ClinicalTrials.gg
CompletedNCT03432143Updated Sep 29, 2022

Community Members as Reviewers of Medical Journal Manuscripts

An interventional study of Community Reviewers in Peer Review, Research, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.

Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
568
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peer Review, Research

Keywords

  • Peer Review
  • Community-Based Research
  • Community Perspectives
03

In context

Lead sponsor

MetroHealth Medical Center is the lead sponsor of 103 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
568 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherCommunity 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.

06

What researchers measure

Primary outcomes

  1. To compare community member reviews with those of scientific reviewers.

    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.

    Time frame: 5 years

Secondary outcomes

  1. To determine the usefulness of community member reviews to editors.

    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.

    Time frame: 5 years

Other outcomes

  1. To explore how community reviews are integrated into published articles.

    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.

    Time frame: 5 years

07

Study locations

1 site
  • MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
08

References and documents

Publications

  • Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19:173-202. doi: 10.1146/annurev.publhealth.19.1.173. PubMed 9611617 ↗
  • Minkler M. Community-based research partnerships: challenges and opportunities. J Urban Health. 2005 Jun;82(2 Suppl 2):ii3-12. doi: 10.1093/jurban/jti034. Epub 2005 May 11. PubMed 15888635 ↗
  • Caron-Flinterman JF, Broerse JE, Teerling J, Bunders JF. Patients' priorities concerning health research: the case of asthma and COPD research in the Netherlands. Health Expect. 2005 Sep;8(3):253-63. doi: 10.1111/j.1369-7625.2005.00337.x. PubMed 16098155 ↗
  • Hewlett S, Wit Md, Richards P, Quest E, Hughes R, Heiberg T, Kirwan J. Patients and professionals as research partners: challenges, practicalities, and benefits. Arthritis Rheum. 2006 Aug 15;55(4):676-80. doi: 10.1002/art.22091. No abstract available. PubMed 16874772 ↗
  • Resnik DB, Kennedy CE. Balancing scientific and community interests in community-based participatory research. Account Res. 2010 Jul;17(4):198-210. doi: 10.1080/08989621.2010.493095. PubMed 20597018 ↗
  • Wallerstein NB, Duran B. Using community-based participatory research to address health disparities. Health Promot Pract. 2006 Jul;7(3):312-23. doi: 10.1177/1524839906289376. Epub 2006 Jun 7. PubMed 16760238 ↗
  • Fleurence RL, Forsythe LP, Lauer M, Rotter J, Ioannidis JP, Beal A, Frank L, Selby JV. Engaging patients and stakeholders in research proposal review: the patient-centered outcomes research institute. Ann Intern Med. 2014 Jul 15;161(2):122-30. doi: 10.7326/M13-2412. PubMed 25023251 ↗
  • Domecq JP, Prutsky G, Elraiyah T, Wang Z, Nabhan M, Shippee N, Brito JP, Boehmer K, Hasan R, Firwana B, Erwin P, Eton D, Sloan J, Montori V, Asi N, Dabrh AM, Murad MH. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014 Feb 26;14:89. doi: 10.1186/1472-6963-14-89. PubMed 24568690 ↗
  • Forsythe LP, Frank L, Walker KO, Anise A, Wegener N, Weisman H, Hunt G, Beal A. Patient and clinician views on comparative effectiveness research and engagement in research. J Comp Eff Res. 2015 Jan;4(1):11-25. doi: 10.2217/cer.14.52. PubMed 25565066 ↗
  • Reich SM, Reich JA. Cultural competence in interdisciplinary collaborations: a method for respecting diversity in research partnerships. Am J Community Psychol. 2006 Sep;38(1-2):51-62. doi: 10.1007/s10464-006-9064-1. PubMed 16807789 ↗
  • Supple D, Roberts A, Hudson V, Masefield S, Fitch N, Rahmen M, Flood B, de Boer W, Powell P, Wagers S; U-BIOPRED PIP group. From tokenism to meaningful engagement: best practices in patient involvement in an EU project. Res Involv Engagem. 2015 Jun 25;1:5. doi: 10.1186/s40900-015-0004-9. eCollection 2015. PubMed 29062494 ↗
  • Barber R, Boote JD, Parry GD, Cooper CL, Yeeles P, Cook S. Can the impact of public involvement on research be evaluated? A mixed methods study. Health Expect. 2012 Sep;15(3):229-41. doi: 10.1111/j.1369-7625.2010.00660.x. Epub 2011 Feb 17. PubMed 21324054 ↗
  • Staley K. 'Is it worth doing?' Measuring the impact of patient and public involvement in research. Res Involv Engagem. 2015 Jul 31;1:6. doi: 10.1186/s40900-015-0008-5. eCollection 2015. PubMed 29062495 ↗
  • Wright D, Foster C, Amir Z, Elliott J, Wilson R. Critical appraisal guidelines for assessing the quality and impact of user involvement in research. Health Expect. 2010 Dec;13(4):359-68. doi: 10.1111/j.1369-7625.2010.00607.x. PubMed 20629767 ↗
  • Frank L, Forsythe L, Ellis L, Schrandt S, Sheridan S, Gerson J, Konopka K, Daugherty S. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Qual Life Res. 2015 May;24(5):1033-41. doi: 10.1007/s11136-014-0893-3. Epub 2015 Jan 6. PubMed 25560774 ↗
  • Huml AM, Albert JM, Beltran JM, Berg KA, Collins CC, Hood EN, Nelson LC, Perzynski AT, Stange KC, Sehgal AR. Community Members as Reviewers of Medical Journal Manuscripts: a Randomized Controlled Trial. J Gen Intern Med. 2023 May;38(6):1393-1401. doi: 10.1007/s11606-022-07802-z. Epub 2022 Sep 26. PubMed 36163530 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Nov 2021, 41 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Feb 14, 2018
StartActual
Jun 13, 2018
Primary completionActual
Nov 30, 2021
CompletionActual
Nov 30, 2021
Last update
Sep 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432143
Responsible party
Ash Sehgal (Investigator, MetroHealth Medical Center) — Principal investigator
First posted
Feb 14, 2018
Start date
Jun 13, 2018
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021
Last update
Sep 29, 2022

Study contacts

Ashwini Sehgal
principal investigator · Case Western Reserve University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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