Toward characterization and definition of fibromyalgia severity

<p>Abstract</p> <p>Background</p> <p>There are no standard criteria for defining or assessing severity of fibromyalgia (FM) as a condition as fibromyalgia is associated with multiple symptom domains. The objective of this study was to evaluate whether patient self-reported severity of FM is associated with severity of pain and sleep interference and the presence of core co-morbidities.</p> <p>Methods</p> <p>We recruited individuals ≥ 18 years of age with a clinician-confirmed diagnosis of FM ≥ 3 months and a current pain rating >2 on a 0-10 numeric rating scale (NRS). Patients completed a questionnaire by mail in which they self-rated their FM severity (very mild, mild, moderate, and severe), their current pain severity and extent of sleep interference (NRS; mild, 0-3; moderate, 4-6, severe, 7-10), and provided information (yes/no) on the presence of core comorbidities (symptoms of depression, anxiety, sleep problems, back pain, neck pain) and medication use for FM. The core symptoms of FM were stratified to assist with patient characterization. Analysis of variance (ANOVA) was used to explore the relationship between self-reported FM severity and continuous variables (pain severity and sleep interference), and Mantel-Haenszel chi-square analysis was used to evaluate the trend in the proportions of patients reporting use of medications and core symptoms of FM by severity of FM. To complement patient-reported FM severity and to understand physicians' perspectives, a survey was performed among 28 physician specialists (rheumatology, neurology, anesthesiology/pain management, family practice, internal medicine, and psychiatry) to determine what they assessed when evaluating FM severity in clinical practice.</p> <p>Results</p> <p>The population (N = 129) of FM patients was predominantly female (89.1%), with a mean age of 49.4 ± 11.0 years, and 81.4% reported duration ≥ 2 years. Self-reported FM severity was moderate/severe in 86.0% of patients; mean current pain score was 6.40 ± 2.19 (moderate), and mean sleep interference score was 7.28 ± 2.23 (severe). Greater FM severity was significantly associated with higher levels of current pain and sleep interference (p < 0.0001), the proportion of patients reporting FM medication use (p = 0.0001), and the presence of core comorbidities (p < 0.05). Pain, functional disability, and fatigue severity were ranked as the top three criteria by the highest proportion of physicians when evaluating FM severity.</p> <p>Conclusion</p> <p>With higher self-reported FM severity, patients have greater pain and sleep interference as well as increased frequency of core comorbidities. Further investigation into understanding FM severity is warranted.</p

Estudio para la implantación de Programas en Inglés en los títulos de grado de la ETSI Agrónomos

El proceso actual de convergencia entre instituciones universitarias europeas ha promovido los Programas Académicos en Inglés como un marco fructífero para su internacionalización con el fin de desarrollar la movilidad de estudiantes y la cooperación institucional dentro y fuera del EEES. El objetivo es alcanzar la Internacionalización de la Universidad a través de dos ejes de actuación: la mejora del nivel de inglés de los alumnos egresados y la captación de alumnos extranjeros. En España, la práctica totalidad de las Universidades Públicas ofrecen algún tipo de Programa en Inglés, existiendo una variada tipología de propuestas. En este contexto, se realizó un estudio para la implantación de Programas en Inglés en los títulos de grado de la ETSI Agrónomos de la Universidad Politécnica de Madrid. Para ello se analizaron las diferentes experiencias existentes en Programas en Inglés en las Universidades Españolas, haciendo especial hincapié en los estudios del ámbito agrario. Se evaluó la opinión de alumnos y profesores de la ETSI Agrónomos sobre tres cuestiones: interés en participar en un Programa en Inglés, tipo de programa en el que estaría dispuesto a participar y autoevaluación del nivel de inglés. También se examinó el interés de los alumnos de bachillerato y del mundo laboral, empresas e instituciones del ámbito agroalimentario, en los Programas en Inglés. Por último, se exploraron las implicaciones administrativas y necesidades de recursos que conlleva la implantación de un Programa Académico Universitario en Inglés. Las conclusiones del trabajo destacan la dispar oferta nacional en programas en inglés y en requerimientos lingüísticos a profesores y alumnos. Existe un gran interés tanto por parte de profesores y alumnos de la ETSI Agrónomos como de alumnos de Bachillerato por participar en este tipo de programas

Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial

Abstract Introduction In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT; ClinicalTrials.gov number NCT01994889), tafamidis reduced the risk of all-cause mortality in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus placebo. Median overall survival was not achieved in either treatment arm (57.1 and 70.5% of patients in the placebo and tafamidis groups, respectively, survived at 30 months), limiting assessment of the potential survival benefits of treatment. Methods A survival extrapolation analysis was conducted following technical support guidelines from the National Institute for Health and Care Excellence. Multiple models (i.e., exponential, Weibull, gamma, log-logistic, log-normal, Gompertz, generalized gamma, and generalized F) were applied to systematically fit different candidate curves to existing patient-level data from the 30-month treatment period in ATTR-ACT. The relative goodness-of-fit for each candidate curve was then tested by Akaike’s and Bayesian information criteria to select a single model that was fitted to the placebo and pooled tafamidis treatment arms. Results A gamma distribution was selected as best fitting model and fitted to both treatment arms. The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months). Conclusions This extrapolation of survival data from ATTR-ACT further supports the efficacy of tafamidis in patients with ATTR-CM. Owing to the limitations of this analysis, these survival estimates should be interpreted with caution; however, they are consistent with recently presented findings from a combined analysis of data from ATTR-ACT and interim data from an ongoing long-term extension study (median follow-up 36 months; ClinicalTrials.gov number NCT02791230). Trial Registration ClinicalTrials.gov: NCT01994889

A data-driven approach to quality risk management

Aim: An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Materials and Methods: Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. Results: Only a subset of the risk factors had a significant association with quality issues, and included: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Conclusion: Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety

Healthcare utilization and costs in patients beginning pharmacotherapy for generalized anxiety disorder: a retrospective cohort study

Abstract Background Patterns of healthcare utilization and costs in patients beginning pharmacotherapy for generalized anxiety disorder (GAD) have not been well characterized. Methods Using a large US health insurance database, we identified all patients with evidence of GAD (ICD-9-CM diagnosis code 300.02) who initiated pharmacotherapy with medications commonly used to treat GAD (eg, selective serotonin reuptake inhibitors [SSRIs], venlafaxine, benzodiazepines) between 1/1/2003 and 12/31/2007. We examined healthcare utilization and costs over the 12-month periods preceding and following date of initial receipt of such therapy ("pretreatment" and "follow-up", respectively). Patients with incomplete data were excluded. Results A total of 10,275 patients met all study inclusion criteria. Forty-eight percent of patients received SSRIs; 34%, benzodiazepines; and 6%, venlafaxine. SSRIs and venlafaxine were about three times more likely to be used on a long-term basis (> 90 days) than benzodiazepines (p Conclusions More than one-half of patients initiating pharmacotherapy for GAD receive either SSRIs or venlafaxine. Levels of healthcare utilization and costs are greater in the year following initiation of therapy than in the immediately preceding one.</p

Financial and Clinical Characteristics of Fibromyalgia: A Case-Control Comparison

Objective: To compare healthcare utilization and costs between subjects with and without fibromyalgia (FM) using claims data from a large health benefits company in the United States. Study Design: Retrospective cohort. Methods: We analyzed 24 months of medical and pharmacy claims data comparing healthcare utilization and costs among Humana members diagnosed with FM to a propensity score matched control group without a diagnosis for FM. FM cases were identified as members aged 18 years and older, with at least 2 medical claims for International Classification of Diseases, Ninth Revision, Clinical Modification codes 729.0 and/or 729.1. The first medical claim for FM was utilized as the index date. Results: A total of 9988 FM cases and 9988 controls were included in the analysis. Compared with controls, the use of pain-related medications by FM cases was approximately 2 times higher with opioids being used most commonly. FM cases utilized a mean (SD) of 22.5 (23.9) and 31.1 (26.6) outpatient services per year in the prediagnosis and postdiagnosis periods, respectively, compared with 14.8 (20.5) and 16.3 (24.5) among controls (P < .01). Office visits, tests, and procedures represented the majority of utilization. During the postdiagnosis period, the mean per-patient per-month costs for outpatient services among FM cases was $377 ($760) and $217 ($740.87) among controls (P < .01). Conclusion: FM cases had significantly higher utilization and costs compared with controls. Office visits, tests and procedures, and the use of pain-related medications accounted for the largest absolute differences between the 2 groups. (Am J Manag Care. 2010; 16: S118-S125