Title: A Feasibility Study to Define and Embed a Common Mental Health Dataset in Physical Health Clinical Trials
Funder: Department of Health and Social Care

Abstract: Background An individual s mental and physical health are closely linked. However, this fails to be reflected in starkly disconnected mental and physical healthcare provision, or in the public health and research sectors (DoH, 2017). Enhanced understanding of the links between physical and mental health is now a priority for patients, research councils and the NHS. The Mental Health Research Framework highlighted the &ldquo;need for securing closer integration of mental and physical health research to maximise research capacity&rdquo; (DoH, 2017, p.5). Routine capture of mental health data in physical health studies was specifically identified as a critical area to address. Our overarching aim is to create a seamless and widely acceptable mechanism to collect a common/core set of mental health data (the Core Mental Health Dataset - CMHDS) for all UK clinical trial participants to enable researchers to analyse the links between physical and mental health. The NIHR Clinical Research Network (CRN) collects data on over 800 000 participants across its clinical portfolio every year in England and Wales. The vast majority of participants are from studies concerned with physical ill health. A significant gap in these data is information about participants mental health and wellbeing. However, public data collection initiatives require substantial PPIE, as well as multi-organisation agreement about the content and format of the datasets collected. Moreover, the technical infrastructure to capture mental health data routinely within all clinical trials needs to be designed. Research Aim To create a seamless and widely accepted mechanism to collect a core set of mental health data for participants in physical health clinical trials. Methods and Timelines There are 4 Work Packages: WP1 (months: 1-3): understand specific concerns people have about sharing their mental health data for research purposes and produce creative media to inform people about the aims of the CMHDS. WP2 (months: 2-6): co-define with all key stakeholders (mental and physical clinical trial stakeholders, data organisations, technical experts, members of the public) the content, structure and collection mechanisms of the CMHDS. WP3 (months: 2-8): develop a safe, usable website to collect the CMHDS for trial participants. The CMHDS dataset will be linkable with other mental and physical health datasets hosted by national bodies (e.g. NHS Digital). WP4 (months 8-20): run a feasibility study in 2 physical health clinical trials in Greater Manchester. The CMHDS dataset will be captured with the support of the physical health Principal Investigators, who are also Co-Investigators on this grant application. Months (20-24): Analysis, Full RCT proposal, Dissemination Impact and Dissemination Enrichment of physical health clinical trial data collected in England and Wales by allowing new links to be made between mental and physical health Better understanding of multi-morbidities, including rates of comorbidity and patterns of linked disorders New resource for researchers that is linkable to other health datasets Wider awareness of the benefits of health data research Publications: BMJ, Lancet, Journal of Public Health, Clinical Trials, JMIR CMHDS shared with key organisations: CRN, COMET, NIHR, NHS Digital. Lay Audiences: blogs for online mental health related magazines.

Lay abstract: Aims The links between mental and physical health are important but little understood because information about physical and mental health are rarely collected together. The aim of this research is to work with people across Greater Mancheser (GM) to create an agreement for how to collect mental health data safely and easily in all clinical trials. We aim to build powerful and safe information from which researchers can improve understanding of links between physical and mental health/illness. Information collected will bring additional patient benefits because researchers will be able to understand who does well and who doesn t in a trial, based on their mental health and wellbeing. Background It is well-known that a person s physical and mental health is closely linked. Conditions like heart disease and cancer are greatly affected by and affect a person s mental health. For example, people with heart disease are twice as likely to suffer depression than the general population and people with mental illness like depression have poorer recovery after surgery or a heart attack. The UK NIHR Clinical Research Network collects data from around 800 000 people each year nationally in studies mostly focused on physical health. Less than 2 in 100 studies collect mental health information, leaving a huge gap for analysing how and why physical and mental health are related. Major government reports stress the need for collecting mental and physical health data from the same people at the same time but this hasn t been done. Design We shall work with service users and stakeholders across GM to understand their views about potential benefits and risks of collecting and sharing mental health information alongside physical health information. Through innovative workshops, we shall co-create a common mental health dataset that stakeholders feel is acceptable for collection within physical health studies. We shall also work with researchers running physical health studies to develop a way to collect mental health data that can be included acceptably within their studies. IT specialists will design a website that safely collects mental health data. PPI PPI is at the heart of this project. Two members of the PRIMER PPI group are Collaborators on this grant and have contributed to the application development. PPI is involved throughout the project lifecycle; Work Packages 1 and 2 work closely with people about sharing their mental health data, so their concerns are fully taken into consideration and so together we build a safe, acceptable way to collect mental health data which benefits their lives. Dissemination We shall share our results widely through co-produced innovative media (animations, films) and share these nationally/internationally through our networks. We shall also produce open-access guidelines for collecting mental health data for patient, public and academic audiences.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: MENTAL HEALTH