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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