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Critchley H.O.D.,Queens Medical Research Institute | Munro M.G.,University of California at Los Angeles | Broder M.,Partnership for Health Analytic Research LLC | Fraser I.S.,University of Sydney
Seminars in Reproductive Medicine | Year: 2011

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. © 2011 by Thieme Medical Publishers, Inc. Source


Fraser I.S.,University of Sydney | Critchley H.O.D.,Queens Medical Research Institute | Broder M.,Partnership for Health Analytic Research LLC | Munro M.G.,University of California at Los Angeles
Seminars in Reproductive Medicine | Year: 2011

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. © 2011 by Thieme Medical Publishers, Inc. Source


Strosberg J.R.,H. Lee Moffitt Cancer Center and Research Institute | Fisher G.A.,Stanford University | Benson A.B.,Northwestern University | Malin J.L.,University of California at Los Angeles | And 2 more authors.
Pancreas | Year: 2013

OBJECTIVES: This study aimed to develop expert consensus for the use of systemic treatments for unresectable metastatic well-differentiated (grade 1-2) carcinoid tumors using the RAND/UCLA modified Delphi process. METHODS: After a comprehensive literature review, 404 patient scenarios addressing the use of systemic treatments for carcinoid tumors were constructed. A multidisciplinary panel of 10 physicians assessed the scenarios as appropriate, inappropriate, or uncertain (on a 1-9 scale) or as an area of disagreement before and after an extended discussion of the evidence. RESULTS: Experts were medical and surgical oncologists, interventional radiologists, and gastroenterologists. Among rated scenarios, disagreement decreased from 14% before the meeting to 4% after. Consensus statements about midgut carcinoids included the following: (1) Somatostatin analogs are appropriate as first-line therapy for all patients; (2) In patients with uncontrolled secretory symptoms, it is appropriate to increase the dose/frequency of octreotide long-acting repeatable up to 60 mg every 4 weeks or up to 40 mg every 3 weeks as second-line therapy for refractory carcinoid syndrome. Other options may also be appropriate. Consensus was similar for non-midgut carcinoids. CONCLUSIONS: The Delphi process provided a structured methodological approach to assist clinician experts in reaching consensus on the appropriateness of specific medical therapies for the treatment of advanced carcinoid tumors. Copyright © 2013 by Lippincott Williams & Wilkins. Source


Broder M.S.,Partnership for Health Analytic Research LLC | Beenhouwer D.,Partnership for Health Analytic Research LLC | Strosberg J.R.,H. Lee Moffitt Cancer Center and Research Institute | Neary M.P.,Novartis | Cherepanov D.,Partnership for Health Analytic Research LLC
World Journal of Gastroenterology | Year: 2015

AIM: To review literature on efficacy and safety of octreotide-long-acting repeatable (LAR) used at doses higher than the Food and Drug Administration (FDA)-approved 30 mg/mo for treatment of neuroendocrine tumors (NETs). METHODS: We searched PubMed and Cochrane Library from 1998-2012, 5 conferences (American Society of Clinical Oncology, Endocrine Society, European Neuroendocrine Tumor Society, European Society for Medical Oncology, North American Neuroendocrine Tumor Society) from 2000-2013 using MeSH and key-terms including neuroendocrine tumors, carcinoid tumor, carcinoma, neuroendocrine, and octreotide. Bibliographies of accepted articles were also searched. Two reviewers reviewed titles, abstracts, and full-length articles. Studies that reported data on efficacy and safety of ≥ 30 mg/mo octreotide-LAR for NETs in human subjects, published in any language were included in the review. RESULTS: The search identified 1086 publications, of which 238 underwent full-text review (20 were translated into English); 17 were included in the review. Studies varied in designs, subjects, octreotide-LAR regimens, and definition of outcomes. Eleven studies reported use of higher doses to control symptoms and tumor progression, although symptom severity and formal quality-of-life analysis were not quantitatively measured. Ten studies reported efficacy, describing 260 subjects with doses ranging from 40 mg/mo or 30 mg/3 wk up to 120 mg/mo. Eight studies reported expert clinical opinion that supported dose escalation of octreotide-LAR up to 60 mg/mo for symptom control and suggested increased doses may be effective at preventing tumor progression. Eight studies reported safety; there was no evidence of increased toxicity associated with doses of octreotide-LAR > 30 mg/mo. CONCLUSION: As reported in this review, octreotide-LAR at doses > 30 mg/mo is being prescribed for symptom and tumor control in NET patients. Furthermore, expert clinical opinion provided support for escalation of somatostatin analogs for refractory hormonal symptoms. © The Author(s) 2015. Source


Broder M.S.,Partnership for Health Analytic Research LLC | Neary M.P.,Novartis | Chang E.,Partnership for Health Analytic Research LLC | Cherepanov D.,Partnership for Health Analytic Research LLC | Katznelson L.,Stanford University
Pituitary | Year: 2014

The economic burden of acromegaly in the US has been largely unknown. We describe the prevalence of treatment patterns, complication rates, and associated healthcare utilization and costs of acromegaly in the US. Patients were identified between 1/1/2002 and 12/31/2009 in claims databases. During 1-year after each continuously-enrolled patient's first acromegaly claim, pharmacy and medical claims were used to estimate outcomes. Regression models were used to adjust outcomes. There were 2,171 acromegaly patients (mean age: 45.3 years; 49.7 % female); 77.8 % received the majority of their care from non-endocrinologists. Pharmacologic treatment was used by 30.8 % of patients: octreotide-LAR in 18.6 %, dopamine agonists in 9.8 %, short-acting octreotide in 4.7 %, pegvisomant in 4.1 %, and lanreotide in 1.2 %; 56 % had biochemical monitoring. Comorbidities were common, ranging from 6.6 % (colon neoplasms) to 25.6 % (musculoskeletal abnormalities). Mean healthcare costs were $24,900. Adjusted analyses indicated comorbidities increased the odds of hospitalization: by 76 % for musculoskeletal abnormalities; 193 % for cardiovascular abnormalities; and 56 % for sleep apnea (p < 0.05). Odds of emergency department visits increased by 87 % (musculoskeletal) and 132 % (cardiovascular abnormalities) (p < 0.01). After adjustments, colon neoplasms were associated with $8,401 mean increase in costs; musculoskeletal abnormalities with $7,502, cardiovascular abnormalities with $13,331, sleep apnea with $10,453, and hypopituitarism with $6,742 (p < 0.01). Complications are common and increase utilization and cost in acromegaly patients. Cardiovascular complications nearly tripled the odds of hospitalization (OR 2.93) and increased annual mean cost by $13,331. Adequate management of this disease may be able to reduce health care utilization and cost associated with these complications and with acromegaly in general. © 2013 Springer Science+Business Media. Source

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