Theme(s) | Details | ||
---|---|---|---|
 | Quantitative studies | Qualitative studies | Mixed-method study |
Global measures of experience (e.g. satisfaction with participation) | Almeida, 2007 [21] - Attitudes of healthy volunteers Au, 2015 [22] - Satisfaction with participation Dayer, 2017 [25] - Satisfaction with participation Henzlova, 1994 [27] - Satisfaction with participation - Negative experiences Kost, 2014 [30] - Overall experience Pflugeisen, 2016 [37] - Satisfaction with participation Pope, 2003 [38] - Satisfaction with participation | Â | Â |
Measures of specific aspects of the trial (e.g. informed consent) | Almeida, 2007 [21] - Perception of the informed consent procedure Johnson, 2008 [28] - Post-trial results sharing (including mode of reception) Kost, 2014 [30] - Understanding of the components of informed consent and other critical information Mello, 2018 [36] - Perception of risk of data sharing Pope, 2003 [38] - Satisfaction with the level of information received through the informed consent process Yessis, 2012 [41] - Perception of information and the informed consent procedure | Harrop, 2016 [26] - Understanding and acceptance of randomisation - Equipoise and acceptability of control and intervention arm - Trial information Kost, 2011 [29] - Satisfaction with informed consent process Locock, 2011 [33] - Information of trial participants - Feelings about randomisation, placebo and control groups - Withdrawing from trial - View on feedback of trial results Zaharoff, 2018 [43] - Participant recruitment | Â |
Participants perception of the positive and/or negative aspects of participation | Almeida, 2007 [21] Au, 2015 [22] Henzlova, 1994 [27] Mathieu, 2012 [34] | Harrop, 2016 [26] Kost, 2011 [29] Kvale, 2010 [31] Lawton, 2003 [32] Tutton, 2018 [39] Wootten, 2011 [40] Yoder, 1997 [42] | Mattson, 1985 [35] |
Willingness to participate again / recommend to others | Almeida, 2007 [21] Dayer, 2017 [25] Kost, 2014 [30] Yessis, 2012 [41] | Yoder, 1997 [42] Locock, 2011 [33] | Mattson, 1985 [35] |
Reasons for participating | Almeida, 2007 [21] Au, 2015 [22] DasMahapatra, 2017 [24] Henzlova, 1994 [27] Kost, 2014 [30] Mathieu, 2012 [34] Pflugeisen, 2016 [37] | Harrop, 2016 [26] Kost, 2011 [29] Kvale, 2010 [31] Lawton, 2003 [32] Locock, 2011 [33] Yoder, 1997 [42] Zaharoff, 2018 [43] | Mattson, 1985 [35] |
Other | DasMahapatra, 2017 [24] - Barriers to trial participation - Necessary infrastructure to engage patients in trial design - Overall attitudes towards trials Dayer, 2017 [25] - Impressions regarding adverse events Henzlova, 1994 [27] - Effect of the trial on health conscious behaviour Kost, 2014 [30] - Level of autonomy exercised - Feeling respected and valued by the research team Yessis, 2012 [41] - Coordination of care - Respect - Trust | Cox, 2000 [23] - Psychosocial impact of trial participation (ways of coping with what was happening to them, identify consequences of trial involvement) Kvale, 2010 [31] - Perception of supportive care needs - Role of hope Locock, 2011 [33] - Attitudes to clinical trials (need for conducting clinical trial research, motivations for taking part, understanding trial process and design, receiving feedback on trial results) - Communication with health professionals Tutton, 2018 [39] - Desire to be involved in research decision-making Wootten, 2011 [40] - Role of social/family support in participating in the clinical trial Yoder, 1997 [42] - Expectations Zaharoff, 2018 [43] - Barriers to participation | Mattson, 1985 [35] - Benefits from participation |