‘It’s a nice thing to do but…’: exploring the methods and impact of patient and public involvement (PPI) in trials
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Date
2020-10-02
Authors
Racine, Emmy
Journal Title
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Publisher
University College Cork
Published Version
Abstract
Background and Aims:
Patient and Public Involvement (PPI), defined as research carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them, is increasingly recognized as an essential component of health research. The rationale for PPI is based on a moral argument where the people whose lives are most affected by research should have a say in what is researched and how it is carried out, and a pragmatic argument that PPI can improve research quality. Although PPI is now required by many research funders, academic journals, and ethics committees, progress to achieve greater involvement has been patchy and slow. There is a lack of clarity on how to conduct ‘strong’ PPI and on why PPI should be used. Research is needed on suitable PPI methodologies and on the impact of PPI if we are to develop a shared understanding of what works, when, how and why. Therefore, the overarching aim of this thesis was to contribute to the evidence on the methods and impact of PPI by exploring PPI contributors’ experiences and contributions at the design, conduct and dissemination stages of trials.
Methods:
At the design stage, two Studies Within A Trial (SWAT) were conducted within the intervention development phase of the Improving Diabetes Eye-screening Attendance (IDEAs) pilot trial. The first used a mixed methods convergent design to compare people with diabetes and healthcare professionals’ experiences of taking part in three different types of consensus meetings to inform intervention development and assess whether their experiences differed according to group composition. The second used a qualitative design to compare people with diabetes and healthcare professionals’ contributions to the intervention content and assess whether their contributions differed according to group composition. At the conduct stage, a systematic review and narrative synthesis was conducted on trial researchers’ perceptions of the impact of PPI on trial retention. At the dissemination stage, a mixed methods SWAT, including an embedded randomised trial, was conducted within the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism (TRUST) trial to identify, develop, and evaluate a patient preferred method of receiving trial results.
Results:
Involving PPI contributors simultaneously with other stakeholders led to a perceived lack of common ground where both stakeholders felt reluctant to fully express their opinions. It also led to conflicting opinions which were difficult to incorporate into the intervention being developed. Researchers perceived PPI to have a positive impact on trial retention as it helped trial researchers to foster a trusting relationship and improve communication with trial participants. PPI was also perceived to improve trial retention by ensuring the trial location was suitable and accessible and enabling researchers to establish cultural appropriateness by ensuring that community customs, norms and social activities were considered in the research design. Although, PPI contributors were involved in the development of the trial result letter, the results of the embedded randomised trial suggested that PPI did not make a difference to participants’ understanding of trial results.
Conclusions
This research shows that although there are a wide variety of methods used to involve PPI contributors, the method used can have an important influence on the impact of involvement. The results suggest that it may be more suitable and useful to involve PPI contributors separately rather than simultaneously with other stakeholder groups. This finding may assist researchers and PPI contributors in designing and conducting more meaningful and effective involvement activities. This research found that PPI can influence the research process by creating and fostering trust between researchers and participants and PPI contributors can help researchers to communicate more effectively with research participants. Although, the results suggest that PPI did not make a difference to participants’ understanding of results, suggestions for how researchers should approach future evaluations of the methods and impact of PPI have been put forward. This research paves the way forward for building an evidence base for PPI to ensure that a shared understanding of what works, when, how and why is developed among researchers, patients, members of the public and research funders.
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Keywords
Patient and public involvement , Public involvement , Stakeholder involvement , Public engagement , Mixed methods research , Trial methodology research , Study within a trial
Citation
Racine, E. 2020. ‘It’s a nice thing to do but…’: exploring the methods and impact of patient and public involvement (PPI) in trials. PhD Thesis, University College Cork.