Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.
Risk-based stratified primary care for common musculoskeletal pain presentations (STarT MSK): a cluster-randomised, controlled trial.
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DOI：
10.1016/s2665-9913(22)00159-x
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发表时间：
2022-09
影响因子：
25.4
通讯作者：
Foster, Nadine E.
中科院分区：
文献类型：
--
作者：
Hill, Jonathan C.;Garvin, Stefannie;Bromley, Kieran;Saunders, Benjamin;Kigozi, Jesse;Cooper, Vince;Lewis, Martyn;Protheroe, Joanne;Wathall, Simon;Chudyk, Adrian;Dunn, Kate M.;Birkinshaw, Hollie;Jowett, Sue;Hay, Elaine M.;van der Windt, Danielle;Mallen, Christian;Foster, Nadine E.
基于风险的分层护理显示了与常规初级护理相比，非特异性腰痛的临床有效性和成本效益，但未对其他常见的肌肉骨骼疾病进行测试。我们旨在测试床旁风险分层（使用Keele的STartT MSK工具和风险匹配治疗）与常规护理对五种最常见的肌肉骨骼表现（背部、颈部、膝关节、肩部和多部位疼痛）的临床有效性和成本效益。在这项在英国初级保健中进行的随机分组对照试验中，我们从英格兰西米德兰兹地区的24个全科诊所招募了患者，并进行了定性和卫生经济学研究。符合条件的患者是年龄在18岁或以上的患者，其全科医生（GP）确认了肌肉骨骼表现的咨询。通过分组代表同意参与的一般实践被随机分配（1：1）到干预或常规护理，使用分层区组随机化。参与数据收集、结果数据输入和统计分析的研究人员在集群和个体参与者水平上均被掩蔽。参与的患者被告知该研究正在检查GP对常见疼痛的治疗，并且不知道他们是在随机试验中。支持分配到干预组的全科医生使用定制的基于计算机的模板提供基于风险的分层护理，包括风险分层工具，以及针对低、中、高风险残疾或疼痛结局差的患者的风险匹配治疗方案。有15种风险匹配的治疗方案。在常规护理组中，肌肉骨骼疼痛患者咨询他们的家庭医生接受常规治疗，通常包括咨询和教育，药物治疗，转诊调查或测试，或转诊其他服务。主要结局是6个月内的时间平均疼痛强度。所有分析均按意向治疗进行。该试验已在ISRCTN注册，ISRCTN 15366334。在2018年5月1日至2019年4月30日期间，来自24个实践的104名全科医生（每个研究组12名）确定了2494名肌肉骨骼疼痛患者。1211名（49%）参与者同意接受问卷调查（干预组534名，常规护理组677名），其中1070名（88%）在6个月时完成了随访问卷。我们发现，时间平均疼痛强度（干预组的平均值（SD）为4.4 [SD 2.3]，对照组为4.6 [SD 2.5];校正后的平均差异为-0.16，95%CI为-0.65至0.34）或标准化功能评分无显著差异（干预组的平均值为−0·06 [SD 0·94] vs 0·05 [1·04];校正的平均差异为−0·07，95% CI为−0·22至0·08）。未报告严重不良事件或不良事件。风险分层得到了患者和临床医生的积极反馈。对具有常见肌肉骨骼表现的初级保健患者进行风险分层并没有导致疼痛或功能的显著改善，尽管GP决策的某些方面受到影响，GP和患者都有积极的经历。基于风险的分层护理的成本与常规护理相似，并且这种策略仅提供成本效益结果的边际变化。这项试验的临床意义在很大程度上是不确定的。国立卫生研究院。
Risk-based stratified care shows clinical effectiveness and cost-effectiveness versus usual primary care for non-specific low back pain but is untested for other common musculoskeletal disorders. We aimed to test the clinical effectiveness and cost-effectiveness of point-of-care risk stratification (using Keele's STarT MSK Tool and risk-matched treatments) versus usual care for the five most common musculoskeletal presentations (back, neck, knee, shoulder, and multi-site pain). In this cluster-randomised, controlled trial in UK primary care with embedded qualitative and health economic studies we recruited patients from 24 general practices in the West Midlands region of England. Eligible patients were those aged 18 years or older whose general practitioner (GP) confirmed a consultation for a musculoskeletal presentation. General practices that consented to participate via a representative of the cluster were randomly assigned (1:1) to intervention or usual care, using stratified block randomisation. Researchers involved in data collection, outcome data entry, and statistical analysis were masked at both the cluster and individual participant level. Participating patients were told the study was examining GP treatment of common aches and pains and were not aware they were in a randomised trial. GPs in practices allocated to the intervention group were supported to deliver risk-based stratified care using a bespoke computer-based template, including the risk-stratification tool, and risk-matched treatment options for patients at low, medium, or high risk of poor disability or pain outcomes. There were 15 risk-matched treatment options. In the usual care group, patients with musculoskeletal pain consulting their GP received treatment as usual, typically including advice and education, medication, referral for investigations or tests, or referral to other services. The primary outcome was time-averaged pain intensity over 6 months. All analyses were done by intention to treat. The trial is registered with ISRCTN, ISRCTN15366334. Between May 1, 2018, and April 30, 2019, 104 GPs from 24 practices (12 per study group) identified 2494 patients with musculoskeletal pain. 1211 (49%) participants consented to questionnaires (534 in the intervention group and 677 in the usual care group), with 1070 (88%) completing the follow-up questionnaire at 6 months. We found no significant difference in time-averaged pain intensity (mean(SD) mean 4·4 [SD 2·3] in the intervention group vs 4·6 [2·5] in the control group; adjusted mean difference −0·16, 95% CI −0·65 to 0·34) or in standardised function score (mean −0·06 [SD 0·94] in the intervention group vs 0·05 [1·04]; adjusted mean difference −0·07, 95% CI −0·22 to 0·08). No serious adverse events or adverse events were reported. Risk stratification received positive patient and clinician feedback. Risk stratification for patients in primary care with common musculoskeletal presentations did not lead to significant improvements in pain or function, although some aspects of GP decision making were affected, and GP and patients had positive experiences. The costs of risk-based stratified care were similar to usual care, and such a strategy only offers marginal changes in cost-effectiveness outcomes. The clinical implications from this trial are largely inconclusive. National Institute for Health Research.
影响因子：
2.9
作者：
Protheroe J;Saunders B;Hill JC;Chudyk A;Foster NE;Bartlam B;Wathall S;Cooper V
通讯作者：
Cooper V