Validity and reliability of 1-h automated office blood pressure measurement for the diagnosis of hypertension.

AIMS: The objective of this study was to examine the validity of 1 h automated office blood pressure measurement for the diagnosis of hypertension. METHODS: We included patients requiring a hypertension diagnostic test. Participants underwent ambulatory blood pressure monitoring, 1 h automated office blood pressure measurement, office blood pressure measurement and home blood pressure monitoring. The prevalence of hypertension and subtypes were calculated. Mean values of ambulatory blood pressure monitoring were compared with 1 h automated office blood pressure measurement using the correlation coefficient and Bland-Altman graphs. The Kappa concordance index, sensitivity, specificity and diagnostic accuracy were calculated, and the area under the receiver operating characteristic curve was used to establish the diagnostic threshold of the 1-h measurement. RESULTS: Of 562 participants, 438 (87.6%) completed the four diagnostic methods. The 1-h method had a sensitivity of 76.6 [95% confidence interval (95% CI): 71.1-81.5], a specificity of 64.8% (95% CI: 57-72.1) and the best diagnostic accuracy (72.1%, 95% CI: 67.7-76.3) compared with the office and home measurements. Moderate-high correlations were observed between DBP (r = 0.73) and SBP (r = 0.58) readings. The 1-h method classified more patients as normotensive (24.4%) and fewer patients with white-coat hypertension (13.3%). A diagnostic threshold of at least 133/83 mmHg for the 1-h method could improve diagnostic accuracy by 2.3%. CONCLUSION: One-hour automated blood pressure measurement is a valid, reliable method for the diagnosis of hypertension in undiagnosed patients. The diagnostic accuracy permits detection of white-coat and masked hypertension. To diagnose hypertension, the 1-h method or conventional home blood pressure monitoring should be used rather than office measurements. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03147573.

Frequency and awareness of hypoglycemia in patients with Type 2 Diabetes treated with two or more insulin injections in primary care outpatient clinics.

AIMS: To assess the frequency of hypoglycemia events, patient characteristics and the prevalence of impaired awareness of hypoglycemia (IAH) in patients with Type 2 Diabetes (T2D) using two or more insulin injections in primary care. METHODS: Cross-sectional study performed at 9 Primary Care Centers including review of electronic medical records and an on-site visit to patients using >2 insulin injections with suboptimal control. Episodes of severe hypoglycemia (SH) in the last 12months were recorded. Non-severe hypoglycemia (NSH) was considered as self-monitoring blood glucose <70mg/dl. IAH was evaluated and HbA1c was obtained. RESULTS: 157 subjects were included (age 68.4+10.7years, 82 women, T2D duration 18.3+8.7years). 57% used multiple daily injections. Total insulin was 66.9+43.4 units/day. The mean HbA1c was 9.2±1.4% (77±12mmol/mol) and only 13.4% had HbA1c <8% (64mmol/mol). The frequency of NSH was 0.74±1.37 episodes/week. Only one patient had a SH the last 12months. Around 10-12% of patients had IAH. In comparison with normal awareness, those with IAH had a longer duration of T2D (25.3±11.6 vs. 16.1±8.2 years, respectively, p<0.01). In the multiple linear regression analysis, only the IAH score and the total insulin dose independently determined the NSH number. CONCLUSIONS: NSH/SH in patients with T2D treated with two or more insulin injections in primary care settings seems to be relatively common. Although hypoglycemia awareness is predominantly preserved, the presence of IAH should not be ignored as it increases the risk of hypoglycemia and constitutes an additional barrier to recognize and address this burden in T2D.

Effectiveness of a new one-hour blood pressure monitoring method to diagnose hypertension: a diagnostic accuracy clinical trial protocol.

INTRODUCTION: 24-hour ambulatory blood pressure monitoring (ABPM) is the gold standard diagnostic method for hypertension, but has some shortcomings in clinical practice while clinical settings often lack sufficient devices to accommodate all patients with suspected hypertension. Home blood pressure monitoring (HBPM) and office blood pressure monitoring (OBPM) also have shortcomings, such as the white coat effect or a lack of accuracy. This study aims to study the validity of a new method of diagnosing hypertension consisting of monitoring blood pressure (BP) for 1 hour and comparing it with OBPM and HBPM and examining the sensitivity and specificity of this method compared with 24-hour ABPM. The patient experience will be examined in each method. METHODS AND ANALYSIS: A minimum sample of 214 patients requiring a diagnostic test for hypertension from three urban primary healthcare centres will be included. Participants will undergo 24-hour ABPM, 1-hour BP measurement (1-BPM), OBPM for three consecutive weeks and HBPM. Patients will follow a random sequence to first receive 24-hour ABPM or 1-hour ABPM. Daytime 24-hour ABPM records will be compared with the other monitoring methods using the correlation coefficient and Bland Altman plots. The kappa concordance index and the sensitivity and specificity of the methods will be calculated. The patient's experience will be studied, with selected indicators of efficiency and satisfaction calculated using parametric tests. ETHICS AND DISSEMINATION: The protocol has been authorised by the research ethics committee of the Hospital Clinic of Barcelona (Ref. HCB/2014/0615): protocol details and amendments will be recorded and reported to ClinicalTrials.com. The results will be disseminated in peer-reviewed literature, and to policy makers and healthcare partners. TRIAL REGISTRATION: NCT03147573; Pre-results.

Health care and therapeutic education program for newly diagnosed type 2 diabetes: A new approach in primary care. / Programa de atención y educación terapéutica en el debut de la diabetes tipo 2: un nuevo modelo de abordaje en atención primaria.

INTRODUCTION: Despite the favorable evidence available, our public health care system has no specific programs including therapeutic education for patients newly diagnosed with type 2 diabetes (T2DM), which would be crucial for the subsequent course of the disease. OBJECTIVES: To assess the effectiveness of a "Health care and Therapeutic Education Program for newly diagnosed type 2 diabetes (PAET-Debut DM2)" agreed by the primary care centers and the reference hospital in a given geographical area. METHODS: A prospective pilot study in patients over 18 years of age diagnosed with T2DM between February 2012 and 2013. The PAET-DebutDM2 is planned and set up in four primary care centers in the area covered by Hospital Clínic in Barcelona. Reference persons (family doctor and nurse) are designated at each center and specific training is provided to standardize the clinical processes and therapeutic education methods. First results are assessed and compared at 6 and 12 months. RESULTS: The program was proposed to 345 patients, of which 191 (55.3%) were enrolled in it and 134 (70.2%) completed the program. At the end of the program, 84% achieved the control goal (HbA1c <7%) and 88% passed the screening of chronic complications. Improvements were seen in body weight, physical activity (p<0,001), and disease awareness (p<0.05), and there were less hospital emergencies due to DM as compared to patients not included in the program (p=0.023). CONCLUSION: The PAET-DebutDM2 standardizes intervention and education and is effective in terms of clinical and educational results and patient satisfaction. The program emphasizes the importance of early education and intervention, reorganizing resources without increasing care pressure in the primary care centers, thus reducing hospital care.

Psychometric analysis of the Spanish and Catalan versions of the Diabetes Self-Care inventory-revised version questionnaire.

BACKGROUND: The purpose of this study was to validate the Spanish and Catalan versions of the Diabetes Self-Care Inventory-Revised Version (SCI-R) questionnaire to assess the degree of adherence to self-care among adults with diabetes. METHODS: We validated the Spanish and Catalan translation from, and back translation to, English and cultural adaptation of the SCI-R in type 1 diabetes patients on multiple insulin doses or continuous subcutaneous insulin infusion and in type 2 diabetes patients on oral agents and/or insulin. Internal reliability, structural validity, and external validity (correlation with glycated hemoglobin) were evaluated. Responsiveness to change was assessed in patients 1 year after onset of type 1 diabetes and following a structured education program. RESULTS: The SCI-R presented good internal reliability Cronbach's α: 0.75, test-retest reliability (r = 0.82) and structural validity (r > 0.40). The external validity was also good; the SCI-R correlated with HbA1c in patients with type 1 diabetes on multiple insulin doses (r = -0.50) or continuous subcutaneous insulin infusion (r = -0.66) and in patients with type 2 diabetes on multiple insulin doses (r = -0.62). However, it was not satisfactory in patients on oral agents (r = -0.20) and/or bedtime insulin (r = -0.35). Responsiveness to change was analyzed in 54 patients (age 27.3±7.4 years, 26% men, HbA1c 6.8% ±1.1%); the SCI-R score was 72.3% ±13.7% and correlated negatively with glycated hemoglobin (r = -0.42) and 3 scales of the Diabetes Quality of Life questionnaire (lower score indicating better perception): Impact (r = -0.37), Social Worry (r = -0.36) and Diabetes Worry (r = -0.38), all at P < 0.05. CONCLUSION: The Spanish and Catalan versions of the SCI-R questionnaire show good psychometric properties and both could be considered as useful tools for evaluating self-care behavior in patients with type 1 or type 2 diabetes. However, there are still some subgroups of patients with type 2 diabetes in which the validity of this questionnaire needs further evaluation.

[Administration of insulin. New recommendations]. / Administración de insulina. Nuevas recomendaciones.

Covered by the new recommendations on the technique of administration of insulin released by a group of experts from different countries (Consensus TITAN) and different types of insulin and incretin GLP1 mimetics marketed in the Spanish market and devices for administration. The purpose is to keep health professionals, especially nurses, on the proper technique for administering insulin, due to the continuous changes of insulin therapy has been introduced in recent decades in their kinetics of action and route of administration. In reference to the technique in the administration of insulin, taking into account the different areas recommended for subcutaneous injection, the needle length and local secondary problems that may arise related to the administration of insulin.