Lecture 9

Question 1

Simple intervention

Answer 1

On that is clearly stated (RCT) and is easy to determine when the intervention is on vs off in a research design.

Question 2

Complex intervention

Answer 2

One that is not clearly stated, thus challenging to implement and difficult to determine when the intervention is on in a study.
May involve multiple interacting components and involve many levels of intervention.

Question 3

All complex interventions have two common characteristics:

Answer 3

1. Intervention complexity (multiple components)

2. Pathway complexity (complicated causal pathways, mediators and moderators of effect)

Question 4

In addition to intervention and pathway complexity, complex interventions may also have the following three complexities:

Answer 4

1. Population complexity-
2. Implementation complexity
3. Contextual complexity

Question 5

Examples of complex interventions

Answer 5

Advice or education to subjects/patients
Education or training to health care staff
Interventions involving ongoing input from subjects

Question 6

Complex intervention Development phase

Answer 6

Helps optimize the intervention and may include interviews, observations, surveys, and pilot (feasibility study)

Question 7

Complex intervention pilot study

Answer 7

Small study performed to work out the details before committing resources to the full complex intervention study.

Allows for modifications and refinement of the methods section.

Question 8

What does it mean if you get negative results from a complex intervention?

Answer 8

May indicate inadequate optimization. May need to revisit the development phase and further refine the intervention.

*May not indicate a failure of the intervention.

Question 9

Core and non-core components of the complex intervention

Answer 9

Core: Standardized aspects of the intervention. Ex: masks, social distancing, hand washing

Non-Core components: Adapted to context and setting of the intervention.

Question 10

Under-standardization leads to ____

Answer 10

Limited generalizability

Question 11

Over-standardization leads to ____

Answer 11

May be unworkable and underestimate effectiveness of intervention.

Don’t be too rigid about everything. Cant apply same rules to everything. Ex: virtual lectures will work. Virtual labs will not.

Question 12

Intervention can be influenced by which 4 things

Answer 12

Social, health, environment, and education.

Question 13

Process evaluation when critiquing complex intervention papers

Answer 13

Qualitative measure of the practical challenges of implementing the intervention.

Includes unexpected findings such as improper venues, external influences.

Question 14

Non-Inferiority trial. Evaluating outcomes of interventional studies.

Answer 14

One sided: Desire experimental not unacceptably worse than control.

Two sided: Desire experimental equivalent (not unacceptably different) to control. Similar to equivalency trial.

Commonly used for evaluation of generic drugs.

Question 15

Limitations to non-inferiority trial

Answer 15

Not unacceptably worse
Margin defined by investigator
Reward carelessness
Low sensitivity

Question 16

Justifications to non-inferiority trial

Answer 16

Not unacceptably worse
Simpler dosing schedule
Reduction of side effects
Greater availability

Question 17

Non-inferiority trial possible outcomes (5)

Answer 17

Superior 
Non-inferior 
No difference in outcomes (null treatment) 
Inconclusive 
inferior 

On a graph, do not confuse these lines with homo or heterogeneity of the intervention.