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

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 conference › Paper › peer-review

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.

Original language	English
Publication status	Published - 22 Oct 2019
Externally published	Yes
Event	International Clinical Trials Methodology Conference (ICTMC 2019) - Brighton, Brighton, United Kingdom Duration: 06 Oct 2019 → 09 Oct 2019

Conference

Conference	International Clinical Trials Methodology Conference (ICTMC 2019)
Abbreviated title	ICTMC
Country/Territory	United Kingdom
City	Brighton
Period	06/10/2019 → 09/10/2019

Bibliographical note

International Clinical Trials Methodology Conference, ICTMC2019 ; Conference date: 06-10-2019 Through 10-10-2019

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., Macefield, R., Pick, M. E., Selman, L. E., Shorter, G. W., Sydes, M. R., Taylor, G., & Lane, J. A. (2019). Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials. Paper presented at International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, United Kingdom.

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

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.",

keywords = "Trial Oversight, Trial Monitoring, Trial Conduct, patient and public involvement, randomised control trials, randomized control trials",

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}",

note = "International Clinical Trials Methodology Conference, ICTMC2019 ; Conference date: 06-10-2019 Through 10-10-2019; International Clinical Trials Methodology Conference (ICTMC 2019), ICTMC ; Conference date: 06-10-2019 Through 09-10-2019",

year = "2019",

month = oct,

day = "22",

language = "English",

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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', Paper presented at International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, United Kingdom, 06/10/2019 - 09/10/2019.

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

N1 - International Clinical Trials Methodology Conference, ICTMC2019 ; Conference date: 06-10-2019 Through 10-10-2019

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 - Paper

T2 - International Clinical Trials Methodology Conference (ICTMC 2019)

Y2 - 6 October 2019 through 9 October 2019

ER -

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

Abstract

Conference

Bibliographical note

Keywords

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Cite this