Guidance for engagement in health guideline development: A scoping review.

Background: Health guideline developers engage with interested people and groups to ensure that guidelines and their recommendations are relevant and useful to those who will be affected by them. These 'interest-holders' include patients, payers/purchasers of health services, payers of health research, peer review editors, product makers, programme managers, policymakers, providers, principal investigators, and the public. The Guidelines International Network (GIN) and McMaster University Guideline Development Checklist describes 146 steps of the guideline process organized into 18 topics.

Protocol: Assessing the impact of interest-holder engagement on guideline development: A systematic review.

This is the protocol for a Campbell systematic review. The objectives are as follows. The objective of this review is to identify and synthesize empirical research on the impacts of interest-holder engagement on the guideline development process and content.

Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases.

Although the US FDA encourages manufacturers of medical devices to submit real-world evidence (RWE) to support regulatory decisions, the ability of real-world data (RWD) to generate evidence suitable for decision making remains unclear. The 2017 Medical Device User Fee Amendments (MDUFA IV), authorized the National Evaluation System for health Technology Coordinating Center (NESTcc) to conduct pilot projects, or 'Test-Cases', to assess whether current RWD captures the information needed to answer research questions proposed by industry stakeholders. We synthesized key lessons about the challenges conducting research with RWD and the strategies used by research teams to enhance their ability to generate evidence from RWD based on 18 Test-Cases conducted between 2020 and 2022.

A protocol for ongoing systematic scoping reviews of World Trade Center Health research.

Background: The World Trade Center (WTC) Health Program ("Program") seeks to assess the inventory, quality, and impact of its funded research in the context of all clinical and translational research involving WTC populations. This paper presents a protocol for ongoing scoping reviews of WTC-related health research.

Methods: Using terms relevant to the September 11 attacks, we will search OVID MEDLINE, PsycINFO, Scopus, Web of Science, CINAHL, and Embase for records of peer-reviewed publications.

Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses.

Background: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes.

Policy Decisionmaking in Long-Term Care: Lessons from Infection Control During the COVID-19 Pandemic.

The COVID-19 pandemic focused attention on long-term care facilities' need for infection-control policies that balanced community safety and individual well-being. Infection-control policies were often developed, implemented, and mandated without the input or involvement of those who are most affected: residents and their family members, administrators, and staff. This failure led to declines in residents' physical and mental health.

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.

Treatment goals for rheumatoid arthritis: patient engagement and goal collection.

We developed the Patient-Engaged Health Technology Assessment strategy for survey-based goal collection from patients to yield patient-important outcomes suitable for use in multi-criteria decision analysis. Rheumatoid arthritis patients were recruited from online patient networks for proof-of-concept testing of goal collection and prioritization using a survey. A Project Steering Committee and Expert Panel rated the feasibility of scaling to larger samples.

Translational Impacts of World Trade Center Health Program Research: A Mixed Methods Study.

The World Trade Center (WTC) Health Program (hereafter Program) provides medical monitoring and treatment for its Members: the responders and survivors who were at the WTC and related sites or located within the New York City disaster area during and after the terrorist attacks of September 11, 2001. Scientific research supported by the Program provides an evidence base for the health monitoring and clinical care of Members. In this article, the authors describe the findings and recommendations of a four-year study of the Program's research portfolio and its translational impact.

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.

Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment.

Objectives: To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers' challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use.

Impact of World Trade Center-Related Health Research: An Application of the NIEHS Translational Framework.

The World Trade Center Health Program (WTCHP) has a research mission to identify physical and mental health conditions that may be related to the 9/11 terrorist attacks as well as effective diagnostic procedures and treatments for WTC-related health conditions. The ability of the WTCHP to serve its members and realize positive impacts on all of its stakeholders depends on effective translation of research findings. As part of an ongoing assessment of the translational impact of World Trade Center (WTC)-related research, we applied the National Institute of Environmental Health Sciences (NIEHS) translational framework to two case studies: WTC-related research on post-traumatic stress disorder (PTSD) and cancer.

Identifying patient decisions and related information needs during decision making related to total knee arthroplasty.

Research regarding decisions patients make about total knee arthroplasty, apart from having the procedure or not, are limited. Understanding patient decision making and related information needs is essential for shared decision making. Focus groups with an online community-based sample identified decisions about total knee arthroplasty beyond the decision to have the surgery itself.

Why clinical trials may not help patients make treatment decisions: results from focus group discussions with 22 patients.

Despite broad interest in advancing personalized medicine, most evidence is currently derived from average results of clinical trials that may obscure heterogeneity of trial participants. Little is known currently about how patients view heterogeneity in trials and whether they can participate in methodological discussions about this concept. In structured discussions with three focus groups involving 22 participants, we assessed how representatives of patient communities have used research to guide individual treatment decisions.

Facilitating stakeholder engagement in early stage translational research.

Introduction: Stakeholder engagement can play an important role in increasing public trust and the understanding of scientific research and its impact. Frameworks for stakeholder identification exist, but these frameworks may not apply well to basic science and early stage translational research.

Methods: Four Clinical and Translational Science Award (CTSA) hubs led six focus groups and two semi-structured interviews using a semi-structured discussion guide to learn from basic science researchers about stakeholder engagement in their work.

Engaging Patients and Other Non-Researchers in Health Research: Defining Research Engagement.

With the increase in patient and consumer activism through the late twentieth century and into this century, patient roles in research evolved into a new model of research engagement, with patients serving as active advisors and co-leading or leading clinical research. By requiring active engagement of patients and other stakeholders, several government research funders have advanced this model, particularly in Canada, the United States (US), United Kingdom (UK), and Australia. A consortium of individuals from these countries formed a Multi-Stakeholder Engagement (MuSE) consortium to examine critical issues in engaged research, establish consensus on definitions, and provide guidance for the field, beginning with an overview of how to involve stakeholders in health research (Concannon et al.

Are Publicly Funded Health Databases Geographically Detailed and Timely Enough to Support Patient-Centered Outcomes Research?

Emerging health care research paradigms such as comparative effectiveness research (CER), patient-centered outcome research (PCOR), and precision medicine (PM) share one ultimate goal: constructing evidence to provide the right treatment to the right patient at the right time. We argue that to succeed at this goal, it is crucial to have both timely access to individual-level data and fine geographic granularity in the data. Existing data will continue to be an important resource for observational studies as new data sources are developed.

Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer.

Background: African Americans in the United States have worse end-of-life care and cancer outcomes than whites. Palliative care may improve this disparity. Community Health Workers may provide a means to improve palliative care disparities.

Understanding Treatment of Mild Traumatic Brain Injury in the Military Health System.

Traumatic brain injury (TBI) is considered a signature injury of modern warfare, though TBIs can also result from training accidents, falls, sports, and motor vehicle accidents. Among service members diagnosed with a TBI, the majority of cases are mild TBIs (mTBIs), also known as concussions. Many of these service members receive care through the Military Health System, but the amount, type, and quality of care they receive has been largely unknown.