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Table 2 Characteristics of the RCT reports from which primary qualitative studies sourced participants

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

  N = 42 (100.0%)
RCT characteristics
Clinical setting
 Primary (home/GP/community based) 4 (9.5%)
 Secondary (hospital based) 27 (64.3%)
 Tertiary (specialized academic health facility based) 11 (26.2%)
Geographical location
 Europe 33 (78.6%)
 America (USA and Central) 1 (2.4%)
 Africa 3 (7.1%)
 Asia 1 (2.4%)
 Oceania 1 (2.4%)
 Multi-continental 3 (7.1%)
RCT funding sources/sponsorship
 Non-profit/academic/public organizations 40 (95.0%)
Blinding of patients
 Yes 13 (31.0%)
Number of trial arms
 2 34 (81.0%)
 3 7 (16.7%)
 4 1 (2.4%)
Intervention **
 Drug (topical, oral, SC, IM, IV) 22 (52.4%)
 Surgical procedure 4 (9.5%)
 Participative (psychological, physical, educational, palliative, rehabilitative) 11 (26.2%)
 Other 5 (11.9%)
Comparator**
 Placebo/Sham treatment 11 (26.2%)
 Usual care/no treatment 18 (42.8%)
 Active treatment 13 (31.0%)
Number of patients randomized
 Mean (SD); n*** 1199 (1999); 46,748
Issues with RCT?
 None reported*** 32 (76.2%)
 Suboptimal recruitment (slow accrual, unwilling to be randomized, high refusal rate, regulatory delays, lack of eligible patients) 8 (19.0%)
 Informed consent in an emergency 2 (4.8%)
  1. *Due to rounding off numbers may not add up to 100
  2. **If the RCT contained more than 2 arms, only 1 experimental intervention and 1 comparator was extracted
  3. ***There is missing data for 5 RCTs as only the protocol was available