Peer ReviewNCT02739737
Testing for the Presence of Authorship Bias in Peer Review
A study testing Blinded manuscript and Unblinded manuscript in people with Peer Review, run by University of Washington.
Trial summary
No consensus exists among biomedical journals on the subject of blinding during the peer review process. Some journals attempt to remove all identifiers of authorship from potential manuscripts before delivering to referees for peer review while others prefer to leave the authorship transparent. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peer Review
- What is being tested?
- Blinded manuscript and Unblinded manuscript
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2015
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Registered peer reviewers in relevant subspecialty sections of CORR's reviewer database.
Who cannot join
- Reviewers who opt out (electronically, by phone, or by post).
About this study
No consensus exists among biomedical journals on the subject of blinding during the peer review process. Some journals attempt to remove all identifiers of authorship from potential manuscripts before delivering to referees for peer review while others prefer to leave the authorship transparent. Although peer review remains the gold standard for manuscript evaluation, the lack of a standardized blinding process between editorial offices may be a source of publication bias and make comparisons of manuscripts published in different journals more difficult to interpret.
Proponents of a blinded peer review system believe that knowledge of authorship may leave referees vulnerable to biases about those authors' previous research, perceived expertise, institution, nationality, or gender. This shifts judgment away from the merits of the scientific work and introduces pre-conceived notions about the identity and background of the author into the review process. Conversely, supporters of transparent authorship argue that knowledge of author identity makes it easier for the referee to provide more appropriate critiques. Open author identification allows referees to compare the current manuscript to previously published work by the author, and to recognize or identify potentially important conflicts of interest.
Read more
The investigators therefore propose an experimental study to address the question of whether blinding affects the likelihood a reviewer will recommend acceptance of a study being peer reviewed. The investigators plan to work in partnership with a journal to have a fabricated manuscript peer reviewed by a large number of reviewers; the authors will send this "test" manuscript out either in blinded form (authors' names/institutions not shown to reviewers) or in open form, with the names of several well-known, well-regarded authors and their institutions visible to peer reviewers. The manuscripts will otherwise be identical.
The partnering journal, Clinical Orthopaedics and Related Research allows both open and blinded peer review, regularly employing both approaches (authors can choose what kind of review they prefer when they submit to CORR), and so the reviewers are unlikely to be troubled by seeing a manuscript in either format.
The primary goal of this study is to determine whether the identification of a manuscript with a prominent group of authors (open authorship) will affect the likelihood that reviewers will recommend the manuscript for publication.
Additionally, the investigators plan to purposely place several errors in the manuscript, and tally how often reviewers detect these mistakes, to determine whether reviewers read the work of prominent authors less critically.
The investigators will also compare the reviewers' grading of the (identical) methods section, to determine whether the identification of a manuscript with prominent authors results in higher reviewer grades for methodological rigor.
This study tests the following specific hypotheses:
- The visibility of prominent author names and institutions on test manuscripts will be associated with increased likelihood that the manuscript will be recommended for publication by peer reviewers. (Primary Study Endpoint)
- The visibility of prominent author names and institutions will be associated with a decreased likelihood that purposefully placed "errors" in the experimental manuscript will be detected by the reviewers.
- The visibility of prominent author names and institutions will be associated with increased scores given by reviewers for the methods section, despite the fact that the methods sections of the experimental manuscript will be identical.
NOTE:
All elements of the research protocol were approved by the University of Washington Human Subjects Review Committee, including the study's opt-out design for reviewer recruitment, since it was considered important that reviewers not know that the paper they evaluated was part of a study. To minimize the potential for harm, the authors chose as the topic of the fabricated test manuscript an intervention that could not be immediately put into practice at reviewers' own centers (a particular team-training process in the operating room). In addition, participating reviewers were informed which paper was the test manuscript at the completion of data collection, so that they did not pursue this sort of team training based on the results of the fabricated study.
To reduce the risk of an observer (Hawthorne) effect, it was important to minimize the likelihood that participant reviewers would learn of the study while it was in progress. To this end, the investigators elected not to pre-register the study in a trial registry.
- Conditions
- Peer Review
- Being tested
- Blinded manuscript, Unblinded manuscript
- Keywords
- Bias, Orthopedics, Peer Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded manuscriptOther
Blinded version of sham manuscript
Unblinded manuscriptOther
Unblinded version of sham manuscript
| Study group | Role | What they receive |
|---|---|---|
| Blinded Reviewers | Experimental | Subjects receiving randomized sham manuscript for review Receives: Other: Blinded manuscript |
| Unblinded Reviewers | Experimental | Subjects receiving randomized sham manuscript for review Receives: Other: Unblinded manuscript |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manuscript acceptance rate
Measured: 13 months
Secondary outcomes (2)
Error detection rate
Measured: 13 months
Methods section score
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peer ReviewStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Leopold, University of Washington
- Investigators
- Seth L Leopold, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739737
- Sponsor's protocol ID
- 46129-EA
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van Rooyen S, Godlee F, Evans S, Black N, Smith R. Effect of open peer review on quality of reviews and on reviewers' recommendations: a randomised trial. BMJ. 1999 Jan 2;318(7175):23-7. doi: 10.1136/bmj.318.7175.23.
PubMed 9872878McNutt RA, Evans AT, Fletcher RH, Fletcher SW. The effects of blinding on the quality of peer review. A randomized trial. JAMA. 1990 Mar 9;263(10):1371-6.
PubMed 2304216Justice AC, Cho MK, Winker MA, Berlin JA, Rennie D. Does masking author identity improve peer review quality? A randomized controlled trial. PEER Investigators. JAMA. 1998 Jul 15;280(3):240-2. doi: 10.1001/jama.280.3.240.
PubMed 9676668Fisher M, Friedman SB, Strauss B. The effects of blinding on acceptance of research papers by peer review. JAMA. 1994 Jul 13;272(2):143-6.
PubMed 8015127Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS. Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med. 2010 Nov 22;170(21):1934-9. doi: 10.1001/archinternmed.2010.406.
PubMed 21098355Okike K, Hug KT, Kocher MS, Leopold SS. Single-blind vs Double-blind Peer Review in the Setting of Author Prestige. JAMA. 2016 Sep 27;316(12):1315-6. doi: 10.1001/jama.2016.11014. No abstract available.
PubMed 27673310
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing for the Presence of Authorship Bias in Peer Review
- ClinicalTrials.gov ID
- NCT02739737
- Acronym / sponsor ID
- 46129-EA
- Conditions
- Peer Review
- Keywords
- Bias, Orthopedics, Peer Review
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
No consensus exists among biomedical journals on the subject of blinding during the peer review process. Some journals attempt to remove all identifiers of authorship from potential manuscripts before delivering to referees for peer review while others prefer to leave the authorship transparent. Although peer review remains the gold standard for manuscript evaluation, the lack of a standardized blinding process between editorial offices may be a source of publication bias and make comparisons of manuscripts published in different journals more difficult to interpret.
Proponents of a blinded peer review system believe that knowledge of authorship may leave referees vulnerable to biases about those authors' previous research, perceived expertise, institution, nationality, or gender. This shifts judgment away from the merits of the scientific work and introduces pre-conceived notions about the identity and background of the author into the review process. Conversely, supporters of transparent authorship argue that knowledge of author identity makes it easier for the referee to provide more appropriate critiques. Open author identification allows referees to compare the current manuscript to previously published work by the author, and to recognize or identify potentially important conflicts of interest.
The investigators therefore propose an experimental study to address the question of whether blinding affects the likelihood a reviewer will recommend acceptance of a study being peer reviewed. The investigators plan to work in partnership with a journal to have a fabricated manuscript peer reviewed by a large number of reviewers; the authors will send this "test" manuscript out either in blinded form (authors' names/institutions not shown to reviewers) or in open form, with the names of several well-known, well-regarded authors and their institutions visible to peer reviewers. The manuscripts will otherwise be identical.
The partnering journal, Clinical Orthopaedics and Related Research allows both open and blinded peer review, regularly employing both approaches (authors can choose what kind of review they prefer when they submit to CORR), and so the reviewers are unlikely to be troubled by seeing a manuscript in either format.
The primary goal of this study is to determine whether the identification of a manuscript with a prominent group of authors (open authorship) will affect the likelihood that reviewers will recommend the manuscript for publication.
Additionally, the investigators plan to purposely place several errors in the manuscript, and tally how often reviewers detect these mistakes, to determine whether reviewers read the work of prominent authors less critically.
The investigators will also compare the reviewers' grading of the (identical) methods section, to determine whether the identification of a manuscript with prominent authors results in higher reviewer grades for methodological rigor.
This study tests the following specific hypotheses:
- The visibility of prominent author names and institutions on test manuscripts will be associated with increased likelihood that the manuscript will be recommended for publication by peer reviewers. (Primary Study Endpoint)
- The visibility of prominent author names and institutions will be associated with a decreased likelihood that purposefully placed "errors" in the experimental manuscript will be detected by the reviewers.
- The visibility of prominent author names and institutions will be associated with increased scores given by reviewers for the methods section, despite the fact that the methods sections of the experimental manuscript will be identical.
NOTE:
All elements of the research protocol were approved by the University of Washington Human Subjects Review Committee, including the study's opt-out design for reviewer recruitment, since it was considered important that reviewers not know that the paper they evaluated was part of a study. To minimize the potential for harm, the authors chose as the topic of the fabricated test manuscript an intervention that could not be immediately put into practice at reviewers' own centers (a particular team-training process in the operating room). In addition, participating reviewers were informed which paper was the test manuscript at the completion of data collection, so that they did not pursue this sort of team training based on the results of the fabricated study.
To reduce the risk of an observer (Hawthorne) effect, it was important to minimize the likelihood that participant reviewers would learn of the study while it was in progress. To this end, the investigators elected not to pre-register the study in a trial registry.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded Reviewers | Experimental | Other: Blinded manuscriptSubjects receiving randomized sham manuscript for review |
| Unblinded Reviewers | Experimental | Other: Unblinded manuscriptSubjects receiving randomized sham manuscript for review |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Registered peer reviewers in relevant subspecialty sections of CORR's reviewer database.
Key exclusion criteria (1 listed)
- Reviewers who opt out (electronically, by phone, or by post).
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 |
|---|---|---|
| Blinded manuscriptBlinded version of sham manuscript | Other | Blinded Reviewers |
| Unblinded manuscriptUnblinded version of sham manuscript | Other | Unblinded Reviewers |
Primary outcome
Manuscript acceptance rate
Time frame: 13 months
2 secondary outcomes
Error detection rate
Time frame: 13 months
Methods section score
Time frame: 13 months
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 15 Apr 2016.
- Background: PubMed 9872878van Rooyen S, Godlee F, Evans S, Black N, Smith R. Effect of open peer review on quality of reviews and on reviewers' recommendations: a randomised trial. BMJ. 1999 Jan 2;318(7175):23-7. doi: 10.1136/bmj.318.7175.23.
- Background: PubMed 2304216McNutt RA, Evans AT, Fletcher RH, Fletcher SW. The effects of blinding on the quality of peer review. A randomized trial. JAMA. 1990 Mar 9;263(10):1371-6.
- Background: PubMed 9676668Justice AC, Cho MK, Winker MA, Berlin JA, Rennie D. Does masking author identity improve peer review quality? A randomized controlled trial. PEER Investigators. JAMA. 1998 Jul 15;280(3):240-2. doi: 10.1001/jama.280.3.240.
- Background: PubMed 8015127Fisher M, Friedman SB, Strauss B. The effects of blinding on acceptance of research papers by peer review. JAMA. 1994 Jul 13;272(2):143-6.
- Background: PubMed 21098355Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS. Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med. 2010 Nov 22;170(21):1934-9. doi: 10.1001/archinternmed.2010.406.
- Derived from this study: PubMed 27673310Okike K, Hug KT, Kocher MS, Leopold SS. Single-blind vs Double-blind Peer Review in the Setting of Author Prestige. JAMA. 2016 Sep 27;316(12):1315-6. doi: 10.1001/jama.2016.11014. No abstract available.
- Individual participant dataSharing planned: No
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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.
Seth L Leopold, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Blinded manuscript and Unblinded manuscript in people with Peer Review, run by University of Washington.
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 1 inclusion and 1 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Manuscript acceptance rate (time frame: 13 months). 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 NCT02739737, which also lists 6 linked publications.
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 15 Apr 2016.