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Table 1 Characteristics of the primary qualitative reports

From: The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

 N = 45 (100.0%)
Primary qualitative report characteristics
 Study design
  Qualitative37 (82.2%)
  Mixed methods8 (17.8%)
 Data collection methods
  Interviews39 (86.6%)
  Focus groups3 (6.7%)
  Surveys with open-ended questions3 (6.7%)
 Data analysis methods
  Content analysis9 (20.0%)
  Thematic analysis21 (46.7%)
  Grounded theory11 (24.4%)
  Interpretive phenomenological analysis2 (4.4%)
  Not reported2 (4.4%)
 For a single qualitative study, the RCT participants were sourced from:
  1 RCT**31 (71.1%)
  Multiple RCTs**8 (15.5%)
  Not reported***6 (13.3%)
 Number of RCT participants in each qualitative study
  Median (Q1, Q3); n21.0 (15, 38); 1732
 Was the primary qualitative study nested in the RCTs?
  Yes27 (60.0%)
 Clinical domain
  Oncology14 (31.1%)
  Chronic diseases12 (26.7%)
  Acute illnesses4 (8.9%)
  Mental health1 (2.2%)
  Trauma/orthopedics2 (4.4%)
  Obstetrics8 (17.8%)
  Urogynecology2 (4.4%)
  Mixed2 (4.4%)
 Publication year of primary qualitative study
  Before 20056 (13.3%)
CASP Tool Quality AppraisalYes
 Q1 Was there a clear statement of the aims of the research?45 (100.0%)
 Q2 Is a qualitative methodology appropriate?45 (100.0%)
 Q3 Was the research design appropriate to address the aims of the research?45 (100.0%)
 Q4 Was the recruitment strategy appropriate to the aims of the research?36 (80.0%)
 Q5 Was the data collected in a way that addressed the research issue?17 (37.8%)
 Q6 Has the relationship between researcher and participants been adequately considered?15 (33.3%)
 Q7 Have ethical issues been taken into consideration?42 (93.3%)
 Q8 Was the data analysis sufficiently rigorous?26 (57.8%)
 Q9 Is there a clear statement of findings?45 (100.0%)
  1. *Due to rounding off numbers may not add up to 100
  2. **31 qualitative studies involved a single RCT, and we were able to retrieve 27 RCT reports or protocols. 8 qualitative studies sourced participants from a total of 50 different RCTs, and we retrieved 15 RCT reports or protocols. Thus, a total of 42 RCT reports were available for description
  3. ***6 qualitative studies did not clearly report the number of RCTs that were involved