在系统评价摘要中添加局限性部分对读者解读的影响：一项随机对照试验。

Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial.

作者信息

Yavchitz Amélie, Ravaud Philippe, Hopewell Sally, Baron Gabriel, Boutron Isabelle

机构信息

Centre de Recherche Épidémiologies et Statistiques INSERM U1153, Paris, France.

出版信息

BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.

DOI:10.1186/1471-2288-14-123

PMID:25420433

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4247631/

Abstract

BACKGROUND

To allow an accurate evaluation of abstracts of systematic reviews, the PRISMA Statement recommends that the limitations of the evidence (e.g., risk of bias, publication bias, inconsistency, imprecision) should be described in the abstract. We aimed to evaluate the impact of adding such limitations sections on reader's interpretation.

METHOD

We performed a two-arm parallel group randomized controlled trial (RCT) using a sample of 30 abstracts of systematic reviews evaluating the effects of healthcare intervention with conclusions favoring the beneficial effect of the experimental treatments. Two formats of these abstracts were derived: one reported without and one with a standardized limitations section written according to the PRISMA statement for abstracts. The primary outcome was readers' confidence in the results of the systematic review as stated in the abstract assessed by a Likert scale from 0, not at all confident, to 10, very confident. In total, 300 participants (corresponding authors of RCT reports indexed in PubMed) were randomized by a web-based randomization procedure to interpret one abstract with a limitations section (n = 150) or without a limitations section (n = 150). Participants were blinded to the study hypothesis.

RESULTS

Adding a limitations section did not modify readers' interpretation of findings in terms of confidence in the results (mean difference [95% confidence interval] 0.19 [-0.37-0.74], p = 0.50), confidence in the validity of the conclusions (0.07 [-0.49-0.62], p = 0.80), or benefit of the experimental intervention (0.12 [-0.42-0.44], p = 0.65).This study is limited because the participants were expert-readers and are not representative of all systematic review readers.

CONCLUSION

Adding a limitations section to abstracts of systematic reviews did not affect readers' interpretation of the abstract results. Other studies are needed to confirm the results and explore the impact of a limitations section on a less expert panel of participants.

TRIAL REGISTRATION

ClinicalTrial.gov (NCT01848782).

摘要

背景

为了准确评估系统评价的摘要，PRISMA声明建议在摘要中描述证据的局限性（如偏倚风险、发表偏倚、不一致性、不精确性）。我们旨在评估添加此类局限性部分对读者解读的影响。

方法

我们进行了一项双臂平行组随机对照试验（RCT），使用了30篇系统评价的摘要样本，这些系统评价评估了医疗保健干预的效果，其结论支持实验性治疗的有益效果。这些摘要有两种形式：一种没有报告局限性部分，另一种按照PRISMA声明的摘要标准格式添加了局限性部分。主要结局是读者对摘要中所述系统评价结果的信心，通过李克特量表进行评估，从0（完全没有信心）到10（非常有信心）。总共300名参与者（PubMed索引的RCT报告的通讯作者）通过基于网络的随机化程序被随机分配，以解读一篇有局限性部分的摘要（n = 150）或没有局限性部分的摘要（n = 150）。参与者对研究假设不知情。

结果

添加局限性部分并未改变读者对研究结果解读的信心（平均差异[95%置信区间]0.19[-0.37 - 0.74]，p = 0.50）、对结论有效性的信心（0.07[-0.49 - 0.62]，p = 0.80）或对实验性干预益处的信心（0.12[-0.42 - 0.44]，p = 0.65）。本研究存在局限性，因为参与者是专业读者，并不代表所有系统评价的读者。