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Improving adherence to acute low back pain guideline recommendations with chiropractors and physiotherapists: the ALIGN cluster randomised controlled trial [with consumer summary]
French SD, O'Connor DA, Green SE, Page MJ, Mortimer DS, Turner SL, Walker BF, Keating JL, Grimshaw JM, Michie S, Francis JJ, McKenzie JE
Trials 2022 Feb 14;23(142):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 3.87; adj risk difference (RD) 0.01; 95% CI -0.02 to 0.04) or patient low back pain-specific disability (adj mean difference 0.37; 95% CI -0.48 to 1.21, scale 0 to 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 to 0.19) and intending to adhere to the guideline recommendations (eg, intention to refer for x-ray adj OR 0.27; 95% CI 0.17 to 0.44; intention to give advice to stay active adj OR 2.37; 95% CI 1.51 to 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609001022257. Retrospectively registered on 25 November 2009.

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