Dataset Information

The National Lung Screening Trial's Endpoint Verification Process: determining the cause of death.

ABSTRACT:

Background

Randomized controlled trials (RCTs) evaluating cancer screening modalities usually employ cause-specific mortality as their primary endpoint. Because death certificate cause of death can be inaccurate, RCTs frequently use review committees to assign an underlying cause of death. We describe the National Lung Screening Trial's (NLST's) death review approach, the Endpoint Verification Process (EVP), which strives to minimize errors in assignment of cause of death due to lung cancer.

Methods

Deaths selected for review include those with a notation of lung cancer on the death certificate and those occurring among participants ever diagnosed with lung cancer. Other criteria that trigger death review include, but are not limited to, death within 6 months of a screen suspicious for lung cancer and death within 60 days of certain diagnostic evaluation procedures associated with a screen suspicious for lung cancer or a lung cancer diagnosis. EVP requires concordance on whether death was due to lung cancer. Deaths are first reviewed by the EVP chair. If concordance is not achieved, the death is next reviewed by an Endpoint Verification Team (EVT) member. If concordance between the chair- and member-assigned cause of death is not achieved, the death is next reviewed by a group of at least three EVT members. Cause of death is assigned at the step in which concordance was achieved, or if necessary, at the team review.

Conclusions

NLST's EVP is designed to produce a highly accurate count of lung cancer deaths.

SUBMITTER: Marcus PM

PROVIDER: S-EPMC3185147 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Publications

The National Lung Screening Trial's Endpoint Verification Process: determining the cause of death.

Marcus Pamela M PM Gareen Ilana F IF Miller Anthony B AB Rosenbaum Jennifer J Keating Kristen K Aberle Denise R DR Berg Christine D CD

Contemporary clinical trials 20110718 6

<h4>Background</h4>Randomized controlled trials (RCTs) evaluating cancer screening modalities usually employ cause-specific mortality as their primary endpoint. Because death certificate cause of death can be inaccurate, RCTs frequently use review committees to assign an underlying cause of death. We describe the National Lung Screening Trial's (NLST's) death review approach, the Endpoint Verification Process (EVP), which strives to minimize errors in assignment of cause of death due to lung can ...[more]

PMID: 21782037

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Project description:Background/aimsRandomized 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.MethodsDeaths 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.ResultsIn 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).ConclusionDeath 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.

Project description:Controversy exists whether the cause of death due to severe acute respiratory syndrome coronavirus 2 is directly related to the infection or to underlying conditions. The purpose of this study is to assess the relationship of severe acute respiratory syndrome coronavirus 2 infection with the cause of death in hospitalized patients.DesignRetrospective observational study; deidentified discharge summaries of deceased patients were reviewed by two intensivists and classified as coronavirus disease 2019-related (caused by severe acute respiratory syndrome coronavirus 2) or coronavirus disease 2019-unrelated (not caused by severe acute respiratory syndrome coronavirus 2 or indeterminate) deaths. For classification disagreement, a separate group of three intensivists reviewed the discharge summaries and arbitrated to determine the cause of death.SettingSingle-center study performed at the University of Texas Medical Branch.PatientsAll adult patients (> 18 yr) admitted from March 10, 2020, to October 22, 2020, with positive severe acute respiratory syndrome coronavirus 2 test results who expired during their hospitalization were identified.InterventionsNone.Measurements and main resultsPatient demographics, comorbidities, prescribed medications, and ventilatory support data were collected. Comparison between groups was performed using t test and chi-square test. During the study period, 1,052 patients were admitted within 14 days of severe acute respiratory syndrome coronavirus 2-positive test results, of whom 100 expired during the hospitalization. Deceased patients were predominantly male and older than 65 years. Obesity (body mass index ≥ 30 kg/m2) was present in 41%, and common comorbidities included hypertension (47%), diabetes (30%), and heart failure (20%). Death was classified as directly caused by severe acute respiratory syndrome coronavirus 2 in 85% and not caused by severe acute respiratory syndrome coronavirus 2 in 5%. An indeterminate cause of death in 10% was due to insufficient information or an atypical presentation. The observed interrater agreement on the cause of death classification was 81%.ConclusionsIn this single-center study, the majority of deaths in severe acute respiratory syndrome coronavirus 2-positive hospitalized patients were related to a typical or atypical presentation of coronavirus disease 2019 disease.

Dataset Information

The National Lung Screening Trial's Endpoint Verification Process: determining the cause of death.

Background

Methods

Conclusions

Publications

The National Lung Screening Trial's Endpoint Verification Process: determining the cause of death.

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