Examining Real-World Adherence to Nusinersen for the Treatment of Spinal Muscular Atrophy Using Two Large US Data Sources.

INTRODUCTION: Spinal muscular atrophy (SMA) is a rare neuromuscular disease characterized by progressive muscular atrophy and weakness. Nusinersen was the first treatment approved for SMA. Per the US label, the nusinersen administration schedule consists of three loading doses at 14-day intervals, a fourth loading dose 30 days later, and maintenance doses every 4 months thereafter. Using two large US databases, we evaluated real-world adherence to nusinersen with its unique dosing schedule among generalizable populations of patients with SMA. METHODS: Patients with SMA treated with nusinersen, likely to have complete information on date of treatment initiation, were identified in the Optum® de-identified electronic health records (EHR) database (7/2017-9/2019), and in the Merative™ MarketScan® Research Databases from commercial (1/2017-6/2020) and Medicaid claims (1/2017-12/2019). Baseline demographics, number of nusinersen administrations on time, and distribution of inter-dose intervals were summarized. RESULTS: Totals of 67 and 291 patients were identified in the EHR and claims databases, respectively. Most nusinersen doses were received on time (93.9% EHR, 80.5% claims). Adherence was higher during the maintenance phase (90.6%) than the loading phase (71.1%) in the claims analysis, in contrast with the EHR analysis (95.5% and 92.6%, respectively), suggesting that not all loading doses of nusinersen may be accurately captured in claims. Inter-dose intervals captured in both databases aligned with the expected dosing schedule. CONCLUSION: Most nusinersen doses were received on time, consistent with the recommended schedule. Our findings also highlight the importance of careful methodological approaches when using real-world administrative databases for evaluation of nusinersen treatment patterns.

Adherence to medicines in the real world is important for patients with chronic disease to see long-term benefits of treatment. This study shows the importance and challenges of measuring adherence using real-world administrative data sources. This is especially important for drugs given through lumbar puncture with unique dosing schedules, such as nusinersen for the treatment of spinal muscular atrophy. In this study, most patients with spinal muscular atrophy received their nusinersen doses on time.

The Association of the First Surge of the COVID-19 Pandemic with the High- and Low-Value Outpatient Care Delivered to Adults in the USA.

BACKGROUND: The first surge of the COVID-19 pandemic entirely altered healthcare delivery. Whether this also altered the receipt of high- and low-value care is unknown. OBJECTIVE: To test the association between the April through June 2020 surge of COVID-19 and various high- and low-value care measures to determine how the delivery of care changed. DESIGN: Difference in differences analysis, examining the difference in quality measures between the April through June 2020 surge quarter and the January through March 2020 quarter with the same 2 quarters' difference the year prior. PARTICIPANTS: Adults in the MarketScan® Commercial Database and Medicare Supplemental Database. MAIN MEASURES: Fifteen low-value and 16 high-value quality measures aggregated into 8 clinical quality composites (4 of these low-value). KEY RESULTS: We analyzed 9,352,569 adults. Mean age was 44 years (SD, 15.03), 52% were female, and 75% were employed. Receipt of nearly every type of low-value care decreased during the surge. For example, low-value cancer screening decreased 0.86% (95% CI, -1.03 to -0.69). Use of opioid medications for back and neck pain (DiD +0.94 [95% CI, +0.82 to +1.07]) and use of opioid medications for headache (DiD +0.38 [95% CI, 0.07 to 0.69]) were the only two measures to increase. Nearly all high-value care measures also decreased. For example, high-value diabetes care decreased 9.75% (95% CI, -10.79 to -8.71). CONCLUSIONS: The first COVID-19 surge was associated with receipt of less low-value care and substantially less high-value care for most measures, with the notable exception of increases in low-value opioid use.

Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial.

BACKGROUND: The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants-nurses and auxiliary nurse midwives (ANMs)-during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. METHODS: This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). RESULTS: Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). CONCLUSIONS: Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. TRIAL REGISTRATION: ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111-1131-5647.

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Relationship Between Quality of Comorbid Condition Care and Costs for Cancer Survivors.

PURPOSE: To estimate the association between cancer survivors' comorbid condition care quality and costs; to determine whether the association differs between cancer survivors and other patients. METHODS: Using the SEER-Medicare-linked database, we identified survivors of breast, prostate, and colorectal cancers who were diagnosed in 2004, enrolled in Medicare fee-for-service for at least 12 months before diagnosis, and survived ≥ 3 years. Quality of care was assessed using nine process indicators for chronic conditions, and a composite indicator representing seven avoidable outcomes. Total costs on the basis of Medicare amount paid were grouped as inpatient and outpatient. We examined the association between care quality and costs for cancer survivors, and compared this association among 2:1 frequency-matched noncancer controls, using comparisons of means and generalized linear regressions. RESULTS: Our sample included 8,661 cancer survivors and 17,332 matched noncancer controls. Receipt of recommended care was associated with higher outpatient costs for eight indicators, and higher inpatient and total costs for five indicators. For three measures (visit every 6 months for patients with chronic obstructive pulmonary disease or diabetes, and glycosylated hemoglobin or fructosamine every 6 months for patients with diabetes), costs for cancer survivors who received recommended care increased less than for noncancer controls. The absence of avoidable events was associated with lower costs of each type. An annual eye examination for patients with diabetes was associated with lower inpatient costs. CONCLUSION: Higher-quality processes of care may not reduce short-term costs, but the prevention of avoidable outcomes reduces costs. The association between quality and cost was similar for cancer survivors and noncancer controls.

The relationship between quality, spending and outcomes among women with breast cancer.

BACKGROUND: Substantial shortcomings in the quality of breast cancer (BC) care have been identified. While breast cancer is responsible for the largest share of cancer care spending, little is known about the value of care provided to US women with BC. METHODS: For women aged 65 to 70 years diagnosed July 1997 through December 2005 with stage 0-III BC who were continuously enrolled in fee-for-service Medicare, we evaluated performance relative to 20 measures recommending for proven therapies and seven measures recommending against unnecessary therapies. Using health care service area as the unit of analysis, we characterized quality for recommended and unnecessary therapies, median per-patient cost in the year after diagnosis for Medicare parts A and B, and five-year overall survival. We analyzed the relationships between quality, cost, and survival. All statistical tests were two-sided. RESULTS: We assessed the care provided to 15357 women and compiled quality, cost, and outcomes data for 99 regions. The median number of patients/region was 85 (interquartile range = 47-158); the five-year overall survival was 87.5%. Part B expenditure correlated positively with measures of recommended therapy (P = .027) and negatively with measures of unnecessary therapy (P = .004). Survival did not correlate with quality or cost. Regions demonstrating lower quality for both recommended and unnecessary therapy measures exhibited higher part A expenditure. CONCLUSIONS: BC patients experience wide variation in quality, cost, and survival. Process measures that assess recommended and unnecessary therapies did not correlate with survival, but did shed light on spending for related and unrelated services. Additional efforts to identify factors that impact the relationships between quality, cost, and outcomes are needed.

It's who you know: patient-sharing, quality, and costs of cancer survivorship care.

PURPOSE: Cancer survivors frequently receive care from a large number of physicians, creating challenges for coordination. We sought to explore whether cancer survivors whose providers have more patients in common (e.g., shared patients) tend to have higher quality and lower cost care. METHODS: We performed a retrospective cohort study of 8,661 patients diagnosed with loco-regional breast, prostate, or colorectal cancer. We examined survivorship care from days 366 to 1,095 following their cancer diagnosis. Our primary independent variable was "care density," a novel metric of the extent to which a patient's providers share patients with one another. Our outcome measures were health care utilization, quality metrics, and costs. RESULTS: In adjusted analyses, we found that patients with high care density--indicating high levels of patient-sharing among their providers--had significantly lower rates of hospitalization (OR 0.87, 95% CI 0.75-1.00) and higher odds of an eye examination for diabetes (OR 1.31, 95% CI 1.03-1.66) compared to patients with low care density. High care density was not associated with emergency department visits, avoidable outcomes, lipid profile following an angina diagnosis, or odds of glycosylated hemoglobin testing for diabetes. Patients with high care density had significantly lower total costs of care over 24 months (beta coefficient -$2,116, 95% CI -$3,107 to -$1,125) along with lower inpatient and outpatient costs. CONCLUSION: Cancer survivors treated by physicians who share more patients with one another tend to have some higher aspects of quality and lower cost care. IMPLICATIONS OF CANCER SURVIVORS: If validated, care density may be a useful indicator for monitoring care coordination among cancer survivors and potentially targeting interventions that seek to improve care delivery.

Use of stereotactic radiosurgery for brain metastases from non-small cell lung cancer in the United States.

PURPOSE: The indications for treatment of brain metastases from non-small cell lung cancer (NSCLC) with stereotactic radiosurgery (SRS) remain controversial. We studied patterns, predictors, and cost of SRS use in elderly patients with NSCLC. METHODS AND MATERIALS: Using the Surveillance, Epidemiology, and End Results-Medicare (SEER-Medicare) database, we identified patients with NSCLC who were diagnosed with brain metastases between 2000 and 2007. Our cohort included patients treated with radiation therapy and not surgical resection as initial treatment for brain metastases. RESULTS: We identified 7684 patients treated with radiation therapy within 2 months after brain metastases diagnosis, of whom 469 (6.1%) cases had billing codes for SRS. Annual SRS use increased from 3.0% in 2000 to 8.2% in 2005 and varied from 3.4% to 12.5% by specific SEER registry site. After controlling for clinical and sociodemographic characteristics, we found SRS use was significantly associated with increasing year of diagnosis, specific SEER registry, higher socioeconomic status, admission to a teaching hospital, no history of participation in low-income state buy-in programs (a proxy for Medicaid eligibility), no extracranial metastases, and longer intervals from NSCLC diagnosis. The average cost per patient associated with radiation therapy was 2.19 times greater for those who received SRS than for those who did not. CONCLUSIONS: The use of SRS in patients with metastatic NSCLC increased almost 3-fold from 2000 to 2005. In addition, we found significant variations in SRS use across SEER registries and socioeconomic quartiles. National practice patterns in this study suggested both a lack of consensus and an overall limited use of the approach among elderly patients before 2008.

Predictors of IMRT and conformal radiotherapy use in head and neck squamous cell carcinoma: a SEER-Medicare analysis.

PURPOSE: The extent to which new techniques for the delivery of radiotherapy for head and neck squamous cell carcinoma (HNSCC) have diffused into clinical practice is unclear, including the use of 3-dimensional conformal RT (3D-RT) and intensity-modulated radiation therapy (IMRT). METHODS AND MATERIALS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database, we identified 2,495 Medicare patients with Stage I-IVB HNSCC diagnosed at age 65 years or older between 2000 and 2005 and treated with either definitive (80%) or adjuvant (20%) radiotherapy. Our primary aim was to analyze the trends and predictors of IMRT use over this time, and the secondary aim was a similar description of the trends and predictors of conformal radiotherapy (CRT) use, defined as treatment with either 3D-RT or IMRT. RESULTS: Three hundred sixty-four (15%) patients were treated with IMRT, and 1,190 patients (48%) were treated with 3D-RT. Claims for IMRT and CRT rose from 0% to 33% and 39% to 86%, respectively, between 2000 and 2005. On multivariable analysis, IMRT use was associated with SEER region (West 18%; Northeast 11%; South 12%; Midwest 13%), advanced stage (advanced, 21%; early, 9%), non-larynx site (non-larynx, 23%; larynx, 7%), higher median census tract income (highest vs. lowest quartile, 18% vs. 10%), treatment year (2003-2005, 31%; 2000-2002, 6%), use of chemotherapy (26% with; 9% without), and higher radiation oncologist treatment volume (highest vs. lowest tertile, 23% vs. 8%). With CRT as the outcome, only SEER region, treatment year, use of chemotherapy, and increasing radiation oncologist HNSCC volume were significant on multivariable analysis. CONCLUSIONS: The use of IMRT and CRT by Medicare beneficiaries with HNSCC rose significantly between 2000 and 2005 and was associated with both clinical and non-clinical factors, with treatment era and radiation oncologist HNSCC treatment volume serving as the strongest predictors of IMRT use.

Timeliness and quality of diagnostic care for medicare recipients with chronic lymphocytic leukemia.

BACKGROUND: Little is known about the patterns of care relating to the diagnosis of chronic lymphocytic leukemia (CLL), including the use of modern diagnostic techniques such as flow cytometry. METHODS: The authors used the SEER-Medicare database to identify subjects diagnosed with CLL from 1992 to 2002 and defined diagnostic delay as present when the number of days between the first claim for a CLL-associated sign or symptom and SEER diagnosis date met or exceeded the median for the sample. The authors then used logistic regression to estimate the likelihood of delay and Cox regression to examine survival. RESULTS: For the 5086 patients analyzed, the median time between sign or symptom and CLL diagnosis was 63 days (interquartile range [IQR] = 0-251). Predictors of delay included age ≥75 (OR 1.45 [1.27-1.65]), female gender (OR 1.22 [1.07-1.39]), urban residence (OR 1.46 [1.19 to 1.79]), ≥1 comorbidities (OR 2.83 [2.45-3.28]) and care in a teaching hospital (OR 1.20 [1.05-1.38]). Delayed diagnosis was not associated with survival (HR 1.11 [0.99-1.25]), but receipt of flow cytometry within thirty days before or after diagnosis was (HR 0.84 [0.76-0.91]). CONCLUSIONS: Sociodemographic characteristics affect diagnostic delay for CLL, although delay does not seem to impact mortality. In contrast, receipt of flow cytometry near the time of diagnosis is associated with improved survival.

Trends in the aggressiveness of end-of-life cancer care in the universal health care system of Ontario, Canada.

PURPOSE: To describe trends in the aggressiveness of end-of-life (EOL) cancer care in a universal health care system in Ontario, Canada, between 1993 and 2004, and to compare with findings reported in the United States. METHODS: A population-based, retrospective, cohort study that used administrative data linked to registry data. Aggressiveness of EOL care was defined as the occurrence of at least one of the following indicators: last dose of chemotherapy received within 14 days of death; more than one emergency department (ED) visit within 30 days of death; more than one hospitalization within 30 days of death; or at least one intensive care unit (ICU) admission within 30 days of death. RESULTS: Among 227,161 patients, 22.4% experienced at least one incident of potentially aggressive EOL cancer care. Multivariable analyses showed that with each successive year, patients were significantly more likely to encounter some aggressive intervention (odds ratio, 1.01; 95% CI, 1.01 to 1.02). Multiple emergency department (ED) visits, ICU admissions, and chemotherapy use increased significantly over time, whereas multiple hospital admissions declined (P < .05). Patients were more likely to receive aggressive EOL care if they were men, were younger, lived in rural regions, had a higher level of comorbidity, or had breast, lung, or hematologic malignancies. Chemotherapy and ICU utilization were lower in Ontario than in the United States. CONCLUSION: Aggressiveness of cancer care near the EOL is increasing over time in Ontario, Canada, although overall rates were lower than in the United States. Health system characteristics and patient or physician cultural factors may play a role in the observed differences.

Lung cancer treatment costs, including patient responsibility, by disease stage and treatment modality, 1992 to 2003.

OBJECTIVES: The objective of this analysis was to estimate costs for lung cancer care and evaluate trends in the share of treatment costs that are the responsibility of Medicare beneficiaries. METHODS: The Surveillance, Epidemiology, and End Results (SEER)-Medicare data from 1991-2003 for 60,231 patients with lung cancer were used to estimate monthly and patient-liability costs for clinical phases of lung cancer (prediagnosis, staging, initial, continuing, and terminal), stratified by treatment, stage, and non-small- versus small-cell lung cancer. Lung cancer-attributable costs were estimated by subtracting each patient's own prediagnosis costs. Costs were estimated as the sum of Medicare reimbursements (payments from Medicare to the service provider), co-insurance reimbursements, and patient-liability costs (deductibles and "co-payments" that are the patient's responsibility). Costs and patient-liability costs were fit with regression models to compare trends by calendar year, adjusting for age at diagnosis. RESULTS: The monthly treatment costs for a 72-year-old patient, diagnosed with lung cancer in 2000, in the first 6 months ranged from $2687 (no active treatment) to $9360 (chemo-radiotherapy); costs varied by stage at diagnosis and histologic type. Patient liability represented up to 21.6% of care costs and increased over the period 1992-2003 for most stage and treatment categories, even when care costs decreased or remained unchanged. The greatest monthly patient liability was incurred by chemo-radiotherapy patients, which ranged from $1617 to $2004 per month across cancer stages. CONCLUSIONS: Costs for lung cancer care are substantial, and Medicare is paying a smaller proportion of the total cost over time.

How does initial treatment choice affect short-term and long-term costs for clinically localized prostate cancer?

BACKGROUND: Data regarding costs of prostate cancer treatment are scarce. This study investigates how initial treatment choice affects short-term and long-term costs. METHODS: This retrospective, longitudinal cohort study followed prostate-cancer cases diagnosed in 2000 for 5 years using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Men age≥66 years, in Medicare fee for service, diagnosed with clinically localized prostate cancer in 2000 while residing in a SEER region, were matched to noncancer controls using age, sex, race, region, comorbidity, and survival. On the basis of treatment received during the first 9 months postdiagnosis, patients were assigned to watchful waiting, radiation, hormonal therapy, hormonal+radiation, and surgery (may have received other treatments). Incremental costs for prostate cancer were the difference in costs for prostate cancer cases versus matched controls. Costs were divided into initial treatment (months -1 to 12), long-term (each 12 months thereafter), and total (months -1 to 60). Sensitivity analyses excluded the last 12 months of life. RESULTS: A total of 13,769 prostate-cancer cases were matched to 13,769 noncancer controls. Watchful waiting had the lowest initial treatment ($4270) and 5-year total costs ($9130). Initial treatment costs were highest for hormonal+radiation ($17,474) and surgery ($15,197). At $26,896, 5-year total costs were highest for hormonal therapy only followed by hormonal+radiation ($25,097) and surgery ($19,214). After excluding the last 12 months of life, total costs were highest for hormonal+radiation ($23,488) and hormonal therapy ($23,199). CONCLUSIONS: Patterns of costs vary widely based on initial treatment. These data can inform patients and clinicians considering treatment options and policy makers interested in patterns of costs.

Breast biopsy patterns and outcomes in Surveillance, Epidemiology, and End Results-Medicare data.

BACKGROUND: Despite known benefits to needle biopsy for suspicious breast lesions, variability in the use of this technique has been documented in practice. We sought to study the use of needle biopsy and open surgical biopsy in women with breast cancer, predictors of needle biopsy use, and the effect of biopsy choice on overall number of surgical procedures needed to treat breast cancer. METHODS: We analyzed Surveillance, Epidemiology, and End Results (SEER)-Medicare data for 45,542 women diagnosed between 1991 and 1999 with ductal carcinoma in situ and stage I-II breast cancer. By using diagnosis and procedure codes from 3 months before to 6 months after the SEER diagnosis, we classified the initial biopsy as needle or surgical. By using multivariate logistic regression, we identified patient and tumor characteristics associated with needle biopsy use, and estimated the association between initial biopsy type and likelihood for multiple breast surgeries. RESULTS: Needle biopsy was the initial procedure for 11,073 (24.3%) women. In multivariate analyses, needle biopsy use varied significantly by race, year of diagnosis, and tumor size. After controlling for patient and tumor characteristics, needle biopsy use was associated with a reduced likelihood of multiple breast surgeries (odds ratio, 0.35; 95% confidence interval, 0.34-0.37). CONCLUSIONS: Use of needle biopsy as the initial breast cancer procedure was more common among black women and those with larger tumors, and increased significantly over time. Providers should consider needle biopsy when clinically feasible as the initial breast procedure, because it may reduce the number of surgeries needed to treat breast cancer.

Surgical mortality in patients with esophageal cancer: development and validation of a simple risk score.

PURPOSE: Surgery has curative potential in a proportion of patients with esophageal cancer, but is associated with considerable perioperative risks. We aimed to develop and validate a simple risk score for surgical mortality that could be applied to administrative data. PATIENTS AND METHODS: We analyzed 3,592 esophagectomy patients from four cohorts. We applied logistic regression analysis to predict mortality occurring within 30 days after esophagectomy for 1,327 esophageal cancer patients older than 65 years of age, diagnosed between 1991 and 1996 in the linked Surveillance, Epidemiology and End Results (SEER)--Medicare database. A simple score chart for preoperative risk assessment of surgical mortality was developed and validated on three other cohorts, including 714 SEER-Medicare patients diagnosed between 1997 and 1999, 349 patients from a population-based registry in the Netherlands diagnosed between 1993 and 2001, and 1,202 patients from a referral hospital in the Netherlands diagnosed between 1980 and 2002. RESULTS: Surgical mortality in the four cohorts was 11% (147 of 1,327), 10% (74 of 714), 7% (25 of 349), and 4% (45 of 1,202), respectively. Predictive patient characteristics included age, comorbidity (cardiac, pulmonary, renal, hepatic, and diabetes), preoperative radiotherapy or combined chemoradiotherapy, and a relatively low hospital volume. At validation, the simple score showed good agreement of predicted risks with observed mortality rates (calibration), but low discrimination (area under the receiver operating characteristic curve 0.58 to 0.66). CONCLUSION: A simple risk score combining clinical characteristics along with hospital volume to predict surgical mortality after esophagectomy from administrative data may form a basis for risk adjustment in quality of care assessment.

Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients.

BACKGROUND: For many diseases, specialized care (i.e., care rendered by a specialist) has been associated with superior-quality care (i.e., better outcomes). We examined associations between physician specialty and outcomes in a population-based cohort of elderly ovarian cancer surgery patients. METHODS: We analyzed the Medicare claims, by physician specialty, of all women aged 65 years or older who underwent surgery for pathologically confirmed invasive epithelial ovarian cancer between January 1, 1992, and December 31, 1999, while living in an area monitored by the Surveillance, Epidemiology, and End Results (SEER) program to assess important care processes (i.e., the appropriate extent of surgery and use of adjuvant chemotherapy) and outcomes (i.e., surgical complications, ostomy rates, and survival). All statistical tests were two-sided. RESULTS: Among 3067 ovarian cancer patients who underwent surgery, 1017 patients (33%) were treated by a gynecologic oncologist, 1377 patients (45%) by a general gynecologist, and 673 patients (22%) by a general surgeon. Among patients with stage I or II disease, those treated by a gynecologic oncologist (60%) were more likely to undergo lymph node dissection than those treated by a general gynecologist (36%) or a general surgeon (16%). Patients with stage III or IV disease were more likely to undergo a debulking procedure if the initial surgery was performed by a gynecologic oncologist (58%) than by a general gynecologist (51%) or a general surgeon (40%; P < .001) and were more likely to receive postoperative chemotherapy when operated on by a gynecologic oncologist (79%) or a general gynecologist (76%) than by a general surgeon (62%, P < .001). Survival among patients operated on by gynecologic oncologists (hazard ratio [HR] of death from any cause = 0.85, 95% confidence interval [CI] = 0.76 to 0.95) or general gynecologists (HR = 0.86, 95% CI = 0.78 to 0.96) was better than that among patients operated on by general surgeons. CONCLUSIONS: Ovarian cancer patients treated by gynecologic oncologists had marginally better outcomes than those treated by general gynecologists and clearly superior outcomes compared with patients treated by general surgeons.

The effect of race on invasive staging and surgery in non-small-cell lung cancer.

PURPOSE: Black patients with early-stage non-small-cell lung cancer (NSCLC) have worse overall survival than white patients. Decreased likelihood of resection has been implicated. To isolate the effect of decision making from access to care, we used receipt of surgical staging as a proxy for access and willingness to undergo invasive procedures, and examined treatments and outcomes by race. PATIENTS AND METHODS: We examined registry and claims data of Medicare-eligible patients with nonmetastatic NSCLC in areas monitored by the Surveillance, Epidemiology, and End Results program from 1991 to 2001. Patients who obtained invasive staging, defined as bronchoscopy, mediastinoscopy, or thoracoscopy, were included. Logistic regression and Cox modeling calculated the odds of having staging and surgery, and survival outcomes. RESULTS: A total of 14,224 patients underwent staging, and 6,972 had surgery for lung cancer. Black patients were less likely to undergo staging (odds ratio [OR] = 0.75; 95% CI, 0.67 to 0.83), and once staged, were still less likely to have surgery than whites (OR = 0.55; 95% CI, 0.47 to 0.64). Survival for blacks and whites was equivalent after resection (hazard ratio = 1.02; P = .06). Staged black patients were less likely to receive a recommendation for surgery when it was not clearly contraindicated (67.0% v 71.4%; P < .05), and were more likely to decline surgery (3.4% v 2.0%; P < .05). CONCLUSION: Black patients obtain surgery for lung cancer less often than whites, even after access to care has been demonstrated. They are more likely not to have surgery recommended, and more likely to refuse surgery. Additional research should focus on the physician-patient encounter as a potential source of racial disparities.

Evaluating claims-based indicators of the intensity of end-of-life cancer care.

OBJECTIVE: To evaluate measures that could use existing administrative data to assess the intensity of end-of-life cancer care. METHODS: Benchmarking standards and statistical variation were evaluated using Medicare claims of 48,906 patients who died from cancer from 1991 through 1996 in 11 regions of the United States. We assessed accuracy by comparing administrative data to 150 medical records in one hospital and affiliated cancer treatment center. RESULTS: Systems not providing overly aggressive care near the end of life would be ones in which less than 10% of patients receive chemotherapy in the last 14 days of life, less than 2% start a new chemotherapy regimen in the last 30 days of life, less than 4% have multiple hospitalizations or emergency room visits or are admitted to the intensive care unit (ICU) in the last month of life, and less than 17% die in an acute care institution. At least 55% of patients would receive hospice services before death from cancer, and less than 8% of those would be admitted to hospice within only 3 days of death. All measures were found to have accuracy ranging from 85 to 97% and 2- to 5-fold adjusted variability between the 5th and 95th percentiles of performance. CONCLUSIONS: The usefulness of these measures will depend on whether the concept of intensity of care near death can be further validated as an acceptable and important quality issue among patients, their families, health care providers, and other stakeholders in oncology.

Trends in the aggressiveness of cancer care near the end of life.

PURPOSE: To characterize the aggressiveness of end-of-life cancer treatment for older adults on Medicare, and its relationship to the availability of healthcare resources. PATIENTS AND METHODS: We analyzed Medicare claims of 28,777 patients 65 years and older who died within 1 year of a diagnosis of lung, breast, colorectal, or other gastrointestinal cancer between 1993 and 1996 while living in one of 11 US regions monitored by the Surveillance, Epidemiology, and End Results Program. RESULTS: Rates of treatment with chemotherapy increased from 27.9% in 1993 to 29.5% in 1996 (P =.02). Among those who received chemotherapy, 15.7% were still receiving treatment within 2 weeks of death, increasing from 13.8% in 1993 to 18.5% in 1996 (P <.001). From 1993 to 1996, increasing proportions of patients had more than one emergency department visit (7.2% v 9.2%; P <.001), hospitalization (7.8% v 9.1%; P =.008), or were admitted to an intensive care unit (7.1% v 9.4%; P =.009) in the last month of life. Although fewer patients died in acute-care hospitals (32.9% v 29.5%; P <.001) and more used hospice services (28.3% v 38.8%; P <.001), an increasing proportion of patients who received hospice care initiated this service only within the last 3 days of life (14.3% v 17.0%; P =.004). Black patients were more likely than white patients to experience aggressive intervention in nonteaching hospitals but not in teaching hospitals. Greater local availability of hospices was associated with less aggressive treatment near death on multivariate analysis. CONCLUSION: The treatment of cancer patients near death is becoming increasingly aggressive over time.