Epidemiological, clinical and economic burden of alopecia areata in Spain: a real-world retrospective study. The PETALO study.

Alopecia areata (AA) is a chronic autoimmune disease that causes non-scarring hair loss. Data are lacking on the epidemiology and clinical and economic burden of AA in Spain. To estimate the prevalence and incidence of AA in Spain and describe sociodemographic and clinical characteristics, treatment patterns, healthcare resource utilization (HCRU) and associated costs. This was an observational, retrospective, descriptive study based on the Health Improvement Network (THIN®) database (Cegedim Health Data, Spain). Patients with ICD9-Code 704.01 for AA, registered between 2014 and 2021, were identified. Prevalence (%) and incidence rates per 1,000 patient-years (IR) of AA were calculated and clinical characteristics, treatment characteristics and HCRU/costs were assessed. A total of 5,488 patients with AA were identified. The point prevalence of AA in 2021 was 0.44 (95% confidence interval [CI]: 0.43-0.45) overall, 0.48 (0.47-0.49) in adults, and 0.23 (0.21-0.26) in children ≤12 years. The 2021 IR for AA in adults was 0.55 (0.51-0.60). Of 3,351 adults with AA, 53.4% were female, mean (standard deviation [SD]) age was 43.1 (14.7) years, and 41.6% experienced comorbidities. Among adults, 2.7% used systemic treatment (0.5% immunosuppressants, 2.5% oral corticosteroids, 0.3% both). Laboratory tests and health care professional visits were the principal drivers of cost, which was €821.2 (1065.6)/patient in the first year after diagnosis. The epidemiology of AA in Spain is comparable with that reported for other countries, being more prevalent among adults. There is a significant burden of comorbidities and cost for patients, with limited use of systemic treatments, suggesting an unmet treatment need in this population.

Psychometric properties of the Spanish SABA Reliance Questionnaire (SRQ) among patients with asthma.

Background: Patient beliefs about their asthma and its treatment may contribute to overreliance on short-acting ß2-agonist (SABA) therapy, leading to increased risk for potentially life-threatening exacerbations. The SABA Reliance Questionnaire (SRQ) is a validated tool for evaluating patients beliefs about SABAs that may lead to overreliance and overuse. Objective: Our aim was to evaluate the psychometric properties of the Spanish version of the SRQ. Methods: This was an observational, cross-sectional, single-country questionnaire validation study in adults with asthma. Reliability (ordinal α) and validity (convergent and discriminant) of SRQ were evaluated. Concurrent validity was assessed with the Beliefs about Medication Questionnaire, the Treatment Satisfaction Questionnaire for Medication, and a visual analog scale item to assess patients' perceptions of the importance of their reliever inhaler. Discriminant validity was assessed through differences in mean SRQ sum score between patients with high adherence to inhaled corticosteroids and those with low adherence, as measured by the Medication Adherence Report Scale-9 and the Test of Adherence to Inhalers. Results: The Spanish-SRQ exhibited good psychometric properties among 131 patients with asthma. Internal consistency was confirmed with an ordinal α of 0.85. All 5 items were useful for measuring patients' beliefs about SABAs that may lead them to be overreliant on SABAs. Concurrent validity with the Beliefs about Medication Questionnaire, Treatment Satisfaction Questionnaire for Medication, and a visual analog scale item assessing patients' perceptions of the importance of their reliever inhaler was demonstrated. Conclusion: The Spanish version of the SRQ is a valid tool for evaluating potential overreliance on SABAs in Spanish-speaking patients to enable early intervention and support.

Heavy Menstrual Bleeding-Visual Analog Scale, an Easy-to-Use Tool for Excessive Menstrual Blood Loss That Interferes with Quality-of-Life Screening in Clinical Practice.

Background: Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss that interferes with quality of life (QoL). The methods for assessing HMB are not suited for clinical practice. We analyzed the validity of a combined visual analog scale (VAS) tool assessing the intensity of menstrual bleeding (VASInt) and its impact on activities of daily living (VASImp) to identify women with HMB. Materials and Methods: Analysis conducted in the data set used to validate the Spanish HMB screening tool SAMANTA questionnaire. A logistic regression analysis was used to construct the model. Reference standard was the pictorial blood loss assessment chart (PBAC). The performance of the HMB-VAS and the SAMANTA questionnaire was compared. Correlation with SAMANTA questionnaire, PBAC, and other QoL measurements was assessed. Results: The resulting function (HMB-VAS score = 10.86 × VASInt score +2.48 × VASImp score) showed a slightly lower accuracy versus the SAMANTA questionnaire (86.8% vs. 87.9%) but a similar area under the curve: 0.9396 versus 0.943, respectively (p = 0.6605). The cutoff point was established as 700. After rounding the regression coefficients, the resulting function (11 × VASInt +2 × VASImp) showed 87.6% accuracy. The correlation of HMB-VAS with the SAMANTA questionnaire was strong (r: 0.79819; p < 0.0001), whereas the correlation was moderate to strong with the PBAC (0.59299; p < 0.0001) and weak with the QoL (EuroQoL five dimensions five levels questionnaire [EQ-5D-5L]) and well-being (Psychological General Well-Being Index [PGWBI]) scales (EQ-5D-5L VAS and Index: -0.20332 and -0.24384; PGWBI: -0.21680; p < 0.0001 for both). Conclusion: The HMB-VAS shows good performance for HMB screening, providing an easy-to-use alternative to other psychometric tools.

The Burden of Progressive Fibrosing Interstitial Lung Disease: A DELPHI Approach.

INTRODUCTION: The term progressive fibrosing interstitial lung disease (ILD) describes patients with fibrotic ILDs who, irrespective of the aetiology of the disease, show a progressive course of their disease despite current available (and non-licensed) treatment. Besides in idiopathic pulmonary fibrosis, little is known about management and the burden of patients with fibrotic ILD, particularly those with a progressive behaviour. METHODS: Using the Delphi method, 40 European experts in ILD management delivered information on management of (progressive) fibrosing ILD and on the impact of the disease on patients' quality of life (QoL) and healthcare resource utilisation (HCRU). Annual costs were calculated for progressive and non-/slow-progressive fibrosing ILD for diagnosis, follow-up management, exacerbation management, and end-of-life care based on the survey data. RESULTS: Physicians reported that progression in fibrosing ILD worsens QoL in both patients and their caregivers. Progression of fibrosing ILD was associated with a greater use of HCRU for follow-up visits and maintenance treatment compared with the non-/slow progression. The number of patients who suffered at least one acute exacerbation was reported to be more than three times higher in progressive fibrosing ILD patients than in patients with non-/slow-progressive fibrosing ILD. On average, annual estimated costs of progressive fibrosing ILD per patient were 1.8 times higher than those of the non-/slow-progressive form of the disease. CONCLUSIONS: Progression in fibrosing ILD causes a significant impact on QoL and HCRU and costs. These survey data underline the need for safe and effective therapies to slow the disease progression.

Evaluation of a New Digital Automated Glycemic Pattern Detection Tool.

BACKGROUND: Blood glucose meters are reliable devices for data collection, providing electronic logs of historical data easier to interpret than handwritten logbooks. Automated tools to analyze these data are necessary to facilitate glucose pattern detection and support treatment adjustment. These tools emerge in a broad variety in a more or less nonevaluated manner. The aim of this study was to compare eDetecta, a new automated pattern detection tool, to nonautomated pattern analysis in terms of time investment, data interpretation, and clinical utility, with the overarching goal to identify early in development and implementation of tool areas of improvement and potential safety risks. METHODS: Multicenter web-based evaluation in which 37 endocrinologists were asked to assess glycemic patterns of 4 real reports (2 continuous subcutaneous insulin infusion [CSII] and 2 multiple daily injection [MDI]). Endocrinologist and eDetecta analyses were compared on time spent to analyze each report and agreement on the presence or absence of defined patterns. RESULTS: eDetecta module markedly reduced the time taken to analyze each case on the basis of the emminens eConecta reports (CSII: 18 min; MDI: 12.5), compared to the automatic eDetecta analysis. Agreement between endocrinologists and eDetecta varied depending on the patterns, with high level of agreement in patterns of glycemic variability. Further analysis of low level of agreement led to identifying areas where algorithms used could be improved to optimize trend pattern identification. CONCLUSION: eDetecta was a useful tool for glycemic pattern detection, helping clinicians to reduce time required to review emminens eConecta glycemic reports. No safety risks were identified during the study.

Patient assessment of onset of action and overall satisfaction with ebastine fast-dissolving tablets in allergic rhinitis.

AIM: To evaluate patient perception of the onset of action and overall satisfaction with a fast-dissolving tablet (FDT) formulation of ebastine in patients with intermittent or persistent allergic rhinitis. PATIENTS AND METHODS: This was a cross-sectional, multicenter, pharmacy-based survey involving adult patients (>18 years) with allergic rhinitis who presented with a prescription for ebastine FDT. Via a telephone interview, patients were asked to evaluate the characteristics of ebastine FDT in comparison with their previous experience with other antihistamines. RESULTS: 100 patients with allergic rhinitis were included in the study (41 had intermittent disease, 57 persistent disease and two with unknown disease states). Patients rated ebastine FDT very highly (mean scores: 4.5-4.7 out of a possible 5) for all characteristics related to convenience, such as easy to take, easy to carry around in a bag or pocket, suitable for taking anytime/anywhere, and convenient to use. A total of 85% of patients perceived ebastine FDTs onset of action to be fast or very fast, and 77% indicated that it acted faster than their usual antihistamine. A total of 96% were satisfied or very satisfied with ebastine FDT and 98% were interested in using the drug again. CONCLUSIONS: Patients with rhinitis rate ebastine FDT very highly in terms of its formulation, convenience of use and its rapid onset of action. These characteristics resulted in a high level of individual satisfaction with the new formulation and a clear preference by the majority of patients to use ebastine FDT in the future.

Efficacy of vardenafil and influence on self-esteem and self-confidence in patients with severe erectile dysfunction.

AIM: To assess the efficacy of vardenafil in a population of Spanish men with erectile dysfunction (ED), its influence on patients' self-esteem and self-confidence, and its effect on their quality of life. MAIN OUTCOME MEASURES: Efficacy was assessed by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain, the Rosenberg Self-Esteem scale, the Johnson and McCoy Self-Confidence scale, the Medical Outcome Short Form (SF-36) scale, items 2 and 3 of the Sexual Encounter Profile questionnaire, and the Global Assessment Question (GAQ). Safety assessments included laboratory tests, physical exam, electrocardiogram, vital signs, and adverse events. METHODS: This was a randomized, double-blind, multicenter, placebo-controlled study. After a 4-week treatment-free period, patients received flexible-dose vardenafil or placebo for 12 weeks. The initial dose was 10 mg, which could be titrated up to 20 mg or down to 5 mg at weeks 4 and 8. RESULTS: A total of 121 patients were included in the intention-to-treat analysis (61 on vardenafil and 60 on placebo). Of these, 16 in the vardenafil group and 14 in the placebo group had severe ED. There was a greater improvement in IIEF-EF domain score with vardenafil vs. placebo for all patients (score change of 10.9 vs. 1.6, respectively, P < 0.001) and for patients with severe ED (score change of 13.4 vs. 2.2, respectively, P = 0.011). A significant difference in favor of vardenafil was also observed for positive responses to the GAQ (73.8% vs. 25.0%, P < 0.001). After 12 weeks, vardenafil-treated patients with severe ED showed a significant improvement in their self-esteem compared with patients receiving placebo (change from baseline -1.51 vs. 3.54, respectively, P = 0.036). Vardenafil treatment was well tolerated. CONCLUSIONS: Vardenafil was highly effective for improving EF in all patients with ED, and resulted in significant improvements in self-esteem in patients with severe ED.

Estudios de intervención no aleatorizados (TREND) / Non-randomized evaluation studies (TREND)

Cuando hay razones que impidan la realización de un ensayo clínico controlado, se necesitan los estudios de intervención no aleatorizados, pero para comunicar con transparencia los resultados obtenidos en ellos debe emplearse de forma sistemática la lista de comprobación TREND. Ello implica que los estudios no aleatorizados deben emplear los restantes grados de calidad metodológica tradicionales en el ensayo aleatorizado y que la incertidumbre añadida por el mecanismo de asignación debe ser explícitamente comentada y, a ser posible, cuantificada (AU)

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified (AU)

[Non-randomized evaluation studies (TREND)]. / Estudios de intervención no aleatorizados (TREND).

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Drug utilization study in patients with Crohn's disease in Spain.

OBJECTIVE: To discover the therapeutic strategies for Crohn's disease used in Spain and to analyse the factors associated with the use of each treatment. DESIGN: Observational, cross-sectional study of patients with Crohn's disease who attended hospitals in Spain. METHODS: Two structured questionnaires were used, one completed by gastroenterologists about demographic clinical data and disease activity, and the other a telephone interview with the patients to obtain epidemiological and drug utilization data. RESULTS: A total of 635 patients from 39 hospitals were included. Aminosalicylates (77%) and corticosteroids (41%) were the most commonly used drugs. Monotherapy was used in 52% of the patients and was associated with less severe disease and relapse. Aminosalicylate use was associated with relapse and associated inversely with use of immunosuppressors. Corticosteroid use was associated with relapse, disease activity, and emergency visit frequency, and associated inversely with perianal disease. Use of immunosuppressors was associated with perianal disease, chronic active disease, and routine visit frequency, and associated inversely with aminosalicylate use. Antibiotic use was associated with relapse, perianal disease, chronic active disease and hospitalization. CONCLUSION: Aminosalicylates, corticosteroids and a combination of both drugs are the drugs used most frequently against Crohn's disease in Spain. Gender, age, clinical pattern and location were not associated with the type of drug used either in monotherapy or in combined therapy.

[Effect of antihypertensive therapy on pulse pressure]. / Efecto del tratamiento antihipertensivo sobre la presión de pulso.

BACKGROUND: Pulse pressure (difference between systolic and diastolic pressure) is an important prognostic factor for cardiovascular mortality and morbidity in elderly hypertensives. However, data regarding the effect of antihypertensive treatment on pulse pressure (PP) are scarce. In the present study, we evaluate the effect of six classes of antihypertensive drugs on PP in an elderly hypertensive cohort. PATIENTS AND METHOD: It was an open, prospective and multicenter study performed by primary care physicians. 857 hypertensive patients (54% women) with a mean age of 68 years were included. Antihypertensive treatment (any antihypertensive drug used in monotherapy) was freely assigned by investigators and then grouped in classes for analysis. Blood pressure was measured by a validated oscillometric device using a standardized protocol. RESULTS: ACE inhibitors were the mostly used class of antihypertensive drugs (27.8%). We found no differences between drug classes in PP reduction. Likewise, no differences were observed regarding the effect on systolic, diastolic, and mean blood pressure. The percentage of adverse reactions was low (6.3%). When effects on PP reduction and adverse reactions were pooled together, angiotensin receptor blockers emerged as the antihypertensive drug class with the best profile. CONCLUSIONS: Antihypertensive drugs do not differ substantially in their ability to reduce PP. Although PP is considered as an important prognostic factor for cardiovascular mortality and morbidity, the present results do not strengthen its usefulness as a distinctive marker of antihypertensive drug classes.

Efecto del tratamiento antihipertensivo sobre la presión de pulso / Effect of antihypertensive therapy on pulse pressure

FUNDAMENTO: La presión de pulso (PP) o diferencia entre presión sistólica y diastólica constituye un importante factor pronóstico en la población hipertensa de edad avanzada. No obstante, existen muy pocos datos sobre la existencia de diferencias en la modificación de dicho parámetro por el tratamiento antihipertensivo. El presente estudio evalúa la posible existencia de dichas diferencias en una cohorte de pacientes hipertensos de edad avanzada. PACIENTES Y MÉTODO: Estudio prospectivo de cohortes, abierto y multicéntrico, realizado en el ámbito de la atención primaria. Se han incluido 857 pacientes hipertensos (54 per cent mujeres) con una edad media de 68 años. Los tratamientos (cualquier fármaco antihipertensivo en monoterapia) fueron asignados libremente a criterio de los médicos investigadores. Posteriormente fueron agrupados por familias para el análisis. La presión arterial se ha determinado mediante un protocolo estandarizado y con la ayuda de un aparato semiautomático oscilométrico validado. RESULTADOS: La familia de fármacos inhibidores de la enzima conversiva de la angiotensina (IECA) ha sido la más utilizada. No se han observado diferencias entre los diferentes grupos farmacológicos en la reducción de la PP. Tampoco se han observado diferencias significativas al analizar el efecto de los diferentes grupos farmacológicos sobre la presión arterial sistólica, diastólica o media. El porcentaje de reacciones adversas producidas ha sido bajo (6,3 per cent). La combinación de efectos sobre la PP (efectividad) y sobre la aparición de reacciones adversas (tolerabilidad) permite observar un mejor perfil para los antagonistas de los receptores de la angiotensina II.CONCLUSIONES: Los fármacos antihipertensivos no difieren de forma sustancial en su capacidad de reducir la PP. A pesar de la importancia de la PP como marcador pronóstico cardiovascular, los presentes resultados no apoyan su utilización generalizada como marcador diferencial de los fármacos antihipertensivos (AU)

Quality of life in functional dyspepsia.

Our purpose was to assess the quality of life of functional dyspepsia patients using the SF-36 generic scale and the Gastrointestinal Symptoms Rating Scale (GSRS). In all, 328 dyspeptic patients were included in a multicenter, prospective, observational study. Both scales were filled out at baseline and one and three months after a prokinetic agent was given as a single-drug therapy. A total of 250 patients completed the study. An improvement in all SF-36 dimensions was observed, although the final scores were lower than the population reference values. Physical role (27% change), emotional role (20%), and physical pain (16%) dimensions showed the greater change. The GSRS total and domain scores also showed significant decreases. The best predictors of quality of life improvement were certain basal symptoms, drug compliance, and the absence of idiopathic dyspepsia. In conclusion, both the generic and the specific scales provide useful and sensitive measures of quality of life in functional dyspepsia patients on single-drug treatment.