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Is a government-regulated rehabilitation guideline more effective than general practitioner education or preferred-provider rehabilitation in promoting recovery from acute whiplash-associated disorders? A pragmatic randomised controlled trial [with consumer summary]
Cote P, Boyle E, Shearer HM, Stupar M, Jacobs C, Cassidy JD, Carette S, van der Velde G, Wong JJ, Hogg-Johnson S, Ammendolia C, Hayden JA, van Tulder M, Frank JW
BMJ Open 2019 Jan 24;9(1):e021283
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; 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*

OBJECTIVE: To evaluate the effectiveness of a government-regulated rehabilitation guideline compared with education and activation by general practitioners, and to a preferred-provider insurance-based rehabilitation programme on self-reported global recovery from acute whiplash-associated disorders (WAD) grade I to II. DESIGN: Pragmatic randomised clinical trial with blinded outcome assessment. SETTING: Multidisciplinary rehabilitation clinics and general practitioners in Ontario, Canada. PARTICIPANTS: 340 participants with acute WAD grade I and II. Potential participants were sampled from a large automobile insurer when reporting a traffic injury. INTERVENTIONS: Participants were randomised to receive one of three protocols: government-regulated rehabilitation guideline, education and activation by general practitioners or a preferred-provider insurance-based rehabilitation. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome was time to self-reported global recovery. Secondary outcomes included time on insurance benefits, neck pain intensity, whiplash-related disability, health-related quality of life and depressive symptomatology at 6 weeks and 3, 6, 9 and 12 months postinjury. RESULTS: The median time to self-reported global recovery was 59 days (95% CI 55 to 68) for the government-regulated guideline group, 105 days (95% CI 61 to 126) for the preferred-provider group and 108 days (95% CI 93 to 206) for the general practitioner group; the difference was not statistically significant (Chi2 = 3.96; 2 df p = 0.138). We found no clinically important differences between groups in secondary outcomes. Post hoc analysis suggests that the general practitioner (hazard rate ratio (HRR) 0.51, 95% CI 0.34 to 0.77) and preferred-provider groups (HRR 0.67, 95% CI 0.46 to 0.96) had slower recovery than the government-regulated guideline group during the first 80 days postinjury. No major adverse events were reported. CONCLUSIONS: Time-to-recovery did not significantly differ across intervention groups. We found no differences between groups with regard to neck-specific outcomes, depression and health-related quality of life. TRIAL REGISTRATION NUMBER: NCT00546806.
Reproduced with permission from the BMJ Publishing Group.

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