Department of Pediatrics, Kalawati Saran Children's Hospital & Lady Hardinge Medical College, New Delhi, India.
Department of Obstetrics and Gynaecology, ESI PGIMER, New Delhi, India.
J Evid Based Med. 2018 May;11(2):89-94. doi: 10.1111/jebm.12294. Epub 2018 Feb 20.
We conducted a systematic review and meta-analysis of literature to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT) abstract guideline in 2008 was followed by change in reporting quality of randomized controlled trial (RCT) abstracts.
Evaluations were included if they compared reporting quality of RCT abstracts before and after the publication of CONSORT-abstract guideline. The literature search was performed (January 2008 to April 2017) in Medline (Ovid), EMbase, CINAHL plus and Cochrane methodologies register. We assessed study validity with a special validity tool, adapted from a previous Cochrane review.
Initial search identified 4142 articles, of which total 10 evaluations including 5184 abstracts were included. Total 22 outcomes related to individual items of CONSORT-abstract guideline were assessed, and 14 showed significant effect sizes favoring CONSORT-abstract guideline. Despite significant effect size, the overall post-CONSORT reporting (PCR) was suboptimal for ten items: title (RR = 1.40, 95% CI 1.23 to 1.59, PCR = 53.4%), participants (RR = 1.58, 95% CI 1.11 to 2.26, PCR = 24.5%), primary outcome (RR = 1.12, 95% CI 1.02 to 1.23, PCR = 65%), blinding (RR = 2.13, 95% CI 1.20 to 3.76, PCR = 13.9%), trial status (RR = 1.81, 95% 1.39 to 2.35, PCR = 10.6%), numbers analyzed (RR = 1.51, 95% CI 1.15 to 1.98, PCR = 26.5%), outcome (RR = 1.40, 95% 1.05 to 1.86, PCR = 21.9%), effect size and precision (RR = 1.59, 95% CI 1.15 to 2.19, PCR = 58.9%), harms (RR = 1.24, 95% CI 1.04 to 1.48, PCR = 41.8%), trial registration (RR = 2.02, 95% CI 1.63 to 2.50, PCR = 33.8%). Three items with favorable effect size in addition had wide CIs: randomization (RR = -4.28, 95% CI 1.56 to 11.75, PCR = -3.3%), allocation concealment (RR = -19.89, 95% CI 1.54 to 256.69, PCR = -5.7%), and funding (RR = -22.61, 95% CI 8.13 to 62.67, PCR = -11.32%).
The change in reporting quality of RCT abstracts is far from satisfactory, as evidenced by suboptimal post-CONSORT rates and wide CIs of effect sizes for majority of improved items. Mere publication of CONSORT-abstract guideline, without strict endorsement has failed to translate into good quality abstracts.
我们进行了系统的文献综述和荟萃分析，以确定 2008 年 CONSORT 摘要指南的发布是否会导致随机对照试验（RCT）摘要报告质量的变化。
如果评估比较了 CONSORT-摘要指南发布前后 RCT 摘要的报告质量，则包括该评估。文献检索于 2008 年 1 月至 2017 年 4 月在 Medline（Ovid）、EMbase、CINAHL plus 和 Cochrane 方法学注册库中进行。我们使用专门的有效性工具评估研究的有效性，该工具改编自以前的 Cochrane 综述。
最初的搜索确定了 4142 篇文章，其中包括 10 项评估，共 5184 篇摘要。共评估了与 CONSORT-摘要指南个别项目相关的 22 项结果，其中 14 项显示 CONSORT-摘要指南具有显著的效果大小。尽管具有显著的效果大小，但十个项目的总体 POST-CONSORT 报告（PCR）仍不理想：标题（RR=1.40，95%CI 1.23-1.59，PCR=53.4%）、参与者（RR=1.58，95%CI 1.11-2.26，PCR=24.5%）、主要结局（RR=1.12，95%CI 1.02-1.23，PCR=65%）、盲法（RR=2.13，95%CI 1.20-3.76，PCR=13.9%）、试验状态（RR=1.81，95%CI 1.39-2.35，PCR=10.6%）、分析数量（RR=1.51，95%CI 1.15-1.98，PCR=26.5%）、结局（RR=1.40，95%CI 1.05-1.86，PCR=21.9%）、效果大小和精度（RR=1.59，95%CI 1.15-2.19，PCR=58.9%）、危害（RR=1.24，95%CI 1.04-1.48，PCR=41.8%）、试验注册（RR=2.02，95%CI 1.63-2.50，PCR=33.8%）。另外三个具有有利效果大小的项目具有较宽的 CI：随机化（RR=-4.28，95%CI 1.56-11.75，PCR=-3.3%）、分配隐藏（RR=-19.89，95%CI 1.54-256.69，PCR=-5.7%）和资金（RR=-22.61，95%CI 8.13-62.67，PCR=-11.32%）。
RCT 摘要报告质量的变化远未令人满意，这表现在大多数改进项目的 PCR 后率和效果大小的 CI 较宽。仅仅发布 CONSORT-摘要指南，而没有严格支持，并没有转化为高质量的摘要。
