataemia	In addition to the standard dietitian visit, the intervention group met with the study physician for a review of food diaries, binder use and compliance, diet choices, and vascular complications. Pictorial and written proper diet choices and pictures of potential vascular complications	Physician	Face‐to‐face	‐	Once a month for 3 months	‐
Cooney 2015	Education and self‐management: Individual vs control	Pharmacist‐based quality improvement intervention	Pharmacist‐based interventions can improve guideline adherence and outcomes	One phone conversation prior to primary care appointment; included medication review and lifestyle modifications. Second phone call post‐investigations/appointment with primary care to discuss results and give recommendations. Informational pamphlet	Pharmacist	Telephone support with pharmacist and face‐to‐face with a physician	‐	‐	The intervention was tailored to each individual
Cummings 1981	Self‐management: Individual vs control	Behavioural contract intervention	Reward‐based behavioural changes, governed by a contract, can increase compliance to medical regimens	Interviews: Before intervention; immediately following completion at 6 weeks; 3 months post‐intervention completion. Contract and signed agreement	‐	Face‐to‐face: Individually or with a family member present	HD: Outpatient dialysis clinic	‐	The intervention was tailored to each individual. Adherence to diet was assessed with patient potassium levels and weight
de Araujo 2010	Education: Individual vs control	A bone disease education program	Educational programs need to be adapted to a level that CKD patients can understand. Education about pathogenesis of bone disease may improve management and complications in this area	Intervention: Course instructing participants to avoid food rich in PO4, the correct use of binders, the importance of serum levels of Ca, PO4, Ca x PO4 product, PTH, and manifestations of bone diseases. Attention control group education about a different topic. Visual educational tools such as images and drawings, anatomic models, and simulator mannequins	‐	Face‐to‐face	During HD	Six 30‐minute meetings before HD	‐
de Brito Ashurst 2003	Education and self‐management: Individual vs control	A dietitian‐led education program about phosphate management in CKD	Dieticians provide education to patients about management of their phosphate levels. Examining whether a dietetic educational intervention can improve blood results	Education session: One‐on‐one session using the education tool. Education tool: Booklet, medication record chart, refrigerator magnet. The booklet was a colourful cartoon and had written descriptions of phosphate and calcium functions, absorption, and excretion. The daily medication record card was given to both groups and was used to monitor medications and blood phosphate and calcium levels	Experienced renal dietitian	Face‐to‐face	Renal unit	One 40‐minute session	Individualised advice on diet, medication compliance, and lifestyle during intervention session
Deimling 1984	Education and self‐management: Videotape vs control	Education plus contracting	Information and changing or adaptive behaviour is more likely to improve medication adherence and phosphorus control	Intervention: Shown slides/tapes and completed behavioural contract	Renal dietitian, researcher, and research nurse	Face‐to‐face individually	HD unit	Pretest at the beginning. Within one week of results, watched slide/tape program. At 10 weeks completed post‐test	The intervention was tailored to each individual
Devins 2003	Education: Individual vs control	Educational program and investigation of anxiety, social support and depression	Predialysis psycho‐educational intervention delays the time to dialysis	Baseline questionnaire, educational session, 6‐month follow‐up questionnaire. Booklet	Health educator and research assistants	Face‐to‐face and phone call	Nephrology unit	90‐minute educational session; 1 phone call in 3 weeks, 10 minutes; 6‐month follow‐up questionnaire, 18‐month follow‐up biomedical data	The intervention was tailored to each individual
Ebrahimi 2016	Education: Individual vs control	Nutritional educational program	Nutritional education may improve knowledge and QoL for people on HD	Educational session: Instructions related to nutrition in CKD based on the contents of the pamphlet, which included the importance of adherence to a healthy diet, avoiding poison accumulation in blood and tissues, food and fluid restrictions	‐	Face‐to‐face individual	‐	40 to 60 minutes, twice/week for 12 weeks	‐
ELITE 2013	Education: Individual vs control	Educational intervention on LDKT knowledge	Increase patient knowledge about live donor kidney transplant before ESKD	Educational video and individual session. Video	‐	Face‐to‐face individual	Transplant centre	20‐minute educational video, 15‐minute face‐to‐face discussion	‐
Espahbodi 2015	Education and self‐management: Group vs control	Educational sessions by nephrologist and psychiatrist	Psycho‐education sessions to improve psychiatric disorders associated with chronic disease	Pre‐test and post‐test, Hospital Anxiety and Depression questionnaire	Nephrologist and psychiatrist	Face‐to‐face group	HD ward	Three 1‐hour sessions	‐
Fishbane 2017	Education and self‐management: Individual vs control	A care management intervention for people with CKD	A patient‐centred care management program developed by a trained nurse and nephrologist may improve outcomes for people with late‐stage CKD	Intervention: Initial home visit for both education assessment and provision of an easy‐to‐use weighing scale. A patient‐centred, goal‐specific plan of care is developed by the nurse and nephrologist based on this home visit, followed by telephone follow‐up. Control: Usual care	Nurse care manager	Face‐to‐face and telephone	In the patient's home	One in‐home session, then telephone follow‐up once a month or more if needed, for 18 months	The intervention was tailored to each individual
Flesher 2011	Education and self‐management: Group vs control	Educational sessions by multidisciplinary team to optimise diet and exercise	Education to minimise hospitalisations and prepare patients for CKD	Motivational interviewing, home visits, dietary education, medication reconciliation, and phone calls. Cookbook, 12‐week exercise program	Dietitian, cook educator, certified exercise physiologist, nurse	Face‐to‐face group, with or without a key caregiver	Medical centre, hospital, private practice clinic	2‐hour session and shopping tour	The intervention was tailored to each individual
Ford 2004	Education and self‐management: Individual vs control	Dietitian‐led education sessions on managing phosphorus levels	Additional individualised education reduces hyperphosphataemia	Pre‐test, additional education sessions with materials every month, post‐test. Posters, handouts, puzzles, and individualised phosphorus tracking tool	Dietitian	Face‐to‐face	HD centre	20 to 30 minutes each month for 6 months	The intervention was tailored to each individual
Forni 2012	Self‐management: Individual vs control	Motivational interviewing to improve medication adherence in people with CKD	Feedback and individual motivational interviewing in regard to medication adherence for people with CKD may improve self‐management	Intervention: Semi‐structured motivational interviews discussing medication adherence results with a graphical report, potential barriers to adherence, and strategies to overcome the barriers. Electronic monitoring bottle for medications	Nephrologist	Face‐to‐face	Dialysis facility	Every 2 months	The intervention was tailored to each individual
Giacoma 1999	Education ‐ Other: Materials vs control	Educational program for kidney transplant recipients	Pre‐ and post‐transplant education to improve transplant outcomes	Pre‐test, teaching video in two parts, medications and discharge care, post‐test. Video, teaching checklist, booklet	Nursing staff	Face‐to‐face, with or without a family member	Organ transplant unit	Prior to surgery; 5 days post‐op	‐
Hall 2004*	Education and self‐management: Individual vs control	Adult learning theory‐based curriculum for new patients starting PD	Training programs to increase peritoneal dialysis outcomes	Intervention: Structured education adhering to the new teaching methodology focused on self‐management Control: Usual care	Nursing staff	‐	‐	‐	‐
Hare 2014	Education and self‐management: Group vs control	Educational program to improve fluid adherence	Increasing education about fluid balance in PD patients	Group sessions with CBT techniques. Treatment manual, record sheets, goal‐setting sheets, and daily planners	Trainee health psychologist	Face‐to‐face group	Hospital	1‐hour sessions, once/week for 4 weeks	‐
Hasanzadeh 2011	Education: Face‐to‐face vs video based	Educational video‐based training to increase diet and fluid adherence	Educational video‐based training is a cost‐effective and easy method for delivering information	Pre‐test, two education film sessions, post‐test. Video	‐	Face‐to‐face group	HD ward	Two 30 to 45‐ minute sessions, with a one‐week interval	‐
Hed‐SMART 2011	Self‐management: Group vs control	Group‐based self‐management trial	Self‐management training to increase medical compliance and improve outcomes	Pre‐test, 3 main sessions, post‐test, phone call, 1 booster session, 3‐month follow‐up phone call, questionnaire, 9‐month follow‐up	Medical social worker, renal nurse, renal dietitian, psychologist	Face‐to‐face group	Dialysis Centre	Four 90‐minute sessions, telephone	‐

Study ID	Tool	Participants	Results (mean ± SD)	Effect
Educational Interventions: individual versus control
Abraham 2012	WHO‐BREF	Intervention: 25 Control: 25	Physical Intervention (24.92 ± 2.15); control (20.54 ± 3.21) Psychological Intervention (23.22 ± 2.45); control (17.78 ± 3.32) Environmental Intervention (12.24 ± 1.87); control (9.44 ± 1.95) Social Intervention (32.08 ± 3.32); control (24.58 ± 4.36)	The intervention group scored significantly higher than the control group in all domains (P < 0.001)
Alikari 2019	Missoula VITAS Quality of Life Index‐15, Greek Version (higher score equates to better QoL)	Intervention: 25 Control: 25	Total score Intervention (21 ± 2.89); control (18.34 ± 3.54) Functionality Intervention (15.04 ± 10.78); control (4.32 ± 9.29)	The intervention group scored significantly higher overall than the control group (P = 0.005) and also in the functionality domain (P < 0.001). There was no significant difference in the remaining domains. There was a within‐group time effect for 4 of the domains for the intervention group
Chow 2010	KDQoL‐ SF‐36	Intervention: 43 Control: 42	Data reported in the study. Nil significant between‐group results	There was no significant difference between the intervention and control groups in any of the domains. There was a within‐group time effect for the Intervention group in some of the domains
Ebrahimi 2016	KDQoL	Intervention: 48 Control: 51	Overall score Intervention (67.4 ± 5.99); control (58.8 ± 6.21) Individual domain analysis not reported in the study	There was a significant difference in the overall QoL score between the intervention and control group (P < 0.001)
Sehgal 2002	KDQoL	Intervention: 85 Control: 84	Data not reported	There was no difference between the intervention and control groups in any domain
Self‐management interventions: individual versus control
Campbell 2008	KDQoL‐SF (higher score equates to better QoL)	Intervention: 23 Control: 24 Lost to follow‐up: 9	Symptoms of kidney disease Intervention (80.09 ± 3.53); control (74.50 ± 3.17) Cognitive functioning Intervention (82.03 ± 2.67); control (72.53 ± 4.90 Vitality Intervention (46.74 ± 3.77); control (38.40 ± 4.29)	There was a statistically significant improvement in mean score in the intervention group compared to the control in symptoms of kidney disease (P = 0.047), cognitive functioning (P = 0.003) and vitality (P = 0.002)
Korniewicz 1994	Sickness Impact Profile (higher equates to worse QoL)	Intervention: 46 Control: 44	Displayed in the table with 2 control groups	There were significant differences among the experimental and 2 control groups on measures of psychosocial adaptation, including the sickness impact profile, with the intervention group reporting a more satisfactory performance
Li 2014b	KDQoL‐SF (higher score equates to better QoL)	Intervention: 69 Control: 69	Displayed in the table with 3 time points. Data for overall between‐group differences analysed	The overall between‐group differences were significant in symptom/problem (P = 0.01), work status (P = 0.02), staff encouragement (P = 0.01), patient satisfaction (P = 0.01) and energy/fatigue (P = 0.02)
MASTERPLAN 2005	EQ‐5D QoL (higher score equates to better QoL)	Intervention: 395 Control: 393	Data not reported or analysed	‐
Rodrigue 2011	SF‐36 and QoLi (higher score equates to better QoL)	Intervention 1: 17 Intervention 2: 18 Control: 20 Did not complete: 9	Displayed in the table with 3 time points	Intervention 1 had higher QoLi and SF‐36 MCS scores than both intervention 2 (P = 0.62 and P = 0.51, respectively) and control (P = 0.63 and P = 0.52, respectively) groups There was no group effect on follow‐up (T3) SF‐36 PCS scores (P = 0.47)
Tzvetanov 2014	SF‐36 (higher score equates to better QoL)	Intervention: 9 Control: 8	Displayed in graph	The mean SF‐36 score at 6 months was significantly higher in the intervention group compared with the control group (583 ± 13 versus 436 ± 22, P = 0.008).
Self‐management interventions: group versus control
Hed‐SMART 2011	KDQoL‐SF and WHO‐BREF (higher score equates to better QoL)	Intervention: 102 Control: 133	Data not reported or analysed	‐
Lii 2007	MOS SF‐36 (higher score equates to better QoL)	Intervention: 20 Control: 28	Physical Intervention (2.55 ± 6.67), control (‐2.96 ± 6.76) Mental Intervention (3.52 ± 7.36), control (0.25 ± 9.05)	The change score of the physical QoL subscale reached a significant improvement for the intervention group, as opposed to the control group (t = 2.8, P = 0.008) The mental subscale did not show a significant difference between the two groups (t = 1.33, P > 0.05)
Self‐management interventions: individual/group versus control
Moattari 2012	Strategies Used by People to Promote Health Overall QoL Score (0‐20) (higher score equates to better QoL)	Intervention: 25 Control 23	Intervention (20.47 ± 2.5), control (17.54 ± 2.51)	The intervention group scored significantly higher than the control group (P < 0.001)
Educational with self‐management interventions: individual versus control
Cooney 2015	KDQoL and SF12 (higher score equates to better QoL)	Intervention: 1070 Control: 1129	KDQoL burden Intervention (89.7 ± 20.5), control (89.4 ± 19.6) KDQoL effects Intervention (94.2 ± 11.9), control (94.4 ± 14.0)	No significant difference between the intervention and control group
INTENT 2014	SF‐26 (higher score equates to better QoL)	Intervention: 18 Control: 18	Physical functioning (mean ± SE) Intervention (77.9 ± 10.1), control (90.8 ± 2.8) Role‐physical (mean ± SE) Intervention (78.8 ± 7.3), control (92.8 ± 2.5) Bodily pain (mean ± SE) Intervention (78.8 ± 7.3), control (90.5 ± 3.8) General health (mean ± SE) Intervention (68.1 ± 7.3), control (76.5 ± 2.9) Vitality (mean ± SE) Intervention (63.5 ± 6.1), control (77.9 ± 2.8) Social functioning (mean ± SE) Intervention (91.7 ± 4.4), control (92.3 ± 3.3) Role‐emotional (mean ± SE) Intervention (93.1 ± 4.4), control (94.9 ± 2.8) Mental health (mean ± SE) Intervention (85.4 ± 2.6), control (87.7 ± 2.7)	There was a significant improvement in the general health domain for the control group (P = 0.03) but not the intervention group (P = 0.3) between 6 and 12 months. There were no significant effects found between the intervention and control group in the other domains
Joost 2014*	SF‐36 (higher score equates to better QoL)	Intervention: 35 Control: 39	Comparison data not reported	“HRQoL … parameters were not influenced as a result of additional pharmaceutical care.”
Kazawa 2015*	WHO‐QoL2 ‐ Japanese version (higher score equates to better QoL)	Intervention: 19 Control: 24	Intervention: (3.29 ± 0.46), control (3.05 ± 0.44)	No significant difference between the intervention and control group
Leon 2006	KDQoL (higher score equates to better QoL)	Intervention: 86 Control: 60	Data not reported	“There were no differences between intervention and control patients in quality‐of‐life sub‐scales, including general health, physical functioning, emotional well‐being, social function, pain, and dialysis‐related symptoms.”
Mathers 1999	PAIS‐SR ‐ psychosocial adjustment to illness scale (higher score equates to better adjustment to illness)	Intervention: 5 Control: 5	“there was no significant difference found in the psychosocial adjustment scores“	No data reported in the text
Urstad 2012	SF‐12 (higher score equates to better QoL)	Intervention: 77 Control: 82 At T3 Intervention: 61 Control: 56	Data not reported for between‐group analysis. Physical functioning domain not reported Mental component summary Intervention (56.20), control (51.04)	“No statistically significant differences were found between the experimental group and the control group on self‐efficacy or quality of life outcomes at second measure.”
Wong 2010	KDQoL (higher score equates to better QoL)	Intervention: 49 Control: 49	Displayed in the table with 3 time points	The Intervention group scored significantly higher in the sleep (P = 0.00) and symptom (P = 0.03) domains than the control group
Educational with self‐management interventions: group versus control
ESCORT 2014	Thai SF‐36 (higher score equates to better QoL)	Intervention: 234 Control: 208	Data not reported	There were no significant differences between the intervention and control group
Hare 2014	SF‐36 (higher score equates to better QoL)	Intervention: 8 Control: 6	Total score Intervention (59.569), control (52.779) Physical health Intervention (55.735), control (46.874) Mental health score Intervention (60.014), control (56.841) Physical function Intervention (58.334), control (46.904) Bodily pain Intervention (56.723), control (54.603) General health Intervention (52.363), control (48.728) Vitality Intervention (49.229), control (47.310) Social function Intervention (70.651), control (55.685) Role‐emotional Intervention (54.057), control (57.363). Mental health Intervention (74.193), control (89.171)	The intervention group performed significantly better than the control group (P = 0.004) in the mental health domain.
Raiesifar 2014	KTQ‐25 (higher score equates to better QoL)	Intervention: 45 Control: 45	Intervention: (94 ± 5.6), control (40.1 ± 4.8)	The overall QoL scores were higher in the intervention group compared with the control (P < 0.001)
Song 2010	Self‐Perception and Relationship Tool	Intervention: 11 Control: 8	Intervention (0.06 ± 0.69), control (‐0.13 ± 0.57)	No significant difference
Sharp 2005	SF‐36 Health survey (higher score equates to better QoL)	Intervention: 29 Control: 27	Physical functioning Intervention (3.28 ± 27.03), control (0.74 ± 25.71) Role‐physical Intervention (0.43 ± 23.50), control (‐4.86 ± 27.37) Bodily pain Intervention (0.00 ± 12.60), control (‐2.06 ± 13.09) General health Intervention (3.14 ± 22.78), control (0.26 ± 25.72) Mental health Intervention (5.17 ± 13.33), control (‐5.37 ± 17.45) Role emotional Intervention (6.61 ± 23.08), control (‐5.73 ± 17.45) Social function Intervention (‐0.86 ± 20.03), control (2.78 ± 16.75) Vitality Intervention (2.80 ± 17.00,) control (‐2.31 ± 16.55)	The intervention group scored significantly higher on the mental health substrate than the control group (P < 0.01)
Tsay 2005	MOS SF‐36 (higher score equates to better QoL)	Intervention: 30 Control: 27	Physical Intervention (43.89 ± 5.79), control (40.29 ± 9.90) Mental Intervention (43.98 ± 7.23), control (40.68 ± 11.94)	The intervention group had a larger adjusted mean and the control group had a smaller adjusted mean in both physical and mental domains
Educational with self‐management interventions: provision of materials versus control
BRIGHT 2013	EuroQoL EQ‐5D (higher score equates to better QoL)	Intervention: 179 Control: 193	Intervention (0.71 ± 0.28), control (0.67 ± 0.29)	There was no significant difference
Tsuji‐Hayashi 2000	Health Status Survey (higher score equates to better QoL)	58 (number per group not reported)	Intervention (0.50), control (‐0.18)	There was a significant improvement in the Intervention group compared to the control (P < 0.05)
Footnotes: WHO‐BREF: World Health Organization Quality of Life BREF (higher score equates to better QoL) KDQoL and KDQoL‐SF: kidney disease quality of life tool and kidney disease quality of life short form (higher score equates to better QoL) SF‐36 Health survey (SF‐36), EuroQoL measurement tool (EQ‐5D), Quality of Life Inventory (QoLI)

Study ID	Mode of delivery	Participants	Results	Effect
Median survival
Live and Learn 1993	Individual	Intervention: 287 Control: 286	Intervention: 7.84 years Control: 5.07 years	Participants in intervention group had a longer median survival in years, over a 20‐year period (Chi² change (1) 3.75 (P = 0.053; RR, 1.32; 95% CI, 1.00 to 1.74))
Wu 2009	Individual	Intervention: 163 Control: 172	Intervention: 11.9 months Control: 11.2 months	Participants in intervention group had a longer median survival in months, in a 24‐month period (Cox–Mantel log rank test, P < 0.001)
Deaths
Wu 2009	Individual	Intervention: 163 Control: 172	Intervention: 5 Control: 29	Significantly more patients died in the control group when compared with the intervention group (P < 0.001)

Study ID	Mode of delivery	Participants	Results	Effect	Notes
Health promotion lifestyle questionnaire
Teng 2013	Individual	Intervention: 52 Control: 51	‐	There was a significant increase in health responsibility (P = 0.001) and physical activity (P = 0.01) for the intervention group compared with control, but this result was not seen for stress management, interpersonal relations, spiritual growth, or nutrition	Analysis controlled for baseline differences in spiritual growth, health responsibility, and physical activity. Post‐intervention mean and SD not reported
Self‐care behaviour inventory questionnaire
Cho 2013a	Individual	Intervention: 21 Control: 22	Intervention: 3.77 ± 0.56 Control: 3.34 ± 0.46	There was a significant increase in self‐care behaviour for the intervention group compared with control (P = 0.011)	Continuous outcome: higher is better
Health education impact questionnaire: self‐management skills
Hed‐SMART 2011	Group	Intervention: 102 Control: 134	Self‐care Intervention: 7.15 ± 1.98 Control: 6.79 ± 1.75 Self‐monitoring and insight Intervention: 3.15 ± 0.41 Control: 2.94 ± 0.38 Skill and technique acquisition Intervention: 2.93 ± 0.45 Control: 2.74 ± 0.48 Health service navigation Intervention: 3.06 ± 0.51 Control: 2.90 ± 0.44	There was significant improvement in self‐monitoring and insight (P < 0.001), skill and technique acquisition (P = 0.002), and health service navigation (P = 0.01), but not self‐care when compared to control	Data taken from time point 3 Continuous outcomes: higher is better
Willingness to perform health behaviours (11 domains)
Liu 2014c	Individual	Intervention: 58 Control: 58	1. Post‐surgery rehab 2. Post‐surgery activities 3. Pain control 4. Wound checking 5. Effective coaching 6. Dental hygiene 7. Showering / changing / toileting 8. Healthy foods 9. Functional rehabilitation	Domains 1, 5, 6, 7 and 9 returned a significant result in favour of intervention group (P < 0.01), while the remaining did not	Dichotomous outcomes: number of people very willing, moderately willing, mildly willing, unwilling for each domain

Bias in selection of participants into the study
2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of t the intervention? If N/PN to 2.1: go to 2.4	Y / PY / PN / N / NI
2.2. If Y/PY to 2.1: Were the post‐intervention variables that influenced selection likely to be associated with intervention?	NA / Y / PY / PN / N / NI
2.3 If Y/PY to 2.2: Were the post‐intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?	NA / Y / PY / PN / N / NI
2.4. Do start of follow‐up and start of intervention coincide for most participants?	Y / PY / PN / N / NI
2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?	NA / Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to selection of participants into the study?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Bias in classification of interventions
3.1 Were intervention groups clearly defined?	Y / PY / PN / N / NI
3.2 Was the information used to define intervention groups recorded at the start of the intervention?	Y / PY / PN / N / NI
3.3 Could classification of intervention status have been affected by knowledge of the outcome or risk of the outcome?	Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to classification of interventions?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Bias due to deviations from intended interventions
If your aim for this study is to assess the effect of assignment to intervention, answer questions 4.1 and 4.2
4.1. Were there deviations from the intended intervention beyond what would be expected in usual practice?	Y / PY / PN / N / NI
4.2. If Y/PY to 4.1: Were these deviations from intended intervention unbalanced between groups and likely to have affected the outcome?	NA / Y / PY / PN / N / NI
If your aim for this study is to assess the effect of starting and adhering to intervention, answer questions 4.3 to 4.6
4.3. Were important co‐interventions balanced across intervention groups?	Y / PY / PN / N / NI
4.4. Was the intervention implemented successfully for most participants?	Y / PY / PN / N / NI
4.5. Did study participants adhere to the assigned intervention regimen?	Y / PY / PN / N / NI
4.6. If N/PN to 4.3, 4.4 or 4.5: Was an appropriate analysis used to estimate the effect of starting and adhering to the intervention?	NA / Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to deviations from the intended interventions?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Bias due to missing data
5.1 Were outcome data available for all, or nearly all, participants?	Y / PY / PN / N / NI
5.2 Were participants excluded due to missing data on intervention status?	Y / PY / PN / N / NI
5.3 Were participants excluded due to missing data on other variables needed for the analysis?	Y / PY / PN / N / NI
5.4 If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Are the proportion of participants and reasons for missing data similar across interventions?	NA / Y / PY / PN / N / NI
5.5 If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Is there evidence that results were robust to the presence of missing data?	NA / Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to missing data?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Bias in measurement of outcomes
6.1 Could the outcome measure have been influenced by knowledge of the intervention received?	Y / PY / PN / N / NI
6.2 Were outcome assessors aware of the intervention received by study participants?	Y / PY / PN / N / NI
6.3 Were the methods of outcome assessment comparable across intervention groups?	Y / PY / PN / N / NI
6.4 Were any systematic errors in measurement of the outcome related to the intervention received?	Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to measurement of outcomes?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Bias in selection of the reported result
Is the reported effect estimate likely to be selected, on the basis of the results, from...
7.1. ... multiple outcome measurements within the outcome domain?	Y / PY / PN / N / NI
7.2 ... multiple analyses of the intervention‐outcome relationship?	Y / PY / PN / N / NI
7.3 ... different subgroups?	Y / PY / PN / N / NI
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the predicted direction of bias due to selection of the reported result?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Overall bias
Risk of bias judgement	Low / Moderate / Serious / Critical / NI
Optional: What is the overall predicted direction of bias for this outcome?	Favours experimental / Favours comparator / Towards null / Away from null / Unpredictable

Studies	Mode of delivery	Participants	Results (mean ± SD)	Effect	Notes
Self‐report questionnaire: Reads nutrition facts label and reads ingredient list
Sullivan 2009	Individual	Intervention: 145 Control: 134	Reads nutrition facts label Intervention: 76 ± 28 Control: 69, 35 Reads ingredient list Intervention: 77 ± 28 Control: 64 ± 35	There was a significant increase in reading nutrition facts labels (P < 0.01) and reading ingredient lists (P = 0.04) in the intervention group compared with control	Continuous outcomes (0‐100): higher is better
Self‐care practice scale
Choi 2012*	Individual/group	Intervention: 31 Control: 30	Intervention: 3.88 ± 0.41 Control: 3.85 ± 0.42	There was no significant difference in self‐care practice in the intervention group compared with control (P = 0.55)	Continuous outcome: higher is better Self‐care Practice Scale developed for this study based on the self‐care measurement tool for patients taking HD^a. Used time point week 8 for analysis
Self‐management questionnaire
Flesher 2011	Group	Intervention: 23 Control: 17	‐	“Overall, the experimental group showed ‘‘improvement’’ in their exercise frequency, concern over health condition, and frequency of visits to health providers or hospitalization. Overall the control group answers indicated an improvement in their communication with health providers in asking questions and discussing personal issues."	Continuous outcome: higher is better Self‐management questionnaire developed by the Stanford School of Medicine 2010^b Results reported in text with no accompanying data
Parameters of chronic disease self‐management questionnaires
Liu 2016d	Individual and group	Intervention: 43 Control: 43	Control of body mass Intervention: 5.83 ± 0.78 Control: 5.09 ± 0.78 Reasonable diet Intervention: 8.46 ± 0.98 Control: 7.18 ± 0.85 Correct drug intake Intervention: 5.86 ± 0.94 Control: 4.88 ± 0.69 Physical activity Intervention: 8.9 ± 1.19 Control: 7.46 ± 1.12 Correct fistula care Intervention: 11.95 ± 1.32 Control: 10.27 ± 0.85 Disease condition monitoring Intervention: 6.04 ± 0.84 Control: 5.20 ± 0.80 Psychological and social behaviours Intervention: 11.67 ± 0.94 Control: 9.25 ± 1.19	The intervention group scored significantly higher than the control group in all seven self‐care parameters (P < 0.001)	Continuous outcomes: higher is better Questionnaires taken from outcome measures for health education and other health care interventions 1996^c
Sun protection behaviours (median and range of change)
Robinson 2014a	Provision of materials	Intervention: 50 Control: 51	Intervention: 12.5 (‐12.5 to 66) Control: 2.5 (‐20 to 50)	Sun protection behaviours increased significantly more in the intervention group compared with control (P = 0.013)	Continuous outcome (13‐66): higher is better Change from baseline scores
Sun protection scale
Robinson 2015	Provision of materials	Intervention: 84 Control: 86	Intervention: 57.73 ± 13.10 Control: 31.10 ± 4.87	Sun protection behaviours increased significantly more in the intervention group compared with control (P < 0.01)	Continuous outcome (20‐100): higher is better Data pooled from groups stratified by ethnicity
Summary of diabetes self‐care activities measure
BRIGHT 2013	Provision of materials	Intervention: 172 Control: 191	Intervention: 4.5 ± 1.2 Control: 4.2 ± 1.2	Self‐care activities increased significantly more in the intervention group compared with control (P = 0.019)	Continuous outcome: higher is better
Percentage of days per month behaviours performed
Kazawa 2015*	Individual	Intervention: 31 Control: 31	‐	‐	Continuous outcome (0‐100): higher is better There were no control group statistics recorded for this outcome.
Number of participants who checked their skin
Robinson 2011	Provision of materials	Intervention: 38 Control: 37	Intervention: 34/38 Control: 8/37	Participants in the intervention group were significantly more likely to check their skin than those in the control group (P < 0.001)	‐
^a Kim 2008 ^b Stanford School of Medicine (2010). Research Instruments Developed, Adapted or Used by the Stanford Patient Education Research Center. Available at: http://patienteducation.stanford.edu/research/index.html ^c Lorig K, Stewart A and Ritter P. Outcome measures for health education and other health care interventions [M]. Thousand Oaks, CA: Sage, 1996, pp.41–46.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Knowledge	14	2632	Std. Mean Difference (IV, Random, 95% CI)	0.99 [0.65, 1.32]
1.1.1 Individual	8	1724	Std. Mean Difference (IV, Random, 95% CI)	0.73 [0.39, 1.07]
1.1.2 Group	3	272	Std. Mean Difference (IV, Random, 95% CI)	2.30 [0.56, 4.05]
1.1.3 Individual/group	1	80	Std. Mean Difference (IV, Random, 95% CI)	1.34 [0.85, 1.83]
1.1.4 Materials	2	556	Std. Mean Difference (IV, Random, 95% CI)	0.37 [‐0.03, 0.77]
1.2 Self‐care behaviours	1	60	Mean Difference (IV, Random, 95% CI)	5.80 [5.07, 6.53]
1.3 Quality of life	2		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.1 KDQoL: effect of kidney disease	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.2 KDQoL: burden of kidney disease	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.3 WHO‐BREF: physical domain	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.4 SF‐36/KDQoL: physical functioning	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.5 SF‐36/KDQoL: role‐physical	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.6 WHO‐BREF: psychological domain	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.7 SF‐36/KDQoL: emotional well‐being	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.3.8 SF‐36/KDQoL: role‐emotional	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.4 Duration of hospital stay	1	445	Mean Difference (IV, Random, 95% CI)	‐8.70 [‐13.54, ‐3.86]
1.4.1 Individual	1	445	Mean Difference (IV, Random, 95% CI)	‐8.70 [‐13.54, ‐3.86]
1.5 Serum albumin	2		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.5.1 Individual	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
1.5.2 Individual/group	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Self‐efficacy	5	417	Std. Mean Difference (IV, Random, 95% CI)	0.58 [0.13, 1.03]
2.1.1 Individual	1	50	Std. Mean Difference (IV, Random, 95% CI)	0.37 [‐0.19, 0.93]
2.1.2 Group	2	283	Std. Mean Difference (IV, Random, 95% CI)	0.84 [0.26, 1.42]
2.1.3 Individual/group	1	48	Std. Mean Difference (IV, Random, 95% CI)	1.06 [0.45, 1.67]
2.1.4 Materials	1	36	Std. Mean Difference (IV, Random, 95% CI)	‐0.40 [‐1.06, 0.26]
2.2 Quality of life	4		Mean Difference (IV, Random, 95% CI)	Subtotals only
2.2.1 KDQoL: effect of kidney disease	2	182	Mean Difference (IV, Random, 95% CI)	1.73 [‐2.87, 6.33]
2.2.2 KDQoL: burden of kidney disease	2	182	Mean Difference (IV, Random, 95% CI)	‐1.14 [‐4.85, 2.56]
2.2.3 SF‐36: physical component score	3	131	Mean Difference (IV, Random, 95% CI)	4.02 [1.09, 6.94]
2.2.4 SF‐36/KDQoL: physical functioning	1	135	Mean Difference (IV, Random, 95% CI)	2.60 [‐2.62, 7.82]
2.2.5 SF‐36/KDQoL: role‐physical	1	135	Mean Difference (IV, Random, 95% CI)	‐1.20 [‐7.08, 4.68]
2.2.6 SF‐36: mental component score	3	131	Mean Difference (IV, Random, 95% CI)	1.45 [‐2.09, 4.99]
2.2.7 SF‐36/KDQoL: emotional well‐being	1	135	Mean Difference (IV, Random, 95% CI)	3.10 [‐1.75, 7.95]
2.2.8 SF‐36/KDQoL: role‐emotional	1	135	Mean Difference (IV, Random, 95% CI)	‐2.70 [‐7.74, 2.34]
2.3 eGFR [mL/min/1.73 m²]	3	855	Mean Difference (IV, Random, 95% CI)	1.53 [‐1.41, 4.46]
2.4 Duration of hospital stay	1	150	Mean Difference (IV, Random, 95% CI)	‐0.26 [‐0.49, ‐0.03]
2.5 Serum albumin	2	130	Mean Difference (IV, Random, 95% CI)	0.14 [‐0.15, 0.43]

PERMALINK

Interventions for improving health literacy in people with chronic kidney disease

Zoe C Campbell

Jessica K Dawson

Suzanne M Kirkendall

Kirsten J McCaffery

Jesse Jansen

Katrina L Campbell

Vincent WS Lee

Angela C Webster

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings 1. Educational interventions versus usual care for improving health outcomes in people with chronic kidney disease (CKD).

Summary of findings 2. Self‐management training versus usual care for improving health outcomes in people with chronic kidney disease (CKD).

Summary of findings 3. Educational interventions and self‐management training versus usual care for improving health outcomes in people with chronic kidney disease (CKD).

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Inclusion criteria

Exclusion criteria

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

Results of the search

1.

Included studies

Study and participant characteristics

Interventions

1. Interventions aimed at improving aspects of health literacy

2. Interventions to improve outcomes for low health literacy populations

Outcomes

Health literacy

Knowledge

Behaviour

Self‐efficacy

Quality of Life

Glomerular filtration rate

Albumin

Hospitalisations

Death

Excluded studies

Risk of bias in included studies

2.

3.

4.

Allocation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Knowledge	14	2124	Std. Mean Difference (IV, Random, 95% CI)	0.67 [0.37, 0.97]
3.1.1 Individual	6	802	Std. Mean Difference (IV, Random, 95% CI)	0.33 [0.04, 0.62]
3.1.2 Group	2	478	Std. Mean Difference (IV, Random, 95% CI)	1.13 [0.70, 1.56]
3.1.3 Individual/group	2	130	Std. Mean Difference (IV, Random, 95% CI)	1.19 [0.54, 1.85]
3.1.4 Materials	4	714	Std. Mean Difference (IV, Random, 95% CI)	0.67 [‐0.12, 1.46]
3.2 Self‐care behaviours	4	913	Std. Mean Difference (IV, Random, 95% CI)	0.91 [0.00, 1.82]
3.2.1 Individual	1	279	Std. Mean Difference (IV, Random, 95% CI)	0.22 [‐0.01, 0.46]
3.2.2 Materials	3	634	Std. Mean Difference (IV, Random, 95% CI)	1.15 [‐0.26, 2.56]
3.3 Self‐care behaviours	1	75	Risk Ratio (M‐H, Random, 95% CI)	4.14 [2.22, 7.72]
3.4 Self‐efficacy	8	687	Std. Mean Difference (IV, Random, 95% CI)	0.50 [0.10, 0.89]
3.4.1 Individual	3	277	Std. Mean Difference (IV, Random, 95% CI)	0.27 [0.03, 0.51]
3.4.2 Group	3	234	Std. Mean Difference (IV, Random, 95% CI)	0.38 [0.12, 0.64]
3.4.3 Materials	2	176	Std. Mean Difference (IV, Random, 95% CI)	0.97 [‐1.04, 2.98]
3.5 Quality of life	7		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.5.1 KDQoL: effect of kidney disease	2	2297	Mean Difference (IV, Random, 95% CI)	‐0.17 [‐1.24, 0.90]
3.5.2 KDQoL: burden of kidney disease	2	2297	Mean Difference (IV, Random, 95% CI)	‐1.32 [‐6.67, 4.02]
3.5.3 SF‐36: physical component score	3	2271	Mean Difference (IV, Random, 95% CI)	2.56 [1.73, 3.38]
3.5.4 SF‐36/KDQoL: physical functioning	3	190	Mean Difference (IV, Random, 95% CI)	1.45 [‐11.98, 14.89]
3.5.5 SF‐36/KDQoL: role‐physical	3	190	Mean Difference (IV, Random, 95% CI)	‐3.12 [‐23.21, 16.97]
3.5.6 SF‐36: mental component score	4	2388	Mean Difference (IV, Random, 95% CI)	2.75 [‐1.09, 6.60]
3.5.7 SF‐36/KDQoL: emotional well‐being	2	154	Mean Difference (IV, Random, 95% CI)	9.54 [‐1.92, 21.01]
3.5.8 SF‐36/KDQoL: role‐emotional	3	190	Mean Difference (IV, Random, 95% CI)	9.71 [‐12.13, 31.55]
3.6 Death	4	2801	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.53, 1.02]
3.6.1 Individual	2	2305	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.51, 1.01]
3.6.2 Group	1	442	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.30, 4.08]
3.6.3 Individual/group	1	54	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 7.84]
3.7 eGFR [mL/min/1.73 m²]	4	618	Mean Difference (IV, Random, 95% CI)	4.28 [‐0.30, 8.85]
3.7.1 Individual	2	126	Mean Difference (IV, Random, 95% CI)	2.34 [‐5.06, 9.74]
3.7.2 Group	1	442	Mean Difference (IV, Random, 95% CI)	2.50 [2.07, 2.93]
3.7.3 Individual/group	1	50	Mean Difference (IV, Random, 95% CI)	13.39 [4.05, 22.73]
3.8 Serum albumin	2	269	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.21, 0.28]
3.8.1 Individual	2	269	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.21, 0.28]
3.9 Serum albumin	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

*Study characteristics*
Methods	Study design Parallel RCT Duration of study 6 months Duration of follow‐up 6 months
Participants	General information Setting: single centre (Nephrology Dept of tertiary care hospital) Country: India Inclusion criteria: ESKD on HD Exclusion criteria: Under the age of 18; not interested in counselling; withdrawn from dialysis; severe illness; psychoses; infection with HIV; pregnant; lactating; < 3 months on HD Baseline information Number: intervention group (25), control group (25) Mean age ± SD (years): intervention group (49.72 ± 13.2); control group (51.5 ± 11.6) Sex (M/F): intervention group (73%/27%), control group (67%/33%) Stage of CKD: ESKD on HD Other information Duration of kidney failure, socioeconomic status, and co‐morbidities seem to be quite evenly distributed between the groups
Interventions	Type of intervention Individual versus control Intervention group Patient counselling given in relation to diet, exercise, lifestyle modification and the importance of regular dialysis and ongoing follow‐up Control group Usual care with no patient counselling
Outcomes	QoL WHO‐BREF
Notes	Conflict of interest Not reported Funding source Not reported Other information Received email from Dr Abraham: Participants were randomised by alternate allocation method; this was an individual intervention
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Emailed author: participants were randomised by alternate allocation method
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	This study was not blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Blinding would not have been possible; QoL is a subjective outcome
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was no reporting of attrition or loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Report included all expected outcomes; did not view protocol
Other bias	High risk	Participants excluded from the study that were not interested in counselling

*Study characteristics*
Methods	Study design Parallel cohort study Duration of study May to June 2010 Duration of follow‐up 2 weeks
Participants	General Information Setting: multicentre (2 sites) Country: Iran Inclusion criteria: 18 to 65 years; ability to speak the Persian or Turkish language; receiving HD for at least one year; having the physical ability to perform self‐care activities;‐ having 3 x self‐efficacy 4‐hour HD sessions/week; no history of known mental disorder, congestive heart failure, or hepatic cirrhosis Exclusion criteria: any incidence of acute emergencies during HD; any disturbance in the process of education; people who did not want to participate Baseline characteristics Number: intervention group (32); control group (31) Mean age ± SD (years): intervention group (52.09 ± 11.31); control group (47.06 ± 15.84) Sex (M/F): intervention group (17/15); control group (19/12) Stage of CKD: ESKD on HD Other information No significant difference between the groups in age, gender, marital status, education, habitancy, urinary output
Interventions	Intervention type Education: self‐efficacy Intervention group Educational materials focused on four components of self efficacy Performance attainment Vicarious experience Verbal persuasion Physiological feedback Educated in small groups (2 or 3 patients in each group) using the face‐to‐face lecture method. Delivered half an hour before and during HD in 6 subsequent sessions. Four groups of 3 people and 10 groups of 2 people. Patients also were provided with a booklet containing a summary of the lecture and related pictures Control group No education
Outcomes	Mean body weight gain Proposed benefit Self‐efficacy Proposed benefit SUPPH questionnaire Four sub‐scales: adaptation, stress management, decision making, enjoying life
Notes	Conflict of interest "No conflict of interest has been declared by the authors" Funding source Not reported Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Non‐RCT overall judgement	Unclear risk	Outcomes 1. Mean body weight gain: proposed benefit 2. Self‐efficacy: proposed benefit Bias due to confounding Moderate: Allocation based on hospital could confound Bias in selection of participants into the study Serious: Start of follow‐up and start of intervention do not coincide Bias in classification of interventions Low Bias due to deviations from intended interventions Insufficient information Bias due to missing data Moderate: Missing participants with insufficient reasons reported Bias in measurement of outcomes O1. NI O2. Moderate: Not clear who completed interview for SE Bias in selection of the reported result Moderate: Did not view protocol but overall followed the plan outlined Overall risk of bias judgement Serious: All outcomes judged at serious risk of bias in at least one domain

*Study characteristics*
Methods	Study design Parallel RCT; stratification test was performed based on the demographic and clinical features Duration of study August 2017 to December 2017 Duration of follow‐up Not reported
Participants	General information Setting: single centre; HD unit Country: Greece Inclusion criteria: HD program 3 times/week for at least 6 months; 18 to 65 years; ability to write, read and understand the Greek language; ability to read and sign the consent; time and space‐oriented Exclusion criteria: cognitive and psychological disorders; eye or hearing problems; limited self‐care Baseline characteristics Number: intervention group (25); control group (25) Mean age ± SD (years): intervention group (51.2 ± 11.5); control group (49.8 ± 8.5) Sex (M/F): intervention group (15/10); control group (15/10) Stage of CKD: ESKD on HD
Interventions	Intervention type Educational intervention versus control Intervention group One‐time face‐to‐face educational intervention lasting 45 minutes and provision of a booklet Control group Provision of a booklet: Dialysis. Answers to common questions
Outcomes	Knowledge Kidney Disease Questionnaire (Greek) Adherence GR‐Simplified Medication Adherence Questionnaire‐HD (Greek) QoL Missoula VITAS Quality of Life Index‐15
Notes	Conflict of interest No conflict of interest reported by the authors Funding source Not reported Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about the randomisation process, which included a stratification test for demographic and clinical features
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to nature of intervention participants and personnel could not be blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Due to nature of intervention participants and personnel could not be blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Objective outcomes should not be affected by blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	High risk	High rate of loss to follow‐up 28%
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting
Other bias	Low risk	No other bias could be identified

*Study characteristics*
Methods	Study design Pre‐test/post‐test and parallel RCT Duration of study 6 weeks Duration of follow‐up 6 weeks
Participants	General information Setting: multicentre (2 sites, HD units) Country: Korea Inclusion criteria: aged 60 to 70 years; HD 3 times/week for more than 1 year; patients in the e‐mail group had to meet the additional requirement of having a valid e‐mail address and checking their e‐mail messages every day using their computer Exclusion criteria: not reported Baseline characteristics Number: intervention group (21); control group (19) Mean age ± SD (years): intervention group (62.59 ± 2.06); control group (63.7 ± 2.42) Sex (M/F): intervention group (10/9); control group (12/9) Stage of CKD: ESKD on HD Other information No significant differences between the 2 groups: age, sex, male, female, education, religion, living with a spouse, employed, monthly income
Interventions	Intervention type Education: provision of materials versus usual care Intervention group E‐mail education: 12 sessions; the material of each session was e‐mailed twice a week for 6 weeks, focused on fluid balance, sodium balance and hyperkalaemia and managing this. Medications, eating out and desirable menu Control group Routine care
Outcomes	Bloods Compliance (potassium and phosphate) Weight gain Compliance (IDWG) Stress Stress instrument developed by Kim JH 1995, reference 13 in this article Cortisol, adrenaline and noradrenaline levels
Notes	Conflict of interest Not reported Funding source Supported financially by a research grant from Cheongju University Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Non‐RCT overall judgement	Unclear risk	Outcomes 1. Stress score 2. IDWG 3. Bloods: serum cortisol, epinephrine, norepinephrine, potassium, phosphorus Bias due to confounding Serious: Didn't adjust for confounders; hospital, SES and education and the effect these could have on outcomes Bias in selection of participants into the study Serious: Selection into the study was related to intervention and outcome; start of follow‐up and start of intervention do not coincide Bias in classification of interventions Low Bias due to deviations from intended interventions NI: Possibility that intervention patients did not read emails and they didn't check this in any way Bias due to missing data Moderate: Outcome data reasonably complete, but didn't give a reason for one intervention participant for missing too many HD sessions Bias in measurement of outcomes O1. Serious: The outcome measure was subjective (i.e. likely to be influenced by knowledge of the intervention received by study participants) and was assessed by outcome assessors aware of the intervention received by study participants O2. NI: Didn't say who or how they took the measurements O3. Low Bias in selection of the reported result Moderate: Did not view protocol but overall followed the plan outlined Overall risk of bias judgement Serious: All outcomes judged at serious risk of bias in at least one domain

*Study characteristics*
Methods	Study design Pre‐test/post‐test design with control group Duration of study Control group: May 2011 to August 2011 Intervention group: September 2011 to March 2012 Duration of follow‐up 8 weeks
Participants	General information Setting: single centre Country: South Korea Inclusion criteria: outpatients diagnosed as CKD; hadn't started KRT; ≥ 20 years; understood the study process and were able to communicate Exclusion criteria: not reported Baseline characteristics Number: intervention group (31); control group (30) Mean age ± SD (years): intervention group (53.93 ± 13.47); control group (58.33 ± 12.54) Sex (M/F): intervention group (21/10); control group (21/9) Stage of CKD: stage not defined Other information No statistical difference between groups at pre‐test in terms of gender, age, sex, education, religion, marital status, job, income, type of caregiver, experience of similar education, knowledge, self‐care practices, or physiological index
Interventions	Intervention type Self‐management and education: group and individual versus control Intervention group Small group face‐to‐face education and individualized consultation Pre‐program session to identify individual characteristics, face‐to‐face education, individualised consultation time each session, and re‐enforcement education one week later Control group No extra education. Was completed first to avoid contamination
Outcomes	Progression of kidney disease GFR Bloods Indicators of kidney function: urea, creatinine, sodium, potassium, calcium, phosphate, Hb Knowledge Knowledge of CKD scale: 20‐item CKD knowledge instrument Self‐management Self‐care practice scale for CKD
Notes	Conflict of interest Not reported Funding source Not reported Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Non‐RCT overall judgement	Unclear risk	Outcomes 1. Knowledge 2. Self‐care 3. BUN/creatinine 4. Sodium/potassium 5. Calcium/phosphate 6. Hb 7. GFR Bias due to confounding Moderate: Although some things were controlled for between groups there is still always going to be an un‐measurable risk of bias when the two groups undertake a study at different times Bias in selection of participants into the study Low Bias in classification of interventions Low Bias due to deviations from intended interventions NI: Can't judge fidelity of implementation based on given information Bias due to missing data Low Bias in measurement of outcomes O1. Moderate O2. Serious: self‐care is subjective O3‐O7. Low: objective measure, no mention of blinding but not important as objective measures Bias in selection of the reported result Low Overall risk of bias judgement Serious: O2 (self‐care) Moderate: O1/O3‐O7 (knowledge and kidney physiology)

*Study characteristics*
Methods	Study design Parallel RCT with a pre‐test and post‐test Duration of study Undertaken in 2005 Duration of follow‐up 12 weeks
Participants	General information Setting: multicentre (2 local regional hospitals) Country: Hong Kong Inclusion criteria: access to a telephone after discharge Exclusion criteria: intermittent PD or HD and those with planned admissions for special treatment procedures; Tenckhoff catheters in situ < 3 months Baseline characteristics Number: intervention group (50); control group (50) Mean age ± SD (years): intervention group (59.4 ± 13.97); control group (54.5 ± 12.8) Sex (M/F): intervention group (28/15); control group (24/18) Stage of CKD: on PD
Interventions	Intervention type Educational: individual versus usual care Intervention group Comprehensive discharge planning protocol including participation of patients and family members in discussions about the plan, assessment of social, physical, cognitive and emotional needs, and an individualised educational program 6‐week nurse‐initiated telephone follow‐up program Control group Routine discharge care: standard information and a telephone hotline service, a set of self‐help printed materials and an appointment reminder. Control and study group participants received the same routine care during hospitalisation as other patients in the unit
Outcomes	QoL KDQoL‐SF
Notes	Conflict of interest "No conflict of interest has been declared by the authors" Funding source "The source of funding of this project was Research Grants Council of Hong Kong (PolyU 5435/05H)" Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Fifty sets of computer‐generated random numbers were used, and patients who fitted the criteria were randomized to the study or control group." Computer generated randomisation
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants were not blinded because of nature of intervention. Nurses conducted education and follow‐up phone calls and were not blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Quote: "Data collection was through face‐to‐face interview." Self report questionnaire collected through face‐to‐face interview neither patient nor interviewer were blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was a dropout reducing the sample size from 123 to 100; the required size for significant effect was 90 The dropout after randomisation seems similar between the groups
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Non‐generalisable sample population

*Study characteristics*
Methods	Study design RCT; pre‐test/post‐test Duration of study Not reported Duration of follow‐up 3 months
Participants	General information Setting: multicentre (2 outpatient dialysis clinics) Country: USA Inclusion criteria: no physical or mental disability; 18 to 80 years; receiving dialysis > 3 months Exclusion criteria: not reported Baseline characteristics Number: intervention group 1 (24); intervention group 2 (19); intervention group 3 (28); control group (25) Mean age: 54.8 years Sex: 54% males Stage of CKD: not reported Other information No difference was found in characteristics between clinics. A significant difference between groups was found for weight gain [F(1,92) = 5.24, P < 0.05]; a non‐statistical difference was found for patients' average SPL. Also, patients in the weekly telephone contact group were less compliant than patients in the other experimental groups. No difference was found for sociodemographics, medical history, and belief variables
Interventions	Intervention type Self‐management Intervention group 1 Individual behavioural contract Identifying a behaviour or set of behaviours to be targeted for change in the contract Working out a timetable for the specified behaviours and how this can be achieved, along with finding out reward system Completing a formal written contract Recording progress with rewards as per the contract Intervention group 2 Behavioural contract with a family member or friend: as above but with a third person selected by the patient included Intervention group 3 Weekly telephone contacts Asking patient what problem they may be having with adherence Providing education and information about potential negative health consequences of not adhering to therapy and suggestions for better compliance Verbal support to patients for maintaining proper adherence Patients were contacted once a week for 6 weeks Control group Routine medical care, which included coming into the clinic for dialysis treatments 2 or 3 times/week and provision of information about their blood levels and weight gains between treatments If a patient was experiencing difficulty complying with the treatment regimen a nurse or a dietician would counsel the patient as per usual care
Outcomes	Dietary compliance Potassium levels, fluid limit adherence Health beliefs Perceived susceptibility to noncompliance complications, beliefs about benefits of the diet, barriers related to diet and fluid intake
Notes	Conflict of interest Not reported Funding source Not reported Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Within clinics, patients were randomly assigned to either an intervention program or a control group." Insufficient information to permit judgement
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding not possible in this setting for either participants or personnel
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Subjective self report questionnaires filled out by unblinded participants
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Blinding not thought to affect objective outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Analysis of drop outs showed attrition, potassium, weight gains and belief scores did not differ significantly; did not use ITT
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Unclear whether results are generalisable

*Study characteristics*
Methods	Study design Parallel RCT and pre‐test/post‐test Duration of study July to September 2001 Duration of follow‐up 3 months
Participants	General information Setting: single centre Country: UK Inclusion criteria: > 18 years; clinically stable; at least 1 phosphate value > 1.7 mmol during a 3‐month period Exclusion criteria: unable to read English; cannot prepare their own food Baseline characteristics Number: intervention group (29); control group (29) Mean age, range (years): intervention group (54.2, 22 to 77); control group (53, 23 to 88) Sex (M/F): intervention group (10/19); control group (16/13) Stage of CKD: ESKD on HD Other information The groups were broadly balanced in terms of patient age, sex, ethnic group, and renal diagnosis
Interventions	Intervention type Education: individual using education tool Intervention group One 40‐minute session using an educational tool with a dietitian focused on knowledge of phosphate balance in dialysis patients. Individualised advice on diet, medication compliance, and lifestyle. The education package “A Patient’s Guide to Keeping Healthy: Managing Your Phosphate” comprised a booklet, a medication record chart, and a refrigerator magnet Control group Usual care
Outcomes	Bloods PO₄, Ca, Ca x PO₄ product
Notes	Conflict of interest Not reported Funding source "We thank Genzyme, Inc, for the supply of the education tool. The company had no other part in the design, conduct, or reporting of the trial" Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "They were randomized by random alternate allocation to either the intervention or the control group." Random alternate allocation
Allocation concealment (selection bias)	Unclear risk	Insufficient information. Probably not done because alternate allocation pattern can be worked out
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The hemodialysis dietitian did not know which dialysis patients were participating in the study." Renal dietitian giving advice was blinded to which group the participants were in The blinding of the other personnel was judged not to affect the outcome
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Not blinded but reviewers do not think this will affect outcome
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Patients who died or underwent transplantation after the intervention were included in all analyses." Quote: "One patient died after randomization but before the intervention had taken place, and another moved from our unit to another before the intervention; both of these patients were in the control group, and their data were removed from the study." Quote: "Reasons for not obtaining results were patient death (2 patients), patient transplantation (1 patient), and administrative (1 patient)." Missing data explained (although does not say which group they were in). Reasons do not seem to be related to intervention
Selective reporting (reporting bias)	Low risk	No reporting of urea or creatinine in outcome data however this is not likely to have a big impact on outcomes
Other bias	Unclear risk	May have been some contamination between patients sharing information from the education session. Authors noted wide variation in outcomes within both groups and therefore improved levels due to another factor ‐ e.g. seasonal variation

*Study characteristics*
Methods	Study design Quasi‐RCT (randomised by day of the week) Duration of study 16 weeks Duration of follow‐up 4 weeks
Participants	General information Setting: single centre Country: Iran Inclusion criteria: > 18 years; no evidence psycho‐emotional problems and no psychotropic medications; literate; have telephone access at home Exclusion criteria: not reported Baseline characteristics Number: intervention group (48); control group (51) Mean age ± SD (years): intervention group (51.6 ± 11.9); control group (50.3 ± 10.1) Sex (M/F): intervention group (31/17); control group (30/21) Stage of CKD: ESKD on HD Other information No significant difference was found in baseline demographic comparison between groups
Interventions	Intervention type Educational intervention: group versus control Intervention group 30 to 40‐minute face‐to‐face education session followed by 10 to 15 minutes to answer questions. Twice a week for 12 weeks Control group Usual care
Outcomes	Knowledge Dietary questionnaire created for this study QoL KDQoL
Notes	Conflict of interest "Authors declare that they have no conflict of interest" Funding source "This study was sponsored by the Vice Chancellor for research at Shahroud University of Medical Sciences (research grant no. 9116)" Other information Not requested
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Randomisation was based on day of the week for dialysis
Allocation concealment (selection bias)	High risk	Unable to conceal allocation with this randomisation method
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the intervention the participants could not be blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Self report questionnaire by unblinded participants
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Objective outcomes should not be affected by blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was no reporting of loss to follow‐up data
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Low risk	No evidence to suggest other forms of bias