A Data Collection Tool to capture a Core Mental Health Dataset within Physical Health Clinical Trials

<p><br></p><p><b>A Data Collection Tool for a Core Mental Health Dataset in Physical Health Research Studies</b></p><p><br></p><p>Project Overview</p><p>The 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 physical health study participants so that researchers can analyse the links between physical and mental health.</p><p><br></p><p>CMHDS Data Collection Tool</p><p>The Core Mental Health DataSet (CMHDS) Open Source tool enables the collection of mental health data from participants in physical health studies. The CMHDS data collection tool was extensively co-designed with members of the public through a series of workshops.</p><p><br></p><p>How participants engage with the tool:</p><p>From a participant perspective, participants are provided with a URL which provides access to the CMHDS website. The website contains:</p><ul><li>A Participant Information Sheet</li><li>A link to a short animation to explain the study in simple terms</li><li>A consent form with mandatory and optional consents</li><li>Clear information about how data collected will be used and for which purposes</li><li>A bespoke mental health history questionnaire</li><li>Validated questionnaires were included in the original CMHDS roll-out including: GHQ12, PHQ8 and GAD7. However, licenses are required to use some of the validated questionnaires and for this purpose they are not included in the source code here. These questionnaires (and others) can be easily added to a future deployment. Technical details of how to do this are included in the README.txt file.</li></ul><p>All questionnaires are optional to complete and the questionnaire can be exited at any time. There is an explanation of what each questionnaire entails that participants can read before answering them.</p><p><br></p><p>The CMHDS website also contains a contact email so that participants can contact the CMHDS team if they have any questions and sources of support for people who have concerns about their mental health.</p><p><br></p><p><b>Author Contributions</b></p><p>Study Chief Investigator</p><p>Professor Kathryn Abel</p><p><br></p><p><b>Co-investigators:</b></p><p>Dr Pauline Whelan</p><p>Professor Ann John</p><p>Professor Paul Dark</p><p>Professor Nawar Diar Bakerly</p><p><br></p><p><b>PPI Lead Contributors</b></p><p>Martin Rathfelder</p><p>Philip Bell</p><p><br></p><p><b>Researchers and Focus Group Facilitators</b></p><p>Dr Kerry Gutridge</p><p>Dr Jenni Jardine</p><p>Auden Edwardes</p><p><br></p><p><b>Operational Lead</b></p><p>Charlie Stockton-Powdrell</p><p><br></p><p><b>Lead Software UX designer - design of the website</b></p><p>Simon Foster</p><p><br></p><p><b>Software Engineers - development of the web app</b></p><p>Henry Gorner</p><p>Paul Smitton</p><p><br></p><p><b>Acknowledgements:</b></p><p>This study/project is funded by the NIHR Research for Patient Benefit, Award ID: NIHR201104.<b> </b>The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.</p><p>and</p><p>This work was funded by UKRI – Medical Research Council through the Datamind Hub (MRC reference: MR/W014386/1). The Datamind Hub and the authors would like to acknowledge the data providers who supplied the data sets enabling this research study.</p><p>Thanks to all of our patient and public contributors who attended workshops and helped co-design the CMHDS tool with us.</p>