Comparisons of Medical Cost Trajectories Between Non-Hispanic Black and Non-Hispanic White Patients With Newly Diagnosed Localized Prostate Cancer.

OBJECTIVES: This study applied a recently developed statistical method to compare the mean cost trajectories between non-Hispanic White (NHW) and non-Hispanic Black (NHB) patients with localized prostate cancer conditioning on patients' survival. METHODS: In this observational study, we modeled cost trajectories of NHW and NHB patients with localized prostate cancer for 3 survival durations: 24, 48, and 72 months. We also compared the cost trajectories between NHW and NHB, stratified by comorbidities scores. RESULTS: We find that the mean cost trajectories of NHB were significantly higher than the trajectories of NHW in the last 12 months before death, regardless of the survival duration and patients' baseline comorbidity scores. For patients with comorbidity score ≥2, mean cost trajectories within the first year of diagnosis for NHB were significantly higher than those for NHW, except for the subgroup of patients with comorbidity 2-3 and whose survival length was 72 months. CONCLUSIONS: Our results suggested that a higher proportion of NHB patients with high comorbidity scores are likely contribute to their higher end-of-life costs than those for NHW patients. To narrow the gap in healthcare-related financial burden between NHB and NHW patients with localized prostate cancer, policy makers need to explore different strategies to better manage comorbidities.

Resource and Reimbursement Barriers to Comprehensive Cancer Care Delivery: An Analysis of Association of Community Cancer Centers Survey Data.

PURPOSE: Comprehensive cancer care (CCC) delivery is recommended in guidelines and considered essential for high-quality cancer management. Barriers, such as insufficient reimbursement, prevent consistent access to and delivery of CCC. Association of Community Cancer Centers conducted a national survey to elucidate capacity and barriers to CCC delivery to inform policy and value-based payment reform. METHODS: Survey methodology included item generation with expert review, iterative piloting, and cognitive validity testing. In the final instrument, 27 supportive oncology services were assessed for availability, reasons not offered, and coverage/reimbursement. RESULTS: 204 of 704 member programs completed survey questions. Despite most services being reported as offered, a minority were funded through insurance reimbursement. The services least likely to obtain reimbursement were those that address practical and family/childcare needs (0.7%), caregiver support (1.5%), advanced care directives (1.7%), spiritual services (1.8%), and navigation (2.7%). These findings did not vary by region or practice type. CONCLUSION: There is a lack of sufficient reimbursement, staffing, and budget to provide CCC across the United States. Care models and reimbursement policies must include CCC services to optimize delivery of cancer care.

Smoking cessation and shared decision-making practices about lung cancer screening among primary care providers.

OBJECTIVE: We describe primary care providers' current practice patterns related to smoking cessation counseling and lung cancer screening (LCS). METHODS: Family, internal medicine, and pulmonary medicine providers from two medical centers were asked to complete an electronic survey to report their practice patterns. RESULTS: Of 52 participating providers, most reported initiating three major components of a smoking cessation intervention often or very often: advise to quit (50, 96%), assess willingness to quit (47, 90%), and assist with counseling or pharmacotherapy (49, 94%). However, other components were less commonly initiated such as arranging follow-ups (only 11 providers indicated recommending them often or very often, 21%) and less than half of providers reported that they often or very often recommend cessation counseling or pharmacotherapy of any type (except varenicline), though family medicine providers were more likely to recommend pharmacotherapy compared to the other specialists (p < 0.01). The majority of providers (47, 92%) reported that they engage in informed/shared decision-making about LCS, although only about one-third (17, 33%) indicated using a patient decision aid. Pulmonary medicine providers were more likely to use decision aids than providers from internal or family medicine (p < 0.04). CONCLUSIONS: Within the context of LCS, primary care providers report often having conversations about smoking cessation with their patients who smoke, have no clear preference for type of treatment, and rarely use follow-up calls or visits pertaining to quitting smoking. While many providers report engaging in shared decision-making about LCS, few use a decision aid for this conversation.

Costs and Complications After a Diagnosis of Prostate Cancer Treated With Time-Efficient Modalities: An Analysis of National Medicare Data.

PURPOSE: Recent trends in payer and patient preferences increasingly incentivize time-efficient (≤2-week treatment time) prostate cancer treatments. METHODS AND MATERIALS: National Medicare claims from January 1, 2011, through December 31, 2014, were analyzed to identify newly diagnosed prostate cancers. Three "radical treatment" cohorts were identified (prostatectomy, brachytherapy, and stereotactic body radiation therapy [SBRT]) and matched to an active surveillance (AS) cohort by using inverse probability treatment weighting via propensity score. Total costs at 1 year after biopsy were calculated for each cohort, and treatment-specific costs were estimated by subtracting total 1-year costs in each radical treatment group from those in the AS group. RESULTS: Mean 1-year adjusted costs were highest among patients receiving SBRT ($26,895), lower for prostatectomy ($23,632), and lowest for brachytherapy ($19,980), whereas those for AS were $9687. Costs of radical modalities varied significantly by region, with the Mid-Atlantic and New England regions having the highest cost ranges (>$10,000) and the West South Central and Mountain regions the lowest range in costs (<$2000). Quantification of toxic effects showed that prostatectomy was associated with higher genitourinary incontinence (hazard ratio [HR] = 10.8 compared with AS) and sexual dysfunction (HR = 3.5), whereas the radiation modalities were associated with higher genitourinary irritation/bleeding (brachytherapy HR = 1.7; SBRT HR = 1.5) and gastrointestinal ulcer/stricture/fistula (brachytherapy HR = 2.7; SBRT HR = 3.0). Overall mean toxicity costs were highest among patients treated with prostatectomy ($3500) followed by brachytherapy ($1847), SBRT ($1327), and AS ($1303). CONCLUSIONS: Time-efficient treatment techniques exhibit substantial variability in toxicity and costs. Furthermore, geographic location substantially influenced treatment costs.

Comparative Effectiveness of Computed Tomography- Versus Ultrasound-Guided Percutaneous Radiofrequency Ablation Among Medicare Patients 65 Years of Age or Older With Hepatocellular Carcinoma.

BACKGROUND: For patients with hepatocellular carcinoma (HCC) not eligible for surgical resection, radiofrequency ablation (RFA) is a promising technique that reduces the risk of disease progression. OBJECTIVES: To evaluate whether the trend of image guidance for RFA is moving toward the more expensive computed tomography (CT) technology and to determine the clinical benefits of CT guidance over the ultrasound (US) guidance. METHODS: A cohort of 463 patients was identified from the Surveillance, Epidemiology, and End Results and Medicare-linked database. The temporal trends in use of image guidance were assessed using the Cochrane-Armitage test. The associations between modality of image guidance and survival, complications, and costs were assessed using the Cox regression model, the logistic regression model, and the generalized linear model, respectively. RESULTS: The use of CT-guided RFA increased sharply, from 20.7% in 2002 to 75.9% in 2011. Compared with CT-guided RFA, those who received US-guided RFA had comparable risk of periprocedural and delayed postprocedural complications. Stratified analyses by tumor size also showed no statistically significant difference. In adjusted survival analysis, no statistically significant difference was observed in overall and cancer-specific survival. Nevertheless, the cost of CT-guided RFA ($2847) was higher than that of US-guided RFA ($1862). CONCLUSIONS: Despite its rapid adoption over time, CT-guided RFA incurred higher procedural costs than US-guided RFA but did not significantly improve postprocedural complications and survival. Echoing the American Board of Internal Medicine's Choosing Wisely campaign and the American Society of Clinical Oncology's Value of Cancer Care initiative, findings from our study call for critical evaluation of whether CT-guided RFA provides high-value care for patients with HCC.

Assessing the Cost-Effectiveness of Updated Breast Cancer Screening Guidelines for Average-Risk Women.

BACKGROUND: Several specialty societies have recently updated their breast cancer screening guidelines in late 2015/early 2016. OBJECTIVES: To evaluate the cost-effectiveness of US-based mammography screening guidelines. METHODS: We developed a microsimulation model to generate the natural history of invasive breast cancer and capture how screening and treatment modified the natural course of the disease. We used the model to assess the cost-effectiveness of screening strategies, including annual screening starting at the age of 40 years, biennial screening starting at the age of 50 years, and a hybrid strategy that begins screening at the age of 45 years and transitions to biennial screening at the age of 55 years, combined with three cessation ages: 75 years, 80 years, and no upper age limit. Findings were summarized as incremental cost-effectiveness ratio (cost per quality-adjusted life-year [QALY]) and cost-effectiveness acceptability frontier. RESULTS: The screening strategy that starts annual mammography at the age of 45 years and switches to biennial screening between the ages of 55 and 75 years was the most cost-effective, yielding an incremental cost-effectiveness ratio of $40,135/QALY. Probabilistic analysis showed that the hybrid strategy had the highest probability of being optimal when the societal willingness to pay was between $44,000/QALY and $103,500/QALY. Within the range of commonly accepted societal willingness to pay, no optimal strategy involved screening with a cessation age of 80 years or older. CONCLUSIONS: The screening strategy built on a hybrid design is the most cost-effective for average-risk women. By considering the balance between benefits and harms in forming its recommendations, this hybrid screening strategy has the potential to optimize the health care system's investment in the early detection and treatment of breast cancer.

Sensitivity of Claims-Based Algorithms to Ascertain Smoking Status More Than Doubled with Meaningful Use.

BACKGROUND: The "meaningful use of certified electronic health record" policy requires eligible professionals to record smoking status for more than 50% of all individuals aged 13 years or older in 2011 to 2012. OBJECTIVES: To explore whether the coding to document smoking behavior has increased over time and to assess the accuracy of smoking-related diagnosis and procedure codes in identifying previous and current smokers. METHODS: We conducted an observational study with 5,423,880 enrollees from the year 2009 to 2014 in the Truven Health Analytics database. Temporal trends of smoking coding, sensitivity, specificity, positive predictive value, and negative predictive value were measured. RESULTS: The rate of coding of smoking behavior improved significantly by the end of the study period. The proportion of patients in the claims data recorded as current smokers increased 2.3-fold and the proportion of patients recorded as previous smokers increased 4-fold during the 6-year period. The sensitivity of each International Classification of Diseases, Ninth Revision, Clinical Modification code was generally less than 10%. The diagnosis code of tobacco use disorder (305.1X) was the most sensitive code (9.3%) for identifying smokers. The specificities of these codes and the Current Procedural Terminology codes were all more than 98%. CONCLUSIONS: A large improvement in the coding of current and previous smoking behavior has occurred since the inception of the meaningful use policy. Nevertheless, the use of diagnosis and procedure codes to identify smoking behavior in administrative data is still unreliable. This suggests that quality improvements toward medical coding on smoking behavior are needed to enhance the capability of claims data for smoking-related outcomes research.

Semiparametric Estimation of Longitudinal Medical Cost Trajectory.

Estimating the average monthly medical costs from disease diagnosis to a terminal event such as death for an incident cohort of patients is a topic of immense interest to researchers in health policy and health economics because patterns of average monthly costs over time reveal how medical costs vary across phases of care. The statistical challenges to estimating monthly medical costs longitudinally are multifold; the longitudinal cost trajectory (formed by plotting the average monthly costs from diagnosis to the terminal event) is likely to be nonlinear, with its shape depending on the time of the terminal event, which can be subject to right censoring. The goal of this paper is to tackle this statistically challenging topic by estimating the conditional mean cost at any month t given the time of the terminal event s. The longitudinal cost trajectories with different terminal event times form a bivariate surface of t and s, under the constraint t ≤ s. We propose to estimate this surface using bivariate penalized splines in an Expectation-Maximization algorithm that treats the censored terminal event times as missing data. We evaluate the proposed model and estimation method in simulations and apply the method to the medical cost data of an incident cohort of stage IV breast cancer patients from the Surveillance, Epidemiology and End Results-Medicare Linked Database.

Promoting the Appropriate Use of Advanced Radiation Technologies in Oncology: Summary of a National Cancer Policy Forum Workshop.

PURPOSE: Leaders in the oncology community are sounding a clarion call to promote "value" in cancer care decisions. Value in cancer care considers the clinical effectiveness, along with the costs, when selecting a treatment. To discuss possible solutions to the current obstacles to achieving value in the use of advanced technologies in oncology, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop, "Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology" in July 2015. The present report summarizes the discussions related to radiation oncology. METHODS AND MATERIALS: The workshop convened stakeholders, including oncologists, researchers, payers, policymakers, and patients. Speakers presented on key themes, including the rationale for a value discussion on advanced technology use in radiation oncology, the generation of scientific evidence for value of advanced radiation technologies, the effect of both scientific evidence and "marketplace" (or economic) factors on the adoption of technologies, and newer approaches to improving value in the practice of radiation oncology. The presentations were followed by a panel discussion with dialogue among the stakeholders. RESULTS: Challenges to generating evidence for the value of advanced technologies include obtaining contemporary, prospective, randomized, and representative comparative effectiveness data. Proposed solutions include the use of prospective registry data; integrating radiation oncology treatment, outcomes, and quality benchmark data; and encouraging insurance coverage with evidence development. Challenges to improving value in practice include the slow adoption of higher value and the de-adoption of lower value treatments. The proposed solutions focused on engaging stakeholders in iterative, collaborative, and evidence-based efforts to define value and promote change in radiation oncology practice. Recent examples of ongoing or successful responses to the discussed challenges were provided. CONCLUSIONS: Discussions of "value" have increased as a priority in the radiation oncology community. Practitioners in the radiation oncology community can play a critical role in promoting a value-oriented framework to approach radiation oncology treatment.

A comparison of patient-centered economic and clinical outcomes of post-mastectomy breast reconstruction between obese and non-obese patients.

BACKGROUND: The objectives of this study were to compare, by patient obesity status, the contemporary utilization patterns of different reconstruction surgery types, understand postoperative complication profiles in the community setting, and analyze the financial impact on health care payers and patients. METHODS: Using data from the MarketScan Health Risk Assessment Database and Commercial Claims and Encounters Database, we identified breast cancer patients who received breast reconstruction surgery following mastectomy between 2009 and 2012. The Cochran-Armitage test was used to evaluate the utilization pattern of breast reconstruction surgery. Multivariable logistic regressions were used to estimate the association between obesity status and infectious, wound, and perfusion complications within one year of surgery. A generalized linear model was used to compare total, complication-related, and out-of-pocket costs. RESULTS: The rate of TE/implant-based reconstruction increased significantly for non-obese patients but not for obese patients during the years analyzed, whereas autologous reconstruction decreased for both patient groups. Obesity was associated with higher odds of infectious, wound, and perfusion complications after TE/implant-based reconstruction, and higher odds of perfusion complications after autologous reconstruction. The adjusted total healthcare costs and out-of-pocket costs were similar for obese and non-obese patients for either type of breast reconstruction surgery. CONCLUSIONS: A greater likelihood of one-year complications arose from TE/implant-based vs autologous reconstruction surgery in obese patients. Given that out-of-pocket costs were independent of the type of reconstruction, greater emphasis should be placed on conveying the surgery-related complications to obese patients to aid in patient-based decision making with their plastic surgeons and oncologists.

Therapeutic substitutions in the midst of new technology diffusion: The case of treatment for localized prostate cancer.

Robotic surgical systems have become increasingly popular worldwide. Robotic assisted radical prostatectomies have been widely adopted in the treatment of localized prostate cancer, replacing the conventional open surgeries. However, it is not clear whether this was achieved by substitution within the same treatment type (i.e., replacing open surgeries with robotic-assisted surgeries) or substitution across treatment types (i.e., expanding the proportion of patients receiving surgery while crowding out other forms of treatment for localized prostate cancer). Given the large number of patients undergoing these procedures each year, it is important to study the impact of the fast diffusion of robotic surgical systems on the overall treatment pattern of localized prostate cancer. We addressed this question using state-level cancer epidemiology data (256 observations) extracted from 2002 to 2010 National Cancer Database, and supply-side variables (e.g. density of robotic surgical systems, urologists) obtained from Area Resource File as well as investor presentations posted at the website of the manufacturer of robotic surgical systems. Recognizing that the purchase decision of robotic systems is potentially endogenous, we used an optimal instrumental variables panel estimation method to examine the impact while taking into account of the panel structure and the potential endogeneity of the density of robotic surgical systems and its quadratic term. We found that the density of robotic systems at state-level had a significantly positive impact on the rate of surgery and a significantly negative impact on the rate of radiation therapy. Further, our age-stratified analysis showed that the increase in surgery rate was most pronounced in the younger population. In conclusion, our findings suggest that part of the increase in the rate of surgery was driven by substitution across treatment types with a large proportion originating from the younger population.

Treatment patterns and costs for metastatic renal cell carcinoma patients with private insurance in the United States.

BACKGROUND: To evaluate the evolution of treatment patterns and associated costs for metastatic renal cell carcinoma (mRCC) in the United States. MATERIALS AND METHODS: The LifeLink Health Plan Claims Database was used to create a cohort of mRCC patients with at least 12 months of continuous enrollment from 2004 to 2011. We summarized treatment patterns over time; we used a nonparametric bootstrapping method to compare costs and logistic regression to examine the association between the likelihood of advancing to third-line therapy and beyond and the number of targeted therapy agents available. RESULTS: A total of 1527 mRCC patients were analyzed. In 2010, nine unique treatment regimens were used for first-line treatment, 8 for second-line treatment, and 8 for third-line treatment. A significant association (odds ratio 1.26; P = .001) between the odds of advancing to third-line therapy or beyond and the number of targeted agents available was noted. For 767 patients receiving modern therapy who were < 65 years old, and stratifying by whether the first-line treatment was oral or intravenous, drug cost per patient with ancillary services was $59,664 versus $86,518, respectively (P = .001). Total costs and drug out-of-pocket costs per patient during the first year increased by the number of switches: $111,680 to $2355 for no switches, $149,994 to $2538 for 1 switch, and $196,706 to $3524 for 2 or more switches. In 2004, the median drug cost was $11,458, while by 2010 it rose to $68,660. CONCLUSION: A marked shift in the management of mRCC has occurred, with wide heterogeneity in treatment patterns. More patients are able to receive more lines of therapy, but treatment costs are high.

Economic analyses in squamous cell carcinoma of the head and neck: a review of the literature from a clinical perspective.

The purpose of this review was to describe cost-effectiveness and cost analysis studies across treatment modalities for squamous cell carcinoma of the head and neck (SCCHN), while placing their results in context of the current clinical practice. We performed a literature search in PubMed for English-language studies addressing economic analyses of treatment modalities for SCCHN published from January 2000 to March 2013. We also performed an additional search for related studies published by the National Institute for Health and Clinical Excellence in the United Kingdom. Identified articles were classified into 3 clinical approaches (organ preservation, radiation therapy modalities, and chemotherapy regimens) and into 2 types of economic studies (cost analysis and cost-effectiveness/cost-utility studies). All cost estimates were normalized to US dollars, year 2013 values. Our search yielded 23 articles: 13 related to organ preservation approaches, 5 to radiation therapy modalities, and 5 to chemotherapy regimens. In general, studies analyzed different questions and modalities, making it difficult to reach a conclusion. Even when restricted to comparisons of modalities within the same clinical approach, studies often yielded conflicting findings. The heterogeneity across economic studies of SCCHN should be carefully understood in light of the modeling assumptions and limitations of each study and placed in context with relevant settings of clinical practices and study perspectives. Furthermore, the scarcity of comparative effectiveness and quality-of-life data poses unique challenges for conducting economic analyses for a resource-intensive disease, such as SCCHN, that requires a multimodal care. Future research is needed to better understand how to compare the costs and cost-effectiveness of different modalities for SCCHN.

Potential effects of racial and ethnic disparities in meeting Medicare medication therapy management eligibility criteria.

OBJECTIVE: Medication therapy management (MTM) has the potential to play an instrumental role in reducing racial and ethnic disparities in health care. However, previous research has found that Blacks and Hispanics are less likely to be eligible for MTM. The purpose of the current study was to examine the potential effects of MTM eligibility criteria on racial and ethnic disparities in health outcomes. METHODS: The current study is a retrospective cross-sectional analysis of the Medicare Current Beneficiary Survey Cost and Use files for the years 2007 and 2008. A difference-in-differences model was used to compare disparities in outcomes between ineligible and eligible beneficiaries according to MTM eligibility criteria in 2010. This was achieved by including in regression models interaction terms between dummy variables for Blacks/Hispanics and MTM eligibility criteria. Interaction terms were interpreted on both multiplicative and additive terms. Various regression models were used depending on the types of variables. KEY FINDINGS: Whites were more likely to report self-perceived good health status than Blacks and Hispanics among both MTM-eligible and MTM-ineligible populations. Disparities were greater among MTM-ineligible than MTM-eligible populations (e.g., on additive term, difference in odds=1.94 and P<0.01 for Whites and Blacks; difference in odds=2.86 and P<0.01 for Whites and Hispanics). A few other measures also exhibited significant patterns. CONCLUSIONS: MTM eligibility criteria may exacerbate racial and ethnic disparities in health status and some measures of health services utilizations and costs and medication utilization. Future research should examine strategies to remediate the effects of MTM eligibility criteria on disparities.

Potential health implications of racial and ethnic disparities in meeting MTM eligibility criteria.

BACKGROUND: Previous studies have found that racial and ethnic minorities would be less likely to meet the Medicare eligibility criteria for medication therapy management (MTM) services than their non-Hispanic White counterparts. OBJECTIVES: To examine whether racial and ethnic disparities in health status, health services utilization and costs, and medication utilization patterns among MTM-ineligible individuals differed from MTM-eligible individuals. METHODS: This study analyzed Medicare beneficiaries in 2004-2005 Medicare Current Beneficiary Survey. Various multivariate regressions were employed depending on the nature of dependent variables. Interaction terms between the dummy variables for Blacks (and Hispanics) and MTM eligibility were included to test whether disparity patterns varied between MTM-ineligible and MTM-eligible individuals. Main and sensitivity analyses were conducted for MTM eligibility thresholds for 2006 and 2010. RESULTS: Based on the main analysis for 2006 MTM eligibility criteria, the proportions for self-reported good health status for Whites and Blacks were 82.82% vs. 70.75%, respectively (difference = 12.07%; P < 0.001), among MTM-ineligible population; and 56.98% vs. 52.14%, respectively (difference = 4.84%; P = 0.31), among MTM-eligible population. The difference between these differences was 7.23% (P < 0.001). In the adjusted logistic regression, the interaction effect for Blacks and MTM eligibility had an OR of 1.57 (95% Confidence Interval, or CI = 0.98-2.52) on multiplicative term and difference in odds of 2.38 (95% CI = 1.54-3.22) on additive term. Analyses for disparities between Whites and Hispanics found similar disparity patterns. All analyses for 2006 and 2010 eligibility criteria generally reported similar patterns. Analyses of other measures did not find greater racial or ethnic disparities among the MTM-ineligible than MTM-eligible individuals. CONCLUSIONS: Disparities in MTM eligibility may aggravate existing racial and ethnic disparities in health outcomes. However, disparities in MTM eligibility may not aggravate existing disparities in health services utilization and costs and medication utilization patterns. Future studies should examine the effects of Medicare Part D on these disparities.

Use of surveillance imaging following treatment of small renal masses.

PURPOSE: With the increasing incidence of small renal masses, there is greater use of ablation, nephron sparing surgery and surveillance compared to radical nephrectomy. However, patterns of care in the use of posttreatment imaging remain uncharacterized. The purpose of this study is to determine the rate of posttreatment imaging after various treatments for small renal mass. MATERIALS AND METHODS: Using SEER (Surveillance, Epidemiology and End Results)-Medicare data during 2005 to 2009, we identified 1,682 subjects diagnosed with small renal mass and treated with open partial nephrectomy (330), minimally invasive partial nephrectomy (160), open radical nephrectomy (404), minimally invasive radical nephrectomy (535), thermal ablation (212) and surveillance (42). Use of imaging was compared within 24 months of treatment and multivariate regression models were constructed to identify factors associated with increased imaging use. RESULTS: On adjusted analyses thermal ablation was associated with almost eightfold greater odds of surveillance imaging compared with open radical nephrectomy (OR 7.7, 95% CI 1.01-59.4). Specifically, thermal ablation was associated with increased computerized tomography (OR 5.28) and magnetic resonance imaging (OR 2.19) use and decreased ultrasound use (OR 0.59). Minimally invasive partial nephrectomy (OR 3.28) and open partial nephrectomy (OR 3.19) were also associated with increased computerized tomography use to a lesser extent. CONCLUSIONS: Subjects undergoing nephron sparing surgery undergo more posttreatment imaging compared to open radical nephrectomy. Although possibly associated with lower morbidity, thermal ablation is associated with significantly greater use of imaging compared to other small renal mass treatments. This may increase costs and radiation exposure, although further study is needed for confirmation.

A checklist for ascertaining study cohorts in oncology health services research using secondary data: report of the ISPOR oncology good outcomes research practices working group.

OBJECTIVES: The ISPOR Oncology Special Interest Group formed a working group at the end of 2010 to develop standards for conducting oncology health services research using secondary data. The first mission of the group was to develop a checklist focused on issues specific to selection of a sample of oncology patients using a secondary data source. METHODS: A systematic review of the published literature from 2006 to 2010 was conducted to characterize the use of secondary data sources in oncology and inform the leadership of the working group prior to the construction of the checklist. A draft checklist was subsequently presented to the ISPOR membership in 2011 with subsequent feedback from the larger Oncology Special Interest Group also incorporated into the final checklist. RESULTS: The checklist includes six elements: identification of the cancer to be studied, selection of an appropriate data source, evaluation of the applicability of published algorithms, development of custom algorithms (if needed), validation of the custom algorithm, and reporting and discussions of the ascertainment criteria. The checklist was intended to be applicable to various types of secondary data sources, including cancer registries, claims databases, electronic medical records, and others. CONCLUSIONS: This checklist makes two important contributions to oncology health services research. First, it can assist decision makers and reviewers in evaluating the quality of studies using secondary data. Second, it highlights methodological issues to be considered when researchers are constructing a study cohort from a secondary data source.

Oncology comparative effectiveness research: a multistakeholder perspective on principles for conduct and reporting.

Comparative effectiveness research (CER) can assist patients, clinicians, purchasers, and policy makers in making more informed decisions that will improve cancer care and outcomes. Despite its promise, the factors that distinguish CER from other types of evidence remain mysterious to many oncologists. One concern is whether CER studies will improve decision making in oncology or only add to the massive amount of research information that decision makers must sift through as part of their professional responsibilities. In this report, we highlight several issues that distinguish CER from the most common way evidence is generated for cancer therapy-phase I-III clinical trials. To identify the issues that are most relevant to busy decision makers, we assembled a panel of active professionals with a wide range of roles in cancer care delivery. This panel identified five themes that they considered most important for CER in oncology, as well as fundamental threats to the validity of individual CER studies-threats they termed the "kiss of death" for their applicability to practice. In discussing these concepts, we also touched upon the notion of whether cancer is special among health issues with regard to how evidence is generated and used.