Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire.

BACKGROUND: Hypoglycemia is a limiting factor to achieving optimal glycemic control in patients with type-2 diabetes mellitus (T2DM), increasing risk of death and complications, reducing health-related quality of life (HRQoL) and work productivity and increasing healthcare costs. The study's primary objective was to develop and validate a specific questionnaire to assess the impact of hypoglycemia on the HRQoL of T2DM patients (QoLHYPO© questionnaire). METHODS: A two-phase multicenter prospective, longitudinal, observational, epidemiologic study of consecutively enrolled patients, not involving any drug, was conducted: In phase 1 (questionnaire development), patients who had given their written informed consent, who were at least 30 years of age, had been diagnosed with T2DM at least 5 years prior, had an HbA1c test in the previous 3 months, and a hypoglycemic episode in the previous 6 months were included. To validate the questionnaire and assess reliability and responsiveness, phase 2 included two cohorts of patients. Patients in the reliability cohort would likely have stable clinical course during the 3 weeks following inclusion in the study and patients in the responsiveness cohort would likely experience changes in their clinical course in the 3 months after enrollment. RESULTS: Phase 1 included 168 patients: 10 attended semi-structured interviews, 18 for face validity, and 140 for the pilot test (Rasch analysis). Phase 2 included 227 patients: 142 in the reliability cohort and 85 in the responsiveness cohort. Of the 37 items initially included in Phase 1, 11 (floor/ceiling effect analysis) and 13 (Rasch analysis) were discarded. The final version of the questionnaire consisted of 13 items. Phase 2 results showed the questionnaire was unidimensional and able to accurately assess HRQoL. Intra-observer reproducibility (ICC = 0.920) and internal consistency (Cronbach's alpha: visit 1 = 0.912; visit 2 = 0.901) were high, showing high reliability. Internal responsiveness was moderate (standardized effect size 0.5-0.8) and external responsiveness was lower (AUC > 0.5; not statistically significant). Minimal clinically important difference (MCID) was estimated to be 3.2 points. CONCLUSIONS: The QoLHYPO© questionnaire is a tool that can be used in routine clinical practice to assess the impact of hypoglycemia on the HRQoL of T2DM patients.

[Continuous monitoring systems of glucose]. / Sistemas de monitorización continua de la glucosa.

The possibility of obtaining a continuous reading of glucose may represent a breakthrough and a useful tool for the management of diabetes. Technological advances can improve the quality of life and people with diabetes metabolic control, even if this means having to learn and incorporate new technical concepts, new algorithms for pattern modification and new challenges in Therapeutic Education.

[Therapeutic education didactic techniques]. / Técnicas didácticas en educacíon terapéutica.

This article includes an introduction to the role of Therapeutic Education for Diabetes treatment according to the recommendations of the American Diabetes Association (ADA), the Diabetes Education Study Group (DESG) of the "European Association for Study of Diabetes (EASD) and the clinical Practice Guidelines (CPG) of the Spanish Ministry of Health. We analyze theoretical models and the differences between teaching vs. learning as well as current trends (including Internet), that can facilitate meaningful learning of people with diabetes and their families and relatives. We analyze the differences, similarities, advantages and disadvantages of individual and group education. Finally, we describe different educational techniques (metaplan, case method, brainstorming, role playing, games, seminars, autobiography, forums, chats,..) applicable to individual, group or virtual education and its application depending on the learning objective.

[Medical nutritional therapy and therapeutic patient education in diabetes]. / Terapia médico-nutricional y educación terapéutica en la diabetes.

This article includes an introduction to the current approach to dietary treatment of diabetes. Are provided the nutritional recommendations to primary secondary and tertiary prevention of diabetes, as recommended by the American Diabetes Association (ADA) adapted to different types of diabetes, treatments and special situations. Secondly, it introduces the concept of Therapeutic Education, especially education and nutritional diet for persons with diabetes and their families, the educational objectives in food according to type of diabetes type 1 or type 2 in different treatment modalities and educational strategies recommended by the Diabetes Education Study Group (wear) of the European Association for the Study of Diabetes (EASD) to facilitate better adherence to dietary treatment.

[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.

Development of the professional role of diabetes nurses in specialised diabetes and primary care in Catalonia.

OBJECTIVES: The aim of this study was to describe therapeutic education programmes in diabetes in Catalonia and the differences according to the healthcare setting in which the patients are attended (primary care [PC] and specialised diabetes care [SDC]). METHOD: We performed a descriptive, cross-sectional, comparative study of diabetes nurses (DN) in SDC and PC in Catalonia. The sample was obtained from all the DN in SDC and a randomised cluster sample of DN in PC. The questionnaire of the Study of European Nurses in Diabetes (SEND) validated in Spanish was used. RESULTS: A total of 287 questionnaires were analysed (24.3% SDC and 75.6% PC). More training in diabetes through masters, postgraduate courses and continuing education was observed in SDC (p<0.001) as well as structured, written, education programmes and the combination of individual and group education strategies (p<0.05). The roles of educator, consultant, researcher, manager, liaison or collaborator and innovator and the telematic follow-up of patients was also more developed in SDC (p<0.05). The grade of work satisfaction was elevated in both groups. CONCLUSIONS: (1) Nursing professionals in SDC assume more roles of specialised clinical nursing and also have more training in diabetes and therapeutic education than PC professionals. (2) Professionals in SDC work with a greater proportion of structured diabetes therapeutic education programmes although this should improve in both settings. According to the results obtained and the scientific evidence currently available, the training of DN working in the care of people with diabetes should be accredited in order to increase the use of structured programmes and investigation by DNs in both healthcare settings.

Hypoglycaemia unawareness in young people with type 1 diabetes transferred to an adult center. / Hipoglucemia desapercibida en jóvenes con diabetes tipo 1 trasladados a un centro de adultos.

OBJECTIVE: To evaluate frequency of hypoglycaemia unawareness (HU) in patients with type 1 diabetes (T1D) transferred from Paediatrics following a specific therapeutic education programme (TEP) in an adult hospital. PATIENTS AND METHODS: Young patients transferred from 2009-2011 were evaluated. The TEP included a coordinated transfer process, individual appointments and a group course. At baseline and at 12 months we evaluated glycated haemoglobin (HbA1c) frequency of severe (SH) hypoglycaemia/patient/year and non severe hypoglycaemia (NSH). The patients were classified into two groups and compared: hypoglycaemia awareness (HA) and HU according to the Clarke Test <3R or>3R respectively. RESULTS: Fifty-six patients (age 18.1±0.3 years, 46% females, HbA1c 8.0±1.2%) underwent the TEP. In the baseline evaluation 16% presented HU. The number of SH was higher in the HU Group (0.33±0.50 vs. 0.09±0.28 P<.05). The percentage of patients with>2 NSH/week was higher, albeit not significantly, in the HU group (66% vs. 34%, p=0.06). At 12 months 11% of the patients continued to present HU. The number of SH remained higher in the HU group (0.38±1.06 vs. 0.02±0.15 P=.04). CONCLUSIONS: The percentage of young people with T1D with HU is quite high at transfer. Although the TEP improves hypoglycaemia awareness it does not solve this important problem. Patients with HU more frequently present SH. It is necessary to identify HU in order to reduce SH which continues to be a problem in people with T1D.

Mobile Health Projects in a High-Complexity Reference Hospital: Case Study.

BACKGROUND: The widespread adoption of mobile and wearable devices and apps makes it essential to assess their possible impact on the management of health and diseases. Health care providers (HCPs) find themselves faced with a new situation in their setting with the proliferation of mobile health (mHealth) intervention tests. Few studies have addressed the development of mHealth and the methodologies to manage these apps in a tertiary hospital. OBJECTIVE: The aim of this study was to evaluate the mHealth projects implemented in the Hospital Clínic of Barcelona to increase awareness of the context in which they are used and to develop policies for the development of good practice in mHealth innovation. METHODS: A prospective, descriptive cross-sectional study was conducted in a highly specialized university hospital with 850 beds for adults and a reference population of 520,000 inhabitants. A specific questionnaire was developed based on the Mobile Health 5 Dimensions European (MOHE 5D-EU) theoretical model to find mHealth projects. Apps, telemedicine, and wearable devices were included in the systematic search. For that purpose, a vertical (top-down) email-based snowball process was conducted. Data were collected from February to December 2018 by conducting personal interviews with HCPs using a structured questionnaire. RESULTS: During the study period, 45 interviews were conducted; 35 mHealth initiatives were found, with 25 targeted to patients and 10 to health professionals. Most mHealth initiatives (34/35, 97%) were related to the software field (apps and telemedicine initiatives), and one was related to wearable devices. Among the projects, 68% (24/35) were classified as medical devices or developments at the edge (developments susceptible to limitations depending on the intended use). In relation to data protection, 27 initiatives managing personal data (27/35, 77%) considered data protection legislation. Only 9% (3/35) of the initiatives had foreseen the use of interconnectivity standards. Most of the initiatives were funded by grants (14/35, 40%), sponsorships (5/35, 14%), or the hospital itself (5/35, 14%). In terms of clinical management, most projects were developed in the field of research, followed by professional tools, clinical information, and therapeutic education. Only 6 projects were involved with health care; all were led by either the industry or small and medium enterprises. CONCLUSIONS: This study helped create the design of a map of the mHealth projects conducted in our hospital that showed the stages of development of the different ongoing projects. This will allow monitoring of mHealth projects and construction of tools to reinforce areas with detected deficiencies. Our theoretical approach using a modified MOHE 5D-EU model was found to be useful for analyzing the characteristics of mHealth projects.

Role of musculoskeletal disorders as concurrent chronic conditions: are they underestimated in the discharge?

BACKGROUND: Differences in recording concurrent chronic conditions (CCs) could change the weight of the influence of the different CCs on health status. OBJECTIVES: To determine the role of musculoskeletal disorders as concurrent CCs. METHODS: Cross-sectional study. Discharged patients with CCs were selected by random stratification. Sociodemographic and clinical variables, health status (SF-36), type and number of self-reported and hospital discharge summary CCs were recorded. Relationships were analyzed using linear regression models. RESULTS: In the 227 patients included, mean self-reported CCs were 6.22 (SD 3.37) and mean hospital discharge CCs were 3.1 (SD 1.95). The most-frequent self-reported CCs were hypertension 48.4%, back pain 40.4%, neck pain 39.6%, and musculoskeletal disorders 38.4%. The most frequent discharge CCs were arterial hypertensive disease 38.3%, all cancers 22.0%, ischemic heart diseases, and angina 15.9%. Musculoskeletal disorders had the greatest negative influence on SF-36 dimensions (p < 0.05). CONCLUSIONS: Musculoskeletal disorders were underestimated in the discharge summary in comparison with those reported by patients.

[Therapeutic education regarding type 1 diabetes (DM1)]. / Educación terapéutica ante la diabetes tipo 1 (DM1).

This article presents an introduction to diabetes and the problems associated with diabetes as well as scientific evidence on how to prevent or retard chronic complications diabetes causes by means of optimizing a diabetes sufferer's metabolic control. The authors make reference to one of the most important studies by The Diabetes Control and Complications Trial-DCCT which has signified a before and an after in the treatment of type 1 diabetes mellitus (DM1). Focusing on the treatment of diabetes with continuous subcutaneous insulin injection (CSII), the authors describe 1) Patients who are candidates for this treatment according to scientific associations; 2) Characteristics and functioning methods for insulin delivery systems as well as the different models of insulin delivery systems, catheters, needles and commercial inserting mechanisms presently available in Spain. The authors report on the experiences that the diabetes team at the Barcelona "Hospital Clinic" have with CSII therapy The authors describe the structure of a Therapeutic Educational Program directed at patients suffering from DM1 who are candidates for CSII therapy the process which these patients follow and the results of this program, evaluated after two years of follow-up study.

The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study.

OBJECTIVE: This study evaluated the impact of an Internet-based telematic system on the economic and clinical management of patients with type 1 diabetes mellitus. RESEARCH DESIGN AND METHODS: This 6-month prospective, randomized, comparative, open, multicenter study included patients with type 1 diabetes >18 years old treated with multiple insulin doses and with a glycated hemoglobin (HbA1c) level of >8%. We compared an intervention group (IG) (two face-to-face and five telematic appointments) with a control group (CG) (seven face-to-face appointments). The variables studied were (1) patient and healthcare team costs, (2) metabolic control, (3) knowledge of diabetes, (4) quality of life, and (5) self-care treatment adherence. RESULTS: Of the 154 patients included, 118 (76.6%) completed the study (IG, 54; CG, 64). The time used by the CG to follow the program was 823±645 min versus 353±222 min in the IG (P<0.0001). Compared with the CG, the IG required less healthcare time from the professionals (288±105 min vs. 232±89 min; P<0.001). HbA1c improved in both groups (IG, 9.2±1.5% [77.0±17.0 mmol/mol] vs. 8.7±1.5% [71.6±17.0 mmol/mol] [P<0.001]; CG, 9.2±0.9% [77.0±10.0 mmol/mol] vs. 8.6±0.9% [70.5±10.0 mmol/mol] [P<0.001], as did knowledge and self-care treatment adherence. CONCLUSIONS: The use of interactive telematic appointments in subjects with type 1 diabetes and inadequate metabolic control is an efficient strategy, providing results comparable to those of face-to-face appointments in relation to improvement in glycemic control, knowledge acquisition, and self-care treatment adherence, with a significant reduction in the time used, especially by patients.

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.

Multidimensional analysis of treatment adherence in patients with multiple chronic conditions. A cross-sectional study in a tertiary hospital.

OBJECTIVE: Determine treatment adherence in patients with multiple chronic conditions (MCC). METHODS: A random patient sample ≥ 15 years, discharged from hospital with ≥1 chronic conditions (CC) was interviewed after 6-12 months. Analysis included variables in 5 dimensions (WHO): socio-demographics, disease, treatment, patient and health system characteristics. Morisky-Green adherence questionnaire was used. High chronic treatment complexity was defined as: >3 pills/day, >6 inhalations/day, >1 injection/day, pharmacological treatment plus diet or self-monitoring techniques. RESULTS: 301 patients were interviewed (62 ± 15 years, 59% males). Despite good treatment information perception (79%), only 3% followed the patient education programme. Poor adherents (82%) were older (64 ± 14 years vs. 55 ± 16 years), had more CC (3.25 ± 2.02 vs. 2.62 ± 2.72), a higher frequency of hypertension (44% vs. 15%), ischaemic heart diseases: (21% vs. 4%), hyperlipidaemia (19% vs. 6%), more pills/day (5.78 ± 4.14 vs. 3.20 ± 4.70) and more complex treatments (95% vs. 70%) (p<0.05). On multivariate analysis number of CC [3.68 (0.75-18.15)], pills/day [2.23 (1.02-4.84)], treatment complexity [4.00 (1.45-11.04)], and hypertension [2.57 (1.06-6.25)] were predictive of poor adherence (OR 95% CI p<0.05). CONCLUSION: The WHO conceptual framework allows the construction of poor adherence risk profiles in patients with MCC after hospital discharge. PRACTICE IMPLICATIONS: Predictive variables of poor adherence could help clinicians detect patients with MCC most likely to present poor adherence.