Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States.

BACKGROUND: Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for migraine prevention in adults. Real-world data on the effectiveness of fremanezumab are limited. This retrospective, observational cohort study assessed patient-reported migraine symptoms, health care resource utilization (HCRU), and direct medical costs before and after fremanezumab treatment initiation. METHODS: Data were extracted from September 2018 through June 2020 from the Midwest component of EMRClaims+®, an integrated health services database containing > 20 million medical records from national commercial insurance claims, Medicare claims, and regional electronic medical records. Patients included in the cohort analysis were aged ≥ 18 years and were administered fremanezumab, with enrollment or treatment history for ≥ 6 months prior (pre-index) to initiating fremanezumab (index date) and ≥ 1 month after the index date (post-index), and without pregnancy or pregnancy-related encounters during the study period. Patient-reported headache frequency, migraine pain intensity (MPI), composite migraine symptoms, and HCRU were assessed pre-index and ≥ 1 month after fremanezumab initiation. Wilcoxon signed-rank tests were used to compare means of migraine symptoms and outcomes and HCRU before and after fremanezumab initiation. RESULTS: Overall, 172 patients were eligible for analysis. Of patients who self-reported (n = 129), 83.7% reported improvement in headache frequency or symptoms after fremanezumab treatment. Specifically, headache frequency decreased by 63% after fremanezumab initiation: mean (standard deviation) headache frequency was 22.24 (9.29) days per month pre-index versus 8.24 (7.42) days per month post-index (P < 0.0001). Mean MPI also decreased by 18% after fremanezumab initiation: MPI was 5.47 (3.19) pre-index versus 4.51 (3.34) post-index (P = 0.014). Mean emergency room (ER) visits per month decreased from 0.72 to 0.54 (P = 0.003), and mean outpatient visits per month decreased from 1.04 to 0.81 (P < 0.001). Mean hospitalizations per month decreased, but the results did not reach statistical significance (P = 0.095). Hospitalization and ER costs decreased, while outpatient costs increased, from pre-index to post-index, but differences were not statistically significant (P ≥ 0.232). CONCLUSIONS: Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting.

Clinical and Economic Burden of Peristomal Skin Complications in Patients With Recent Ostomies.

PURPOSE: The purpose of this study was to estimate the risk and economic burden of peristomal skin complications (PSCs) in a large integrated healthcare system in the Midwestern United States. DESIGN: Retrospective cohort study. SUBJECTS AND SETTING: The sample comprised 128 patients; 40% (n = 51) underwent colostomy, 50% (n = 64) underwent ileostomy, and 10% (n = 13) underwent urostomy. Their average age was 60.6 ± 15.6 years at the time of ostomy surgery. METHODS: Using administrative data, we retrospectively identified all patients who underwent colostomy, ileostomy, or urostomy between January 1, 2008, and November 30, 2012. Trained medical abstractors then reviewed the clinical records of these persons to identify those with evidence of PSC within 90 days of ostomy surgery. We then examined levels of healthcare utilization and costs over a 120-day period, beginning with date of surgery, for patients with and without PSC, respectively. Our analyses were principally descriptive in nature. RESULTS: The study cohort comprised 128 patients who underwent ostomy surgery (colostomy, n = 51 [40%]; ileostomy, n = 64 [50%]; urostomy, n = 13 [10%]). Approximately one-third (36.7%) had evidence of a PSC in the 90-day period following surgery (urinary diversion, 7.7%; colostomy, 35.3%; ileostomy, 43.8%). The average time from surgery to PSC was 23.7 ± 20.5 days (mean ± SD). Patients with PSC had index admissions that averaged 21.5 days versus 13.9 days for those without these complications. Corresponding rates of hospital readmission within the 120-day period following surgery were 47% versus 33%, respectively. Total healthcare costs over 120 days were almost $80,000 higher for patients with PSCs. CONCLUSIONS: Approximately one-third of ostomy patients over a 5-year study period had evidence of PSCs within 90 days of surgery. Costs of care were substantially higher for patients with these complications.

The Real-World Utilization Pattern of Increased Utilization of Advanced Topical Adjunctive Hemostats in a Vertically Integrated Healthcare System.

Hemostasis products, such as SURGICEL®, have been increasingly used across a wide variety of surgical procedures to mitigate bleeding-related risks and complications. This retrospective observational study described the utilization pattern of the SURGICEL® family of oxidized regenerated cellulose products (SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL SNoW®) in a large, vertically integrated healthcare system, by utilizing electronic medical records (EMR) extracted from August 2013 through June 2015 at Henry Ford Health System (HFHS). Descriptive measurements were compared between SURGICEL® ORIGINAL and advanced SURGICEL® products (SURGICEL® FIBRILLAR™ and SURGICEL SNoW®) for pooled common surgical procedures. Among 1471 patients, 450 received SURGICEL® ORIGINAL, and 1021 received advanced SURGICEL® products. A significantly greater proportion of patients given advanced SURGICEL® products had comorbidities (91.0% vs 85.6%, p=.0024), prior bleeding conditions (49.9% vs 30.9%, p<.0001), and prior use of anticoagulants (27.7% vs 5.3%, p<.0001). Advanced SURGICEL® products were more likely to be used in coronary artery bypass grafting (13.7% vs 1.6%, p<.0001). Among a sub-set of 1420 patients with complete package size information (988 Advanced and 432 ORIGINAL), significantly fewer mean normalized units of Advanced SURGICEL® were used per patient case (3.9 vs 5.5, p<.0001). Despite Advanced SURGICEL® products being utilized in higher risk bleeding situations compared to cases where SURGICEL® ORIGINAL was utilized, fewer overall normalized units of Advanced SURGICEL® were required per patient case. Further research is needed to investigate the implications of topical hemostat use in continuous oozing bleeding situations on outcomes, hospital costs, and resources.

Association Between Complementary and Alternative Medicine Use and Breast Cancer Chemotherapy Initiation: The Breast Cancer Quality of Care (BQUAL) Study.

IMPORTANCE: Not all women initiate clinically indicated breast cancer adjuvant treatment. It is important for clinicians to identify women at risk for noninitiation. OBJECTIVE: To determine whether complementary and alternative medicine (CAM) use is associated with decreased breast cancer chemotherapy initiation. DESIGN, SETTING, AND PARTICIPANTS: In this multisite prospective cohort study (the Breast Cancer Quality of Care [BQUAL] study) designed to examine predictors of breast cancer treatment initiation and adherence, 685 women younger than 70 years with nonmetastatic invasive breast cancer were recruited from Columbia University Medical Center, Kaiser Permanente Northern California, and Henry Ford Health System and enrolled between May 2006 and July 31, 2010. Overall, 306 patients (45%) were clinically indicated to receive chemotherapy per National Comprehensive Cancer Network guidelines. Participants were followed for up to 12 months. EXPOSURES: Baseline interviews assessed current use of 5 CAM modalities (vitamins and/or minerals, herbs and/or botanicals, other natural products, mind-body self-practice, mind-body practitioner-based practice). CAM use definitions included any use, dietary supplement use, mind-body use, and a CAM index summing the 5 modalities. MAIN OUTCOMES AND MEASURES: Chemotherapy initiation was assessed via self-report up to 12 months after baseline. Multivariable logistic regression models examined a priori hypotheses testing whether CAM use was associated with chemotherapy initiation, adjusting for demographic and clinical covariates, and delineating groups by age and chemotherapy indication. RESULTS: A cohort of 685 women younger than 70 years (mean age, 59 years; median age, 59 years) with nonmetastatic invasive breast cancer were recruited and followed for up to 12 months to examine predictors of breast cancer treatment initiation. Baseline CAM use was reported by 598 women (87%). Chemotherapy was initiated by 272 women (89%) for whom chemotherapy was indicated, compared with 135 women (36%) for whom chemotherapy was discretionary. Among women for whom chemotherapy was indicated, dietary supplement users and women with high CAM index scores were less likely than nonusers to initiate chemotherapy (odds ratio [OR], 0.16; 95% CI, 0.03-0.51; and OR per unit, 0.64; 95% CI, 0.46-0.87, respectively). Use of mind-body practices was not related to chemotherapy initiation (OR, 1.45; 95% CI, 0.57-3.59). There was no association between CAM use and chemotherapy initiation among women for whom chemotherapy was discretionary. CONCLUSIONS AND RELEVANCE: CAM use was high among patients with early-stage breast cancer enrolled in a multisite prospective cohort study. Current dietary supplement use and higher number of CAM modalities used but not mind-body practices were associated with decreased initiation of clinically indicated chemotherapy. Oncologists should consider discussing CAM with their patients during the chemotherapy decision-making process.

Psychosocial factors related to non-persistence with adjuvant endocrine therapy among women with breast cancer: the Breast Cancer Quality of Care Study (BQUAL).

Non-adherence to adjuvant endocrine therapy (ET) for breast cancer (BC) is common. Our goal was to determine the associations between psychosocial factors and ET non-persistence. We recruited women with BC receiving care in an integrated healthcare system between 2006 and 2010. Using a subset of patients treated with ET, we investigated factors related to ET non-persistence (discontinuation) based on pharmacy records (≥90 days gap). Serial interviews were conducted at baseline and every 6 months. The Functional Assessment of Cancer Therapy (FACT), Medical Outcomes Survey, Treatment Satisfaction Questionnaire (TSQM), Impact of Events Scale (IES), Interpersonal Processes of Care measure, and Decision-making beliefs and concerns were measured. Multivariate models assessed factors associated with non-persistence. Of the 523 women in our final cohort who initiated ET and had a subsequent evaluation, 94 (18 %) were non-persistent over a 2-year follow-up. The cohort was primarily white (74.4 %), stage 1 (60.6 %), and on an aromatase inhibitor (68.1 %). Women in the highest income category had a lower odds of being non-persistent (OR 0.43, 95 % CI 0.23-0.81). Quality of life and attitudes toward ET at baseline were associated with non-persistence. At follow-up, the FACT, TSQM, and IES were associated with non-persistence (p < 0.001). Most women continued ET. Women who reported a better attitude toward ET, better quality of life, and more treatment satisfaction, were less likely to be non-persistent and those who reported intrusive/avoidant thoughts were more likely to be non-persistent. Interventions to enhance the psychosocial well-being of patients should be evaluated to increase adherence.

Prevalence of Chronic Pain in a Large Integrated Healthcare Delivery System in the U.S.A.

BACKGROUND: There is a paucity of published data on the prevalence of chronic pain conditions within large, integrated healthcare organizations in the U.S.A. Such data are essential to inform the development of appropriate treatment programs. METHODS: Twenty-five selected pain conditions were used to identify patients receiving care within the Henry Ford Health System (HFHS) who were enrolled in the Health Alliance Plan (HAP), a subsidiary of HFHS. Patients aged ≥ 18 years, enrolled in HAP in 2010, and having ≥ 2 encounters, ≥ 30 days apart, with an ICD-9-CM diagnosis code for a pain condition of interest during 2010 were counted. Variables included in the study were as follows: age, gender, body mass index (BMI), and Charlson comorbidity conditions and index score. RESULTS: Altogether, 14,784 persons (11.6% of the total adult population) met the criteria for having a chronic pain condition. Overall, the study population was 64.4% female and had mean age (SD) of 61.2 (15.6) years and mean BMI of 31.4 (7.2) kg/m(2) . Musculoskeletal pain conditions were the most common diagnoses, comprising 75.4% of all pain diagnoses. Diabetes and chronic pulmonary disease were the most common medical comorbidities. CONCLUSIONS: In this comprehensive analysis of 2 years of data from a large, vertically integrated metropolitan health system, chronic pain was identified in 12% of adult patients. Approximately 75% of chronic pain conditions were musculoskeletal. The triad of age ≥ 60 years, BMI ≥ 30, and female sex were the most salient demographic characteristics of patients with chronic pain conditions. These diagnostic and demographic data may be used to inform treatment program development.

Cost Burden of Chronic Pain Patients in a Large Integrated Delivery System in the United States.

OBJECTIVES: To estimate all-cause healthcare resource utilization and costs among chronic pain patients within an integrated healthcare delivery system in the United States. METHODS: Electronic medical records and health claims data from the Henry Ford Health System were used to determine healthcare resource utilization and costs for patients with 24 chronic pain conditions. Patients were identified by ≥ 2 ICD-9-CM codes ≥ 30 days apart from January to December, 2010; the first ICD-9 code was the index event. Continuous coverage for 12 months pre- and postindex was required. All-cause direct medical costs were determined from billing data. RESULTS: A total of 12,165 patients were identified for the analysis. After pharmacy, the most used resource was outpatient visits, with a mean of 18.8 (SD 13.2) visits per patient for the postindex period; specialty visits accounted for 59.0% of outpatient visits. Imaging was utilized with a mean of 5.2 (SD 5.5) discrete tests per patient, and opioids were the most commonly prescribed medication (38.7%). Annual direct total costs for all conditions were $386 million ($31,692 per patient; a 40% increase from the pre-index). Pharmacy costs comprised 14.3% of total costs, and outpatient visits were the primary cost driver. CONCLUSIONS: Chronic pain conditions impose a substantial burden on the healthcare system, with musculoskeletal conditions associated with the highest overall costs. Costs appeared to be primarily related to use of outpatient services. This type of research supports integrated delivery systems as a source for assessing opportunities to improve patient outcomes and lower the costs for chronic pain patients.

All-Cause Mortality and Progression Risks to Hepatic Decompensation and Hepatocellular Carcinoma in Patients Infected With Hepatitis C Virus.

BACKGROUND: A key question in care of patients with chronic hepatitis C virus (HCV) infection is beginning treatment immediately vs delaying treatment. Risks of mortality and disease progression in "real world" settings are important to assess the implications of delaying HCV treatment. METHODS: This was a cohort study of HCV patients identified from 4 integrated health systems in the United States who had liver biopsies during 2001-2012. The probabilities of death and progression to hepatocellular carcinoma, hepatic decompensation (hepatic encephalopathy, esophageal varices, ascites, or portal hypertension) or liver transplant were estimated over 1, 2, or 5 years by fibrosis stage (Metavir F0-F4) determined by biopsy at beginning of observation. RESULTS: Among 2799 HCV-monoinfected patients who had a qualifying liver biopsy, the mean age at the time of biopsy was 50.7 years. The majority were male (58.9%) and non-Hispanic white (66.9%). Over a mean observation of 5.0 years, 261 (9.3%) patients died and 34 (1.2%) received liver transplants. At 5 years after biopsy, the estimated risk of progression to hepatic decompensation or hepatocellular carcinoma was 37.2% in stage F4, 19.6% in F3, 4.7% in F2, and 2.3% in F0-F1 patients. Baseline biopsy stage F3 or F4 and platelet count below normal were the strongest predictors of progression to hepatic decompensation or hepatocellular carcinoma. CONCLUSIONS: The risks of death and progression to liver failure varied greatly by fibrosis stage. Clinicians and policy makers could use these progression risk data in prioritization and in determining the timing of treatment for patients in early stages of liver disease.

Racial differences in breast cancer survival in a large urban integrated health system.

BACKGROUND: African American (AA) women are known to have poorer breast cancer survival than whites, and the differences may be related to underlying disparities in their clinical presentation or access to care. This study evaluated the relationship between demographic, treatment, and socioeconomic factors and breast cancer survival among women in southeast Michigan. METHODS: The population included 2387 women (34% AA) with American Joint Committee on Cancer stage I to III breast cancer who were treated at the Henry Ford Health System (HFHS) from 1996 through 2005. Linked data sets from the HFHS, the Metropolitan Detroit Cancer Surveillance System, and the US Census Bureau were used to obtain demographic and clinical information. Comorbidities were classified with the modified Charlson comorbidity index (CCI). Economic deprivation was categorized with a census tract-based deprivation index (DI), which was stratified into 5 quintiles of increasing socioeconomic disadvantage. RESULTS: Compared with whites, AA women were significantly more likely to have larger, hormone receptor-negative tumors and more comorbidities and to reside in an economically deprived area. In an unadjusted analysis, AAs had a significantly higher risk of death (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.16-1.59); however, after adjustments for clinical (age, stage, hormone receptor, and CCI) and societal factors (DI), the effect of race was not significant (HR, 1.13 [95% CI, 0.96-1.34] , and HR, 0.97 [0.80-1.19] respectively). CONCLUSIONS: Racial differences in breast cancer survival can be explained by clinical and socioeconomic factors. Nonetheless, AA women with breast cancer remain disproportionately affected by unfavorable tumor characteristics and economic deprivation, which likely contribute to their increased overall mortality.

Is previous exposure to hepatitis B a risk factor for pancreatic cancer or hepatocellular carcinoma?

GOALS: We evaluated whether prior infection with the hepatitis B virus (HBV) influences the development of pancreatic cancer or hepatocellular carcinoma (HCC). BACKGROUND: Prior infection with HBV may predispose patients to developing pancreatic cancer or HCC. STUDY: We conducted a retrospective cohort study using administrative data from an integrated health care system. We identified all patients who had HBV testing over a 13-year period. These patients were divided into 1 of 3 cohorts based on HBV status: negative infection (n=28,719), previous exposure (n=5141), or active infection (n=404). Pancreatic cancer and HCC data were obtained from pathology reports in the health system's cancer registry. RESULTS: In a multivariable model, age [hazards ratio (HR), 1.08; confidence interval (CI), 1.06-1.09; P<0.001)] and presence of diabetes (HR, 1.88; CI, 1.27-2.80; P=0.002) were identified to have significant influence on pancreatic cancer development, whereas previous HBV exposure did not have a significant influence (HR, 1.41; CI, 0.88-2.27; P=0.16). In a separate multivariable model, male sex (HR, 2.05; CI, 1.35-3.11; P<0.001), age (HR, 1.08; CI, 1.06-1.09; P<0.001), being hepatitis C positive (HR, 5.40; CI, 3.51-8.33; P<0.001), and presence of cirrhosis (HR, 27.84; CI, 17.43-44.46, P<0.001) were all significant predictors of HCC. However, previous HBV exposure was not associated with HCC development (HR, 1.03; CI, 0.68-1.56; P=0.88). CONCLUSIONS: Data from this study indicate that previous HBV exposure is not a risk factor for the development of either pancreatic cancer or HCC.

Can dialysis patients be accurately identified using healthcare claims data?

BACKGROUND: While health insurance claims data are often used to estimate the costs of renal replacement therapy in patients with end-stage renal disease (ESRD), the accuracy of methods used to identify patients receiving dialysis - especially peritoneal dialysis (PD) and hemodialysis (HD) - in these data is unknown. METHODS: The study population consisted of all persons aged 18 - 63 years in a large US integrated health plan with ESRD and dialysis-related billing codes (i.e., diagnosis, procedures) on healthcare encounters between January 1, 2005, and December 31, 2008. Using billing codes for all healthcare encounters within 30 days of each patient's first dialysis-related claim ("index encounter"), we attempted to designate each study subject as either a "PD patient" or "HD patient." Using alternative windows of ± 30 days, ± 90 days, and ± 180 days around the index encounter, we reviewed patients' medical records to determine the dialysis modality actually received. We calculated the positive predictive value (PPV) for each dialysis-related billing code, using information in patients' medical records as the "gold standard." RESULTS: We identified a total of 233 patients with evidence of ESRD and receipt of dialysis in healthcare claims data. Based on examination of billing codes, 43 and 173 study subjects were designated PD patients and HD patients, respectively (14 patients had evidence of PD and HD, and modality could not be ascertained for 31 patients). The PPV of codes used to identify PD patients was low based on a ± 30-day medical record review window (34.9%), and increased with use of ± 90-day and ± 180-day windows (both 67.4%). The PPV for codes used to identify HD patients was uniformly high - 86.7% based on ± 30-day review, 90.8% based on ± 90-day review, and 93.1% based on ± 180-day review. CONCLUSIONS: While HD patients could be accurately identified using billing codes in healthcare claims data, case identification was much more problematic for patients receiving PD.

Noninitiation of adjuvant chemotherapy in women with localized breast cancer: the breast cancer quality of care study.

PURPOSE: For some women, adjuvant chemotherapy for nonmetastatic breast cancer decreases recurrences and increases survival; however, patient-physician decisions regarding chemotherapy receipt can be influenced by medical and nonmedical factors. PATIENTS AND METHODS: We used a prospective cohort design and multivariate modeling to investigate factors related to noninitiation of chemotherapy among women with newly diagnosed breast cancer recruited from three US sites. We interviewed patients at baseline and during treatment on sociodemographic, tumor, and treatment decision-making factors. Patients were categorized according to National Comprehensive Cancer Network guidelines as those for whom chemotherapy was definitely indicated, clinically discretionary, or discretionary based on age greater than 70 years. RESULTS: Of 1,145 patients recruited, chemotherapy was clinically indicated for 392 patients, clinically discretionary for 459 patients, discretionary because of age for 169 patients, and not indicated for 93 patients; data were insufficient for 32 patients. Chemotherapy rates were 90% for those in whom chemotherapy was clinically indicated, 36% for those in whom it was discretionary because of clinical factors, and 19% for those in whom it was discretionary based on age greater than 70 years. Nonreceipt of chemotherapy was associated with older age, more negative beliefs about treatment efficacy, less positive beliefs about chemotherapy, and more concern about adverse effects. In the two discretionary groups, clinical predictors of worse outcome (greater tumor size, positive nodes, worse grade, and estrogen receptor- and progesterone receptor-negative status) were associated with increased chemotherapy initiation. CONCLUSION: Utilization of adjuvant chemotherapy was most common among patients who, based on clinical criteria, would most likely benefit from it, patients with more positive than negative beliefs regarding treatment efficacy, and patients with few concerns about adverse effects.

Racial differences in the use of adjuvant chemotherapy for breast cancer in a large urban integrated health system.

Background. Racial differences in breast cancer survival may be in part due to variation in patterns of care. To better understand factors influencing survival disparities, we evaluated patterns of receipt of adjuvant chemotherapy among 2,234 women with invasive, nonmetastatic breast cancer treated at the Henry Ford Health System (HFHS) from 1996 through 2005. Methods. Sociodemographic and clinical information were obtained from linked datasets from the HFHS, Metropolitan Detroit Cancer Surveillance Systems, and U.S. Census. Comorbidity was measured using the Charlson comorbidity index (CCI), and economic deprivation was categorized using a neighborhood deprivation index. Results. African American (AA) women were more likely than whites to have advanced tumors with more aggressive clinical features, to have more comorbidity and to be socioeconomically deprived. While in the unadjusted model, AAs were more likely to receive chemotherapy (odds ratio (OR) 1.22, 95% confidence interval (CI) 1.02-1.46) and to have a delay in receipt of chemotherapy beyond 60 days (OR 1.68, 95% CI, 1.26-1.48), after multivariable adjustment there were no racial differences in receipt (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.73-1.43), or timing of chemotherapy (OR 1.18, 95 CI, 0.8-1.74). Conclusions. Societal factors and not race appear to have an impact on treatment delay among African American women with early breast cancer.

Administrative data algorithms to identify second breast cancer events following early-stage invasive breast cancer.

BACKGROUND: Studies of breast cancer outcomes rely on the identification of second breast cancer events (recurrences and second breast primary tumors). Cancer registries often do not capture recurrences, and chart abstraction can be infeasible or expensive. An alternative is using administrative health-care data to identify second breast cancer events; however, these algorithms must be validated against a gold standard. METHODS: We developed algorithms using data from 3152 women in an integrated health-care system who were diagnosed with stage I or II breast cancer in 1993-2006. Medical record review served as the gold standard for second breast cancer events. Administrative data used in algorithm development included procedures, diagnoses, prescription fills, and cancer registry records. We randomly divided the cohort into training and testing samples and used a classification and regression tree analysis to build algorithms for classifying women as having or not having a second breast cancer event. We created several algorithms for researchers to use based on the relative importance of sensitivity, specificity, and positive predictive value (PPV) in future studies. RESULTS: The algorithm with high specificity and PPV had 89% sensitivity (95% confidence interval [CI] = 84% to 92%), 99% specificity (95% CI = 98% to 99%), and 90% PPV (95% CI = 86% to 94%); the high-sensitivity algorithm had 96% sensitivity (95% CI = 93% to 98%), 95% specificity (95% CI = 94% to 96%), and 74% PPV (95% CI = 68% to 78%). CONCLUSIONS: Algorithms based on administrative data can identify second breast cancer events with high sensitivity, specificity, and PPV. The algorithms presented here promote efficient outcomes research, allowing researchers to prioritize sensitivity, specificity, or PPV in identifying second breast cancer events.

Relationship of vancomycin minimum inhibitory concentration to mortality in patients with methicillin-resistant Staphylococcus aureus hospital-acquired, ventilator-associated, or health-care-associated pneumonia.

BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is a leading cause of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and health-care-associated pneumonia (HCAP). These infections are associated with significant morbidity, mortality, and cost. The impact of vancomycin minimum inhibitory concentration (MIC) on mortality for patients with MRSA pneumonia has not been determined. METHODS: Adult patients in ICUs with a diagnosis of MRSA HAP, VAP, or HCAP were entered in the study. Clinical and laboratory information were prospectively collected. Vancomycin MIC and heteroresistance were determined for each MRSA isolate. Data were collected from February 2006 through August 2007. The primary outcome variable was all-cause mortality at day 28. A propensity score approach was used to adjust for confounding variables. RESULTS: The study sample consisted of 158 patients. All-cause mortality at day 28 was 32.3%. The majority of MRSA isolates had a vancomycin MIC ≥ 1.5 mg/mL (115/158, 72.8%). Propensity score analysis demonstrated an increase in 28-day mortality as vancomycin MIC increased from 0.75 to 3 mg/mL (P ≤ .001). Heteroresistance to vancomycin, demonstrated in 21.5% isolates, was not associated with mortality. CONCLUSIONS: Mortality in patients with MRSA HAP, VAP, and HCAP increases as a function of the vancomycin MIC, even for strains with MIC values within the susceptible range. Evaluation of vancomycin MICs should be contemplated at the institutional level and for individual cases of MRSA pneumonia. The use of vancomycin therapy in patients with MRSA pneumonia caused by isolates with MICs between 1 and 2 mg/mL should be undertaken with caution, and alternative therapies should be considered.

Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a single integrated health network.

OBJECTIVE: To determine the association between the discontinuation of clopidogrel therapy prior to 1 year and the risk of acute myocardial infarction (AMI) hospitalization, coronary intervention or all-cause mortality in a cohort of managed-care patients following AMI hospitalization or stent insertion. RESEARCH DESIGN AND METHODS: This observational cohort study included 1152 patients enrolled in the Health Alliance Plan who were hospitalized for AMI, or who underwent coronary stent placement. Clopidogrel use was assessed using pharmacy claims data. The association between discontinuation of clopidogrel prior to 1 year following the initial ACS event and the primary outcome of AMI hospitalization/procedure was assessed using Cox proportional hazards models. Additionally, an analysis was conducted to determine the association of discontinuation prior to 1 year with a secondary composite outcome of AMI hospitalization/coronary stent procedure or all-cause mortality. MAIN OUTCOME MEASURES: The primary outcome was AMI hospitalization or procedure. The secondary outcome was a composite of AMI hospitalization/ procedure, or all-cause mortality. RESULTS: Discontinuation of clopidogrel in the total cohort of patients was associated with a significantly higher risk of the primary outcome of AMI hospitalization/ coronary intervention (HR 2.712, 95% CI 1.634-4.502). Consistent with this finding, discontinuation of clopidogrel was also associated with a significantly higher risk of the secondary composite endpoint (HR 1.844, 95% CI 1.281-2.653). CONCLUSIONS: In patients enrolled in an integrated health network, clopidogrel discontinuation prior to 1 year following AMI hospitalization or stent placement is associated with adverse outcomes including greater risk of death, AMI hospitalization or coronary intervention. These results should be interpreted within the context and limitations of observational research, which cannot attribute causality.

Diffusion of aromatase inhibitors for breast cancer therapy between 1996 and 2003 in the Cancer Research Network.

PURPOSE: Clinical trials demonstrated adjuvant aromatase inhibitor treatment is superior for decreasing breast cancer recurrence risk over adjuvant tamoxifen treatment as early as 2001. Yet clinical use for adjuvant treatment was not recommended by the American Society of Clinical Oncology until 2004. Aromatase inhibitor uptake after the first public presentation of randomized trial results but before the release of national guidelines is unclear. We evaluated diffusion of aromatase inhibitor dispensings for breast cancer treatment in integrated healthcare delivery systems across the United States. METHODS: We collected automated data for 13,245 women enrolled at seven integrated healthcare delivery systems in the Cancer Research Network. All women were aged >55 and diagnosed with estrogen receptor positive, invasive breast cancer between 1996 and 2003. We used electronic pharmacy data to identify aromatase inhibitor and tamoxifen dispensings through 2004. We evaluated the proportions of women who received hormone dispensings in two ways: (1) at any point after diagnosis to capture all use, and (2) in the two-year period following diagnosis to approximate adjuvant use. RESULTS: Over time, adjuvant aromatase inhibitor use increased whereas tamoxifen use decreased. Aromatase inhibitor dispensings within 2 years of diagnosis increased from 4.1% among women diagnosed in 2000 to 13% in 2001, 24% in 2002, and 40% in 2003. Tamoxifen use declined starting in 2001 at every system. CONCLUSION: Aromatase inhibitor use rose dramatically after 2001 while tamoxifen use decreased. It appears results from early clinical trials changed practice in these integrated healthcare systems before formal changes in national guidelines.

Racial differences in tumor stage and survival for colorectal cancer in an insured population.

BACKGROUND: Despite declining death rates from colorectal cancer (CRC), racial disparities have continued to increase. In this study, the authors examined disparities in a racially diverse group of insured patients. METHODS: This study was conducted among patients who were diagnosed with CRC from 1993 to 1998, when they were enrolled in integrated healthcare systems. Patients were identified from tumor registries and were linked to information in administrative databases. The sample was restricted to non-Hispanic whites (n = 10,585), non-Hispanic blacks (n = 1479), Hispanics (n = 985), and Asians/Pacific Islanders (n = 909). Differences in tumor stage and survival were analyzed by using polytomous and Cox regression models, respectively. RESULTS: In multivariable regression analyses, blacks were more likely than whites to have distant or unstaged tumors. In Cox models that were adjusted for nonmutable factors, blacks had a higher risk of death from CRC (hazard ratio [HR], 1.17; 95% confidence interval [95% CI], 1.06-1.30). Hispanics had a risk of death similar to whites (HR, 1.04; 95% CI, 0.92-1.18), whereas Asians/Pacific Islanders had a lower risk of death from CRC (HR, 0.89; 95% CI, 0.78-1.02). Adjustment for tumor stage decreased the HR to 1.11 for blacks, and the addition of receipt of surgical therapy to the model decreased the HR further to 1.06. The HR among Hispanics and Asians/Pacific Islanders was stable to adjustment for tumor stage and surgical therapy. CONCLUSIONS: The relation between race and survival from CRC was complex and appeared to be related to differences in tumor stage and therapy received, even in insured populations. Targeted interventions to improve the use of effective screening and treatment among vulnerable populations may be needed to eliminate disparities in CRC.

Use of guideline recommended follow-up care in cancer survivors: routine or diagnostic indications?

BACKGROUND: After potentially curative cancer treatment, patients may receive procedures for routine monitoring for recurrence or for evaluation of symptoms or signs. OBJECTIVE: We sought to characterize surveillance care guideline-recommended and other procedures performed in cancer survivors according to routine versus diagnostic indications. METHODS: This was a retrospective cohort study of paper and electronic medical records between 1990 and 2000 from a large midwestern U.S. integrated health care delivery system of 500 patients who received curative treatment of breast, colorectal, endometrial, lung, or prostate cancer. Our measures were the indications for potential surveillance procedures as recommended by clinical practice guidelines or otherwise. RESULTS: Among 14,670 procedures of interest received, 82.0% were performed for routine surveillance, whereas 10.6% were performed for diagnostic indications and 7.3% had indeterminate indications. Office visits most were often delivered for routine indications (91.6%), followed by guideline recommended tests for local recurrence (range 74.1-98.4%, depending on the specific test and cancer). In general, tests that were not recommended in established guidelines were for the purposes of detection of metastatic recurrence and were less often delivered for routine indications (overall frequency 59.2%, P<0.0001 compared with recommended testing). CONCLUSION: Office visits and testing for local recurrence of cancer generally are performed for routine surveillance, regardless of recommendation by practice guidelines. Because procedures not recommended by practice guidelines were more often for diagnostic purposes, classification of patients as undergoing intensive surveillance may be misleading and may require record review to confirm.

Building a virtual cancer research organization.

BACKGROUND: The Cancer Research Network (CRN) comprises the National Cancer Institute and 11 nonprofit research centers affiliated with integrated health care delivery systems. The CRN, a public/private partnership, fosters multisite collaborative research on cancer prevention, screening, treatment, survival, and palliation in diverse populations. METHODS: The CRN's success hinges on producing innovative cancer research that likely would not have been developed by scientists working individually, and then translating those findings into clinical practice within multiple population laboratories. The CRN is a collaborative virtual research organization characterized by user-defined sharing among scientists and health care providers of data files as well as direct access to researchers, computers, software, data, research participants, and other resources. The CRN's research management Web site fosters a high-functioning virtual scientific community by publishing standardized data definitions, file specifications, and computer programs to support merging and analyzing data from multiple health care systems. RESULTS: Seven major types of standardized data files developed to date include demographics, health plan eligibility, tumor registry, inpatient and ambulatory utilization, medication dispensing, laboratory tests, and imaging procedures; more will follow. Data standardization avoids rework, increases multisite data integrity, increases data security, generates shorter times from initial proposal concept to submission, and stimulates more frequent collaborations among scientists across multiple institutions. CONCLUSIONS: The CRN research management Web site and associated standardized data files and procedures represent a quasi-public resource, and the CRN stands ready to collaborate with researchers from outside institutions in developing and conducting innovative public domain research.