Validation of Self-Report of Chest X-Ray Exam at a Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Center
2015
It is imperative to measure the degree of contamination throughout the course of randomized
controlled trials, as contamination, the receipt of the intervention arm regimen by control arm
participants, can affect trial power. In the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer
Screening Trial, contamination was estimated through use of the self-administered Health Status
Questionnaire (HSQ) annually to a randomly-selected subset of control arm participants. We examined agreement of selfreport
of chest x-ray on the HSQ with clinic records at one of the 10 PLCO screening centers (Henry Ford Health System,
or HFHS). We focus on HFHS participants covered by the Health Alliance Plan (HAP), a managed health care insurance
plan owned and operated by HFHS, because claims for care received both at HFHS and other facilities are available in
HFHS databases for HAP enrollees. We examined agreement for the six years prior to HSQ completion, with HFHS clinic
records considered to be the gold standard. For those who had complete HAP coverage during the six years, percent
agreement was 0.69, sensitivity was 0.84, and positive predictive value was 0.76. Specificity and negative predicted value
were low, however (0.28 and 0.38, respectively), and Cohen’s kappa was 0.13. For groups with incomplete or no HAP
coverage, and when timing of exam was considered, performance measures typically became lower, in some instances below
0.20. These data suggest that self-report of chest x-ray screening may not be accurate, although high prevalence of
chest x-ray may make performance measures less interpretable.
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