Abstract：
BACKGROUND: Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors\' and physiotherapists\' adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective.
METHODS: Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months).
RESULTS: A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74).
CONCLUSIONS: Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.
METHODS: Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months).
RESULTS: A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74).
CONCLUSIONS: Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.
摘要：
背景：急性下腰痛是一种常见病，负担很高，并且在脊椎指压疗法和物理治疗设置中存在证据到实践的差距，用于成像和提供建议以保持活跃。这项整群随机试验的目的是评估基于理论和证据的实施干预的效果，以提高脊医和物理治疗师对急性下腰痛指南的依从性，与比较者(指南的被动传播)相比。特别是,干预的主要目的是减少不适当的影像学转诊，并改善患者下腰痛的预后，并确定这种干预措施是否具有成本效益。
方法：维多利亚州的物理治疗和脊椎按摩实践，澳大利亚,包括至少一名为急性下腰痛患者提供护理的执业临床医生，被邀请参加。参加这些实践的患者如果有急性非特异性下腰痛（持续时间少于3个月），年龄在18岁或以上，并且能够理解和阅读英语。实践被随机分配给一个量身定制的，基于指南的多方面干预（交互式教育研讨会加学术细节）或指南的被动传播（比较器）。独立于研究小组的统计学家使用计算机生成的随机数进行了分层随机化；按专业小组以及实践的农村或大都市位置定义了四个层次。未参与干预交付的研究人员对分配视而不见。主要结果是临床医生使用检查表自我报告的X射线转诊和患者腰背痛特异性残疾（3个月时）。
结果：总共104个实践（43个脊医，85名物理治疗师；755名患者)被分配到干预措施和106名实践(45名脊医，97名物理治疗师；603名患者）到比较者；449名患者可用于患者级别的主要结局。患者接受X线检查的几率没有重要差异（调整后（调整）OR：1.40；95％CI0.51，3.87；调整风险差异（RD）：0.01；95％CI-0.02，0.04）或患者腰痛特异性残疾（调整平均差异：0.37；95％CI-0.48，1.21，量表0-24）。干预确实改善了一些关键的次要结局，包括提供保持活跃的建议(调整OR:1.96;95%CI1.20,3.22;调整RD:0.10;95%CI0.01,0.19),并打算遵守指南建议(例如,打算参考X线:调整OR:0.27;95%CI0.17,0.44;打算提供保持活跃的建议:调整OR:2.37;95%CI1.51,3.74)。
结论：干预组的临床医生更倾向于建议保持活跃，并打算遵守关于X线转诊的指南建议。干预没有改变主要研究结果，两组之间的X射线转诊和患者残疾没有重要差异，这意味着假设的医疗服务利用率和/或生产率提高的减少不太可能抵消干预的直接成本。我们报告了这些结果，并警告我们纳入试验的患者少于我们确定的样本量。我们不能建议将这种干预措施作为具有成本效益的资源使用。
背景：澳大利亚新西兰临床试验注册ACTRN12609001022257。2009年11月25日进行了回顾性登记。
方法：维多利亚州的物理治疗和脊椎按摩实践，澳大利亚,包括至少一名为急性下腰痛患者提供护理的执业临床医生，被邀请参加。参加这些实践的患者如果有急性非特异性下腰痛（持续时间少于3个月），年龄在18岁或以上，并且能够理解和阅读英语。实践被随机分配给一个量身定制的，基于指南的多方面干预（交互式教育研讨会加学术细节）或指南的被动传播（比较器）。独立于研究小组的统计学家使用计算机生成的随机数进行了分层随机化；按专业小组以及实践的农村或大都市位置定义了四个层次。未参与干预交付的研究人员对分配视而不见。主要结果是临床医生使用检查表自我报告的X射线转诊和患者腰背痛特异性残疾（3个月时）。
结果：总共104个实践（43个脊医，85名物理治疗师；755名患者)被分配到干预措施和106名实践(45名脊医，97名物理治疗师；603名患者）到比较者；449名患者可用于患者级别的主要结局。患者接受X线检查的几率没有重要差异（调整后（调整）OR：1.40；95％CI0.51，3.87；调整风险差异（RD）：0.01；95％CI-0.02，0.04）或患者腰痛特异性残疾（调整平均差异：0.37；95％CI-0.48，1.21，量表0-24）。干预确实改善了一些关键的次要结局，包括提供保持活跃的建议(调整OR:1.96;95%CI1.20,3.22;调整RD:0.10;95%CI0.01,0.19),并打算遵守指南建议(例如,打算参考X线:调整OR:0.27;95%CI0.17,0.44;打算提供保持活跃的建议:调整OR:2.37;95%CI1.51,3.74)。
结论：干预组的临床医生更倾向于建议保持活跃，并打算遵守关于X线转诊的指南建议。干预没有改变主要研究结果，两组之间的X射线转诊和患者残疾没有重要差异，这意味着假设的医疗服务利用率和/或生产率提高的减少不太可能抵消干预的直接成本。我们报告了这些结果，并警告我们纳入试验的患者少于我们确定的样本量。我们不能建议将这种干预措施作为具有成本效益的资源使用。
背景：澳大利亚新西兰临床试验注册ACTRN12609001022257。2009年11月25日进行了回顾性登记。
