Development and psychometric properties of the human papillomavirus‑quality of life (HPV‑QoL) questionnaire to assess the impact of HPV on women health‑related‑quality‑of‑life.

Purpose The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. Methods After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. Results The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. Conclusion This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.pre-print927 K

Use of aspirin for primary and secondary prevention of cardiovascular disease in diabetic patients in an ambulatory care setting in Spain

<p>Abstract</p> <p>Background</p> <p>This study was conducted in order to determine the use of aspirin and to assess the achievement of therapeutic targets in diabetic patients according to primary (PP) or secondary prevention (SP).</p> <p>Methods</p> <p>This is a retrospective, observational study including patients ≥18 years with diabetes mellitus followed in four primary care centers. Measurements included demographics, use of aspirin and/or anticoagulant drugs, co-morbidities, clinical parameters and proportion of patient at therapeutic target (TT). Descriptive statistics, chi-square test and logistic regression model were used for significance.</p> <p>Results</p> <p>A total of 4,140 patients were analyzed, 79.1% (95% confidence intervals [CI]: 77.7–80.5%) in PP and 20.9% (95% CI: 18.2–23.7%) in SP. Mean age was 64.1 (13.8) years, and 49.3% of patient were men (PP: 46.3, SP: 60.7, p = 0.001). Aspirin was prescribed routinely in 20.8% (95% CI: 19.4–22.2%) in PP and 60.8% (95% CI: 57.6–64.0%) in SP. Proportion of patient at TT was 48.0% for blood pressure and 59.8% for cholesterol. Use of aspirin was associated to increased age [OR = 1.01 (95% CI: 1.00–1.02); p = 0.011], cardiovascular-risk factors [OR = 1.14 (95% CI: 1.03–1.27); p = 0.013], LDL-C [OR = 1.42 (95% CI: 1.06–1.88); p = 0.017] and higher glycated hemoglobin [OR = 1.51 (95% CI: 1.22–1.89); p = 0.000] were covariates associated to the use of aspirin in PP.</p> <p>Conclusion</p> <p>Treatment with aspirin is underused for PP in patients with diabetes mellitus in Primary Care. Achievement of TT should be improved.</p

Comparative effectiveness and costs of generic and brand-name gabapentin and venlafaxine in patients with neuropathic pain or generalized anxiety disorder in Spain

Antoni Sicras-Mainar,1 Javier Rejas-Guti&eacute;rrez,2 Ruth Navarro-Artieda3 1Planning Directorate, Badalona Serveis Assistencials SA, Badalona, Barcelona, Spain; 2Department of Health Economics and Outcomes Research, Pfizer SLU, Alcobendas, Madrid, Spain; 3Medical Documentation, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain Objective: To explore adherence/persistence with generic gabapentin/venlafaxine versus brand-name gabapentin/venlafaxine (Neurontin&reg;/Vandral&reg;) in peripheral neuropathic pain (pNP) or generalized anxiety disorder (GAD), respectively, and whether it is translated into different costs and patient outcomes in routine medical practice. Methods: A retrospective, new-user cohort study was designed. Electronic medical records (EMR) of patients included in the health plan of Badalona Serveis Assistencials SA, Barcelona, Spain were exhaustively extracted for analysis. Participants were beneficiaries aged 18+ years, followed between 2008 and 2012, with a pNP/GAD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code, who initiated treatment with generic or brand-name gabapentin or venlafaxine. Assessments included 1-year treatment persistence and adherence (medication possession ratio), health care costs, and reduction in severity of pain and anxiety symptoms. Results: A total of 2,210 EMR were analyzed; 1,369 on gabapentin (brand 400; generic 969) and 841 on venlafaxine (brand 370 and generic 471). Brand-name gabapentin and venlafaxine were both significantly associated with longer persistence than generic: 7.3 versus 6.3 months, P&lt;0.001; and 8.8 versus 8.1 months, P&lt;0.05, respectively. Brand-name was associated with higher adherence: 86.5% versus 81.3%, P&lt;0.001; and 82.1% versus 79.0%, P&lt;0.05, respectively. Adjusted average costs were higher with generic compared with brand: &euro;1,277 versus &euro;1,057 (difference of &euro;220 per patient; P&lt;0.001) for gabapentin; and &euro;1,110 versus &euro;928 (difference of &euro;182 per patient; P=0.020) for venlafaxine, both because of more use of medical visits and concomitant medication. Compared with generic, brand-name was associated with higher reduction in pain (7.8%; P&lt;0.001) and anxiety (13.2%; P&lt;0.001). Conclusion: Patients initiating brand-name gabapentin or venlafaxine were more likely to adhere and persist on treatment of pNP or GAD, have lower health care costs, and show further reduction of pain and anxiety symptoms than with generic drugs in routine medical practice. Keywords: brand medicinal products, generic medicinal products, adherence, persistence, use of resources, costs, outcome

Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex

Objective: We aimed to analyse the effects of age and sex on performance and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). Methods: We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio, MPR), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. Results: We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4% ≥ 65 years]. 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P  18 años, que iniciaron nuevo tratamiento con gabapentina de marca o genérico. Durante un año se midió adherencia (ratio posesión medicación, RPM) y persistencia, utilización de recursos sanitarios, costes y reducción del dolor. Resultados: Se analizaron 1.369 RMEs [61,1% mujeres; edad 64,6 (15,9) años, 52,4% ≥ 65 años]: marca: 400, EFG: 969. Persistencia y adherencia fueron mayores con marca; 7,3 vs. 6,3 meses (p < 0,001), y 86,5% vs. 81,3% de RPM (p < 0,001). Con marca, se observaron costes sanitarios menores, tanto en < 65 como ≥ 65 años; diferencias medias por paciente de 220€ (IC 95%; 59-382) y 216€ (51-382), respectivamente (p = 0,004), como en hombres; diferencias medias de 197€ (63-328) o mujeres; diferencias de 239€ (96-397), p = 0,005 y p = 0,004, respectivamente. Comparado con EFG, el tratamiento con marca mostró una reducción mayor del dolor; 13,5% (10,9-16,2) y 10,8% (8,2-13,5), en < 65 y ≥ 65 años, respectivamente (p < 0,001), y 10,7% (8,2-13,2) y 13,8% (11,0-16,5), y en mujeres y hombres, respectivamente (p < 0,001). Conclusiones: Con independencia del género o la edad, los pacientes que iniciaron tratamiento del DNp con gabapentina de marca vs. genérico, mostraron un mayor grado de adherencia y persistencia al tratamiento, repercutiendo en unos menores costes sanitarios, a la vez que se observaron mayores reducciones del dolor. Keywords: Neuropathic pain, Gabapentin, Brand name drugs, Generic drugs, Adherence, Costs, Age, Sex, Palabras clave: Dolor neuropático, Gabapentina, Medicamentos de marca, Genéricos, Adherencia, Costes, Edad, Géner

Evaluation of the Legal Certainty in the IT Projects: Key Aspects in Viability

Abstract: Considering the relevance that acquires a suitable legal protection of software in financial and commercial terms, it begins to be essential, of a side a detailed and systematic analysis of the instruments and legal measures of protection available that would be of application for this area, and of another one a method that transfers to numerical magnitudes the protection that presents a project, calculated on the basis of the instruments and applied measures. This work firstly presents a classification of the different aspects that would have to be considered to obtain a suitable legal protection of the software that is going away to develop and secondly a model that allows to evaluate this protection

Efecto de la edad y el género sobre las consecuencias clínicas y económicas del tratamiento con especialidad farmacéutica de marca o genérica en pacientes con dolor neuropático periférico en práctica clínica habitual

Resumen: Objetivo: Analizar el efecto de la edad y el género sobre el dolor y los costes en pacientes con dolor neuropático periférico (DNp) crónico que inician tratamiento con gabapentina (marca) frente a gabapentina genérica (EFG). Métodos: Estudio multicéntrico-retrospectivo, realizado con registros médicos electrónicos (RME) de pacientes de ambos géneros, > 18 años, que iniciaron nuevo tratamiento con gabapentina de marca o genérico. Durante un año se midió la adherencia (ratio posesión medicación [RPM]) y la persistencia, la utilización de recursos sanitarios, los costes y la reducción del dolor. Resultados: Se analizaron 1.369 RME (61,1% mujeres; edad 64,6 [15,9] años, 52,4% ≥ 65 años); marca: 400, EFG: 969. La persistencia y la adherencia fueron mayores con marca: 7,3 vs. 6,3 meses (p < 0,001) y 86,5 vs. 81,3% de RPM (p < 0,001). Con marca, se observaron costes sanitarios menores, tanto en < 65 como en ≥ 65 años (diferencias medias por paciente de 221 € [IC 95%: 59-382] y de 217 € [51-382], respectivamente [p < 0,01]), como en hombres (diferencias medias de 197 € [63-328]) o mujeres (diferencias de 239 € [96-397]), p = 0,005 y p = 0,004, respectivamente. Comparado con EFG, el tratamiento con marca mostró una reducción mayor del dolor: 13,5% (10,9-16,2) y 10,8% (8,2-13,5) en < 65 y ≥ 65 años, respectivamente (p < 0,001), así como del 10,7% (8,2-13,2) y del 13,8% (11,0-16,5) en mujeres y hombres, respectivamente (p < 0,001). Conclusiones: Con independencia del género o la edad, los pacientes que iniciaron tratamiento del DNp con gabapentina de marca vs. genérico mostraron un mayor grado de adherencia y persistencia al tratamiento, repercutiendo en unos menores costes sanitarios, a la vez que se observaron mayores reducciones del dolor. Abstract: Objective: We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). Methods: We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. Results: We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4% ≥ 65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P < .001; 86.5% vs 81.3% MPR, P < .001). Lower healthcare costs were observed in patients using brand-name gabapentin in both age groups (< 65 and ≥ 65). Mean difference in cost per patient amounted to €221 (95% CI: 59-382) and €217 (95% CI: 51-382) in the < 65 and ≥ 65 age groups, respectively (P < .01). Mean difference in cost among men amounted to €197 (63-328), while mean difference in cost among women amounted to €239 (96-397) (P = .005 and P = .004, respectively). Compared with EFG, brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in < 65 and ≥ 65 year patients, respectively (P < .001), and 10.7% (8.2-13.2) and 13.8% (11.0-16.5) in women and men respectively (P < .001). Conclusions: Regardless of sex and age, patients who started PNP treatment with brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief. Palabras clave: Dolor neuropático, Gabapentina, Medicamentos de marca, Genéricos, Adherencia, Costes, Keywords: Neuropathic pain, Gabapentin, Brand name drugs, Generic drugs, Adherence, Cost