Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.

A group of international researchers, patient partners, and other stakeholders are working together to create a checklist for when and how to involve stakeholders in health guideline development. Health guidelines include clinical practice guidelines, which your healthcare provider uses to determine treatments for health conditions. While working on this checklist, the team identified key issues to work on, including: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. This paper describes each issue and how the team plans to produce guidance papers to address them.

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update.

These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.

Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action.

Patients' experiences of their diagnosis, condition, and treatment (including the impact on their lives), and their experiences surrounding expectations of care, are becoming increasingly important in shaping healthcare systems that meet the evolving needs and priorities of different patient communities over time; this is an ongoing goal of all healthcare stakeholders. Current approaches that capture patient experiences with data are fragmented, resulting in duplication of effort, numerous requests for information, and increased patient burden. Application of patient experience data to inform healthcare decisions is still emerging and there remains an opportunity to align diverse stakeholders on the value of these data to strengthen healthcare systems. Given the collective value of understanding patient experiences across multiple stakeholder groups, we propose a more aligned approach to the collection of patient experience data. This approach is built on the principle that the patients' experiences are the starting point, and not just something to be considered at the end of the process. It must also be based on meaningful patient engagement, where patients are collaborators and decision makers at each step, thereby ensuring their needs and priorities are accurately reflected. The resulting data and evidence should be made available for all stakeholders, to inform their decision making and healthcare strategies in ways that meet patient priorities. We call for multi-stakeholder collaboration that will deliver healthcare systems and interventions that are better centered around and tailored to patient experiences, and that will help address patients' unmet needs.

A practical 'How-To' Guide to plain language summaries (PLS) of peer-reviewed scientific publications: results of a multi-stakeholder initiative utilizing co-creation methodology.

BACKGROUND: Peer-reviewed scientific publications and congress abstracts are typically written by scientists for specialist audiences; however, patients and other non-specialists are understandably interested in the potential implications of research and what they may mean for them. Plain language summaries (PLS)-summaries of scientific articles in easy-to-read language-are emerging as a valuable addition to traditional scientific publications. Co-creation of PLS with the intended audience is key to ensuring a successful outcome, but practical guidance on how to achieve this has been lacking. METHODS: Building on the Patient Engagement (PE) Quality Guidance previously developed by Patient Focused Medicines Development (PFMD), a multi-stakeholder working group (WG) of individuals with patient engagement experience and/or expertise in PLS was established to develop further activity-specific guidance. PLS guidance was developed through a stepwise approach that included several rounds of co-creation, public consultation (two rounds), internal review and a final external review. The iterative development process incorporated input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). Feedback from each step was consolidated by the WG and used for refining the draft guidance. The final draft was then validated through external consultation. RESULTS: The WG comprised 14 stakeholders with relevant experience in PE and/or PLS. The WG developed a set of 15 ethical principles for PLS development. These include the necessity for objective reporting and the absence of any promotional intent, the need for balanced presentation, the importance of audience focus, the need to apply health literacy principles, and the importance of using inclusive and respectful language. The first public consultation yielded 29 responses comprising 478 comments or edits in the shared draft guidance. The second public consultation was an online survey of 14 questions which had 32 respondents. The final 'How-To' Guide reflects feedback received and provides a rational, stepwise breakdown of the development of PLS. CONCLUSIONS: The resulting 'How-To' Guide is a standalone, practical, ready-to-use tool to support multi-stakeholder co-creation of PLS.

We wanted to create practical guidance for people who are interested in developing plain language summaries of publications (PLS for short). PLS are summaries of scientific research published in journals or presented at conferences and are written in language that is easy to read and understand. We focused on how to involve patients in developing PLS, as they are often an important audience for these summaries. We brought together a group of people who had experience in PLS and patient involvement. As a working group, we wrote the first version of the 'How-To' Guide. Then we asked for feedback from others experienced in patient involvement and also from members of the general public. We got feedback on how we could improve what was in the guidance and also on how useful and user-friendly the guidance was. We used this feedback to create the final version of the 'How-To' Guide which is freely available online from https://pemsuite.org/How-to-Guides/WG5.pdf .

Hidden in plain sight? Identifying patient-authored publications.

BACKGROUND: Patient advocates are increasingly authoring peer-reviewed publications that could enhance patient care and understanding of the lived experience. Although patient authorship may be seen as an innovation in the peer-reviewed publication environment and some may not be aware of or accept patient authorship, we know patient-authored publications exist. However, identifying patient-authored publications is often challenging and time-consuming. MAIN BODY: In this commentary, we propose a definition for a patient author and patient-authored publications. We outline factors driving the increase in patient authorship, including patient interest, recognition of the value of including the patient voice and major funders recognising the importance of involving patient advocates in research. Evidence and experience-based guidance on patient authorship is emerging, and we highlight practical guidance for patient advocates on authoring peer-reviewed publications. To gain a better understanding of patient authorship, an efficient method is needed to identify patient-authored publications. A dataset on patient-authored publications could be used for a range of quantitative and qualitative research studies. The affiliation search function in PubMed can provide an easy, and reproducible way to identify a dataset of patient-authored publications in the international peer-reviewed literature, but only if patient authors include a standard metatag, (e.g. Patient Author) as one of their listed affiliations, combined with other affiliations as appropriate. From 2020 to 2021, there was a nine-fold increase in patient-authored publications in PubMed identified using the Patient Author tag. We recognize that terminology can be contentious and some authors may prefer alternative metatags. Further efforts are required to gain consensus on a suitable, standard metatag or set of metatags to use to show the true extent of patient authorship. CONCLUSION: Patient authorship is not only legitimate, but it also exemplifies the principles of diversity, equity and inclusion. Stakeholders in the publication community need to review their policies and procedures to identify and address barriers to patient authorship. Patient advocates, funders, researchers and publishers could all help to promote awareness and acceptance of patient authorship and the merits of using a standard metatag or set of metatags, so that patient-authored publications are no longer hidden in plain sight.

Some patients are leading or helping with medical research to improve understanding of their condition and patient care. To share research findings, patients can author articles published in scientific journals. These articles are reviewed by experts and are known as peer-reviewed publications. Patient authors can provide unique and valuable insights from their experience of living with a condition. Demonstrating that patients can be authors would be easier if there was a quick way to find patient-authored publications. In this article, we describe who a patient author is and what patient-authored publications are. We identify factors that may encourage patients to author research publications. We highlight the practical guidance available to help patient authors and those working with them. To help future research about patient authorship, we need a way to find patient-authored publications. One way is for patients to include a standard search term, such as 'Patient Author' in the affiliation section of their publication. Like all authors, patient authors can list more than one affiliation, such as their workplace if they wish. We used the 'Patient Author' search term to look at publications in PubMed, a free resource to access scientific publications. We found the number of patient-authored publications using the 'Patient Author' tag increased nine times from 2020 and 2021. We encourage patients, funders, researchers and publishers to use a standard metatag or an agreed set of metatags. This could make it easier to find and raise awareness of patient-authored publications.

Factors to Consider During Identification and Invitation of Individuals in a Multi-stakeholder Research Partnership.

BACKGROUND: Health research teams increasingly partner with stakeholders to produce research that is relevant, accessible, and widely used. Previous work has covered stakeholder group identification. OBJECTIVE: We aimed to develop factors for health research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership, with the aim of forming equitable and informed teams. DESIGN: Consensus development. PARTICIPANTS: We involved 16 stakeholders from the international Multi-Stakeholder Engagement (MuSE) Consortium, including patients and the public, providers, payers of health services/purchasers, policy makers, programme managers, peer review editors, and principal investigators. APPROACH: We engaged stakeholders in factor development and as co-authors of this manuscript. Using a modified Delphi approach, we gathered stakeholder views concerning a preliminary list of 18 factors. Over two feedback rounds, using qualitative and quantitative analysis, we concentrated these into ten factors. KEY RESULTS: We present seven highly desirable factors: 'expertise or experience', 'ability and willingness to represent the stakeholder group', 'inclusivity (equity, diversity and intersectionality)', 'communication skills', 'commitment and time capacity', 'financial and non-financial relationships and activities, and conflict of interest', 'training support and funding needs'. Additionally, three factors are desirable: 'influence', 'research relevant values', 'previous stakeholder engagement'. CONCLUSIONS: We present factors for research teams to consider during identification and invitation of individual representatives in a multi-stakeholder research partnership. Policy makers and guideline developers may benefit from considering the factors in stakeholder identification and invitation. Research funders may consider stipulating consideration of the factors in funding applications. We outline how these factors can be implemented and exemplify how their use has the potential to improve the quality and relevancy of health research.

Introducing Volume 10 of the Journal of Comparative Effectiveness Research.

I am very pleased to welcome readers to the tenth volume of the Journal of Comparative Effectiveness Research (JCER). As in previous years, it is great to start off this issue with a look back on some of our article highlights from 2020, alongside some of this month's key content.

Welcome to the 11th Volume of Pain Management.

I would like to welcome our readers to volume 11 of Pain Management. Since the launch of the journal in 2011, the title has gone from strength to strength, and we are delighted to bring you a new year of content. We are starting off this issue with a look back on some of our article highlights from 2020, alongside some of this month's key content.

Introducing volume 8 of Neurodegenerative Disease Management.

Welcome to the eighth volume of Neurodegenerative Disease Management. At the start of a new volume, it is interesting to look back at which content proved most popular in 2017, and also to take a look forward to the content of this issue and beyond.