Skip to main content

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