NCT03432143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

3.5 years

First QC Date

February 7, 2018

Last Update Submit

September 27, 2022

Conditions

Keywords

Peer ReviewCommunity-Based ResearchCommunity Perspectives

Outcome Measures

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.

    5 years

Secondary Outcomes (1)

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

    5 years

Other Outcomes (1)

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

    5 years

Study Arms (2)

Community Reviewers

EXPERIMENTAL

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

Scientific Reviewers Only

NO INTERVENTION

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

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.

Community Reviewers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Full length
  • Original research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (16)

  • 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.

    PMID: 9611617BACKGROUND
  • 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.

    PMID: 15888635BACKGROUND
  • 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.

    PMID: 16098155BACKGROUND
  • 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.

    PMID: 16874772BACKGROUND
  • 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.

    PMID: 20597018BACKGROUND
  • 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.

    PMID: 16760238BACKGROUND
  • 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.

    PMID: 25023251BACKGROUND
  • 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.

    PMID: 24568690BACKGROUND
  • 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.

    PMID: 25565066BACKGROUND
  • 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.

    PMID: 16807789BACKGROUND
  • 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.

    PMID: 29062494BACKGROUND
  • 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.

    PMID: 21324054BACKGROUND
  • 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.

    PMID: 29062495BACKGROUND
  • 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.

    PMID: 20629767BACKGROUND
  • 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.

    PMID: 25560774BACKGROUND
  • 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.

Study Officials

  • Ashwini Sehgal

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 14, 2018

Study Start

June 13, 2018

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations