Characteristics

Ideal

Research Challenges to Consider

Smoking-ban intervention

  • Occurs at clearly defined time

  • No other activities occur at same time that could affect smoking rates or secondhand-smoke exposure

  • Investigators have no control over terms or timing of smoking-ban legislation, implementation, or enforcement

Exposure assessment

  • Need for exposure assessment depends on hypothesis tested

    • Exposure data not needed to test effect of smoking ban

    • Exposure data needed to test effect of secondhand-smoke exposure

  • If study is prospective, study design can include air monitoring or biomonitoring before and after implementation of smoking ban, but increases costs and biomonitoring requires more complex human-subjects approval

Outcome

  • Both morbidity and mortality data analyzed

  • Confirmation of acute coronary event:

    • Mortality data confirmed by autopsy or independent review of medical records

    • Acute MI data independently confirmed clinically with standardized criteria

  • Access to data is sometimes inadequate

  • It is often not practical to have autopsies conducted on all cases unless sample is very small

  • Conducting an independent review of mortality data or clinically confirming morbidity data with standardized criteria is possible but would increase costs and require more complex human-subjects approval

  • In absence of independent review, data are only as good as what is recorded

Time between implementation and effect

  • Time between implementation and effect is clear

  • Period between implementation and effect is difficult to establish because intervention does not occur at clearly defined time (because of other activities concurrent with ban); effect may increase over time because, for example, there are gradual changes in smoking behavior



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