title: Comparing breast cancer mortality rates before-and-after a change in availability of screening in different regions: extension of the paired availability design.
abstract: BACKGROUND
  In recent years there has been increased interest in evaluating breast cancer screening using data from before-and-after studies in multiple geographic regions. One approach, not previously mentioned, is the paired availability design. The paired availability design was developed to evaluate the effect of medical interventions by comparing changes in outcomes before and after a change in the availability of an intervention in various locations. A simple potential outcomes model yields estimates of efficacy, the effect of receiving the intervention, as opposed to effectiveness, the effect of changing the availability of the intervention. By combining estimates of efficacy rather than effectiveness, the paired availability design avoids confounding due to different fractions of subjects receiving the interventions at different locations. The original formulation involved short-term outcomes; the challenge here is accommodating long-term outcomes.
  
  
  METHODS
  The outcome is incident breast cancer deaths in a time period, which are breast cancer deaths that were diagnosed in the same time period. We considered the plausibility of the basic five assumptions of the paired availability design and propose a novel analysis to accommodate likely violations of the assumption of stable screening effects.
  
  
  RESULTS
  We applied the paired availability design to data on breast cancer screening from six counties in Sweden. The estimated yearly change in incident breast cancer deaths per 100,000 persons ages 40-69 (in most counties) due to receipt of screening (among the relevant type of subject in the potential outcomes model) was -9 with 95% confidence interval (-14, -4) or (-14, -5), depending on the sensitivity analysis.
  
  
  CONCLUSIONS
  In a realistic application, the extended paired availability design yielded reasonably precise confidence intervals for the effect of receiving screening on the rate of incident breast cancer death. Although the assumption of stable preferences may be questionable, its impact will be small if there is little screening in the first time period. However, estimates may be substantially confounded by improvements in systemic therapy over time. Therefore the results should be interpreted with care.
authors.affiliation: Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892-7354, USA. sb16i@nih.gov
authors.forename: Stuart G
authors.initials: SG
authors.lastname: Baker
authors.forename: Barrett S
authors.initials: BS
authors.lastname: Kramer
authors.forename: Philip C
authors.initials: PC
authors.lastname: Prorok
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000401:mortality*; D005260:Female; D005843:Geography; D006297:Health Services Accessibility / Q000706:statistics & numerical data*; D006801:Humans; D008327:Mammography / Q000706:statistics & numerical data*; D008403:Mass Screening / Q000706:statistics & numerical data*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D016012:Poisson Distribution; D011336:Probability; D012107:Research Design; D013548:Sweden / Q000453:epidemiology; D013997:Time Factors