Investigating musculoskeletal health and wellbeing; A cohort study protocol

Millar, Bonnie; McWilliams, Daniel F.; Abhishek, Abhishek; Akin-Akinyosoye, Kehinde; Auer, Dorothee P.; Chapman, Victoria; Doherty, Michael; Ferguson, Eamonn; Gladman, John R.F.; Greenhaff, Paul; Stocks, Joanne; Valdes, Ana M.; Walsh, David A.

Abstract

© 2020 The Author(s). Background: In an ageing population, pain, frailty and disability frequently coexist across a wide range of musculoskeletal diagnoses, but their associations remain incompletely understood. The Investigating Musculoskeletal Health and Wellbeing (IMH&W) study aims to measure and characterise the development and progression of pain, frailty and disability, and to identify discrete subgroups and their associations. The survey will form a longitudinal context for nested research, permitting targeted recruitment of participants for qualitative, observational and interventional studies; helping to understand recruitment bias in clinical studies; and providing a source cohort for cohort randomised controlled trials. Methods: IMH&W will comprise a prospective cohort of 10,000 adults recruited through primary and secondary care, and through non-clinical settings. Data collection will be at baseline, and then through annual follow-ups for 4 years. Questionnaires will address demographic characteristics, pain severity (0-10 Numerical Rating Scale), pain distribution (reported on a body Manikin), pain quality (McGill Pain Questionnaire), central aspects of pain (CAP-Knee), frailty and disability (based on Fried criteria and the FRAIL questionnaire), and fracture risk. Baseline characteristics, progression and associations of frailty, pain and disability will be determined. Discrete subgroups and trajectories will be sought by latent class analysis. Recruitment bias will be explored by comparing participants in nested studies with the eligible IMH&W population. Discussion: IMH&W will elucidate associations and progression of pain, frailty and disability. It will enable identification of people at risk of poor musculoskeletal health and wellbeing outcomes who might be suitable for specific interventions, and facilitate generalisation and comparison of research outcomes between target populations. The study will benefit from a large sample size and will recruit from diverse regions across the UK. Purposive recruitment will enrich the cohort with people with MSK problems with high representation of elderly and unwell people. Trial registration: Clinicaltrials.gov NCT03696134. Date of Registration: 04 October 2018.

Citation

Millar, B., McWilliams, D. F., Abhishek, A., Akin-Akinyosoye, K., Auer, D. P., Chapman, V., …Walsh, D. A. (2020). Investigating musculoskeletal health and wellbeing; A cohort study protocol. BMC Musculoskeletal Disorders, 21(1), Article 182. https://doi.org/10.1186/s12891-020-03195-4

• Journal Article Type: Article
• Acceptance Date: Mar 6, 2020
• Online Publication Date: Mar 21, 2020
• Publication Date: Mar 21, 2020
• Deposit Date: Mar 30, 2020
• Journal: BMC Musculoskeletal Disorders
• Electronic ISSN: 1471-2474
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Article Number: 182
• DOI: https://doi.org/10.1186/s12891-020-03195-4
• Keywords: Rheumatology; Orthopedics and Sports Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/4224804
• Publisher URL: https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03195-4
• Additional Information: Received: 20 December 2019; Accepted: 9 March 2020; First Online: 21 March 2020; : Approved by the Central London Research Ethics Committee (REC ref. 18/LO/0870).Participation requires ongoing informed consent, documented at baseline through a signed consent form, and at each follow up by written confirmation of willingness for continued participation and further contact.; : Not applicable.; : BM has no competing interests for this work.DFM grant support from Pfizer.AA has received departmental research funding from AstraZeneca and Oxford Immunotech.KAA has no competing interests for this work.DPA has no competing interests for this work.VC has departmental grant support from Eli Lilly.MD has received honoraria for ad hoc advisory boards from AstraZeneca and Grunenthal.EF has no competing interests for this work.JG has no competing interests for this work.PG has no competing interests for this work.JS has no competing interests for this work.AMV –consultancy for Zoe Global.DAW has departmental grant support from Pfizer and Eli Lilly and consultancy work for Pfizer and GSK.