Safety and diagnostic performance of parathyroid hormone assay in fine-needle aspirate in suspicious parathyroid adenomas.

OBJECTIVE: To evaluate the safety and diagnostic performance of parathyroid hormone assay in fine-needle aspirate (PTH-FNA) in patients with primary hyperparathyroidism and suspicious parathyroid adenomas. METHODOLOGY: A retrospective observational study was performed in 47 patients (57.7 ±â€¯11.2 years of average age, 74% women) attending an endocrinology clinic for primary hyperparathyroidism (average calcemia: 11.6 ±â€¯1.6 mg/dl and PTH: 276 ±â€¯477 pg/mL) in which PTH-FNA was made. Sensibility, specificity, positive predictive value and negative predictive value were calculated in all surgical patients. RESULTS: Forty-seven lesions were punctured (mean adenoma maximum diameter: 1.8 ±â€¯2.6 cm): negative image in the sestamibi scan (26 patients); the discordance between ultrasonography and the sestamibi scan (6 patients); possible intrathyroidal adenomas (4 patients); a positive sestamibi scan in 2 or more localizations (4 patients); ectopic adenoma (3 patients); persistent primary hyperparathyroidism (2 patients) and atypical adenomas (2 patients). Mean PTH-FNA was 2853 ±â€¯3957 pg/mL and 68% were considered positive (PTH-FNA ≥ 100 pg/mL). No complications were detected during or after the puncture. Thirty-seven patients were operated on, 95% were cured and no parathyromatosis cases were detected. PTH-FNA ≥ 100 pg/mL as a diagnostic test had a sensitivity of 93.7%, a specificity of 100%, a positive predictive value of 100% and an negative predictive value of 71.4%. CONCLUSION: PTH-FNA is an easy and safe diagnostic test and has a high sensitivity and specificity for differentiating between parathyroid adenomas and other cervical masses in patients with primary hyperparathyroidism.

The presence of microvascular complications is associated with a poor evolution of metabolic control in patients with type 1 diabetes mellitus.

OBJECTIVE: To report the evolution of metabolic control and to assess the clinical and metabolic factors associated with the presence of microvascular complications in patients with type 1 diabetes mellitus (T1DM). MATERIAL AND METHODS: This was a retrospective, observational study analysing clinical, laboratory, and therapeutic data from a registry of patients with T1DM created in 2010. RESULTS: Data recorded from 586 patients (males: 50.2%; mean age: 36.1±13.5 years; T1DM duration: 18.0±12.1 years) followed for a mean of 6.0±3.1 years were assessed, and 8133 HbA1c levels (13.2±7.6 measurements/patient) were analysed, with a mean evolutionary HbA1c of 7.9%±1.2%. The mean annual HbA1c level gradually improved from 8.6%±1.6% in 2010 to 7.5%±1.4% in 2019, with 34.3% and 69.0% of patients having HbA1c levels ≤7% and ≤8% respectively. Patients with T1DM duration of <10 years and ≥20 years, non-smokers, CSII users, and those using the insulin/carbohydrate ratio had better current and evolutionary HbA1c levels. The presence of microvascular complications was independently associated with T1DM lasting ≥20 years, the presence of HBP, and evolutionary HbA1c≥7.0%. CONCLUSION: A progressive but still inadequate improvement in metabolic control over 10 years was seen in patients with T1DM. Poor metabolic control (mean HbA1c over 10 years ≥7%) was independently associated with the presence of microvascular complications.

Elevada capacidad de localización ecográfica de adenomas paratiroideos en endocrinología (estudio ETIEN 4) / High capacity of ultrasound for locating parathyroid adenomas in endocrinology (the ETIEN 4 study)

OBJETIVO: Evaluar el rendimiento diagnóstico de la ecografía de localización de adenomas de paratiroides realizada por endocrinólogos en pacientes con hiperparatiroidismo primario (HPTP). METODOLOGÍA: Estudio observacional retrospectivo en 135 pacientes (74,8% mujeres; edad media: 60,0±12,3 años) atendidos en consultas de endocrinología por HPTP (calcemia media: 11,3±1,2 mg/dl y PTH plasmática media: 240,4±346,8 pg/ml) a los cuales se realiza eco cervical en consulta de endocrinología y se solicita gammagrafía 99mTc-MIBI previamente a la cirugía. Se calcula sensibilidad, especificidad y valor predictivo de ambas pruebas en el subgrupo de pacientes intervenidos. RESULTADOS: Un total de 98 pacientes fueron intervenidos de HPTP y se curaron el 97,8% a 6 meses. La ecografía de localización tuvo una sensibilidad del 85% (IC 95: 75,7-91,2%) y un valor predictivo positivo (VPP) del 95,2% (IC 95%: 87,5-98,4%) para localizar adenomas de paratiroides de 1,7±0,9 cm de diámetro medio máximo (69,4% en glándulas inferiores), presentando una elevada correlación (r = 0,661 y r = 0,716) con el diámetro máximo y el volumen del adenoma extirpado. El 60% presentaba patología nodular tiroidea (64,2% bilateral con un diámetro máximo medio nodular de 1,5±0,9 cm) y se realizaron tiroidectomías en el 31,6%. El mayor rendimiento diagnóstico se observó con la combinación de eco cervical y gammagrafía 99mTc-MIBI (sensibilidad: 96,8% y VPP: 95,8%). CONCLUSIÓN: En nuestro medio, la ecografía de localización de adenomas de paratiroides en pacientes con HPTP realizada por endocrinólogos tiene una elevada capacidad diagnóstica y permite detectar la presencia de patología tiroidea en el 60% de los pacientes

OBJECTIVE: To assess the diagnostic performance of neck ultrasound examination performed by endocrinologists to locate parathyroid adenomas in patients with primary hyperparathyroidism (PHPT). METHODOLOGY: A retrospective observational study in 135 patients (mean age, 60.0 ± 12.3 years; 74.8% females) seen at endocrinology for PHPT (mean calcium level, 11.3 ± 1.2 mg/dL mean PTH level, 240.4 ± 346.8 pg/mL) who underwent neck ultrasound examinations at the endocrinology department. 99mTc-MIBI parathyroid scintigraphy was performed before surgery in all patients. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated in surgical patients. RESULTS: Ninety-eight patients underwent surgery for PHPT and 97.8% were cured at 6 months. Parathyroid ultrasound had a sensitivity of 85% (95% CI: 75.7%-91.2%) and a positive predictive value (PPV) of 95.2% (95% CI: 87.5%-98.4%) to locate parathyroid adenomas 1.7 ± 0.9 cm in maximum diameter (69.4% in smaller glands), showing a high correlation (r = 0.661 and r = 0.716) with maximum diameter and volume of the excised adenoma. Sixty percent of patients had nodular thyroid disease (64.2% bilateral nodules with mean maximum diameter of 1.5 ± 0.9cm), and thyroidectomy was performed in 31.6%. The highest diagnostic performance was seen with a combination of neck ultrasound and 99mTc-MIBI scintigraphy (sensitivity: 96.8% and PPV: 95.8%). CONCLUSIÓN: In our area, parathyroid adenoma localization with ultrasound performed by endocrinologists has a high diagnostic yield and allows for detecting nodular thyroid disease in 60% of patients

Rendimiento diagnóstico del sistema de evaluación de riesgo ecográfico del nódulo tiroideo de la American Thyroid Association en endocrinología (estudio ETIEN 3) / Diagnostic performance of the American Thyroid Association ultrasound risk assessment of thyroid nodules in endocrinology (the ETIEN 3 study)

Introducción: Hasta la actualidad no se ha publicado en nuestro país ningún estudio sobre la utilidad del sistema de evaluación del riesgo ecográfico del nódulo tiroideo de la American Thyroid Association (ATA) aplicada por endocrinólogos. Objetivos: Evaluar el rendimiento diagnóstico de la clasificación ATA del nódulo tiroideo aplicada por endocrinólogos respecto a los resultados histológicos. Metodología: Estudio observacional retrospectivo de 317 pacientes (51,7 ± 13,7 años de edad media; 83,3% mujeres) con nódulos tiroideos (diámetro máximo: 3,2 ± 1,4 cm) evaluados en consulta de eco-PAAF de endocrinología entre octubre de 2015 y diciembre de 2018, a los cuales se les aplicó la clasificación ATA y que fueron intervenidos. Se evalúan los criterios de calidad de la clasificación ecográfica prequirúrgica respecto a los resultados histológicos. Resultados: El 61,2% de los nódulos evaluados fueron clasificados como benignos (n = 3), de muy baja (n = 60) o de baja sospecha (n = 131), el 11,7% como sospecha intermedia (n = 37) y el 27,1% como alta sospecha (n = 86). Se detectaron 260 casos de enfermedad nodular benigna y 57 cánceres de tiroides. Hubo 14 microcarcinomas papilares incidentales. La clasificación de nódulos de alta sospecha presentó un elevado rendimiento diagnóstico para identificar nódulos malignos (sensibilidad 87,7%, especificidad 86,2% y valor predictivo negativo 97,0%), mejorando la sensibilidad (93,0%) y reduciéndose la especificidad (73,1%) al considerar de riesgo los nódulos de sospecha alta e intermedia. Conclusiones: La aplicación por endocrinólogos del sistema de evaluación de riesgo ecográfico del nódulo tiroideo de la ATA presenta un elevado rendimiento diagnóstico para identificar prequirúrgicamente nódulos tiroideos malignos

Introduction: No study has been published to date in Spain about the value of the American Thyroid Association (ATA) ultrasound risk assessment of thyroid nodules applied by endocrinologists. Objectives: To assess the diagnostic performance of ATA thyroid nodule risk classification applied by endocrinologists with respect to histological results. Methods: A retrospective, observational study of 317 patients (mean age, 51.7 ± 13.7 years; 83.3% women) with thyroid nodules (maximum diameter: 3.2 ± 1.4 cm) who underwent US-guided FNA in endocrinology between October 2015 and December 2018, were classified based on the ATA ultrasound risk assessment. Surgery was performed in all of them. Quality criteria of the ultrasound classification were assessed as compared to histological results. Results: Overall, 61.2% of nodules assessed were classified as benign (n = 3) and very low (n = 60) or low suspicion (n = 131), 11.7% as intermediate suspicion (n = 37), and 27.1% as high suspicion (n = 86). Benign nodular disease was found in 260 patients, and thyroid cancer in 57 patients. There were 14 incidental papillary microcarcinomas. Classification of thyroid nodules as high suspicion showed a high diagnostic performance to identify malignant nodules (87.7% sensitivity, 86.2% specificity, negative predictive value 97.0%), improving sensitivity (93.0%) and reducing specificity (73.1%) when considering high and intermediate suspicion nodules as a risk for thyroid cancer. Conclusions: Application by endocrinologists of the ATA ultrasound risk assessment of thyroid nodules shows a high diagnostic performance to identify malignant thyroid nodules before surgery

High capacity of ultrasound for locating parathyroid adenomas in endocrinology (the ETIEN 4 study). / Elevada capacidad de localización ecográfica de adenomas paratiroideos en endocrinología (estudio ETIEN 4).

OBJECTIVE: To assess the diagnostic performance of neck ultrasound examination performed by endocrinologists to locate parathyroid adenomas in patients with primary hyperparathyroidism (PHPT). METHODOLOGY: A retrospective observational study in 135 patients (mean age, 60.0±12.3 years; 74.8% females) seen at endocrinology for PHPT (mean calcium level, 11.3±1.2mg/dL mean PTH level, 240.4±346.8pg/mL) who underwent neck ultrasound examinations at the endocrinology department. 99mTc-MIBI parathyroid scintigraphy was performed before surgery in all patients. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated in surgical patients. RESULTS: Ninety-eight patients underwent surgery for PHPT and 97.8% were cured at 6 months. Parathyroid ultrasound had a sensitivity of 85% (95% CI: 75.7%-91.2%) and a positive predictive value (PPV) of 95.2% (95% CI: 87.5%-98.4%) to locate parathyroid adenomas 1.7±0.9cm in maximum diameter (69.4% in smaller glands), showing a high correlation (r=0.661 and r=0.716) with maximum diameter and volume of the excised adenoma. Sixty percent of patients had nodular thyroid disease (64.2% bilateral nodules with mean maximum diameter of 1.5±0.9cm), and thyroidectomy was performed in 31.6%. The highest diagnostic performance was seen with a combination of neck ultrasound and 99mTc-MIBI scintigraphy (sensitivity: 96.8% and PPV: 95.8%). CONCLUSION: In our area, parathyroid adenoma localization with ultrasound performed by endocrinologists has a high diagnostic yield and allows for detecting nodular thyroid disease in 60% of patients.

Diagnostic performance of the American Thyroid Association ultrasound risk assessment of thyroid nodules in endocrinology (the ETIEN 3 study). / Rendimiento diagnóstico del sistema de evaluación de riesgo ecográfico del nódulo tiroideo de la American Thyroid Association en endocrinología (estudio ETIEN 3).

INTRODUCTION: No study has been published to date in Spain about the value of the American Thyroid Association (ATA) ultrasound risk assessment of thyroid nodules applied by endocrinologists. OBJECTIVES: To assess the diagnostic performance of ATA thyroid nodule risk classification applied by endocrinologists with respect to histological results. METHODS: A retrospective, observational study of 317 patients (mean age, 51.7±13.7 years; 83.3% women) with thyroid nodules (maximum diameter: 3.2±1.4cm) who underwent US-guided FNA in endocrinology between October 2015 and December 2018, were classified based on the ATA ultrasound risk assessment. Surgery was performed in all of them. Quality criteria of the ultrasound classification were assessed as compared to histological results. RESULTS: Overall, 61.2% of nodules assessed were classified as benign (n=3) and very low (n=60) or low suspicion (n=131), 11.7% as intermediate suspicion (n=37), and 27.1% as high suspicion (n=86). Benign nodular disease was found in 260 patients, and thyroid cancer in 57 patients. There were 14 incidental papillary microcarcinomas. Classification of thyroid nodules as high suspicion showed a high diagnostic performance to identify malignant nodules (87.7% sensitivity, 86.2% specificity, negative predictive value 97.0%), improving sensitivity (93.0%) and reducing specificity (73.1%) when considering high and intermediate suspicion nodules as a risk for thyroid cancer. CONCLUSIONS: Application by endocrinologists of the ATA ultrasound risk assessment of thyroid nodules shows a high diagnostic performance to identify malignant thyroid nodules before surgery.

Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study.

OBJECTIVE: To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS: At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS: The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

Effect of Telephone-Delivered Interventions on Glycemic Control in Type 2 Diabetes Treated with Glargine Insulin.

Background:Telephone-delivered intervention can provide support in diabetes self-management to improve glycemic control. "eStar® program" is a telephone support platform for type 2 diabetes on glargine insulin treatment. Its objective is to help patients to perform insulin titration to reach target fasting blood glucose levels. Patients are contacted by trained nurses on a regular basis to adjust the basal insulin dose and reinforce the diabetes education. This study aimed to evaluate if eStar program was effective in helping patients reach their optimal insulin glargine dose within 6 months.Materials and Methods:An observational prospective study was conducted with type 2 diabetes patients who were initiating insulin glargine or requiring dose titration and were eligible to be included in the eStar program. Those participants who followed the program comprised the intervention group, while those who discontinued, the control group. The primary outcome was to evaluate if this program was effective in helping patients reach their optimal insulin glargine dose within 6 months. Secondary outcomes included changes in glycosylated hemoglobin (HbA1C), fasting plasma glucose (FPG), insulin dose, and body mass index after 6 months.Results:A total of 228 subjects [intervention group, 143 (62.7%); control group, 85 (37.3%)] were included in the study. A significantly greater percentage of patients in the intervention group reached their optimal glargine dose than in the control group (83.8% vs. 31.5%; p < 0.001). After 6 months, significant reductions in mean HbA1C levels were observed in both groups: 1.49% (p < 0.001) for the intervention group and 1.08% (p < 0.001) for the control group. Furthermore, a mean reduction in FPG between group was achieved (34.96 mg/dL; p < 0.001).Conclusions:The eStar program is an effective way to help patients reach their optimal insulin glargine dose, besides improving their glycemic control.

Impacto asistencial y económico de la ecografía tiroidea en acto único en consultas de endocrinología (estudio ETIEN 1) / Care and economic impact of thyroid ultrasound examination at single visits to endocrinology clinics (the ETIEN 1 study)

OBJETIVO: La realización de ecografía tiroidea en consultas en acto único está escasamente implantada en nuestro país. El objetivo de este estudio fue evaluar el impacto asistencial y económico de la utilización de la ecografía tiroidea en consultas de endocrinología en acto único. MÉTODOS: Se trata de un estudio prospectivo, observacional y descriptivo en el que se analizaron los datos de 2.274 pacientes (edad media: 59 +/- 16 años; 83% mujeres) a los cuales se les realizó al menos una ecografía tiroidea en acto único en consultas de endocrinología durante 2013 y 2014. Se evaluaron el número de consultas de acto único, consultas con alta directa y la variación en el número de ecografías solicitadas y realizadas en radiodiagnóstico durante el período de estudio. RESULTADOS: En 2013 y 2014 se realizaron 2.558 ecografías tiroideas en consultas de endocrinología en acto único, siendo el 42,2% consultas de alta directa sin revisión de resultados, con un ahorro estimado de 58.946,40 €. En 2013 y 2014 se redujo el número de ecografías solicitadas a radiodiagnóstico en un 43,3% y 86,0%, respectivamente. De forma global se realizaron en radiodiagnóstico un 28,1% y un 68,3% menos ecografías tiroideas respecto al año 2012, estimándose un ahorro económico de 94.441,36 euros. CONCLUSIONES: La realización de ecografías tiroideas en consultas de endocrinología en acto único permite reducir tanto el número de revisiones de recogida de resultados como las ecografías tiroideas realizadas en radiodiagnóstico, lo cual disminuye el número de desplazamientos innecesarios de pacientes y favorece un ahorro económico considerable

OBJECTIVE: Routine thyroid ultrasound examination in a single medical appointment is rarely performed in Spain. The objective of this study was to evaluate the care and economic impact of thyroid US examination in a single endocrine appointment. METHODS: A prospective, observational, descriptive study was conducted to analyze data from 2274 patients (mean age, 59 ± 16 years; 83% females) performed at least one thyroid US in a single visit to an endocrinology clinic during 2013 and 2014. The number of endocrine acts with thyroid US, single endocrine and US acts without review, and the change in the number of thyroid US requested by endocrinologists to the radiology department and total thyroid US examinations performed at the radiology department during the study period were assessed. RESULTS: In 2013 and 2014, 2558 endocrine acts with thyroid US were performed, of which 42.2% were single endocrine and US appointments without a second endocrine act, with estimated savings of €58,946.40. As compared to 2012, the number of thyroid US requested by endocrinologists to the radiology department decreased by 43.3% and 86.0% in 2013 and 2014 respectively, and total thyroid US performed by the radiology department decreased by 28.1% and 68.3% respectively, with estimated savings of €94,441.36. CONCLUSIONS: Thyroid US examination in a single endocrine appointment allows for decreasing the number of both second endocrine acts and thyroid US examinations performed at the radiology department, thus reducing the number of unnecessary clinic visits and promoting considerable economic savings

Care and economic impact of thyroid ultrasound examination at single visits to endocrinology clinics (the ETIEN 1 study).

OBJECTIVE: Routine thyroid ultrasound examination in a single medical appointment is rarely performed in Spain. The objective of this study was to evaluate the care and economic impact of thyroid US examination in a single endocrine appointment. METHODS: A prospective, observational, descriptive study was conducted to analyze data from 2274 patients (mean age, 59±16 years; 83% females) performed at least one thyroid US in a single visit to an endocrinology clinic during 2013 and 2014. The number of endocrine acts with thyroid US, single endocrine and US acts without review, and the change in the number of thyroid US requested by endocrinologists to the radiology department and total thyroid US examinations performed at the radiology department during the study period were assessed. RESULTS: In 2013 and 2014, 2558 endocrine acts with thyroid US were performed, of which 42.2% were single endocrine and US appointments without a second endocrine act, with estimated savings of €58,946.40. As compared to 2012, the number of thyroid US requested by endocrinologists to the radiology department decreased by 43.3% and 86.0% in 2013 and 2014 respectively, and total thyroid US performed by the radiology department decreased by 28.1% and 68.3% respectively, with estimated savings of €94,441.36. CONCLUSIONS: Thyroid US examination in a single endocrine appointment allows for decreasing the number of both second endocrine acts and thyroid US examinations performed at the radiology department, thus reducing the number of unnecessary clinic visits and promoting considerable economic savings.

Web-based telemedicine system is useful for monitoring glucose control in pregnant women with diabetes.

OBJECTIVE: The aim of this study was to examine the impact of a Web-based telemedicine system for monitoring glucose control in pregnant women with diabetes on healthcare visits, metabolic control, and pregnancy outcomes. SUBJECTS AND METHODS: A prospective, single-center, interventional study with two parallel groups was performed in Puerto Real University Hospital (Cadiz, Spain). Women were assigned to two different glucose monitoring groups: the control group (CG), which was managed only by follow-ups with the Gestational Diabetes Unit (GDU), and the telemedicine group (TMG), which was monitored by both more spaced GDU visits and a Web-based telemedicine system. The number of healthcare visits, degree of metabolic control, and maternal and neonatal outcomes were evaluated. RESULTS: One hundred four pregnant women with diabetes (77 with gestational diabetes, 16 with type 1 diabetes, and 11 with type 2 diabetes) were included in the TMG (n=40) or in the CG (n=64). There were no significant differences in mean glycated hemoglobin level during pregnancy or after delivery, despite a significantly lower number of visits to the GDU (3.2±2.3 vs. 5.9±2.3 visits; P<0.001), nurse educator (1.7±1.3 vs. 3.0±1.7 visits; P<0.001), and general practitioner (3.7±2.0 vs. 4.9±2.8 visits; P<0.034) in the TMG. There were no significant differences between groups in maternal or neonatal outcomes. CONCLUSIONS: A Web-based telemedicine system can be a useful tool facilitating the management of pregnant diabetes patients, as a complement to conventional outpatient clinic visits.

Desarrollo y validación de un cuestionario específico de evaluación de la satisfacción del paciente diabético con glucómetros / Development and validation of a specific questionnaire to evaluate diabetic patient satisfaction with the use of glucometers

OBJETIVO: Desarrollar un cuestionario específico de evaluación de la satisfacción del paciente diabético con el uso del glucómetro y evaluar sus propiedades psicométricas (factibilidad, fiabilidad y validez). MATERIAL Y MÉTODOS: 1) Tras una revisión bibliográfica se construyó un banco de 53 ítems inicial. Un panel de 6 expertos y 50 pacientes concluyeron una versión del cuestionario de 25 ítems (dimensiones: satisfacción, molestias, valor añadido y aspecto). 2) Para la validación del instrumento se diseñó un estudio epidemiológico, multicéntrico y transversal de 2 meses de duración en el que participaron 283 pacientes mayores de edad con diabetes mellitus (DM) (tipo 1 y tipo 2) que usaban un glucómetro portátil. Se recogieron las respuestas al cuestionario SATIGLU, junto con variables complementarias en visita única. Para evaluar la fiabilidad Test-Retest, 51 pacientes han respondido al cuestionario tras 15 días de la primera visita. RESULTADOS: El cuestionario demuestra tener alta consistencia interna (α de Cronbach de 0,88). Además muestra correlación positiva y estadísticamente significativa con los cuestionarios de medida de la satisfacción del paciente con el tratamiento en general (SAT-Q) y con el tratamiento para la DM (DTSQs(c)). Se observaron diferencias estadísticamente significativas en la puntuación total del cuestionario en función del tipo de DM a favor de los DMT1 (z = 6,69; p = 0,000), y en hemoglobina glucosilada a favor de los pacientes con HbA1c < 7 (z = -3,13; p = 0,002). CONCLUSIONES: El cuestionario SATIGLU muestra unas adecuadas propiedades psicométricas como instrumento de evaluación de la satisfacción de los pacientes diabéticos con el uso del glucómetro

OBJECTIVE: The aim of the study was to develop a specific questionnaire to assess patient satisfaction with the use of glucometers, and to evaluate their psychometric properties (feasibility, reliability and validity). MATERIAL AND METHODS: (I) An initial 53 item bank was constructed from a systematic review of literature. A panel composed of 6 experts and 50 patients concluded a 25 item version of the questionnaire (dimensions: Satisfaction, inconveniences, added value and appearance). (II) In order to evaluate the psychometric properties, an epidemiological multi-centred, crosssectional and 2 month long study was designed, for which 283 patients 18 years or older who were suffering from DM (type 1 and 2) and using a portable glucometer were recruited. Responses to the questionnaire that was the purpose of the study were gathered, together with complementary variables in a single visit. To evaluate test-retest reliability, 51 patients responded again 15 days after initial visit. RESULTS: There was high internal consistency (Cronbach alpha = 0.88). Moreover, it showed a positive and statistically significant correlation with patient overall satisfaction (SAT-Q), and with patient treatment-satisfaction (DTSQs(c)) questionnaires. Statistically significant differences were found in SATIGLU total score depending on the type of DM, in favour of type 1 DM patients (z = 6.69; P = 0.000), and glycated haemoglobin favouring patients who observe a good control of their disease, HbA1c < 7 (z = -3.13; P = 0.002). CONCLUSION: The SATIGLU Questionnaire showed adequate psychometric properties as an evaluation tool of patient satisfaction with the use of glucometers

Intense physical activity is associated with better metabolic control in patients with type 1 diabetes.

OBJECTIVES: To analyze the association between adherence to physical activity guideline recommendations and metabolic control in patients with type 1 diabetes (DM1). METHODS: An observational, cross-sectional study was conducted in 130 adult DM1 patients from Spain with a mean age of 33.9±11.5 years and disease duration of 16.5±9.5 years. We analyzed several clinical, anthropometric and laboratory variables together with information obtained from the Minnesota Leisure Time Physical Activity Questionnaire. RESULTS: Evaluated patients reported an average of 850.6±493.2min of physical activity per week, being classified as light (567.4±425.4min/week), moderate (169.9±212.1min/week) and intense activities (120.6±184.2). Patients who dedicated more time to intense physical activity were younger, had university studies and were males more often than those who spent none or less time on intense physical activity. We observed no differences in HbA1c levels in relation to time dedicated to moderate physical activities. However, patients who dedicated more than 150min to intense physical activity per week had lower levels of HbA1c (HbA1c: 7.2±1.0% versus 7.8±1.1% versus 8.0±1.0% in more than 149min, between 0 and 149min or 0min of intense physical activity per week, respectively). CONCLUSION: Performing more than 150min of intense physical activity a week is associated with better metabolic control in type 1 Spanish patients. No positive impact in metabolic control was observed in relation to the time spent in moderate physical activity.

La mayor adhesión a la dieta mediterránea no se asocia a un mejor control metabólico en pacientes con diabetes tipo 1 / Greater adherence to mediterranean diet is not associated with better metabolic control in patients with type 1 diabetes

Objetivos: El objetivo del presente estudio es evaluar el nivel de adhesión al modelo de dieta mediterránea en un grupo de pacientes con diabetes tipo 1 y analizar si un mayor nivel de adherencia a la dieta mediterránea se asocia con un mejor control metabólico y de factores de riesgo vascular. Material y métodos: Estudio observacional descriptivo realizado en 132 pacientes con diabetes tipo 1 de 33,7 ± 11,7 años de edad media. La adhesión a la dieta mediterránea fue evaluada mediante cuestionario validado que proporciona una puntuación entre 0 y 14. Los parámetros clínicos, antropométricos y metabólicos analizados han sido recopilados mediante entrevista personal, estudio del historial clínico y extracción analítica orientada a la evaluación del control metabólico. Resultados: La adhesión media a la dieta mediterránea fue de 8,9 ± 1,9 puntos; el 59% de los pacientes presentó una puntuación igual o inferior a 9 puntos. No se encontraron diferencias significativas en la adhesión a la dieta mediterránea por ninguno de los parámetros clínicos, antropométricos ni analíticos analizados. Los pacientes con mayor nivel de adhesión a la dieta mediterránea no presentaban perfiles lipídicos más favorables, menores niveles de hemoglobina glucosilada ni una menor prevalencia de complicaciones microvasculares. Conclusiones: La mayoría de los pacientes con diabetes tipo 1 evaluados en nuestro estudio muestran un nivel medio-bajo de adhesión al modelo tradicional de dieta mediterránea. La mayor adhesión a la dieta mediterránea no se asoció a un mejor control metabólico ni de otros factores de riesgo vascular(AU)

Objectives: The objective of the present study is to evaluate the level of adherence to the Mediterranean diet model in a group of patients with type diabetes 1 and to determine whether a higher level of adherence to a Mediterranean diet is associated with a better metabolic control or vascular risk factors. Material and methods: A descriptive study was conducted on 132 patients with type diabetes 1 and a mean age 33.7 ± 11.7 years. Adherence to the Mediterranean diet was evaluated by means of a validated questionnaire that provided a score between 0 and 14. The clinical, anthropometric and metabolic parameters analysed were compiled by means of personal interviews; a study of the clinical history and analytical results measured for metabolic control. Results: The mean adherence to the Mediterranean diet scored 8.9 ± 1.9 points, with 59% of the patients having a score of 9 points or lower. Significant differences in adherence to the Mediterranean diet were not found for any of the clinical, anthropometric or analytical parameters analysed. Patients with a higher level of adherence to the Mediterranean diet did not have more favourable lipid profiles, or lower levels of glycated haemoglobin, or less microvascular complications. Conclusions: Most patients with type diabetes 1 evaluated in our study showed a level medium-low level of adherence to the traditional Mediterranean diet model. Higher adherence to the Mediterranean diet was not associated with better metabolic control or other vascular risk factors(AU)

¿Es posible alcanzar en la práctica clínica los objetivos de control metabólico establecidos para pacientes con diabetes mellitus tipo 1 / Can the metabolic control targets established for patients with type 1 diabetets be achieved in clinical in clinical practice?

Objetivo: Evaluar el grado de consecución de indicadores de calidad de atención en pacientes con diabetes mellitus tipo 1 (DM1) atendidos en la Unidad de Gestión Clínica (UGC) de Endocrinología y Nutrición del Hospital Puerta del Mar de Cádiz. Metodología: Explotación de la base de datos incluida en la aplicación informática HP-Doctor utilizada para todos los pacientes atendidos en la UGC (hospitalización, consultas y centros periféricos). Se incluye a todos los pacientes con diagnóstico principal o secundario de DM1. Los indicadores de calidad analizados han sido seleccionados de las principales guías de práctica clínica de atención a pacientes con diabetes. Resultados: Se analiza una amplia cohorte de pacientes con DM1 (489pacientes) en seguimiento por nuestra UGC desde 2005 a 2007. En el período estudiado, el valor medio de glucohemoglobina (HbA1c) mejoró del 7,78 al 7,36%; se incrementó el porcentaje de pacientes con HbA1cmedia menor del 7% desde el 24,6 hasta el 27,1%, y disminuyó del 42,6hasta el 38,7% el porcentaje de pacientes con HbA1c media superior al 8%.En el año 2007, tan sólo un 35,5% de los pacientes mantenían cifras medias de colesterol de las lipoproteínas de baja densidad menores de100 mg/dl. Conclusiones: A pesar de la mejora obtenida en los parámetros de control metabólico, la mayoría de los pacientes con DM1 en seguimiento por nuestra unidad mantienen un inadecuado control glucémico y lipídico (AU)

Objective: To evaluate the quality of healthcare in patients with type 1 diabetes attended in the Endocrinology and Clinical Nutrition Unit of the Hospital Puerta del Mar in Cadiz (Spain).Methodology: The database included in the computer application HP-Doctor used forall patients attended in our unit(admissions, consultations and peripheral centers) was analyzed. All patients with a principal or secondary diagnosis of type 1diabetes were included. The quality indicators analyzed were selected from the main clinical practice guidelines for these patients. Results: A large cohort of patients with type 1 diabetes (n = 489) followed-up from2005 to 2007 was analyzed. During the study period, the mean glycated hemoglobin level (HbA1c) decreased from7.78% to 7.36%, the percentage of patients with HbA1c lower than 7% increased from24.6% to 27.1% and the percentage patients with a mean HbA1c of more than8% decreased from 42.6% to 38.7%. In2007, only 35.5% of patients maintained low-density lipoprotein concentrations ofless than 100 mg/dl. Conclusions: Despite the improvement obtained in metabolic control parameters, most of the patients with type 1 diabetes studied showed inadequate glycemic and lipid control (AU)

Can the metabolic control targets established for patients with type 1 diabetes be achieved in clinical practice?

OBJECTIVE: To evaluate the quality of healthcare in patients with type 1 diabetes attended in the Endocrinology and Clinical Nutrition Unit of the Hospital Puerta del Mar in Cadiz (Spain). METHODOLOGY: : The database included in the computer application HP-Doctor used for all patients attended in our unit (admissions, consultations and peripheral centers) was analyzed. All patients with a principal or secondary diagnosis of type 1 diabetes were included. The quality indicators analyzed were selected from the main clinical practice guidelines for these patients. RESULTS: A large cohort of patients with type 1 diabetes (n=489) followed-up from 2005 to 2007 was analyzed. During the study period, the mean glycated hemoglobin level (HbA(1c)) decreased from 7.78% to 7.36%, the percentage of patients with HbA(1c) lower than 7% increased from 24.6% to 27.1% and the percentage patients with a mean HbA(1c) of more than 8% decreased from 42.6% to 38.7%. In 2007, only 35.5% of patients maintained low-density lipoprotein concentrations of less than 100 mg/dl. CONCLUSIONS: Despite the improvement obtained in metabolic control parameters, most of the patients with type 1 diabetes studied showed inadequate glycemic and lipid control.

Economic cost associated with type II diabetes in Spanish patients.

An observational descriptive study was carried out of the healthcare resources consumed during 1 year by a sample of patients with type II diabetes of a healthcare area in southern Spain. A total of 517 patients with a mean duration of disease of 9.7+/-8 years were assessed. A total annual health cost of 4,278 euro/patient was calculated (direct 2,504 euro; indirect 1,774 euro). Multiple regression analysis showed an independent association between total costs and obesity, male sex, number of hospitalizations related to diabetes, permanent disability, macrovascular complications, and both micro- and macrovascular complications. Our findings confirm both the high economic cost associated with type II diabetes and the direct relationship between the costs of the disease and the presence of obesity, male sex, hospitalizations related to diabetes, permanent disability and chronic complications.

Increased hospital expenditures in diabetic patients hospitalized for cardiovascular diseases.

OBJECTIVES: To measure the impact of diabetes on hospital resource use and expenditures in patients hospitalized for cardiovascular diseases (CVD). RESEARCH DESIGN AND METHODS: We conducted an observational study of 4865 hospitalizations for CVD over 2 years (January 1998 to December 1999). Information with respect of the presence of diabetes mellitus, length of stay, readmissions, mortality, and costs were obtained through retrospective chart review. RESULTS: Diabetic patients accounted for 35.1% of hospital admissions (1706 admissions), 40.8% of hospital stays (23,309 days), and 39% of direct medical cost (5,735,884 euros). On average, diabetic patients had longer hospital stay (13.6+/-13.2 vs. 10.7+/-11.2 days; P<.001) and direct in-patient cost (3438+/-4308 vs. 2513+/-3384 euros; P<.001) and experienced more readmissions (relative risk: 1.67; 95% CI: 1.45-1.91) compared with nondiabetic patients. However, despite the hospital mortality rate being higher in nondiabetic patients (6.3% vs. 5.8%), these results were not statistically significant (relative risk: 1.09; 95% CI: 0.86-1.40). CONCLUSIONS: Diabetic patients hospitalized for CVD have longer hospital stay, greater risk of short-term readmission, and are more costly than nondiabetic patients. However, in-hospital mortality risk in patients hospitalized by CVD is no greater in diabetic than in nondiabetics.

Hospital discharge records under-report the prevalence of diabetes in inpatients.

The objective of our study was to estimate the hospital inpatient prevalence of diabetes mellitus in a Spanish tertiary care teaching hospital. We analyzed a cohort of 1036 patients consecutively admitted over a 7-day period to our hospital. We classified this total of hospitalized patients based on information obtained from individual analysis of medical history and values of plasma glucose after fasting, into groups with the following conditions: recognized diabetes, unrecognized diabetes, other hyperglycaemic situations, impaired fasting glucose (IFG) or non diabetes. One hundred and seventy-eight patients were estimated to have diabetes (total prevalence: 17.2%), including 158 patients with recognized diabetes and 20 patients with diabetes unrecognized before admission. Additionally, 25 patients were considered to have other hyperglycaemic situations and 20 patients were estimated to have IFG. The mean age of the diabetic patients was 65+/-13.7 years (50.5% men), and 94.4% had type 2 diabetes. Diabetes disproportionately affects the elderly inpatient, with a prevalence of 30.9% in people older than 64 years. Of the total number of patients with diabetes, only 144 (diabetes prevalence: 13.8%) were registered in hospital discharge records as having diabetes. We conclude that the extent of hospital diabetes prevalence considerably exceeds levels reported in the literature, suggesting that true diabetes prevalence in hospitals could be significantly under-reported, resulting in a serious underestimate of required expenditures.

Care resource utilization and direct costs incurred by people with diabetes in a Spanish hospital.

The objective of our study was to determine the hospital care resource utilization and direct medical costs incurred for in-patients with diabetes compared with non-diabetic in-patients. The data were obtained from the records division of the Puerta del Mar University Hospital, an 800-bed tertiary care hospital in Cádiz in the south of Spain. We assessed the rate of hospital admissions, length of stay, readmissions, mortality and costs for both diabetic and non-diabetic people. People with diabetes accounted for 10.9% of total hospital discharges (2453 discharges), 15.3% of total stays (30,771 days) and 16.1% of total cost (Euro 7,417,688). We estimated a hospitalization rate of 135 per 1000 persons with diabetes (compared with 95 per 1000 non-diabetic persons). Diabetic patients were hospitalized, on average, for 4 days longer than non-diabetic patients (12.5 +/- 14.5 (+/-SD) vs 8.5 +/- 10.6 days; P < 0.001) and had higher risks of readmission (RR: 2.29 (95% CI: 1.91-2.74)) and of mortality during the in-patient period (2.29 (1.91-2.74)) than non-diabetic patients. The overall hospitalization cost was significantly higher in diabetic (Euro 3023 +/- 3463) than in non-diabetic patients (Euro 1949 +/- 2528), 55% higher than the average general cost. We conclude that the hospital care resource utilization and economic burden due to diabetes mellitus in our hospital is substantial and disproportionate to the number of affected people.