Rajiv Mallick

Recommendations for including multiple symptoms as endpoints in cancer clinical trials: A report from the ASCPRO (Assessing the Symptoms of Cancer Using Patient-Reported Outcomes) Multisymptom Task Force

The multiple symptoms arising from cancer and its treatment impose significant distress for patients. However, in clinical research, there is no agreed‐upon way of assessing and presenting the effects of treatment on multiple symptoms, as either individual scores or a composite score. The ASCPRO (Assessing the Symptoms of Cancer Using Patient‐Reported Outcomes) Multisymptom Task Force was established to make recommendations about measuring multiple symptoms as outcomes in cancer clinical trials. The Multisymptom Task Force addressed how to choose the symptoms to be assessed and how multiple individual symptom scores or composite scores of several symptoms might be used as clinical trial outcomes. Consensus was reached on a definition of a multisymptom outcome, the problem of source attribution, and the need for a hypothesis‐driven conceptual framework to measure multisymptom outcomes. Validated single‐item and multi‐item measures currently available or that can be easily generated for oncology use were deemed sufficient for measuring multiple symptoms. The relative value of a composite score versus a set of individual symptom scores was discussed, along with issues in developing and deploying such a composite measure. The results indicated that more research on combining scores of different symptoms is needed. Symptom data should be a required component of cancer clinical trials. Patient‐reported symptoms provide a unique patient perspective on treatment benefit and risk that goes beyond clinician‐reported adverse events. A representation of changes in multiple symptoms would clarify the impact of treatment and enhance the interpretation of cancer clinical trials for clinicians, patients, and those who make health care policy. Cancer 2013.

Failure of surgical and endovascular infrainguinal and iliac procedures in the management of peripheral arterial disease using data from electronic medical records.

PURPOSE To understand rates of procedure failure among patients undergoing revascularization for peripheral arterial disease (PAD) in clinical practice. MATERIALS AND METHODS This retrospective analysis of patients with PAD who underwent a PAD-related procedure used claims and electronic medical record data from 2005 to 2009. Procedures were grouped by type (endovascular [ie, angioplasty with/without stent, atherectomy] or surgical [ie, bypass surgery, endarterectomy, thrombectomy]) and site (ie, iliac, infrainguinal). The study assessed antiplatelet and anticoagulant agent use; procedure failure, defined as a subsequent procedure or amputation; and predictors of time to procedure failure. RESULTS A sample of 248 patients with PAD who underwent a PAD-related procedure was identified. The population was 59% male, had a mean age of 73 years, and had a mean follow-up of 23 months. Endovascular procedures alone were performed in 37% of patients, with the remainder receiving surgery only or surgery with an endovascular procedure, and 79% of patients had an infrainguinal intervention. Antiplatelet and anticoagulant use rates after the procedure were 90% and 25%, respectively. After their initial procedure, 20% of patients required a second procedure or amputation, with an average failure time of 228 days. Patients treated with infrainguinal procedures had a significantly higher failure rate versus those treated with iliac procedures (23% vs 8%; P = .011). In multivariate analysis, patients without anticoagulant use before the procedure were at significantly lower failure risk (P = .022). CONCLUSIONS Repeated intervention and/or major amputation after revascularization of PAD was common. Further investigation of the factors associated with procedure failure is warranted.

Predictors of non-adherence to systemic oral therapy for advanced hepatocellular carcinoma.

Abstract Objectives: With increasing use and cost of oral oncology medications, patient non-adherence with oral therapy is of concern. This study evaluated non-adherence among patients receiving first-line oral therapy for hepatocellular carcinoma (HCC). Methods: This retrospective study used the employer-based MarketScan medical and pharmacy claims database (2005–2011) to identify adult patients with two or more diagnoses of HCC (ICD-9 155), and two or more filled prescriptions for sorafenib. Additional eligibility requirements were not having other previous cancers and a 4 month wash-out period prior to the index sorafenib date. Adherence was assessed using a modified proportion of days covered (PDC) measure with patient-specific sorafenib exposure from index date to treatment discontinuation. Non-adherence was categorized as PDC <85% (base case), with sensitivity analyses using an 80% cut-off and allowance for physician-directed therapy gaps. Logistic regression models were estimated to identify predictors of non-adherence. Results: A total of 1127 patients (median age = 61.0 years; 78.4% male) met eligibility criteria. Median duration of enrollment was 223 days and median sorafenib exposure was 121 days. Between 21.1% (PDC < 0.80) and 28.0% (PDC < 0.85) of patients were non-adherent. Higher age (p = 0.022), number of baseline medications (p = 0.003) and number of baseline comorbidities (p = 0.002) were associated with lower non-adherence, while prior procedures were associated with greater non-adherence (p = 0.002). Limitations: In this study using billing claims data, we were unable to evaluate patient severity in terms of clinical characteristics such as the Child–Pugh score. Similarly, we could not assess clinical outcomes such as tumor response, radiological progression or overall survival, although median duration of sorafenib exposure and duration of health plan enrollment respectively were found to be good proxies. Conclusions: Using a modified PDC approach, 22–29% of patients were non-adherent. Identified predictors of non-adherence in HCC should be assessed for newly emerging oral therapies, and may be used to guide patient education and other adherence-enhancing initiatives.

Real-World Assessment of Interventional Treatment Timing and Outcomes for Varicose Veins: A Retrospective Claims Analysis.

PURPOSE To evaluate the impact of delaying interventional treatment on varicose vein disease progression, complications, and health care costs in a real-world setting. MATERIALS AND METHODS This was a retrospective analysis of adults diagnosed with varicose veins between January 2008 and June 2010. Patients were followed for 2 years after diagnosis and categorized into three cohorts based on the timing of interventional therapy: early (≤ 2 mo), intermediate (> 2 mo but ≤ 6 mo), and late (> 6 mo). Disease progression and all-cause health care costs were evaluated. RESULTS A total of 44,206 patients were included, with 43% classified as receiving early interventional therapy, 33% as intermediate, and 24% as late. Early interventional treatment was associated with lower disease progression rates (29.2%) compared with intermediate (42.5%; P < .0001) and late treatment (52.2%; P < .0001). Also, early interventional treatment was associated with lower costs (

Colesevelam, Ezetimibe, and Patients With Type 2 Diabetes Mellitus Characteristics and Clinical Outcomes From a Health Care Database

17,564) than intermediate (

The Outcomes and Costs of Acute Myeloid Leukemia Among the Elderly

17,923; P > .05) and late treatment (

Incidence of venous thromboembolism among chemotherapy-treated patients with lung cancer and its association with mortality: a retrospective database study.

18,399; P < .05). Each 30-day delay in treatment initiation was associated with a 7% higher risk of disease progression (P < .0001) and a 1% increase in costs (P < .0001). CONCLUSIONS Findings suggest that early initiation of interventional varicose vein treatment was significantly associated with a decreased risk of disease progression and costs.

Treatment patterns and outcomes in patients with non-squamous advanced non-small cell lung cancer receiving second-line treatment in a community-based oncology network

Background:Despite the prevalence of therapies available to patients at highest coronary heart disease risk, only a minority of type 2 diabetes mellitus (T2DM) patients reach desired cholesterol treatment levels, with limited data regarding their outcomes. Objective: To examine “real-world” effectiveness of initiating treatment with either colesevelam or ezetimibe among individuals with evidence of T2DM and hypercholesterolemia (HCh). Key outcomes included treatment patterns and cardiovascular (CV) events. Methods: This retrospective administrative claims-based study utilized medical, pharmacy, and enrollment data linked to laboratory results information from a large United States health plan (January 1, 2006, to March 31, 2011) and included individuals with recorded evidence of T2DM and HCh. The index date was the date of first pharmacy claim for colesevelam or ezetimibe, with cohort assignment based on index medication. Assessments included baseline characteristics, follow-up treatment patterns, and composite CV event, with propensity score matching to correct for sample selection bias. Results: In total, 4231 individuals were identified with evidence of HCh and T2DM (ezetimibe n = 3384; colesevelam n = 847). After matching, the baseline characteristics between cohorts were rendered to be similar. Mean days of persistent medication use was lower with colesevelam compared with ezetimibe (P < 0.001). Compared with ezetimibe, a smaller percentage of individuals in the colesevelam cohort experienced a follow-up composite CV event, and adjusted Cox model results suggested decreased risk (hazard ratio = 0.58; P = 0.004) of a follow-up composite CV event. Conclusion: In this health care database analysis among patients with HCh and T2DM, colesevelam was associated with decreased risk of a composite CV event compared with ezetimibe, despite lower persistence.