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

April 19, 2023 updated by: University of Oxford

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 criterial 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIRIT checklist plus usual practice
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

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)
Other: Usual practice
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
Peer review as it is usual practice at the journal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Through study completion, an average of 4 months; will be assessed from routinely collected data
Through study completion, an average of 4 months; will be assessed from routinely collected data
Proportion of articles published
Time Frame: Through study completion, an average of 9 months; will be assessed from routinely collected data
Through study completion, an average of 9 months; will be assessed from routinely collected data
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.
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed from available peer-reviewer responses; on average 3 months after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SPIRIT-PR 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to publish the anonymised data set together with the main publication.

IPD Sharing Time Frame

The full protocol is publicly available on OSF (https://osf.io/z2hm9)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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