Introduction to Pragmatic Clinical Trials

Question 1

Evidence paradox

Answer 1

In order to inform clinicians on how to treat patients, we need real-life patients

Question 2

Clinical research is not relevant to practice

Answer 2

Traditional RCTs study the efficacy of treatments delivered to carefully selected populations under ideal conditions

Question 3

Problems with clinical trials

Answer 3

Expensive
Small
Often drugs are compared against placebo
Exclude elderly, children, pregnant women, patients with important comorbidities
May be unethical
Not timely

Question 4

Pragmatic research design

Answer 4

Pragmatic research is designed with input from health systems - and produces evidence that can be readily used to improve patient care
By engaging health systems, providers, and patients as partners, pragmatic research accelerates the integration of research, policy, and practice

Question 5

Pragmatic clinical trials

Answer 5

Designed to improve practice and policy
Take place in settings where everyday care happens, such as community clinics, hospitals and health systems
Collaborating providers and organizations are integral partners and gain practical evidence on how to improve patient health and satisfaction

Question 6

Benefits of PCTs

Answer 6

Designed to test what will work in everyday care, with emphasis on successful implementation
PCTs study diverse populations receiving care in real-world settings using broadly inclusive criteria for study participation
Health systems, providers, and patients are involved in study design, collecting data, interpreting results, and acting on the findings
Results designed to directly inform decision making of administrators, providers, patients, and policymakers

Question 7

Implementation outcome variables

Answer 7

Acceptability
Adoption
Feasibility
Fidelity
Implementation cost
Sustainability

Question 8

Core characteristics of PCTs

Answer 8

Questions from and important to stakeholders
Multiple, heterogenous settings
Multiple outcomes important to decision and policy makers
Comparison conditions are real-world alternative, not a placebo or no treatment
Diverse, representative populations

Question 9

Common pragmatic research features

Answer 9

Use of EHRs
Randomization of treatment alternative based on normal health care operations

Question 10

RCT-PCT continuum

Answer 10

PCTs are not as abandonment of the scientific methods that have led to countless breakthroughs
They don’t take away from basic science or diminish the importance of traditional RCTs - we just need a balance
No clinical trial is completely explanatory or pragmatic. RCTs and PCTs exist on a continuum

Question 11

Why we need PCTs

Answer 11

We aren’t reaching patients with complex, comorbid problems and those most in need
Traditional research rarely happens in typical clinical settings, so findings often aren’t feasible for real-world uptake
We aren’t asking questions important to providers, patients, and administrators or policymakers