Patient and public involvement in pragmatic trials: online survey of corresponding authors of published trials

Abstract

I n recent years, there has been increasing interest in conducting randomized controlled trials (RCTs) that are pragmatic in orientation. 1,2 Pragmatic trials use study settings and methods similar to usual care, as well as taking into account the perspectives of patients. 3,4 Some of the design features of pragmatic trial design -for example, selecting outcomes that are important to patients 5 -overlap with objectives of patient-oriented research. [6][7][8] Patient and public involvement (PPI) in research provides an opportunity for patients and families to share their lived experiences and better align research with patient values and priorities. 6 For the purpose of this research and in alignment with the Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR), 6 we define PPI as "researchers consulting or working with members of the public, patients, service users, and carers in any or all part(s) of the research process, including the choice of research topic, design, planning, conduct or dissemination of research." 9 We refer to these individuals as "PPI partners"; partners could include, for example, grant co-applicants, members of a Trial Steering Committee, or members of a patient or public advisory panel. In health research, PPI is strongly encouraged by international funding bodies, 6,10,11 institutions 12 and stakeholder groups. 13,14 Previous reviews of RCTs found low prevalence of PPI, with inconsistent reporting. [15][16][17][18][19][20][21] However, no trial-specific reporting guidelines require authors to indicate whether their trial included PPI (although the generic Guidance for Reporting Involvement of Patients and the Public [GRIPP2] 22 checklist may be used when PPI was part of an intervention), and journals rarely require PPI to be reported. 17 Relying

Clinical trial learning needs of musculoskeletal researchers: an inter-disciplinary consensus study by the Australia & New Zealand Musculoskeletal Clinical Trials Network

“…( 22) Despite reported bene ts of consumer involvement, (23,24,25) many clinical trialists do not involve consumers in their research. (22,26) There are several areas of uncertainty around 'involving' consumers in research, which may explain why this topic was so highly ranked in our study. Barriers to researchers involving consumers in trials include a perceived lack of requirement to involve consumers, lack of knowledge on how to involve consumers effectively and systematically, and lack of infrastructure or resources to do so.…”

“…Barriers to researchers involving consumers in trials include a perceived lack of requirement to involve consumers, lack of knowledge on how to involve consumers effectively and systematically, and lack of infrastructure or resources to do so. (22,27) A recent survey of clinical trial networks in Australia found that only 27% of research organisations provided speci c training to their employees on consumer involvement in research, and very few had an established policy or process for involving consumers in clinical trials. (27) Similarly, a survey of musculoskeletal researchers in Aotearoa New Zealand found that only 1 in 10 studies involve consumer partners.…”

Reporting of equity in observational epidemiology: A methodological review

“…We recognise the challenges with attaining and sustaining the engagement of members of populations yet advise engaging interest holders, particularly representatives of populations experiencing inequities. It is also a possibility that the engagement of interest holders might have been underreported [ 55 ].…”

Prioritisation of clinical trial learning needs of musculoskeletal researchers: an inter-disciplinary modified Delphi study by the Australia & New Zealand musculoskeletal clinical trials network

“…The third highest ranked learning need by panellists was “Involving consumers from musculoskeletal trial design through to dissemination”, reflecting growing recognition of the importance of involving consumers in research [ 27 ]. The most common reasons that researchers involve consumers within their trials is to increase research relevance and trial quality [ 28 ]. Despite reported benefits of consumer involvement, [ 29 – 31 ] many clinical trialists do not involve consumers in their research [ 28 , 32 ].…”

“…The most common reasons that researchers involve consumers within their trials is to increase research relevance and trial quality [ 28 ]. Despite reported benefits of consumer involvement, [ 29 – 31 ] many clinical trialists do not involve consumers in their research [ 28 , 32 ]. There are several areas of uncertainty around ‘involving’ consumers in research, which may explain why this topic was so highly ranked in our study.…”