TABLE A4.
Reference | Rationale for including users shown | Appropriate level of user involvement | Appropriate recruitment strategy | Appropriate training | Ethical considerations of user involvement | Methodological considerations of user involvement | Users involved in dissemination | Added user value shown | Evaluation of the user involvement component of the research |
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Anderson et al 36 | A sample of 8 patients provided feedback on a preliminary questionnaire draft | ||||||||
Lee et al 37 | Patients were consulted in a second round of interviews after feedback from stakeholder groups to discuss their experience with and perspectives on PGHD use in postoperative SSI detection | Patients who had experience using PGHD for postoperative monitoring | Helped to form the beginnings of a “community of practice” comprising diverse stakeholder perspectives to inform future research on this important topic | ||||||
McCaughan et al 38 (United Kingdom) | Patient advisors included as key informants throughout study | Collaboration with three patient advisors involving design and piloting of topic guide, data analyses, interpretation of study findings, and comments on early drafts | Patient advisors selected with personal experience with an open surgical wound due to their unique perspective on a niche area | Advisors commented and provided feedback on early drafts of the manuscript | Patient involvement at all key stages of the research process was an important strength and crucial to reflection on the meaning of the interview data and its interpretation | ||||
McNair et al 39 | Lists patients as essential stakeholders | A patient representative was consulted to help group patient‐reported outcomes into domains. Patients were consulted to pilot a survey draft and vote on the final core outcome set. The patient advocate coauthor collaborated throughout research process including contributing to manuscript writing and agreeing with manuscript overall results and conclusion | Attendees to the consensus meeting had previously been recruited to complete a questionnaire, where non‐probabilistic sampling was used to ensure geographical and caseload variation. The co‐author credentials included being a member of various patient advocate groups | Patient advocate co‐author received travel reimbursement | With concerns that patients may not fully comprehend the clinical terminology used, the “unsure” category was added to the patient consensus meetings so that the terminology could be explained in more detail | The patient advocate coauthor involved in manuscript writing and agreed with overall results and conclusions | Differences between patient and provider consensus meetings lead to changes in the final core outcome set, with domains considered by patients to have overlapping content or themes combined | ||
Reeves et al 40 | PPI group to inform the conduct and design of a future main trial | Consultation via PPI meetings to discuss RCT design and protocol elements. One PPI member also read and commented on lay summary of report. One patient representative collaborated throughout study as part of the steering committee | Participants had previously been recruited for semi‐structured interviews, where sampling became increasingly purposeful to achieve maximum variation according to age, sex, and type of surgery. Patients recruited were undergoing elective or unplanned (emergency) abdominal operations, including caesarean section, with a primary closed surgical wound | In the PPI meeting, a brief overview of the purpose of a patient information leaflet was presented including structure and type of information reported | PPI group member commented and gave feedback on the plain English summary. Findings from Bluebelle study have been presented at conferences including outside conventional academic circles or generic audiences | PPI meetings influenced study design including questionnaire and PIL refinement and strategies for future participant retention, including increasing the font size of the PIL, making the instructions for completing the Wound Experience Questionnaire more prominent and providing more flexibility around the timing of questionnaire completion | Recommend that there is clarity about the role of PPI work,to make best use of PPI panel members' and researchers' time. Written feedback on the PPI meeting was rated as excellent (4/7 response) or very good (3/7 responses). Comments from members included that PPI was regarded as very important and that it had been valuable to meetothers and share experiences | ||
Sanger et al 41 | Highlights that including diverse perspectives from a multidisciplinary team including a patient with previous SSI experience a core strength of study | ||||||||
Sanger et al 42 | Patient advisor and patient advocates as part of a iterative process for developing an app to track symptoms of infections after surgery | Collaboration with patient advisor involved in study design, data analysis, technology development, and manuscript development; consultation with patient advocates on design refinement, coding, and design recommendations | Patient advisors who had previous personal experience with a postoperative SSI were recruited via email using convenience sampling from a pre‐existing database | Recruitment from established advocate database could introduce self‐selection bias, although the value of having expert panel outweighs any potential bias introduced | Patient advisor was involved in manuscript preparation | Highlights the importance of bringing patients into the design process iteratively and directly on the research team. Key discussions related to agreements and conflicts between providers and patients led to significant implications for app design | |||
Wiseman et al 43 United States | The use of a community‐based research advisory focus group (CARDS) to gain patient's perspectives and help develop and inform a preliminary draft of a survey | Consulted with research advisory focus group to gain patient perspective, which informed and developed preliminary draft of survey to assess smartphone capability in outpatient wound assessment | CARDS are a trained focus group that advise researchers and represent the views of racial, ethnic, and socioeconomic groups that are rarely represented in research |
Abbreviations: PGHD, patient‐generated health data; PIL, patient information leaflet; PPI, patient and public involvement; RCT, randomised control trial; SSI, surgical site infection.