Consensus-based recommendations on physical activity and exercise in patients with diabetes at risk of foot ulcerations: a Delphi study.

BACKGROUND: Patients with diabetes mellitus are exposed to important complications. Currently little evidence exist on the guidelines that these patients, at some risk of foot ulceration, should follow for physical exercise. OBJECTIVES: To reach a consensus among multidisciplinary and international experts on physical activity/exercise recommendations for patients with diabetes, according to foot ulcer risk. METHODS: Using a three-round Delphi method, a panel composed of 28 multidisciplinary experts in the management of diabetic foot assessed 109 recommendations on physical activity/exercise for patients with diabetes mellitus, according to their risk of foot ulcer. Consensus was assumed when 80% of responses matched the same category (agreement/disagreement). RESULTS: Twenty-nine experts participated in the first and second rounds of consultation, and twenty-eight did so in the third, reaching final agreement on 86 of the 109 recommendations considered (78.9%). The study, thus, generated a consensus set of recommendations concerning different aspects of diabetic footcare before, during, and after exercise (e.g. when to examine the foot, how to assess it, what type of sock and insole to use, what types of exercise to perform, and when it is advisable to return to activity after an ulceration). CONCLUSION: This Delphi study generated recommendations based on the consensus of international experts on physical activity and exercise by patient with diabetes at risk of ulceration. Recommendations considered the state of the foot and the patient's history and status before physical activity and included information on intensity, duration, frequency, and progressions of physical activity/exercise, and the use of custom-made plantar orthoses, shoe prescription, and the convenience of returning to physical activity after an ulceration.

Psychometric properties of the Clarke questionnaire for hypoglycemia awareness in the Spanish population with type 2 diabetes.

OBJECTIVES: The Clarke questionnaire, validated in Spanish language, assesses hypoglycemia awareness in patients with type 1 diabetes. This study aimed to analyze its psychometric properties in patients with type 2 diabetes (T2DM). METHODS: This was a questionnaire validation study. Patients with T2DM and treated with insulin, sulfonylureas or glinides were consecutively recruited from six endocrinology consultations and six primary care centers. The internal structure of the 8-item Clarke questionnaire was analyzed by exploratory (training sample) and confirmatory (testing sample) factor analysis; the internal consistency using Omega's McDonald coefficient; and goodness of fit with comparative fit index (CFI, cutoff >0.9), Goodness of Fit Index (GFI, cutoff >0.9), and root mean-square error of approximation (RMSEA, cutoff <0.09), as well as unidimensionality indicators. RESULTS: The 265 participants (56.8% men) had a mean age of 67.8 years. Confirmatory factor analysis for one dimension obtained poor indicators: fit test (p < 0.001); CFI = 0.748; RMSEA = 0.122 and SRMR = 0.134. Exploratory factor analysis showed 2 or 3 dimensions with poor adjustment indicators. Omega's McDonald was 0.739. CONCLUSIONS: The Spanish version of the Clarke questionnaire was not valid or reliable for assessing hypoglycemia awareness in people with T2DM in Spanish population.

C-Reactive Protein and Serum Albumin Ratio: A Feasible Prognostic Marker in Hospitalized Patients with COVID-19.

(1) Background: C-reactive protein (CRP) and albumin are inflammatory markers. We analyzed the prognostic capacity of serum albumin (SA) and CRP for an outcome comprising mortality, length of stay, ICU admission, and non-invasive mechanical ventilation in hospitalized COVID-19 patients. (2) Methods: We conducted a retrospective cohort study based on the Spanish national SEMI-COVID-19 Registry. Two multivariate logistic models were adjusted for SA, CRP, and their combination. Training and testing samples were used to validate the models. (3) Results: The outcome was present in 41.1% of the 3471 participants, who had lower SA (mean [SD], 3.5 [0.6] g/dL vs. 3.8 [0.5] g/dL; p < 0.001) and higher CRP (108.9 [96.5] mg/L vs. 70.6 [70.3] mg/L; p < 0.001). In the adjusted multivariate model, both were associated with poorer evolution: SA, OR 0.674 (95% CI, 0.551−0.826; p < 0.001); CRP, OR 1.002 (95% CI, 1.001−1.004; p = 0.003). The CRP/SA model had a similar predictive capacity (honest AUC, 0.8135 [0.7865−0.8405]), with a continuously increasing risk and cutoff value of 25 showing the highest predictive capacity (OR, 1.470; 95% CI, 1.188−1.819; p < 0.001). (4) Conclusions: SA and CRP are good independent predictors of patients hospitalized with COVID-19. For the CRP/SA ratio value, 25 is the cutoff for poor clinical course.

Clinical efficacy of urea treatment in syndrome of inappropriate antidiuretic hormone secretion.

The aim of this work is to examine our experience in the use of urea in patients with SIADH. Observational retrospective analysis of 48 patients with SIADH that have been treated with urea in a third-level hospital. Pre-post analysis of serum sodium levels. The 48 patients with SIADH had a median age of 78.5 (range 26-97 years). The serum sodium nadir was 119.8 ± 5.0 mmoL/L and at the beginning of treatment 125.6 ± 4.1 mmoL/L. The patients continued the treatment for a mean time of 2.95 ± 6.29 months, being the treatment still active in 4 patients. In all patients there was an improvement in serum sodium, being the final serum sodium at the end of treatment 134.4 ± 4.9 mmoL/L (p < 0.01). This improvement was observed from the first week. Adverse events were only detected in 2 patients with mild digestive symptomatology and 2 patients refused the treatment due to the low palatability of the urea. There was an economic cost reduction of 87.9% in comparison with treatment with tolvaptan. Urea has shown to be a safe and cost-effective option for the treatment of hyponatremia caused by SIADH.

Nutritional and Functional Impact of Acute SARS-CoV-2 Infection in Hospitalized Patients.

Aim: To assess the prevalence of malnutrition, frailty, and sarcopenia and the relationships between them in patients hospitalized for COVID-19. Methods: This was a cross-sectional study of the prevalence, determinants, and associations between malnutrition (GLIM 2019 criteria), sarcopenia (SARC-F scale, dynamometry, and calf circumference), and frailty (FRAIL scale) upon discharge following hospitalization for COVID 19. Results: A total of 101 patients (67.3% men, mean age 66.3 years) were recruited. Malnutrition was diagnosed in 49.5%, sarcopenia in 32.7%, and frailty in 28.7% of patients. Of the patients with malnutrition, 48% were also sarcopenic, and 42% were frail. There was a significant association between malnutrition and the severity of pneumonia according to the CURB-65 scale (odds ratio [OR] 2.61, p = 0.036), between sarcopenia and a Barthel score lower than 60 points (OR 29.52, p < 0.001), and between frailty and both a Barthel score lower than 60 points (OR 32.27, p < 0.001) and a length of hospital stay of over 30 days (OR 9.11, p = 0.008). Conclusions: Malnutrition, sarcopenia, and frailty are prevalent and interrelated entities in patients hospitalized for acute SARS CoV-2 infection, especially in patients with greater baseline functional impairment prior to admission and a higher infection severity.

Diabetes Does Not Increase the Risk of Hospitalization Due to COVID-19 in Patients Aged 50 Years or Older in Primary Care-APHOSDIAB-COVID-19 Multicenter Study.

The purpose of this study was to identify clinical, analytical, and sociodemographic variables associated with the need for hospital admission in people over 50 years infected with SARS-CoV-2 and to assess whether diabetes mellitus conditions the risk of hospitalization. A multicenter case-control study analyzing electronic medical records in patients with COVID-19 from 1 March 2020 to 30 April 2021 was conducted. We included 790 patients: 295 cases admitted to the hospital and 495 controls. Under half (n = 386, 48.8%) were women, and 8.5% were active smokers. The main comorbidities were hypertension (50.5%), dyslipidemia, obesity, and diabetes (37.5%). Multivariable logistic regression showed that hospital admission was associated with age above 65 years (OR from 2.45 to 3.89, ascending with age group); male sex (OR 2.15, 95% CI 1.47-3.15), fever (OR 4.31, 95% CI 2.87-6.47), cough (OR 1.89, 95% CI 1.28-2.80), asthenia/malaise (OR 2.04, 95% CI 1.38-3.03), dyspnea (4.69, 95% CI 3.00-7.33), confusion (OR 8.87, 95% CI 1.68-46.78), and a history of hypertension (OR 1.61, 95% CI 1.08-2.41) or immunosuppression (OR 4.97, 95% CI 1.45-17.09). Diabetes was not associated with increased risk of hospital admission (OR 1.18, 95% CI 0.80-1.72; p = 0.38). Diabetes did not increase the risk of hospital admission in people over 50 years old, but advanced age, male sex, fever, cough, asthenia, dyspnea/confusion, and hypertension or immunosuppression did.

["Working without patients": a new strategy to improve the glycemic control in patients with type 2 diabetes. Avoiding therapeutic inertia.] / "Trabajando sin pacientes": una nueva estrategia para mejorar el control glucémico en pacientes con diabetes mellitus tipo 2 evitando la inercia terapéutica.

OBJECTIVE: Inertia has been described as one of the causes of persistent poor glycemic control. The aim of this study was to evaluate, after one year of implementation in a health area, the effect of an intervention to improve the degree of glycemic control of patients with type 2 diabetes (DM2). METHODS: A pre-post intervention study was carried out in one health department during 2018. Health department with 222,767 inhabitants, 111 primary care physicians and 14,154 patients with DM2. Each primary care physician reviewed, outside consultation hours ("working without patients"), the electronic health record to identify patients with DM2 and with poor glycemic control, and they cited them for review. The glycemic control for the month of December 2017 and 2018 were compared, defined as the percentage of patients who reach the control objective of glycosylate hemoglobin (HbA1c). RESULTS: The proportion of patients with good glycemic control was 44.8% in 2017 and 50.1% in 2018, being the department that obtained the greatest improvement in the indicator in 2018 in the Valencian Community. The proportion of primary care physicians that had at least half of their patients with good glycemic control increased from 39% to 51% after the intervention. CONCLUSIONS: The strategy "working without patients" was associated with an improvement in the degree of glycemic control of patients with DM2.

OBJETIVO: La inercia se ha descrito como una de las causas de la persistencia del mal control glucémico. El objetivo del este estudio fue evaluar, tras un año de implantación en un área de salud, el efecto de una intervención para mejorar el grado de control glucémico de los pacientes con diabetes mellitus tipo 2 (DM2). METODOS: Estudio de intervención antes-después en un departamento de salud (área de salud) con 222.767 habitantes, 111 médicos de atención primaria y 14.154 pacientes con DM2. Cada médico de atención primaria revisó, fuera del horario de consulta ("trabajando sin pacientes"), la historia de salud electrónica para identificar pacientes con DM2 y con mal control glucémico, y los citaron para revisión. Se comparó el control glucémico del mes de diciembre de 2017 y 2018 definido como porcentaje de pacientes que alcanza objetivo de control de hemoglobina glicosilada (HbA1c). RESULTADOS: La proporción de pacientes con buen control glucémico fue de 44,8% en 2017 y 50,1% en 2018, siendo el departamento que obtuvo la mayor mejora del indicador en 2018 en la Comunidad Valenciana. La proporción de médicos de atención primaria que tenían al menos la mitad de sus pacientes con buen control glucémico pasó del 39% al 51% tras la intervención. CONCLUSIONES: La estrategia "trabajando sin pacientes" se asoció a una mejora del grado de control glucémico de los pacientes con DM2.

Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain / Escala de adherencia terapéutica Morisky: validación y propiedades psicométricas en pacientes con diabetes tipo II en España

AIMS: To validate a translated and culturally adapted version of the Morisky Medication Adherence Scale for use in Spanish population, and to examine the psychometric properties of this scale in patients with type 2 diabetes mellitus in Spain. DESIGN: This cross-sectional study was conducted in a single university hospital in Spain. Patients diagnosed with type 2 diabetes mellitus at least 1 year before inclusion, being treated with anti-diabetic medication were included. Intervention: We used the Spanish version of the scale to measure treatment adherence. Principal measurements: three level categorical scale is broken down into low adherence (score of < 6), medium adherence (score of 6 to < 8) and high adherence (score of 8). To validate the questionnaire, we measured internal consistency through Cronbach's α, confirmed construct validity through an exploratory principal component analysis and assessed test-retest reliability. RESULTS: 232 patients met the inclusion criteria. The Cronbach's α coefficient was 0.40 (95% CI 0.28-0.52). The exploratory principal component analysis showed three components. The intraclass correlation coefficient was 0.718 (95% CI 0.564-0.823). CONCLUSIONS: the Spanish version of the Morisky Medication Adherence scale showed low internal consistency, the exploratory factor analysis identified three dimensions, and the test-retest reliability was acceptable, therefore, psychometric properties of MMAS-8 are not suitable for measuring medication adherence in type 2 diabetes mellitus patients from Spain

OBJETIVO: Validar la herramienta de adherencia terapéutica de Morisky tras una adaptación cultural y lingüística para su uso en la población española, y examinar sus propiedades psicométricas en pacientes con diabetes mellitus tipo 2 en España. DISEÑO: Se realizó un estudio transversal en un hospital universitario en España. PARTICIPANTES: Se incluyeron pacientes diagnosticados de diabetes mellitus tipo 2 al menos un año antes del estudio y tratados con antidiabéticos orales. Intervención: Se utilizó la versión traducida de la escala para medir la adherencia al tratamiento. Mediciones principales: Nivel de adherencia categorizado a través de 3 escalas, baja (< 6 puntos), media (6 a < 8 puntos) o alta (8 puntos). La consistencia interna del cuestionario se evaluó a través del coeficiente α de Cronbach, y se realizó un análisis exploratorio de los componentes principales para confirmar la validez del constructo, y se evaluó la fiabilidad a través del test-retest. RESULTADOS: Doscientos treinta y dos pacientes cumplieron con los criterios de inclusión. El coeficiente α de Cronbach era 0,40 (IC 95%: 0,28-0,52). El análisis exploratorio mostró 3 componentes principales. El coeficiente de correlación intraclase era de 0,718 (IC 95%: 0,564-0,823). CONCLUSIONES: La versión adaptada de la escala de adherencia terapéutica de Morisky mostró una consistencia interna baja, el análisis factorial exploratorio identificó 3 dimensiones y la fiabilidad test-retest fue aceptable, por lo tanto, las propiedades psicométricas de MMAS-8 no son adecuadas para medir la adherencia a la medicación en pacientes con diabetes mellitus tipo 2 en España

Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain.

AIMS: To validate a translated and culturally adapted version of the Morisky Medication Adherence Scale for use in Spanish population, and to examine the psychometric properties of this scale in patients with type 2 diabetes mellitus in Spain. DESIGN: This cross-sectional study was conducted in a single university hospital in Spain. Patients diagnosed with type 2 diabetes mellitus at least 1 year before inclusion, being treated with anti-diabetic medication were included. INTERVENTION: We used the Spanish version of the scale to measure treatment adherence. PRINCIPAL MEASUREMENTS: three level categorical scale is broken down into low adherence (score of <6), medium adherence (score of 6 to <8) and high adherence (score of 8). To validate the questionnaire, we measured internal consistency through Cronbach's α, confirmed construct validity through an exploratory principal component analysis and assessed test-retest reliability. RESULTS: 232 patients met the inclusion criteria. The Cronbach's α coefficient was 0.40 (95% CI 0.28-0.52). The exploratory principal component analysis showed three components. The intraclass correlation coefficient was 0.718 (95% CI 0.564-0.823). CONCLUSIONS: the Spanish version of the Morisky Medication Adherence scale showed low internal consistency, the exploratory factor analysis identified three dimensions, and the test-retest reliability was acceptable, therefore, psychometric properties of MMAS-8 are not suitable for measuring medication adherence in type 2 diabetes mellitus patients from Spain.

Hospital admissions trends for severe hypoglycemia in diabetes patients in Spain, 2005 to 2015.

AIMS: To analyze hospital admissions trends, inpatient mortality, and mean length of hospital stay due to hypoglycemia in patients with diabetes in Spain from 2005 to 2015. METHODS: National Institute of Statistics provided information on hospital discharge and mortality. Hospital admissions due to severe hypoglycemia were identified using ICD-9 codes. Age-adjusted admission and mortality rates were stratified by sex and year. Joinpoint regression models were used to estimate trends. RESULTS: Admissions rates per 100,000 population were higher for men than women in 2005 (30.2, 95%CI:29.3, 31.0 versus 21.5, 95%CI:20.9, 22.1) and 2015 (23.7, 95%CI:23.0, 24.4 versus 13.2, 95%CI:12.7, 13.6). Mortality per 100,000 population was also higher for men in both years (2005: 9.4, 95%CI:7.8, 11.0 versus 8.6, 95%CI:7.4, 9.8; 2015: 6.4, 95%CI:5.3, 7.6 versus 4.1, 95%CI:3.3, 4.8). Mortality dropped 5.2 percentage points annually (95%CI:-8.4, -1.9) in men and 7.0 percentage points annually (95%CI:-8.7, -5.2) in women from 2005 to 2015. Mean length of hospital stay changed only for women: 7.8 days (95%CI:7.5, 8.0) to 6.7 days (95%CI:6.4, 6.9). CONCLUSIONS: Hospital admissions and inpatient mortality due to hypoglycemia in diabetes patients decreased from 2005 to 2015. This trend was more pronounced in women. Mean length of hospital stay decreased in women.

Variability in the clinical diagnosis of diabetic peripheral neuropathy.

AIMS: The aims of this study are to assess the variability in the prevalence of diabetic peripheral neuropathy (DPN), according to the diagnostic and clinical guidelines used. METHODS: A cross-sectional observational study was conducted of 111 patients with diabetes mellitus. The presence/absence of DPN was determined according to 12 different criteria stipulated in various clinical guidelines (ADA 2018, IWGDF 2016, IDF 2012 and CONUEI 2018). The Cohen's kappa coefficient (κ) was performed to determine the degree of agreement for DPN diagnosis among the different criteria. RESULTS: The recorded prevalence of DPN ranged from 13.1% (criterion ADA 2018) to 68.5% (criterion IDF 2012). The sensory parameter that was most commonly affected was the non-perception of vibration (68.5%) and the absence of Achilles reflexes (59.4%). IWGDF, based on the use of a monofilament, cotton wisp and tuning fork, was the test with more agreements, presenting good agreement with 2 criteria from ADA 2018 (k=0.845), 1b2 (k=0.817), 2 criteria from IWGDF 2016 (k=0.933), (k=0.817), 1 criteria from IDF 2012 (k=0.845) and 1 criteria from CONUEI 2018 (k=0.860), all p<0.001. CONCLUSION: The IWGDF criterion based on the use of a monofilament, cotton wisp and tuning fork for the diagnosis presented the highest level of concordance with the other criteria (>0.8).

Predictive model to identify the risk of losing protective sensibility of the foot in patients with diabetes mellitus.

Diabetic neuropathy is defined as the presence of symptoms and signs of peripheral nerve dysfunction in diabetics. The aim of this study is to develop a predictive logistic model to identify the risk of losing protective sensitivity in the foot. This descriptive cross-sectional study included 111 patients diagnosed with diabetes mellitus. Participants completed a questionnaire designed to evaluate neuropathic symptoms, and multivariate analysis was subsequently performed to identify an optimal predictive model. The explanatory capacity was evaluated by calculating the R2 coefficient of Nagelkerke. Predictive capacity was evaluated by calculating sensitivity, specificity, and estimation of the area under the receiver operational curve. Protective sensitivity loss was detected in 19.1% of participants. Variables associated by multivariate analysis were: educational level (OR: 31.4, 95% CI: 2.5-383.3, P = .007) and two items from the questionnaire: one related to bleeding and wet socks (OR: 28.3, 95% CI: 3.7-215.9, P = .001) and the other related to electrical sensations (OR: 52.9, 95% CI: 4.3-643.9, P = .002), which were both statistically significant. The predictive model included the variables of age, sex, duration of diabetes, and educational level, and it had a sensitivity of 81.3% and a specificity of 95.5%. This model has a high predictive capacity to identify patients at risk of developing sensory neuropathy.