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Table 4 Summary of results for type(s) of interventions, data collection procedures, reporting of participant consent procedures for study interventions and data collection, timing of any participant consent, and whether participants can opt out of the intervention or data collection

From: Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review

Component

Intervention arm

n (%)

Control arm

n (%)

Type(s) of interventions (i.e., all components of intervention)Â¥

N total = 31

N total = 8**

 Educational/ quality improvement interventions targeted at health professionals (e.g., transplant education and engagement activities targeting health professionals, etc.)

4 (13%)

0 (0%)

 Quality improvement interventions targeted at organization of health care or health services delivery (e.g., nutrition screening, change in catheter exit-site care, etc.)

10 (32%)

2 (25%)

 Patient health promotion or educational intervention (e.g., education about benefits of resistance exercise program, dietary counseling, education on avoiding foods with phosphorus additives, etc.)

22 (71%)

4 (50%)

 Direct patient therapeutic intervention (e.g., intradialytic resistance training, antimicrobial barrier caps for catheters, etc.)

6 (19%)

1 (12%)

 Other €

1 (3%)

1 (12%)

Types of Data collection procedures ¥

N total = 31

N total = 31

 Routinely collected outcomes extracted locally from existing patient medical records (physical charts or electronic records)

30 (97%)

30 (97%)

 Data query from clinical data registry or other central source of routinely collected data (e.g., administrative data)

11 (35%)

11 (35%)

 Specimen collection or physical examination that were not required for usual patient care

4 (13%)

4 (13%)

 Interviewer-administered patient questionnaires done face-to-face or by telephone that were not required for usual patient care

9 (29%)

9 (29%)

 Self-administered patient questionnaires (done by mail, e-mail or Internet) that were not required for usual patient care

18 (58%)

16 (52%)

 Other ₳

5 (16%)

2 (6%)

Reporting of participant consent procedures for study interventions

N total = 31

N total = 31

 Reported written informed consent

9 (29%)

10 (32%)

 Reported verbal informed consent

1 (3%)

0 (0%)

 Reported informed consent but no details about method or what consent was for

12 (39%)

11 (35%)

 Reported the study was exempt from research ethics committee review, received waiver of consent, or explicitly stated no consent

4 (13%)

4 (13%)

 Unclear if participants consented

1 (3%)

2 (6%)

 Not mentioned

4 (13%)

4 (13%)

Reporting of participant consent procedures for data collection

N total = 31

N total = 31

 Reported written informed consent

7 (22%)

6 (19%)

 Reported verbal informed consent

1 (3%)

1 (3%)

 Reported informed consent but no details about method or what consent was for

14 (45%)

14 (45%)

 Reported the study was exempt from research ethics committee review, received waiver of consent, or explicitly stated no consent

4 (13%)

4 (13%)

 Unclear if participants consented

1 (3%)

2 (6%)

 Not mentioned

4 (13%)

4 (13%)

  1. ¥The responses to these questions were not mutually exclusive
  2. ₳Active data collection, including using case report form
  3. €Surrogate decision-maker educational intervention in the intervention arm; audit feedback from previous year in the control arm
  4. **These questions were not applicable when the comparator arm was usual care