Center for Evidence-Based Medicine and Clinical Research, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, China.
Chinese evidence based medicine Center, West China Hospital, Sichuan University, Chengdu, China.
BMC Med Res Methodol. 2019 Apr 11;19(1):78. doi: 10.1186/s12874-019-0715-y.
To investigate the prevalence of protocol registration (or development) among published dose-response meta-analyses (DRMAs), and whether DRMAs with a protocol are better than those not.
Three databases were searched for eligible DRMAs. The modified AMSTAR (14 items) and PRISMA checklists (26 items) were used to assess the methodological and reporting quality, with each item assigned 1 point if it met the requirement or 0 if not. We matched (1,2) DRMAs with registered or published protocol to those not, by region and publication years. The summarized quality score and compliance rate of each item were compared between the two groups. Multivariable regression was employed to see if protocol registration or development was associated with total quality score.
We included 529 DRMAs, with 45 (8.51%) completed protocol registration or development. We observed a higher methodological score for DRMAs with protocol than the matched controls (9.47 versus 8.58, P < 0.01); this embodied in 4 out of 14 items of AMSTAR [e.g., Duplicate data extraction (rate difference, RD = 0.17, 95% CI: 0.04, 0.30; P = 0.01). A higher reporting score (cubic transformed) for DRMAs with protocol than the matched controls was also observed (11,875.00 versus 10,229.53, P < 0.01); which embodied in 6 out of 26 items of PRISMA [e.g. Describe methods for publication bias (RD = 0.08, 95% CI: 0.01, 0.14; P = 0.02)]. Regression analysis suggested positive association between protocol registration or development and total reporting score (P = 0.012) while not for methodological score (P = 0.87).
Only a small proportion of DRMAs completed protocol registration or development, and those with protocol were better reported than those not. Protocol registration or development is highly desirable.
调查已发表的剂量反应荟萃分析(DRMA)中方案注册(或制定)的流行情况,以及是否具有方案的 DRMA 优于没有方案的 DRMA。
在三个数据库中搜索合格的 DRMA。使用改良的 AMSTAR(14 项)和 PRISMA 清单(26 项)评估方法学和报告质量,每个项目符合要求得 1 分,不符合要求得 0 分。我们按地区和出版年份将已注册或发表方案的(1,2)DRMA 与未注册或发表方案的 DRMA 进行匹配。比较两组之间每个项目的汇总质量评分和符合率。采用多变量回归分析方案注册或制定是否与总质量评分相关。
我们纳入了 529 项 DRMA,其中 45 项(8.51%)完成了方案注册或制定。我们观察到具有方案的 DRMA 的方法学评分高于匹配对照(9.47 对 8.58,P < 0.01);这体现在 AMSTAR 的 14 个项目中的 4 个项目中 [例如,重复数据提取(率差,RD=0.17,95%CI:0.04,0.30;P=0.01)]。我们还观察到具有方案的 DRMA 的报告评分(立方变换)高于匹配对照(11,875.00 对 10,229.53,P < 0.01);这体现在 PRISMA 的 26 个项目中的 6 个项目中 [例如,描述发表偏倚的方法(RD=0.08,95%CI:0.01,0.14;P=0.02)]。回归分析表明,方案注册或制定与总报告评分呈正相关(P=0.012),但与方法学评分无关(P=0.87)。
只有一小部分 DRMA 完成了方案注册或制定,具有方案的 DRMA 报告质量优于没有方案的 DRMA。方案注册或制定是非常需要的。