Public Comments - Submissions

Patient-Centered Outcomes Research Institute

Peer Review Process Comments

Name of person or organization submitting comments: Ann Bonham, PhD; Chief Scientific Officer, Association of American Medical Colleges

Please identify which stakeholder group you represent: Clinician/Clinician Society

Registration at ClinicalTrials.gov, RoPR, or PROSPERO

The AAMC supports PCORI’s goals for PCORI research project registration at the site appropriate to the study design. Specifically, the AAMC supports the Awardee Institutions’ registration of clinical trials or observational comparative effectiveness studies at Clinical Trials.gov, clinical registries at the Registry of Patient Registries (RoPR), and evidence synthesis studies at PROSPERO.

Production of a draft final report, scientific abstract, and standalone results table

As indicated in the draft guidance, the Awardee Institution must submit a draft final report to PCORI within three months of the completion of data analysis specified in the study protocol. The AAMC believes that the requirements for the timing and content of the report as well as the specifications sections listed in the proposed process are appropriate for the purposes of peer review. The proposed process for engaging in the peer review of the draft final report appears to provide reasonable steps through which PCORI can meet its obligations prior to publication to ensure that the evidence and analyses presented support the conclusions of the report and the study methods adhere to PCORI’s methodology standards.

PCORI peer review process of the draft final report

The AAMC supports PCORI’s outlined requirements for submission of the draft final report, the review team, review conference, revisions to the draft final report, and formal acceptance. Given the importance of balancing Awardee Institutions’ administrative responsibilities with meeting federal requirements, the AAMC strongly recommends that PCORI assess the process as implemented after one year to evaluate the effectiveness of the steps in facilitating PCORI’s responsibilities and the consequences of the process.

Providing a version of the results summary that will be useful and comprehensible for use by patients and the general public

One of PCORI’s most critical responsibilities is ensuring that the results of PCORI-funded research are understandable to and effectively disseminated to the patients and populations that could benefit from the findings. In addition to the translation of a medical abstract into a lay abstract for patients and the general public, the AAMC recommends that PCORI provide a description of the context of the research findings, the relevance of the research results, and an easily comparable rating of the strength of the evidence. Posted abstracts should be appropriately indexed and tagged to allow for continued accessibility by patients and the general population. In particular, special attention should be paid to focusing communications for special groups of patients, especially populations where there is a longstanding history of disparities. Patient and/or community review of the lay abstract before posting would further demonstrate their involvement and could improve the uptake.

Submission of results table to ClinicalTrials.gov and/or other sites as appropriate, with a link to the abstract and standalone results table on PCORI’s website

In order to ensure consistency among posted information for PCORI supported projects, the AAMC recommends that PCORI take a leadership role, working with its investigators, in posting the abstract, the stand alone table, and ancillary information to clinicaltrials.gov and other sites as appropriate.

Public posting of full final reports on PCORI’s website

The AAMC supports PCORI’s outlined requirements for posting the final report of each study on the PCORI website no later than 12 months after the final report is accepted by the PCORI review board. However, the AAMC also urges PCORI to consider how it can help investigators and others in developing the most effective dissemination strategies for the results of PCORI-funded research. A truly patient centered approach may require a strategy that goes beyond posting results on the PCORI website or publication in a peer-reviewed journal. PCORI could provide examples and assistance to ensure that the results of patient centered outcomes research reach those who could most benefit from the information and who may not be searching for it on the PCORI website.

Awardee institution notification to PCORI of submission to journals and subsequent publication of papers resulting from funded projects

We note that PCORI may delay posting beyond 12 months to coordinate posting with publication of a peer-reviewed journal version of study findings. It is possible that due to differing recommendations from PCORI’s peer review panel and that of the journal, the two abstracts may describe or emphasize differing analysis and results. The AAMC recommends that PCORI provide information to describe and explain any differences that may exist in the journal’s published abstract (to which the PCORI website links) and the updated abstract presented on PCORI’s website.

Timeline of the proposed peer review and public release process

We note that PCORI may delay posting beyond 12 months to coordinate posting with publication of a peer-reviewed journal version of study findings. Given the importance of balancing Awardee Institutions’ administrative responsibilities with meeting federal requirements, the AAMC strongly recommends that PCORI assess the process as implemented after one year to evaluate the effectiveness of the steps in facilitating PCORI’s responsibilities and the consequences of the process.

Please rate how well the proposal meets PCORI’s obligations under its authorizing legislation Somewhat Well

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Please rate how well the proposal provides a clear understanding of the peer review and public release process Somewhat Clear

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Please comment on the proposal’s feasibility given any competing obligations that awardee institutions funded by PCORI, or their investigators, may face.

Given the importance of balancing Awardee Institutions’ administrative responsibilities with meeting federal requirements, the AAMC strongly recommends that PCORI assess the process as implemented after one year to evaluate the effectiveness of the steps in facilitating PCORI’s responsibilities and the consequences of the process. The AAMC urges PCORI to consider how it can help investigators and others in developing the most effective dissemination strategies for the results of PCORI-funded research. A truly patient centered approach may require a strategy that goes beyond posting results on the PCORI website or publication in a peer-reviewed journal.

The law requires that PCORI both conduct peer review of our funded primary research and make it available publicly within a specific timeframe. We propose to conduct peer review first, then post the results, so they can benefit from the review process. Do you agree or disagree with the sequencing of this process? Strongly Agree

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Please provide any additional comments that you have not already provided about any aspect of this proposal.

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