Wood Lianne, Foster Nadine E, Lewis Martyn, Bronfort Gert, Groessl Erik J, Hewitt Catherine, Miyamoto Gisela C, Reme Silje E, Bishop Annette
Primary Care Centre Versus Arthritis, School of Medicine, Faculty of Medicine, Keele University, Newcastle-under-Lyme, UK; Nottingham University Hospitals NHS Trust, Queens Medical Centre, Derby Road, Nottingham, UK.
Primary Care Centre Versus Arthritis, School of Medicine, Faculty of Medicine, Keele University, Newcastle-under-Lyme, UK.
Arch Phys Med Rehabil. 2023 Feb;104(2):218-228. doi: 10.1016/j.apmr.2022.07.012. Epub 2022 Aug 4.
To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD.
We conducted exploratory secondary analyses of data.
Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics).
The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897).
Exercise compared with no exercise.
The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses.
Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.10).
These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes.
探讨采用单一匹配结局或综合结局是否会影响既往针对非特异性下腰痛（NSLBP）进行运动测试的随机对照试验（RCT）结果。第一个目的是探究与原始未匹配的主要结局标准化均数差（SMD）相比，单一匹配结局是否会产生更大的SMD。第二个目的是探究由匹配结局组成的综合指标与原始主要结局SMD相比，是否会产生更大的SMD。
我们对数据进行了探索性二次分析。
纳入了7项RCT，其中2项在美国（大学研究诊所、退伍军人事务医疗中心）和英国（基层医疗诊所、非医疗中心）开展。挪威（诊所）、巴西（基层医疗）和日本（门诊诊所）各有1项。
第一次分析纳入了1）5项RCT（n = 1033），这些研究使用了未匹配的主要结局，但包括（一些）匹配结局作为次要结局；第二次分析纳入了2）4项RCT（n = 864），这些研究通过制定综合结局纳入了多个匹配结局（N = 1897）。
运动与不运动进行比较。
综合指标由标准化平均匹配结局组成。所有分析重复了RCT的主要结局分析。
在5项RCT中，3项研究的匹配结局SMD更大（合并效应SMD 0.30 [95%置信区间{CI} 0.04, 0.56]，P = 0.02），而未匹配的主要结局合并效应SMD为0.19 [95% CI -0.03, 0.40]，P = 0.09。在4项综合结局分析中，3项RCT的综合结局SMD更大（合并效应SMD 0.28 [95% CI 0.05, 0.51]，P = 0.02），而主要结局合并效应SMD为0.24 [95% CI -0.04, 0.53]，P = 0.10。
这些探索性分析表明，在NSLBP RCT中使用与运动治疗目标匹配的结局可能比未匹配的主要结局产生更大的SMD。与单一领域结局相比，综合结局可能为研究运动的优越性提供一种有意义的方式。
