Lecture 10

Question 1

What question is asked for a non-inferiority trial?

Answer 1

Is experimental intervention not inferior to active control?

Question 2

Is the non-inferiority trial one or two sided

Answer 2

One sided. It is similar to the equivalency trial, which is two sided.

Question 3

One sided, non inferiority trial.
One sided desires ____
one sided requires ____

Answer 3

Experimental to be better than control. Although, “not unacceptably worse” is required.

Question 4

Two sided, equivalency trial desires

Answer 4

Desires experimental equivalent to control. Commonly used for the evaluation of generic drugs.

Question 5

Efficacy of the intervention:
What is a NI margin
What is the 0 line

Answer 5

NI: Non inferiority margin- not unacceptably worse. Defined by people who made the study.

The zero line is the null treatment: The point of no difference in outcomes.

Question 6

Guidelines

Answer 6

Not rules- recommendations.

Systematically developed statements to assist practitioner decisions about appropriate healthcare for specific clinical circumstances.

Express general principles. Allow for professional judgment.

Question 7

Protocols

Answer 7

Instructions used in specific, predictable circumstances with reduced judgment. Ex: how do you conduct an eye exam?

Question 8

Evidence based vs evidence biased guidelines

Answer 8

Concerns that guidelines may force the clinician to use evidence acquired from select populations that may not apply to individuals.

Question 9

Purpose of guidelines

Answer 9

1. Provide evidence based standards that are accessible (online)
2. To educate patients and professionals about current best practice
3. Yardstick to assess performance
4. To improve cost-effectiveness
5. To serve as tool for external control (gov, insurance)
6. To make decision making in the clinic more objective

Question 10

Ways to be a lifelong learner

Answer 10

Continue education
Manuscript eval
Professional meetings
Research

Question 11

Drawbacks of guidelines

Answer 11

1. GOBSAT was used to formulate
2. Standardized to “average” may result rather than “best practice”
3. Innovation inhibited
4. Local needs may not be addressed (based on broad guidelines)
5. Guidelines developed in secondary care may not be relevant in primary care
6. May be politically motivated
7. New evidence may be delayed in implementation of the guidelines.

Question 12

Best practices for implementing guidelines

Answer 12

Develop guidelines based on broad evidence ,but apply it locally.
Disseminate guidelines through problem based learning.
Provide patient specific prompt to practitioner based on codings. Ex: Conjunctivitis Dx. Culture? meds rx?

Question 13

Traditional vs problem based learning

Answer 13

Traditional: Memorize. Problem assigned to illustrate how to use it.

Problem based learning: Problem assigned, identify what we need to know, learn and apply it to solve the problem.

Question 14

Best practices for implementing guidelines

Answer 14

Sense of ownership is important. Practitioners will oppose changes perceived as threatening to livelihood/self esteem/sense of competence/autonomy

Question 15

Effective practice and organization of care (EPOC)

Answer 15

Best practices for implementing guidelines.
Subgorup of cochrane collaboration. Review and summarize research on implementing research based evidence into clinical practice.

Question 16

What is the goal of AGREE

Answer 16

Advancing the science of practice guidelines

Question 17

Clinical guidelines should be evaluated in three general areas:

Answer 17

Content, process, presentation.

Question 18

Non-inferiority trails are extensions of the

Answer 18

Consort statement for writing guidelines.