Term
| Name some of the most common forms of interventions |
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Definition
1. Treatment
2. Prevention
3. Biomedical/environmental: insecticide
4. Biomedical/Behavioral: micronutrient supplementation
5. Behavioral: condom use |
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Term
| Name some of the most common types of evaluations |
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Definition
1. Product evaluation
2. Delivery system evaluation
3. Communication approach evaluation
4. Control strategy evaluation |
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Term
| Name the steps that are commonly followed to move from concept to product |
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Definition
1. Basic research
2. Pre-clinical research: animals
3. Clinical research:
RCT: humans Ph1: safety and
efficacy. Ph 2: efficacy Ph 3:
effectiveness.
4. Demonstration trials: effectiveness.
5. Post-marketing surveillance: safety |
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Term
| What is a step-wedge design? |
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Definition
| It is a design that is used frequently in large scale interventions that can't be introduced at the same time to all members of s population (eg government program) |
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Term
| What is an equivalence trial? |
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Definition
| Trial that is used to test Ho that a difference of at least DELTA exists between 2 intervention. Here, a type 1 error is different from what is usually understood (Pr of detecting equality when difference exists). You want to prove that the new intervention is equal or not worse than the current approach. This trial usually demand greater POWER. |
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Term
| Name some characteristics of a clinical trial |
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Definition
1. Clinic based
2. Randomization unit is the individual
3. Complex design.
4. Main interest is on efficacy
5. Usually small number of patients. |
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Term
| Name some characteristics of a community trial |
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Definition
1. Community based
2. Unit of randomization can be the individual, community, hospital, school, etc)
3. Large number of people enrolled
4. Less complex design.
5. Main focus is on effectiveness, although efficacy can also be the primary focus.
6. Important logistic, ethical and cultural issues need to be addressed.
7. Have strong internal and external validity. |
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Term
| Name the elements to consider in a study design? |
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Definition
1. Intervention: assess literature, potential impact, feasibility of intervention, cost of I, benefits outweight risks.
2. Population: well defined group were intervention will be applied. Consider a group with high prevalence, where disease is important, accessible, good local collaborators and politically stable.
3. Outcomes: effects, and how they will be measured
4. Randomization
5. Blinding
6. identification of confounders and effect modifiers. |
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Term
| How can we control for effect modification in a community trial? |
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Definition
1. Increase sample size
2. Sub-group analysis
Studies are rarely powered to detect effect modification. |
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Term
| What is the CONSORT statement and STROBE? |
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Definition
CONSORT is the Consolidated Standards of Reporting Trials.
STROBE is Strengthening The Reporting of Observational Epidemiology.
This are a set of guidelines for reporting randomized trial in the literature.
Arose from clinical trials model.
Has been extended to cluster randomized clinical trials.
This is used by many journals. |
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Term
| What is included in the CONSORT guidelines? |
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Definition
1. Title: needs to specify that it us a randomized clinical trial.
2. Abstract
3. Intro: Hypo, aims
4. Methods: population, inc/exclusion, intervention/timing, stop criteria, methods for I allocation and masking, primary and secondary outcomes, delta and sample size justification.
4. Results: flow diagram and follow-up, estimated intervention effect, describe confounders, discuss protocol deviation and why?, describe internal/external validity, bias and imprecision. |
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Term
| What is the relation between sensitivity, specificity, incidence and efficacy? |
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Definition
1. With decreased sensitivity, the apparent efficacy has little or no change.
2. With decreased specificity, the apparent efficacy decreases.
3. When the true incidence is lower than the expected, the effect of specificity on apparent efficacy is enhanced. |
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Term
| What is the relation between sensitivity, specificity, incidence and efficacy? |
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Definition
1. With decreased sensitivity, the apparent efficacy has little or no change.
2. With decreased specificity, the apparent efficacy decreases.
3. When the true incidence is lower than the expected, the effect of specificity on apparent efficacy is enhanced. |
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