Estimating bias in causes of death ascertainment in the Finnish Randomized Study of Screening for Prostate Cancer |
| |
| Institution: | 1. Dept. of Urology, University of Helsinki and Helsinki University Hospital, FI-00029 Helsinki, Finland;2. Department of Surgery, Seinäjoki Central Hospital, FI-60220 Seinäjoki, Finland;3. Department of Forensic Medicine, School of Medicine, University of Tampere and Fimlab Laboratories, Tampere University Hospital Region, Finland;4. Department of Internal Medicine, Tampere University Hospital, FI-33521 Tampere, Finland;5. Finnish Cancer Registry, FI-00130 Helsinki, Finland;6. Dept. of Urology, University of Tampere and Tampere University Hospital, FI-33521 Tampere, Finland;7. School of Health Sciences, University of Tampere, FI-33014 Tampere, Finland;1. Department of Cancer Epidemiology–Oncological Research Center of Santa Catarina (CEPON/SC), Brazil;2. Department of Public Health–Post-graduation Program, Federal University of Santa Catarina (UFSC), Brazil;1. Department of Clinical Sciences and Community Health, Branch of Medical Statistics, Biometry and Epidemiology “G.A. Maccacaro”, Università degli Studi di Milano, Milan, Italy;2. Department of Epidemiology, IRCCS—Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy;3. Unit of Cancer Epidemiology, CRO Aviano National Cancer Institute, Aviano, Italy;4. Unit of Epidemiology, National Cancer Institute G. Pascale Foundation, Naples, Italy;5. Department of Biomedical Sciences, Università di Catania, Catania, Italy;6. Department of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy;7. Unit of Hygiene and Epidemiology, Department of Biological and Medical Sciences, Università di Udine, Udine, Italy;1. Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sahlgrenska University Hospital, Göteborg, Sweden;2. Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden;3. Department of Pathology, Institute of Biomedicine, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden;4. Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden;1. Department of Urology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus, Denmark;2. The Danish Clinical Registries (RKKP), Olaf Palmes Allé 15, 8200, Aarhus N, Denmark;3. Department of Public Health, Aarhus University, Bartholins Allé 2, Building 1260, 8000, Aarhus, Denmark;4. Diet, Genes and Environment, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark;5. Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014, Copenhagen, Denmark |
| |
| Abstract: | BackgroundPrecise cause of death (CoD) ascertainment is crucial in any cancer screening trial to avoid bias from misclassification due to excessive recording of diagnosed cancer as a CoD in death certificates instead of non-cancer disease that actually caused death. We estimated whether there was bias in CoD determination between screening (SA) and control arms (CA) in a population-based prostate cancer (PCa) screening trial.MethodsOur trial is the largest component of the European Randomized Study of Screening for Prostate Cancer with more than 80,000 men. Randomly selected deaths in men with PCa (N = 442/2568 cases, 17.2%) were reviewed by an independent CoD committee. Median follow-up was 16.8 years in both arms.ResultsOverdiagnosis of PCa was present in the SA as the risk ratio for PCa incidence was 1.19 (95% confidence interval (CI) 1.14–1.24). The hazard ratio (HR) for PCa mortality was 0.94 (95%CI 0.82–1.08) in favor of the SA. Agreement with official CoD registry was 94.6% (κ = 0.88) in the SA and 95.4% (κ = 0.91) in the CA. Altogether 14 PCa deaths were estimated as false-positive in both arms and exclusion of these resulted in HR 0.92 (95% CI 0.80–1.06).ConclusionsA small differential misclassification bias in ascertainment of CoD was present, most likely due to attribution bias (overdiagnosis in the SA). Maximum precision in CoD ascertainment can only be achieved with independent review of all deaths in the diseased population. However, this is cumbersome and expensive and may provide little benefit compared to random sampling. |
| |
| Keywords: | Mass screening Prostatic neoplasms Prostate-specific antigen Randomized controlled trials Mortality Cause of death |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
