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Translating evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial
Slater H, Briggs AM, Watkins K, Chua J, Smith AJ
PLoS ONE 2013 Aug;8(8):e71918
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; 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: This cluster-randomised controlled trial determined the effectiveness of an evidence-based, pamphlet intervention in improving low back pain (LBP)-related beliefs among pharmacy consumers. METHODS: Thirty five community pharmacies were randomised to three groups: pamphlet+education intervention (n = 11); pamphlet only intervention (n = 11); control: usual care (n = 13). Eligibility requirements for clusters included: community-based pharmacies and proprietor participation consent. Pharmacy consumers (n = 317) aged 18 to 65 years currently experiencing LBP participated. Intervention group allocation depended on the pharmacy attended. Individual-level outcomes were measured at pre-intervention (T0), at two (T1) and eight (T2) weeks post-intervention and included beliefs about LBP (Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)). Secondary outcomes included pain severity, activity impairment and pamphlet perceived usefulness. Blinding to group allocation included primary investigators, outcome assessors and the statistician. Pharmacy staff and consumers were un-blinded. RESULTS: Of 35 pharmacies recruited (317 consumers), no clusters were lost to follow-up. Follow-up was available for n = 24 at 2 weeks only; n = 38 at 8 weeks only; n = 148 at both time points, with n = 148+24+38 = 210 analysed (107 excluded: no follow up). Adjusting for baseline scores demonstrated no significant differences in beliefs (2 or at 8 weeks) between pamphlet (with or without education) versus control, or between 'pamphlet with' versus 'without' education. Work-related fear (FABQ) was significantly lower in consumers receiving pamphlet (with or without education) versus control (difference -2.3, 95%CI -4.4 to -0.2). There was no significant difference between "pamphlet with" versus "pamphlet without" groups. Consumers receiving the "pamphlet with" reported greater perceived usefulness than consumers receiving the "pamphlet without" (difference 0.9 (95%CI 0.0 to 1.8)). CONCLUSION: Community pharmacies provided a feasible primary care portal for implementing evidence-based information. The associated improvement in work-related LBP-beliefs for consumers receiving the pamphlet suggests this simple intervention may be a useful component of care. TRIAL REGISTRATION: ACTR.org.au ACTRN12611000053921.

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