Lecture 21: Non-experimental intervention studies (cont)

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Presentation transcript:

Lecture 21: Non-experimental intervention studies (cont) Describe the following sources of bias in the evaluation of screening programs: - Length-biased sampling - Lead time bias Compare experimental vs non-experimental intervention study designs, taking into account the following considerations: - Ethical issues - Feasibility and practicality - Validity (internal and external), precision, and efficiency

Evaluation of screening Example: evaluation of the effectiveness of breast cancer screening (HIP study) 1st RCT of breast cancer screening Study population: Members of HMO Intervention: Invitation to receive annual mammography and clinical exam (3 years) Possible outcomes: survival rate (1 year, 5 year) case-fatality rate mortality rate Which would you use?

Bias in RCTs of screening Definition of time zero? Date of first symptoms? Date of detection? Date of diagnosis? Bias if difference in “time zero”between study groups: screening/early detection intervention shifts time zero intervention appears to lengthen time to outcome without real change in prognosis “lead time” bias “length” bias

Other types of bias in studies of interventions Hawthorne effect: Non-specific effect of being in a study Prevention? Contamination bias: Control group receives some component(s) of intervention Confounding variables Variables associated with intervention group and outcome, not in causal chain

Internal vs external validity Internal validity Lack of bias in study External validity Generalizability Representativeness of study sample

Selection of study design for evaluation of interventions Observational study design Cohort Case-control Quasi-experimental study design Non-equivalent control group Time-series: single or multiple (controlled) Experimental RCT

Considerations in selection of a study design Cost Feasibility Ethical issues Internal validity External validity Credibility