基层医疗中针对腰痛的认知患者教育：一项整群随机对照试验及成本效益分析。
Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis.
作者信息
Werner Erik L, Storheim Kjersti, Løchting Ida, Wisløff Torbjørn, Grotle Margreth
机构信息
*Department of General Practice, Institute of Health and Society, University of Oslo, Norway †Research Unit for General Practice, Uni Research Health, Uni Research, Bergen, Norway ‡FORMI, Clinic for Surgery and Neurology, Oslo University Hospital, Norway §Department of Clinical Medicine, University of Oslo, Norway ¶Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Norway ||Department of Health Management and Health Economics, University of Oslo, Norway **Department of Physiotherapy, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Norway.
出版信息
Spine (Phila Pa 1976). 2016 Mar;41(6):455-62. doi: 10.1097/BRS.0000000000001268.
STUDY DESIGN
A pragmatic cluster randomized controlled trial in primary care.
OBJECTIVE
The aim of this study was to estimate the clinical effectiveness and cost-effectiveness of a cognitive-based education program on patients with subacute or chronic low back pain (LBP) in primary care, compared to usual treatment, provided by general practitioners (GP) and physiotherapists (PT).
SUMMARY OF BACKGROUND DATA
Patient education has been reported to have a favorable effect on patients with chronic musculoskeletal disorders. In this study, an "Explain Pain" model was adapted to fit into an ordinary clinical setting in Norwegian primary care.
METHODS
Sixteen GPs and 20 PTs participated in the study and a total of 216 patients were recruited. The GPs and PTs were randomly assigned to provide either a cognitive patient education or usual treatment. All patients in both groups were provided with four consultations of 30 min with their provider during the study. In the intervention group the patients were educated according to a specific manual written for the purpose of this study.
RESULTS
Eighty-one percent responded at 4-week, and 68% at the 12-month follow-up. There was a substantial improvement in function, pain, and sick leave in both groups. After 4 weeks the intervention group scored 0.51 RMDQ points lower than the control group (Beta -0.506 [95% CI -1.76-0.75]). After 12 months the intervention group scored 0.66 RMDQ points higher than the control group (Beta 0.66 [95% CI -0.56-1.88]). There was no significant difference in QALYs in the two treatment groups; the estimated difference was 0.005 (-0.016-0.027) in favor of the intervention.
CONCLUSION
This study showed no clinical or health economic benefits as a result of adding a cognitive education program to usual treatment for patients with subacute and chronic LBP. Potential weaknesses such as a long recruiting period and potentially low compliance with the cognitive intervention warrant a careful interpretation of the results.
研究设计
一项在初级保健机构中进行的实用整群随机对照试验。
目的
本研究旨在评估与由全科医生（GP）和物理治疗师（PT）提供的常规治疗相比，基于认知的教育项目对初级保健机构中患有亚急性或慢性腰痛（LBP）患者的临床疗效和成本效益。
背景数据总结
据报道，患者教育对慢性肌肉骨骼疾病患者有积极作用。在本研究中，一种“解释疼痛”模型被改编以适用于挪威初级保健的普通临床环境。
方法
16名全科医生和20名物理治疗师参与了研究，共招募了216名患者。全科医生和物理治疗师被随机分配提供认知患者教育或常规治疗。在研究期间，两组的所有患者都与他们的医疗服务提供者进行了4次每次30分钟的咨询。在干预组中，患者根据为本研究编写的特定手册接受教育。
结果
4周时81%的患者做出回应，12个月随访时68%的患者做出回应。两组在功能、疼痛和病假方面都有显著改善。4周后，干预组的RMDQ评分比对照组低0.51分（β -0.506 [95% CI -1.76 - 0.75]）。12个月后，干预组的RMDQ评分比对照组高0.66分（β 0.66 [95% CI -0.56 - 1.88]）。两个治疗组的质量调整生命年（QALY）没有显著差异；估计差异为0.005（-0.016 - 0.027），有利于干预组。
结论
本研究表明，对于亚急性和慢性腰痛患者，在常规治疗基础上增加认知教育项目没有临床或健康经济效益。诸如招募期长和认知干预依从性可能较低等潜在弱点需要对结果进行谨慎解读。
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