Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada.
UOIT-CMCC Centre for Disability Prevention and Rehabilitation, Toronto, Ontario, Canada.
BMJ Open. 2019 Jan 24;9(1):e021283. doi: 10.1136/bmjopen-2017-021283.
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-II.
Pragmatic randomised clinical trial with blinded outcome assessment.
Multidisciplinary rehabilitation clinics and general practitioners in Ontario, Canada.
340 participants with acute WAD grade I and II. Potential participants were sampled from a large automobile insurer when reporting a traffic injury.
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.
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.
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 (Χ=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.
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.
NCT00546806.
评估政府监管的康复指南与全科医生的教育和激活以及基于首选提供者保险的康复计划在自我报告的急性颈扭伤相关障碍（WAD）I-II 级的整体康复方面的效果。
盲法结局评估的实用随机临床试验。
安大略省的多学科康复诊所和全科医生。
340 名患有急性 WAD I 和 II 级的参与者。潜在参与者是在报告交通事故伤害时从一家大型汽车保险公司中抽样的。
参与者被随机分配接受以下三种方案之一：政府监管的康复指南、全科医生的教育和激活或基于首选提供者保险的康复。
我们的主要结局是自我报告的整体康复时间。次要结局包括保险福利时间、颈部疼痛强度、颈扭伤相关残疾、健康相关生活质量和受伤后 6 周、3、6、9 和 12 个月的抑郁症状。
政府监管指南组自我报告全球康复的中位数时间为 59 天（95%CI 55 至 68），首选提供者组为 105 天（95%CI 61 至 126），全科医生组为 108 天（95%CI 93 至 206）；差异无统计学意义（Χ=3.96；2 df：p=0.138）。我们在次要结局方面没有发现组间有临床意义的差异。事后分析表明，全科医生（危险比（HRR）=0.51，95%CI 0.34 至 0.77）和首选提供者组（HRR=0.67，95%CI 0.46 至 0.96）在受伤后 80 天内的康复速度比政府监管指南组慢。没有报告重大不良事件。
干预组之间的恢复时间没有显著差异。我们在颈部特定结局、抑郁和健康相关生活质量方面没有发现组间差异。
NCT00546806。
