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Patient peer reviews: An unorthodox approach to clinical trial publication

Patient peer reviews: An unorthodox approach to clinical trial publication

There is no doubt about the fact that patients are the most important component of clinical trials. However, typically, once clinical trials are completed, patients cease to be involved and researchers proceed to present their findings in the form of journal articles. While this has been the norm, some journals and publishers have felt the need to increase patients’ involvement in clinical trials, particularly by soliciting their feedback on a study or the way in which it is presented.  In an attempt to move toward a more inclusive publication process, two major publishers in the UK are adopting patient peer reviews as part of their publishing cycle.

In November 2014, BioMed Central (BMC) announced the launch of its new journal Research Involvement and Engagement in 2015. The journal will publish studies that are peer reviewed by patients who were enrolled in clinical trials. The journal will also adopt an open peer review model, enabling the reviews of published articles to be freely available. While most journals have one editor in chief, Research Involvement and Engagement will have two – Dr. Sophie Staniszewska (who leads the Patient and Public Involvement and Experiences of Care Programme at the Royal College of Nursing Research Institute, University of Warwick) will work closely with Richard Stephens (a patient advocate in research and cancer survivor). This combination symbolizes what the journal aims to achieve – an intensive collaboration between the researchers involved in clinical trials and patients enrolled in the trials.

How patient peer review will work

The initial questions that come to mind, here, are whether patients will be able to review scientific manuscripts and how such a system would work. The journal will follow a joint peer review process in which each article submitted will be reviewed by at least one patient and one academic. The academic peer reviewers will examine the methodology, scientific reliability, etc. Patient peer reviewers (who will be selected based on their medical experiences) will draw upon their own academic/professional backgrounds or experience as patients to comment on whether the issue addressed in the study is relevant to the field and whether the findings can be applied in a global context. Those with the relevant technical knowledge will also comment on the technical aspects of the research. To ensure that the patient peer reviewers are able to review journal articles, the journal provides detailed reviewing guidelines that induce patient peer reviewers to think about the manuscript organization, study methodology, and ethical aspects.

The British Medical Journal (The BMJ), one of the oldest medical publishers in the world, has also recently adopted patient peer review and sees the process as an opportunity for patients (as mentioned in the peer reviewer guidelines section of their website) “to have a real voice in shaping the way researchers design and report research and clinicians act, and to further their understanding on what is most important to, and of benefit to patients.” Their guidelines for patient peer reviewers urge reviewers to think about whether an article introduces an intervention or treatment with potential benefits for patients, what challenges patients may face, and whether the outcomes are relevant to patients.

What patients feel about playing the role of a reviewer

Carolyn Thomas, a heart attack survivor and patient reviewer for The BMJ blogged about her first manuscript reviewing experience:

What patients feel about reviewing manuscripts

Carolyn’s full post can be accessed here.

Benefits of patient peer review

Based on the framework followed by BMC journals and The BMJ, the patient peer review process does seem promising. Here are a few basic advantages that immediately come to mind.

  • Clinical research is about patients: Patient peer reviews seek to involve the stakeholders that constitute an essential part of the clinical/medical research process. By referring to their personal experiences, patients can indicate the extent to which a study was successful and the effects it had on them.
  • A new publication model: The process facilitates greater collaboration between the patients and academic sides of clinical trials. It also introduces a publication model in which a journal is co-produced by every stakeholder, from the author and journal editor to the patient and policymaker.
  • Access to a new talent pool: According to Stephens, given their high level of involvement in clinical trials, patients are already equipped to critically evaluate the research. Their skills, experience, and understanding can take research evaluation to a whole new level.
  • Publication turnaround times: By providing journals access to an additional pool of reviewers, the process could help reduce the time to publication.

Some unanswered questions

The concept of patient peer review is fairly new and has not yet fully developed as a global publishing trend. Some immediate questions that it raises include: Who will qualify to become a patient peer reviewer? Will the journals include patients who dropped out of trials because of adverse effects? To what extent will the patient peer reviewers be trained? Will the patient reviews be screened or edited? If yes, how will journals manage the increased publication costs or time? Both BMC and The BMJ adopt the open peer review system to enable the sharing of reviews once an article is published – What happens to reviews of rejected manuscripts? What if the reviews include relevant inputs from patient peer reviewers? Will patient peer reviewers be allowed to use their reviews (of published or unpublished papers) for their own purpose (e.g., including it in their curriculum vitae)?

Answers to these and related questions or concerns may not be available immediately. However, patient peer review does show tremendous potential as a process that could revolutionize the way in which medical/clinical research is conducted and communicated. How it develops as a streamlined process in the UK and whether it will be adopted by other publishers globally remain to be seen.

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