Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists' current practices, barriers and facilitators.
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ABSTRACT: Objective
We aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it.Design
We developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains.Setting
Online survey targeting UK-based trial units.Participants
Stakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study.Outcome measures
Trialists' behaviour of involving patients and the public in numerical aspects of trials and its determinants.Results
We included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists' perception of public and patient partners' skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it.Conclusions
More training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners' motivation to be involved. Future research should focus on identifying public and patient partners' motivations and develop strategies to improve the communication of numerical aspects.
SUBMITTER: Goulao B
PROVIDER: S-EPMC7978289 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundUnderstanding the barriers and facilitators to behaviour change by primary care practitioners (PCPs) is vital to inform the design and implementation of successful Behaviour Change Interventions (BCIs), embed evidence-based medicine into routine clinical practice, and improve quality of care and population health outcomes.MethodsA theory-led systematic review of reviews examining barriers and facilitators to clinical behaviour change by PCPs in high-income primary care contexts using PRISMA. Embase, MEDLINE, PsychInfo, HMIC and Cochrane Library were searched. Content and framework analysis was used to map reported barriers and facilitators to the Theoretical Domains Framework (TDF) and describe emergent themes. Intervention functions and policy categories to change behaviour associated with these domains were identified using the COM-B Model and Behaviour Change Wheel (BCW).ResultsFour thousand three hundred eighty-eight reviews were identified. Nineteen were included. The average quality score was 7.5/11. Reviews infrequently used theory to structure their methods or interpret their findings. Barriers and facilitators most frequently identified as important were principally related to 'Knowledge', 'Environmental context and resources' and 'Social influences' TDF domains. These fall under the 'Capability' and 'Opportunity' domains of COM-B, and are linked with interventions related to education, training, restriction, environmental restructuring and enablement. From this, three key areas for policy change include guidelines, regulation and legislation. Factors least frequently identified as important were related to 'Motivation' and other psychological aspects of 'Capability' of COM-B. Based on this, BCW intervention functions of persuasion, incentivisation, coercion and modelling may be perceived as less relevant by PCPs to change behaviour.ConclusionsPCPs commonly perceive barriers and facilitators to behaviour change related to the 'Capability' and 'Opportunity' domains of COM-B. PCPs may lack insight into the role that 'Motivation' and aspects of psychological 'Capability' have in behaviour change and/or that research methods have been inadequate to capture their function. Future research should apply theory-based frameworks and appropriate design methods to explore these factors. With no 'one size fits all' intervention, these findings provide general, transferable insights into how to approach changing clinical behaviour by PCPs, based on their own views on the barriers and facilitators to behaviour change.Systematic review registrationA protocol was submitted to the London School of Hygiene and Tropical Medicine via the Ethics and CARE form submission on 16.4.2020, ref number 21478 (available on request). The project was not registered on PROSPERO.
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Project description:BackgroundWhile patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)'s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU's role in PPI.MethodsA mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors.Results(1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10-50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI.ConclusionsWhile highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.
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