Public Comments - Submissions

Peer Review Process Comments

Name of person or organization submitting comments: Carla Zema

Please identify which stakeholder group you represent: Researcher

Registration at ClinicalTrials.gov, RoPR, or PROSPERO Fully support

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

PCORI peer review process of the draft final report

Fully support - However, the quality of this step of the process is dependent on the quality of and the direction given to reviewers. Having served as both an application reviewer as well as a reviewer for peer review journals, I can see the potential for Applicants getting conflicting information from their application review panel and the reviewers of their study results. PCORI, or their vendor, must provide high quality oversight and direction to reviewers to ensure that feedback from the application review, which help to shape study design and analysis decisions, are considered when reviewing the study results.

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

Fully support - I caution PCORI in setting a target reading level for abstracts. Strategies to improve the readability, such as using introductory clauses in sentences, can actually raise the measured reading level. Reading level alone is not a perfect indicator of readability for consumer audiences. Efforts to reach a target reading level may be counterproductive to achieving a consumer-friendly readability.

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 Fully support

Public posting of full final reports on PCORI’s website Fully support

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

Timeline of the proposed peer review and public release process Fully support

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

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

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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This is a necessary step since results may change given input from the peer review process.

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

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