Evaluation of an Online Tool (COBPeer) Dedicated to Junior Peer Reviewers for Assessing the Reporting of Randomized Controlled Trial Reports
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the mean number of items accurately classified per manuscript
研究概览
简要总结
The peer review process is a cornerstone of biomedical research publication. Despite being essential, the assessment of the completeness of the reporting and the identification of switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a high level of expertise and could be performed by junior researchers.
To assess the completeness of reporting and identified switched outcome(s), junior peer reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of each checklist item. The aim of this study that will compare the accuracy of junior peer reviewers using the tool to that of usual peer reviewers when evaluating the completeness of reporting and switched of primary outcome(s) in reports of RCTs
详细描述
BACKGROUND: Context Inadequate reporting is a frequent cause of waste of research. To overcome this issue, the CONSORT statement, an evidence-based, minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines have since been updated in 2001 and more recently in 2010. Many journals endorse the CONSORT statement. Some journals provide recommendations to authors to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines by requesting authors to submit a checklist in either the submission or acceptance stage. Nevertheless, inadequate reporting remains.
HYPOTHESE: To assess the completeness of reporting, junior peer reviewers could use a simple online tool based on the CONSORT 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCT
OBJECTIVE: 1) Develop an online tool and training module dedicated to junior peer reviewers for a) assessing the completeness of reporting of key items and b) identifying switched primary outcome(s) in reports of RCTs. 2) Compare the performance of junior peer reviewers using this tool with the usual peer-review process in identifying inadequate reporting and switched primary outcome(s) in reports of RCTs.
STUDY DESIGN: randomized ratio 1:1 controlled trial with two parallel arms. Participants will be invited to participate by invitation.
ELIGIBILITY: eligible participants are juniors peer reviewers. Junior peer reviewers are defined as early stage researchers: master students, PhD students, residents involved in clinical research during their study, and clinicians who have never reviewed a manuscript
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •master students,
- •PhD students,
- •residents involved in clinical research during their study,
- •clinicians who have never reviewed a manuscript
排除标准
- 未提供
研究组 & 干预措施
USUAL PEER REVIEWER
Two researchers will read all the peer-review reports and editors' comments for the first round. The researchers will determine whether the peer-reviewers and/or editors raised some concern on the completeness of reporting of the 10 CONSORT items considered and identified a switch primary outcome(s) between the manuscript and the register. The assessment of all peer-review reports and editors' comments for each manuscript will be combined (i.e., the item will be rated as incompletely reported if at least one peer reviewer rated it as such). The 2 researchers will be blinded to the gold standard assessment.
COBPeer
Junior peer reviewers will be invited to participate in an online training course on peer review (COBPeer).
干预措施: COBPEER (Other)
GOLD STANDARD
Pairs of systematic reviewers will independently extract data from eligible reports. Reviewers involved in the data extraction will have expertise in the conduct of systematic reviews and will assess the completeness of reporting from the systematic reviewer perspective. They will not have access to the tool to avoid being influenced by the tool. The systematic reviewers will also systematically compare the primary outcome(s) reported in the manuscript and the primary outcome(s) reported in the registry and will document any discrepancies.
结局指标
主要结局
the mean number of items accurately classified per manuscript
时间窗: through study completion, an average of 6 month
Each item will be classified as"adequately reported" (yes/no)
次要结局
- the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify switch in primary outcome(s).(through study completion, an average of 6 month)
- the mean number of items accurately classified per manuscript for the 10 CONSORT items(through study completion, an average of 6 month)
研究者
Isabelle BOUTRON
Professor
Assistance Publique - Hôpitaux de Paris