A History of Health Economics and Healthcare Delivery Research at the National Cancer Institute.

With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and delivery has become increasingly important. The Healthcare Delivery Research Program (HDRP) in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) was formed in 2015 to provide a hub for cancer-related healthcare delivery and economics research. However, the roots of this program trace back much farther, at least to the formation of the NCI Division of Cancer Prevention and Control in 1983. The creation of a division focused on understanding and explaining trends in cancer morbidity and mortality was instrumental in setting the direction of cancer-related healthcare delivery and health economics research over the subsequent decades. In this commentary, we provide a brief history of health economics and healthcare delivery research at NCI, describing the organizational structure and highlighting key initiatives developed by the division, and also briefly discuss future directions. HDRP and its predecessors have supported the growth and evolution of these fields through the funding of grants and contracts; the development of data, tools, and other research resources; and thought leadership including stimulation of research on previously understudied topics. As the availability of new data, methods, and computing capacity to evaluate cancer-related healthcare delivery and economics expand, HDRP aims to continue to support this growth and evolution.

Evaluating Lung Cancer Screening Across Diverse Healthcare Systems: A Process Model from the Lung PROSPR Consortium.

Numerous organizations, including the United States Preventive Services Task Force, recommend annual lung cancer screening (LCS) with low-dose CT for high risk adults who meet specific criteria. Despite recommendations and national coverage for screening eligible adults through the Centers for Medicare and Medicaid Services, LCS uptake in the United States remains low (<4%). In recognition of the need to improve and understand LCS across the population, as part of the larger Population-based Research to Optimize the Screening PRocess (PROSPR) consortium, the NCI (Bethesda, MD) funded the Lung PROSPR Research Consortium consisting of five diverse healthcare systems in Colorado, Hawaii, Michigan, Pennsylvania, and Wisconsin. Using various methods and data sources, the center aims to examine utilization and outcomes of LCS across diverse populations, and assess how variations in the implementation of LCS programs shape outcomes across the screening process. This commentary presents the PROSPR LCS process model, which outlines the interrelated steps needed to complete the screening process from risk assessment to treatment. In addition to guiding planned projects within the Lung PROSPR Research Consortium, this model provides insights on the complex steps needed to implement, evaluate, and improve LCS outcomes in community practice.

Screening flexible sigmoidoscopy versus colonoscopy for reduction of colorectal cancer mortality.

PURPOSE: Colonoscopy and flexible sigmoidoscopy are both recommended colorectal cancer (CRC) screening strategies, but their relative effectiveness is unclear. We sought to evaluate the ability of each of these two modalities to reduce CRC mortality. METHODS: We conducted a case-control study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Cases were persons aged 70-85 years who died of CRC and were matched to up to three non-CRC controls. Receipt of endoscopy was ascertained from Medicare claims and endoscopy indication assigned using a validated algorithm. Conditional logistic regression models were developed to estimate the association between screening colonoscopy or sigmoidoscopy and CRC mortality. We conducted secondary analyses by race, sex, and endoscopist characteristics, and with varying duration of the look-back period. RESULTS: In the initial analysis using all available look-back years, screening flexible sigmoidoscopy was associated with a 35% reduction in CRC mortality (OR 0.65, 95% CI 0.48, 0.89), while screening colonoscopy was associated with a 74% reduction (OR 0.26, 95% CI 0.23, 0.30). Sigmoidoscopy was not associated with any reduction in proximal CRC mortality. The association between colonoscopy and reduced CRC mortality was stronger in the distal than the proximal colon. Results were similar in analyses using a 5-year look-back period. CONCLUSIONS: Screening colonoscopy was associated with greater reductions in CRC mortality than screening sigmoidoscopy, and with a greater reduction in the distal than the proximal colon. These results provide additional information on the relative benefits of screening for CRC with sigmoidoscopy and colonoscopy.

Case-Control Studies of the Efficacy of Screening Tests That Seek to Prevent Cancer Incidence: Results of an Approach That Utilizes Administrative Claims Data That Do Not Provide Information Regarding Test Indication.

Case-control studies evaluating a screening test's efficacy in reducing cancer mortality require accurate classification of test indication to obtain a valid result. However, for analogous studies of cancer incidence, determination of test indication is not as critical because, to define exposure, we need consider only tests that can identify precursor lesions whose treatment might prevent cancer, not tests leading to cancer diagnosis. This study utilizes US Surveillance, Epidemiology, and End Results (SEER)-Medicare data, which do not include information about colonoscopy indication, to evaluate the efficacy of colonoscopy in preventing colorectal cancer (CRC) incidence. Cases were Medicare enrollees diagnosed with CRC between 1996 and 2013; up to 3 controls were matched to each case. Colonoscopy receipt prior to presumed onset of occult cancer was associated with an approximately 60% reduction in CRC incidence (odds ratio = 0.41, 95% confidence interval: 0.40, 0.42). The association was robust to differing exposure windows and estimates of occult cancer duration and is similar to those from CRC incidence studies in which exam indication was available. Our results suggest that, when it is impractical/impossible to determine whether tests were conducted for screening, the efficacy of a test in preventing cancer incidence can still be estimated using a case-control study design.

Evaluating Lung Cancer Screening Uptake, Outcomes, and Costs in the United States: Challenges With Existing Data and Recommendations for Improvement.

The National Lung Screening Trial (NLST) reported substantial reduction in lung cancer mortality among high-risk individuals screened annually with low-dose helical computed tomography (LDCT). As a result, the US Preventive Services Task Force issued a B recommendation for annual LDCT in high-risk individuals, which requires private insurers to cover it without cost-sharing. The Medicare program also covers LDCT for high-risk beneficiaries without cost-sharing. However, the NLST findings may not be generalizable to the community setting because of differences in patients, providers, and practices participating in the NLST. Thus, examining uptake of LDCT screening in community practice is critical, as is evaluating the immediate and downstream outcomes of screening, including false-positive scans, follow-up examinations and adverse events, costs, stage of disease at diagnosis, and survival. This commentary presents an overview of the landscape of the data resources currently available to evaluate the uptake, outcomes, and costs of LDCT screening in the United States. We describe the strengths and limitations of existing data sources, including administrative databases, surveys, and registries. Thereafter, we provide recommendations for improving the data infrastructure pertaining to three overarching research areas: receipt of guideline-consistent screening and follow-up, weighing benefits and harms of screening, and costs of screening.

Training in the Conduct of Population-Based Multi-Site and Multi-Disciplinary Studies: the Cancer Research Network's Scholars Program.

Expanding research capacity of large research networks within health care delivery systems requires strategically training both embedded and external investigators in necessary skills for this purpose. Researchers new to these settings frequently lack the skills and specialized knowledge conducive to multi-site and multi-disciplinary research set in delivery systems. This report describes the goals and components of the Cancer Research Network (CRN) Scholars Program, a 26-month training program developed to increase the capacity for cancer research conducted within the network's participating sites, its progression from training embedded investigators to a mix of internal and external investigators, and the content evolution of the training program. The CRN Scholars program was launched in 2007 to assist junior investigators from member sites develop independent and sustainable research programs within the CRN. Resulting from CRN's increased emphasis on promoting external collaborations, the 2013 Scholars program began recruiting junior investigators from external institutions committed to conducting delivery system science. Based on involvement of this broader population and feedback from prior Scholar cohorts, the program has honed its focus on specific opportunities and issues encountered in conducting cancer research within health care delivery systems. Efficiency and effectiveness of working within networks is accelerated by strategic and mentored navigation of these networks. Investing in training programs specific to these settings provides the opportunity to improve multi-disciplinary and multi-institutional collaboration, particularly for early-stage investigators. Aspects of the CRN Scholars Program may help inform others considering developing similar programs to expand delivery system research or within large, multi-disciplinary research networks.

Screening colonoscopy and risk for incident late-stage colorectal cancer diagnosis in average-risk adults: a nested case-control study.

BACKGROUND: The effectiveness of screening colonoscopy in average-risk adults is uncertain, particularly for right colon cancer. OBJECTIVE: To examine the association between screening colonoscopy and risk for incident late-stage colorectal cancer (CRC). DESIGN: Nested case-control study. SETTING: Four U.S. health plans. PATIENTS: 1039 average-risk adults enrolled for at least 5 years in one of the health plans. Case patients were aged 55 to 85 years on their diagnosis date (reference date) of stage IIB or higher (late-stage) CRC during 2006 to 2008. One or 2 control patients were selected for each case patient, matched on birth year, sex, health plan, and prior enrollment duration. MEASUREMENTS: Receipt of CRC screening 3 months to 10 years before the reference date, ascertained through medical record audits. Case patients and control patients were compared on receipt of screening colonoscopy or sigmoidoscopy by using conditional logistic regression that accounted for health history, socioeconomic status, and other screening exposures. RESULTS: In analyses restricted to 471 eligible case patients and their 509 matched control patients, 13 case patients (2.8%) and 46 control patients (9.0%) had undergone screening colonoscopy, which corresponded to an adjusted odds ratio (AOR) of 0.29 (95% CI, 0.15 to 0.58) for any late-stage CRC, 0.36 (CI, 0.16 to 0.80) for right colon cancer, and 0.26 (CI, 0.06 to 1.11; P = 0.069) for left colon/rectum cancer. Ninety-two case patients (19.5%) and 173 control patients (34.0%) had screening sigmoidoscopy, corresponding to an AOR of 0.50 (CI, 0.36 to 0.70) overall, 0.79 (CI, 0.51 to 1.23) for right colon late-stage cancer, and 0.26 (CI, 0.14 to 0.48) for left colon cancer. LIMITATION: The small number of screening colonoscopies affected the precision of the estimates. CONCLUSION: Screening with colonoscopy in average-risk persons was associated with reduced risk for diagnosis of incident late-stage CRC, including right-sided colon cancer. For sigmoidoscopy, this association was seen for left CRC, but the association for right colon late-stage cancer was not statistically significant.

Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty.

PURPOSE: We designed this study to evaluate the association of colonoscopy with colorectal cancer (CRC) death in the United States by site of CRC and endoscopist specialty. METHODS: We designed a case-control study using Surveillance, Epidemiology, and End Results (SEER)-Medicare data. We identified patients (cases) diagnosed with CRC age 70 to 89 years from January 1998 through December 2002 who died as a result of CRC by 2007. We selected three matched controls without cancer for each case. Controls were assigned a referent date (date of diagnosis of the case). Colonoscopy performed from January 1991 through 6 months before the diagnosis/referent date was our primary exposure. We compared exposure to colonoscopy in cases and controls by using conditional logistic regression controlling for covariates, stratified by site of CRC. We determined endoscopist specialty by linkage to the American Medical Association (AMA) Masterfile. We assessed whether the association between colonoscopy and CRC death varied with endoscopist specialty. RESULTS: We identified 9,458 cases (3,963 proximal [41.9%], 4,685 distal [49.5%], and 810 unknown site [8.6%]) and 27,641 controls. In all, 11.3% of cases and 23.7% of controls underwent colonoscopy more than 6 months before diagnosis. Compared with controls, cases were less likely to have undergone colonoscopy (odds ratio [OR], 0.40; 95% CI, 0.37 to 0.43); the association was stronger for distal (OR, 0.24; 95% CI, 0.21 to 0.27) than proximal (OR, 0.58; 95% CI, 0.53 to 0.64) CRC. The strength of the association varied with endoscopist specialty. CONCLUSION: Colonoscopy is associated with a reduced risk of death from CRC, with the association considerably and consistently stronger for distal versus proximal CRC. The overall association was strongest if colonoscopy was performed by a gastroenterologist.