Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067633
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-21
Brief Title:
Triple-masking v Double-masking a Trial of Scientific Publication in Public Health
Sponsor:
Queens College The City University of New York
Organization:
Queens College The City University of New York
Study Overview
Official Title:
Triple-masking v Double-masking a Trial of Scientific Publication in Public Health
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TripleMasking
Brief 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 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 raceethnicity 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
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 raceethnicity 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 ie triple-masked editors authors reviewers or not ie 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 11 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 httpswwweditorialmanagercomajphdefault2aspx 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 andor 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 Editors Choice and re-submissions
Randomization procedure 11 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
Administrationimplementation 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 wont be assigned to editors they wont 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 wont 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
1 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 ie 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 ie 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 48 RR148 in acceptance rate with 5 type I error for a two-sided test This translates to an acceptance rate of 148 for the triplemasked Additionally the trial is projected to have 84 power to detect a difference of 5 RR15 and 90 power to detect a difference of 55 RR155 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
To determine whether masking ie triple-masked editors authors reviewers or not ie 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 11 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 httpswwweditorialmanagercomajphdefault2aspx 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 andor 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 Editors Choice and re-submissions
Randomization procedure 11 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
Administrationimplementation 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 wont be assigned to editors they wont 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 wont 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
1 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 ie 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 ie 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 48 RR148 in acceptance rate with 5 type I error for a two-sided test This translates to an acceptance rate of 148 for the triplemasked Additionally the trial is projected to have 84 power to detect a difference of 5 RR15 and 90 power to detect a difference of 55 RR155 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None