PCORI Methodology Work Featured in Journal Supplement

A paper authored by PCORI staff and a member of PCORI’s Methodology Committee is featured in a special issue of Journal of General Internal Medicine on implementation science and quality improvement. The authors detail PCORI’s iterative process to develop a set of standards for conducting and reporting comparative effectiveness for complex health interventions (CHI).

The standards, which are part of the PCORI Methodology Standards, were adopted by the Board of Governors in April 2018.

According to the paper, CHIs are generally defined as multicomponent, adaptable interventions that act independently or interdependently to change care processes and outcomes and typically require specific involvement and behaviors by patients, caregivers, and health professionals.

CHIs are increasingly studied in comparative effectiveness research, and PCORI’s work uncovered a need for improvements in CHI research practices. The standards recommend the following research approaches:

• Fully describe the intervention and comparator and define their core functions
• Specify the hypothesized causal pathways and their theoretical basis
• Specify how adaptations to the form of the intervention and comparator will be allowed and recorded
• Plan and describe a process evaluation
• Select patient outcomes informed by the causal pathway.

The standards are intended to apply to research examining a broad range of healthcare interventions including delivery system, behavior change, and other non-pharmacological interventions.

As we’ve said for years at PCORI, methodological standards can improve the ways in which research questions are selected and formulated, studies are designed and conducted to address those questions, and findings are reported. Standards help prevent the use of flawed methods and provide a common set of expectations about high-quality research.