Patient and public involvement in the design of clinical trials: An overview of systematic reviews
<h4>Background</h4> <p>Funders encourage lay-volunteer inclusion in research but this is not without controversy or resistance, given concerns of role confusion, exploratory methods and limited evidence about what value this brings to research. This overview explores these element...
| Main Authors: | , , , , , , |
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| Format: | Journal article |
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Wiley
2017
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| _version_ | 1826285831410679808 |
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| author | Price, A Albarqouni, L Kirkpatrick, J Clarke, M Liew, S Roberts, N Burls, A |
| author_facet | Price, A Albarqouni, L Kirkpatrick, J Clarke, M Liew, S Roberts, N Burls, A |
| author_sort | Price, A |
| collection | OXFORD |
| description | <h4>Background</h4> <p>Funders encourage lay-volunteer inclusion in research but this is not without controversy or resistance, given concerns of role confusion, exploratory methods and limited evidence about what value this brings to research. This overview explores these elements.</p> <h4>Methods</h4> <p>Eleven databases and gray literature were searched without date or language restrictions for systematic reviews of public involvement in clinical trials design. This systematic overview of patient and public involvement (PPI) included 27 reviews from which areas of good and bad practice were identified. PPI strengths, weaknesses, opportunities and threats were explored through use of meta-narrative analysis.</p> <h4>Results</h4> <p>Inclusion criteria was met by 27 reviews. Confidence in the findings was assessed using Cerqual, Nice-H, CASP for qualitative research and CASP systematic reviews. Quality ranged from high (n=7), medium (n=14) to low (n=6) in the reviews. Four reviews report the risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation and dissemination. Challenges identified include lack of clarity within common language, roles and research boundaries; while logistical needs include extra time, training and funding, Researchers report struggling to report involvement and avoid tokenism.</p> <h4>Conclusions</h4> <p>Involving patients and the public in clinical trials design, can be beneficial but requires resources, preparation, training, flexibility and time. Issues to address include reporting deficits in the areas of risk of bias, study quality and conflicts of interests. There is a need for improved dissemination strategies to increase public involvement and health literacy. Improvements in funding, training, and reporting of PPI are needed to facilitate meaningful and effective PPI.</p> |
| first_indexed | 2024-03-07T01:34:43Z |
| format | Journal article |
| id | oxford-uuid:94c01e47-296a-43e0-965a-538fd6f5da2c |
| institution | University of Oxford |
| last_indexed | 2024-03-07T01:34:43Z |
| publishDate | 2017 |
| publisher | Wiley |
| record_format | dspace |
| spelling | oxford-uuid:94c01e47-296a-43e0-965a-538fd6f5da2c2022-03-26T23:41:38ZPatient and public involvement in the design of clinical trials: An overview of systematic reviewsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:94c01e47-296a-43e0-965a-538fd6f5da2cSymplectic Elements at OxfordWiley2017Price, AAlbarqouni, LKirkpatrick, JClarke, MLiew, SRoberts, NBurls, A <h4>Background</h4> <p>Funders encourage lay-volunteer inclusion in research but this is not without controversy or resistance, given concerns of role confusion, exploratory methods and limited evidence about what value this brings to research. This overview explores these elements.</p> <h4>Methods</h4> <p>Eleven databases and gray literature were searched without date or language restrictions for systematic reviews of public involvement in clinical trials design. This systematic overview of patient and public involvement (PPI) included 27 reviews from which areas of good and bad practice were identified. PPI strengths, weaknesses, opportunities and threats were explored through use of meta-narrative analysis.</p> <h4>Results</h4> <p>Inclusion criteria was met by 27 reviews. Confidence in the findings was assessed using Cerqual, Nice-H, CASP for qualitative research and CASP systematic reviews. Quality ranged from high (n=7), medium (n=14) to low (n=6) in the reviews. Four reviews report the risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation and dissemination. Challenges identified include lack of clarity within common language, roles and research boundaries; while logistical needs include extra time, training and funding, Researchers report struggling to report involvement and avoid tokenism.</p> <h4>Conclusions</h4> <p>Involving patients and the public in clinical trials design, can be beneficial but requires resources, preparation, training, flexibility and time. Issues to address include reporting deficits in the areas of risk of bias, study quality and conflicts of interests. There is a need for improved dissemination strategies to increase public involvement and health literacy. Improvements in funding, training, and reporting of PPI are needed to facilitate meaningful and effective PPI.</p> |
| spellingShingle | Price, A Albarqouni, L Kirkpatrick, J Clarke, M Liew, S Roberts, N Burls, A Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title | Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title_full | Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title_fullStr | Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title_full_unstemmed | Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title_short | Patient and public involvement in the design of clinical trials: An overview of systematic reviews |
| title_sort | patient and public involvement in the design of clinical trials an overview of systematic reviews |
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