Related Experiment Video
Updated: Jul 27, 2026

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered
Laura C Esmail1,2, Rebecca Barasky3, Brian S Mittman4
1Clinical Effectiveness and Decision Science Program, Patient-Centered Outcomes Research Institute (PCORI), Washington, DC, USA. laura.esmail@gmail.com.
New standards improve complex health intervention research. These guidelines ensure scientifically valid, transparent, and reproducible comparative effectiveness research (CER) for healthcare interventions.
Area of Science:
- Health Services Research
- Comparative Effectiveness Research (CER)
- Methodology of Health Interventions
Background:
- Complex health interventions (CHIs) require improved research practices for comparative effectiveness research (CER).
- The Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee (MC) initiated the development of formal guidance for CHI research in 2016.
Purpose of the Study:
- To establish minimal standards for scientifically valid, transparent, and reproducible CER studies of CHIs.
- Standards apply to diverse healthcare interventions, including delivery system, behavior change, and non-pharmacological approaches.
Main Methods:
- Literature review and analysis of existing methods guidance.
- Iterative standard development involving the PCORI MC, expert panels, and a public comment period.
- Final standards approved by PCORI MC and Board of Governors in April 2018.
Main Results:
- Standards require detailed description of interventions and comparators, including core functions.
- Emphasis on specifying hypothesized causal pathways and their theoretical underpinnings.
- Mandate for planning and describing process evaluations and selecting patient outcomes informed by causal pathways.
Conclusions:
- The new standards provide a framework for addressing key methodological features of CHI studies.
- Highlights the importance of understanding how CHIs achieve effects, not just measuring outcomes.
- Standards, while formal for PCORI, offer broad applicability for improving CHI research methodology.
More Related Videos
06:28E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
06:05The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
Related Concept Videos
Patient-centered Care
Guidelines for Writing Outcome
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care evaluation by...
Nursing Interventions II: Selecting and Classifying the Nursing Interventions
Methods of Documentation II: POMR
Standards of Care II
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...