7. Effect of interventions on secondary outcomes: interventions targeting patients compared with usual care.
| Continous Data | Meta‐analysis | |||||||
| Study | Intervention | Control | Outcome | N | SMD | SMD (95% CI) | I2 | |
| Landrey 2012 | Patient‐mediated intervention (mailed flyer) | Usual care | Knowledge/knowledge not addressed in decision aid | 148 | 0.14 (‐0.19 to 0.46) | 0.38 (0.16 to 0.61) | 44% | x |
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | Pre: 304 Post: 262 | 0.52 (0.27 to 0.77) | x | |||
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | 262 | 0.81 (0.55 to 1.06) | ||||
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Pre: 167; Post: 155 | 0.45 (0.13 to 0.77) | x | |||
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Knowledge (items addressed in decision aid) | Pre: 164; Post: 152 | 0.77 (0.44 to 1.10) | 0.77 (0.44 to 1.10) | na | na |
| Vodermaier 2009 | Patient mediated intervention (decision aid) | Usual care | Satisfaction with decision and treatment | 107 | 0.14 (‐0.24 to 0.52) | 0.14 (‐0.24 to 0.52) | na | na |
| Murray 2001 | Patient‐mediated intervention (decision aid) | Usual care | Decisional conflict | 105 | ‐0.66 (‐1.06 to ‐0.27] | ‐0.30 (‐0.68 to 0.09) | 71% | x |
| Vodermaier 2009 | Patient‐mediated intervention (decision aid) | Usual care | 107 | ‐0.28 (‐0.66 to 0.10) | x | |||
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | 155 | 0.01 (‐0.31 to 0.32) | x | |||
| van Tol‐Geerdink 2016 | Patient‐mediated intervention (decision aid) | Usual care | Decision regret (6 months) | 212 | ‐0.10 (‐0.39 to 0.19) | ‐0.10 (‐0.39 to 0.19) | na | na |
| van Tol‐Geerdink 2016 | Patient‐mediated intervention (decision aid) | Usual care | Decision regret (12 months) | 201 | ‐0.20 (‐0.50 to 0.10) | ‐0.20 (‐0.50 to 0.10) | ||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Patient‐physician communication (number of topics raised by the patient) | 100 | 0.26 (‐0.13 to 0.65) | 0.26 (‐0.13 to 0.65) | na | x |
| Deen 2012 | Patient‐mediated intervention (decision aid) | Usual care | Decision self‐efficacy | 137 | 0.07 (‐0.26 to 0.41) | 0.16 (‐0.08 to 0.40) | 0% | |
| Deen 2012 | Patient‐mediated intervention (Patient Activation) | Usual care | 142 | 0.18 (‐0.15 to 0.51) | x | |||
| Deen 2012 | Patient‐mediated intervention (decision aid + Patient Activation) | Usual care | 135 | 0.08 (‐0.25 to 0.42) | ||||
| Maranda 2014 | Patient mediated intervention | Usual care | 132 | 0.14 (‐0.20 to 0.48) | x | |||
| Pickett 2012 | Patient‐mediated intervention (training for patients) | Usual care | Empowerment (time 2) | Pre: 428; Post: 342 | 0.26 (0.05 to 0.48) | 0.26 (0.05 to 0.48) | na | na |
| Pickett 2012 | Patient‐mediated intervention (training for patients) | Usual care | Empowerment (time 3) | Pre: 428; Post: 318 | 0.17 (‐0.05 to 0.39) | 0.17 (‐0.05 to 0.39) | ||
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | Health‐related QoL (physical) | Pre: 133; Post: 116 | 0.00 (‐0.36 to 0.36) | 0.00 (‐0.36 to 0.36) | na | x |
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | Health‐related QoL (mental) | Pre: 133; Post: 116 | 0.10 (‐0.26 to 0.46) | 0.10 (‐0.26 to 0.46) | na | x |
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | Anxiety (20‐80) | Pre: 304 Post: 262 | ‐0.17 (‐0.49 to 0.14) | ‐0.17 (‐0.49 to 0.14) | na | na |
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Anxiety (state) | Pre: 166; Post: 157 | 0.18 (‐0.06 to 0.43) | 0.18 (‐0.06 to 0.43) | na | na |
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Consultation length (min: sec) | 100 | 0.35 (‐0.04 to 0.75) | 0.10 (‐0.39 to 0.58) | 70% | x |
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Consultation length | 124 | ‐0.15 (‐0.50 to 0.21) | x | ||
| Murray 2001 | Patient mediated intervention (decision aid) | Usual care | Cost (excluding intervention) | 105 | 0.25 (‐0.14 to 0.63) | 0.25 (‐0.14 to 0.63) | na | na |
| Murray 2001 | Patient mediated intervention (decision aid) | Usual care | Cost (including intervention) | 105 | 0.82 (0.42 to 1.22) | 0.82 (0.42 to 1.22) | ||
| Categorical data | Meta‐analysis | |||||||
| Study | Intervention | Control | Outcome | N | RD | RD (95% CI) | I2 | |
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | Overall knowledge/Knowledge of risk without medication | 41 | 0.27 (‐0.05 to 0.60) | 0.17 (0.05 to 0.29) | 0% | x |
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | 41 | 0.38 (0.06 to 0.69) | ||||
| Krist 2007 | Patient‐mediated intervention (decision aid brochure) | Usual care | 271 | 0.16 (0.03 to 0.29) | x | |||
| Krist 2007 | Patient‐mediated intervention (decision aid web) | Usual care | 301 | 0.16 (0.03 to 0.28) | ||||
| Sheridan 2014 | Patient‐mediated intervention (decision aid) | Usual care | Patient‐physician communication (patient raised discussion) | 157 | 0.29 (0.14 to 0.44) | 0.29 (0.14 to 0.44) | na | x |
| Sheridan 2014 | Patient mediated intervention (decision aid) | Usual care | Patient‐physician communication (patient participation in discussion) | 157 | 0.27 (0.13 to 0.42) | 0.27 (0.13 to 0.42) | na | x |
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | Empowerment (number of fully empowered couples) | Pre: 304 Post: 262 | 0.18 (0.09 to 0.27) | 0.18 (0.09 to 0.27) | na | na |
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Adherence (% of patients who filled their prescription within 30 days) | 197 | ‐0.07 (‐0.15 to 0.01) | ‐0.07 (‐0.15 to 0.01) | na | na |
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Adherence (% of patients with a PDC > 80%) | 206 | ‐0.03 (‐0.08 to 0.02) | ‐0.03 (‐0.08 to 0.02) | na | na |
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Adherence to medication (sometimes forget take cholesterol medicine) | 98 | ‐0.04 (‐0.23 to 0.15) | ‐0.04 (‐0.23 to 0.15) | na | na |
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Adherence to medication (did not miss a dose last week) | 97 | 0.07 (‐0.06 to 0.20) | 0.07 (‐0.06 to 0.20) | na | na |
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | Anxiety (mild, moderate and severe) | Pre: 138; Post: 127 | 0.04 (‐0.07 to 0.15) | 0.04 (‐0.07 to 0.15) | na | na |
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | Depression (mild, moderate and severe) | Pre: 138; Post: 127 | 0.16 (0.05 to 0.28) | 0.16 (0.05 to 0.28) | na | na |
| Qualitative statement | Meta‐analysis | |||||||
| Study | Intervention | Control | Outcome | Direct quotes | ||||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | Knowledge (overall: generic and tailored) | No significant differences between groups (table 2, page 9 of the publication and table 2 of the supplementary material) | na | |||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Significant difference in favor of the intervention group (p=0.03) (table 2; page 1767) | na | ||||
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | "Intervention patients ... had a better knowledge of prosthetic valves (85% versus 68%; P=0.004)" Page 1 | na | ||||
| Sheridan 2014 | Patient‐mediated intervention (decision aid) | Usual care | Results reported only for the intervention group | na | ||||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Knowledge : Generic | No differences between groups (p=0.65) (table 2; page 1767) | na | |||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | No significant differences betwwen groups (table 2, page 9 of the publication and table 2 of the supplementary material) | na | ||||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Knowledge : Tailored to information in the decision aid | Significant difference in favour of the intervention group (p<0.001) (table 2; page 1767) | na | |||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | Significant differences between groups (table 2, page 9 of the publication and table 2 of the supplementary material) | na | ||||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Satisfaction with the consultation | Intervention group (median; range) 5.0 (4–5) vs control group 5.0 (3–5) (p‐value=0.27). Page 231 (table 2) | na | |||
| Almario 2016 | Patient‐mediated intervention (GI PROMIS) | Usual care | "Table 3 presents the CG‐CAHPS provider rating scores for the GI PROMIS and control arms in the intention‐to‐treat analysis. After adjusting for confounders, we found no difference in provider rating between groups." Page 7 | na | ||||
| Haskard 2008 | Patient‐mediated intervention | Usual care | Satisfaction with care | "There were no significant main effects of patient training on patient satisfaction questionnaire items." Page 518 | na | |||
| van der Krieke 2013 | Patient‐mediated intervention (web‐based information and decision tool) | Usual care | "Patients also did not differ in self‐reported satisfaction with care (CSQ) (F1,70=0.014, P=.91)." (no page number, in the resuts section) | na | ||||
| Landrey 2012 | Patient‐mediated intervention (mailed flyer) | Usual care | Satisfaction with the intervention | “Among patients who reported receiving the flyer, 86.4% felt the content was clearly presented, 86.4% felt it contained about the right amount of information, 45.5% felt the information was completely balanced, and 43.2% viewed it as biased against PSA testing; 88.6% would recommend it to others.” Page 71 | na | |||
| Murray 2001 | Patient‐mediated intervention (decision aid) | Usual care | “Patients reacted positively to the decision aid (table 3)” Page 5 | na | ||||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | "Fifteen patients rated the QPS as not helpful, while 16 rated it as somewhat helpful and 20 patients as helpful." Page 230 | na | ||||
| LeBlanc 2015a | Patient mediated intervention (decision aid) | Usual care | "After the encounters with their clinicians, patients in the decision aid arm ... were more … satisfied (ranging from risk ratio [RR], 1.25 [P = .81] to RR, 2.40 [P = .002]) compared with patients in the control arm (Table 2)." Page 1765 | na | ||||
| van der Krieke 2013 | Patient‐mediated intervention (web‐based information and decision tool) | Usual care | "They agreed or completely agreed with the following statements: “I have been well informed about the treatment options offered by Friesland Mental Health Care Service by the decision aid” (22/29, 76%), “The advice presented by the decision aid has helped me to reflect on what I want” (22/29, 76%), “The decision aid was easy to use” (20/28, 71%), “I would recommend the decision aid to others” (20/27, 74%) and “The decision aid helped me to get a clearer view on what my problem areas or points of interest are” (17/28, 61%). Patients were divided on whether the decision aid helped them to better prepare the evaluation meeting with their clinicians, 44% (12/27) said it did help; 56% (15/27) were neutral or said it did not help. " (no page number, in the result section) | na | ||||
| Eggly 2017 | Patient‐mediated intervention (question prompt list) | Usual care | "The mean patient response across the eight questions about the QPL booklet was 2.80 (SD = 0.23). T‐tests showed no significant differences between the two intervention arms on any of these questions (p’s > 0.05). The mean response across the five questions about coaching was 2.83 (SD = 0.29) (Table 3)." Page 823 | na | ||||
| Eggly 2017 | Patient‐mediated intervention (question prompt list + communication coach) | Usual care | "The mean patient response across the eight questions about the QPL booklet was 2.80 (SD = 0.23). T‐tests showed no significant differences between the two intervention arms on any of these questions (p’s > 0.05). The mean response across the five questions about coaching was 2.83 (SD = 0.29) (Table 3)." Page 823 | na | ||||
| Krist 2007 | Patient‐mediated intervention (decision aid brochure) | Usual care | Decisional conflict | "DCS scores among all 3 groups were equally low and did not differ signifi cantly (control, 1.58; brochure, 1.54; and Web site, 1.55)." Page 115 | na | |||
| Krist 2007 | Patient‐mediated intervention (decision aid web) | Usual care | "DCS scores among all 3 groups were equally low and did not differ significantly (control, 1.58; brochure, 1.54; and website, 1.55)." Page 115 | na | ||||
| Sheridan 2014 | Patient‐mediated intervention (decision aid) | Usual care | Results reported only for the intervention group | na | ||||
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | No differences between groups (p>0.05). Page 5; table 2 | na | ||||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | "Decision conflict was low for both groups, and was lower in the Decision Aid arm, but no significant difference was found in the overall scale or in its subscales across arms (Table 2)." Page 8 | na | ||||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Decisional conflict (0 = conflict, 100 = comfort) | "After the encounters with their clinicians, patients in the decision aid arm reported significantly higher comfort with the decision (mean difference [MD], 5.3 out of 100; 95% CI, 1.1‐9.5; P = .01)" Page 1765 | na | |||
| Korteland 2017 | Patient‐mediated intervention (decision aid) | Usual care | Decision regret (3 months post‐operative) | "Three months postoperative regret with regard to prosthetic valve choice ranged from 0 to 55, with no statistical difference between the intervention and control groups. The majority of patients in the intervention and control groups did not experience any regret (70% versus 64%, respectively; P=0.513)." Page 4 | na | |||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Patient‐physician communication (Dominant behaviour of physician) | There was more dominant behaviour in the control group compared to the intervention group (Median, range: intervention group 2.0 (0–4) control group 3.0 (0–4); p= 0.03) (table 2) | na | |||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Patient‐physician communication (Dominant behaviour of patient) | There no difference between groups (Median, range: intervention group 1.0 (0–4) control group 1.0 (0–4); p= 0.46) (table 2) | na | |||
| Hamann 2014 | Patient‐mediated intervention (question prompt sheet) | Usual care | Patient‐physician communication (Patient shows interest, raises questions) | There no difference between groups (Median, range: intervention group 2.0 (0–4) control group 1.0 (0–3); p= 0.31) (table 2) | na | |||
| Sheridan 2014 | Patient‐mediated intervention (decision aid) | Usual care | Patient‐physician communication (Patients’ perceptions of discussions and the health care visit) | "Intervention participants also tended to report better interactions with their provider, with improvements for the following 3 of 6 items from the Healthcare Climate questionnaire: “My provider provided me with choices and options about lowering my chances of heart disease” (+15 percentage points; adjusted p = .02); “My provider listened to how I would like to do things” (+21 percentage points; adjusted p < .01); and “My provider tried to understand how I see things before suggesting new ways to lower my chances of heart disease” (+15 percentage points; adjusted p = .05)." Page 5 | na | |||
| Vestala 2013 | Patient‐mediated intervention (patient participation in nursing documentation) | Usual care | Empowerment | "No statistical difference was identified between the intervention and control group with regards to empowerment." page 70 | na | |||
| Krist 2007 | Patient‐mediated intervention (decision aid brochure) | Usual care | Match between preferred and actual level of participation in decision making | "Concordance did not differ between the 3 study groups (P1 = .41)." Page 117 | na | |||
| Krist 2007 | Patient‐mediated intervention (decision aid web) | Usual care | "Concordance did not differ between the 3 study groups (P1 = .41)." Page 117 | na | ||||
| Cooper 2011 | Patient‐mediated intervention | Usual care | Adherence to medication | “Changes in patient‐reported adherence to medications at 12 months did not differ for any of the intervention groups compared to the patient+physician minimal intervention group.” Page 1300 | na | |||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Differents forms of usual care [Reminder (copy of patient's estimated risk of fracture as computed by the FRAX) OR usual care] | "No difference was found in adherence to the medication that was prescribed for both, those who filled their initial prescription [PDC Median 46.7%, IQR (30, 62) for Decision Aid arm vs. 85%, IQR (55.3, 92.6) for FRAX/Usual Care arm, Table 3] or for all that were prescribed bisphosphonates [PDC Median (IQR) 46.7%, (7.8, 46.7) for Decision Aid arm vs. 0%, (0, 72.5) for FRAX/Usual Care arm]. Only one patient in the Decision Aid arm and 3 in the FRAX/Usual Care arm had PDC >80%." page 8 | na | ||||
| Murray 2001 | Patient‐mediated intervention (decision aid) | Usual care | Health status and physical function | "We found no difference between the two groups in the trends over time in the EQ5D responses nor in the SF36 scores." Page 5 | na | |||
| Murray 2001 | Patient‐mediated intervention (decision aid) | Usual care | Health states and valuation of health states | "We found no difference between the two groups in the trends over time in the EQ5D responses nor in the SF36 scores." Page 5 | na | |||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | Usual care | Health‐related QoL | "We found no difference between the FRAX and usual care arms, nor were overall results significantly impacted by analyses comparing the three arms versus only two arms (Decision aid arm vs. FRAX/usual care arms together, see Tables A, B, C, D, and E in S1 File. Therefore, the results comparing the FRAX arm and the Usual Care arm were combined and all subsequent results are presented as Decision Aid vs. FRAX/Usual Care arm (i.e. different forms of usual care)." page 7 There were no difference between group regarding quality of life [Median (IQR); Decision aid: 85 (80 to 95) FRAX/UC: 85 (73 to 90); p=0.19 (table 4)] | na | |||
| Murray 2001 | Patient‐mediated intervention (decision aid) | Usual care | Anxiety | "The Spielberger scores were similar at the final assessment in the two groups (MannWhitney U test). " page 5 | na | |||
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | Depression (number with subclinical depression) | "At uptake of in vitro fertilisation the frequency of subclinical depression did not differ between the intervention and control group: 11% (16/147) v 9% (113/151). After patients received the empowerment strategy, however, this frequency was higher in the intervention group (13% (16/126) v 4% (5/136); P=0.01); this difference diminished after embryo transfer, however (14% (17/123) v 14% (17/120); P=0.94)." Page 5 | na | |||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Depression (symptoms) ‐ 3 months | "There was no observed difference across arms in control of depression symptoms (mean PHQ‐9 score), remission rate (PHQ‐9 score <5), or responsiveness (>50% PHQ‐9 improvement) at 3 and 6 months" Pages 1765‐1766 | na | |||
| LeBlanc 2015a | Patient‐mediated intervention (decision aid) | Usual care | Depression (symptoms) ‐ 6 months | "There was no observed difference across arms in control of depression symptoms (mean PHQ‐9 score), remission rate (PHQ‐9 score <5), or responsiveness (>50% PHQ‐9 improvement) at 3 and 6 months" Pages 1765‐1766 | na | |||
| Vestala 2013 | Patient‐mediated intervention (patient participation in nursing documentation) | Usual care | Depression | Not reported | na | |||
| Perestelo‐Perez 2016 | Patient‐mediated intervention (decision aid) | Usual care | Stress (diabete related) | No difference between groups (page 298; table 2) | na | |||
| Krist 2007 | Patient‐mediated intervention (decision aid brochure) | Usual care | Consultation length | “These [discussion times] patient‐physician differences did not differ significantly across the control, brochure, and Web groups.” Page 116 | na | |||
| Krist 2007 | Patient‐mediated intervention (decision aid web) | Usual care | “These [discussion times] patient‐physician differences did not differ significantly across the control, brochure, and Web groups.” Page 116 | na | ||||
| Vodermaier 2009 | Patient‐mediated intervention (decision aid) | Usual care | “No time differences emerged in the length of the treatment decision consultation with the physicians on patient self‐reports. The mean time for the treatment decision making appointment was about 15 minutes” Page 593 | na | ||||
| Eggly 2017 | Patient‐mediated intervention (question prompt list) | Usual care | "There were no significant differences in interaction length between either of the two intervention arms and the usual care arm (Arm 2 vs. Arm 1, p = 0.21); Arm 3 vs. Arm 1, p = 0.11)." Page 823 | na | ||||
| Eggly 2017 | Patient‐mediated intervention (question prompt list + communication coach) | Usual care | "There were no significant differences in interaction length between either of the two intervention arms and the usual care arm (Arm 2 vs. Arm 1, p = 0.21); Arm 3 vs. Arm 1, p = 0.11)." Page 823 | na | ||||
| LeBlanc 2015b | Patient‐mediated intervention (decision aid) | usual care] | "Encounter duration in the FRAX/Usual Care arm had a median of 10.7 minutes and a range of 2.5 to 54.9 minutes, where encounters in the Decision Aid arm had a median duration of 11.5 with a range of 5.4 to 21.4 minutes (median difference 0.8 minutes, range ‐33.6 to 3.0)." Page 10 | na | ||||
| Maclachlan 2016 | Patient‐mediated intervention (educational meeting for patient) | Usual care | "The overall average length of consultations was 5.58 minutes, 5.78 minutes in the trained group and 5.37 minutes in the untrained group." Page 5 | na | ||||
| van Peperstraten 2010 | Patient‐mediated intervention (decision aid + support call) | Usual care | Cost | “The mean total savings in the intervention group were calculated to be EURO169.75 per couple included from the waiting list for in vitro fertilisation” Page 5 | na | |||
CI: confidence interval; CSQ: Client Satisfaction Questionnaire; DA: decision aid; DCS: Decisional Conflict Scale; GI PROMIS: gastrointestinal Patient Reported Outcomes Measurement Information System; N: sample size; na: not applicable; PDC: percentage of days covered; PHQ‐9: Patient Health questionnaire for depression; PSA: Prostatic Specific Antigen; QPL: question prompt list; QPS: question prompt sheet; QoL: quality of life; RD: risk difference; RR: relative risk; SD: standard deviation; SMD: standardized mean difference.