Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial
Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial
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DOI：
10.1186/s12875-019-1074-9
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发表时间：
2020-02-11
影响因子：
2.9
通讯作者：
Foster, N. E.
中科院分区：
文献类型：
--
作者：
Hill, J. C.;Garvin, S.;Foster, N. E.
背景肌肉骨骼（MSK）疼痛从五种最常见的表现到初级保健（背部、颈部、肩部、膝盖或多部位疼痛），大多数患者在初级保健中得到管理，是一个昂贵的全球健康挑战。目前，一线决策是基于临床推理和分层模式的护理只在腰痛患者进行了测试。因此，我们研究了以下可行性：a）一项未来的确定性群集随机对照试验（RCT），和B）全科医生（GP）在咨询时为这五种最常见的MSK疼痛表现提供分层护理。方法设计是一个务实的试点，两个平行臂（分层与非分层护理），集群RCT和设置为8英国GP的做法（4干预，4对照）与随机（分层实践规模）和试验统计学家和结果数据收集者的盲法。参与者是患有MSK疼痛的成年咨询者，没有严重病理，紧急医疗需求或脆弱性的指标。潜在的参与者记录被标记，个人使用GP咨询点电子病历（EMR）模板发送邮寄邀请。该干预得到了包含Keele STarT MSK工具的EMR模板的支持（将持续性疼痛和残疾的预后亚组分为低、中和高风险），并推荐了匹配的治疗方案。可行性结果包括探索招募和随访率，选择偏倚和GP干预保真度。为了获得包括疼痛和功能在内的推荐结果，参与者完成了初始问卷、简短的月度问卷（邮寄或短信）和6个月的随访问卷。一个匿名的EMR审计描述了GP的决策。结果全科医生筛选了3063例患者（干预组= 1591，对照组= 1472），完成了EMR模板，其中1237例符合条件的患者（干预组= 513，对照组= 724），524例参与者（42%）同意收集数据（干预组= 231，对照组= 293）。招募耗时28周（目标12周），后续保留率> 90%（目标> 75%）。我们未检测到任何值得关注的选择偏倚，也未识别出任何损害。GP分层工具保真度未能达到先验成功标准，而匹配治疗的保真度达到了“完全成功”。结论：MSK疼痛分层护理的未来确定性集群RCT是可行的，正在进行中，主要修订包括临床医生完成的分层工具版本和推荐匹配治疗的改进。
Background Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations. Methods The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making. Results GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success". Conclusions A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.