Adequate Reporting in Published Study Protocols of Randomized Controlled TrialsSPIRIT-PRNCT05820984
A Short SPIRIT Checklist for Peer Reviewers to Improve the Reporting Quality in Published Articles (SPIRIT-PR)
A study testing SPIRIT checklist plus usual practice and Usual practice in people with Adequate Reporting in Published Study Protocols of Randomized Controlled Trials, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adequate Reporting in Published Study Protocols of Randomized Controlled Trials
- What is being tested?
- SPIRIT checklist plus usual practice and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- All submitted manuscripts sent out for external review that described protocols for RCTs.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the detailed description
The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9
- Being tested
- SPIRIT checklist plus usual practice, Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIRIT checklist plus usual practiceOther
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 practiceOther
Peer review as it is usual practice at the journal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Completeness of reporting
Mean proportion of adequate reporting of the 10 most important and poorly reported SPIRIT items, considering each sub-item as a separate item.
Measured: Through study completion, an average of 1 year
Completeness of reporting
Mean proportion for each of the 10 most important and poorly reported SPIRIT items separately (including also separate analysis of sub-items).
Measured: 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).
Measured: 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
Measured: Through study completion, an average of 4 months; will be assessed from routinely collected data
Proportion of articles published
Measured: Through study completion, an average of 9 months; will be assessed from routinely collected data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adequate Reporting in Published Study Protocols of Randomized Controlled TrialsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820984
- Sponsor's protocol ID
- SPIRIT-PR 2019
- Acronym
- SPIRIT-PR
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish the anonymised data set together with the main publication.
Publications
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.
PubMed 37294569
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05820984
- Acronym / sponsor ID
- SPIRIT-PR / SPIRIT-PR 2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The full protocol is available on Open Science Framework where the study was prospectively registered: https://osf.io/z2hm9
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIRIT checklist plus usual practice | Experimental | Other: SPIRIT checklist plus usual practiceAfter 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. |
| Usual practice | Other | Other: Usual practiceAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- All submitted manuscripts sent out for external review that described protocols for RCTs.
Key exclusion criteria (3 listed)
- 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
- -Peer reviewers that were invited following usual journal practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIRIT checklist plus usual practicePeer 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 | SPIRIT checklist plus usual practice |
| Usual practicePeer review as it is usual practice at the journal | Other | Usual practice |
Primary outcome
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.
5 secondary outcomes
Completeness of reporting
Time frame: Through study completion, an average of 1 year
Completeness of reporting
Time frame: 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).
Time frame: 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
Proportion of articles published
Time frame: Through study completion, an average of 9 months; will be assessed from routinely collected data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 37294569Speich 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.
- Individual participant dataSharing planned: Yes. We plan to publish the anonymised data set together with the main publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIRIT checklist plus usual practice and Usual practice in people with Adequate Reporting in Published Study Protocols of Randomized Controlled Trials, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of reporting (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.