Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials

Claire Planner (Corresponding Author), Peter Bower, Ailsa Donnelly, K Gillies, Katrina Turner, Bridget Young

Research output: Contribution to journalReview article

Abstract

BACKGROUND: Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently 'patient-centred' (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial.

METHODS: A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis.

RESULTS: We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others).

CONCLUSIONS: Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

Original languageEnglish
Article number381
JournalTrials
Volume20
DOIs
Publication statusPublished - 24 Jun 2019

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Clinical Trials
Patient Participation
Process Assessment (Health Care)
Patient Preference
Nursing
Research Personnel
Outcome Assessment (Health Care)
Health

Keywords

  • trial
  • participation
  • patient experience
  • patient satisfaction
  • patient-centred trials
  • Participation
  • Trial
  • Patient experience
  • Patient satisfaction
  • Patient-centred trials
  • RANDOMIZED CONTROLLED-TRIALS
  • RECRUITMENT
  • QUALITATIVE RESEARCH
  • INVOLVEMENT
  • CANCER
  • PATIENT SURVEY
  • PERCEPTION
  • INFORMED-CONSENT
  • SATISFACTION
  • HEALTH-CARE

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine (miscellaneous)

Cite this

Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials. / Planner, Claire (Corresponding Author); Bower, Peter; Donnelly, Ailsa; Gillies, K; Turner, Katrina; Young, Bridget.

In: Trials, Vol. 20, 381, 24.06.2019.

Research output: Contribution to journalReview article

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title = "Trials need participants but not their feedback?: A scoping review of published papers on the measurement of participant experience of taking part in clinical trials",
abstract = "BACKGROUND: Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently 'patient-centred' (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial.METHODS: A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis.RESULTS: We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others).CONCLUSIONS: Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.",
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author = "Claire Planner and Peter Bower and Ailsa Donnelly and K Gillies and Katrina Turner and Bridget Young",
note = "CP is funded by the NIHR School for Primary Care Research (Launching Fellowship). Earlier work informing this review was funded by the Medical Research Council (MRC) Hub for Trials Methodology (MR/L004933/2 - R46).",
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AU - Planner, Claire

AU - Bower, Peter

AU - Donnelly, Ailsa

AU - Gillies, K

AU - Turner, Katrina

AU - Young, Bridget

N1 - CP is funded by the NIHR School for Primary Care Research (Launching Fellowship). Earlier work informing this review was funded by the Medical Research Council (MRC) Hub for Trials Methodology (MR/L004933/2 - R46).

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N2 - BACKGROUND: Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently 'patient-centred' (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial.METHODS: A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis.RESULTS: We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others).CONCLUSIONS: Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

AB - BACKGROUND: Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently 'patient-centred' (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial.METHODS: A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis.RESULTS: We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others).CONCLUSIONS: Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

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KW - CANCER

KW - PATIENT SURVEY

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KW - INFORMED-CONSENT

KW - SATISFACTION

KW - HEALTH-CARE

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