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Dimopoulos M.A.,National and Kapodistrian University of Athens | Delforge M.,University Hospital Leuven | Kropff M.,University of Munster | Petrucci M.T.,University of Rome La Sapienza | And 5 more authors.
Haematologica | Year: 2013

The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756). © 2013 Ferrata Storti Foundation.

Naegeli A.N.,Eli Lilly and Company | Nixon A.,An ICON Plc Company | Burge R.,Eli Lilly and Company | Gold D.T.,Duke University | Silverman S.,Cedars Sinai Medical Center
Osteoporosis International | Year: 2014

Summary: We have developed a short, patient-reported outcome questionnaire - the Osteoporosis Assessment Questionnaire - Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire - Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 (n =1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69%) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. © The Author(s) 2013.

Shingler S.L.,An ICON Plc Company | Garside J.,Roche Holding AG | Samanta K.,Roche Holding AG | Lear J.T.,Royal Infirmary | And 2 more authors.
Journal of Medical Economics | Year: 2013

Objective: Most incidences of basal cell carcinoma are cured by a number of surgical or non-surgical treatments. However, a few patients have lesions which have metastasized or progressed to an extent that surgery or other treatment options are not possible. The lesions associated with advanced basal cell carcinoma (aBCC) can be disfiguring, affecting patients' psychological state, general quality-of-life (QoL), and potentially life expectancy. The objective of this study was to capture societal utility values for health states related to aBCC, using the time trade-off (TTO) methodology. Methods: Nine health states were developed with input from expert clinicians and literature. States included: complete response (CR), post-surgical, partial response (PR) (with differing sized lesions [2 or 6cm]), stable disease (SD) (with differing size and number of lesions [2 or 6cm, or multiple 2cm]) and progressive disease (PD) (with differing sized lesions [2 or 6cm]). A representative sample of 100 members of the UK general public participated in the valuation exercise. The TTO method was used to derive utility values based upon subjects' responses to decision scenarios; between living in the health state for 10 years or living in a state of full health for 10-x years. Results: Mean utility scores were calculated for each state. The least burdensome state as valued by subjects was CR (mean=0.94; SD=0.08), suggesting only a minimal impact on QoL. The state valued as having a greatest impact on QoL was PD, with a 6cm lesion (mean=0.67, SD=0.25). Limitations and conclusions: Not all possible presentations of aBCC were included; the disease is a challenging condition to characterise given its rarity, the nature of the patients affected, and its variable progression. Findings suggest that aBCC is associated with significant burden for individuals, even when their disease is stable or where surgical treatment has been successful. © 2013 Informa UK Ltd. All rights reserved: reproduction in whole or part not permitted.

Khan N.,IMS Health | Shah D.,an ICON plc Company | Tongbram V.,an ICON plc Company | Verdian L.,Eisai Inc | Hawkins N.,An ICON Plc Company
Current Medical Research and Opinion | Year: 2013

Objectives: This paper compares the efficacy and tolerability of perampanel (PER) relative to other recently approved anti-epileptic drug (AEDs)-lacosamide (LCS), retigabine (RTG), and eslicarbazepine (ESL) for the adjunctive treatment of partial onset seizures with or without secondary generalization and specifically in the secondary generalization subgroup. Materials and methods: A systematic literature review of all RCTs of PER and selected AEDs in EMBASE, Medline, and the Cochrane Central from 1998 to January 2011 with an update in PubMed in March 2013 was performed. A network meta-analysis was conducted for 50% responder rate for overall seizures; withdrawal due to adverse events; seizure freedom; and 50% responder rate for secondary generalized seizures. Results: Twelve RCTs (three PER, three LCS, three RTG and three ESL) were included. PER performed significantly better than placebo for 'responder rate' (OR 2.151, 95% CrI 1.348-3.472) and 'seizure freedom' (OR 2.507, 95% CrI 1.067-7.429). When compared to other agents, PER was found to be equally effective. For 'withdrawal due to adverse events', PER had the lowest odds ratio vs. placebo compared with other AEDs. In the analysis for the subgroup of patients with secondary generalization, only four RCTs (three PER and one LCS) met the inclusion criteria for one outcome (responder rate) for LCS. In this subgroup, PER was statistically significantly better than placebo (OR 2.448, 95% CrI 1.088-5.828). Conclusion: PER was statistically significantly superior to placebo in responder rate, seizure freedom, and responder rate in the secondary generalization population. Though PER had statistically significant greater withdrawal compared to placebo, it had the lowest ORs vs. placebo, suggesting a superior safety profile among the comparators included in this analysis. In patients with partial onset seizure with secondary generalization, PER had a statistically significant effect on responder rate compared to placebo. © 2013 Informa UK Ltd.

Sterling K.L.,Eli Lilly and Company | Gallop K.,An ICON Plc Company | Swinburn P.,Eli Lilly and Company | Flood E.,Eli Lilly and Company | And 5 more authors.
Lupus | Year: 2014

Fatigue is a hallmark symptom of systemic lupus erythematosus (SLE), often associated with flares, side effects of treatment, and extensive organ damage and may have a significant impact on health-related quality of life (HrQoL). To date, the experience of fatigue in patients with SLE is underexplored. This study explored the experience of fatigue in patients with SLE and its impact on their lives through qualitative interviews.This cross-sectional qualitative study was conducted with 22 adult patients with SLE, recruited from two clinical sites in the United States. In-person semi-structured interviews were conducted and thematic analysis was performed focusing on the experience of fatigue in SLE.Results indicated that 21 out of 22 patients experienced fatigue due to SLE. Patients reported that fatigue was variable in nature in terms of both severity and frequency. Fatigue was described as having an impact on multiple aspects of a patient's life: emotions, cognition, work, activities of daily living, leisure activities, social activities, and family activities.Understanding how patients with SLE describe the symptom of fatigue and how it impacts their lives is the key to better understanding how to measure fatigue in clinical studies evaluating new treatments for SLE. © The Author(s) 2013.

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