Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.
Keele Clinical Trials Unit, Keele University, Keele, UK.
Health Technol Assess. 2020 Oct;24(49):1-130. doi: 10.3310/hta24490.
Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics.
The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care.
This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial.
Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK.
Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery.
In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service.
The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist.
A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy.
The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration.
Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results.
Other approaches to stratified care may provide superior outcomes for sciatica.
Current Controlled Trials ISRCTN75449581.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.
坐骨神经痛会对患者和社会造成重大影响。目前的治疗方法是“分阶段”的，包括对大多数患者进行初始的简单建议和镇痛措施，通常随后是物理治疗，然后如果症状未缓解，则进行更强化的干预。目前尚无研究测试过分层护理模式，该模式根据患者的预后和临床特征对患者进行亚组划分，并为他们匹配不同的护理路径。
旨在研究分层护理模式与常规、非分层护理相比的临床效果和成本效益。
这是一项两平行组、多中心、实用、1:1 随机对照试验。
参与者在英国北斯塔福德郡、北什罗普郡/威尔士和柴郡的基层医疗（42 家普通诊所）招募。
符合条件的患者年龄≥18 岁，患有疑似坐骨神经痛，可使用手机/固定电话，未怀孕，正在接受同一问题的治疗，且之前未接受过脊柱手术。
在分层护理中，使用与转诊至脊柱专科服务相关的预后和临床标准对患者进行分组，将他们分配到三种匹配的护理路径组之一。第 1 组接受建议和最多两次物理治疗，第 2 组接受最多 6 次物理治疗，第 3 组快速接受磁共振成像和脊柱专科评估。常规护理基于阶梯式治疗方法，不使用任何分层工具/算法。患者使用远程网络随机化服务进行随机分组。
主要结局是坐骨神经痛症状首次缓解的时间（六点有序量表，通过短信收集）。次要结局（在第 4 个月和第 12 个月）包括疼痛、功能、心理健康、缺勤天数、工作生产力、对护理的满意度和卫生保健使用情况。进行了为期 12 个月的成本-效用分析。一项定性研究探讨了患者和临床医生对快速通道到脊柱专家的看法。
共有 476 名患者被随机分组（每组 238 名）。在主要结局方面，整体应答率为 89.3%（分层护理组和常规护理组分别为 88.3%和 90.3%）。在分层护理组中，症状缓解速度略快（中位数差异 2 周），但差异无统计学意义（风险比 1.14，95%置信区间 0.89 至 1.46； = 0.288）。随着时间的推移，两组参与者平均都报告了在大多数结局上从基线有良好的改善。在研究诊所进行评估后，常规护理组的大多数参与者都被转介到物理治疗。
该试验中测试的分层护理模式在临床效果上并不优于常规护理，也不太可能是一种具有成本效益的选择。快速通道被患者和临床医生认为是可以接受的；然而，如果症状持续时间较短，临床医生表示不愿意考虑侵入性治疗。
常规护理组的参与者平均报告了良好的结果，这使得证明分层护理的优越性具有挑战性。用于将患者分配到治疗路径的算法的性能可能影响了结果。
其他分层护理方法可能为坐骨神经痛提供更好的结果。
当前对照试验 ISRCTN75449581。
该项目由英国国家卫生研究院（NIHR）健康技术评估计划资助，将在 ; 第 24 卷，第 49 期全文发表。请访问 NIHR 期刊库网站以获取更多项目信息。
