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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. 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)
  2. 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.
  3. 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 groups in NCT02739737
Study groupRoleWhat they receive
Blinded ReviewersExperimentalSubjects receiving randomized sham manuscript for review
Receives: Other: Blinded manuscript
Unblinded ReviewersExperimentalSubjects 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.

  1. Manuscript acceptance rate

    Measured: 13 months

Secondary outcomes (2)
  1. Error detection rate

    Measured: 13 months

  2. 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.

  1. First posted15 Apr 2016 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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)
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 9872878
  • McNutt 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 2304216
  • Justice 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 9676668
  • Fisher 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 8015127
  • Emerson 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 21098355
  • Okike 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

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.

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