Did death certificates and a death review process agree on lung cancer cause of death in the National Lung Screening Trial?
| العنوان: | Did death certificates and a death review process agree on lung cancer cause of death in the National Lung Screening Trial? |
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| المؤلفون: | Heather M. Rozjabek, Ilana F. Gareen, Anthony B. Miller, Kathy L. Clingan, Pamela M. Marcus, Vincent P. Doria-Rose, JoRean D. Sicks, Brenda K. Brewer, Kristen Keating, Jennifer Rosenbaum, Joshua M. Rathmell |
| المصدر: | Clinical Trials. 13:434-438 |
| بيانات النشر: | SAGE Publications, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Lung Neoplasms, Sensitivity and Specificity, Article, Death Certificates, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Cause of Death, Internal medicine, Cancer screening, medicine, Humans, Mass Screening, 030212 general & internal medicine, Lung cancer, Intensive care medicine, Mass screening, Aged, Randomized Controlled Trials as Topic, Cause of death, Pharmacology, business.industry, Smoking, General Medicine, Middle Aged, medicine.disease, 030220 oncology & carcinogenesis, Female, National Lung Screening Trial, Death certificate, business, Algorithms, Lung cancer screening |
| الوصف: | Background/aims: Randomized controlled trials frequently use death review committees to assign a cause of death rather than relying on cause of death information from death certificates. The National Lung Screening Trial, a randomized controlled trial of lung cancer screening with low-dose computed tomography versus chest X-ray for heavy and/or long-term smokers ages 55–74 years at enrollment, used a committee blinded to arm assignment for a subset of deaths to determine whether cause of death was due to lung cancer. Methods: Deaths were selected for review using a pre-determined computerized algorithm. The algorithm, which considered cancers diagnosed during the trial, causes and significant conditions listed on the death certificate, and the underlying cause of death derived from death certificate information by trained nosologists, selected deaths that were most likely to represent a death due to lung cancer (either directly or indirectly) and deaths that might have been erroneously assigned lung cancer as the cause of death. The algorithm also selected deaths that might be due to adverse events of diagnostic evaluation for lung cancer. Using the review cause of death as the gold standard and lung cancer cause of death as the outcome of interest (dichotomized as lung cancer versus not lung cancer), we calculated performance measures of the death certificate cause of death. We also recalculated the trial primary endpoint using the death certificate cause of death. Results: In all, 1642 deaths were reviewed and assigned a cause of death (42% of the 3877 National Lung Screening Trial deaths). Sensitivity of death certificate cause of death was 91%; specificity, 97%; positive predictive value, 98%; and negative predictive value, 89%. About 40% of the deaths reclassified to lung cancer cause of death had a death certificate cause of death of a neoplasm other than lung. Using the death certificate cause of death, the lung cancer mortality reduction was 18% (95% confidence interval: 4.2–25.0), as compared with the published finding of 20% (95% confidence interval: 6.7–26.7). Conclusion: Death review may not be necessary for primary-outcome analyses in lung cancer screening trials. If deemed necessary, researchers should strive to streamline the death review process as much as possible. |
| تدمد: | 1740-7753 1740-7745 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b921275c36a87b3109cdae76d2d7895b https://doi.org/10.1177/1740774516638345 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b921275c36a87b3109cdae76d2d7895b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17407753 17407745 |
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