Publication of Articles Submitted to the American Journal of Public HealthTripleMaskingNCT06067633
Triple-masking v Double-masking: a Trial of Scientific Publication in Public Health
A study testing Triple-Masked and Usual Procedures in people with Publication of Articles Submitted to the American Journal of Public Health, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
The trial is designed to determine whether knowledge of the identity of the authors, their institutions and of the reviewers of a given article submitted to American Journal of Public Health impacts the final editorial decision. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Publication of Articles Submitted to the American Journal of Public Health
- What is being tested?
- Triple-Masked and Usual Procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to 1 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New submissions
- Article formats: research articles, notes from the field, non-commissioned editorials, analytic essays, systematic reviews
Who cannot join
- Resubmissions
- Article formats: Commissioned editorials, book reviews, Letters to the Editor, Public Health of Consequence editorials, Editor's Choice.
Trial locations and contacts
1 site in 1 country.
ALFREDO MORABIA contact
United States1 site, 1 recruiting
- Recruiting
QueensC
New York, New York, 11365
ALFREDO MORABIA, amorabia@qc.cuny.edu
About this study
The trial is designed to determine whether knowledge of the identity of the authors, their institutions and of the reviewers of a given article submitted to American Journal of Public Health impacts the final editorial decision. The concept of triple masked editorial process (where editors are unaware of author identities and affiliations in addition to the authors' and reviewers' identities being masked from one another) compared to a double masked process (only authors' and reviewers' identities are hidden from one another; editors are aware of author and reviewer identities) has not been formally tested in a scientific journal, and particularly not in medicals social science, or public health journal. Triple-masking is expected to lead to greater acceptance of articles submitted overall because it will neutralize biases against some authors and reviewers because of who they are or the institutions they are related to.
The triple masked editorial process, in which the editors, the authors and the reviewers ignore their respective identities will be compared to a double masked, in which the editor knows the identity of the authors and reviewers, because double masked is currently the editorial process used by the American Journal of Public Health.
Even though only manuscripts are randomized, the trial will collect information about the identity of the authors (eg, genes, race/ethnicity, seniority) and the reviewers to be used for secondary analysis. In this sense it is dealing with human subjects and has obtained an exemption from the Institutional Review Board of Queens College.
Read the detailed description
Aim:
To determine whether masking (i.e., triple-masked: editors, authors, reviewers) or not (i.e., double-masked: authors, reviewers) the identity, seniority, gender, race, ethnicity, and institutions of the authors and of the reviewers to the editors leads to a greater proportion of accepted manuscripts compared with double-masked review. Additionally, we will conduct exploratory analyses to determine whether the differences are related to the identity, seniority, gender, race, ethnicity, and institutions of the authors and of the reviewers.
Trial design: two group, parallel, superiority trial with 1:1 allocation
Study setting: The trial will solely take place at the American Journal of Public Health in a virtual capacity. All submissions will be electronic via the Editorial Manager (https://www.editorialmanager.com/ajph/default2.aspx). Eligible manuscripts in the blinded editorial process arm will be masked electronically before being entered in the trial by the editorial assistant, who will also place all manuscripts in Dropbox folders to be accessed by the editors. The questionnaire that will be sent to all authors, reviewers, and editors is housed in Survey Monkey and will be administered via email and/or text messaging by someone external to the trial.
Inclusions: All eligible, new submissions (research, notes from the field, non-commissioned editorials, analytic essays, systematic reviews) for the regular issue and supplements from September 5, 2023 to March 1, 2024.
Exclusions: Commissioned editorials, book reviews, Letters to the Editor, Public Health of Consequence editorials, Editor's Choice, and re-submissions
Randomization procedure: 1:1 allocation of eligible articles to either triple-masked or usual process in the order of submission, after exclusion of non-eligible submissions by the editorial assistant.
Planned generation: Randomization, stratified by three article types (ie, Research Articles, Analytic Essay, Editorial \& Notes from the Field), by blocks of random sizes to balance articles by type over time, and to conceal allocation order.
Administration/implementation: Editorial assistant allocates the submissions following computer generated allocation orders for each of the three article types.
Masking securities: Editors will be restricted from accessing the Editorial Manager for the duration of the project. Additionally, since articles won't be assigned to editors, they won't be able to see anything from their immediate accounts. This should block them from the masked information and preserve the integrity of the project. Editors will be able to search for reviewers with specific expertise from an external, cleaned nominative version of the Editorial Manager database. They won't however know who, from the reviewers selected, accepted the invitation and wrote the review. In this sense, reviews' authorship will be masked to the editor.
Procedures:
- Questionnaire: All authors of new, eligible submissions will receive an email from a research assistant external to the trial that will explain the on-going trial. The email will invite them to fill out an optional, short, Survey Monkey questionnaire asking for age, gender, race, ethnicity, career position, and institution location. The questionnaire data will be collected in a stand-alone database, handled by the research assistant. Missing value are expected to be equally distributed in both arms of the study. However, for secondary analysis they may be correlated with the outcome. The same questionnaire will be sent but only once to the editors.
Primary outcome: Difference in the proportion of manuscripts submitted within the six-month window that are accepted for publication (i.e., not rejected at any stage); risk difference, unadjusted
Secondary outcome: Difference in the proportion of manuscripts submitted within the six-month window that are sent for peer review (i.e., not desk rejected); risk difference, unadjusted
Proportion accepted in the double-masked group: ~10% Clinically meaningful difference: 5% Framework: Superiority N= 1500 (750 manuscripts in each group), 80% power to detect a difference of 4.8% (RR=1.48) in acceptance rate with 5% type I error for a two-sided test. This translates to an acceptance rate of 14.8% for the triple=masked. Additionally, the trial is projected to have 84% power to detect a difference of 5% (RR=1.5), and 90% power to detect a difference of 5.5% (RR=1.55) while remaining a 5% type I error for a two-sided test.
The statistical power to detect differences if they exist in subgroups defined by article type or authors identities will be very small because of the small numbers of articles. It is expected that the proportion of articles with a diverse authorship will not exceed one third of the submissions in each groups.
Ethics committee The protocol has been exempted from institutional review board by the IRB of Queens College CUNY, where the editor in chief and PI of the supporting grant has his primary appointment (Appendix B).
- Being tested
- Triple-Masked, Usual Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-MaskedOther
Eligible manuscripts in the triple-masked editorial process arm will be masked electronically before being entered in the trial by the editorial assistant
Usual ProceduresOther
Articles will be processed by the editors with identifiable/unmasking content of cover page and letters.
| Study group | Role | What they receive |
|---|---|---|
| Triple-Masked | Experimental | For articles allocated to the blinded (masked) editorial process, the editorial assistant will delete identifiable/unmasking content of cover page and letters. All articles will be flagged as being in triplemasked editorial process arm in the document title Receives: Other: Triple-Masked |
| Usual Procedures | Active comparator | All articles will be flagged as being in usual editorial process arm in the document title. For articles allocated to the usual (double-masked) editorial process, the editorial assistant will leave identifiable/unmasking content of cover page and letters for the editors. Receives: Other: Usual Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of manuscripts submitted within the six-month window that are accepted for publication (i.e., not rejected at any stage); risk difference, unadjusted
Primary outcome
Measured: full duration of the study, 6 months, from September 5 2023 to March 1 2024
Secondary outcomes (1)
Secondary outcome
Difference in the proportion of manuscripts submitted within the six-month window that are sent for peer review (i.e., not desk rejected); risk difference, unadjusted
Measured: full duration of the study, 6 months, from September 5 2023 to March 1 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start6 Sep 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
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 Publication of Articles Submitted to the American Journal of Public HealthStudies of the same condition, open and under way.
- 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
- Model description
- Two group, parallel, superiority trial with 1:1 allocation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALFREDO MORABIA, Principal investigator, Queens College, The City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067633
- Sponsor's protocol ID
- 2023-0516-QC
- Acronym
- TripleMasking
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymized and any re-identifiable information will be shared.
Publications
Brodie S, Frainer A, Pennino MG, Jiang S, Kaikkonen L, Lopez J, Ortega-Cisneros K, Peters CA, Selim SA, Vaidianu N. Equity in science: advocating for a triple-blind review system. Trends Ecol Evol. 2021 Nov;36(11):957-959. doi: 10.1016/j.tree.2021.07.011. Epub 2021 Aug 26.
PubMed 34456068
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-masking v Double-masking: a Trial of Scientific Publication in Public Health
- ClinicalTrials.gov ID
- NCT06067633
- Acronym / sponsor ID
- TripleMasking / 2023-0516-QC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 5 Oct 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.
The trial is designed to determine whether knowledge of the identity of the authors, their institutions and of the reviewers of a given article submitted to American Journal of Public Health impacts the final editorial decision. The concept of triple masked editorial process (where editors are unaware of author identities and affiliations in addition to the authors' and reviewers' identities being masked from one another) compared to a double masked process (only authors' and reviewers' identities are hidden from one another; editors are aware of author and reviewer identities) has not been formally tested in a scientific journal, and particularly not in medicals social science, or public health journal. Triple-masking is expected to lead to greater acceptance of articles submitted overall because it will neutralize biases against some authors and reviewers because of who they are or the institutions they are related to.
The triple masked editorial process, in which the editors, the authors and the reviewers ignore their respective identities will be compared to a double masked, in which the editor knows the identity of the authors and reviewers, because double masked is currently the editorial process used by the American Journal of Public Health.
Even though only manuscripts are randomized, the trial will collect information about the identity of the authors (eg, genes, race/ethnicity, seniority) and the reviewers to be used for secondary analysis. In this sense it is dealing with human subjects and has obtained an exemption from the Institutional Review Board of Queens College.
Detailed description
Aim:
To determine whether masking (i.e., triple-masked: editors, authors, reviewers) or not (i.e., double-masked: authors, reviewers) the identity, seniority, gender, race, ethnicity, and institutions of the authors and of the reviewers to the editors leads to a greater proportion of accepted manuscripts compared with double-masked review. Additionally, we will conduct exploratory analyses to determine whether the differences are related to the identity, seniority, gender, race, ethnicity, and institutions of the authors and of the reviewers.
Trial design: two group, parallel, superiority trial with 1:1 allocation
Study setting: The trial will solely take place at the American Journal of Public Health in a virtual capacity. All submissions will be electronic via the Editorial Manager (https://www.editorialmanager.com/ajph/default2.aspx). Eligible manuscripts in the blinded editorial process arm will be masked electronically before being entered in the trial by the editorial assistant, who will also place all manuscripts in Dropbox folders to be accessed by the editors. The questionnaire that will be sent to all authors, reviewers, and editors is housed in Survey Monkey and will be administered via email and/or text messaging by someone external to the trial.
Inclusions: All eligible, new submissions (research, notes from the field, non-commissioned editorials, analytic essays, systematic reviews) for the regular issue and supplements from September 5, 2023 to March 1, 2024.
Exclusions: Commissioned editorials, book reviews, Letters to the Editor, Public Health of Consequence editorials, Editor's Choice, and re-submissions
Randomization procedure: 1:1 allocation of eligible articles to either triple-masked or usual process in the order of submission, after exclusion of non-eligible submissions by the editorial assistant.
Planned generation: Randomization, stratified by three article types (ie, Research Articles, Analytic Essay, Editorial \& Notes from the Field), by blocks of random sizes to balance articles by type over time, and to conceal allocation order.
Administration/implementation: Editorial assistant allocates the submissions following computer generated allocation orders for each of the three article types.
Masking securities: Editors will be restricted from accessing the Editorial Manager for the duration of the project. Additionally, since articles won't be assigned to editors, they won't be able to see anything from their immediate accounts. This should block them from the masked information and preserve the integrity of the project. Editors will be able to search for reviewers with specific expertise from an external, cleaned nominative version of the Editorial Manager database. They won't however know who, from the reviewers selected, accepted the invitation and wrote the review. In this sense, reviews' authorship will be masked to the editor.
Procedures:
- Questionnaire: All authors of new, eligible submissions will receive an email from a research assistant external to the trial that will explain the on-going trial. The email will invite them to fill out an optional, short, Survey Monkey questionnaire asking for age, gender, race, ethnicity, career position, and institution location. The questionnaire data will be collected in a stand-alone database, handled by the research assistant. Missing value are expected to be equally distributed in both arms of the study. However, for secondary analysis they may be correlated with the outcome. The same questionnaire will be sent but only once to the editors.
Primary outcome: Difference in the proportion of manuscripts submitted within the six-month window that are accepted for publication (i.e., not rejected at any stage); risk difference, unadjusted
Secondary outcome: Difference in the proportion of manuscripts submitted within the six-month window that are sent for peer review (i.e., not desk rejected); risk difference, unadjusted
Proportion accepted in the double-masked group: ~10% Clinically meaningful difference: 5% Framework: Superiority N= 1500 (750 manuscripts in each group), 80% power to detect a difference of 4.8% (RR=1.48) in acceptance rate with 5% type I error for a two-sided test. This translates to an acceptance rate of 14.8% for the triple=masked. Additionally, the trial is projected to have 84% power to detect a difference of 5% (RR=1.5), and 90% power to detect a difference of 5.5% (RR=1.55) while remaining a 5% type I error for a two-sided test.
The statistical power to detect differences if they exist in subgroups defined by article type or authors identities will be very small because of the small numbers of articles. It is expected that the proportion of articles with a diverse authorship will not exceed one third of the submissions in each groups.
Ethics committee The protocol has been exempted from institutional review board by the IRB of Queens College CUNY, where the editor in chief and PI of the supporting grant has his primary appointment (Appendix B).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two group, parallel, superiority trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Triple-Masked | Experimental | Other: Triple-MaskedFor articles allocated to the blinded (masked) editorial process, the editorial assistant will delete identifiable/unmasking content of cover page and letters. All articles will be flagged as being in triplemasked editorial process arm in the document title |
| Usual Procedures | Active comparator | Other: Usual ProceduresAll articles will be flagged as being in usual editorial process arm in the document title. For articles allocated to the usual (double-masked) editorial process, the editorial assistant will leave identifiable/unmasking content of cover page and letters for the editors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New submissions
- Article formats: research articles, notes from the field, non-commissioned editorials, analytic essays, systematic reviews
Key exclusion criteria (2 listed)
- Resubmissions
- Article formats: Commissioned editorials, book reviews, Letters to the Editor, Public Health of Consequence editorials, Editor's Choice.
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 |
|---|---|---|
| Triple-MaskedEligible manuscripts in the triple-masked editorial process arm will be masked electronically before being entered in the trial by the editorial assistant | Other | Triple-Masked |
| Usual ProceduresArticles will be processed by the editors with identifiable/unmasking content of cover page and letters. | Other | Usual Procedures |
Primary outcome
Difference in the proportion of manuscripts submitted within the six-month window that are accepted for publication (i.e., not rejected at any stage); risk difference, unadjusted
Time frame: full duration of the study, 6 months, from September 5 2023 to March 1 2024
Primary outcome
1 secondary outcome
Secondary outcome
Time frame: full duration of the study, 6 months, from September 5 2023 to March 1 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 34456068Brodie S, Frainer A, Pennino MG, Jiang S, Kaikkonen L, Lopez J, Ortega-Cisneros K, Peters CA, Selim SA, Vaidianu N. Equity in science: advocating for a triple-blind review system. Trends Ecol Evol. 2021 Nov;36(11):957-959. doi: 10.1016/j.tree.2021.07.011. Epub 2021 Aug 26.
- Individual participant dataSharing planned: No. Only anonymized and any re-identifiable information will be shared.
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.
ALFREDO MORABIA contact
ALFREDO MORABIA principal investigator
Queens College, The City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple-Masked and Usual Procedures in people with Publication of Articles Submitted to the American Journal of Public Health, run by Queens College, The City University of New York at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALFREDO MORABIA (9176648789, amorabia@qc.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of manuscripts submitted within the six-month window that are accepted for publication (i.e., not rejected at any stage); risk difference, unadjusted (time frame: full duration of the study, 6 months, from September 5 2023 to March 1 2024). 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 NCT06067633, 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 5 Oct 2023.