April 28, 2017: Perspective on the Boundary Between Quality Improvement Studies and Research
Perspective on the Boundary Between Quality Improvement Studies and Research: Patients, QI Leaders, IRB Leaders
Sherrie H. Kaplan, PhD, MPH, Professor of Medicine and Assistant Vice Chancellor for Healthcare Evaluation and Measurement at the University of California, Irvine School of Medicine
Susan Huang, MD, MPH, Professor of Medicine in the Division of Infectious Diseases at the University of California, Irvine School of Medicine; Quantitative research; Survey data
ABATE Infection; Active Bathing to Eliminate Infection; Healthcare-associated infections; Quality improvement; QI; Comparative effectiveness research; CER; Informed consent; Survey data
- Converging trends highlight the importance of identifying types of interventions to improve care that require patient consent:
- Quality improvement strategies
- Increasing focus on comparative effectiveness research
- Pragmatic trials
- Learning healthcare systems
- Boundaries between clinical research and quality improvement are unclear. The search for definitions is ongoing but with limited empirical study and missing the patient perspective. This study sought the perspectives of hospital patients, QI leaders, and IRB leaders on whether quality improvement/comparative effectiveness research (CER) studies can or should go on without consent.
- The survey used example scenarios to determine willingness to waive consent for minimal risk QI projects. The survey evaluated perspectives around 5 constructs:
- Hospital environment
- Things put on or used by patients
- Medications, health equipment, and devices
- Policies and procedures
- Data collection, use, and sharing
Which, if any, categories of interventions are eligible for waiver of consent?
The current informed consent process is burdensome, time consuming, ill-timed, and unintelligible to most patients.
How do we inform without making people more concerned? How do we bring about the understanding that improvement is an integral part of healthcare?
For More Information
Read more about the ABATE Infection pragmatic clinical trial.
@PCTGrandRounds, @Collaboratory1, @PCORnetwork