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Community Members as Reviewers of Medical Journal Manuscripts

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ClinicalTrials.gov Identifier: NCT03432143
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ash Sehgal, MetroHealth Medical Center

Brief Summary:

Manuscripts submitted to medical journals are typically reviewed by physicians or researchers, with no input from patients or other community members. However, involvement of community members in other phases of the research process suggests that they provide distinct and useful expertise. Such involvement may lead to enhanced understanding of community priorities, refinement of study designs to minimize participant burden, and increased recruitment and retention of subjects.

The investigators propose a randomized controlled trial involving 24 community members who will receive training and mentoring in reviewing manuscripts. A total of 568 manuscripts submitted to 2 medical journals will be randomly assigned to an intervention or control group. Intervention manuscripts will be reviewed by both a community member and by scientific reviewers while control manuscripts will be reviewed only by scientific reviewers. Journal editorial teams will use all reviews to help them make decisions about acceptance, revision, or rejection of manuscripts.


Condition or disease Intervention/treatment Phase
Peer Review, Research Other: Community Reviewers Not Applicable

Detailed Description:

Manuscripts submitted to medical journals are typically reviewed by physicians or researchers, with no input from patients or other community members. However, involvement of community members in other phases of the research process suggests that they provide distinct and useful expertise. Such involvement may lead to enhanced understanding of community priorities, refinement of study designs to minimize participant burden, and increased recruitment and retention of subjects. In general, community involvement in research is more common in the earlier phases of the research process (selection of research question and development of a study protocol) and less common in later phases (dissemination and implementation of findings). In the investigators' previous work, they conducted a pilot study that recruited and trained community members to review medical journal manuscripts. They found that community reviewers were much more likely than scientific reviewers to comment on i) the relevance of the study to patients and communities, ii) the diversity and complexity of the study participants, iii) the social context of the condition studied, and iv) barriers to implementation of study findings by patients and communities.

The investigators now propose a randomized controlled trial involving 24 community members who will receive training and mentoring in reviewing manuscripts. A total of 568 manuscripts submitted to 2 medical journals will be randomly assigned to an intervention or control group. Intervention manuscripts will be reviewed by both a community member and by scientific reviewers while control manuscripts will be reviewed only by scientific reviewers. Community reviewers will follow each journal's instructions regarding electronic access to manuscripts, use of drop-down menus and free-text boxes to address specific aspects of the review, and completion within the time frame specified by the journal. Journal editorial teams will use all reviews to help them make decisions about acceptance, revision, or rejection of manuscripts. Quantitative and qualitative analyses will i) compare the content of community and scientific reviews, ii) determine the usefulness of community reviews to journal editors, and iii) explore how community reviewer comments are integrated into published articles.

The proposed project is a novel approach to engaging health disparity populations and other community members in dissemination of research findings. This approach has the potential to provide new and distinct perspectives, to increase the quality and relevance of articles published in medical journals, and to enhance dissemination and implementation of research findings.

Primary Aim A. To compare community member reviews with those of scientific reviewers.

Hypothesis: Compared to scientific reviewers, community reviewers will be more likely to comment on relevance to patients and communities, subject diversity, social context, and implementation barriers.

Primary Aim B. To determine the usefulness of community member reviews to editors.

Hypothesis: Editors will report utilizing community reviewer comments in manuscript decisions.

Secondary Aim C. To explore how community reviews are integrated into published articles.

Hypothesis: Community perspectives that were not present in manuscripts at the time of original submission will subsequently be discernible in published articles.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 24 community members will receive training and mentoring in reviewing manuscripts. The trial will involve 568 manuscripts that will be randomly assigned to two groups using a random number generator.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Community Members as Reviewers of Medical Journal Manuscripts
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Community Reviewers
24 community members will receive training and mentoring in reviewing manuscripts. Approximately 284 manuscripts will be randomized into the intervention group over the duration of the study. Manuscripts will be reviewed by both a community member and scientific reviewers.
Other: Community Reviewers
Intervention manuscripts will be reviewed by both a trained community member and scientific reviewers. Community reviewers will follow each journal's instructions regarding electronic access to manuscripts, use of drop-down menus and free-text boxes to address specific aspects of the review, and completion within the time frame specified by the journal.The journal editorial team will use all reviews to make decisions about acceptance, revision, or rejection of manuscripts.

No Intervention: Scientific Reviewers Only
Approximately 284 manuscripts will be randomized into the control group over the duration of the study. Manuscripts will be reviewed by multiple scientific reviewers. Community reviewers will not be involved in reviewing these manuscripts.



Primary Outcome Measures :
  1. To compare community member reviews with those of scientific reviewers. [ Time Frame: 5 years ]
    The investigators will examine community and scientific reviewer ratings of intervention group manuscripts, including overall recommendations and ratings of specific aspects of the manuscripts. The overall recommendation categories will be converted into a 4 point Likert scale and combine data across journals.


Secondary Outcome Measures :
  1. To determine the usefulness of community member reviews to editors. [ Time Frame: 5 years ]
    The investigators will examine editor ratings of the usefulness of intervention group manuscript reviews submitted by community and scientific reviewers. The investigators will use qualitative analyses to identify specific themes present in editors' responses to open-ended questions about the usefulness of community reviews.


Other Outcome Measures:
  1. To explore how community reviews are integrated into published articles. [ Time Frame: 5 years ]
    The investigators will examine how specific community reviewer comments are addressed by authors. They will also examine how often community and patient perspectives are present in published articles.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Community Reviewer Eligibility:

Inclusion Criteria:

  • 18 years or older
  • At least a high school diploma
  • Proficient in English speaking, reading, and writing
  • Computer access
  • Personal experience (having the condition or being a caregiver to someone with the condition) with 1 or more of these conditions: Cancer, diabetes, dementia, heart disease, hypertension, liver disease, lung disease, kidney disease, and stroke

Exclusion Criteria:

  • Children under 18 years of age
  • Non-high school graduates
  • Individuals who work in health care settings
  • Individuals who have formal training in health care or scientific research

Manuscript Eligibility:

Inclusion Criteria:

  • Full length
  • Original research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432143


Contacts
Contact: Katrice D Cain, MA (216) 778-8467 kcain@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Katrice Cain       kcain@metrohealth.org   
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Principal Investigator: Ashwini Sehgal Case Western Reserve University

Publications:

Responsible Party: Ash Sehgal, Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03432143     History of Changes
Other Study ID Numbers: IRB17-00374
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ash Sehgal, MetroHealth Medical Center:
Peer Review
Community-Based Research
Community Perspectives