Diabetes diagnosis from administrative claims and estimation of the true prevalence of diabetes among 4.2 million individuals of the Veneto region (North East Italy).

BACKGROUND AND AIMS: Diabetes can often remain undiagnosed or unregistered in administrative databases long after its onset, even when laboratory test results meet diagnostic criteria. In the present work, we analyse healthcare data of the Veneto Region, North East Italy, with the aims of: (i) developing an algorithm for the identification of diabetes from administrative claims (4,236,007 citizens), (ii) assessing its reliability by comparing its performance with the gold standard clinical diagnosis from a clinical database (7525 patients), (iii) combining the algorithm and the laboratory data of the regional Health Information Exchange (rHIE) system (543,520 subjects) to identify undiagnosed diabetes, and (iv) providing a credible estimate of the true prevalence of diabetes in Veneto. METHODS AND RESULTS: The proposed algorithm for the identification of diabetes was fed by administrative data related to drug dispensations, outpatient visits, and hospitalisations. Evaluated against a clinical database, the algorithm achieved 95.7% sensitivity, 87.9% specificity, and 97.6% precision. To identify possible cases of undiagnosed diabetes, we applied standard diagnostic criteria to the laboratory test results of the subjects who, according to the algorithm, had no diabetes-related claims. Using a simplified probabilistic model, we corrected our claims-based estimate of known diabetes (6.17% prevalence; 261,303 cases) to account for undiagnosed cases, yielding an estimated total prevalence of 7.50%. CONCLUSION: We herein validated an algorithm for the diagnosis of diabetes using administrative claims against the clinical diagnosis. Together with rHIE laboratory data, this allowed to identify possibly undiagnosed diabetes and estimate the true prevalence of diabetes in Veneto.

Detecting Undiagnosed Diabetes: Proof-of-Concept Based on the Health-Information Exchange System of the Veneto Region (North-East Italy).

Diabetes is a chronic illness characterised by elevated blood glucose levels, driving excess mortality. Its prompt detection and accurate management are critical for delaying complications. Nevertheless, diabetes can remain undiagnosed for years from the onset. The identification of undiagnosed diabetes is a public health priority: in Italy, it is estimated that up to 30% of diabetes cases remain undetected, i.e., that ~1.8 million citizens may be unaware they need medical help. Sometimes, this happens even though these subjects undergo routine or emergency check-ups. Veneto, a region in North-East Italy with 4.9 million residents, implements a regional Health Information Exchange system (rHIE) to collect healthcare data, including laboratory reports, and integrate them with administrative claims. Their combination may be instrumental in finding otherwise undetected cases of diabetes. On the one hand, known diabetic patients should have disease management-generated claims; on the other, laboratory test results can be independently evaluated against diagnostic criteria. In the present work, we examined the anonymised claims and laboratory data, extracted from the rHIE, of 23,376 citizens of the Veneto region. We compared their exemptions, diabetes-related hospitalisation discharge codes, and antidiabetic drugs between 2012 and 2018 to the results of their fasting glucose, glycated haemoglobin, and oral glucose tolerance tests in 2017-2018. We identified 1,407 (6.02%) subjects who, according to administrative claims, appear to be free from diabetes, but met at least one laboratory diagnostic criterion. Such a discrepancy suggests that these people may be undiagnosed diabetic patients. To the best of our knowledge, this is the first proof of concept of an automatic system for the detection of undiagnosed diabetes in Italy. Its full integration in the rHIE and its consequent capillary application could potentially reveal thousands of hidden cases throughout Veneto.

Telemonitoring of Type 2 Diabetes Mellitus in Italy.

BACKGROUND: Type 2 diabetes mellitus (DM) affects 382 million people worldwide. INTRODUCTION: This study aimed at assessing whether telemonitoring (TM) of DM patients improves health-related quality of life (HRQoL). MATERIALS AND METHODS: As part of the RENEWING HEALTH project, 299 DM patients with HbA1c >7.0% were enrolled in a randomized controlled trial, with 208 patients in the TM group and 91 patients in the usual-care group. TM electronically transmitted glucose measurements to physicians during a 12-month follow-up. The SF-36v2 questionnaire was used to assess HRQoL. RESULTS: In a total of 243 patients analyzed, the study did not identify any clinically important improvement in HRQoL, our primary endpoint. There was no statistically significant difference in HbA1c between the two groups; however, outpatient visits and planned hospitalizations were significantly reduced in the TM group (p < 0.0001 and p = 0.02). DISCUSSION: The results regarding HRQoL might be, at least in part, an artifact stemming from the criteria used to select patients. TM reduced ambulatory visits and planned hospital admissions, an important result that plausibly reflects the fact that clinicians can strictly monitor their patients' health status without face-to-face contacts. CONCLUSIONS: Enhancement of HRQoL should represent the most critical goal of DM healthcare delivery. Effects of TM on HRQoL of diabetic patients should be studied further.

Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

BACKGROUND: Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services. METHODS: A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths. RESULTS: Three hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 - 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively]. CONCLUSION: Study results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission. TRIAL REGISTRATION: Retrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980 .

Assessment of Patients' Perception of Telemedicine Services Using the Service User Technology Acceptability Questionnaire.

INTRODUCTION: The purpose of this paper is to assess if similar telemedicine services integrated in the management of different chronic diseases are acceptable and well perceived by patients or if there are any negative perceptions. THEORY AND METHODS: Participants suffering from different chronic diseases were enrolled in Veneto Region and gathered into clusters. Each cluster received a similar telemedicine service equipped with different disease-specific measuring devices. Participants were patients with diabetes (n = 163), chronic obstructive pulmonary disease (n = 180), congestive heart failure (n = 140) and Cardiac Implantable Electronic Devices (n = 1635). The Service User Technology Acceptability Questionnaire (SUTAQ) was initially translated, culturally adapted and pretested and subsequently used to assess patients' perception of telemedicine. Data were collected after 3 months and after 12 months from the beginning of the intervention. Data for patients with implantable devices was collected only at 12 months. RESULTS: Results at 12 months for all clusters are similar and assessed a positive perception of telemedicine. The SUTAQ results for clusters 2 (diabetes), 5 (COPD) and 7 (CHF) after 3 months of intervention were confirmed after 12 months. CONCLUSIONS: Telemedicine was perceived as a viable addition to usual care. A positive perception for telemedicine services isn't a transitory effect, but extends over the course of time.

A one-to-one telestroke network: the first Italian study of a web-based telemedicine system for thrombolysis delivery and patient monitoring.

Over 10 years after European approval, thrombolysis is still limited by a restricted time window and non-optimal territorial coverage. Implementation of telestroke can give a growing number of patients access to treatment. We hereby present the first Italian telemedicine study applied to both the acute and the monitoring phase of stroke care. From January 2011 to December 2013, we tested a web-based, drip, and treat interaction model, connecting the cerebrovascular specialist of one hub center to the Emergency Department of a Spoke center. We then compared thrombolysis delivered using the telestroke model with thrombolysis provided at the Hub Stroke Unit at the time when the telemedicine program was activated. Telethrombolysis data were then compared with data from the two main international telestroke projects (TEMPiS and REACH), and other European telestroke studies performed at the time of writing. We collected a total of 131 thrombolysis procedures (25 telethrombolysis and 106 thrombolysis patients at the Stroke Unit). Statistical analysis with the t test yielded no statistically significant differences between the two populations in door-to-scan, door-to-needle (DTN), and onset-to-treatment times (OTT). Our OTT and DTN pathway times were longer than the TEMPiS and REACH studies but comparable with other European telemedicine trials, despite different models of interaction and number of centers. Our study in a northeastern province of Italy confirms the potential of applying telemedicine to a cerebrovascular pathology.

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

BACKGROUND: Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. OBJECTIVE: The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. METHODS: A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. RESULTS: In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per patient per year were detected within a mean (SD) time of 1.18 (2.08) days. Mean time spent by physicians to treat a patient was lower in the I-group compared to the U-group (-4.1 minutes PM; -13.7 minutes ICD). Organizational analysis showed that remote monitoring implementation was rather haphazard and fragmented. From a health care system perspective, the economic analysis showed statistically significant gains (P<.001) for the I-group using PM. CONCLUSIONS: This study contributes to build solid evidence regarding the usefulness of RM in detecting and managing clinical and technical events with limited use of manpower and other health care resources. To fully gain the benefits of RM of PM/ICD, it is vital that organizational processes be streamlined and standardized within an overarching strategy.

The neurosurgical telecounseling network in the Veneto Region: 4 years of experience of HEALTH OPTIMUM.

BACKGROUND: Neurosurgery is a highly specialized service that, because of high costs, is often centralized. Since 2005, a neurosurgical telecounseling service was defined and then deployed in the Veneto Region. It was aimed at creating the same range of services for head trauma by using standardized protocols at regional levels and at rationalizing the use of human and technological resources by providing a network of services that manages patients at the local level. The main objective of the study was to evaluate the use of this service. MATERIALS AND METHODS: Interoperability and flexibility were granted by creating a technological framework based on international standards. Physicians of local hospitals electronically transmit patients' clinical data and images to neurosurgeons located at a central hospital. These physicians respond to the requesting physicians by providing all the necessary recommendations. RESULTS: The outcomes were collected over a period of 41 months. The service is now available in 34 hospitals. Every year 3,181 telecounselings are conducted for patients with an average age of 65.5 years (55% male, 45% female) whose health status is mainly not serious. Within 30 min from the request of telecounseling, 49% of responses are sent. In 84% of cases the patient was not moved. The overall appreciation of clinicians is positive (4.3/5). Intervention time was reduced, and resources were optimized. CONCLUSIONS: The service brought remarkable benefits at the organizational level. The reorganization of the processes and patient management leads to rationalization of both human and technological resources.

Structured reporting using a shared indexed multilingual radiology lexicon.

PURPOSE: A system for creating structured reports (SRs) using a standardized radiology lexicon was developed and tested to facilitate automated translation of content and multidisciplinary international communications. METHODS: A database of radiology terms, RadLex developed by the Radiological Society of North America, was used to create a shared indexed multilingual radiology lexicon. A diagnostic workstation for generating structured reports (OpenEye) was implemented with a "RadLex manager" function for adding new words to the lexicon in both English and Italian. Sample reports of examinations included in the Medical Imaging Resource Center (MIRC) radiology imaging database of clinical cases were prepared using this system. The system was evaluated for teaching purposes and scientific dissemination. RESULTS: The OpenEye system was able to manage the glossary to create new SRs and manually translate existing reports containing freely worded descriptions. The OpenEye system provides instant translation from Italian into English and enables clinical cases to be published in the MIRC, while making them accessible for consultation on an international scale. CONCLUSION: The SR is advantageous compared with a freely worded report in terms of clarity and completeness of the content. Creating SRs for each clinical case enables rapid and focused analysis at multidisciplinary meetings. All our cases have been included in the MIRC database as part of a broader-based European Project for research on soft tissues sarcomas (CONTICANET).

Bone fractal analysis.

Fractal analysis is a quantitative method used to evaluate complex anatomic findings in their elementary component. Its application to biologic images, particularly to cancellous bones, has been well practiced within the past few years. The aims of these applications are to assess changes in bone and the loss of spongious architecture, indicate bone fragility, and to show the increased risk for fracture in primary or secondary osteoporosis. The applications are very promising to help complete the studies that can define bone density (bone mineral density by dual energy x-ray absorptiometry or quantitative computed tomography), and also have the capacity to distinguish the patients with a high or low risk for fracture. Their extension to the clinical fields, to define a test for fracture risk, is still limited by difficult application to the medical quantitative imaging of bones, between correct application at superficial bones and unreliable application to deep bones. The future evolution and validity do not depend upon fractal methods but upon well-detailed imaging of the bones in clinical conditions.