Title: Application Development Award – Methodology generation for core outcome data sets in population health research
Funder: Department of Health and Social Care

Abstract: WHAT IS THE PROBLEM?_x000D_ Population health interventions, such as funding for provision of extra school physical activity clubs, are aimed at whole populations or subgroups of populations. They are often delivered by non-health organisations, such as local authorities. They may be funded and delivered by sectors such as education, housing or transport and have the potential to improve both health and other outcomes e.g. extra school physical activity clubs might improve child health and educational outcomes. We need to test whether they work and therefore need agreement on what outcomes are important and should be measured. _x000D_ One way to decide the most important things to measure is to ask members of the public, patients, carers, healthcare or public health professionals, local authorities or other researchers – we refer to them as “stakeholders”. When they agree on what the most important effects to measure are, this is called a Core Outcome Set (COS). We need to develop COS for population health so that researchers and practitioners all measure the same things. This way, the findings from several research studies can be compared and combined to see the strength of the evidence. _x000D_ We want to learn more about developing COS in population health research and how this should be done._x000D_ WHAT IS THE AIM OF THE RESEARCH?_x000D_ We aim to answer whether, for population health research, we need to adapt the usual ways to make COS. We want to find out who should be involved in developing COS and whether there are any interventions that are a priority for developing a COS. _x000D_ WHAT WE ARE PROPOSING TO DO_x000D_ Our study has three stages: _x000D_ (1) Review public health reviews published on a research database to find out how much the outcomes measured in evaluations of population health interventions vary. _x000D_ (2) Identify groups/types of people who should be asked to contribute to developing a population health COS. We will use publicly available websites to:_x000D_ - Identify who worked on the COS that have already been developed for population health interventions; _x000D_ - Identify stakeholders who helped develop NICE public health guidance. _x000D_ (3) Finally, by feeding in the findings from the above and working through an online workshop, people who are interested in PH research will consider: _x000D_ - How to develop COS for population health interventions;_x000D_ - How a COS can be used to understand how interventions may work differently in sub-groups of the population, based on their social characteristics._x000D_ _x000D_ INVOLVING THE PUBLIC_x000D_ We consulted public contributors from the ARC West Midlands’ Public Health Theme in developing this grant. We will continue to engage with this group every 6 weeks, seeking input and advice where required. We presented this proposal to the group at any early stage and the panel were keen for PH COS development to include people not usually involved in research. As a result, we explore this in two of the three research stages. _x000D_ SHARING OUR FINDINGS_x000D_ We will write up the findings in a report for NIHR, produce plain English summaries and write articles to publish in academic journals._x000D_ MAKING A DIFFERENCE_x000D_ This research should eventually lead to better population health research through involvement of relevant stakeholders in COS development and harmonisation of outcomes, focused on those that are most important.

Lay abstract: BACKGROUND:_x000D_ Core Outcome Sets (COS), the consensus-driven ratification of a minimum set of outcomes to be collected and reported in all trials in a specific health research area, aid evidence synthesis, ensure that the research findings are relevant to patients, and reduce research waste. COS have been used in biomedical research in individual patients but in population health (PH), the focus of study is on populations or communities as a whole, interventions are often complex, relevant outcomes may be behavioural or non-health related, and a wider range of stakeholders may be needed in the COS development._x000D_ _x000D_ AIMS: To develop methodology to underpin the development of core outcome sets in population health research relating to the wider determinants of health. _x000D_ _x000D_ OBJECTIVES:_x000D_ 1. Evaluate data quality and heterogeneity of outcomes in PH using systematic reviews to identify research areas that would benefit from COS development._x000D_ 2. Identify the stakeholders that should be involved in PH COS development. _x000D_ 3. Develop methods for developing COS for PH research on the wider determinants of health by building upon existing COS methodology._x000D_ 4. Understand the factors that may affect COS uptake in PH research context._x000D_ 5. Explore the scope for and acceptability of integrating indicators of inequality and disadvantage into PH COS._x000D_ 6. Explore how to promote involvement of those traditionally excluded from research but disproportionately experiencing poor health outcomes in PH COS development._x000D_ _x000D_ METHODS: Mixed methods study composed of three work-packages: _x000D_ 1. Rapid review of public health reviews (n=103) on Cochrane database to identify heterogeneity of outcomes, data quality, reporting bias and need for COS in the review area. (Objective 1) _x000D_ 2. Review of stakeholder involvement data on all COS registered on the Core Outcome Measures in Effectiveness Trials Initiative database (approx. 30) and NICE public health guidance addressing wider determinants of health (approx. 30). (Objective 2) _x000D_ 3. A virtual workshop with 20-25 experts, including public participants, to explore adaptations to COS development for the PH research context; methods to involve seldom heard groups in COS development; inclusion of indicators of inequality; and priority topics for COS development. (Objectives 3-6)_x000D_ _x000D_ TIMELINES: Duration 6 months from Feb 2022_x000D_ _x000D_ IMPACT AND DISSEMINATION: _x000D_ This research will address the demand for guidance in relation to COS development to evaluate PH interventions which address the wider determinants of health. It will direct COS development efforts by identifying fields of PH research that would benefit from such development._x000D_ _x000D_ The main output from this award will be a report to be submitted to NIHR describing the findings and how this methodology generation will add rigour to future COS development in PH research and inform decisions relating to priority areas for COS development. This exercise will involve input from the entire co-application group, including PPIE advisors, to decide key messages. _x000D_ _x000D_ Additional outputs from the research will be in the form of academic publications in research methodology or population health specialty journals. _x000D_ _x000D_ Our PPIE panel will advise on outputs, which will include Plain English Summaries of the findings. Research participants and co-applicants will be encouraged to disseminate these via their networks.

Research activity codes: 2.5 RESEARCH DESIGN AND METHODOLOGIES (AETIOLOGY)
Health categories: GENERIC HEALTH RELEVANCE