Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process

Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Denegri, Simon; Muir, Delia; Simon, Natalie; Thomas, Stephen B.; Elliot, Jim T.; Bulbeck, Helen; Crocker, Joanna; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry

doi:10.1111/hex.12583

Cited by 37 publications

(42 citation statements)

References 46 publications

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“…Various research approaches have been used to elicit patient views on research priorities including focus groups, PPI consultation workshops and expert panels, as well as structured consensus seeking methodologies such as the Delphi technique . In this study, the use of focus groups permitted us not only to explore patient views on research priorities, but also to shed light on some of the emotional and experiential reasons behind these priorities, helping to inform our understanding of this complex topic.…”

Section: Discussionmentioning

confidence: 99%

Hope, disappointment and perseverance: Reflections of people with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Multiple Sclerosis participating in biomedical research. A qualitative focus group study

Lacerda

McDermott

Kingdon

et al. 2019

Health Expectations

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Background The Clinical Understanding and Research Excellence in ME/CFS group (CureME) at the London School of Hygiene & Tropical Medicine has supported and undertaken studies in immunology, genetics, virology, clinical medicine, epidemiology and disability. It established the UK ME/CFS Biobank (UKMEB), which stores data and samples from three groups: participants with ME/CFS, Multiple Sclerosis (MS) and healthy controls. Patient and public involvement have played a central role from its inception. Aim To explore the views of participants with ME/CFS and MS on CureME research findings, dissemination and future biomedical research priorities. Method Five ME/CFS and MS focus groups were conducted at two UK sites. Discussions were transcribed and analysed thematically. Results A total of 28 UKMEB participants took part: 16 with ME/CFS and 12 with MS. Five themes emerged: (a) Seeking coherence: participants’ reactions to initial research findings; (b) Seeking acceptance: participants explore issues of stigma and validation; (c) Seeking a diagnosis: participants explore issues around diagnosis in their lives; (d) Seeking a better future: participants’ ideas on future research; and (e) Seeking to share understanding: participants’ views on dissemination. Focus groups perceived progress in ME/CFS and MS research in terms of “putting together a jigsaw” of evidence through perseverance and collaboration. Conclusion This study provides insight into the emotional, social and practical importance of research to people with MS and ME/CFS, suggesting a range of research topics for the future. Findings should inform biomedical research directions in ME/CFS and MS, adding patients’ voices to a call for a more collaborative research culture.

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Section: Discussionmentioning

confidence: 99%

Hope, disappointment and perseverance: Reflections of people with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Multiple Sclerosis participating in biomedical research. A qualitative focus group study

Lacerda

McDermott

Kingdon

et al. 2019

Health Expectations

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“…However, the methods of Delphi studies do vary as noted in a systematic review conducted by Boulkedid and colleagues [ 10 ] and the “The RAND/UCLA Appropriateness Method User's Manual” [ 13 ]. Based on currently used cut-off values, we used a scoring of 1–9 for the importance of the different items with median scores of 7–9 being considered high enough to reach consensus [ 10 , 14 , 15 ].…”

Section: Methodsmentioning

confidence: 99%

Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians

Neyro

Elie²,

Thiele³

et al. 2018

PLoS ONE

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ObjectivesParental consent for the participation of their neonate in neonatal research is influenced by the quality of the information delivered and the interaction between parents and investigators. Failure to provide important information may lead to difficulties in the decision making process of parents. This Delphi survey aims to establish a consensus between parent representatives of neonatal associations and healthcare professionals concerning the information deemed essential by both parties in order to improve the recruitment of neonates into clinical trials.MethodThis study was conducted in Europe among parent representatives and healthcare professionals. In this 3-phase study, 96 items were defined by the Scientific Committee (CS), composed of 11 clinicians (from 8 countries) and 1 parent representative of the European network of neonatal associations. Then the Committee of Experts (CE) composed of 16 clinicians were matched by country with 16 national parent representatives and evaluated these items in two rounds. The importance of each item was evaluated by each member of the CE on a scale between 1 and 9 based on their personal experience.ResultsFifty eight items reached the second and final level of consensus. In contrast to clinicians, parent representatives preferred to be informed about the study by the physician in charge of their child. They also favoured additional support during the informed consent process and stated that both parents need to agree and sign.ConclusionThe set of 58 items on which parents and clinicians reached consensus will be helpful to healthcare professionals seeking parental consent for the inclusion of a neonate in a clinical trial. Providing parents with information about the trial by the investigator in the presence of the patient’s neonatologist, developing closer contacts with parents and informing them of the available support by parents associations may be helpful for parents.

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“…As a number of ESRs pointed to uncertainty about how to implement PPI in research future learning opportunities could look specifically at ways of implementation such as coproduction, we note such guidance already exists for PPI in primary research [40]. More investigation is also needed on training PPI contributors receive in methodological research to improve the current practice [41].…”

Section: Discussionmentioning

confidence: 99%

PPI in research: a reflection from early stage researchers

2019

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Background: The importance of patient and public involvement (PPI) in the design and conduct of health research projects is gaining widespread recognition; however, it is still a developing area. Furthermore, PPI in methodological health research can help increase research value Thus, it is of great importance that researchers, especially early stage researchers continue to discuss and learn about the future challenges and opportunities of PPI. Objective: With this commentary, we aim to disseminate i) key messages from a recent PPI training event and ii) discuss what early stage researchers (ESRs) in the "Methods in Research on Research" (MiRoR) project can do to improve our current and future work by considering and incorporating PPI. Main body: The latest MiRoR network meeting held at the University of Split in Croatia (2nd-3rd October), included a PPI training session with presentations from Mr. Stephens a patient, about "Waste in research" and Dr. Westmore a funder on "Research integrity", followed by smaller round-table discussions. This provided early stage researchers (ESRs) with an opportunity to discuss and explore the benefits and challenges of PPI in research, and the appropriate questions and research that is required for improving the implementation of PPI in clinical research. Conclusion: As with intervention research, PPI is also important for methodological research since this will help to increase both the value, integrity and quality of research. By providing early stage researchers with appropriate educational, interactive and real-world training, this will introduce the various merits and challenges associated with PPI in early-stage research.

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Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process

Cited by 37 publications

References 46 publications

Hope, disappointment and perseverance: Reflections of people with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Multiple Sclerosis participating in biomedical research. A qualitative focus group study

Hope, disappointment and perseverance: Reflections of people with Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Multiple Sclerosis participating in biomedical research. A qualitative focus group study

Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians

PPI in research: a reflection from early stage researchers

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