A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)

NCT05820984 | Completed

• 1 other identifier: SPIRIT-PR 2019
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. The aim of this project is to evaluate whether reminding peer reviewers of the most important SPIRIT reporting items (including a short explanation of those items) will result in higher adherence to SPIRIT guidelines in published protocols for RCTS. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the SPIRIT checklist including the ten most important and poorly reported SPIRIT items ; or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented articles.

Conditions

Adequate Reporting in Published Study Protocols of Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• Completeness of reporting

  The primary outcome of this study will be the difference of the mean proportion of adequately reported items of the 10 most important and poorly reported SPIRIT items between the two intervention arms.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Completeness of reporting

  Through study completion, an average of 1 year

• Completeness of reporting

  Through study completion, an average of 1 year

• Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review).

  Through study completion, an average of 4 months; will be assessed from routinely collected data

• Proportion of articles directly rejected after the first round of peer-review

  Through study completion, an average of 4 months; will be assessed from routinely collected data

• Proportion of articles published

  Through study completion, an average of 9 months; will be assessed from routinely collected data

Other Outcomes (1)

• Peer reviewer comments for any reference to SPIRIT and trial reporting

  Assessed from available peer-reviewer responses; on average 3 months after randomisation

Study Arms (2)

SPIRIT checklist plus usual practice

EXPERIMENTAL

After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice (e.g. where to access the manuscript, date when the peer review report is due). In addition, peer-reviewers who received a manuscript which was randomised to the experimental arm will receive an additional email including a short version of the SPIRIT checklist together with a short explanation of those items.

Other: SPIRIT checklist plus usual practice

Usual practice

OTHER

After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice.

Other: Usual practice

Interventions

SPIRIT checklist plus usual practice OTHER

Peer reviewer will be reminded of the following 10 CONSORT items (including a short description): Outcomes (12) Sample size (14) Recruitment (15) Allocation implementation (16 c) Blinding (17 a) Data collection methods (18 a) Data collection methods - retention (18 b) Statistical methods (20 a) Population analysed (20 c) Access to data (29)

SPIRIT checklist plus usual practice

Usual practice OTHER

Peer review as it is usual practice at the journal

Usual practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All submitted manuscripts sent out for external review that described protocols for RCTs.

You may not qualify if:

• We excluded (i) Manuscripts which were clearly labelled as a pilot or feasibility study (ii) Studies randomizing animals or cells (iii) Separate publications of data analysis plans
• Included peer-reviewers:
• Peer reviewers that were invited following usual journal practice

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

The BMJ Publishing Group

London, United Kingdom

Location

Related Publications (1)

• Speich B, Mann E, Schonenberger CM, Mellor K, Griessbach AN, Dhiman P, Gandhi P, Lohner S, Agarwal A, Odutayo A, Puebla I, Clark A, Chan AW, Schlussel MM, Ravaud P, Moher D, Briel M, Boutron I, Schroter S, Hopewell S. Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials. JAMA Netw Open. 2023 Jun 1;6(6):e2317651. doi: 10.1001/jamanetworkopen.2023.17651.

  PMID: 37294569 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Authors will be blinded to the intervention allocation. Editors will not be informed about the randomisation. To avoid potential bias, peer reviewers and authors will not be informed of the study hypothesis, design and intervention. All submitting authors and invited reviewers are routinely told that BMJ has a research programme and their article/review may be included in this research. Outcomes will be assessed in duplicate by blinded outcome assessors
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 20, 2023
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The full protocol is publicly available on OSF (https://osf.io/z2hm9)

Locations

GB (1)