Each funding cycle, we at PCORI update our announcements to ensure we support projects that address critical research gaps. In this blog post, we address changes to the Cycle 2 2015 announcement related to improving methods for conducting patient-centered outcomes research. A subsequent post will describe other changes in PCORI’s most recent funding announcements, published June 29.
In PCORI’s CER Methods and Infrastructure program, we seek to fund research with the greatest potential to advance rigorous methods for patient-centered outcomes research (PCOR) and comparative clinical effectiveness research (CER) and, ultimately, generate research findings that improve patients’ outcomes. In the latest funding announcement, we’ve made important changes to the list of six research areas that we seek to support (although we will consider applications that address other methodological gaps). Please note this is just an overview of the updates, and we encourage you to review the full announcement.
Methods for patient and stakeholder engagement
We have built a substantial portfolio of methods for patient and stakeholder engagement. In this announcement, we are primarily interested in funding projects that identify effective methods of engagement for the planning, conduct, and dissemination of PCOR and CER across different patients, settings, and/or health conditions.
Specifically, we aim to support methods projects that are relevant and useful to end users including patients, caregivers, clinicians, advocates, payers, and policy makers, as well as to researchers in the field of PCOR/CER. Such methods would provide guidance to reconcile the complex and varied perspectives of patients, stakeholders, and researchers. We also aim to support methods of engagement that improve the recruitment and retention of patients into trials, observational studies, and registries.
Methods for patient-centered outcomes and patient-reported outcomes
We have built a substantial portfolio that develops and refines patient-centered outcomes and patient-reported outcomes (PROs) focused on specific diseases, health conditions, and behaviors. In this announcement, we primarily aim to fund projects that evaluate the interpretability, value, and use of existing PROs by clinicians, as well as the relationships between PROs and clinical outcomes such as hospitalization and medication use. Toward this goal, we seek to support projects that identify and address the barriers to integrating PROs into clinical care and research.
Lastly, we seek to support projects that assess differences in PRO data by mode of collection (e.g., clinic-based, home-based, mobile devices), by person (e.g., patient, caregiver, clinician), and by the optimal times to collect PRO data (e.g., every three months, after each illness episode).
Research related to human subjects protection
A key aspect of ensuring that research is patient centered is the protection of research participants. We invite evidence-based proposals on issues such as Institutional Review Board review of PCOR studies and novel approaches to informed consent, research on ethical issues arising in the context of particular CER study designs or the use of particular data sources for CER, and research on the ethics of randomization of standard clinical interventions.
Methods to improve study design
In this cycle, we are prioritizing research on methods related to study designs, including projects that foster improvements in study design to address comparative effectiveness questions. Research areas of interest include methods related to cluster-randomized trials, adaptive trials, registries, recruitment and retention, complex interventions, and medical devices and diagnostic tests.
Methods to improve validity and efficiency of analyses
We continue to seek proposals that develop, refine, and disseminate analytic methods to improve causal inference in PCOR/CER. However, because we have already funded projects on methods related to heterogeneity of treatment effect and validity of methods for reducing confounding and bias in randomized controlled trials and observational studies, we will not fund applications on these topics that significantly overlap with our current research portfolio.
Methods to support data research networks
This Research Area of Interest, added in the Fall 2014 funding cycle, remains a priority. We are particularly interested in proposals on methods to optimize the use of large amounts of data while preserving patient privacy and data security and to obtain longitudinal and complete data in data research networks.
If you applied previously under our Improving Methods funding announcement, please be aware of some other changes. Our Letter of Intent (LOI) template has been updated, as have our considerations for LOI review (see page 13 of the funding announcement). These review criteria, which are different from PCROI’s general merit review criteria, have been revised slightly—with updates to Criterion 2 (Potential for the Study to Improve PCOR Methods) and Criterion 5 (Patient and Stakeholder Engagement).
As part of a learning organization, our program continues to evolve in response to input from stakeholders and advances in the field of PCOR and CER methods, and our funding announcements reflect this growth and development. We look forward to feedback from our stakeholders on the types of methodological research that would be most useful and have the greatest impact.