PCORI

PCORI is faced in developing this new set of Standards with the challenge of being prescriptive without being overly directive. When describing the relevant stakeholders within this Standard, PCORI should consider changing the language to say, “Other relevant stakeholders may include but are not limited to clinicians, purchasers…” There are other stakeholder categories that may fall beyond the list identified—one example being community-based organizations working with health care systems—that researchers should also consider when determining the types of individuals who will be involved within the study and their approach to engagement. As currently written, PCORI’s list is more exclusive than illustrative. Beyond this, here PCORI defines the role of consumers or stakeholders in a manner that is appropriate in terms of a particular research project, but it does not speak to the fact that stakeholders should be involved in the research enterprise more broadly. There’s a greater role for researchers to play in engaging consumers and patients in governance and oversight processes, beyond simply the research project. AcademyHealth’s Electronic Data Methods (EDM) Forum authored a paper in 2012 (http://repository.edm-forum.org/cgi/viewcontent.cgi?article=1001&context=edm_briefs) that examines and offers insight into these issues that may be useful to PCORI for incorporating these critical concepts into its revised Methodology Standards. In addition, the final bullet regarding PCORI’s Engagement Rubric is not proportionate in level and scope with the other bullets on processes. This statement should act as a broader note within the Standard, and thereby be removed from the bulleted list. We would also raise that in the last sentence of the Standard— “If engagement is not necessary or appropriate in these processes, explain why”—it is not clear whether the intent is to note where engagement is or is not appropriate for each of the project’s components or for the project overall.

We applaud the Committee on clarifying how patients and stakeholders should be involved in the prioritization of research, conduct of research, and the dissemination of research findings. As outlined in the standards, a broad set of stakeholders, including the biopharmaceutical industry, contribute to a more robust research process. Purchasers, payers, and industry communities seek to ensure that relevant questions are addressed, research findings are usable, and results are translated and implemented in practice. This engagement is an important aspect towards improving the relevance of CER questions and ultimately the impact of CER on health care decision-making.

Patient Advocates need to be added to the stakeholders list

The bolded print here refers to "ways that are appropriate and necessary". This is very broad. Essentially, this will result on everyone conceivable being drawn into the process, or the investigator being compelled to offer explanations as to why some segment was not engaged. Can the authors be more specific about how one determines what groups are really appropriate and necessary for such engagement?

While patients' participation in different portions of the research process is certainly of interest to researchers, the benefits from a patient perspective might not be immediately obvious. It is therefore important that their participation be compensated with a reciprocal gain. This gain could be in form of information to be taken back to their community, free lectures provided by researchers with expertise in the field, or anything else that might make this collaboration feel like a fair exchange with mutual gain.