Patient Data Access News

Guidelines for Designing Patient-Centered Research Initiatives

PCORI's Patient Engagement Rubric helps healthcare researchers design patient-centered study protocols, making initiatives more relevant to patients and their caregivers.


Source: Thinkstock

By Sara Heath

- Developing patient-centered research initiatives is key to driving meaningful study protocol and fueling literature that is useful and relevant to patients.

However, not enough healthcare experts are well-versed in how to create patient-centered research design, according to a PCORI-commissioned report published in the Annals of Family Medicine.

“Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process,” said the report’s authors.

“To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric).”

Although PCORI first issued its PE Rubric back in 2014, the organization updated the Rubric in 2016. This new publication outlines how the organization developed the Rubric, how the Rubric ensures patient engagement, and how PCORI expects the Rubric to shape future research.

The research team consulted numerous patient engagement resources to inform the Rubric, including conducting a literature review, a qualitative study with patients, a review of patient engagement studies that had already been approved by PCORI, and a discussion with the organization’s Advisory Panel on Patient Engagement.

Using the insights gleaned from those sources, PCORI created the Rubric to include the following: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects.

The Rubric covers three domains, including research planning, research methodology, and disseminating of study results.

Patient-centered research planning means developing research questions and outcome measures that are relevant to patients. Under this domain, researchers must determine which patient populations and stakeholders to include in study design and then facilitate easy study participation.

The research methodology domain called for creating clear study protocols. Researchers should engage patients in recruitment, conduct patient-centered data analysis, and consult patient representatives on a data safety monitoring board.

The third domain, disseminating study results, asks researchers to ensure patients can access and understand study results. Researchers should identify partner organizations and avenues for delivering results, working to incorporate the patient into all efforts.

Overall, the researchers believe the Rubric will help future researchers create patient-centered study designs, helping to drive patient-centered care.

“[The Rubric] provides a practical resource that distills and prioritizes information from promising practices intended to systematically bring stakeholders into the research process in the most impactful way,” the researchers said.

On a practical level, the Rubric serves as a step-by-step guide for writing research proposals. Researchers can consult the Rubric when applying for PCORI grant funding or when working to create research material that is relevant to patients.

By offering a broad framework, PCORI also allows researchers and their patient partners to select which patient-centered initiatives work best for their study purposes.

“Researchers, patients, and other stakeholder partners can work together… to determine which of the activities, as well as any additional innovative approaches, best fit their projects given the population or condition to be studied, the nature of past research and incorporation of patient and other stakeholder views into that work, and the gaps to be addressed by the work,” the research team reported.

Currently, there are some limitations to the Rubric.

First, the resource was built on expectations for PCORI-funded projects, and therefore may not be applicable for all patient-centered research. Additionally, the guide primarily concerns engagement from the researchers’ perspectives rather than from the view of patients and other stakeholders.

Going forward, PCORI hopes to conduct more investigations into how patient-centered research affects study quality. Ideally, these patient-centered guidelines will create positive outcomes and drive more researchers to include patient prerogatives into study protocols.

“By encouraging PCORI applicants, awardees, and others to apply the rubric, PCORI hopes to shift the research paradigm from one of conducting research on patients as subjects to a pursuit carried out in collaboration with patients and other stakeholders to better reflect the values, preferences, and outcomes that matter to the patient community,” the researchers concluded.


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