Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, 2109, Australia.
School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Road, Melbourne, Victoria, 3004, Australia.
Trials. 2022 Feb 14;23(1):142. doi: 10.1186/s13063-022-06053-x.
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.
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).
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).
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.
Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.
急性腰痛是一种常见病症,负担沉重,在整脊和物理治疗领域,针对影像学检查和保持活动的建议,存在证据与实践之间的差距。本项集群随机试验的目的是评估一项基于理论和循证的实施干预措施,以增加整脊师和物理治疗师对急性腰痛指南的遵从性,与对照组(被动传播指南)相比。该干预措施的主要目的是减少不适当的影像学转诊,并改善患者的腰痛结局,并确定该干预措施是否具有成本效益。
澳大利亚维多利亚州的物理治疗和整脊实践被邀请参加本试验,这些实践包括至少一位为急性腰痛患者提供护理的执业临床医生。如果患者患有急性非特异性腰痛(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,则可参加本试验。实践被随机分配到基于指南的量身定制的多方面干预组(互动教育研讨会加学术详细信息)或被动传播指南组(对照组)。统计学家使用计算机生成的随机数对研究小组进行分层随机分组;根据专业组和实践的农村或城市位置定义了四个层。不参与干预实施的研究人员对分配情况不知情。主要结局是临床医生使用检查表报告的 X 射线转诊率和患者腰痛特异性残疾(3 个月时)。
共有 104 个实践(43 名整脊师,85 名物理治疗师;755 名患者)被分配到干预组,106 个实践(45 名整脊师,97 名物理治疗师;603 名患者)被分配到对照组;449 名患者有资格进行患者水平的主要结局评估。在患者接受 X 射线检查的可能性方面,两组之间没有重要差异(调整后的(Adj)比值比(OR):1.40;95%置信区间(CI):0.51,3.87;Adj 风险差异(RD):0.01;95%CI:-0.02,0.04)或患者腰痛特异性残疾(Adj 平均差异:0.37;95%CI:-0.48,1.21,0-24 分)。该干预措施确实导致了一些关键次要结局的改善,包括建议保持活动(Adj OR:1.96;95%CI:1.20,3.22;Adj RD:0.10;95%CI:0.01,0.19)和打算遵循指南建议(例如,X 射线转诊的意向:Adj OR:0.27;95%CI:0.17,0.44;建议保持活动的意向:Adj OR:2.37;95%CI:1.51,3.74)。
干预组临床医生更有可能提供保持活动的建议,并打算遵循指南关于 X 射线转诊的建议。该干预措施并未改变主要研究结局,两组之间 X 射线转诊和患者残疾无重要差异,这意味着假设减少卫生服务利用和/或生产力提高不太可能抵消干预措施的直接成本。我们报告这些结果时,存在一个警告,即我们招募的患者数量少于我们确定的样本量。我们不能推荐这种干预措施作为一种具有成本效益的资源利用方式。
澳大利亚和新西兰临床试验注册 ACTRN12609001022257 。于 2009 年 11 月 25 日进行回顾性注册。