Karen L. Woolley,1-3 Serina Stretton,4 Lauri Arnstein5
The Guidance for Developers of Health Research Reporting Guidelines recommend multidisciplinary stakeholder involvement, transparent and complete reporting, and updating guidelines based on feedback. Developers are accountable for stakeholder engagement, but how broad and meaningful is such engagement? Our objective was to provide empirical feedback to developers by investigating (1) the involvement of those ultimately affected by guidelines (eg, patients and carers) and regular end users of guidelines (eg, publication professionals), and (2) the transparency and completeness of reporting stakeholder involvement.
For this prospective study, conducted from September 2016 to January 2017, we included every reporting guideline for the main study types, as listed on the EQUATOR Network website. We pilot-tested a standardized data collection spreadsheet to extract data from the corresponding guideline publications. We quantified patient, carer, and publication professional involvement and used statisticians (listed as stakeholders in the guidelines) as a control group. We assessed reporting transparency and completeness using the AGREE reporting checklist for documenting stakeholder involvement. For qualitative insights, we interviewed leaders from nonprofit, international, patient advocacy (International Alliance of Patients’ Organizations [IAPO]) and publication professional (Global Alliance of Publication Professionals [GAPP]) organizations.
Of the 33 guideline publications, the mean (SD) number of authors was 9 (5.7) (median, 7; IQR, 5-11) and the mean (SD) number of working group members was 45 (38.4) (median, 30; IQR, 23-43). Statisticians were authors of 8 publications (24%) and were working group members for 5 publications (15%). Patients, carers, and publication professionals were rarely identified, either as authors (0, 0, and 0, respectively) or working group members (0, 1 [3%], and 0, respectively). Reporting stakeholder involvement was deficient (eg, for statistician involvement, less than 25% publications met AGREE recommendations). Leaders from IAPO and GAPP were not aware of having been invited to participate in developing guidelines but thought that their stakeholders could provide unique and important insights. They encourage guideline developers to contact them to facilitate meaningful involvement.
Guideline developers have rarely involved the stakeholders affected by guidelines (patients, carers) or those regularly using guidelines (publication professionals) in the development process. The involvement of these key stakeholders could enhance the credibility, dissemination, and use of guidelines. If patients, carers, and publication professionals were represented by other stakeholders (which is not ideal given potential conflicts of interest), this was not documented; readers do not know who represented whom. The transparency and completeness of reporting of stakeholder involvement must be improved.
1ProScribe KK Envision Pharma Group, Tokyo, Japan; 2University of Queensland, Brisbane, Queensland, Australia, email@example.com; 3University of the Sunshine Coast, Maroochydore DC, Queensland, Australia; 4ProScribe Envision Pharma Group, Sydney, New South Wales, Australia; 5Alligent Envision Pharma Group, London, UK
Conflict of Interest Disclosures:
The authors acknowledge the valuable feedback provided by the International Alliance of Patients’ Organizations during the development of the abstract. All authors are employees of the Envision Pharma Group and members of nonprofit associations that support ethical practices for publication professionals. Dr Woolley serves on the Patient Safety and Quality Committee of the Sunshine Coast Hospital and Health Services Board, served on the Board of the International Society for Medical Publication Professionals (Asia Pacific Trustee), cofounded the Global Alliance of Publication Professionals (GAPP), and has shares in Johnson & Johnson. Dr Stretton is a voluntary member of GAPP. No other disclosures are reported.