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In 2011, Ann Rheum Dis published the European League Against Rheumatism (EULAR) recommendations for the inclusion of patient representatives in scientific projects.1 Patient research partners were defined as ‘persons with a relevant disease who operate as active research team members’.1 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.1 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 health-related 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.2
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 industry-initiated 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.3 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 between patient priorities and scientific focus, increasing opportunities for funding, dissemination and implementation, and empowering patients.1 A decade after these recommendations were published, reporting of patient research partner involvement in rheumatology clinical trials remains rare. Our data highlight the need for involvement of patient research partners in all rheumatology clinical trial programmes, consistent reporting of these collaborations in publications, and for journals to require reporting of patient research partner involvement.
Handling editor Josef S Smolen
Contributors HW was involved in data acquisition, analysis and interpretation of the data. SS and ND were involved in the design, data acquisition, and analysis and interpretation of the data. BD, BH, GH and JC were involved in the design and analysis and interpretation of the data. All authors were involved in drafting of the work or revising it critically for important intellectual content. All authors approved the final version to be published and agree to be accountable for all aspects of the work.
Funding This study was funded by a University of Auckland summer studentship awarded to H Wang.
Competing interests ND has received consulting fees, speaker fees or grants from AstraZeneca, Horizon, Amgen, Selecta, Arthrosi, Dyve BioSciences, Hengrui. Abbvie and Janssen, outside the submitted work.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.