跳至主要内容
临床试验/NCT03751878
NCT03751878已完成不适用

Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial

Universitat Politècnica de Catalunya1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Overall completeness of reporting

研究概览

简要总结

Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice. Different stakeholders, including biomedical journals, have taken different actions to try to improve author adherence to CONSORT. The most popular action among biomedical journals is to instruct authors to submit a completed RG checklist with page numbers indicating where the CONSORT items are addressed when they submit their manuscript. However, this measure alone has been proven not to be effective. In this study, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.

详细描述

Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice.

In recent years, different stakeholders have acted to boost the completeness of reporting of the published randomised trials, and therefore their transparency and reproducibility. In a recently completed scoping review, the investigators identified and classified 31 interventions to improve adherence to reporting guidelines. This review revealed that it is primarily journals that have taken most efforts to improve the completeness of reporting of randomised trials - although most of their actions have been shown not to have the desired effect.

One of the most popular strategies used by journals to improve adherence to CONSORT requires authors to submit a populated checklist together with their manuscript indicating page numbers corresponding to each item. However, journals usually lack further actions throughout the editorial process to ensure that the corresponding information to each item is reported in the randomised trial manuscript. This has been hypothesized to be one of the reasons why this editorial strategy has not achieved optimal results.

In an effort to take full advantage of requiring the submission of populated checklists, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Manuscripts will be eligible if:
  • •They have been submitted to BMJ Open,
  • •They are original research submissions reporting the results of a randomised trial, and
  • •They have passed the first editorial filters and have been subsequently sent out for peer review.
  • •Authors of these manuscripts have provided a completed CONSORT checklist.
  • •According to the official CONSORT extensions, the investigators will also consider other study designs (cluster, non-inferiority and equivalence, pragmatic, N-of-1 trials, Pilot and feasibility, and within person trials), and different intervention types (Herbal, non-pharmacologic, acupuncture and Chinese herbal medicine formulas) in all areas of clinical specialty.

排除标准

  • •Protocols of randomised trials
  • •Secondary trial analysis studies

研究组 & 干预措施

Intervention arm

Experimental

Evaluation of reporting inconsistencies between the CONSORT checklist and the information reported in the manuscript. Feedback is provided to authors.

干预措施: Evaluation of reporting inconsistencies (Behavioral)

Control arm

Other

Standard peer review process.

干预措施: Standard Peer Review. (Behavioral)

结局指标

主要结局

Overall completeness of reporting

时间窗: Following manuscript revision (usually 2-3 months)

Proportion of adequately reported CONSORT items in the first revised manuscript

次要结局

  • Completeness of reporting for each item(Following manuscript revision (usually 2-3 months))
  • Time to perform the evaluation(Following the evaluation of reporting inconsistencies (1 week))

研究者

发起方
Universitat Politècnica de Catalunya
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Blanco

Principal Investigator

Universitat Politècnica de Catalunya

研究点 (1)

Loading locations...

相似试验