The screening of persons at risk for lung cancer may reduce lung-cancer mortality by 20%. Although cost-effectiveness estimates vary widely depending on assumptions, a careful analysis indicates that ...the cost is $81,000 per quality-adjusted life-year.
Lung cancer is the leading cause of cancer-related deaths in the United States
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; however, until recently, no method of screening had been shown to reduce mortality from lung cancer. The National Lung Screening Trial (NLST) showed that screening with low-dose helical computed tomography (CT) of the chest in patients at high risk for lung cancer was associated with a 20% reduction in lung-cancer mortality.
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Several major medical societies have since recommended screening with low-dose CT for patients with a similarly high risk of lung cancer.
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The U.S. Preventive Services Task Force has released a grade B recommendation for low-dose . . .
Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, ...critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.
Some
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readers may have noticed more parsimonious reporting of P values in our research articles over the past year. For example, in November 2018, we published two reports from the Vitamin D ...and Omega-3 Trial (VITAL),
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a two-by-two factorial, placebo-controlled, randomized trial assessing whether vitamin D or marine n−3 (also known as omega-3) fatty acids prevent cardiovascular disease or cancer. For the n−3 portion of the trial, Manson et al.
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reported 2 prespecified primary outcomes and 22 prespecified and other secondary outcomes — not uncommon in large, expensive randomized or observational studies. The n−3 fatty acids did not significantly . . .
Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, ...critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting Diagnostic Accuracy (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.
An analysis of the results of this trial, which compared low-dose CT with chest radiography, showed that CT had a lower positive predictive value for a positive screening result but detected more ...lung cancers at earlier stages.
The National Lung Screening Trial (NLST) was a randomized trial of lung-cancer–specific mortality among participants in an asymptomatic high-risk cohort who underwent screening with the use of low-dose helical computed tomography (CT) as compared with screening with the use of single-view posteroanterior chest radiography. The NLST showed a 20% relative reduction in mortality from lung cancer with three rounds of low-dose CT screening (rounds T0, T1, and T2) as compared with radiography.
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In this article, we present more detailed findings from the two incidence screenings (rounds T1 and T2), including information on rates of positive screening tests, performance characteristics of . . .
Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient ...groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports.
To evaluate volumetric magnetic resonance (MR) imaging for predicting recurrence-free survival (RFS) after neoadjuvant chemotherapy (NACT) of breast cancer and to consider its predictive performance ...relative to pathologic complete response (PCR).
This HIPAA-compliant prospective multicenter study was approved by institutional review boards with written informed consent. Women with breast tumors 3 cm or larger scheduled for NACT underwent dynamic contrast-enhanced MR imaging before treatment (examination 1), after one cycle (examination 2), midtherapy (examination 3), and before surgery (examination 4). Functional tumor volume (FTV), computed from MR images by using enhancement thresholds, and change from baseline (ΔFTV) were measured after one cycle and before surgery. Association of RFS with FTV was assessed by Cox regression and compared with association of RFS with PCR and residual cancer burden (RCB), while controlling for age, race, and hormone receptor (HR)/ human epidermal growth factor receptor type 2 (HER2) status. Predictive performance of models was evaluated by C statistics.
Female patients (n = 162) with FTV and RFS were included. At univariate analysis, FTV2, FTV4, and ΔFTV4 had significant association with RFS, as did HR/HER2 status and RCB class. PCR approached significance at univariate analysis and was not significant at multivariate analysis. At univariate analysis, FTV2 and RCB class had the strongest predictive performance (C statistic = 0.67; 95% confidence interval CI: 0.58, 0.76), greater than for FTV4 (0.64; 95% CI: 0.53, 0.74) and PCR (0.57; 95% CI: 0.39, 0.74). At multivariate analysis, a model with FTV2, ΔFTV2, RCB class, HR/HER2 status, age, and race had the highest C statistic (0.72; 95% CI: 0.60, 0.84).
Breast tumor FTV measured by MR imaging is a strong predictor of RFS, even in the presence of PCR and RCB class. Models combining MR imaging, histopathology, and breast cancer subtype demonstrated the strongest predictive performance in this study.
Systematic reviews of diagnostic test accuracy (DTA) studies are fundamental to the decision making process in evidence based medicine. Although such studies are regarded as high level evidence, ...these reviews are not always reported completely and transparently. Suboptimal reporting of DTA systematic reviews compromises their validity and generalisability, and subsequently their value to key stakeholders. An extension of the PRISMA (preferred reporting items for systematic review and meta-analysis) statement was recently developed to improve the reporting quality of DTA systematic reviews. The PRISMA-DTA statement has 27 items, of which eight are unmodified from the original PRISMA statement. This article provides an explanation for the 19 new and modified items, along with their meaning and rationale. Examples of complete reporting are used for each item to illustrate best practices.
Patients with chest pain have a high hospital admission rate, but often no cardiac cause is found. In this trial, coronary CT angiography accurately identified patients who were free from coronary ...disease and could be safely discharged from the emergency department.
Patients who present to the emergency department with signs and symptoms consistent with a possible acute coronary syndrome pose a diagnostic dilemma.
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Despite the introduction of clinical decision rules
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and the improved sensitivity of cardiac markers,
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–
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most patients are admitted to the hospital so that an acute coronary syndrome can be ruled out, even though for most of these patients, the symptoms are ultimately found not to have a cardiac cause.
The absence of evidence of coronary disease on invasive coronary angiography is associated with a low risk of future cardiac events.
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,
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Coronary computed tomographic angiography . . .
Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by ...the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies.
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