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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.

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 1 ; 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. 2 Several major medical societies have since recommended screening with low-dose CT for patients with a similarly high risk of lung cancer. 3 The U.S. Preventive Services Task Force has released a grade B recommendation for low-dose . . .

Some Journal 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), 1,2 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. 2 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 . . .

To improve the quality of observational studies, target trial emulation requires careful specification of design elements, analytic methods for addressing confounding, and reporting of sensitivity analyses.

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. 1 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 . . .

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.

Annual low-dose CT screening for lung cancer has been recommended for high-risk individuals, but the necessity of yearly low-dose CT in all eligible individuals is uncertain. This study examined rates of lung cancer in National Lung Screening Trial (NLST) participants who had a negative prevalence (initial) low-dose CT screen to explore whether less frequent screening could be justified in some lower-risk subpopulations. We did a retrospective cohort analysis of data from the NLST, a randomised, multicentre screening trial comparing three annual low-dose CT assessments with three annual chest radiographs for the early detection of lung cancer in high-risk, eligible individuals (aged 55–74 years with at least a 30 pack-year history of cigarette smoking, and, if a former smoker, had quit within the past 15 years), recruited from US medical centres between Aug 5, 2002, and April 26, 2004. Participants were followed up for up to 5 years after their last annual screen. For the purposes of this analysis, our cohort consisted of all NLST participants who had received a low-dose CT prevalence (T0) screen. We determined the frequency, stage, histology, study year of diagnosis, and incidence of lung cancer, as well as overall and lung cancer-specific mortality, and whether lung cancers were detected as a result of screening or within 1 year of a negative screen. We also estimated the effect on mortality if the first annual (T1) screen in participants with a negative T0 screen had not been done. The NLST is registered with ClinicalTrials.gov, number NCT00047385. Our cohort consisted of 26 231 participants assigned to the low-dose CT screening group who had undergone their T0 screen. The 19 066 participants with a negative T0 screen had a lower incidence of lung cancer than did all 26 231 T0-screened participants (371·88 [95% CI 337·97–408·26] per 100 000 person-years vs 661·23 [622·07–702·21]) and had lower lung cancer-related mortality (185·82 [95% CI 162·17–211·93] per 100 000 person-years vs 277·20 [252·28–303·90]). The yield of lung cancer at the T1 screen among participants with a negative T0 screen was 0·34% (62 screen-detected cancers out of 18 121 screened participants), compared with a yield at the T0 screen among all T0-screened participants of 1·0% (267 of 26 231). We estimated that if the T1 screen had not been done in the T0 negative group, at most, an additional 28 participants in the T0 negative group would have died from lung cancer (a rise in mortality from 185·82 [95% CI 162·17–211·93] per 100 000 person-years to 212·14 [186·80–239·96]) over the course of the trial. Participants with a negative low-dose CT prevalence screen had a lower incidence of lung cancer and lung cancer-specific mortality than did all participants who underwent a prevalence screen. Because overly frequent screening has associated harms, increasing the interval between screens in participants with a negative low-dose CT prevalence screen might be warranted. None.

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. 1 – 6 Despite the introduction of clinical decision rules 6 – 15 and the improved sensitivity of cardiac markers, 15 – 17 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. 18 , 19 Coronary computed tomographic angiography . . .

Abstract Rationale Annual computed tomography (CT) is now widely recommended for lung cancer screening in the United States, although concerns remain regarding the potential harms, including those from overdiagnosis. Objectives To examine the effect of airflow limitation on overdiagnosis by comparing lung cancer incidence, histology, and stage shift in a subgroup of the National Lung Screening Trial (NLST). Methods In an NLST subgroup (n = 18,714), screening participants were randomized to annual computed tomography (CT, n = 9,357) or chest radiograph (n = 9,357) screening and monitored for a mean of 6.1 years. After baseline prebronchodilator spirometry, to identify the presence of airflow limitation, 18,475 subjects (99%) were assigned as having chronic obstructive pulmonary disease (COPD) or no COPD. Lung cancer prevalence, incidence, histology, and stage shift were compared after stratification by COPD. Measurements and Main Results For screening participants with spirometric COPD (n = 6,436), there was a twofold increase in lung cancer incidence (incident rate ratio, 2.15; P < 0.001) and, when compared according to screening arm, no excess lung cancers and comparable histology. Compared with chest radiography, there was also a trend favoring reduced late-stage and increased early-stage cancers in the CT arm (P = 0.054). For those with normal baseline spirometry (n = 12,039), we found an excess of lung cancers during screening in the CT arm, almost exclusively early-stage adenocarcinoma-related cancers (histology shift and overdiagnosis). After correction for these excess cancers, stage shift was marginal (P = 0.077). Conclusions In the CT arm of the NLST-ACRIN (American College of Radiology Imaging Network) cohort, COPD status was associated with a doubling of lung cancer incidence, no apparent overdiagnosis, and a more favorable stage shift.