Konstantinou Kika, Lewis Martyn, Dunn Kate M, Ogollah Reuben, Artus Majid, Hill Jonathan C, Hughes Gemma, Robinson Michelle, Saunders Benjamin, Bartlam Bernadette, Kigozi Jesse, Jowett Sue, Mallen Christian D, Hay Elaine M, van der Windt Danielle A, Foster Nadine E
Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Haywood Hospital, Midlands Partnership Foundation NHS Trust, Staffordshire, UK.
Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Keele Clinical Trials Unit, Keele University, Keele, UK.
Lancet Rheumatol. 2020 Jun 25;2(7):e401-e411. doi: 10.1016/S2665-9913(20)30099-0. eCollection 2020 Jul.
Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care.
We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581.
Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care.
The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica.
National Institute for Health Research.
坐骨神经痛对个人和社会都有重大影响。分层护理已被证明能使非特异性腰痛患者获得更好的治疗效果，但尚未在坐骨神经痛患者中进行测试。我们旨在研究在初级保健中，分层护理与非分层常规护理相比，对坐骨神经痛患者的临床效果和成本效益。
我们在英国的三个中心（北斯塔福德郡、北什罗普郡/威尔士和柴郡）进行了一项双臂平行、实用的随机对照试验。符合条件的患者年龄在18岁及以上，临床诊断为坐骨神经痛，能提供手机号码或固定电话号码，未怀孕，目前未因同一问题接受治疗，且既往无脊柱手术史。患者从全科诊所招募，并通过远程网络服务按中心和分层组分配以1:1的比例随机分配到分层护理或常规护理组。在分层护理组中，结合与转诊至脊柱专科服务相关的预后和临床标准，将患者分配到三个组之一，以匹配护理路径。第1组患者可获得最多两次物理治疗疗程的简短建议和支持；第2组患者可获得最多六次物理治疗疗程；第3组患者在随机分组后4周内可快速接受磁共振成像（MRI）检查和脊柱专科评估。主要结局是自我报告的坐骨神经痛症状首次缓解时间，定义为在6分序数量表上达到“完全康复”或“好多了”，通过短信或电话收集。分析采用意向性分析。还评估了医疗保健成本和成本效益。本试验已在国际标准随机对照试验编号注册库（ISRCTN）注册，注册号为ISRCTN75449581。
在2015年5月28日至2017年7月18日期间，来自英国三个中心周围42家全科诊所的476例患者被随机分配到分层护理组或常规护理组（每组238例）。对于主要结局，总体回复率为89%（发送的10601条短信中有9467条回复；分层护理组5310条中有4688条[88%]回复，常规护理组5291条中有4779条[90%]回复）。分层护理组症状缓解的中位时间为10周（95%置信区间6.4 - 13.6），常规护理组为12周（9.4 - 14.6），生存分析显示两组之间无显著差异（风险比1.14[95%置信区间0.89 - 1.46]）。与常规护理相比，分层护理不具有成本效益。
在初级保健中就诊的坐骨神经痛患者的分层护理模式在临床或健康经济结局方面并不优于常规护理。这些结果不支持向坐骨神经痛患者过渡到这种分层护理模式。
英国国家卫生研究院。
