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Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

ABSTRACT: BACKGROUND:Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions. OBJECTIVE:To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders. METHODS:Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded. RESULTS:110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI. CONCLUSIONS:Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.

SUBMITTER: Gamble C

PROVIDER: S-EPMC4120322 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

Gamble Carrol C Dudley Louise L Allam Alison A Bell Philip P Goodare Heather H Hanley Bec B Preston Jennifer J Walker Alison A Williamson Paula P Young Bridget B

BMJ open 20140723 7

<h4>Background</h4>Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions.<h4>Objective</h4>To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders.<h4>Methods</h4>Documentation fr ...[more]

PMID: 25056972

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Project description:ObjectivesOrganisations that develop clinical practice guidelines (CPGs) encourage involvement of patients and the publics in their development, however, there are no standard methodologies for doing so. To examine how CPGs report patient and public involvement (PPI), we conducted a scoping review of the evidence addressing the following four questions: (1) who are the patients and publics involved in developing the CPG?; (2) from where and how are the patients and publics recruited?; (3) at what stage in the CPG development process are the patients and publics involved? and (4) how do the patients and publics contribute their views? We also extracted data on the use of PPI reporting checklists by the included studies.DesignWe used the methodology developed by Arksey and O'Malley and refined by the Joanna Briggs Institute. We searched PubMed, Embase, CINAHL and PsycINFO, websites of national guideline bodies from the UK, Canada, Australia and the USA, and conducted a forward citation search. No language, date or participant demographics restrictions were applied. Data were synthesised narratively.ResultsWe included 47 studies addressing 1 or more of the 4 questions. All included studies reported who the patient and publics involved (PPI members) were, and several studies reported PPI members from different groups. Patients were reported in 43/47 studies, advocates were reported in 22/47 studies, patients and advocates reported in 17/47 studies, and general public reported in 2/47 studies. Thirty-four studies reported from where the patients and publics were recruited, with patient groups being the most common (20/34). Stage of involvement was reported by 42/47 studies, most commonly at question identification (26/42) and draft review (18/42) stages. Forty-two studies reported how the patients contributed, most commonly via group meetings (18/42) or individual interviews. Ten studies cited or used a reporting checklist to report findings.ConclusionsOur scoping review has revealed knowledge gaps to inform future research in several ways: replication, terminology and inclusion. First, no standard approach to PPI in CPG development could be inferred from the research. Second, inconsistent terminology to describe patients and publics reduces clarity around which patients and publics have been involved in developing CPGs. Finally, the under-representation of research describing PPI in the development of screening, as opposed to treatment, CPGs warrants further attention.

Project description:IntroductionThe importance of meaningfully involving patients and the public in digital health innovation is widely acknowledged, but often poorly understood. This review, therefore, sought to explore how patients and the public are involved in digital health innovation and to identify factors that support and inhibit meaningful patient and public involvement (PPI) in digital health innovation, implementation and evaluation.MethodsSearches were undertaken from 2010 to July 2020 in the electronic databases MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus and ACM Digital Library. Grey literature searches were also undertaken using the Patient Experience Library database and Google Scholar.ResultsOf the 10,540 articles identified, 433 were included. The majority of included articles were published in the United States, United Kingdom, Canada and Australia, with representation from 42 countries highlighting the international relevance of PPI in digital health. 112 topic areas where PPI had reportedly taken place were identified. Areas most often described included cancer (n = 50), mental health (n = 43), diabetes (n = 26) and long-term conditions (n = 19). Interestingly, over 133 terms were used to describe PPI; few were explicitly defined. Patients were often most involved in the final, passive stages of an innovation journey, for example, usability testing, where the ability to proactively influence change was severely limited. Common barriers to achieving meaningful PPI included data privacy and security concerns, not involving patients early enough and lack of trust. Suggested enablers were often designed to counteract such challenges.ConclusionsPPI is largely viewed as valuable and essential in digital health innovation, but rarely practised. Several barriers exist for both innovators and patients, which currently limits the quality, frequency and duration of PPI in digital health innovation, although improvements have been made in the past decade. Some reported barriers and enablers such as the importance of data privacy and security appear to be unique to PPI in digital innovation. Greater efforts should be made to support innovators and patients to become meaningfully involved in digital health innovations from the outset, given its reported benefits and impacts. Stakeholder consensus on the principles that underpin meaningful PPI in digital health innovation would be helpful in providing evidence-based guidance on how to achieve this.Patient or public contributionThis review has received extensive patient and public contributions with a representative from the Patient Experience Library involved throughout the review's conception, from design (including suggested revisions to the search strategy) through to article production and dissemination. Other areas of patient and public contributor involvement include contributing to the inductive thematic analysis process, refining the thematic framework and finalizing theme wording, helping to ensure relevance, value and meaning from a patient perspective. Findings from this review have also been presented to a variety of stakeholders including patients, patient advocates and clinicians through a series of focus groups and webinars. Given their extensive involvement, the representative from the Patient Experience Library is rightly included as an author of this review.

Project description:Background: Losing a family member during childhood is a potentially traumatic event and increases the risk of mental health difficulties. Adolescents have the right to express their views in research of relevance to them, but few studies have involved bereaved adolescents as collaborators (i.e. Patient and Public Involvement (PPI)). Furthermore, to ensure meaningful and non-tokenistic involvement, bereaved adolescents' levels of participation and experiences of taking part in research need to be evaluated.Objectives: The aim was to describe and evaluate a PPI process working with bereaved adolescents to develop a self-management mobile app for adolescents in grief.Methods: The PPI process consisted of four workshops during which the app's logo, colours, name, content, and layout were discussed with six parentally bereaved adolescents aged 13-18 years. The adolescents were recruited through a non-profit organisation providing support for adolescents in grief. The PPI process was documented and evaluated using participant observations and an online survey completed by the adolescents, covering the themes of social context, participation, and influence.Results: The adolescents perceived the social context as comfortable and inclusive, where their knowledge was valued. Their participation was characterised by ownership and motivated by a desire to help others with similar experiences. The adolescents' ability to participate in PPI activities was assisted by the researchers' flexibility, although challenging assignments may have made participation harder. Throughout PPI activities, adolescents contributed with relevant input and reported feeling influential. The study reached the intended levels of participation and appeared to adequately fulfil the adolescents' right to participation.Conclusions: Engaging adolescents who have undergone a potentially traumatic event, such as the loss of a family member, in research can enhance the overall relevance of the study. Moreover, it can entail a meaningful and positive experience for the participating adolescents, while also fulfilling their fundamental right to participation.

Project description:BackgroundSmartphones are being increasingly used for research owing to their multifunctionality and flexibility, and crowdsourced research using smartphone applications (apps) is effective in the early detection and management of chronic diseases. We developed the AllerSearch app to gather real-world data on individual subjective symptoms and lifestyle factors related to hay fever. This study established a foundation for interactive research by adopting novel, diverse perspectives accrued through implementing the principles of patient and public involvement (PPI) in the development of our app.MethodsPatients and members of the public with a history or family history of hay fever were recruited from November 2019 to December 2021 through a dedicated website, social networking services, and web briefing according to the PPI Guidebook 2019 by the Japan Agency for Medical Research and Development. Nine opinion exchange meetings were held from February 2020 to December 2021 to collect opinions and suggestions for updating the app. After each meeting, interactive evaluations from PPI contributors and researchers were collected. The compiled suggestions were then incorporated into the app, establishing an active feedback loop fed by the consistently interactive infrastructure.ResultsFour PPI contributors (one man and three women) were recruited, and 93 items were added/changed in the in-app survey questionnaire in accordance with discussions from the exchange meetings. The exchange meetings emphasized an atmosphere and opportunity for participants to speak up, ensuring frequent opportunities for them to contribute to the research. In March 2020, a public website was created to display real-time outcomes of the number of participants and users' hay-fever-preventative behaviors. In August 2020, a new PPI-implemented AllerSearch app was released.ConclusionsThis study marks the first research on clinical smartphone apps for hay fever in Japan that implements PPI throughout its timeline from research and development to the publication of research results. Taking advantage of the distinct perspectives offered by PPI contributors, a step was taken toward actualizing a foundation for an interactive research environment. These results should promote future PPI research and foster the establishment of a social construct that enables PPI efforts in various fields.

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Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

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Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation.

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