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Peer Review, ResearchNCT03432143

Community Members as Reviewers of Medical Journal Manuscripts

A study testing Community Reviewers in people with Peer Review, Research, run by MetroHealth Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peer Review, Research
What is being tested?
Community Reviewers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
568 participants
Where
1 siteUnited States
Study dates
13 Jun 2018to 30 Nov 2021
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Full length
  • Original research

Who cannot join

  • 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:

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

Other trials in United States

About this study

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.

Being tested
Community Reviewers
Keywords
Peer Review, Community-Based Research, Community Perspectives

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community ReviewersOther

    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.

Study groups in NCT03432143
Study groupRoleWhat they receive
Community ReviewersExperimental24 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.
Receives: Other: Community Reviewers
Scientific Reviewers OnlyNo interventionApproximately 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (1)
  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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start13 Jun 2018
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

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
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)
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432143
Sponsor's protocol ID
IRB17-00374
Status last verified
Sep 2022
First submitted
7 Feb 2018
Last updated
29 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Community Reviewers in people with Peer Review, Research, run by MetroHealth Medical Center 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare community member reviews with those of scientific reviewers. (time frame: 5 years). 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 NCT03432143, which also lists 16 linked publications.

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 29 Sep 2022.

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