Medical Care Costs Were Similar Across the Low-dose Computed Tomography and Chest X-Ray Arms of the National Lung Screening Trial Despite Different Rates of Significant Incidental Findings.

BACKGROUND: The National Lung Screening Trial (NLST) reported lung cancer and all-cause mortality reductions for low-dose computed tomography (LDCT) versus chest x-ray (CXR) screening. Although LDCT lung screening has received a grade B from the United States Preventive Services Task Force and is a covered service under most health plans, concerns remain on the costs engendered by screening, and the impact of the high rate of significant incidental finding (SIF) detection on those costs. METHODS: We linked American College of Radiology Imaging Network NLST and Medicare fee-for-service claims data for participants from 23 sites for 2002-2009. We performed participant-level analyses using generalized linear regression models to estimate the adjusted annual mean of the 3-year total medical costs per person in each study arm and within screen outcome categories (ever positive with abnormalities suspicious for lung cancer, always negative for abnormalities suspicious for lung cancer, but with SIFs, and always negative without SIFs). RESULTS: The adjusted annual mean total per person costs were not significantly different between screening arms [LDCT, $11,029 (95% confidence interval, $10,107-$11,951); CXR, $10,905 (95% confidence interval, $10,059-$11,751)], despite higher proportions of individuals with SIFs in the LDCT versus the CXR arm (18% vs. 4%; P<0.0001). CONCLUSIONS: We found little difference in total annual per person costs between LDCT-screened and CXR-screened Medicare participants, despite the higher number of SIFs in the LDCT arm of the study.

Regional Variation of Computed Tomographic Imaging in the United States and the Risk of Nephrectomy.

Importance: While computed tomography (CT) represents a tremendous advance in diagnostic imaging, it also creates the problem of incidental detection-the identification of tumors unrelated to the clinical symptoms that initiate the test. Objective: To determine the geographic variation in the United States in CT imaging and the corresponding association with one of the most consequential sequelae of incidental detection: nephrectomy. Design, Setting, and Participants: This study is a cross-sectional analysis of age-, sex-, and race-adjusted Medicare data (January 2010-December 2014) from 306 hospital referral regions (HRRs) in the United States and includes information from 15 million fee-for-service Medicare beneficiaries age 65 to 85 years. Exposures: Regional CT risk (ie, the proportion of the population receiving either a chest or abdominal CT over 5 years). Main Outcomes and Measures: Five-year risk of nephrectomy (partial or total). Results: Data from 15 million fee-for-service Medicare beneficiaries age 65 to 85 years were gathered and illustrate that 43% of Medicare beneficiaries age 65 to 85 years received either a chest or abdominal CT from January 2010 to December 2014. This risk varied across the HRRs, ranging from 31% in Santa Cruz, California, to 52% in Sun City, Arizona. Increased regional CT risk was associated with a higher nephrectomy risk (r = 0.38; 95% CI, 0.28-0.47), particularly among HRRs with more than 50 000 beneficiaries (r = 0.47; 95% CI, 0.31-0.61). After controlling for HRR adult smoking rates, imaging an additional 1000 beneficiaries was associated with 4 additional nephrectomies (95% CI, 3-5). Case-fatality rates for those who underwent nephrectomy were 2.1% at 30 days and 4.3% at 90 days. Conclusions and Relevance: Fee-for-service Medicare beneficiaries are commonly exposed to CT imaging. Those residing in high-scanning regions face a higher risk of nephrectomy, presumably reflecting the incidental detection of renal masses. Additional surgery should be considered one of the risks of excessive CT imaging.

Computed tomography screening for lung cancer in the National Lung Screening Trial: a cost-effectiveness analysis.

The National Lung Screening Trial (NLST) demonstrated that screening with low-dose CT versus chest radiography reduced lung cancer mortality by 16% to 20%. More recently, a cost-effectiveness analysis (CEA) of CT screening for lung cancer versus no screening in the NLST was performed. The CEA conformed to the reference-case recommendations of the US Panel on Cost-Effectiveness in Health and Medicine, including the use of the societal perspective and an annual discount rate of 3%. The CEA was based on several important assumptions. In this paper, I review the methods and assumptions used to obtain the base case estimate of $81,000 per quality-adjusted life-year gained. In addition, I show how this estimate varied widely among different subsets and when some of the base case assumptions were changed and speculate on the cost-effectiveness of CT screening for lung cancer outside the NLST.

Cost-effectiveness of CT screening in the National Lung Screening Trial.

BACKGROUND: The National Lung Screening Trial (NLST) showed that screening with low-dose computed tomography (CT) as compared with chest radiography reduced lung-cancer mortality. We examined the cost-effectiveness of screening with low-dose CT in the NLST. METHODS: We estimated mean life-years, quality-adjusted life-years (QALYs), costs per person, and incremental cost-effectiveness ratios (ICERs) for three alternative strategies: screening with low-dose CT, screening with radiography, and no screening. Estimations of life-years were based on the number of observed deaths that occurred during the trial and the projected survival of persons who were alive at the end of the trial. Quality adjustments were derived from a subgroup of participants who were selected to complete quality-of-life surveys. Costs were based on utilization rates and Medicare reimbursements. We also performed analyses of subgroups defined according to age, sex, smoking history, and risk of lung cancer and performed sensitivity analyses based on several assumptions. RESULTS: As compared with no screening, screening with low-dose CT cost an additional $1,631 per person (95% confidence interval [CI], 1,557 to 1,709) and provided an additional 0.0316 life-years per person (95% CI, 0.0154 to 0.0478) and 0.0201 QALYs per person (95% CI, 0.0088 to 0.0314). The corresponding ICERs were $52,000 per life-year gained (95% CI, 34,000 to 106,000) and $81,000 per QALY gained (95% CI, 52,000 to 186,000). However, the ICERs varied widely in subgroup and sensitivity analyses. CONCLUSIONS: We estimated that screening for lung cancer with low-dose CT would cost $81,000 per QALY gained, but we also determined that modest changes in our assumptions would greatly alter this figure. The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).

Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the U.S. Preventive Services Task Force.

BACKGROUND: The optimum screening policy for lung cancer is unknown. OBJECTIVE: To identify efficient computed tomography (CT) screening scenarios in which relatively more lung cancer deaths are averted for fewer CT screening examinations. DESIGN: Comparative modeling study using 5 independent models. DATA SOURCES: The National Lung Screening Trial; the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial; the Surveillance, Epidemiology, and End Results program; and the U.S. Smoking History Generator. TARGET POPULATION: U.S. cohort born in 1950. TIME HORIZON: Cohort followed from ages 45 to 90 years. PERSPECTIVE: Societal. INTERVENTION: 576 scenarios with varying eligibility criteria (age, pack-years of smoking, years since quitting) and screening intervals. OUTCOME MEASURES: Benefits included lung cancer deaths averted or life-years gained. Harms included CT examinations, false-positive results (including those obtained from biopsy/surgery), overdiagnosed cases, and radiation-related deaths. RESULTS OF BEST-CASE SCENARIO: The most advantageous strategy was annual screening from ages 55 through 80 years for ever-smokers with a smoking history of at least 30 pack-years and ex-smokers with less than 15 years since quitting. It would lead to 50% (model ranges, 45% to 54%) of cases of cancer being detected at an early stage (stage I/II), 575 screening examinations per lung cancer death averted, a 14% (range, 8.2% to 23.5%) reduction in lung cancer mortality, 497 lung cancer deaths averted, and 5250 life-years gained per the 100,000-member cohort. Harms would include 67,550 false-positive test results, 910 biopsies or surgeries for benign lesions, and 190 overdiagnosed cases of cancer (3.7% of all cases of lung cancer [model ranges, 1.4% to 8.3%]). RESULTS OF SENSITIVITY ANALYSIS: The number of cancer deaths averted for the scenario varied across models between 177 and 862; the number of overdiagnosed cases of cancer varied between 72 and 426. LIMITATIONS: Scenarios assumed 100% screening adherence. Data derived from trials with short duration were extrapolated to lifetime follow-up. CONCLUSION: Annual CT screening for lung cancer has a favorable benefit-harm ratio for individuals aged 55 through 80 years with 30 or more pack-years' exposure to smoking. PRIMARY FUNDING SOURCE: National Cancer Institute.

Methodology and application of clinical trials in radiology: self-assessment module.

The educational objectives of this self-assessment module are for the participant to understand the differences between cohort and case-control studies in radiology, to understand the advantages of randomized controlled trials over observational studies, to understand the basic principles underlying the use of imaging examinations for screening asymptomatic populations for particular diseases, and to understand the biases associated with the use of survival statistics in the evaluation of screening.

Methodology and application of prospective reader studies: self-assessment module.

The educational objectives of this self-assessment module are for the participant to read selected sources on prospective reader study methodologies and to self-assess and improve his or her knowledge of this subject.

Computed tomography screening for lung cancer: review of screening principles and update on current status.

Screening for lung cancer with low-dose computed tomography (CT) is controversial. In favor of screening, lung cancer is the leading cause of cancer death in the United States, and those at greatest risk are identified readily on the basis of age and smoking history. In addition, it is well established that CT is far more sensitive than chest radiography in detecting lung cancer when it is small and asymptomatic. Furthermore, very high rates of survival were reported recently for screen-detected lung cancers in a large, multinational, single-arm observational study. However, a reduction in lung cancer mortality has not been demonstrated to date, and a recent longitudinal study with a simulated control group suggested little or no mortality reduction. In addition, there are important harms from CT screening, including false-positive test results and overdiagnosis. Furthermore, healthcare resources are finite. Therefore, even if the benefits do outweigh the harms, the cost-effectiveness of CT screening for lung cancer still will need to be considered in the context of competing healthcare alternatives. The objectives of this article were 3-fold: 1) to review the basic principles of screening and study designs related to cancer screening, 2) to summarize the results of the observational and analytical studies of CT screening that have been reported to date, and 3) to describe the design of the 2 ongoing, randomized controlled trials of CT screening and what may be learned from these studies in the near future.

Randomized clinical trials for cancer screening: rationale and design considerations for imaging tests.

Since the 1960s, there have been revolutionary developments in imaging technology. Undoubtedly, these advances in imaging technology have made it possible to detect most cancers much earlier than they would have presented with clinical signs or symptoms. However, there are harms from screening, including false-positive results and overdiagnosis, and the costs of screening can be substantial. Therefore, screening for cancer must be rigorously evaluated to ensure that it provides more benefit than harm at an acceptable cost. Unfortunately, the evaluation of cancer screening is difficult and susceptible to several forms of bias. Randomized clinical trials are the most valid study design for cancer screening, but they cannot be expected to answer all the questions that arise with the implementation of screening. Decision modeling can be used to extrapolate the results of randomized clinical trials to help inform public policy and individual decision making.

Clinicians' perceptions of the value of ventilation-perfusion scans.

RATIONALE: The goal of this investigation was to understand clinicians' perceptions of the probability of pulmonary embolism as a function of V/Q scan results of normal, low, intermediate, and high probability. METHODS: A questionnaire was developed and distributed to 429 clinicians at a single academic medical center. The response rate was 44% (188 of 429). The questions included level of training, specialty, probability of PE given 1 of the 4 V/Q scan results, and estimations of the charges for V/Q scanning and pulmonary angiography, and estimations of the risks of pulmonary angiography. RESULTS: The medians and ranges for the probability of pulmonary embolism given a normal, low, intermediate, and high probability V/Q scan result were 2.5% (0-30), 12.5% (0.5-52.5), 41.25% (5-75), and 85% (5-100), respectively. Eleven percent (21 of 188) of the respondents listed the probability of PE in patients with a low probability V/Q scan as being 5% or less, and 33% (62 of 188) listed the probability of PE given an intermediate probability scan as 50% or greater. The majority correctly identified the rate of serious complications of pulmonary arteriography, but many respondents underestimated the charge for V/Q scans and pulmonary arteriography. CONCLUSIONS: A substantial minority of clinicians do not understand the probability of pulmonary embolism in patients with low and intermediate probability ventilation-perfusion scans. More quantitative reporting of results is recommended. This could be particularly important because VQ scans are used less frequently but are still needed in certain clinical situations.

The appropriateness of employing imaging screening technologies: report of the methods committee of the ACR task force on screening technologies.

Screening for disease using imaging technologies is a growing phenomenon. For some applications (e.g., mammography and breast cancer), there is solid evidence that imaging screening reduces disease-specific mortality. However, for other applications, the public interest in imaging screening is progressing despite a lack of valid scientific evidence that such screening improves the public's health. Clinical trials promise to eventually shed light on the value of imaging screening, but the results of these trials will not be known for several years. In the meantime, physicians and the public need guidance on whether specific imaging screening examinations are appropriate. The ACR charged the Methods Committee of its Task Force on Screening Technologies to advise the organization on how it could best use available evidence to make public recommendations on imaging screening technologies. This article is the outcome of the committee's deliberations, including recommendations for the method of arriving at a recommendation, the approach to dissemination, and to whom the recommendations should be targeted.