Carolyn Sweeney

Gastrointestinal side effects in chronic opioid users: results from a population-based survey.

Background  Gastrointestinal side effects are commonly associated with opioid treatment for pain.

Evidence-Based Medicine, Appropriate-Use Criteria, and Sports Medicine: How Best to Develop Meaningful Treatment Guidelines

We propose using appropriate-use criteria (AUC) as the methodology of choice for formulating and disseminating evidence-based medicine guidelines in sports medicine and arthroscopy. AUC provide a structured process for integrating findings from the scientific literature with clinical judgment to produce explicit criteria for determining the appropriateness of specific treatments. The use of AUC will enable surgeons to treat patients in a more consistent manner based on expert clinical consensus and evidence-based medicine. This methodology also will ensure that guidelines represent all stakeholders and available evidence.

Work Productivity and Activity Impairment Among Chronic Spontaneous/Idiopathic Urticaria Patients: ResultsFrom The First International Burden of Illness Study (Assure-Csu).

SPONTANEOUS/IDIOPATHIC URTICARIA PATIENTS: RESULTS FROM THE FIRST INTERNATIONAL BURDEN OF ILLNESS STUDY (ASSURE-CSU) Balp MM1, Chambenoit O2, Chiva-Razavi S2, Lynde C3, Sussman G4, Chapman-Rothe N5, Weller K6, Maurer M6, Koenders J7, Knulst AC8, Halliday A9, Alexopoulos ST9, Nakonechna A10, Grattan C11, Abuzakouk M12, Sweeney C13, Radder C13, Wolin D14, McBride D15, Hollis K13, Tian H16, Oude Elberink JNG17 1Novartis Pharma AG, Basel, Switzerland | 2Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada | 3Lynderm Research Inc., Toronto, ON, Canada | 41St Michael’s Hospital, University of Toronto, Toronto, ON, Canada | 5Novartis Pharma GmbH, Nuernberg, Germany | 6Charite Universitatsmedizin Berlin, Berlin, Germany | 7Novartis Pharma B.V., Arnhem, Netherlands | 8University Medical Center Utrecht, Utrecht, Netherlands, 9Novartis Pharmaceuticals UK Limited, Surrey, United Kingdom | 10Royal Liverpool and Broadgreen University Hospitals NHS Trust, United Kingdom | 11Norfolk and Norwich University Hospital, Norwich, United Kingdom, 12Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi, UAE | 13RTI Health Solutions, Research Triangle Park, NC, USA | 14RTI Health Solutions, Ann Arbor, MI, USA | 15RTI Health Solutions, Manchester, United Kingdom | 16Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA | 17University Medical Center Groningen, Groningen, Netherlands

Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study

OBJECTIVES To inform health-technology assessments of new adjuvant treatments, we describe treatment patterns in patients with complete resection of stage IB-IIIA non-small cell lung cancer (NSCLC) in France, Germany, and the United Kingdom (UK). MATERIALS AND METHODS Data were collected via medical record abstraction. Patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC, diagnosed between 01 January 2009 and 31 December 2011. Median follow-up was 26 months. Adjuvant treatment patterns and clinical outcomes were summarized descriptively. RESULTS Among the 831 patients studied, 239 (29%) had stage IB disease, 179 (22%) had stage IIA disease, 165 (20%) had stage IIB disease, and 248 (30%) had stage IIIA disease. Adjuvant systemic therapy was received by 402 patients (48.4%), (France, 61.8%; Germany, 51.9%; UK, 33.4%). Use of adjuvant therapy increased with increasing stage of disease. Cisplatin/vinorelbine and carboplatin/vinorelbine were the most frequently prescribed adjuvant regimens. Median disease-free survival was 48.0 months (95% confidence interval [CI] 42.3-not estimable); the 25th percentile was 13.2 months (95% CI, 11.0-15.3). 204 patients (24%) died during the follow-up period. The median overall survival was not reached, the 25th percentile was 31.2 months (95% CI 26.8-36.0 months). 272 patients (33%) had disease recurrence during the follow-up period. For 86 of those patients, the first recurrence was local or regional with no distant metastasis and 14 had further progression to metastatic disease during the follow-up time. For the other 186 patients, the first recurrence involved distant metastases. A total of 200 patients had metastatic disease at any time during study follow-up. CONCLUSIONS Less than half the patients with stage IB-IIIA NSCLC in this observational study received adjuvant systemic therapy. A high rate of first recurrence with distant metastatic disease was observed, emphasising the need for more effective systemic adjuvant therapies in this population.

Economic burden of resected (stage IB-IIIA) non-small cell lung cancer in France, Germany and the United Kingdom: A retrospective observational study (LuCaBIS)

OBJECTIVES New adjuvant treatments are being developed for patients with resected non-small cell lung cancer (NSCLC). Due to scarcity of real-world data available for treatment costs and resource utilization, health technology and cost-effectiveness assessments can be limited. We estimated the burden and cost-of-illness associated with completely resected stage IB-IIIA NSCLC in France, Germany and the United Kingdom (UK). MATERIALS AND METHODS Eligible patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC between August 2009 and July 2012. Patients (living or deceased) were enrolled at clinical sites by a systematic sampling method. Data were obtained from medical records and patient surveys. Direct, indirect and patient out-of-pocket expenses were estimated by multiplying resource use by country-specific unit costs. National annual costs were estimated based on disease prevalence data available from published sources. RESULTS 39 centers provided data from 831 patients of whom patient surveys were evaluable in 306 patients. Median follow-up was 26 months. The mean total direct costs per patient during follow-up were: €19,057 (France), €14,185 (Germany), and €8377 (UK). The largest cost drivers were associated with therapies received (€12,375 France; €3694 UK), and hospitalization/emergency costs (€7706 Germany). Monthly direct costs per patient were the highest during the distant metastasis/terminal illness phase in France (€15,562) and Germany (€6047) and during the adjuvant treatment period in the UK (€2790). Estimated mean total indirect costs per patient were: €696 (France), €2476 (Germany), and €1414 (UK). Estimates for the annual national direct cost were €478.4 million (France), €574.6 million (Germany) and €325.8 million (UK). CONCLUSION To our knowledge, this is the first comprehensive study describing the burden of illness for patients with completely resected stage IB-IIIA NSCLC. The economic burden was substantial in all three countries. Treatment of NSCLC is associated with large annual national costs, mainly incurred during disease progression.

First Real-World Study Assessing Health Utility Values For Chronic Spontaneous/Idiopathic Urticaria Using The Eq-5d

CHRONIC SPONTANEOUS/IDIOPATHIC URTICARIA USING THE EQ-5D McBride D1, Chambenoit O2, Chiva-Razavi S2, Lynde C3, Sussman G4, Chapman-Rothe N5, Weller K6, Maurer M6, Koenders J7, Knulst AC8, Oude Elberink JNG9, Halliday A10, Alexopoulos ST10, Nakonechna A11, Abuzakouk M12, Sweeney C13, Radder C13, Wolin D14, Hollis K13, Tian H15, Balp MM16, Grattan C17 1RTI Health Solutions, Manchester, United Kingdom | 2Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada | 3Lynderm Research Inc., Toronto, ON, Canada | 41St Michaels Hospital, University of Toronto, Toronto, ON, Canada | 5Novartis Pharma GmbH, Nuernberg, Germany | 6Charite Universitätsmedizin Berlin, Berlin, Germany | 7Novartis Pharma B.V., Arnhem, Netherlands | 8University Medical Center Utrecht, Utrecht, Netherlands | 9University Medical Center Groningen, Groningen, Netherlands | 10Novartis Pharmaceuticals UK Limited, Surrey, United Kingdom | 11Royal Liverpool and Broadgreen University Hospitals NHS Trust, United Kingdom | 12Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi, UAE | 13RTI Health Solutions, Research Triangle Park, NC, USA | 14RTI Health Solutions, Ann Arbor, MI, USA | 15Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA | 16Novartis Pharma AG, Basel, Switzerland | 17Norfolk and Norwich University Hospital, Norwich, United Kingdom