Table 1 Summary of articles reporting on participant experience measures
Study | Geographical location(s) | Number of trials or facilities in the study | Delivery and administration | Items | Participants surveyed (response rate) | Domains |
|---|---|---|---|---|---|---|
Almeida et al. (2007) [22] | Portugal | 1 facility | Self-report In person Before discharge from the study | 14 | 136 (100%) | i) Motivations for taking part ii) Perception of informed consent iii) Perception of study participation |
Aman et al. (1995) [23] | Not reported | 2 trials | Self-report Postal 4 weeks after enrolment | 6 | 63 (63.5%) | i) Staff characteristics ii) Study operations iii) Specific features of trial iv) Incentives and reinforcements |
Bahati et al. (2010) [24] | East Africa | 3 facilities | Interviewer Not reported Study end | Not reported | Not reported (98%) | i) Satisfaction with service received ii) Satisfaction with major components of the research study |
Bertoli et al. (2007) [25] | Argentina | 3 trials | Self-report Postal Not reported | 34 | 114 (94.6%) | i) Socio-demographics ii) Overall trial satisfaction iii) Quality of information given by the Investigator iv) Participants’ self-perception of knowledge about randomised controlled trials (RCTs) v) Objective evaluation of participants’ knowledge about RCTs |
Bevan et al. (1993) [26] | UK | 1 trial | Interviewer In person Not reported | Not reported | 199 (99%) | i) Reasons for participation or declining participation ii) Aspects of trials disliked |
Cain et al. (2005) [27] | UK and Republic of Ireland | Self-report Postal Study end | 23 | 44 (82%) | i) Information provided ii) Reasons for taking part iii) Best and worst aspects of participation iv) Willingness to participate in the future | |
Dias et al. (2005) [28] | Not reported | 1 trial | Self-report Postal 3.5 year follow-up | 19 | 469 (88%) | i) Staff characteristics ii) Study operations iii) Specific features of trial iv) Incentives and reinforcements |
Fearn et al. (2010) [29] | UK | 1 trial | Self-report Postal Study end | Not reported | 910 (59%) | i) Motivations for taking part ii) Health professional involvement iii) Randomisation iv) Filling in questionnaires v) Experience of participation |
Friesen et al. (2016) [30] | USA | 1 trial | Self-report In person At final clinic appointment | 47 | 180 (98%) | i) Attitudes towards trials ii) Working with study team iii) Perception of risk benefit iv) General satisfaction |
Van Gelderen, et al. (1993) [31] | The Netherlands | 10 trials | Self-report Combination of postal, taken home and at end of trial Study end | 12 | 153 (94%) | i) Reason for participation ii) Information received iii) Most unpleasant aspects iv) Most pleasant aspects v) Experience of participation |
Hassar et al. (1976) [32] | USA | 1 trial | Interviewer Not reported Study end | 12 | 1503 (80%) | i) Reasons for investigators taking part ii) Participant impression of clinical studies iii) Medical practice in general |
Henzlova et al. (1994) [33] | USA and Canada | 1 trial | Self-report Not reported Before close out visit | 10 | 4751 (74%) | i) Primary motivation for participation ii) Satisfaction with participation and perceived outcome iii) Effect on health-conscious behaviour iv) Negative experiences |
USA | 29 facilities | Self-report Not reported Study end | 76 | 18,890 (29% of participants surveyed) | i) Informed consent ii) Trust iii) Coordination of care iv) Information, education and communication v) Respect for participant preferences | |
Luzurier et al. (2015) [36] | France | 1 trial | Self-report Not reported Not reported | Not reported | 210 (% not reported) | i) Satisfaction (with overall welcome and protocol management) ii) Motivation for taking part iii) Participation outlook |
Martin et al. (2011) [37] | USA | 3 trials | Self-report Postal Not reported | 47 | 75 (89%) | i) Understanding of participation ii) Reasons for participating iii) General experience iv) Overall satisfaction v) Willingness to participate in a future study including a placebo-controlled trial |
McAdam et al. (2002) [38] | Not reported | 1 trial | Not reported Not reported Not reported | 7 | 21 (81%) | i) Information provided ii) Staff iii) Research processes iv) Research outcomes v) Willingness to participate in the future |
Mattson et al. (1985) [39] | USA | 1 trial | Self-report/Interview Postal Before final follow-up | 5 | 1503 (80%) | i) Perceived benefits ii) Perceived beneficiaries iii) Perceived disadvantages iv) Perceived effects of medication v) Participation in a future trial |
Renfroe et al. (2002) [40] | USA and Canada | 1 trial | Self-report Postal Study end | 7 | 664 (71%) | i) Would participate again ii) Main reasons for participation iii) Study benefits iv) Study problems v) Quality of care. |
Schron et al. (1997) [41] | USA | 1 trial | Self-report Postal Final follow-up (4.5 years after enrolment) | 10 | 4281 (82%) | i) Reason for participating ii) Satisfaction with participating |
Tangrea et al. (1992) [42] | USA | 1 trial | Self-report Postal Study end | 7 | 891 (97%) | i) Benefits ii) Most unpleasant aspects iii) Importance iv) Satisfaction v) Physical well-being vi) Willingness to take active treatment if shown to be effective vii) Participation in future trials |
Verheggen et al. (1998) [43] | The Netherlands | 26 trials | Personal interview (at start of the trial) Telephone interview (3 months later) | Not reported | Personal interview = 172 (93%); Telephone interview = 172 (78.5%); control group (only participating in telephone interview) = 34 (100%) | i) Medical technical aspects ii) Interpersonal iii) Organisational aspects |