Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

BACKGROUND: A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. METHODS: Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. RESULTS: While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. CONCLUSIONS: The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

A networked electronic patient record system for diabetes.

This paper describes the development and clinical implementation of the SincroDiab--a synchronized diabetes register for the routine clinical practice in a LAN and for design of long-term trials and epidemiological studies based on the GEHR (Good European Health Record) architecture. The objectives of the SincroDiab system were to address the need to establish a more efficient and more effective information infrastructure to improve the ability to share patient record information among health care providers, to reduce the health care delivery costs, to meet the requirements of legal, regulatory or accreditation standards, to share comparable patients data among different sites within a multi-entity health care delivery system and to improve quality of care by network connecting the data repository to clinical workstations and departmental systems.

The Black Sea Tele-Diab System: development-implementation-clinical evaluation.

This paper describes the application of the GEHR (Good European Health Record) architecture to develop a system to enable the storage and exchange of EHCRs (Electronic Health Care Record) of patients with diabetes, in the Black Sea area. The objectives of the Black Sea Tele Diab System (BSTD) were to develop and evaluate the use of a fully-computerised healthcare record system in a clinical setting, to promote the use of electronic data exchange of healthcare information and to provide a framework for the epidemiological study and monitoring of diabetes care.

Black Sea TeleDiab: diabetes computer system with communication technology for Black Sea region.

BlackSea TeleDiab (BSTD) is a multidisciplinary research project whose aim is to promote the exchange of healthcare information between clinicians and scientists in countries of the Black Sea area to provide a means by which the care of patients with diabetes may be enhanced. The project is built on an existing organizational framework provided by the WHO Diabcare Quality Network (Q-Net) and the Black Sea Diab Action Project. The aim is to develop a standardized software package (in the national languages of the CCE/NIS Black Sea partners) for the storage and transfer of medical information and healthcare data between participating institutions. It will utilize a standard format for medical records based on the Good European Health Record (GEHR), a project within the Advanced Informatics in Medicine (AIM) program, which aims to develop and propagate a common architecture for computerized health records across Europe that can be used across clinical domains, countries, and computer systems.

The pattern of the electrodermal activity as indicator of stress related reaction.

The aim of the present study was to characterize the patterns of signals associated with noninvasively detected skin sudomotor transient reflexes in a group of 221 apparently healthy people, aged between 16 and 72 years. By means of two pairs of surface electrodes applied respectively to the palm of the hand and to the sole of the foot skin impedance changes were recorded as two electrodermal parameters: skin electrical resistance and skin electrical capacitance. The recordings were obtained under standard conditions initially in the basal resting state of the subject and then, after the application of some standardized stimuli (evoked electrodermal responses). In terms of the basal (spontaneous) electrodermal activity and the evoked responses the subjects were divided into three categories: I--those with a high threshold of sympathetic activation (quiet basal trace and ample evoked responses); II--those with a medium threshold for sympathetic activation (basal trace with some spontaneous electrodermal activity, but obviously of a lower amplitude than the evoked responses); III--those with a low threshold for sympathetic activation (a tracing showing frequent, larger spontaneous sympathetic discharges from which the evoked responses cannot be distinguished). Of the 221 subjects, 22.2% in group I, 69.2% were included in group II, and 8.6% in group III. Our data show that each individual presents a characteristic electrodermal pattern which expresses the degree of stability/instability of the sympathetic nervous system, the most sensitive component of the physiological stress reaction system.

Diabetic gangrene: medical and surgical causes and consequences.

Diabetic gangrene is the chronic complication which involves many medical, economic and social problems. In this study we have analyzed the medical and surgical causes and consequences of diabetic gangrene on three groups of patients: 120 patients (96 males and 24 females; aged (X +/- SD) 57 +/- 14 years hospitalised in the Clinic of Diabetes, Nutrition and Metabolic Diseases of the "N. Paulescu" Institute, 72 patients (59 males and 13 females; mean age 60 +/- 10 years) hospitalised in the Surgical Clinic of Cantacuzino Hospital; 29 patients (23 males and 6 females; mean age 58 +/- 11 years) hospitalised in the Cardiovascular Department of Fundeni Hospital. The analyses of data obtained showed: in 77% of cases the initial lesions might have been avoided by an appropriate education programme of the patients; in 66% of cases the progression of lesion from medical to surgical stage was caused by tardily coming of patient to physician; average duration of hospitalization was 27 days in the Clinic of Diabetes, Nutrition and Metabolic Diseases, 33 days in the Clinic of Surgery of "Cantacuzino" Hospital and 25 days in Cardiovascular Department of Fundeni Hospital; the surgical mortality was 8%; 47% operated patients were cured and 53% were incompletely cured and required more out patient care; 35% were thigh amputations, that shows the high invalidity potential of diabetic gangrene; the cost of medical and/or surgical care of diabetic gangrene is higher than the cost of hospitalisation for other patients; the diabetic gangrene predominantly neuropathic was better cured and the arteriopathic component breaks the medical curing and impose high amputations; diabetic gangrene is more frequent with older people, but with young people it is a cause of early retiring and psycho-social concern.

Peripheral sympathetic neuropathy evaluated by recording the evoked electrodermal response using an impedance reactometer.

Autonomic nervous dysfunction was indirectly evaluated on the basis of the skin electrical resistance relative variation (SERV), recorded by our recently developed system, with two pairs of surface electrodes placed on the palm and on the sole of the foot, after the application to the subject of a sensory stimulus (sound 60 dB, 860 Hz, 0.5 s duration) or in the course of a Valsalva manoeuvre. The results were digitally measured and recorded on thermosensitive millimetric paper analysing the following parameters: latency (LT), i.e. the time interval(s) between application of the stimulus and onset of SERV, both at palm (LTh) and foot (LTf); amplitude of the response (mm) recorded and evaluated in the form of SERV; velocity of the response as rate of time change (Vr) and autonomic conduction velocity, -ACV (m/s), calculated by the height/LT ratio. The present study refers to a group of 60 diabetic patients: 32 F/28 M; mean age +/- SD 46.8 +/- 11.8 years; 29 insulin-dependent, 21 non-insulin-dependent; duration of diabetes 8.6 +/- 4.6 years. The data were compared to those recorded in a group of 50 nondiabetics (22 F/28 M; mean age 47.5 +/- 14.1 years) who were apparently healthy. A significant statistical difference (P less than 0.001) was found between diabetic patients and controls for all studied parameters: LTh (s) 2.65 +/- 1.2 vs. 1.91 +/- 0.6; LTf(s) 3.6 +/- 1.4 vs. 2.6 +/- 0.7; SERV (mm) 7.5 +/- 4.8 vs. 18.5 +/- 6.6; Vr (mm) 4.4 +/- 2.1 vs. 13.5 +/- 5.3; ACT (m/s) 0.41 +/- 0.23 vs. 0.97 +/- 0.18.(ABSTRACT TRUNCATED AT 250 WORDS)

Improved technique for testing autonomic dysfunction: evaluation of transient behaviour of the autonomic response.

The transient behaviour of the autonomic response has been studied by means of a reactometer incorporating self-balancing of the electrodermal impedance. This instrument has been used for the indirect measurement of certain parameters associated with the autonomic response detected as skin electrical resistance relative variation (SERV) and capacitance (SECV). Transient signals of the electrodermal impedance response were obtained online by differentiating the analogue output of the impedance reactometer: d(SERV)/dt and d(SECV)/dt. We describe here how the use of the transient signals of the electrodermal impedance response can improve the accuracy and reduce variability and dispersion of the results and how autonomic conduction velocities (ACV) can be indirectly measured.

Quantitative noninvasive electrophysiological evaluation of the activity of the cutaneous division of the sympathetic nervous system.

The functional status of the cutaneous division of the orthosympathetic nervous system was indirectly and non-invasively assessed by monitoring the skin electrical relative resistance variations (SERV). The advantages of our recording system of second generation were (1) simultaneous recording on two or four channels of the evoked electrodermal response to psychic or to sensorial stimulus; (2) self-balancing system which allows the recording of the relative variation of the electric parameter, i.e. its variation with time; (3) precise determination of the amplitude (omega/s, mu F/s) of the evoked response; (4) reference of the latency time (LT) of the evoked response to the length of the anatomical pathway of the signal giving the autonomic conduction velocity (ACV). Decrease in diabetic autonomic neuropathy of both spontaneous and evoked electrodermal activities suggested their relationship with cutaneous sympathetic activity.

Measurement of perception threshold to an electric stimulus using a phase-sensitive technique in normal and diabetic subjects.

To evaluate the functional state of peripheral sensitivity we measured the perception threshold to an electrical stimulus applied deeply at the level of the lower limbs in both diabetic and nondiabetic patients. The data were obtained using a phase-sensitive technique with a sinusoidal applied voltage at 1592 Hz. The test signal applied through needle electrodes was monitored using a current-to-voltage convertor, the current being considered to have two components, one resistive (IR) in phase with the voltage V across the electrodes, and the other capacitive (IC) 90 degrees out of phase. A significantly (p less than 0.001) higher perception threshold was found in diabetic patients than in nondiabetic subjects with all three electrical variables measured: IR, IC and V.

The perception threshold to an electric stimulus deeply applied in the lower limbs in normal and diabetic subjects.

The loss of sensitivity to nociceptive stimuli is one of the main factors involved in the pathogeny of diabetic gangrene. The aim of this study was to develop a simple and practical method for selecting the cases prone to such a complication. The perception threshold (either voltage, mV or current, microA) was determined in 137 randomly selected diabetic patients and 38 non-diabetic controls, by an original electronic device using sinusoidal waves, delivered through two electrode needles introduced at a depth of 0.5 cm at two points located on the anterior aspect of the shank about 12 cm apart. At each of the eight frequencies studied (10, 20, 50, 100, 200, 500, 1000 and 2000 Hz) three electrical parameters (voltage across the needle electrodes, the resistive and the capacitive current component) were recorded when the subject first perceived the stimulus. A significantly higher perception threshold was found in diabetic patients vs. non-diabetic subjects, at all frequencies studied and with all three electrical parameters recorded. A greater difference in the perception threshold between diabetic and non-diabetic subjects (a ratio higher than 3) was, however, found using the resistive component of the current and at frequencies higher than 200 Hz.

Evaluation in autonomic diabetic neuropathy using a dual-channel self-balancing impedance reactometer. Preliminary study.

The electrodermal reflex to an external acoustic stimulus was determined by means of an original device "'The Neurovegetative Reactometer", as variation of the skin electric resistance delta R/R (recorded on millimetric paper) and latency in the appearance of the response (seconds), in 39 diabetic patients (20 males, 19 females, aged 55 +/- 10 years, and the duration of diabetes of 6 +/- 4 years) with or without clinical neuropathy and, comparatively, in 24 apparently healthy controls. The results showed a statistically significant difference both between the amplitude of the skin electric resistance variation evaluated on millimetric paper (6.77 +/- 4.06 mm versus 22.79 +/- 5.39 mm in the controls, p less than 0.001) and latency (4.29 +/- 1.55 versus 2.49 +/- 0.57 seconds, p less than 0.001). These two parameters reflect quantitatively the skin sympathetic activity in lower limbs. The results obtained recommend neurovegetative reactometry as a practical, non-invasive, rapid and readily applicable method, which is highly technical and sensitive for evaluating autonomic dysfunction in diabetic neuropathy.

Electroacupunctogram: a new recording technique of the acupoint potentials.

The monitoring of the bioelectric activity of acupoints by means of electroacupunctogram (EAG) represents a direct and precise recording technique of the acupoints functional state. The EAG recording is done by introduction in the acupoint at corresponding depth of a standard silvered-steel electrode-needle and the measurements are made bipolar, i.e., versus a reference electrode. Useful information can be obtained by studying the difference in the electroacupoint potential in the following conditions: during introduction of the electrode-needle into the acupoint; after mechanical stimulation (by rotation) of the electrode-needle; after indirect heating of the acupoint; after deep breathing of the subject; by shunting the point investigated with a homonymous acupoint. The paper is based on the analysis of the EAG traces recorded in 112 apparently healthy subjects and in 230 patients affected by different diseases.