Patient research partner involvement in rheumatology clinical trials: analysis of journal articles 2016–2020

Abstract

In 2011, Ann Rheum Dis published the European League Against Rheumatism (EULAR) recommendations for the inclusion of patient representatives in scientific projects. Patient research partners were defined as ‘persons with a relevant disease who operate as active research team members’. The document strongly recommended participation of patient research partners in clinical research projects, and stated that ‘participation of patient research partners should be considered in all phases of the project’. Involvement of at least two patient research partners was recommended. It is unknown to what extent these recommendations have been integrated into the design and conduct of rheumatology clinical research since publication a decade ago. This study aimed to determine the involvement of patient research partners in rheumatology clinical trials published in the last 5 years. We analysed all original articles reporting clinical trials published between January 2016 and December 2020 in rheumatology journals with Thomas Reuter’s Impact Factors >3.0 and rheumatology clinical trials in general medical journals with Impact Factors >15.0. All included trials prospectively assigned human participants to healthrelated interventions to evaluate the effects on health outcomes. Descriptive statistics were used to report the proportion of articles with patient research partner involvement, the proportion of articles with patient authors, and patient research partner involvement at each stage of the research cycle according to the UK National Institute for Health Research INVOLVE framework: identifying and prioritising; commissioning; designing and managing; undertaking; disseminating; implementing and evaluating impact. Of the 622 clinical trials, 11 (1.8%) reported involvement of patient research partners in either the text of the manuscript (n=3) or under a specific ‘Patient Research Partner Involvement’ section within the methods or declarations sections (n=8) (table 1). Most of the trials reporting patient research partner involvement were from Europe and published in 2020. Patient research partner involvement was not reported in any industryinitiated trials, or in rheumatology trials published in general medical journals. Patient research partners were mostly involved in the trial design and/or management (n=10). Patient involvement in identifying and dissemination stages was uncommon (n=1 and n=3 trials, respectively). No trials reported patient involvement in the commissioning or undertaking stages. Nine trials involved at least two patient research partners, and one trial reported that the patient research partner was a coauthor. There were 24 trials with a specific ‘Patient Research Partner Involvement’ declaration section; of these, eight (33%) reported patient research partner involvement. Additionally, some authors misinterpreted the meaning of patient research partner involvement and reported statements in these declarations relating to patients as research participants. However, there were two exemplary trials, both reporting the involvement of at least two research partners, with details provided in supplementary text on their involvement throughout the research process. 4 In summary, patient research partner involvement in rheumatology clinical trials is rarely reported. It is possible that the number of trials reporting patient research partner involvement does not reflect the true number with patient collaboration. However, for journals that require a ‘Patient Research Partner Involvement’ declaration (including BMJ Journals in recent years), the majority of articles reported no patient research partner involvement. The 2011 EULAR recommendations for inclusion of patient representatives in scientific projects highlighted the benefits of collaboration with patients research partners, including improved representation of patients’ needs, preventing a mismatch Letter