调查肌肉骨骼健康与福祉；一项队列研究方案。
Investigating musculoskeletal health and wellbeing; a cohort study protocol.
作者信息
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
机构信息
NIHR Biomedical Research Centre, Academic Rheumatology, University of Nottingham Clinical Sciences Building, City Hospital, Nottingham, NG5 1PB, UK.
Division of ROD, School of Medicine, University of Nottingham, Nottingham, UK.
出版信息
BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.
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.
背景
在老龄化人口中，疼痛、虚弱和残疾在多种肌肉骨骼疾病中经常并存，但其关联仍未完全明确。肌肉骨骼健康与福祉调查（IMH&W）研究旨在测量和描述疼痛、虚弱和残疾的发生发展及进程，并识别不同的亚组及其关联。该调查将为嵌套研究形成纵向背景，允许有针对性地招募参与者进行定性、观察性和干预性研究；有助于了解临床研究中的招募偏差；并为队列随机对照试验提供一个源队列。
方法
IMH&W将包括通过初级和二级医疗保健以及非临床环境招募的10000名成年人的前瞻性队列。数据收集将在基线时进行，然后在4年中每年进行随访。问卷将涉及人口统计学特征、疼痛严重程度（0 - 10数字评分量表）、疼痛分布（在人体模型上报告）、疼痛性质（麦吉尔疼痛问卷）、疼痛的中枢方面（CAP - 膝关节）、虚弱和残疾（基于弗里德标准和FRAIL问卷）以及骨折风险。将确定虚弱、疼痛和残疾的基线特征、进程及关联。将通过潜在类别分析寻找不同的亚组和轨迹。通过比较嵌套研究中的参与者与符合条件的IMH&W人群来探索招募偏差。
讨论
IMH&W将阐明疼痛、虚弱和残疾的关联及进程。它将能够识别肌肉骨骼健康和福祉状况不佳风险较高且可能适合特定干预措施的人群，并促进目标人群之间研究结果的推广和比较。该研究将受益于大样本量，并将从英国不同地区招募。有目的的招募将使队列中患有肌肉骨骼问题的人群更加丰富，其中老年人和身体不适者占比很高。
试验注册
Clinicaltrials.gov NCT03696134。注册日期：2018年10月4日。
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