Showing papers by "Michael S. Broder published in 2011"

The FIGO recommendations on terminologies and definitions for normal and abnormal uterine bleeding.

Abstract: Over the past 5 years there has been a major international discussion aimed at reaching agreement on the use of well-defined terminologies to describe the normal limits and range of abnormalities related to patterns of uterine bleeding. This article builds on concepts previously presented, which include the abandonment of long-used, ill-defined, and confusing English-language terms of Latin and Greek origin, such as menorrhagia and metrorrhagia. The term DYSFUNCTIONAL UTERINE BLEEDING should also be discarded. Alternative terms and concepts have been proposed and defined. The terminologies and definitions described here have been comprehensively reviewed and have received wide acceptance as a basis both for routine clinical practice and for comparative research studies. It is anticipated that these terminologies and definitions will be reviewed again on a regular basis through the International Federation of Gynecology and Obstetrics Menstrual Disorders Working Group.

Physician Survey of the Effect of the 21-Gene Recurrence Score Assay Results on Treatment Recommendations for Patients With Lymph Node–Positive, Estrogen Receptor–Positive Breast Cancer

Abstract: To survey the effect of the 21-gene recurrence score (RS) assay results on adjuvant treatment recommendations for patients with lymph node-positive (N), estrogen receptor-posi- tive (ER) breast cancer. Methods: Medical oncologists who ordered the 21-gene RS assay were invited to complete a survey regarding their most recent patient with N/ER breast cancer. We obtained re- sponses from 160 (16%) of the 1,017 medical oncologists. Results: Most of the respondents were in community (71%) versus academic (25%) settings and had practiced for a median of 11 years. T1, T2, or T3 disease was reported in 62%, 35%, and 3% of patients, respectively. One, two, three, or 4 nodes were reported in 69%, 18%, 6%, and 3% of patients, respec- tively. Eighty-six percent of the oncologists made treatment rec- ommendations before obtaining the RS; 51% changed their recommendations after receiving the RS. In 33%, treatment in- tensity decreased from chemotherapy plus hormonal therapy to hormonal therapy alone. In 9%, treatment intensity increased from hormonal therapy alone to chemotherapy plus hormonal therapy. In 8%, treatment recommendations changed in a way that did not fit the definition of either increased or decreased intensity. Conclusion: In this survey of physician practice, the RS result was used to guide adjuvant treatment decision making in N/ ER breast cancer more often in patients with tumors less than 5 cm in size and one to three positive lymph nodes than in patients with larger tumors and four or more positive nodes and yielded an overall reduction in recommendations for chemotherapy.

Cost-effectiveness of 21-gene assay in node-positive, early-stage breast cancer.

Abstract: OBJECTIVE: To assess impact on health outcomes and healthcare expenditures of adopting a 21-gene assay for women with early-stage, minimally node-positive, estrogen receptor-positive (N (1-3)/ER) HER2-negative breast cancer STUDY DESIGN: We adapted a deterministic decision-analytic model to estimate costs and quality-of-life outcomes associated with chemotherapy, adverse events, supportive care, recurrence, and second primary cancers for usual care compared with care determined by the 21-gene assay recurrence score, where 71% and 54% of women, respectively, were treated with adjuvant chemotherapy Model input data were based on national statistics, published literature, physician surveys, and Medicare Part B prices METHODS: Annual numbers of events were multiplied by quality-adjusted life-years (QALYs) lost and costs to estimate net health and economic impacts of each strategy Analyses were from a managed care payer perspective for the US population RESULTS: Patients receiving the assay were predicted to gain 0127 QALY and save $4359 annually from avoiding chemotherapy, adverse events, supportive care, and secondary primary tumors For a 2-million member plan, net gains were 444 QALYs/year and savings were $13,476/year Cost savings were greater for the Medicare population Although overall results were sensitive only to reduced impact of testing and chemotherapy costs, they were still highly cost-effective (incremental cost-effectiveness ratio <$20,000/QALY) CONCLUSIONS: Use of a 21-gene assay in patients with early-stage N (1-3)/ER HER2-negative breast cancer may improve health outcomes and add no incremental cost, thereby providing valuable insight for health plans, the Centers for Medicare and Medicaid Services, and clinicians regarding coverage policies and treatment decisions

Impact of alvimopan (entereg) on hospital costs after bowel resection: results from a large inpatient database.

Abstract: Purpose: Delayed gastrointestinal (GI) recovery after bowel resection is associated with longer hospital stays and increased health care costs. Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, accelerates GI recovery after bowel-resection surgery. We undertook a study to evaluate the economic impact of alvimopan in clinical practice. Methods: We conducted a retrospective matched cohort study using data from a large national hospital database and identified adults who had undergone small-bowel or largebowel resection with primary anastomosis. The patients were discharged between January 1, 2009, and June 30, 2009. The surgery was performed at a hospital where alvimopan was used at least once during the study period. We matched each alvimopan patient (“user”) with two controls (“non-users”). The primary outcome of total hospital costs (including the cost of alvimopan) and secondary outcomes of cost components and length of stay were compared between groups. Results: The final study cohort included 480 alvimopan patients and 960 matched controls. The mean total hospital cost was $12,865 for alvimopan patients, compared with $13,905 for controls, for a difference of $1,040 (P = 0.033). There was a nonsignificant trend toward lower ileus-related costs between groups ($83 for alvimopan vs. $114 for controls, P = 0.086). Pharmacy and diagnostic radiology costs did not differ significantly. The mean length of stay was 5.6 days for alvimopan patients and 6.5 days for controls (P < 0.001). Conclusion: Patients receiving alvimopan capsules had significantly lower total hospital costs compared with controls. Along with other initiatives to improve quality and reduce costs of surgical care, alvimopan might be a good choice for

An international response to questions about terminologies, investigation, and management of abnormal uterine bleeding: use of an electronic audience response system.

Abstract: More than 600 registrants attended a two-hour interactive symposium on abnormal uterine bleeding (AUB) at the Federation of Gynecology and Obstetrics World Congress in Cape Town, October 2009. Nearly 250 of these participants answered multiple questions through an electronic audience responder system. The audience heard five structured presentations on clinically important and controversial aspects of AUB, including terminologies and definitions, classification of causes, mechanisms of AUB in the absence of structural lesions of the reproductive tract, the potential for a structured menstrual history, and management of heavy menstrual bleeding (HMB) in low-resource settings. Numerous demographic details were collected, and a total of 30 questions to the audience were interspersed through each of the presentations. The audience demonstrated great variation in the way the terms AUB, menorrhagia, and dysfunctional uterine bleeding (DUB) are used, and considerable majorities agreed that the terms menorrhagia and DUB should be abolished. AUB should be the overarching term to describe all symptomatic departures from normal menstruation or the menstrual cycle. HMB is a suitable replacement term for menorrhagia. DUB can be replaced by the three clinical entities comprising "nonstructural" causes of AUB. There was a high consistency across demographic subgroups in answers to most questions. Acute and chronic AUB were defined, and aspects of a classification system for causes of AUB and of a structured menstrual history were explored. Issues related to investigation and hormonal treatment of HMB in low-resource settings were explored by registrants from developing countries.

A five-year international review process concerning terminologies, definitions, and related issues around abnormal uterine bleeding.

Abstract: Over the past decade there has been an increasing realization about the extent of confusion associated with the many terminologies used to describe abnormal uterine bleeding (AUB). This led to the organization of an international workshop of 35 experts from 15 countries in Washington, D.C., USA, in 2005, which addressed the confusions and controversies around AUB. The workshop comprehensively addressed anomalies in the terminologies, definitions, and causes of AUB. It also began to address broader issues including investigations, quality of life, the need for structured symptom questionnaires, cultural aspects, and future research needs. This workshop led to a series of recommendations and publications and to the establishment of the International Federation of Gynecology and Obstetrics (FIGO) Menstrual Disorders Working Group. Since then, a series of international presentations and small group workshops has resulted in a wide awareness of the program and a comprehensive series of recommendations and publications. A particularly influential large-scale interactive workshop with 600 attendees was held during the 2009 FIGO World Congress, which demonstrated the broad acceptability of the current recommendations. This article describes the process leading to the development of international recommendations on terminologies, definitions, and classification of causes of AUB and the establishment of the FIGO Menstrual Disorders Working Group.

Cost effectiveness of atazanavir-ritonavir versus lopinavir-ritonavir in treatment-naïve human immunodeficiency virus-infected patients in the United States

Abstract: Objective:To evaluate lifetime cost effectiveness of atazanavir-ritonavir (ATV + r) versus lopinavir-ritonavir (LPV/r), both with tenofovir-emtricitabine, in US HIV-infected patients initiating first-line antiretroviral therapy.Methods:A Markov microsimulation model was developed to calculate quality-adjusted life-years (QALYs) based on CD4 and HIV RNA levels, coronary heart disease (CHD), AIDS, opportunistic infections (OIs), diarrhea, and hyperbilirubinemia. A million-member cohort of HIV-1-infected, treatment-naive adults progressed at 3-month intervals through eight health states. Baseline characteristics, virologic suppression, cholesterol changes, and diarrhea and hyperbilirubinemia rates were based on 96-week CASTLE trial results. HIV mortality, OI rates, adherence, costs, utilities, and CHD risk were from literature and experts.Limitations:The incremental cost-effectiveness ratio (ICER) may be overestimated because the ATV + r treatment effect was based on an intention-to-treat analysis. T...

Concomitant asthma medication use by patients receiving omalizumab 2003-2008

Abstract: Objective. To examine patterns of omalizumab use in the first 5 years of its availability. Methods. Our study comprised a series of descriptive retrospective cohort analyses using healthcare claims data. The study population comprised patients of any age who had omalizumab claims in the 5 years after 1 July 2003, and we created five 1-year cohorts from this population. Each cohort included patients continuously enrolled for at least 12 months with ≥2 omalizumab claims during the year. Cohorts contained between 302 and 1382 unique omalizumab users, and over 99% of patients with an omalizumab claim had at least one asthma diagnosis. Results. In all years, the specialty most commonly seen in conjunction with the initial omalizumab prescription was allergy/immunology. In all years, omalizumab was used in conjunction with three or more additional classes of asthma medications at least 70% of the time and with five or more classes at least 33% of the time; the proportion of patients filling omalizumab prescript...

Health care utilization and costs in patients with early onset myelodysplastic syndrome in a commercially insured population.

Abstract: 6552 Background: Myelodysplastic syndrome (MDS) affects about 1 in 10,000 individuals. After diagnosis, patients are treated with hypomethylating agents (HMA) and thalidomide analogues (TA) or rece...