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Completed

NCT Number: NCT05820984

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

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.

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Key information

Conditions

Adequate Reporting in Published Study Protocols of Randomized Controlled Trials

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The BMJ Publishing Group

London, United Kingdom

About this study

The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for journals:

It was planned from the beginning that this study will only be conducted at the BMJ Open as it publishes numerous protocols. Hence, no inclusion criteria for the journal were specified.

Inclusion criteria

for manuscripts:

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

Exclusion criteria

l for manuscripts:

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

Treatment and study plan

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)

Usual practice

Other

Peer review as it is usual practice at the journal

Primary outcomes

  1. Completeness of reporting

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Completeness of reporting

    Time frame: Through study completion, an average of 1 year

    Mean proportion of adequate reporting of the 10 most important and poorly reported SPIRIT items, considering each sub-item as a separate item.

  2. Completeness of reporting

    Time frame: Through study completion, an average of 1 year

    Mean proportion for each of the 10 most important and poorly reported SPIRIT items separately (including also separate analysis of sub-items).

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

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

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

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

  5. Proportion of articles published

    Time frame: 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

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

    For journals where peer reviewer comments are subsequently published alongside the published article, we will examine the peer reviewer comments for any reference to SPIRIT and trial reporting.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Impact of a Short Form of the SPIRIT Checklist for Peer Reviewers to Improve the Reporting of Protocols for Randomised Controlled Trials Published in Biomedical Journals: a Randomised Controlled Trial (SPIRIT-PR)

Acronym: SPIRIT-PR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.