Study Set Content:
refers to the extent to which the results of a study accurately represent the causal relationship between an intervention and an outcome in the particular circumstances of that study.
• Internal validity
refers to the extent to which the results of a study conducted under particular circumstances can be generalized (or are applicable) to other circumstances.
External validity
• assess internal validity
– (), i.e., following a study population over time as it receives an intervention or exposure and experiences outcomes, rather than retrospective design
– ()rather than observational
– (), i.e., with one or more comparison groups, rather than uncontrolled
Prospective, Experimental , Controlled
assess internal validity
– () assignment of patients to intervention and control groups
–() of patients, clinicians, and investigators as to patient assignment to intervention and control groups
Randomized, Blinding
• assess external validity
– () entry criteria to identify/enroll patient population that is representative of patient diversity likely to be offered the intervention in practice
–()of the intervention consistent with anticipated practice
Flexible
Dosing, regimen, technique, delivery
secondary or synthesis methods
Integrative methods
• these medthods involve combining data or information from existing sources, including from primary data studies
Integrative methods
Most HTA programs rely on () (especially systematic reviews), particularly to formulate findings based on available evidence from primary data studies that are identified through systematic literature searches.
integrative methods
Methods used to combine or integrate data from primary sources include the following:
– Systematic literature review – Meta-analysis – Modeling (e.g., decision trees, state-transition models, infectious disease models) – Group judgment (“consensus development”) – Unstructured literature review – Expert opinion
Four major types of integrative methods:
–systematic literature reviews–meta-analysis–decision analysis–consensus development
is a form of structured literature review that addresses one or more evidence questions (or key questions) that are formulated to be answered by analysis of evidence
systematic literature review
often includes a meta-analysis
systematic literature review
involves
– () means of searching the literature
– Applying predetermined ()() criteria to this literature – Critically appraising the relevant literature
– ()and synthesis of data from evidence base to formulate answers to key questions
Objective,
inclusion and exclusion
Extraction
“PICOTS” format
Population
Intervention
Comparator
Outcomes
Timing
Setting
condition, disease severity/stage,
Population
comorbidities,
Population
technology type
Intervention
regimen/dosage/frequency,
Intervention
risk factors
Population
demographics
Population
