EURADOS project on the impact of the proposed ICRU operational dose quantities.

Following the publication of the joint The International Commissions on Radiation Units and Measurements (ICRU) and on Radiological Protection (ICRP) report on new operational quantities for radiation protection, the European Dosimetry Group (EURADOS) have carried out an initial evaluation. The EURADOS report analyses the impact that the new quantities will have on: radiation protection practice; calibration and reference fields; European and national regulation; international standards and, especially, dosemeter and instrument design. The task group included experienced scientists drawn from across the various EURADOS working groups.

Primate richness and abundance is driven by both forest structure and conservation scenario in Costa Rica.

Variation in tropical forest management directly affects biodiversity and provisioning of ecosystem services on a global scale, thus it is necessary to compare forests under different conservation approaches such as protected areas, payments for ecosystem services programs (PES), and ecotourism, as well as forests lacking any formal conservation plan. To examine the effectiveness of specific conservation approaches, we examined differences in forest structure and tree recruitment, including canopy cover; canopy height; seedling, sapling, and adult tree density; and average and total diameter at breast height (DBH) across 78 plots in 18 forests across Costa Rica representing protected areas, private forests utilizing PES and/or ecotourism, and private forests not utilizing these economic incentives. The effectiveness of conservation approaches in providing suitable primate habitat was assessed by conducting broad primate census surveys across a subset of eight forests to determine species richness and group encounter rate of three primate species: mantled howler monkey (Alouatta palliata), Central American spider monkey (Ateles geoffroyi), and the white-faced capuchin monkey (Cebus imitator). Only canopy height was significantly different across the three approaches, with protected areas conserving the tallest and likely oldest forests. Canopy height was also significantly associated with the group encounter rate for both mantled howler and spider monkeys, but not for capuchins. Total group encounter rate for all three monkey species combined was higher in incentivized forests than in protected areas, with capuchin and howler monkey group encounter rates driving the trend. Group encounter rate for spider monkeys was higher in protected areas than in incentivized forests. Incentivized conservation (PES and ecotourism) and protected areas are paragons of land management practices that can lead to variation in forest structure across a landscape, which not only protect primate communities, but support the dietary ecologies of sympatric primate species.

Outcomes of older COVID-19 patients in Acute Care at Home, Southern HSC Trust, Northern Ireland, from March - June 2020.

INTRODUCTION: The older population has been most affected by COVID-19, with mortality rates of around 27%. The Acute Care at Home (ACAH) team aims to improve outcomes in the older population by preventing hospital admission or facilitating early discharge, allowing patients to be treated in their own environment. During the COVID-19 pandemic, the ACAH team administered oxygen therapy, antibiotics, anticipatory medications and other vital interventions to combat the ill effects of COVID-19. METHOD: An observational approach has been used in this study. Patients were included if they were admitted to ACAH during March-June 2020 for treatment of COVID-19. Biochemistry, oxygen saturations and co-morbidities are among the studied parameters. Lymphocyte count and serum magnesium were compared with a non-COVID-19 cohort. Trends within parameters and associated mortality were analysed and tabulated. RESULTS: 70% of admissions were lymphopenic, whilst 54% were hypoxic. There was a 28-day mortality rate of 35%, with an 18% increase in mortality rate when comparing residence in long-term care facilities (LTCF) to personal residence. All patients had existing co-morbidities. CONCLUSION: The data indicates that hypoxaemia, hyperferritinaemia and hypermagnesaemia are associated with early mortality in the older population infected with COVID-19. National Early Warning Score and frailty score are predictive of mortality in this cohort, with higher scores correlating to worse outcomes. Those living in LTCF are at an increased risk of mortality. However, ACAH mortality rates are comparable to those admitted to hospital, validating the concept of ACAH. The highlighted trends can be used to improve outcomes in future admissions.

Efficient and safe glycaemic control with basal-bolus insulin therapy during fasting periods in hospitalized patients with type 2 diabetes using decision support technology: A post hoc analysis.

AIM: To evaluate the efficacy and safety of basal-bolus insulin therapy in managing glycaemia during fasting periods in hospitalized patients with type 2 diabetes. MATERIALS AND METHODS: We performed a post hoc analysis of two prospective, uncontrolled interventional trials that applied electronic decision support system-guided basal-bolus (meal-related and correction) insulin therapy. We searched for fasting periods (invasive or diagnostic procedures, medical condition) during inpatient stays. In a mixed model analysis, patients' glucose levels and insulin doses on days with regular food intake were compared with days with fasting periods. RESULTS: Out of 249 patients, 115 patients (33.9% female, age 68.3 ± 10.3 years, diabetes duration 15.1 ± 10.9 years, body mass index 30.1 ± 5.4 kg/m2 , HbA1c 69 ± 20 mmol/mol) had 194 days with fasting periods. Mean daily blood glucose (BG) was lower (modelled difference [ModDiff]: -0.5 ± 0.2 mmol/L, P = .006), and the proportion of glucose values within the target range (3.9-10.0 mmol/L) increased on days with fasting periods compared with days with regular food intake (ModDiff: +0.06 ± 0.02, P = .005). Glycaemic control on fasting days was driven by a reduction in daily bolus insulin doses (ModDiff: -11.0 ± 0.9 IU, P < .001), while basal insulin was similar (ModDiff: -1.1 ± 0.6 IU, P = .082) compared with non-fasting days. Regarding hypoglycaemic events (BG < 3.9 mmol/L), there was no difference between fasting and non-fasting days (χ2 0.9% vs. 1.7%, P = .174). CONCLUSIONS: When using well-titrated basal-bolus insulin therapy in hospitalized patients with type 2 diabetes, the basal insulin dose does not require adjustment during fasting periods to achieve safe glycaemic control, provided meal-related bolus insulin is omitted and correction bolus insulin is tailored to glucose levels.

Safe and Sufficient Glycemic Control by Using a Digital Clinical Decision Support System for Patients With Type 2 Diabetes in a Routine Setting on General Hospital Wards.

The aim was to investigate the applicability of a clinical decision support system in a real-world inpatient setting for patients with type 2 diabetes on general hospital wards.A total of 150 patients with type 2 diabetes requiring subcutaneous insulin therapy were treated with basal-bolus insulin therapy guided by a decision support system (GlucoTab) providing automated workflow tasks and suggestions for insulin dosing to health care professionals.By using the system, a mean daily blood glucose (BG) of 159 ± 32 mg/dL was achieved. 68.8% of measurements were in the target range (70 to <180 mg/dL). The percentage of BG values <40, <70, and ≥300 mg/dL was 0.02%, 2.2%, and 2.3%, respectively. Health care professionals' adherence to suggested insulin doses and workflow tasks was high (>93% and 91%, respectively).The decision support system facilitates safe and efficacious inpatient diabetes care by standardizing treatment workflow and providing decision support for basal-bolus insulin dosing.

Electronic Diabetes Management System Replaces Paper Insulin Chart: Improved Quality in Diabetes Inpatient Care Processes Due to Digitalization.

BACKGROUND: GlucoTab, an electronic diabetes management system (eDMS), supports healthcare professionals (HCPs) in inpatient blood glucose (BG) management at point-of-care and was implemented for the first time under routine conditions in a regional hospital to replace the paper insulin chart. METHOD: To investigate quality of the eDMS for inpatients with type 2 diabetes mellitus a monocentric retrospective before-after evaluation was conducted. We compared documentation possibilities by assessing a blank paper chart vs the eDMS user interface. Further quality aspects were compared by assessing filled-in paper charts (n = 106) vs filled-in eDMS documentation (n = 241). HCPs (n = 59) were interviewed regarding eDMS satisfaction. RESULTS: The eDMS represented an improvement of documentation possibilities by offering a more structured and comprehensive user interface compared to the blank paper chart. The number of good diabetes days averaged to a median value of four days in both groups (paper chart: 4.38 [0-7] vs eDMS: 4.38 [0-7] days). Median daily BG was 170 (117-297) mg/dL vs 168 (86-286) mg/dL and median fasting BG was 152 (95-285) mg/dL vs 145 (69-333) mg/dL, and 0.1% vs 0.4% BG values <54 mg/dL were documented. Diabetes documentation quality improved when using eDMS, for example, documentation of ordered BG measurement frequency (1% vs 100%) and ordered BG targets (0% vs 100%). HCPs stated that by using eDMS errors could be prevented (74%), and digital support of work processes was completed (77%). Time saving was noted by 8 out of 11 HCPs and estimated at 10-15 minutes per patient day by two HCPs. CONCLUSIONS: The eDMS completely replaced the paper chart, showed comparable glycemic control, was positively accepted by HCPs, and is suitable for inpatient diabetes management.

Diabetes Management According to Health Status in Older Adults with Type 2 Diabetes Staying in Geriatric Care Facilities.

BACKGROUND: About 25% of adults >70 years suffer from type 2 diabetes. Due to the heterogeneity of the geriatric population, guidelines emphasize the need to individualize glycemic goals and simplify treatment strategies with the main focus of avoiding hypoglycemia. The aim of this study was to assess glycemic control in patients with type 2 diabetes in geriatric care facilities based on their individual health status. METHODS: 170 medical records of older adults with type 2 diabetes in geriatric care facilities were retrospectively assessed (64.7% female, age 80 ± 9 years; glycated hemoglobin 6.8% ± 3.6% [51 ± 16 mmol/mol]; body mass index 27.9 ± 5.8 kg/m2). Based on the individual health status, patients were allocated to three groups (healthy n = 27, complex n = 86, and poor n = 57). RESULTS: The overall blood glucose (BG) value was highest in the poor health group with 188 ± 47 mg/dL (poor) vs 167 ± 42 mg/dL (complex) vs 150 ± 34 mg/dL (healthy). BG values of 1.6% (poor) vs 2.8% (complex) vs 1.5% (healthy) of patients were below 90 mg/dL. 36.8% (poor) vs 23.4% (complex) vs 18.5% (healthy) of patients received insulin as the main diabetes therapy, but of these only 14.3% (poor) vs 20% (complex) vs 40% (healthy) were treated with basal insulin. CONCLUSIONS: Overall, BG values were higher in the poor and complex health group. There were a few low BG values in all groups. Although recommended by international guidelines, basal insulin therapy with its low complexity and low hypoglycemic risk is still underused, especially in the poor health group. Therefore, simplification of diabetes therapy should be considered further.

Debunking a Surgical Myth: Do Not Touch the Temporalis.

BACKGROUND: A longstanding dictum exists to avoid surgical manipulation of the temporalis muscle out of concern for an exceedingly high rate of muscle atrophy and recurrent temporal hollowing. The authors challenge this surgical myth, considering such advice to be erroneous. The authors hypothesize that elevation of the temporalis muscle, if performed using standard muscle flap principles, will demonstrate excellent results. METHODS: To assess temporalis response to surgical manipulation, the authors reviewed patients who underwent calvarial vault remodeling by the senior author for craniosynostosis between 1988 and 2011. Nonsyndromic patients with single-suture synostosis and 5 years of follow-up were eligible for inclusion. The medical record was used to measure rates of reoperation, recurrent temporal hollowing, and persistent temporalis overcorrection. RESULTS: Of the cohort reviewed, 196 patients met inclusion criteria. Ten patients (5.1%) exhibited recurrent bitemporal constriction. One patient (0.5%) underwent a revision temporalis turnover flap, and 2 patients (1.0%) underwent soft tissue augmentation. The overall reoperation rate was 1.5%. Temporalis overcorrection, in an attempt to prophylactically rectify the expected atrophy after temporalis manipulation, persisted in 11 patients (5.6%). Three of these patients required treatment with steroid injections, Botox injections, or operative muscle debulking. The overall reoperation rate for temporalis overcorrection was 1.5%. CONCLUSIONS: The authors' low reoperation rates for recurrent deformity, in combination with persistent temporalis overcorrection in 5.6% of patients, should dispel the myth that manipulation of the temporalis invariably results in atrophy. The muscle may be surgically manipulated, as long as plastic surgery principles are followed.

GlucoTab-guided insulin therapy using insulin glargine U300 enables glycaemic control with low risk of hypoglycaemia in hospitalized patients with type 2 diabetes.

AIMS: To investigate efficacy, safety and usability of the GlucoTab system for glycaemic management using insulin glargine U300 in non-critically ill hospitalized patients with type 2 diabetes (T2D). MATERIALS AND METHODS: In this open, non-controlled single-arm pilot study, glycaemic control at the general ward of a tertiary care hospital was guided by a mobile decision support system (GlucoTab) for basal-bolus insulin dosing using the novel basal insulin analogue insulin glargine U300 for the first time. Glycaemic control was surveilled with capillary glucose measurements and continuous glucose monitoring (CGM). The primary endpoint was efficacy of glycaemic management, defined as the percentage of blood glucose measurements within the target range of 3.9 to 7.8 mmol/L. RESULTS: A total of 30 patients with T2D (12 female; age, 67 ± 11 years; HbA1c, 70 ± 26 mmol/mol; BMI, 31.8 ± 5.6 kg/m2 ; length of study, 8.5 ± 4.5 days) were included. In total, 894 capillary glucose values and 49 846 data points of CGM were available, of which 56.1% of all measured capillary glucose values and 54.3% of CGM values were within the target area (3.9-7.8 mmol/L). Overall capillary mean glucose was 8.5 ± 1.2 and 8.4 ± 1.2 mmol/L assessed by CGM. Time within glucose target improved continuously during the course of treatment, while time within hypoglycaemia (<3.9 mmol/L) decreased substantially. The GlucoTab-suggested total daily dose was accepted by staff in 97.3% of situations. CONCLUSIONS: Treatment with GlucoTab using insulin glargine U300 in hospitalized patients with T2D is effective and safe.

Targeted Molecular Characterization of Aldosterone-Producing Adenomas in White Americans.

Context: Somatic mutations have been identified in more than half of aldosterone-producing adenomas (APAs) through mutation hotspot sequencing. The underlying pathogenesis of inappropriate aldosterone synthesis in the remaining population is still unknown. Objective: To investigate the prevalence and spectrum of somatic mutations in APAs using an aldosterone synthase (CYP11B2) immunohistochemistry (IHC)‒guided next-generation sequencing (NGS) approach. Methods: Formalin-fixed paraffin-embedded adrenal tissue from white American patients with primary aldosteronism who underwent adrenalectomy at the University of Michigan was used. Genomic DNA was isolated from 75 APAs (identified by CYP11B2 IHC). NGS was performed to identify somatic mutations by sequencing the entire coding region of a panel of genes mutated in APAs. Results: Somatic mutations were identified in 66 of 75 APAs (88%). Of the APAs with somatic mutations, six were smaller than coexisting CYP11B2-negative adrenocortical adenomas. The most frequently mutated gene was KCNJ5 (43%), followed by CACNA1D (21%), ATP1A1 (17%), ATP2B3 (4%), and CTNNB1 (3%). In addition to identification of previously reported mutations, we identified five previously unreported mutations (two in KCNJ5, one in ATP1A1, one in ATP2B3, and one in CACNA1D genes). KCNJ5 mutations were more frequent in women (70% vs 24% in men). Conclusion: Comprehensive NGS of CYP11B2-expressing adrenal tumors identified somatic mutations in aldosterone-driving genes in 88% of APAs, a higher rate than in previous studies using conventional approaches.

A Mobile Computerized Decision Support System to Prevent Hypoglycemia in Hospitalized Patients With Type 2 Diabetes Mellitus.

BACKGROUND: Diabetes management requires complex and interdisciplinary cooperation of health care professionals (HCPs). To support this complex process, IT-support is recommended by clinical guidelines. The aim of this article is to report on results from a clinical feasibility study testing the prototype of a mobile, tablet-based client-server system for computerized decision and workflow support (GlucoTab®) and to discuss its impact on hypoglycemia prevention. METHODS: The system was tested in a monocentric, open, noncontrolled intervention study in 30 patients with type 2 diabetes mellitus (T2DM). The system supports HCPs in performing a basal-bolus insulin therapy. Diabetes therapy, adverse events, software errors and user feedback were documented. Safety, efficacy and user acceptance of the system were investigated. RESULTS: Only 1.3% of blood glucose (BG) measurements were <70 mg/dl and only 2.6% were >300 mg/dl. The availability of the system (97.3%) and the rate of treatment activities documented with the system (>93.5%) were high. Only few suggestions from the system were overruled by the users (>95.7% adherence). Evaluation of the 3 anonymous questionnaires showed that confidence in the system increased over time. The majority of users believed that treatment errors could be prevented by using this system. CONCLUSIONS: Data from our feasibility study show a significant reduction of hypoglycemia by implementing a computerized system for workflow and decision support for diabetes management, compared to a paper-based process. The system was well accepted by HCPs, which is shown in the user acceptance analysis and that users adhered to the insulin dose suggestions made by the system.

Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study.

OBJECTIVE: Most preventable adverse drug events and medication errors occur during medication ordering. Medication order entry and clinical decision support are available on paper or as computerized systems. In this post-hoc analysis we investigated frequency and clinical impact of blood glucose (BG) documentation- and user-related calculation errors as well as workflow deviations in diabetes management. We aimed to compare a paper-based protocol to a computerized medication management system combined with clinical workflow and decision support. METHODS: Seventy-nine hospitalized patients with type 2 diabetes mellitus were treated with an algorithm driven basal-bolus insulin regimen. BG measurements, which were the basis for insulin dose calculations, were manually entered either into the paper-based workflow protocol (PaperG: 37 patients) or into GlucoTab(®)-a mobile tablet PC based system (CompG: 42 patients). We used BG values from the laboratory information system as a reference. A workflow simulator was used to determine user calculation errors as well as workflow deviations and to estimate the effect of errors on insulin doses. The clinical impact of insulin dosing errors and workflow deviations on hypo- and hyperglycemia was investigated. RESULTS: The BG documentation error rate was similar for PaperG (4.9%) and CompG group (4.0%). In PaperG group, 11.1% of manual insulin dose calculations were erroneous and the odds ratio (OR) of a hypoglycemic event following an insulin dosing error was 3.1 (95% CI: 1.4-6.8). The number of BG values influenced by insulin dosing errors was eightfold higher than in the CompG group. In the CompG group, workflow deviations occurred in 5.0% of the tasks which led to an increased likelihood of hyperglycemia, OR 2.2 (95% CI: 1.1-4.6). DISCUSSION: Manual insulin dose calculations were the major source of error and had a particularly strong influence on hypoglycemia. By using GlucoTab(®), user calculation errors were entirely excluded. The immediate availability and automated handling of BG values from medical devices directly at the point of care has a high potential to reduce errors. Computerized systems facilitate the safe use of more complex insulin dosing algorithms without compromising usability. In CompG group, missed or delayed tasks had a significant effect on hyperglycemia, while in PaperG group insufficient precision of documentation times limited analysis. The use of old BG measurements was clinically less relevant. CONCLUSION: Insulin dosing errors and workflow deviations led to measurable changes in clinical outcome. Diabetes management systems including decision support should address nurses as well as physicians in a computerized way. Our analysis shows that such systems reduce the frequency of errors and therefore decrease the probability of hypo- and hyperglycemia.

Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension.

BACKGROUND: Adherence to medication and lifestyle interventions are essential keys for the management of hypertension. In this respect, a structured educational program for hypertensive patients has got remarkable merits (herz.leben). In order to determine the isolated effect of participation in the educational program, neglecting the possible impact of more intense care, this prospective multicenter randomized controlled study was designed (NCT00453037). METHODS: A total of 256 patients in 13 centers were enrolled and randomly assigned to 2 groups (G). G-I (n = 137) underwent the educational program immediately (T-0), G-II (n = 119) after 6 months (T-6). Follow-up visits were done after 6 (T-6) and 12 (T-12) months. Primary endpoint was a difference in office blood pressure (BP) at T-6, when only G-I had undergone the educational program. RESULTS: Patients' baseline characteristics were comparable. At T-6, systolic office and home BP were significantly lower in G-I compared to G-II: office BP systolic 139 (134-150) mm Hg vs. 150 (135-165) mm Hg (P < 0.01); diastolic 80 (76-85) mm Hg vs. 84 (75-90) mm Hg (ns); home BP systolic 133 (130-140) mm Hg vs. 142 (132-150) mm Hg (P < 0.01); diastolic 80 (75-85) mm Hg vs. 80 (76-89) mm Hg (ns)). At T-12, when all patients had undergone the educational program differences in BP disappeared. CONCLUSION: The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients.

Standardized Glycemic Management with a Computerized Workflow and Decision Support System for Hospitalized Patients with Type 2 Diabetes on Different Wards.

BACKGROUND: This study investigated the efficacy, safety, and usability of standardized glycemic management by a computerized decision support system for non-critically ill hospitalized patients with type 2 diabetes on four different wards. MATERIALS AND METHODS: In this open, noncontrolled intervention study, glycemic management of 99 patients with type 2 diabetes (62% acute admissions; 41 females; age, 67±11 years; hemoglobin A1c, 65±21 mmol/mol; body mass index, 30.4±6.5 kg/m(2)) on clinical wards (Cardiology, Endocrinology, Nephrology, Plastic Surgery) of a tertiary-care hospital was guided by GlucoTab(®) (Joanneum Research GmbH [Graz, Austria] and Medical University of Graz [Graz, Austria]), a mobile decision support system providing automated workflow support and suggestions for insulin dosing to nurses and physicians. RESULTS: Adherence to insulin dosing suggestions was high (96.5% bolus, 96.7% basal). The primary outcome measure, percentage of blood glucose (BG) measurements in the range of 70-140 mg/dL, occurred in 50.2±22.2% of all measurements. The overall mean BG level was 154±35 mg/dL. BG measurements in the ranges of 60-70 mg/dL, 40-60 mg/dL, and <40 mg/dL occurred in 1.4%, 0.5%, and 0.0% of all measurements, respectively. A regression analysis showed that acute admission to the Cardiology Ward (+30 mg/dL) and preexisting home insulin therapy (+26 mg/dL) had the strongest impact on mean BG. Acute admission to other wards had minor effects (+4 mg/dL). Ninety-one percent of the healthcare professionals felt confident with GlucoTab, and 89% believed in its practicality and 80% in its ability to prevent medication errors. CONCLUSIONS: An efficacious, safe, and user-accepted implementation of GlucoTab was demonstrated. However, for optimized personalized patient care, further algorithm modifications are required.

Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy.

BACKGROUND: Inpatient glucose management is based on four daily capillary blood glucose (BG) measurements. The aim was to test the capability of continuous glucose monitoring (CGM) for assessing the clinical impact and safety of basal-bolus insulin therapy in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Eighty-four patients with T2DM (age, 68±10 years; glycosylated hemoglobin, 72±28 mmol/mol; body mass index, 31±7 kg/m(2)) were treated with basal-bolus insulin. CGM was performed with the iPro(®)2 system (Medtronic MiniMed, Northridge, CA) and calibrated retrospectively. RESULTS: A remarkable consistency between CGM and BG measurements and therapy improvement was shown over the study period of 501 patient-days. The number of CGM and BG measurements (CGM/BG) in the range from 3.9-10 mmol/L increased from 67.7%/67.2% (on Day 1) to 77.5%/78.6% (on the last day) (P<0.04). The number of low glycemic episodes (3.3 to <3.9 mmol/L) during nighttime detected by CGM was 15-fold higher, and the number of episodes >13.9 mmol/L detected by CGM during night was 12.5-fold higher than the values from the BG measurements. Ninety-nine percent of data points were in the clinically accurate or acceptable Clarke Error Grid Zones A+B, and the relative numbers of correctly identified episodes of <3.9 and >13.9 mmol/L detected by CGM (sensitivity) were 47.3% and 81.5%, respectively. CONCLUSIONS: Our data exhibit a good agreement between overall CGM and BG measurements, but there were a high number of missed hypo- and hyperglycemic episodes with BG measurements, particularly during nighttime. Overall assessment of glycemic control using CGM is feasible, whereas the use of CGM for individualized therapy decisions needs further improvement.

Automatic system testing of a decision support system for insulin dosing using Google Android.

Hyperglycaemia in hospitalized patients is a common and costly health care problem. The GlucoTab system is a mobile workflow and decision support system, aiming to facilitate efficient and safe glycemic control of non-critically ill patients. Being a medical device, the GlucoTab requires extensive and reproducible testing. A framework for high-volume, reproducible and automated system testing of the GlucoTab system was set up applying several Open Source tools for test automation and system time handling. The REACTION insulin titration protocol was investigated in a paper-based clinical trial (PBCT). In order to validate the GlucoTab system, data from this trial was used for simulation and system tests. In total, 1190 decision support action points were identified and simulated. Four data points (0.3%) resulted in a GlucoTab system error caused by a defective implementation. In 144 data points (12.1%), calculation errors of physicians and nurses in the PBCT were detected. The test framework was able to verify manual calculation of insulin doses and detect relatively many user errors and workflow anomalies in the PBCT data. This shows the high potential of the electronic decision support application to improve safety of implementation of an insulin titration protocol and workflow management system in clinical wards.

Cross-border flow of health information: is 'privacy by design' enough? Privacy performance assessment in EUBIROD.

BACKGROUND: The EUBIROD project aims to perform a cross-border flow of diabetes information across 19 European countries using the BIRO information system, which embeds privacy principles and data protection mechanisms in its architecture (privacy by design). A specific task of EUBIROD was to investigate the variability in the implementation of the EU Data Protection Directive (DPD) across participating centres. METHODS: Compliance with privacy requirements was assessed by means of a specific questionnaire administered to all participating diabetes registers. Items included relevant issues e.g. patient consent, accountability of data custodian, communication (openness) and complaint procedures (challenging compliance), authority to disclose, accuracy, access and use of personal information, and anonymization. The identification of an ad hoc scoring system and statistical software allowed an overall quali-quantitative analysis and independent evaluation of questionnaire responses, automated through a dedicated IT platform ('privacy performance assessment'). RESULTS: A total of 18 diabetes registers from different countries completed the survey. Over 50% of the registers recorded a maximum score for accountability, openness, anonymization and challenging compliance. Low average values were found for disclosure and disposition, access, consent, use of personal information and accuracy. A high heterogeneity was found for anonymization, consent, accuracy and access. CONCLUSIONS: The novel method of privacy performance assessment realized in EUBIROD may improve the respect of privacy in each data source, reduce overall variability in the implementation of privacy principles and favour a sound and legitimate cross-border exchange of high quality data across Europe.

Diabetes management using modern information and communication technologies and new care models.

BACKGROUND: Diabetes, a metabolic disorder, has reached epidemic proportions in developed countries. The disease has two main forms: type 1 and type 2. Disease management entails administration of insulin in combination with careful blood glucose monitoring (type 1) or involves the adjustment of diet and exercise level, the use of oral anti-diabetic drugs, and insulin administration to control blood sugar (type 2). OBJECTIVE: State-of-the-art technologies have the potential to assist healthcare professionals, patients, and informal carers to better manage diabetes insulin therapy, help patients understand their disease, support self-management, and provide a safe environment by monitoring adverse and potentially life-threatening situations with appropriate crisis management. METHODS: New care models incorporating advanced information and communication technologies have the potential to provide service platforms able to improve health care, personalization, inclusion, and empowerment of the patient, and to support diverse user preferences and needs in different countries. The REACTION project proposes to create a service-oriented architectural platform based on numerous individual services and implementing novel care models that can be deployed in different settings to perform patient monitoring, distributed decision support, health care workflow management, and clinical feedback provision. RESULTS: This paper presents the work performed in the context of the REACTION project focusing on the development of a health care service platform able to support diabetes management in different healthcare regimes, through clinical applications, such as monitoring of vital signs, feedback provision to the point of care, integrative risk assessment, and event and alarm handling. While moving towards the full implementation of the platform, three major areas of research and development have been identified and consequently approached: the first one is related to the glucose sensor technology and wearability, the second is related to the platform architecture, and the third to the implementation of the end-user services. The Glucose Management System, already developed within the REACTION project, is able to monitor a range of parameters from various sources including glucose levels, nutritional intakes, administered drugs, and patient's insulin sensitivity, offering decision support for insulin dosing to professional caregivers on a mobile tablet platform that fulfills the need of the users and supports medical workflow procedures in compliance with the Medical Device Directive requirements. CONCLUSIONS: Good control of diabetes, as well as increased emphasis on control of lifestyle factors, may reduce the risk profile of most complications and contribute to health improvement. The REACTION project aims to respond to these challenges by providing integrated, professional, management, and therapy services to diabetic patients in different health care regimes across Europe in an interoperable communication platform.

Design of a mobile, safety-critical in-patient glucose management system.

Diabetes mellitus is one of the most widespread diseases in the world. People with diabetes usually have long stays in hospitals and need specific treatment. In order to support in-patient care, we designed a prototypical mobile in-patient glucose management system with decision support for insulin dosing. In this paper we discuss the engineering process and the lessons learned from the iterative design and development phases of the prototype. We followed a user-centered development process, including real-life usability testing from the outset. Paper mock-ups in particular proved to be very valuable in gaining insight into the workflows and processes, with the result that user interfaces could be designed exactly to the specific needs of the hospital personnel in their daily routine.