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Objectives: To measure medical journal Editor-in-Chiefs’ perceptions regarding including patients as (co-)authors on research publications and to measure their views on the application of the ICMJE authorship criteria to patient partners.Design: Cross-sectional survey co-developed with a patient partner Participants: Editor-in-Chiefs of medical journals were identified via a random sample of journals obtained from the Scopus source list, which contains all MEDLINE and EMBASE content. We restricted the Scopus source list to journals with a classification code of ‘Medicine’ and that were listed as active. Editor-in-Chiefs contact names and contact details were manually extracted from journal websites or obtained via online searching. Main outcome measures: The key outcome measures were whether Editor-in-Chiefs believed: 1) patient partners should be (co-)authors and; 2) whether they felt the ICMJE criteria for authorship required modification for use with patient partners. We also measured Editor-in-Chiefs description of how their journal’s operations incorporate patient partner perspectives. Results: 112 Editor-in-Chiefs responded to our survey (18.7% response rate; 66.69% male). Participants were able to skip any questions they did not want to answer, so there is missing data for some items. 69.2% (N = 74) of Editor-in-Chiefs indicated it was acceptable for patient partners to be authors or co-authors on published biomedical research articles, with the remaining 30.8% (N = 33) indicating this would not be appropriate. When asked specifically about the ICMJE authorship criteria, and whether this should be revised to be more inclusive of patient partners, 35.8% (N = 39) indicated it should be revised, 35.8% (N = 39) indicated it should not be revised, and 28.4% (N = 31) were unsure about a revision. Acceptability of the individual components of the ICMJE authorship criteria by Editor-in-Chiefs varied. 67.9% (N=74) of Editor-in-Chiefs felt a patient partner would likely be able to “give final approval a manuscript to be published” but only 42.6% (N = 46) of Editor-in-chiefs felt patient partners could be “accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved”. 74.1% (N = 80) of Editor-in-Chiefs did not think patients should be required to have an academic affiliation to published while 16.7% (N = 18) and 9.3% (N = 10) indicated they should or were unsure, respectively. 3.6% (N = 4) of Editor-in-Chiefs indicated their journal had a policy that specifies how patients or patient partners should be considered as authors. Conclusions: We found that a substantial proportion of medical journal Editor-in-Chiefs do not agree that patient partners should act as authors on publications, and that there is little consensus as to whether the ICMJE authorship criteria is appropriate for use with patient partners. Further, few journals involve patient or patient partners in the operations of their journal or have independent policy guidance around how authorship might apply to these groups. Access to, and awareness of, appropriate authorship criteria is an important right for patient partners to recognize contributions to research. Our findings highlight gaps that may act as barriers to patient partner participation in research.

Aim Though patient engagement in clinical research is growing, recent reports suggest few clinical trials report on such activities. To address this gap, we describe our approach to patient engagement in the development of a clinical trial protocol to assess a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy). Methods Our team developed a clinical trial protocol by working with patient partners from inception. Two patient partners with lived blood cancer experience were identified through referrals from our team’s professional network and patient organization contacts. Our patient partners were onboarded to the team and engaged in several studies conducted to develop the clinical trial protocol, including a systematic review of the existing literature on the therapy, patient interviews and a survey to obtain perspectives on barriers and enablers to participating in the trial, an early economic analysis, and a retrospective cohort study. Results Engaging patient partners enhanced our research in ways that would not have otherwise occurred. By selecting patient important outcomes for data collection, our partners helped flag that quality of life and health utility measures have not been reported in previous CAR-T cell therapy trials for blood cancer. Our partners also co-developed a non-technical summary of the systematic review that summarized results in an accessible manner. Our patient partners reviewed interview and survey questions, to improve the language and appropriateness; provided recruitment suggestions; and provided a patient perspective on the results, thereby confirming the importance of findings. Input was also obtained on costs for the early economic analysis. Our patient partners identified costs that may be a burden to both patients and caregivers during a trial and helped to confirm that the overall structure of the economic model reflected the patient care pathway. Our patient partners also shared their diagnosis and treatment stories, which helped to provide the research team with insight into this experience. Conclusions Contributions by our patient partners were invaluable to each component study, as well as the overall development of the trial protocol. We plan to use this approach in the future in order to meaningfully engage patients in the development of other clinical trials; we also hope that by reporting our methods this will help other research teams to do the same. Trial registration Affiliated with the development of NCT03765177.

Background Rapid reviews (RRs) are useful products to healthcare policy-makers and other stakeholders, who require timely evidence. Therefore, it is important to assess how well RRs convey useful information in a format that is easy to understand so that decision-makers can make best use of evidence to inform policy and practice. Methods We assessed a diverse sample of 103 RRs against the BRIDGE criteria, originally developed for communicating clearly to support healthcare policy-making. We modified the criteria to increase assessability and to align with RRs. We identified RRs from key database searches and through searching organisations known to produce RRs. We assessed each RR on 26 factors (e.g. organisation of information, lay language use). Results were descriptively analysed. Further, we explored differences between RRs published in journals and those published elsewhere. Results Certain criteria were well covered across the RRs (e.g. all aimed to synthesise research evidence and all provided references of included studies). Further, most RRs provided detail on the problem or issue (96%; n = 99) and described methods to conduct the RR (91%; n = 94), while several addressed political or health systems contexts (61%; n = 63). Many RRs targeted policy-makers and key stakeholders as the intended audience (66%; n = 68), yet only 32% (n = 33) involved their tacit knowledge, while fewer (27%; n = 28) directly involved them reviewing the content of the RR. Only six RRs involved patient partners in the process. Only 23% (n = 24) of RRs were prepared in a format considered to make information easy to absorb (i.e. graded entry) and 25% (n = 26) provided specific key messages. Readability assessment indicated that the text of key RR sections would be hard to understand for an average reader (i.e. would require post-secondary education) and would take 42 (± 36) minutes to read. Conclusions Overall, conformity of the RRs with the modified BRIDGE criteria was modest. By assessing RRs against these criteria, we now understand possible ways in which they could be improved to better meet the information needs of healthcare decision-makers and their potential for innovation as an information-packaging mechanism. The utility and validity of these items should be further explored. Protocol availability The protocol, published on the Open Science Framework, is available at: osf.io/68tj7

Background As production of rapid reviews (RRs) increases in healthcare, knowing how to efficiently convey RR evidence to various end-users is important given they are often intended to directly inform decision-making. Little is known about how often RRs are produced in the published or unpublished domains, and what and how information is structured. Objectives To compare and contrast report format and content features of journal-published (JP) and non-journal published (NJP) RRs. Methods JP RRs were identified from key databases, and NJP RRs were identified from a grey literature search of 148 RR producing organizations and were sampled proportionate to cluster size by organization and product type to match the JP RR group. We extracted and formally compared ‘how’ (i.e., visual arrangement) and ‘what’ information was presented. Results We identified 103 RRs (52 JP and 51 NJP) from 2016. A higher percentage of certain features were observed in JP RRs compared to NJP RRs (e.g., reporting authors ; use of a traditional journal article structure ; section headers including abstract, methods, discussion, conclusions, acknowledgments, conflict of interests, and author contributions ; and use of figures (e.g., Study Flow Diagram) in the main document). For NJP RRs, a higher percentage of features were observed (e.g., use non-traditional report structures ; bannering of executive summary sections and appendices ; use of typographic cues ; and including outcome tables). NJP RRs were more than double in length versus JP RRs. Including key messages was uncommon in both groups. Conclusions This comparative study highlights differences between JP and NJP RRs. Both groups may benefit from better use of plain language, and more clear and concise design. Alternative innovative formats and end-user preferences for content and layout should be studied further with thought given to other considerations to ensure better packaging of RR results to facilitate uptake into policy and practice. Copyright: © 2020 Garritty et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Aim: Though patient engagement in clinical research is growing, recent reports suggest few clinical trials report on such activities. To address this gap, we describe our approach to patient engagement in the development of a clinical trial protocol for a new immunotherapy for blood cancer (chimeric antigen receptor T-cell therapy, CAR-T cell therapy). Methods: Our team developed a clinical trial protocol by working with patient partners from inception. Two patient partners with lived blood cancer experience were identified through referrals from our team’s professional network and patient organization contacts. Our patient partners were onboarded to the team and engaged in several studies conducted to develop the clinical trial protocol, including a systematic review of the existing literature on the therapy, patient interviews and a survey to obtain perspectives on barriers and enablers to participating in the trial, an early economic analysis, and a retrospective cohort study. Results: Engaging patient partners enhanced our research in ways that would not have otherwise occurred. By selecting patient important outcomes for data collection, our partners helped flag that quality of life and health utility measures have not been reported in previous CAR-T cell therapy trials for blood cancer. Our partners also co-developed a non-technical summary of the systematic review that summarized results in an accessible manner. Our patient partners reviewed interview and survey questions, to improve the language and appropriateness; provided recruitment suggestions; and provided a patient perspective on the results, thereby confirming the importance of findings. Input was also obtained on costs for the early economic analysis. Our patient partners identified costs that may be a burden to both patients and caregivers during a trial and helped to confirm that the overall structure of the economic model reflected the patient care pathway. Our patient partners also shared their diagnosis and treatment stories, which helped to provide the research team with insight into this experience.Conclusions: Contributions by our patient partners were invaluable to each component study, as well as the overall development of the trial protocol. We plan to use this approach in the future, to meaningfully engage patients in the development of other clinical trials; we also hope that by reporting our methods this will help other research teams to do the same. Trial Registration: Affiliated with the development of NCT03765177

Background ‘Patient engagement’ involves meaningful collaboration between researchers and ‘patient partners’ to co-create research. It helps ensure that research being conducted is relevant to its ultimate end-users. Although patient engagement within clinical research has been well documented, the prevalence and effects of patient engagement in translational preclinical laboratory research remain unclear. The aim of this scoping review is to present current patient engagement activities reported in preclinical laboratory research. Methods MEDLINE, Embase, and grey literature were systematically searched from inception to April 2021. Studies that described or investigated patient engagement in preclinical laboratory research were included. Patient engagement activities where patients (i.e. patients, family members, caregivers or community members) provided input, or consultation on at least one element of the research process were eligible for inclusion. Study characteristics and outcomes were extracted and organized thematically. Findings 32 reports were included (30 primary studies, 1 narrative review, and 1 researcher guide). Most studies engaged patients at the education or priority setting stages (n=26). The most frequently reported benefit of patient engagement was ‘providing a mutual learning opportunity’. Reported barriers to patient engagement reflected concerns around ‘differences in knowledge and research experience’ and how this may challenge communication and limit meaningful collaboration. Interpretation Patient engagement is feasible and beneficial for preclinical laboratory research. Future work should focus on assessing the impacts of patient engagement in this area of research. Funding None.

Plain English summary With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement? We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Abstract Background Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181–94, JAMA 2012, 307:1587–8]. Since POR’s inception, questions have been raised as to how best to achieve this goal. We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials. Methods The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included. Results Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results. Conclusions The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined. Electronic supplementary material The online version of this article (10.1186/s40900-018-0099-x) contains supplementary material, which is available to authorized users.

KEY POINTS Over the past seven years, the Strategy for Patient-Oriented Research (SPOR) has been a catalyst of major developments in patient-oriented research practices in Canada. The Canadian Institutes of Health Research (CIHR) created SPOR to provide the evidence needed to inform the development