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Table 4 Summary of measured themes

From: Methodological approaches for conducting follow-up research with clinical trial participants: a scoping review and expert interviews

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

  

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

 

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