一项针对工作人群中非特异性亚急性低背痛演变的生物心理社会多学科干预的成本效益和成本效用的研究方案： 集群随机试验。
Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.
机构信息
Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Institut Català de la Salut, C/Gran Via de les Corts Catalanes 587 àtic, 08007 Barcelona, Spain.
出版信息
BMC Musculoskelet Disord. 2011 Aug 22;12:194. doi: 10.1186/1471-2474-12-194.
BACKGROUND
Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres.
METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term).Assessment of outcomes will be blinded and will follow the intention-to-treat principle.
DISCUSSION
We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres.
TRIAL REGISTRATION
ISRCTN: ISRCTN58719694.
背景
腰痛（LBP）发病率和患病率高，是最常见的就诊原因之一，导致大量病假，造成高昂的健康和社会成本。本研究旨在评估非特异性亚急性 LBP 的多学科生物心理社会教育团体干预（MBEGI）与初级保健中心常规护理相比的成本效益和成本效用分析。
方法/设计：本研究设计是比较 MBEGI 与非特异性亚急性 LBP 的常规护理的成本效益和成本效用分析。两种干预措施的效果和成本的测量将从在 38 个加泰罗尼亚初级保健中心进行的一项多中心随机对照临床试验中获得，共招募 932 名 18-65 岁的非特异性亚急性 LBP 患者。有效性测量指标包括：药物治疗、工作病假（%和天数）、Roland Morris 残疾、McGill 疼痛强度、恐惧回避信念（FAB）和 Goldberg 问卷。效用测量将从 SF-12 中计算得出。分析将从社会角度进行。时间范围为 3 个月（转为慢性 LBP）和 12 个月（长期评估结果）。结果评估将采用盲法，并遵循意向治疗原则。
讨论
我们希望证明 MBEGI 的成本效益和成本效用，看到患者生活质量的提高，减少发作的持续时间和非特异性腰痛的慢性化，并能够报告社会成本的降低。如果干预措施具有成本效益和成本效用，则可以将其应用于初级保健中心。
试验注册
ISRCTN：ISRCTN58719694。
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