Intro To Pragmatic Clinical Trials

Question 1

RCTs are the golden standard, but two big issues with them include how _____ and ______ they are (in addition to the evidence paradox).

Answer 1

Slow, expensive!

Question 2

What are some reasons RCTs don’t translate well to the real world?

Answer 2

• expensive
• small pool of subjects
• drugs are compared w/ placebo
• exclude elderly, children, pregnant women, comorbid
• unethical
• untimely

Question 3

T/F: Partnerships with other healthcare systems can improve the speed and relevance of research

Answer 3

True

Question 4

Where do pragmatic clinical trials take place?

Answer 4

Places where everyday care happens: community clinics, hospitals, health systems

Question 5

What are some benefits of pragmatic clinical trials?

Answer 5

1. Practical - worked into everyday care
2. Inclusive - diverse populations studied without omissions
3. Engaged - health systems/providers/patients all involved
4. Relevant - results designed to inform real-world decision-making

Question 6

What factors affect implementation of PCTs?

Answer 6

Acceptability
Adoption
Feasibility
Fidelity (can we implement as intended?)
Cost
Sustainability

Question 7

What are two common features of PCTs?

Answer 7

1. Use of EHR for data collection
2. Randomized treatment alternatives based on normal health care operations

Question 8

T/F: RCTs and PCTs exist separately, the future will use only PCTs

Answer 8

False
RCTs and PCTs exist in a continuum, need both!

Question 9

What tool assess the pragmaticity of studies by accounting for multiple variables?

Answer 9

Pragmatic-Explanatory Continuum Indicator Summary (PRECIS)