Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials

KD Coulman, A Nicholson, A Shaw, Anne Daykin, Helen Cramer, Carrol Gamble, Rhiannon Macefield, Malcolm E Pick, Lucy E Selman, Gillian W Shorter, Matt R Sydes, Gordon Taylor, J Athene Lane

Research output: Contribution to conferenceAbstract

Abstract

Introduction: Trial oversight is important for trial governance and
conduct. Patients and/or lay members of the public are increasingly
included in oversight committees, influenced by international
patient and public involvement (PPI) initiatives to
improve research quality and relevance. However, guidance on
undertaking PPI in trial oversight is lacking. We explore how PPI
functions in oversight committees and provide recommendations
to optimise PPI in future trials as part of a larger study investigating
the role and function of oversight committees in trials facing
challenges.
Methods: Using an ethnographic study design, we observed oversight
meetings of eight UK trials and conducted semi-structured interviews
with members of their trial steering committees (TSCs) and
trial management groups (TMGs) including PPI contributors, trial
sponsors and funders. Thematic analysis of data was undertaken,
with findings integrated to provide a multi-perspective account of
how PPI functions in trial oversight.
Results: Eight TSC and six TMG meetings from eight trials were
observed. 52 purposively sampled oversight group members, including
three PPI contributors, were interviewed. PPI was reported
as beneficial in trial oversight, with PPI members
contributing a patient voice and advocacy role. However, PPI contributors
were not always active at meetings and were sometimes
felt to have a tokenistic role, with trialists reporting a lack of understanding
of how to undertake PPI. Interviewees highlighted
the importance of planning effective strategies to recruit PPI contributors,
considering the level of oversight and stage(s) of trial
to include PPI, and regular support for PPI contributors by the
trial team.
Discussion: Consideration should be given at trial design stage on
how to recruit and involve PPI contributors within trial oversight,
and support and mentorship for both PPI contributors and trialists
(in how to undertake PPI effectively). This study further
strengthens the evidence base on facilitating meaningful PPI
within clinical trials.

Conference

ConferenceInternational Clinical Trials Methodology Conference
Abbreviated titleICTMC2019
CountryUnited Kingdom
CityBrighton
Period6/10/1910/10/19

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Clinical Trials
Patient Advocacy
Mentors
Group Processes

Keywords

  • Trial Oversight
  • Trial Monitoring
  • Trial Conduct
  • patient and public involvement
  • randomised control trials
  • randomized control trials

Cite this

Coulman, KD., Nicholson, A., Shaw, A., Daykin, A., Cramer, H., Gamble, C., ... Lane, J. A. (2019). Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. 578-578. Abstract from International Clinical Trials Methodology Conference, Brighton, United Kingdom.
Coulman, KD ; Nicholson, A ; Shaw, A ; Daykin, Anne ; Cramer, Helen ; Gamble, Carrol ; Macefield, Rhiannon ; Pick, Malcolm E ; Selman, Lucy E ; Shorter, Gillian W ; Sydes, Matt R ; Taylor, Gordon ; Lane, J Athene. / Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. Abstract from International Clinical Trials Methodology Conference, Brighton, United Kingdom.
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abstract = "Introduction: Trial oversight is important for trial governance andconduct. Patients and/or lay members of the public are increasinglyincluded in oversight committees, influenced by internationalpatient and public involvement (PPI) initiatives toimprove research quality and relevance. However, guidance onundertaking PPI in trial oversight is lacking. We explore how PPIfunctions in oversight committees and provide recommendationsto optimise PPI in future trials as part of a larger study investigatingthe role and function of oversight committees in trials facingchallenges.Methods: Using an ethnographic study design, we observed oversightmeetings of eight UK trials and conducted semi-structured interviewswith members of their trial steering committees (TSCs) andtrial management groups (TMGs) including PPI contributors, trialsponsors and funders. Thematic analysis of data was undertaken,with findings integrated to provide a multi-perspective account ofhow PPI functions in trial oversight.Results: Eight TSC and six TMG meetings from eight trials wereobserved. 52 purposively sampled oversight group members, includingthree PPI contributors, were interviewed. PPI was reportedas beneficial in trial oversight, with PPI memberscontributing a patient voice and advocacy role. However, PPI contributorswere not always active at meetings and were sometimesfelt to have a tokenistic role, with trialists reporting a lack of understandingof how to undertake PPI. Interviewees highlightedthe importance of planning effective strategies to recruit PPI contributors,considering the level of oversight and stage(s) of trialto include PPI, and regular support for PPI contributors by thetrial team.Discussion: Consideration should be given at trial design stage onhow to recruit and involve PPI contributors within trial oversight,and support and mentorship for both PPI contributors and trialists(in how to undertake PPI effectively). This study furtherstrengthens the evidence base on facilitating meaningful PPIwithin clinical trials.",
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author = "KD Coulman and A Nicholson and A Shaw and Anne Daykin and Helen Cramer and Carrol Gamble and Rhiannon Macefield and Pick, {Malcolm E} and Selman, {Lucy E} and Shorter, {Gillian W} and Sydes, {Matt R} and Gordon Taylor and Lane, {J Athene}",
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Coulman, KD, Nicholson, A, Shaw, A, Daykin, A, Cramer, H, Gamble, C, Macefield, R, Pick, ME, Selman, LE, Shorter, GW, Sydes, MR, Taylor, G & Lane, JA 2019, 'Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials' International Clinical Trials Methodology Conference, Brighton, United Kingdom, 6/10/19 - 10/10/19, pp. 578-578.

Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. / Coulman, KD; Nicholson, A; Shaw, A; Daykin, Anne; Cramer, Helen; Gamble, Carrol; Macefield, Rhiannon; Pick, Malcolm E; Selman, Lucy E; Shorter, Gillian W; Sydes, Matt R; Taylor, Gordon; Lane, J Athene.

2019. 578-578 Abstract from International Clinical Trials Methodology Conference, Brighton, United Kingdom.

Research output: Contribution to conferenceAbstract

TY - CONF

T1 - Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials

AU - Coulman, KD

AU - Nicholson, A

AU - Shaw, A

AU - Daykin, Anne

AU - Cramer, Helen

AU - Gamble, Carrol

AU - Macefield, Rhiannon

AU - Pick, Malcolm E

AU - Selman, Lucy E

AU - Shorter, Gillian W

AU - Sydes, Matt R

AU - Taylor, Gordon

AU - Lane, J Athene

PY - 2019/10/22

Y1 - 2019/10/22

N2 - Introduction: Trial oversight is important for trial governance andconduct. Patients and/or lay members of the public are increasinglyincluded in oversight committees, influenced by internationalpatient and public involvement (PPI) initiatives toimprove research quality and relevance. However, guidance onundertaking PPI in trial oversight is lacking. We explore how PPIfunctions in oversight committees and provide recommendationsto optimise PPI in future trials as part of a larger study investigatingthe role and function of oversight committees in trials facingchallenges.Methods: Using an ethnographic study design, we observed oversightmeetings of eight UK trials and conducted semi-structured interviewswith members of their trial steering committees (TSCs) andtrial management groups (TMGs) including PPI contributors, trialsponsors and funders. Thematic analysis of data was undertaken,with findings integrated to provide a multi-perspective account ofhow PPI functions in trial oversight.Results: Eight TSC and six TMG meetings from eight trials wereobserved. 52 purposively sampled oversight group members, includingthree PPI contributors, were interviewed. PPI was reportedas beneficial in trial oversight, with PPI memberscontributing a patient voice and advocacy role. However, PPI contributorswere not always active at meetings and were sometimesfelt to have a tokenistic role, with trialists reporting a lack of understandingof how to undertake PPI. Interviewees highlightedthe importance of planning effective strategies to recruit PPI contributors,considering the level of oversight and stage(s) of trialto include PPI, and regular support for PPI contributors by thetrial team.Discussion: Consideration should be given at trial design stage onhow to recruit and involve PPI contributors within trial oversight,and support and mentorship for both PPI contributors and trialists(in how to undertake PPI effectively). This study furtherstrengthens the evidence base on facilitating meaningful PPIwithin clinical trials.

AB - Introduction: Trial oversight is important for trial governance andconduct. Patients and/or lay members of the public are increasinglyincluded in oversight committees, influenced by internationalpatient and public involvement (PPI) initiatives toimprove research quality and relevance. However, guidance onundertaking PPI in trial oversight is lacking. We explore how PPIfunctions in oversight committees and provide recommendationsto optimise PPI in future trials as part of a larger study investigatingthe role and function of oversight committees in trials facingchallenges.Methods: Using an ethnographic study design, we observed oversightmeetings of eight UK trials and conducted semi-structured interviewswith members of their trial steering committees (TSCs) andtrial management groups (TMGs) including PPI contributors, trialsponsors and funders. Thematic analysis of data was undertaken,with findings integrated to provide a multi-perspective account ofhow PPI functions in trial oversight.Results: Eight TSC and six TMG meetings from eight trials wereobserved. 52 purposively sampled oversight group members, includingthree PPI contributors, were interviewed. PPI was reportedas beneficial in trial oversight, with PPI memberscontributing a patient voice and advocacy role. However, PPI contributorswere not always active at meetings and were sometimesfelt to have a tokenistic role, with trialists reporting a lack of understandingof how to undertake PPI. Interviewees highlightedthe importance of planning effective strategies to recruit PPI contributors,considering the level of oversight and stage(s) of trialto include PPI, and regular support for PPI contributors by thetrial team.Discussion: Consideration should be given at trial design stage onhow to recruit and involve PPI contributors within trial oversight,and support and mentorship for both PPI contributors and trialists(in how to undertake PPI effectively). This study furtherstrengthens the evidence base on facilitating meaningful PPIwithin clinical trials.

KW - Trial Oversight

KW - Trial Monitoring

KW - Trial Conduct

KW - patient and public involvement

KW - randomised control trials

KW - randomized control trials

M3 - Abstract

SP - 578

EP - 578

ER -

Coulman KD, Nicholson A, Shaw A, Daykin A, Cramer H, Gamble C et al. Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. 2019. Abstract from International Clinical Trials Methodology Conference, Brighton, United Kingdom.