The mutual benefits of patient and public involvement in research: an example from a feasibility study (MoTaStim-Foot)

Abstract Background Patient and public involvement (PPI) in research has increased steadily over the last two decades and is now both expected and appropriately resourced by many funding bodies, including the National Institute for Health Research (NIHR). However, PPI in research occurs in many different capacities and numerous frameworks exist for reporting or appraising patient involvement activities. The aim of this article is to describe processes involving PPI contributions to an NIHR-funded mixed-methods feasibility study (MoTaStim-Foot). Details of PPI advisors’ input, from initial identification and prioritisation of research ideas, to research delivery and dissemination, are discussed. Methods Extensive PPI for MoTaStim-Foot is reported, with consideration of Research Design Service (RDS) advice for PPI for research, involving identifying and prioritising: design; grant proposal development; undertaking/managing research; analysing and interpreting; dissemination; implementation; monitoring and evaluation. Two PPI workshops were undertaken; success in meeting UK standards for public involvement was audited against specific success criteria by two researchers, with discussion and consideration regarding how well our PPI achieved inclusive opportunities, working together, support and learning, governance, communications and impact. How PPI can be improved for future trials was also considered. Although the advantages of PPI for researchers were considered, the benefits for PPI advisors were also analysed. Results UK standards for public involvement were achieved, along with seven relevant research processes suggested by the RDS. PPI advisor contributions: informed study design; contributed to successful funding; enhanced trial delivery by informing participant information sheets and daily diaries; added value through undertaking note-taker roles in focus groups and helping to analyse focus group transcripts; and assisted in dissemination. However, benefits were mutual with PPI advisors reporting feeling valued and respected, a sense of pride with renewed confidence and purpose in life. Conclusions Importance and value of PPI, to researchers and patient advisors, have been highlighted, reinforcing the benefits of working in partnership with PPI advisors. Trial registration ISRCTN 13676183; Central Portfolio Management System ID 30449. Registered 02/01/2015, https://www.isrctn.com/ISRCTN13676183.

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‘I’m sure we made it a better study…’: Experiences of adults with intellectual disabilities and parent carers of patient and public involvement in a health research study

Journal of Intellectual Disabilities ◽

10.1177/1744629517723485 ◽

2017 ◽

Vol 23 (1) ◽

pp. 78-96 ◽

Cited By ~ 10

Author(s):

Carole Beighton ◽

Christina Victor ◽

Iain M Carey ◽

Fay Hosking ◽

Steve DeWilde ◽

...

Keyword(s):

Intellectual Disabilities ◽

Health Research ◽

Public Involvement ◽

Patient And Public Involvement ◽

Future Research ◽

Self Confidence ◽

The United Kingdom ◽

Working Together ◽

Adults With Intellectual Disabilities ◽

Group Interviews

Patient and public involvement is considered integral to health research in the United Kingdom; however, studies documenting the involvement of adults with intellectual disabilities and parent carers in health research studies are scarce. Through group interviews, this study explored the perspectives and experiences of a group of adults with intellectual disabilities and a group of parent carers about their collaborative/participatory involvement in a 3-year study which explored the effectiveness of annual health checks for adults with intellectual disabilities. Thematic analysis identified five key themes consistent across both groups; authenticity of participation, working together, generating new outcome measures, dissemination of findings and involvement in future research. Although reported anecdotally rather than originating from the analysis, increased self-confidence is also discussed. The groups’ unique perspectives led to insights not previously considered by the research team which led to important recommendations to inform healthcare practice.

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PP124 Smart Capability Building For Effective Patient Involvement

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319002423 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 59-60

Author(s):

Claire Davis ◽

Sophie Hughes ◽

Susan Myles

Keyword(s):

Best Practice ◽

Patient Involvement ◽

Public Involvement ◽

Health Technology ◽

Patient And Public Involvement ◽

The Public ◽

Health Technologies ◽

Capability Building ◽

Working Together ◽

Strategy Building

IntroductionA new Health Technology Assessment (HTA) agency, Health Technology Wales (HTW), has been established to consider the identification, appraisal, and adoption of non-medicine health technologies. This includes, for example, medical devices, surgical procedures and diagnostics. HTW recognizes the importance of effective patient and public involvement (PPI) and is building smart capabilities.MethodsHTW consulted with external organizations to identify the first steps toward effective PPI. Public partners were recruited as a priority before working together on a PPI strategy. Building smart capabilities is key to establishing effective PPI and future-proofing. HTW established a PPI Standing Group to inform HTW throughout its work, including the development of processes and procedures.ResultsKnowledge and resources have been shared and future collaborations identified, including events to encourage new topics from patients and the public. The HTW PPI lead has become a member of key PPI groups, locally and internationally. HTW has recruited public partners who are actively contributing as full members of the Assessment Group and the Appraisal Panel; two members on each Committee. The PPI Standing Group has been established. They have provided advice and co-produced PPI tools for piloting.ConclusionsThe PPI Standing Group concluded that PPI methods and approaches should be tailored for each project based on best practice, and should be piloted to allow them to evolve based on impact evaluation. A PPI strategy or framework would be more useful at a later stage. HTW is committed to identifying and following best practice. Future-proofing and building smart capability will be key to ensuring that HTW develops effective PPI that can be dynamic and responsive to the evolving PPI and HTA landscapes.

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An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

HRB Open Research ◽

10.12688/hrbopenres.12981.1 ◽

2020 ◽

Vol 3 ◽

pp. 4 ◽

Cited By ~ 1

Author(s):

Christopher P. Dwyer ◽

Robert A. Joyce ◽

Eimear M. Bane ◽

Anusha Moses ◽

Alberto Alvarez-Iglesias ◽

...

Keyword(s):

Multiple Sclerosis ◽

Public Involvement ◽

Patient And Public Involvement ◽

Information Sheet ◽

Double Blind ◽

Link Type ◽

Participant Information Sheet ◽

Study Within A Trial ◽

Trials Methodology ◽

Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

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How to make study documents clear and relevant: the impact of patient involvement

BJPsych Open ◽

10.1192/bjo.2021.1040 ◽

2021 ◽

Vol 7 (6) ◽

Author(s):

Sagar Jilka ◽

Georgie Hudson ◽

Sonja M. Jansli ◽

Esther Negbenose ◽

Emma Wilson ◽

...

Keyword(s):

Public Involvement ◽

Patient And Public Involvement ◽

Mixed Methods Design ◽

Information Sheet ◽

Participant Information Sheet ◽

Before And After ◽

Research Document ◽

The Impact ◽

Participant Information ◽

Over Time

Background Patient and public involvement can improve study outcomes, but little data have been collected on why this might be. We investigated the impact of the Feasibility and Support to Timely Recruitment for Research (FAST-R) service, made up of trained patients and carers who review research documents at the beginning of the research pipeline. Aims To investigate the impact of the FAST-R service, and to provide researchers with guidelines to improve study documents. Method A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Quantitative measures were readability, word count, jargon words before and after review, the effects over time and if changes were implemented. We also asked eight reviewers to blindly select a pre- or post-review participant information sheet as their preferred version. Reviewers’ comments were analysed qualitatively via thematic analysis. Results After review, documents were longer and contained less jargon, but did not improve readability. Jargon and the number of suggested changes increased over time. Participant information sheets had the most suggested changes. Reviewers wanted clarity, better presentation and felt that documents lacked key information such as remuneration, risks involved and data management. Six out of eight reviewers preferred the post-review participant information sheet. FAST-R reviewers provided jargon words and phrases with alternatives for researchers to use. Conclusions Longer documents are acceptable if they are clear, with jargon explained or substituted. The highlighted barriers to true informed consent are not decreasing, although this study has suggestions for improving research document accessibility.

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OP338 Involving Patients In Research: Early Consultation Of Women To Improve Study Design And Investigate Trial Acceptability

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321000994 ◽

2021 ◽

Vol 37 (S1) ◽

pp. 14-14

Author(s):

Jamie Erskine ◽

Alejandra Castanon

Keyword(s):

Data Collection ◽

Clinical Research ◽

Feasibility Study ◽

Public Involvement ◽

Research Output ◽

Patient And Public Involvement ◽

English Summary ◽

Ongoing Research ◽

Consultation Group ◽

Funding Application

IntroductionGaining the perspective of patients is invaluable in the design, management and reporting of research. As part of the process of facilitating clinical research into the effectiveness of a digital colposcope in a cervical cancer pathway, patients were involved from the outset.MethodsUsing funding made available by a Public Involvement Fund, a patient consultation group was established. The group's initial discussions informed the design of a feasibility study and funding application, which was submitted to the UK National Institute of Health Research (NIHR). A Patient and Public Involvement (PPI) representative was recruited and along with the consultation group, contributed to the ethical approvals for the study. The Patient Information Sheet and Consent Form were reviewed by the patients, to ensure readability, understandability and accessibility. The patient questionnaires and interview topics that are part of the feasibility study were also developed in conjunction with the PPI group, to make sure that women's concerns are being addressed in the research design and protocols.ResultsThe PPI consultation group's contributions helped strengthen the funding application and funding for a feasibility study was granted as part of the NIHR's Research for Patient Benefit funding scheme. Part of the grant will be used for training and reimbursement for time spent for the PPI representative. Data collection for the study is due to commence in the summer of 2021. The PPI group will be consulted at the beginning and end of the data collection period and will contribute to the data analysis and dissemination of the research output, including a Plain English Summary.ConclusionsInvolving patients greatly amplified the quality of the funding and ethical applications and will continue to benefit the ongoing research. Resources were widely available within the researcher's University and also through UK-wide schemes. Such resources are crucial and should be encouraged as part of all clinical research.

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An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

HRB Open Research ◽

10.12688/hrbopenres.12981.2 ◽

2020 ◽

Vol 3 ◽

pp. 4 ◽

Cited By ~ 1

Author(s):

Christopher P. Dwyer ◽

Robert A. Joyce ◽

Eimear M. Bane ◽

Anusha Moses ◽

Alberto Alvarez-Iglesias ◽

...

Keyword(s):

Multiple Sclerosis ◽

Public Involvement ◽

Patient And Public Involvement ◽

Information Sheet ◽

Double Blind ◽

Link Type ◽

Participant Information Sheet ◽

Study Within A Trial ◽

Trials Methodology ◽

Participant Information

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SENSE-Cog Asia: A Feasibility Study of a Hearing Intervention to Improve Outcomes in People With Dementia

Frontiers in Neurology ◽

10.3389/fneur.2021.654143 ◽

2021 ◽

Vol 12 ◽

Author(s):

Saima Sheikh ◽

Sehrish Tofique ◽

Nosheen Zehra ◽

Rabia Amjad ◽

Maham Rasheed ◽

...

Keyword(s):

Capacity Building ◽

Feasibility Study ◽

Hearing Aids ◽

Cultural Adaptation ◽

Public Involvement ◽

Patient And Public Involvement ◽

Structured Interviews ◽

Support Intervention ◽

People With Dementia ◽

Home Based

Background: There are few evidence-based non-pharmacological interventions adapted for people with dementia (PwD) in lower- and middle-income countries (LMIC). Thus, there is value in culturally adapting existing interventions from other settings. One such intervention for PwD involves hearing rehabilitation, which may improve dementia-related outcomes.Objective: To culturally adapt and evaluate the feasibility and acceptability of a multi-faceted hearing support intervention to enhance quality of life in PwD for a LMIC setting, Pakistan.Design: This was a study in three phases: (1) training and capacity building to deliver the study, including Patient and Public Involvement (PPI); (2) cultural adaptation of the intervention; and (3) delivery of a single-group feasibility study with a pre-test post-test design.Setting: Home-based intervention, in two cities of Pakistan.Participants: Adults aged ≥ 60 with mild-moderate dementia and uncorrected or partially corrected hearing impairment, and their study partners (n = 14).Intervention: An adapted hearing support intervention (HSI) comprising a full assessment of hearing function, fitting of hearing aids, and home-based support from a “hearing support practitioner.”Outcomes: Ratings of the feasibility of the study procedures, and acceptability/tolerability of the adapted intervention were ascertained through questionnaires, participant diaries, therapist logbooks and semi-structured interviews. A signal of effectiveness of the intervention was also explored using a battery of dementia-related outcome measures.Results: Following cultural adaptation and capacity building for study conduct and delivery, we successfully implemented all intervention components in most participants, which were well-received and enacted by participant dyads. Acceptability (i.e., understanding, motivation, sense of achievement) and tolerability (i.e., effort, fatigue) ratings and safety of the intervention were within a priori target ranges. Recruitment and retention targets required improvement, due to the COVID-19 pandemic outbreak, as well as the lack of a clear clinical diagnostic pathway for dementia in both sites. Areas for future modification were clearly identified, including: the assessment/delivery logistics circuit; procedures for arranging visits; communication among referring clinicians and the study team.Conclusion: This is the first study in a LMIC of sensory enhancement to improve dementia outcomes. Positive feasibility, acceptability and tolerability findings suggest that a full-scale effectiveness trial, with certain modifications is warranted.

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