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Virginia Bellido,1 Natalia Duque,2 Rachel S Newson,3 Esther Artime,2 Erik Spaepen,4 Miriam Rubio de Santos,2 Jennifer Redondo-Antón,2 Silvia Díaz-Cerezo,2 Jorge Navarro5 1Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, Spain; 2Medical Department, Medical Affairs, Eli Lilly and Company, Madrid, Spain; 3NAPAC Real World Evidence, Medical Affairs, Eli Lilly and Company, Sydney, NSW, Australia; 4Statistics, HaaPACS GmbH, Schriesheim, Germany; 5Department of Medicine, University of Valencia, Valencia, SpainCorrespondence: Natalia Duque, Eli Lilly and Company, Alcobendas, Madrid, Spain, Email duque_natalia@lilly.comBackground: This study aimed to determine physicians’ perceptions of the extent of suboptimal insulin dosing and the barriers and solutions to optimal dosing in people with diabetes (PwD) treated with insulin.Methods: A cross-sectional online survey was conducted in four countries with primary care physicians and endocrinologists treating PwD using insulin pens, which included 53 questions on physicians’ characteristics and their perceptions of the behaviors of PwD in relation to insulin dosing routines, unmet needs and potential solutions. Analyses were descriptive.Results: Of the 160 physicians (80 primary care physicians, 80 specialists) surveyed in Spain, 58.1% were male and 88.8% had been qualified to practice for more than five years. Most physicians (> 65%) indicated that 0– 30% of PwD missed or skipped, mistimed, or miscalculated an insulin dose in the last 30 days. Common reasons for these actions were that PwD forgot, were out of their normal routine, were too busy or distracted, or were unsure of how much insulin to take. To optimize insulin dosing, over 75% of physicians considered it very helpful for PwD to have real-time insulin dosing calculation guidance, mobile app reminders, a device automatically recording glucose measurements and/or insulin, having insulin and glucose data in one place, and having the time for more meaningful conversations about insulin dosing routines.Conclusion: According to physicians’ perspectives, suboptimal insulin dosing remains common among PwD. This survey highlights the need for integrated and automated insulin dosing support to manage the complexity of insulin treatment, improve communications between PwD and physicians, and ultimately improve outcomes for PwD.Plain Language Summary: In Spain, more than 50% of people with diabetes (PwD) do not reach glycemic targets (glycated hemoglobin [HbA1C] under 7%). While there are many innovations in insulin therapy and device technology, treatment adherence is often poor.This study presents results from an online survey of physicians’ perceptions of insulin dosing and the barriers and solutions to optimal insulin dosing in Spain. Most physicians indicated that PwD missed or skipped, mistimed, or miscalculated an insulin dose. Common reasons included PwD being out of their normal routine, being too busy or distracted, or being unsure of how much insulin to take. To improve insulin dosing, physicians suggested real-time insulin dosing calculation guidance, mobile app reminders, and a device that automatically records glucose measurements and insulin. Furthermore, having time for more meaningful conversations about insulin dosing routines was found as a solution to improve insulin dosing.There is a need for integrated and automated insulin dosing support to manage insulin treatment, improve communications between PwD and physicians, and improve outcomes for PwD.Keywords: diabetes mellitus, type 1 diabetes mellitus, type 2 diabetes mellitus, insulin dosing, physicians, Spain, barriers, solutions

Ángel Luis Guerrero-Peral,1 Jesús Porta-Etessam,2 Jaime Rodríguez-Vico,3 Mercedes Núñez,4 Antonio Ciudad,4 Silvia Díaz-Cerezo,4 Carla Garí-Peris,5 Francisco Javier Pérez-Sádaba,5 Luis Lizán,5 Sonia Santos-Lasaosa6 1Headache Unit, Neurology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 2Neurology Department, Hospital Clínico San Carlos, Madrid, Spain; 3Neurology Department, Fundación Jimenez Diaz, Madrid, Spain; 4Medical Department, Eli Lilly, Madrid, Spain; 5Outcomes’ 10, Castellón, Spain; 6Neurology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, SpainCorrespondence: Mercedes Núñez, Eli Lilly, Av. de la Industria, 30, Alcobendas, Madrid, 28108, Spain, Tel +34 647447827, Email nunez_mercedes@lilly.comPurpose: We aimed to validate the Spanish version of the Decisional Conflict Scale (DCS) and analyze its psychometric properties in people with migraine.Patients and Methods: The DCS validation comprised two phases. First, a translation and cross-cultural adaptation following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practices: 1-preparation, 2-independent forward translation, 3-reconciliation, 4-back-translation, 5-harmonization, 6-clinical review, and 7-content validation in a group of migraine patients. Second, the analysis of the psychometric properties. The reliability or internal consistency of the DCS scale and subscales was assessed using Cronbach’s α value. The item-subscale correlation was also evaluated. A floor and ceiling effects for DCS score was considered when at least 15% of respondents obtained DCS > 90 (ceiling) or < 10 (floor). The construct validity was studied through the correlation between the DCS subscales and by the correlation between the DCS and other questionnaires (Decision Self-Efficacy Scale [DSES] and 9-item Shared Decision-Making [SDM-Q-9]). Spearman’s coefficients were estimated for the correlations.Results: The cross-cultural adaptation was conducted on 17 patients who completed the questionnaire in a mean of 2.4 ± 1.1 minutes. Generally, more than 75% of them considered that DCS items were adequate, easy to understand, and relevant. The psychometric properties were evaluated in a sample of n=128 patients. Accordingly, the internal consistency of DCS was high, with a Cronbach’s α of 0.97 for the scale and between 0.87 to 0.96 for subscales. Also, a slight floor effect was observed, with 24.2% of patients having DCS scores < 10. The correlation between subscales exceeded Spearman’s coefficient of 0.7. Whereas the correlation between the DCS and the other questionnaires was generally moderate (Spearman’s coefficient > 0.4).Conclusion: The Spanish version (Spain) of the DCS has very acceptable psychometric properties (reliability and construct validity) and good potential for assessing decisional conflicts among migraine patients.Keywords: migraine, decision-making, decisional conflict scale, psychometric properties, adaptation, Spanish

Antoni Sicras-Mainar,1 Silvia Díaz-Cerezo,2 Verónica Sanz de Burgoa,3 Ruth Navarro-Artieda41Directorate of Planning, Badalona Serveis Assistencials SA, Badalona, Spain; 2Health Economics and Outcomes Research Department, Pfizer, SLU, Alcobendas, Spain; 3Medical Department, Pfizer, SLU, Alcobendas, Spain; 4Medical Documentation Unit, Hospital Germans Trias i Pujol, Badalona, SpainAbstract: This cohort retrospective study explored the cost and clinical consequences of smoking cessation in outpatients after cardiovascular events (CVEs), in Spain. A total of 2,540 patients (68.1 years; 60.7% male; 8.4% smokers, 52.9% ex-smokers, and 38.7% never smokers) fulfilling the selection criteria and followed up throughout a period of 36 months after the event were considered eligible for analysis. Total costs were higher among current smokers in comparison with ex-smokers and never smokers (€7,981 versus [vs] €7,322 and €5,619, respectively) (P < 0.001). Both health care costs (€6,273 vs €5,673 and €4,823, respectively) (P < 0.001) and loss of productivity at work costs (€1,708 vs €1,650 and €796, respectively) (P < 0.001) accounted for such differences. There was also a difference in CVE recurrence rates (18.6% vs 16.5% and 9.6%, respectively) (P < 0.01). Smoking cessation in CVE outpatients was associated with lower cost and risk of CVE recurrence compared with smokers, and their health status was similar to that of never smokers, in routine clinical practice in Spain.Keywords: mortality, health resources, health care costs

Introduction: The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness., Methods: A retrospective chart review study was carried out in six hospitals. Information of adults with migraine, who started treatment with galcanezumab between November 2019 and September 2021, was analyzed until end or loss of follow-up. Continuous variables were described as mean (standard deviation, SD) and median (interquartile range, IQR), and categorical variables as frequency and percentages. Persistence to treatment was estimated using Kaplan-Meier analysis., Results: A total of 314 patients were analyzed over median follow-up period of 17.5 months (13.8-20.7), with a mean age of 46.3 (12.6), 85% women, 80.6% chronic migraine, and reporting a mean of monthly migraine days of 16.7 (7.8). Overall, 72.9% had comorbid conditions, with anxiety and depression disorders being the most frequent. More than 60% had received ≥ 6 previous preventive drugs, the most common being antiepileptics, antidepressants, and botulinum toxin (95.2%, 89.8% and 84.1%, respectively). Overall, 60.3% of the patients with other preventive treatments maintained them after galcanezumab initiation. The median time on galcanezumab was 14.6 months (9.4-22.8); 95.7%, 82.0%, 76.2% and 59.8% of patients were persistent to treatment at 3, 6, 9 and 12 months, respectively. Of the patients who discontinued (151: 48.1%), 57.6% were due to lack of effectiveness and 31.1% were due to improvement in migraine. The average reduction of monthly migraine days at 3, 6, 9 and 12 months was 7.9 (7.2), 9.1 (7.5), 8.8 (6.6) and 9.0 (6.9) days, respectively., Conclusions: In real clinical practice, galcanezumab is an effective treatment and has a high persistence in patients with migraine, mostly chronic and with multiple use of previous preventive treatments., (© 2024. The Author(s).)

Background: An estimated 17.2% of patients continue to smoke following diagnosis of cardiovascular disease (CVD). To reduce the risk of further morbidity or mortality in cardiovascular patients, smoking cessation has been shown to reduce the risk of mortality by 36% and myocardial infarction by 32%. The objective of this study was to evaluate the long-term health and economic consequences of smoking cessation in patients with CVD., Design and Methods: Results of a randomized clinical trial comparing varenicline plus counselling vs. placebo plus counselling were extrapolated using a Markov model to simulate the lifetime costs and health consequences of smoking cessation in patients with stable CVD. For the base case, we considered a payer's perspective including direct costs attributed to the healthcare provider, measuring cumulative life years (LY) and quality adjusted life (QALY) years as outcome measures. Secondary analyses were conducted from a societal perspective, evaluating lost productivity due to premature mortality. Sensitivity and subgroup analyses were also undertaken. Results were analysed for Belgium, Spain, Portugal, and Italy., Results: Varenicline plus counselling was associated with a gain in LY and QALY across all countries; relative to placebo plus counselling. From a payer's perspective, incremental cost effectiveness ratios were € 6120 (Belgium), € 5151 (Spain), € 5357 (Portugal), and € 5433 (Italy) per QALY gained. From a societal perspective, varenicline in addition to counselling was less costly than placebo and counselling in all cases. Sensitivity analyses showed little sensitivity in outcomes to model assumptions or uncertainty in model parameters., Conclusions: Varenicline in addition to counselling is cost-effective compared to placebo and counselling in smokers with CVD.