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ABSTRACT: BACKGROUND: Low-intensity warfarin is among the most frequently prescribed thromboprophylaxis regimens after major orthopedic surgery in the United States. This has been a source of controversy as the American College of Chest Physicians historically recommended standard intensity warfarin (INR 2-3) over low-intensity warfarin in this setting. The updated guidelines include low-intensity warfarin as a recommended option, but data evaluating this intervention has not kept pace with newer agents. MATERIALS AND METHODS: We describe the risk of symptomatic venous thromboembolism and clinically relevant bleeding in a retrospective cohort of patients receiving low-intensity warfarin (INR 1.5 to 2.5) for six weeks after total hip arthroplasty. Outcomes were identified within a joint replacement registry and cross-verified by queries of electronic inpatient and outpatient databases and independently adjudicated by chart review. RESULTS: 835 surgeries in 800 patients were included in the analysis. Mean patient age was 66years, 61.7% were female and 81.1% were prescribed mechanical prophylaxis in addition to warfarin. In the 90days after surgery, there were 13 cases of symptomatic venous thromboembolism (1.6% of surgeries) which included 10 cases of pulmonary embolism (1.2% of surgeries). The incidence of clinically relevant bleeding during warfarin therapy was 0.8% and one death unrelated to bleeding or venous thromboembolism occurred. CONCLUSIONS: Although warfarin produced low rates of clinically relevant bleeding and symptomatic venous thromboembolism, pulmonary embolism made up a greater proportion of events than anticipated. Low-intensity warfarin should be considered in future studies to identify the regimen that optimally balances risk of bleeding and symptomatic venous thromboembolism in a real world setting.
Thrombosis Research 03/2013; · 2.44 Impact Factor
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Jennifer Webster,
Tia L Kauffman,
Heather Spencer Feigelson,
Pamala A Pawloski,
Adedayo A Onitilo,
Arnold L Potosky,
Deanna Cross,
Paul R Meier,
Anousheh S Mirabedi, Thomas Delate,
Yihe Daida,
Andrew E Williams,
Gwen L Alexander,
Catherine A McCarty,
Stacey Honda,
Lawrence H Kushi,
Katrina A B Goddard
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ABSTRACT: BACKGROUND: In metastatic colorectal cancer (mCRC), mutations in the KRAS gene predict poor response to epidermal growth factor receptor (EGFR) inhibitors. Clinical treatment guidelines now recommend KRAS testing if EGFR inhibitors are considered. Our study investigates the clinical uptake and utilization of KRAS testing. METHODS: We included 1,188 patients with mCRC diagnosed from 2004 to 2009, from seven integrated health care delivery systems with a combined membership of 5.5 million. We used electronic medical records and targeted manual chart review to capture the complexity and breadth of real-world clinical oncology care. RESULTS: Overall, 428 patients (36%) received KRAS testing during their clinical care, and 266 (22%) were treated with EGFR inhibitors. Age at diagnosis (p=0.0034), comorbid conditions (p=0.0316), and survival time from diagnosis (p<0.0001) influence KRAS testing and EGFR inhibitor prescribing. The proportion who received KRAS testing increased from 7% to 97% for those treated in 2006 and 2010, respectively, and 83% of all treated patients had a KRAS wild type genotype. Most patients with a KRAS mutation (86%) were not treated with EGFR inhibitors. The interval between mCRC diagnosis and receipt of KRAS testing decreased from 26 months (2006) to 10 months (2009). CONCLUSIONS: These findings demonstrate rapid uptake and incorporation of this predictive biomarker into clinical oncology care. Impact: In this delivery setting, KRAS testing is widely used to guide treatment decisions with EGFR inhibitors in patients with mCRC. An important future research goal is to evaluate utilization of KRAS testing in other delivery settings in the US.
Cancer Epidemiology Biomarkers & Prevention 11/2012; · 4.12 Impact Factor
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ABSTRACT: OBJECTIVE To assess the effect of continuing professional development (CPD) on perceptions of learning behaviors compared with traditional continuing pharmacy education (CPE). DESIGN Randomized controlled trial. SETTING Kaiser Permanente Colorado (KPCO) from August 2008 to June 2009. PARTICIPANTS Licensed pharmacists employed at KPCO. INTERVENTION After completing a basic CPD course, participants were randomized into a control group that continued with traditional CPE or an intervention group that completed three CPD workshops and used the CPD approach for their professional learning needs. At baseline and follow-up, all participants completed a study questionnaire on perceptions of their learning behaviors. MAIN OUTCOME MEASURE Comparison of responses to questionnaire items at follow-up. RESULTS 100 pharmacists were enrolled. The intervention (n = 44; 7 lost to follow-up) and control (n = 47; 2 lost to follow-up) groups were similar at baseline. At follow-up, a higher percentage of intervention than control participants reported changing their learning behaviors/activities sometimes (41% vs. 0%, P < 0.01) or frequently/always (18% vs. 4%, P < 0.05). More intervention than control participants responded that they frequently/always participated in learning by doing (61% vs. 36%, P < 0.05), identified specific learning objectives (93% vs. 30%, P < 0.01), and documented their learning plan (82% vs. 13%, P < 0.01). A higher percentage of intervention than control participants responded that they adhered to their learning plan partially/to a large extent (80% vs. 15%, P < 0.01) and more than three-quarters of the intervention participants responded that they partially/to a large extent achieved their learning objectives ( P < 0.01). CONCLUSION Pharmacists who adopted a CPD approach were more likely to report that various aspects of their learning behaviors improved as a result of education activities compared with pharmacists who participated in traditional CPE.
Journal of the American Pharmacists Association 11/2012; 52(6):742-52.
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ABSTRACT: STUDY OBJECTIVE: To compare clinical and safety outcomes of warfarin therapy before and after implementation of a novel patient self-management (PSM) program in which patients received their venipuncture-derived international normalized ratio (INR) results through a secure online messaging system and adjusted their warfarin dosages and follow-up visits according to provided support tools. DESIGN: Prospective, open-label, 3-month, pilot study. SETTING: Centralized clinical pharmacy anticoagulation service. PATIENTS: Forty-four patients with atrial fibrillation who were receiving warfarin for more than 6 months were enrolled in the trial between January 1, 2011, and February 28, 2011; 39 patients completed the trial. Patients acted as their own controls. INTERVENTION: Patients received dosing decision support tools during a 2-hour live PSM training class. Those who then demonstrated proficiency in PSM assumed responsibility for their warfarin therapy management. MEASUREMENTS AND MAIN RESULTS: Outcomes of warfarin therapy were measured in each patient before and after implementation of the PSM program. Study variables included time in the therapeutic INR range (TTR), numbers of INR tests performed, and episodes of major bleeding or thrombosis. No significant difference in TTR occurred between the 90 days before PSM program participation and the 90 days of PSM (82.9% vs 81.2%, p=0.65). The mean number of INR tests performed for each patient increased from 2.97 before PSM program participation to 4.38 during PSM (p<0.01). No bleeding or thrombotic events occurred during the PSM phase. CONCLUSION: Patients were trained to engage in PSM using support tools and venipuncture-derived INR results received by an online messaging system to adjust warfarin dosage and frequency of INR testing. No significant difference in TTR occurred in these patients before and during the PSM. This novel PSM model appears to be a feasible method of managing warfarin therapy in carefully selected patients; however, a larger, randomized controlled trial is needed to evaluate the safety and efficacy of the model and its effect on anticoagulation service workload.
Pharmacotherapy 10/2012; · 2.90 Impact Factor
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ABSTRACT: BACKGROUND: Relatively low rates of chemotherapy receipt have been observed in older patients diagnosed with advanced non-small cell lung cancer (NSCLC) in SEER-Medicare-based studies. However, little is known about variation in first-line NSCLC chemotherapy use in younger patients, health maintenance organization (HMO)-based settings, and for high-cost, novel agents, such as bevacizumab and erlotinib. METHODS: A cohort of 6614 stage IIIB/IV NSCLC patients aged ≥21 years diagnosed between 2000 and 2007 was identified at four HMOs that participate in the Cancer Research Network (CRN). Demographic, comorbidity, tumor characteristics, and chemotherapy treatment data were included in logistic regression models to identify factors associated with chemotherapy receipt and tests of association examined secular and age-specific variation in first-line chemotherapy regimens. RESULTS: Within 120 days of diagnosis, 3612 (55%) patients received chemotherapy; increasing from 52% of patients diagnosed in 2000 to 59% in 2007 (p<0.001). Receipt was significantly higher for patients aged <65 years (64% versus 46% in ≥65) and was inversely related to stage and comorbidites (all p<0.001). Carboplatin and paclitaxel were received most frequently. Erlotinib and bevacizumab use in the later years of the study was associated with a significant change in distributions of first-line chemotherapies (p<0.001). CONCLUSIONS: For patients alive 30 days post diagnosis, chemotherapy use was higher in the aged population (>65 years) than previously published estimates, and higher still among younger patients. Chemotherapy use increased over the observation period, and the mix of first-line therapies used changed substantially over time. Of note, novel, high cost treatments were used in first-line therapy prior to FDA approval, increasing significantly throughout the study period. These findings demonstrate the utility of HMO CRN data to augment SEER-Medicare to conduct comparative effectiveness research related to chemotherapy use and the use of specific agents, especially among younger patients.
Lung cancer (Amsterdam, Netherlands) 09/2012; · 3.14 Impact Factor
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ABSTRACT: STUDY OBJECTIVE: As data that prompted a 2009 labeling change detailing contraindications, precautions, and dosing recommendations for the first branded colchicine product were limited to case reports of myotoxicity and blood dyscrasias ascribed to the drug, we sought to quantify the association of colchicine therapy with serious adverse outcomes in a cohort of insured patients. DESIGN: Case-control study. DATA SOURCE: Kaiser Permanente Colorado electronic data warehouses and electronic medical records. PATIENTS: Cases were patients with a creatine kinase (CK) level of at least 2000 U/L or who developed a clinically significant non-cancer-related blood dyscrasia (thrombocytopenia, neutropenia, leukopenia, aplastic anemia, or pancytopenia) between January 1, 2006, and June 30, 2009 (954 cases). Each case was matched to up to 10 controls by age, sex, and index date (date of the increased CK level or blood dyscrasia-supporting laboratory value). Controls were patients without elevated CK levels or blood dyscrasias who had a routine health maintenance examination during the same time period (index date was the date of their health maintenance examination [9007 controls]). MEASUREMENTS AND MAIN RESULTS: The primary study outcome was colchicine exposure, defined as a colchicine prescription purchase in the 100 days before the index date. The likelihood of colchicine exposure was examined with conditional logistic regression. Cases experienced a higher rate of previous colchicine exposure compared with controls (0.6% vs 0.2%, odds ratio 3.9, 95% confidence interval 1.4-10.7). In addition, cases had higher hospitalization rates (14.9% vs 5.0%, p<0.001), higher mean chronic disease scores (2.5 vs 0.0, p<0.001), and were more likely to have been exposed to drugs that may increase the risk of adverse events due to an interaction with a CYP3A4 inhibitor drug (6.9% vs 2.3%, p<0.001). CONCLUSION: Patients with confirmed elevations in CK level and/or blood dyscrasias had a higher rate of previous colchicine exposure, although low overall, and greater hospitalization rates and exposure to drugs that may increase the risk of adverse events compared with controls. These findings support the 2009 United States Food and Drug Administration labeling for the first branded colchicine product, cautioning use in patients with liver impairment or renal dysfunction and/or those receiving concurrent drugs that may increase risk of adverse events.
Pharmacotherapy 09/2012; · 2.90 Impact Factor
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ABSTRACT: BACKGROUND Patients who not only survive a warfarin-associated gastrointestinal tract bleeding (GIB) event but also have an ongoing risk for thromboembolism present 2 clinical dilemmas: whether and when to resume anticoagulation. The objective of this study was to determine the incidence of thrombosis, recurrent GIB, and death, as well as the time to resumption of anticoagulant therapy, during the 90 days following a GIB event. METHODS In this retrospective, cohort study using administrative and clinical databases, patients experiencing GIB during warfarin therapy were categorized according to whether they resumed warfarin therapy after GIB and followed up for 90 days. Variables describing the management and severity of the index GIB were also collected. Kaplan-Meier curves were constructed to estimate the survival function of thrombosis, recurrent GIB, and death between the "resumed warfarin therapy" and "did not resume warfarin therapy" groups, with Cox proportional hazards modeling to adjust for potentially confounding factors. RESULTS There were 442 patients with warfarin-associated index GIB included in the analyses. Following the index GIB, 260 patients (58.8%) resumed warfarin therapy. Warfarin therapy resumption after the index GIB was associated with a lower adjusted risk for thrombosis (hazard ratio [HR], 0.05; 95% CI, 0.01-0.58) and death (HR, 0.31; 95% CI, 0.15-0.62), without significantly increasing the risk for recurrent GIB (HR, 1.32; 95% CI, 0.50-3.57). CONCLUSIONS The decision to not resume warfarin therapy in the 90 days following a GIB event is associated with increased risk for thrombosis and death. For many patients who have experienced warfarin-associated GIB, the benefits of resuming anticoagulant therapy will outweigh the risks.
Archives of internal medicine 09/2012; · 11.46 Impact Factor
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Erin J Aiello Bowles,
Robert Wellman,
Heather Spencer Feigelson,
Adedayo A Onitilo,
Andrew N Freedman, Thomas Delate,
Larry A Allen,
Larissa Nekhlyudov,
Katrina A B Goddard,
Robert L Davis,
Laurel A Habel,
Marianne Ulcickas Yood,
Catherine McCarty,
David J Magid,
Edward H Wagner,
Pharmacovigilance Study Team
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ABSTRACT: Background Clinical trials demonstrated that women treated for breast cancer with anthracycline or trastuzumab are at increased risk for heart failure and/or cardiomyopathy (HF/CM), but the generalizability of these findings is unknown. We estimated real-world adjuvant anthracycline and trastuzumab use and their associations with incident HF/CM. Methods We conducted a population-based, retrospective cohort study of 12 500 women diagnosed with incident, invasive breast cancer from January 1, 1999 through December 31, 2007, at eight integrated Cancer Research Network health systems. Using administrative procedure and pharmacy codes, we identified anthracycline, trastuzumab, and other chemotherapy use. We identified incident HF/CM following chemotherapy initiation and assessed risk of HF/CM with time-varying chemotherapy exposures vs no chemotherapy. Multivariable Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) with adjustment for age at diagnosis, stage, Cancer Research Network site, year of diagnosis, radiation therapy, and comorbidities. Results Among 12 500 women (mean age = 60 years, range = 22-99 years), 29.6% received anthracycline alone, 0.9% received trastuzumab alone, 3.5% received anthracycline plus trastuzumab, 19.5% received other chemotherapy, and 46.5% received no chemotherapy. Anthracycline and trastuzumab recipients were younger, with fewer comorbidities than recipients of other chemotherapy or none. Compared with no chemotherapy, the risk of HF/CM was higher in patients treated with anthracycline alone (adjusted HR = 1.40, 95% CI = 1.11 to 1.76), although the increased risk was similar to other chemotherapy (adjusted HR = 1.49, 95% CI = 1.25 to 1.77); the risk was highly increased in patients treated with trastuzumab alone (adjusted HR = 4.12, 95% CI = 2.30 to 7.42) or anthracycline plus trastuzumab (adjusted HR = 7.19, 95% CI = 5.00 to 10.35). Conclusions Anthracycline and trastuzumab were primarily used in younger, healthier women and associated with increased HF/CM risk compared with no chemotherapy. This population-based observational study complements findings from clinical trials on cancer treatment safety.
CancerSpectrum Knowledge Environment 09/2012; 104(17):1293-305. · 14.07 Impact Factor
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ABSTRACT: Background/Aims Research has demonstrated that platinum-based chemotherapy may prolong short-term survival and improve symptom control in patients with advanced (stage IIIb-IV) non-small cell lung cancer (NSCLC). Newer chemotherapy agents (e.g., taxanes, antimetabolites, monoclonal antibodies, drugs targeting EGFRs), used as singlet, doublet, or triplet regimens, may improve survival. However, these agents are expensive and may produce side effects requiring hospitalization. Little is known regarding variation in both use (singlet vs. doublet vs. triplet regimens) and outcomes (survival, hospitalizations, cost) in community practices over time for non-aged populations, adjusting for comorbidities. Aims Using information from the HMO Cancer Research Network's (CRN) Virtual Data Warehouse (VDW), we examined the impact on variation over time in use of first-line chemotherapy regimens (singlet vs. doublet vs. triplet) in stage lIIb-IV NSCLC patients on survival, hospitalizations, and costs. Methods Patients aged less than 21 years with stage IIIb-IV NSCLC diagnosed between 2000-2007 at four CRN sites were included in the analysis. Patients were followed from diagnosis date through 2008 (or death or disenrollment). Patient demographics, comorbidities, chemotherapy treatment data, and mortality were obtained from the CRN VDW. Propensity-adjusted survival and Poisson modeling were employed to examine variation in survival days and hospitalizations. Average wholesale price data were used to examine the relative difference in costs by chemotherapy regimen. Results We identified 3,072 stage lIIb-IV NSCLC patients who received first-line chemotherapy of which 24% were <65 years old at diagnosis. The distribution of first-line therapy changed significantly over time with the introduction of taxane, monoclonal antibody, and antimetabolite agents in the later years of the study period. Those receiving singlet regimens were older and had more comorbidities. Unadjusted survival rates were higher for those receiving triplet therapy, but only against singlet regimens in adjusted models. Those receiving singlet regimens had the greatest number of hospitalizations. The costs of doublet and triplet regimens were significantly higher than the singlet regimens. Discussion There was significant variation over time in chemotherapy regimens used in the CRN. Triplet therapy appeared to be associated with the best outcomes and fewest side effects. However, cost considerations for triplet therapy warrant assessments of their cost-effectiveness.
Clinical Medicine & Research 08/2012; 10(3):158.
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ABSTRACT: Background/Aims Variation in utilization and costs of chemotherapy agents for colorectal cancer (CRC) patients not captured by SEER-Medicare or clinical trials has not been well studied. Little is known about how chemotherapy is administered to patients with advanced disease who are treated in community practices, including such key factors as treatment intent (curative vs. palliative), dosing, treatment modifications, and discontinuations, and whether patients receive new lines of chemotherapy after failing to respond to prior regimens. Aims Using the wealth of cancer treatment data newly available as a result of recent VDW infrastructure development efforts associated with infusion and chemotherapy utilization, we characterize the number of unique chemotherapy protocols and regimens administered to patients with advanced CRC. Methods Patients aged > 21 years with stage III or IV CRC, diagnosed between 2007-2010 at three CRN sites were included in the analysis. Using VDW files including tumor registries and data files derived from Kaiser Permanente's HealthConnect Oncology Beacon® module, patients were followed from diagnosis date through 2010 (or death or disenrollment). We identified and tabulated treatment information including treatment intent, treatment protocols, oral and infused treatment regimens, early cessation and/or dose modification of therapy due to toxicities, and patient characteristics. We also estimate the variation in costs associated with the treatment regimens identified. Results Preliminary findings suggest that more than 40% of advanced CRC patients receiving chemotherapy were less than 65 years old. For the majority of cases, treatment intent was noted as adjuvant or neo-adjuvant. Chemotherapy treatments were distributed across 14 standard adult oncology protocols. The most common first line treatment was Oxaliplatin + Fluorouracil + Leucovorin. However, a large number of regimens included the monoclonal antibody, bevacizumab. A number of cases were noted to have treatment plan changes and modifications. Treatment costs were positively correlated to the use of regimens that included bevacizumab. Discussion Newly available VDW chemotherapy infusion data derived from the EpicCare and Kaiser Permanente's HealthConnect Oncology Beacon® files (along with other infusion data sources) is a rich cancer treatment data source that researchers can use to conduct clinical- and policy-relevant comparative effectiveness research studies in patients with advanced colorectal cancer.
Clinical Medicine & Research 08/2012; 10(3):152.
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ABSTRACT: BACKGROUND:: Most data regarding medical care for cancer patients in the United States comes from Surveillance, Epidemiology and End Results-linked Medicare analyses of individuals aged 65 years or older and typically excludes Medicare Advantage enrollees. OBJECTIVES:: To assess the accuracy of chemotherapy and hormone therapy treatment data available through the Cancer Research Network's Virtual Data Warehouse (VDW). RESEARCH DESIGN:: Retrospective, longitudinal cohort study. Medical record-abstracted, tumor registry-indicated treatments (gold standard) were compared with VDW-indicated treatments derived from health maintenance organization pharmacy, electronic medical record, and claim-based data systems. SUBJECTS:: Enrollees aged 18 years and older diagnosed with incident breast, colorectal, lung, or prostate cancer from 2000 through 2007. MEASURES:: Sensitivity, specificity, and positive predictive value were computed at 6 and 12 months after cancer diagnosis. RESULTS:: Approximately 45% of all cancer cases (total N=23,800) were aged 64 years or younger. Overall chemotherapy sensitivity/specificities across the 3 health plans for incident breast, colorectal, lung, and prostate cancer cases were 95%/90%, 95%/93%, 93%/93%, and 85%/77%, respectively. With the exception of prostate cancer cases, overall positive predictive value ranged from 86% to 89%. Small variations in chemotherapy data accuracy existed due to cancer site and data source, whereas greater variation existed in hormone therapy capture across sites. CONCLUSIONS:: Strong concordance exists between gold standard tumor registry measures of chemotherapy receipt and Cancer Research Network VDW data. Health maintenance organization VDW data can be used for a variety of studies addressing patterns of cancer care and comparative effectiveness research that previously could only be conducted among elderly Surveillance, Epidemiology and End Results-Medicare populations.
Medical care 04/2012; · 3.24 Impact Factor
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ABSTRACT: This study aimed to compare major hemorrhage rates among patients receiving warfarin, acetylsalicylic acid (ASA), and clopidogrel
to those receiving ASA and clopidogrel following percutaneous coronary intervention with stent implantation. This retrospective
cohort study identified patients with stents implanted between September 1, 2003 and December 31, 2006. Patients treated with
warfarin, ASA, and clopidogrel within 30days of hospital discharge (Triple Therapy group) were matched by age, sex, and stent type to patients treated with ASA and clopidogrel (Dual Therapy group). Outcomes included the incidence rates of major hemorrhage and major adverse coronary events (MACE) within 12months
of stent implantation. There were 175 and 339 patients in the Triple Therapy and Dual Therapy groups, respectively. There were 25 (14.3%) and 10 (3.0%) major hemorrhages in the Triple Therapy and Dual Therapy groups, respectively (OR 9.0; 95% CI, 3.1–26.1). Patients in the Triple Therapy group had a greater likelihood of MACE compared to patients in the Dual Therapy group (OR 2.0; 95% CI 1.1–3.8). Post-stent treatment with warfarin, ASA, and clopidogrel was associated with a substantially
greater likelihood of major hemorrhage than treatment with ASA and clopidogrel alone.
KeywordsPercutaneous coronary-Aspirin/therapeutic use-Drug eluting stents-Hemorrhage/chemically induced-International normalized ratio-Warfarin/adverse effects-Warfarin/therapeutic use
Journal of Thrombosis and Thrombolysis 04/2012; 29(3):316-321. · 1.48 Impact Factor
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Thomas Delate,
Erin J Aiello Bowles,
Roy Pardee,
Robert D Wellman,
Laurel A Habel,
Marianne Ulcickas Yood,
Larissa Nekhlyudov,
Katrina A Goddard,
Robert L Davis,
Catherine A McCarty,
Adedayo A Onitilo,
Heather Spencer Feigelson,
Jared Freml,
Edward Wagner
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ABSTRACT: Cancer Research Network (CRN) sites use administrative data to populate their Virtual Data Warehouse (VDW). However, information on VDW chemotherapy data validity is limited. The purpose of this study was to assess the validity of VDW chemotherapy data.
This was a retrospective cohort study of women ≥18 years with incident, invasive breast cancer diagnosed between January 1999 and December 2007. Pharmacy and procedure chemotherapy data were extracted from each site's VDW. Random samples of 50 patients stratified on trastuzumab, anthracyclines, and no chemotherapy exposure was selected from each site for detailed chart abstraction. Weighted sensitivities and specificities of VDW compared with abstracted data were calculated. Cumulative doses calculated from VDW data were compared with doses obtained from the medical chart review.
The cohort included 13,497 patients with 6,456 (48%) chart review eligible. Patients in the sample (N = 400) had a mean age of 65 years. Trastuzumab, anthracycline, and other chemotherapy weighted sensitivities were 95%, 97%, and 100%, respectively; specificities were 99%, 99%, and 93%, respectively; positive predictive values were 96%, 99%, and 55%, respectively; and negative predictive values were 99%, 96%, and 100%. Trastuzumab and anthracyclines VDW mean doses were 873 and 386 mg, respectively, whereas abstracted mean doses were 1,734 and 369 mgs, respectively (R(2) = 0.14, P < 0.01 and R(2) = 0.05, P = 0.03, respectively).
Sensitivities and specificities for CRN chemotherapy VDW data were high and dosages were correlated with chart information.
The findings support the use of CRN data in evaluating chemotherapy exposures and related outcomes.
Cancer Epidemiology Biomarkers & Prevention 02/2012; 21(4):673-80. · 4.12 Impact Factor
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ABSTRACT: Evidence-based treatment guidelines recommend low molecular weight heparin (LMWH) monotherapy for cancer-associated venous thromboembolism (VTE). This analysis assessed the first-line treatment strategies for VTE in patients with advanced solid tumors.
Using administrative data from advanced lung, prostate, colon, or breast cancer patients diagnosed between January 2000 and December 2007 at four HMOs with integrated delivery systems, patients with an inpatient or outpatient VTE diagnosed within 2 years after cancer diagnosis and an outpatient purchase of warfarin, LMWH, and/or fondaparinux anticoagulant within 7 days of the VTE diagnosis were identified. First-line outpatient VTE pharmacological treatment and factors independently associated with receipt/non-receipt of LMWH monotherapy were assessed.
Overall, 25% of the 1,089 eligible patients received LMWH monotherapy as primary VTE treatment. The percentage increased steadily over time from 18% among patients diagnosed in 2000 to 31% among those diagnosed in 2007. Factors associated with LMWH monotherapy included VTE diagnosis year, chemotherapy within 60 days prior to VTE diagnosis, history of VTE prior to cancer diagnosis, and invasive surgery in the 90 days following VTE diagnosis. Colorectal and prostate cancer patients versus lung cancer patients and stage III versus stage IV patients were less likely to be treated with LMWH monotherapy.
Adoption of LMWH monotherapy as initial treatment for cancer-associated VTE was low but increased steadily over the study period. Future studies should explore reasons underlying the underutilization of this preferred evidence-based treatment as well as the comparative effectiveness of LMWH versus warfarin-based anticoagulation in real-world cancer patients with VTE.
The Oncologist 02/2012; 17(3):419-27. · 3.91 Impact Factor
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ABSTRACT: When interacting medications, such as doxycycline, are initiated during warfarin therapy, one method to correct for non-therapeutic international normalized ratio (INR) is adjusting the warfarin dose, if necessary. Another approach is preemptive warfarin dose adjustment. This study's objective was to evaluate the utility of preemptive warfarin dose adjustment for preventing non-therapeutic INR following doxycycline-warfarin co-administration.
Patients were randomized to either a 10% to 20% preemptive warfarin dose reduction (intervention) or reactive warfarin dose adjustment (control) within 72 hours of warfarin-doxycycline co-administration. Subjects received a follow-up INR within 7 days (index INR). Primary outcome was the occurrence of index INR ≥ 1 point over the INR goal range upper limit. Secondary outcomes included INR control, purchases of prescription vitamin K, and warfarin-associated adverse events in the 30 days after doxycycline initiation.
Twenty and 17 patients comprised the intervention and control groups. The intervention group's warfarin dose was reduced by a median of 11%. More control patients (n=2) experienced an INR ≥ 1 point over the INR goal range upper limit compared to intervention (n=0); however, the difference (12% vs. 0%) was not statistically significant (p=0.20). A higher percentage of intervention patients had subtherapeutic index INRs compared to control (35% vs. 6%, p<0.05). One patient from each group experienced warfarin-associated bleeding. No thromboembolic complications or vitamin K use were observed.
For warfarin patients initiating doxycycline therapy, preemptive warfarin dose reduction did not result in supratherapeutic INRs but increased the likelihood of subtherapeutic INRs compared to INR monitoring with reactive warfarin dose adjustment.
Thrombosis Research 01/2012; 130(2):152-6. · 2.44 Impact Factor
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ABSTRACT: Bargain generic programs have proliferated rapidly since 2006. Little is known about the use of these programs. The purpose of this study was to assess the rate and characteristics of prescriptions written in a managed care organization (MCO) to an out-of-plan pharmacy (OOPP).
This retrospective health services investigation examined characteristics of patients in an MCO who did and did not have a prescription written to an OOPP from October 1, 2006 through September 30, 2010, and patients who had a prescription transferred to an OOPP in September 2008 (only month with data available). Descriptions of the longitudinal rate of OOPP use, OOPP patient and medication characteristics, and OOPPs where prescriptions were transferred are reported. Patient characteristics independently associated with an OOPP prescription were analyzed with logistic regression modeling.
A total of 10,353,283 prescriptions were included. The monthly rate of OOPP usage during the study period increased from 1.5% to 5.2% and then stabilized at around 5%. Prescriptions written to an OOPP were more likely to be for chronic disease states. Patient age and MCO termination were associated with having a prescription written to an OOPP; whereas increasing medication purchases, a drug benefit, and a health maintenance organization plan type were associated with not having a prescription written to an OOPP. More than 80% of transferred prescriptions went to an OOPP with a bargain generic program.
The rate of OOPP prescriptions increased rapidly over the study period. Prescriptions written to an OOPP were predominantly for chronic diseases. Further research is warranted to assess if OOPP use results in reduced quality of health care system oversight or compromises patient health.
The Permanente journal 01/2012; 16(2):15-21.
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ABSTRACT: Background/Aims Injectible low-molecular-weight heparin (LMWH) monotherapy is recommended over other anticoagulant therapies (e.g., oral warfarin + injectible anticoagulant) for venous thromboembolism (VTE) in cancer patients based on superior clinical outcomes. The aim of this retrospective study was to evaluate the extent of use of LMWH for cancer patients with incident post-cancer diagnosis VTE. Methods Patients aged =21 years with stage III and IV breast, colorectal, lung, and prostate cancer diagnosed between 2000-2007 at five Cancer Research Network (CRN) sites and diagnosed with VTE within two years of cancer diagnosis who received outpatient VTE treatment were included. Patient characteristics, clinical information, pharmacy and healthcare utilization, and mortality were obtained from the CRN Virtual Data Warehouse. Patients were followed for one year after VTE diagnosis. Outcomes include the rates of initial anticoagulant(s) treatment within seven days of VTE diagnosis, VTE recurrence, and post-treatment bleeding. Logistic regression was used to identify factors associated with LMWH choice. Results Data for 662 cancer patients from three study sites were available. Patients were primarily =65 years (52%, 347/662), male (52%, 347/662), diagnosed with stage IV cancer (54%, 360/662), lung cancer (51%, 338/662), received chemotherapy prior to VTE diagnosis (64%, 425/662), and had a mean Charlson-Deyo risk score of 1.6 (±1.5). Only 29% (195/662) of patients received LMWH monotherapy while 69% (456/662) and 2% (11/662) received warfarin + an injectible anticoagulant and injectible foundaparinux, respectively. Recurrent VTE occurred in 1.6% (3/195) vs. 3.3% (15/456) of patients who received LMWH monotherapy vs. warfarin + injectible anticoagulant, respectively (p=0.298). Bleeding rates were similar across treatment groups (p=0.710). Factors independently associated with LMWH monotherapy treatment choice include stage IV cancer, lung cancer, reception of chemotherapy, and history of VTE diagnosis prior to cancer diagnosis. Conclusions Adherence to evidence-based treatment recommendations for VTE in cancer patients was low. Future studies will analyze the data from all participating sites and should evaluate rationale(s) for patient/provider preference for LMWH monotherapy.
Clinical Medicine & Research 11/2011; 9(3-4):145.
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ABSTRACT: Background Several studies have demonstrated that chemotherapy prolongs survival by upwards of 3 months in patients with advanced (stage IIIb-IV) non-small cell lung cancer (NSCLC), but often at considerable costs. Analyses of SEER-Medicare data suggests that only 25% of older patients receive chemotherapy, however, little is known about how these treatment rates compare to younger patients and to those receiving care in an HMO. Aims Using the HMO Cancer Research Network's (CRN) Virtual Data Warehouse (VDW) at 4 CRN sites, we examine the characteristics of stage lIIb-IV NSCLC patients who receive chemotherapy, and we assess the first-line chemotherapy patterns overtime. Methods Patients aged =21 years with stage IIIb and IV NSCLC diagnosed between 2000-2007 at 4 CRN sites were included in the analysis. Patients were followed from diagnosis date through the end of 2008 (or death or disenrollment). Patient characteristics, clinical information, chemotherapy treatment data, and mortality were obtained from the CRN Virtual Data Warehouse. Current Procedural Terminology codes and National Drug Codes from the VDW were used to identify chemotherapy regimens. Descriptive statistics were performed to describe the study samples, both overall, overtime, and by subgroups (age category, stage, etc). Differences in the proportion of patients receiving various chemotherapy regimens, (by health plan, age category, stage, etc) were tested using parametric and non-parametric statistics. Results Preliminary finding suggest, that while slightly more than half of our study population received chemotherapy, the proportions varied by stage and age, with younger patients (<65) and those diagnosed at a lower stage (lllb) were significantly more likely to receive treatment. The most common first line treatment was Carboplatin and paclitaxel. However, with the introduction of taxenes, monoclonal antibodies, antimetabolites, and targeted agents in the later years of the study period, the distribution of first line therapy changed significantly overtime. Conclusions The findings from this analysis could have significant clinical and policy relevance given that NSCLC is the number one cause of cancer death. Future analyses will compare the variation in treatment patterns overtime for CRN enrollees as compared to SEER-Medicare, NCCN data and ASCO guidelines.
Clinical Medicine & Research 11/2011; 9(3-4):149-150.
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Thomas Delate,
Erin Bowles,
Roy Pardee,
Robert Wellman,
Laurel Habel,
Marianne Yood,
Larissa Nekhlyudov,
Katrina Goddard,
Robert Davis,
Catherine McCarty,
Adedayo Onitilo,
Heather Feigelson,
Jared Freml,
Edward Wagner
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ABSTRACT: Background/Aims Chemotherapy-related toxicity, while a major focus of randomized clinical trials, has been understudied in population-based research. Eight Cancer Research Network (CRN) sites used Virtual Data Warehouse (VDW) data to examine the risk of cardiotoxicity following chemotherapy for invasive breast cancer. However, information on VDW chemotherapy data validity is limited. This study assessed the validity of VDW data related to the reception and dosages of cardiotoxic chemotherapeutic agents among breast cancer (BC) patients. Methods This was a retrospective, cohort study of women =18 years diagnosed with incident, invasive BC between January 1999 and December 2007. Pharmacy and procedure chemotherapy data were extracted from each site's administrative databases for up to one year following cancer diagnosis date. Random samples of 50 patients stratified on trastuzumab, anthracyclines, and no chemotherapy exposure were selected from each CRN site for detailed medical chart abstraction. We calculated weighted sensitivities and specificities (and 95% confidence intervals [CI]) of using administrative data to accurately capture chemotherapy treatment compared to medical records. Median cumulative doses calculated from administrative data were compared to median doses obtained from the medical chart using the Spearman's correlation coefficient. Results The total cohort included 13,497 BC patients. Patients in the random sample (n=400) had a mean age of 65 (±14) years and were primarily white with most tumors diagnosed at AJCC stage 1 or 2. From the sample, 20% (80/400), 38% (152/400), and 40% (158/400) of patients had VDW exposure to trastuzumab, an anthracycline, and any type chemotherapy, respectively. Trastuzumab, anthracycline, and any chemotherapy sensitivities were 97% (CI=94%-98%), 97% (CI=93%-98%), and 99% (CI=97%-99%), respectively; and specificities were 99% (CI=98%-100%), 99% (CI=96%-99%), and 86% (CI=79%-91%), respectively. Median doses for trastuzumab and anthracyclines from administrative data were 227 mgs and 420 mgs, respectively, while median doses from the medical chart were 2370 mgs and 416 mgs, respectively (r=0.60, p<0.001 and r=0.23, p=0.030, respectively). Conclusions Sensitivities and specificities for CRN chemotherapy administrative data were high and dosages were correlated moderately with chart information. These findings support the use of CRN data in evaluating chemotherapy exposures and related outcomes.
Clinical Medicine & Research 11/2011; 9(3-4):146.
