ORCID Profile
0000-0002-7524-227X
Current Organisations
University of Bologna
,
University of Amsterdam
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Publisher: Elsevier BV
Date: 2011
DOI: 10.1016/J.JBMT.2010.03.005
Abstract: Aim of the present study was to investigate the association between osteopathic treatment and hypertension. The design was a non-randomized trial including consecutive subjects affected by hypertension and vascular alterations, using pre-post differences in intima-media thickness, systolic and diastolic blood pressure as primary endpoints. Statistical analysis was based on univariate t tests and multivariate linear regression. A total of N = 31 out of N = 63 eligible subjects followed by a single cardiologist received osteopathic treatment in addition to routine care. Clinical measurements were recorded at baseline and after 12 months. Univariate analysis found that osteopathic treatment was significantly associated to an improvement in all primary endpoints. Multivariate linear regression showed that, after adjusting for all potential confounders, osteopathic treatment was performing significantly better for intima-media thickness (delta between pre-post differences in treated and control groups: -0.517 95% c.i.: -0.680, -0.353) and systolic blood pressure (-4.523 -6.291, -2.755), but not for diastolic blood pressure. Our study shows that, among patients affected by cardiovascular disorders, osteopathic treatment is significantly associated to an improvement in intima-media and systolic blood pressure after one year. Multicentric randomized trials of adequate s le size are needed to evaluate the efficacy of OMT in the treatment of hypertension.
Publisher: Oxford University Press (OUP)
Date: 04-05-2012
Abstract: 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. 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'). 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. 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.
Publisher: Oxford University Press (OUP)
Date: 29-06-2020
Abstract: In the framework of targeted action for continuous safety monitoring, we aimed to evaluate the consistency of indicators derived from available databases for regular reporting. We used a quality of care interpretative model to select characteristics from five national databases, aggregated and linked by homogeneous groups of providers. The target population included all subjects admitted to public hospitals for acute care in four regions of Italy between 2011 and 2013. The association between structures, processes and safety-related outcomes was investigated using odds ratios from generalized estimating equations logistic regression. Outcome measures included claims of malpractice and five patient safety indicators calculated from discharge abstracts using standardized algorithms. Over 3 years, claims of malpractice and sepsis increased, whereas deep vein thrombosis and pulmonary embolism decreased. Hospitals with high vs. low volume of discharges were associated with −16% lower rates of claims, but +12% increased risk of sepsis. Compared with research institutes, university clinics had −17% lower rates of claims and −41% cases of dehiscence, with a +32% increased risk of deep vein thrombosis. Local health care authorities recorded −49% deep vein thrombosis, −26% pulmonary embolism, −40% sepsis and +37% risk of claims. Hospitals submitting cases of safe practices and implementing safety recommendations showed significantly higher rates for most outcome measures. Indicators from regular databases can be conveniently used to develop a national safety monitoring system for hospital care. Although deeper analysis is needed, institutions with a higher propensity to implement safe practices and recommendations consistently showed higher rates of adverse events.
Publisher: S. Karger AG
Date: 11-11-2014
DOI: 10.1159/000363520
Publisher: BMJ
Date: 28-09-0028
DOI: 10.1136/BMJ.M799
Publisher: Springer Science and Business Media LLC
Date: 03-07-2023
DOI: 10.1186/S40001-023-01166-8
Abstract: We investigated the possible role of the immune profile at ICU admission, among other well characterized clinical and laboratory predictors of unfavorable outcome in COVID-19 patients assisted in ICU. Retrospective analysis of clinical and laboratory data collected for all consecutive patients admitted to the ICUs of the General Hospital of Pescara (Abruzzo, Italy), between 1 st March 2020 and 30 th April 2021, with a confirmed diagnosis of COVID-19 respiratory failure. Logistic regressions were used to identify independent predictors of bacteremia and mortality. Out of 431 patients included in the study, bacteremia was present in N = 191 (44.3%) and death occurred in N = 210 (48.7%). After multivariate analysis, increased risk of bacteremia was found for viral reactivation (OR = 3.28 95% CI:1.83–6.08), pronation (3.36 2.12–5.37) and orotracheal intubation (2.51 1.58–4.02). Increased mortality was found for bacteremia (2.05 1.31–3.22), viral reactivation (2.29 1.29–4.19) and lymphocytes 0.6 × 10 3 c/µL (2.32 1.49–3.64). We found that viral reactivation, mostly due to Herpesviridae, was associated with increased risk of both bacteremia and mortality. In addition, pronation and intubation are strong predictors of bacteremia, which in turn together with severe lymphocytopenia due to SARS-CoV2 was associated with increased mortality. Most episodes of bacteremia, even due to Acinetobacter spp, were not predicted by microbiological evidence of colonization.
Publisher: Frontiers Media SA
Date: 11-10-2021
DOI: 10.3389/FCDHC.2021.744516
Abstract: Registries and data sources contain information that can be used on an ongoing basis to improve quality of care and outcomes of people with diabetes. As a specific task of the EU Bridge Health project, we carried out a survey of diabetes-related data sources in Europe. We aimed to report on the organization of different sources of diabetes information, including their governance, information infrastructure and dissemination strategies for quality control, service planning, public health, policy and research. Survey using a structured questionnaire to collect targeted data from a network of collaborating institutions managing registries and data sources in 17 countries in the year 2017. The 18 data sources participating in the study were most frequently academic centres (44.4%), national (72.2%), targeting all types of diabetes (61.1%) covering no more than 10% of the target population (44.4%). Although population-based in over a quarter of cases (27.8%), sources relied predominantly on provider-based datasets (38.5%), fewer using administrative data (16.6%). Data collection was continuous in the majority of cases (61.1%), but 50% could not perform data linkage. Public reports were more frequent (72.2%) as well as quality reports (77.8%), but one third did not provide feedback to policy and only half published ten or more peer reviewed papers during the last 5 years. The heterogeneous implementation of diabetes registries and data sources h ers the comparability of quality and outcomes across Europe. Best practices exist but need to be shared more effectively to accelerate progress and deliver equitable results for people with diabetes.
Publisher: Elsevier BV
Date: 12-2021
DOI: 10.1016/J.PCD.2021.06.003
Abstract: To pilot two dashboards to monitor prescribing of metformin and aspirin according to the National Institute for Health and Care Excellence (NICE) 'Do-Not-Do' recommendations. This quality assurance programme was conducted in twelve general practices of the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. We developed dashboards to flag inappropriate prescribing of metformin and aspirin to people with type 2 diabetes mellitus (T2DM). In Phase 1, six practices (Group A) received a dashboard flagging suboptimal metformin prescriptions in people with reduced renal function. The other six practices (Group B) were controls. In Phase 2, Group B were provided a dashboard to flag inappropriate aspirin prescribing and Group A were controls. We used logistic regression to explore associations between dashboard exposure and inappropriate prescribing. The cohort comprised 5644 in iduals (Group A, n = 2656 Group B, n = 2988). Half (51.6%, n = 2991) were prescribed metformin of which 15 (0.5%) were inappropriate (Group A, n = 10 Group B, n = 5). A fifth (17.6%, n = 986) were prescribed aspirin of which 828 (84.0%) were inappropriate. During Phase 1, metformin was stopped in 50% (n = 5) of people in Group A, compared with 20% (n = 1) in the control group (Group B) in Phase 2, the odds ratio of inappropriate aspirin prescribing was significantly lower in practices that received the dashboard versus control (0.44, 95%CI 0.27-0.72). It was feasible to use a dashboard to flag inappropriate prescribing. Whilst underpowered to report a change in metformin, we demonstrated a reduction in inappropriate aspirin prescribing.
Publisher: Elsevier BV
Date: 04-2015
DOI: 10.1016/J.HEALTHPOL.2014.11.016
Abstract: The European Union needs a common health information infrastructure to support policy and governance on a routine basis. A stream of initiatives conducted in Europe during the last decade resulted into several success stories, but did not specify a unified framework that could be broadly implemented on a continental level. The recent debate raised a potential controversy on the different roles and responsibilities of policy makers vs the public health community in the construction of such a pan-European health information system. While institutional bodies shall clarify the statutory conditions under which such an endeavour is to be carried out, researchers should define a common framework for optimal cross-border information exchange. This paper conceptualizes a general solution emerging from past experiences, introducing a governance structure and overarching framework that can be realized through four main action lines, underpinned by the key principle of "Essential Levels of Health Information" for Europe. The proposed information model is amenable to be applied in a consistent manner at both national and EU level. If realized, the four action lines outlined here will allow developing a EU health information infrastructure that would effectively integrate best practices emerging from EU public health initiatives, including projects and joint actions carried out during the last ten years. The proposed approach adds new content to the ongoing debate on the future activity of the European Commission in the area of health information.
Publisher: JMIR Publications Inc.
Date: 22-04-2022
DOI: 10.2196/35971
Abstract: Social distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. The aim of this study is to explore the impact of the COVID-19 pandemic’s first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A1c (HbA1c) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA1c monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Inter isional Research Ethics Committee (September 2, 2021, reference R77306/RE001). The analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. The COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. DERR1-10.2196/35971
Publisher: Springer Science and Business Media LLC
Date: 11-10-2019
DOI: 10.1007/S00592-019-01423-5
Abstract: International comparisons of diabetes-related lower extremity utation rates are still h ered by different criteria used for data collection and analysis. We aimed to evaluate trends and variation of major/minor utations, using agreed definitions adopted by the Organization for Economic Cooperation and Development in 2015. Direct age-sex standardized rates were calculated per 100,000 subjects per year between 2000 and 2013, using major/minor utations with diabetes diagnosis as numerators and the total population or number of people with diabetes as denominators. Longitudinal trends were investigated using generalized estimating equations. Twenty-one countries reported major utations referred to the general population, showing a mean reduction from 10.8 to 7.5 per 100,000 (- 30.6%). Eleven countries also reported major utations among people with diabetes, showing a mean reduction from 182.9 to 128.3 per 100,000 (- 29.8%). Minor utations remained stable over the study period. Longitudinal trends showed a significant average annual decrease of - 0.19 per 100,000 in the general population (95% CI - 0.36 to - 0.02 p = .03) and - 4.52 per 100,000 among subjects with diabetes (95% CI - 6.09 to - 2.94 p < .001). The coefficient of variation of major utation rates between countries was fairly high (64%-in the total population, 67% among people with diabetes). The study highlighted a clinically significant reduction of major utations, in both the general population and among people with diabetes. The use of standardized definitions, while increasing the comparability of multinational data, highlighted remarkable differences between countries. These results can help identifying and sharing best practices effectively on a global scale.
Publisher: Elsevier BV
Date: 03-2012
DOI: 10.1016/J.HEALTHPOL.2011.11.015
Abstract: The "Tallinn Charter: Health Systems, Health and Wealth" signed by 53 member states of the WHO European Region provides guidance for strengthening health systems. A systematic search was conducted to compare studies and actions related to the commitments of the Tallinn Charter. Target keywords were identified directly from the Charter. Structured web search was conducted on Pubmed/Google. Results for 2007-2010 were analyzed as frequencies before/after the end of the year of signature and classified by relevance and category of content. Searches for 2007-2010 extracted N=717 papers in Medline and N=634 links in Google using combined keywords. Additional N=165 direct links to the Charter were found by Google for 2008-2010. An increase by 18% (scientific literature) and 10% (grey literature) was observed after 2008. The number of conceptual, methodological, analytical or system evaluation reports related to the themes of the Charter increased after 2008, while benchmarking and cross-country comparisons were less frequent. Opposite trends were observed for the grey literature. The implementation of the Tallinn Charter is supported by more information available on the topic. The methodology used to perform a rapid search may be usefully repeated to monitor the process.
Publisher: BMJ
Date: 30-11-2009
Abstract: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. 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. 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. 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.
Publisher: Oxford University Press (OUP)
Date: 05-1997
DOI: 10.1093/OXFORDJOURNALS.EURHEARTJ.A015349
Abstract: Clinical and epidemiological studies support the hypothesis that ischaemic cardiovascular diseases are consistently associated with psychological, social and behavioural factors. Nevertheless, the joint effect of clinical characteristics and psychological variables in determining the prognosis of acute myocardial infarction survivors has been seldom investigated. In the framework of the GISSI-2 trial, the impact of psychological factors on 6-month mortality and their interaction with clinical features was included as an ad hoc research project. Overall, 2449 patients were evaluated, 63 of whom died during the study period. All patients undertook a self-administered questionnaire (Cognitive Behavioural Assessment Hospital Form), investigating 16 psychological dimensions relative to three areas (state variables, vital exhaustion, trait variables). The impact of psychological variables on prognosis and their interaction with clinical variables were investigated by using a tree-growing technique (RECursive Partitioning and AMalgamation-RECPAM) applied to survival analysis. This statistical method allowed the identification of three separate classes, characterized by different prognoses: Class I (presence of vital exhaustion), Class II (concomitance of no vital exhaustion, depression and low levels of anxiety) and Class III (all other patients). After adjusting for the clinical variables, Class I was associated with an intermediate prognosis (hazard ratio [HR] = 2.2 95% confidence intervals [CI], 1.2-4.0) and Class II to the worst (HR = 3.2 95% CI = 1.6-6.2), as compared to Class III. High levels of neuroticism and extroversion were associated with a better prognosis. When clinical and psychological variables were simultaneously investigated by RECPAM, Type A behaviour was shown to be an important risk predictor among patients with better clinical conditions, i.e. those eligible for exercise test (HR = 2.6, 95% CI = 1.2-5.5). Finally, a striking difference in the impact of the most predictive clinical variables (exercise test ineligibility, late and early ventricular failure) was found among patients with and without vital exhaustion. This study shows that acute myocardial infarction survivors are heterogeneous with respect to 6-month mortality according to their psychological profile. More important, the impact of these variables appears comparable to that of very well known clinical risk predictors. The availability of a large study population, together with the use of innovative statistical techniques, allowed us to identify subgroups of patients for whom the joint action of clinical and psychological characteristics has been clearly documented. This suggests the need for incorporating psychological evaluation in the care of acute myocardial infarction patients.
Publisher: Elsevier BV
Date: 12-2006
Publisher: Springer Science and Business Media LLC
Date: 28-06-2011
Publisher: Springer Science and Business Media LLC
Date: 21-07-2016
Publisher: Elsevier BV
Date: 12-1999
DOI: 10.1016/S0002-8703(99)70070-0
Abstract: The efficacy of reperfusion therapy after acute myocardial infarction is time dependent. The risk profile of every patient should be available as soon as possible. Our aim was to determine whether collection of simple clinical markers at hospital admission might allow reliable risk stratification for in-hospital mortality. The subjects were 11,483 patients with acute myocardial infarction from the GISSI-2 cohort. The GISSI-1 and GISSI-3 populations were selected to validate the classification. To stratify patients, the tree-growing method called recursive partitioning and amalgamation (RECPAM) was used. This method is used to identify homogeneous and distinct subgroups with respect to outcome. The RECPAM algorithm provided 6 classes. RECPAM class I included Killip class 3 to class 4 patients (516 deaths/1000). RECPAM class II included Killip 2 patients older than 66 years and with anterior infarction or sites of infarction that could not be evaluated (314 deaths/1000). Killip 1 patients older than 75 years and with anterior or multiple sites or sites that could not be evaluated were included in RECPAM class III with Killip class 2 patients younger than 66 years and with systolic blood pressure less than 120 mm Hg or older than 66 years and with any other infarction site (207 deaths/1000). The other classes showed lower mortality rates (91, 32, and 12 deaths/1000 for RECPAM classes IV, V, and VI). In the GISSI 1 and GISSI 3 s les the 6 classes ranked in the same order in terms of mortality rate. With respect to low-risk strata, patients belonging to RECPAM class VI without serious clinical events in the first 4 days had a very low incidence of in-hospital death (0.9%) or morbidity. Cumulative 6-month mortality for the 6 RECPAM classes was 59.6%, 41.2%, 26.4%, 12.9%, 4. 8%, and 2.2%. Four simple clinical markers readily available at admission of patients with myocardial infarction allow a quick, reliable, and inexpensive prediction of risk for in-hospital and 6-month mortality. The RECPAM classification also helped identify a large subgroup of patients fit for early hospital discharge.
Publisher: Wiley
Date: 02-1997
DOI: 10.1002/(SICI)1096-9136(199702)14:2<158::AID-DIA319>3.0.CO;2-2
Publisher: Elsevier BV
Date: 03-1995
DOI: 10.1016/0895-4356(94)00148-J
Abstract: To assess appropriateness of surgical care delivered to breast cancer patients in Italy and quantify the use of unnecessary radical procedures, a retrospective charts review of patients treated in 1988-1989 was conducted. A series of 1724 consecutive patients (median age 61 years range 17-89) treated in 63 hospitals selected from within 8 regions with newly diagnosed operable breast carcinoma was evaluated. Overall, 541 (38%) patients had inappropriate surgery with more than two thirds of it being accounted for by the use of unnecessary mutilating Halsted mastectomy. Substantial geographic variation emerged in the overall rates of appropriateness (range 88-52%) which were not substantially affected by allowance for imbalances in patient- and hospital-related variables. Despite the important contribution given by Italian clinical researchers to the demonstration that less radical surgery can be as good as more radical procedures, still a substantial proportion of breast cancer patients are treated too aggressively. Besides pointing to the urgent need of interventions aimed at facilitating the process of technology transfer in order to promote more appropriate surgical care, these results suggest that efforts to increase patients' participation into treatment decision and awareness about alternative treatment options are warranted.
Publisher: Wiley
Date: 12-1996
DOI: 10.1002/(SICI)1096-9136(199612)13:12<1017::AID-DIA252>3.0.CO;2-Z
Abstract: IgG4-related ophthalmic disease (IgG4ROD) is a phenotype of IgG4-related disease (IgG4RD) with ophthalmic involvement. The pathological IgG4+ plasmacyte count has only been used for diagnosis. We aimed to explore its possible clinical value in the management of IgG4ROD. Fifty-five pathologically diagnosed IgG4ROD patients were included, and their clinical, pathological, serological, and radiological findings and treatment outcomes were reviewed and analyzed. The pathological IgG4+ plasmacyte counts in lesions from different anatomic sites were compared, and their association with serum IgG4 concentrations, systemic involvement, and relapse risk was analyzed. The patients were ided into groups according to the anatomic site of their biopsied lesions, namely, the lacrimal gland, extraocular muscle, and orbital soft tissue. No significant difference was found in the pathological IgG4+ plasma cell counts among these groups (p = 0.975). The pathological IgG4+ plasmacyte count positively correlated with the IgG4 concentration in peripheral blood (R Lesions from different ophthalmic sites in IgG4ROD patients have similar counts of IgG4+ and IgG+ plasmacytes. The quantity of pathological IgG4+ plasmacytes corresponded to the serum IgG4 concentration in patients with IgG4ROD and could be meaningful in identifying systemic involvement and predicting subsequent relapse.
Publisher: Elsevier BV
Date: 1998
DOI: 10.1016/S1056-8727(97)00001-9
Abstract: Diabetic lower extremity complications may be influenced by a number of factors, including those related to the interaction between patients and the health-care system. Our objective is to identify risk factors for the development of lower limb complications, by looking for classical clinical variables and those related to quality of care. A case-control study was carried out between December 1993 and June 1994 by interviewing 348 patients with lower-limb diabetic complications and 1050 controls enrolled from 35 diabetes outpatient clinics and 49 general practitioner's offices in Italy. Among sociodemographic characteristics associated with increased risk of lower limb complications were male gender [odds ratio (OR) = 2.5, confidence interval (CI) 1.6-3.9], age between 50 and 70 years as opposed to younger than 50 (OR = 3.6, CI 2.1-6.3) and being single as opposed to married (OR = 1.4, CI 1.1-1.8). Among clinical variables, treatment with insulin for IDDM and NIDDM patients was an important predictor of lower extremity complications compared to NIDDM patients not being treated with insulin. Cardio-cerebrovascular disease and presence of diabetic neuropathy were associated with a higher risk of being a case (OR = 1.4, CI 1.2-1.8 and OR = 3.0, CI 2.1-4.2, respectively). Patients who needed help to reach the health facility before the onset of the complications and those who did not attend health facilities regularly were more liable to develop complications (OR = 1.5, CI 1.1-2.2 and OR = 2.0, CI 1.3-3.0, respectively). Patients who had never received educational intervention had a threefold risk of being a case as compared to those who received health information regularly. The study identifies factors most likely to be related to adverse outcome and permits to discriminate between avoidable and unavoidable factors.
Publisher: Georg Thieme Verlag KG
Date: 2016
DOI: 10.3414/ME15-01-0016
Abstract: 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.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 30-04-2021
Publisher: BMJ
Date: 05-12-2013
DOI: 10.1136/MEDETHICS-2013-101603
Abstract: The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services,but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government,corporate or market research, falls under the same rule.The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical,administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.
Publisher: American Diabetes Association
Date: 10-1996
DOI: 10.2337/DIACARE.19.10.1091
Abstract: The aim of this meta-analysis was to review the existent evidence on the effectiveness of tolrestat in the treatment of diabetic peripheral neuropathy. In idual patient data on 738 subjects from the three randomized clinical trials published on this topic were analyzed using changes in motor nerve conduction velocities (NCVs) as endpoints. Nerves investigated included median, ulnar, tibial, and peroneal. The pooled analysis of NCV taken as a continuous measurement showed a significant treatment effect, the magnitude of this benefit being approximately equal to 1 m/s for all the nerves investigated. When looking at the proportion of patients experiencing a loss of NCV of at least 1 or 2 m/s in at least two out of the four nerves investigated, it emerged that treatment reduced by & 40% the risk of such outcomes after adjusting for patients' characteristics. The odds ratios relative to the placebo group were 1.82 (1.30–2.52) and 1.70 (1.15–2.48) for a decrease of 1 and 2 m/s, that is, placebo-treated patients have an 82 and 70% increased risk for a loss of nerve function of 1 and 2 m/s, respectively. No statistically significant difference in treatment effect emerged after stratification according to baseline motor NCV and glycated hemoglobin levels. After a treatment duration ranging between 24–52 weeks, patients treated with tolrestat had a reduced risk for developing nerve function loss compared with placebo-treated patients. Future long-term trials are needed to evaluate the impact of the treatment on more clinically meaningful endpoints such as the development of foot complications.
Publisher: American Diabetes Association
Date: 09-1998
DOI: 10.2337/DIACARE.21.9.1439
Abstract: The aim of this study was to identify subgroups of patients for whom the interactions among clinical, socioeconomic, and care-related factors determine a substantial increase in the risk of developing long-term diabetic complications. We performed a case-control study aimed at identifying and quantifying the risk factors for the development of major diabetic complications (eye, renal, and lower limb complications) in type 1 and type 2 diabetic patients. A total of 886 patients with renal, eye, or lower limb complications and 1,888 control subjects were enrolled in 35 diabetes outpatient clinics and 49 general practitioners' offices in 17 out of the 20 Italian regions. The main results were obtained using recursive partitioning and amalgamation (RECPAM), a technique that attempts to integrate the advantages of main effect logistic regression and tree-growing. The application of RECPAM led to the detection of important interactions involving clinical, socioeconomic, and care-related characteristics and allowed the identification of internally homogeneous subgroups characterized by a marked difference in the risk of developing major complications. In type 1 diabetic patients, the interaction between hypertension and smoking habits led to a dramatic increase in the complication risk, while in type 2 diabetic subjects, a poor compliance with visit scheduling was the most important predictor of complications. Furthermore, a marked difference in the risk profile was associated with patient characteristics (age, years of education, occupation). In the definition of the risk profile for each in idual patient, socioeconomic status and level of education need to be taken under serious consideration, since they can determine a complication risk not dissimilar from hard clinical variables, such as hypertension and diabetes duration. Specific educational interventions, targeted to the socially disadvantaged strata of the population, need to be designed and implemented.
Publisher: Springer Science and Business Media LLC
Date: 14-07-2020
DOI: 10.1186/S12961-020-00593-X
Abstract: The COVID-19 pandemic is a complex global public health crisis presenting clinical, organisational and system-wide challenges. Different research perspectives on health are needed in order to manage and monitor this crisis. Performance intelligence is an approach that emphasises the need for different research perspectives in supporting health systems’ decision-makers to determine policies based on well-informed choices. In this paper, we present the viewpoint of the Innovative Training Network for Healthcare Performance Intelligence Professionals (HealthPros) on how performance intelligence can be used during and after the COVID-19 pandemic. A lack of standardised information, paired with limited discussion and alignment between countries contribute to uncertainty in decision-making in all countries. Consequently, a plethora of different non-data-driven and uncoordinated approaches to address the outbreak are noted worldwide. Comparative health system research is needed to help countries shape their response models in social care, public health, primary care, hospital care and long-term care through the different phases of the pandemic. There is a need in each phase to compare context-specific bundles of measures where the impact on health outcomes can be modelled using targeted data and advanced statistical methods. Performance intelligence can be pursued to compare data, construct indicators and identify optimal strategies. Embracing a system perspective will allow countries to take coordinated strategic decisions while mitigating the risk of system collapse.A framework for the development and implementation of performance intelligence has been outlined by the HealthPros Network and is of pertinence. Health systems need better and more timely data to govern through a pandemic-induced transition period where tensions between care needs, demand and capacity are exceptionally high worldwide. Health systems are challenged to ensure essential levels of healthcare towards all patients, including those who need routine assistance. Performance intelligence plays an essential role as part of a broader public health strategy in guiding the decisions of health system actors on the implementation of contextualised measures to tackle COVID-19 or any future epidemic as well as their effect on the health system at large. This should be based on commonly agreed-upon standardised data and fit-for-purpose indicators, making optimal use of existing health information infrastructures. The HealthPros Network can make a meaningful contribution.
Publisher: American Diabetes Association
Date: 09-1996
Abstract: To identify and quantify risk factors for the development of long-term diabetic complications (i.e., critical limb ischemia, utation, chronic renal failure [creatinine & 3 mg/dl], dialysis treatment, proliferative retinopathy, blindness), with particular emphasis on those variables that, being related to quality of care, can be considered avoidable. We designed a case-control study that enrolled 886 patients with long-term diabetic complications and 1,888 control subjects without complications from 35 diabetic outpatient clinics and 49 general practitioners' offices during a 6-month period. Selected socioeconomic, pathophysiologic, self-care, health care, and lifestyle information were collected for all patients. A logistic regression analysis showed that several factors are related to the development of major diabetic complications. Among patient characteristics, male sex (odds ratio [OR] = 1.8, 95% CI 1.4–2.3) and age (OR = 1.7, 95% CI 1.2–2.4 for patients between 50 and 69 years of age as opposed to those younger than 50 years of age) were associated with an increased risk of complication. Among clinical variables, the type and the duration of diabetes were the most important predictors of diabetic complications. The presence of hypertension was also associated with the development of diabetic complications, particularly when it was poorly controlled by treatment (OR = 3.1, 95% CI 2.3–4.3). Patients who needed help to reach a health care facility and those who did not regularly attend such a facility were at higher risk of developing complications (OR = 1.5, 95% CI 1.2–1.9 OR = 1.7, 95% CI 1.3–2.2, respectively). Educational aspects were also related to the outcome: patients who did not receive any kind of educational intervention had an increased risk of developing complications (OR = 4.1, 95% CI 1.7–9.7), while self-management of insulin therapy had a protective effect (OR = 0.6, 95% CI 0.5–0.8). The summary attributable risk related to avoidable risk factors (i.e., uncontrolled hypertension, poor compliance with visit scheduling, inadequate diabetes education, no self-management of insulin treatment) was 0.39. Our data suggest that, by removing avoidable risk factors, the number of diabetic complications considered could be reduced by more than one-third. The case-control methodology represents an efficient way of monitoring clinical practice and relating it to important outcomes. It can be of help for policy makers in identifying the more effective strategies and in tailoring specific interventions aimed at improving the quality of the care delivered to diabetic patients.
Publisher: Oxford University Press (OUP)
Date: 29-05-2023
DOI: 10.1093/EURHEARTJ/EHAD260
Abstract: To develop and validate a recalibrated prediction model (SCORE2-Diabetes) to estimate the 10-year risk of cardiovascular disease (CVD) in in iduals with type 2 diabetes in Europe. SCORE2-Diabetes was developed by extending SCORE2 algorithms using in idual-participant data from four large-scale datasets comprising 229 460 participants (43 706 CVD events) with type 2 diabetes and without previous CVD. Sex-specific competing risk-adjusted models were used including conventional risk factors (i.e. age, smoking, systolic blood pressure, total, and HDL-cholesterol), as well as diabetes-related variables (i.e. age at diabetes diagnosis, glycated haemoglobin [HbA1c] and creatinine-based estimated glomerular filtration rate [eGFR]). Models were recalibrated to CVD incidence in four European risk regions. External validation included 217 036 further in iduals (38 602 CVD events), and showed good discrimination, and improvement over SCORE2 (C-index change from 0.009 to 0.031). Regional calibration was satisfactory. SCORE2-Diabetes risk predictions varied several-fold, depending on in iduals’ levels of diabetes-related factors. For ex le, in the moderate-risk region, the estimated 10-year CVD risk was 11% for a 60-year-old man, non-smoker, with type 2 diabetes, average conventional risk factors, HbA1c of 50 mmol/mol, eGFR of 90 mL/min/1.73 m2, and age at diabetes diagnosis of 60 years. By contrast, the estimated risk was 17% in a similar man, with HbA1c of 70 mmol/mol, eGFR of 60 mL/min/1.73 m2, and age at diabetes diagnosis of 50 years. For a woman with the same characteristics, the risk was 8% and 13%, respectively. SCORE2-Diabetes, a new algorithm developed, calibrated, and validated to predict 10-year risk of CVD in in iduals with type 2 diabetes, enhances identification of in iduals at higher risk of developing CVD across Europe.
Publisher: Elsevier BV
Date: 11-2012
DOI: 10.1016/J.HEALTHPOL.2012.07.010
Abstract: The Italian National Health Plan 2011-2013 expressly recognizes the Tallinn Charter as the most solid international reference for the definition of National priorities. At sub-national level, many regions apply performance monitoring as an integral part of quality improvement policies. A national workshop allowed reviewing the state of the art of performance monitoring in Italian regions and Autonomous Provinces in relation to the Tallinn Charter. Participants included representatives of regions and Autonomous Provinces, the National Agency of Regional Health Services, the Italian Ministry of Health and WHO Europe. Six specific questions were used to facilitate brainstorming and to collect updated information. A total of eighteen regions out of twenty-one participated in the meeting. Ten regions were found to use different systems for performance evaluation: two adopting a unique balanced scorecard, two applying different systems for different levels of governance, six using a structured multidimensional system. Different organizational and operational capacities affect the ability to uptake information for policy making. Italian regions are striving to respond to the collective need of performance improvement, through an increased production of systems of indicators and achievement reports that still need to be made comparable across the country. The Tallinn Charter may provide a common platform to improve and share best practices in performance monitoring. The experience of Italian regions is relevant for the international debate and provides specific responses to general questions that can be usefully applied in other decentralized contexts.
Publisher: Springer Science and Business Media LLC
Date: 19-08-2022
DOI: 10.1186/S12913-022-08421-4
Abstract: The hospital management of patients diagnosed with COVID-19 can be h ered by heterogeneous characteristics at entry into the emergency department. We aimed to identify demographic, clinical and laboratory parameters associated with higher risks of hospitalisation, oxygen support, admission to intensive care and death, to build a risk score for clinical decision making at presentation to the emergency department. We carried out a retrospective study using linked administrative data and laboratory parameters available in the initial phase of the pandemic at the emergency department of the regional reference hospital of Pescara, Abruzzo, Italy, March–June 2020. Logistic regression and Cox modelling were used to identify independent predictors for risk stratification. Validation was carried out collecting data from an extended timeframe covering other variants of concern, including Alpha (December 2020–January 2021) and Delta/Omicron (January–March 2022). Several clinical and laboratory parameters were significantly associated to the outcomes of interest, independently from age and gender. The strongest predictors were: for hospitalisation, monocyte distribution width ≥ 22 (4.09 2.21–7.72) and diabetes (OR = 3.04 1.09–9.84) for oxygen support: saturation 95% (OR = 11.01 3.75–41.14), lactate dehydrogenase≥237 U/L (OR = 5.93 2.40–15.39) and lymphocytes 1.2 × 10 3 /μL (OR = 4.49 1.84–11.53) for intensive care, end stage renal disease (OR = 59.42 2.43–2230.60), lactate dehydrogenase≥334 U/L (OR = 5.59 2.46–13.84), D-dimer≥2.37 mg/L (OR = 5.18 1.14–26.36), monocyte distribution width ≥ 25 (OR = 3.32 1.39–8.50) for death, procalcitonin≥0.2 ng/mL (HR = 2.86 1.95–4.19) and saturation 96% (HR = 2.74 1.76–4.28). Risk scores derived from predictive models using optimal thresholds achieved values of the area under the curve between 81 and 91%. Validation of the scoring algorithm for the evolving virus achieved accuracy between 65 and 84%. A set of parameters that are normally available at emergency departments of any hospital can be used to stratify patients with COVID-19 at risk of severe conditions. The method shall be calibrated to support timely clinical decision during the first hours of admission with different variants of concern.
Publisher: Springer Berlin Heidelberg
Date: 16-04-2012
Publisher: Elsevier BV
Date: 12-2006
Publisher: JMIR Publications Inc.
Date: 24-12-2021
Abstract: ocial distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. he aim of this study is to explore the impact of the COVID-19 pandemic’s first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A sub c /sub (HbA sub c /sub ) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA sub c /sub monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Inter isional Research Ethics Committee (September 2, 2021, reference R77306/RE001). he analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. he COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. ERR1-10.2196/35971
Publisher: Springer Science and Business Media LLC
Date: 14-11-2022
DOI: 10.1186/S12879-022-07803-7
Abstract: Monocyte Distribution Width (MDW), a simple cellular marker of innate monocyte activation, can be used for the early recognition of sepsis. We performed an observational prospective monocentric study to assess the predictive role of MDW in detecting sepsis in a s le of consecutive patients presenting at the Emergency Department. Prospective observational study using demographic and clinical characteristics, past medical history and other laboratory measurements to predict confirmed sepsis using multivariate logistic regression. A total of 2724 patients were included in the study, of which 272 (10%) had sepsis or septic shock. After adjusting for known and potential risk factors, logistic regression found the following independent predictors of sepsis: SIRS equal to 1 (OR: 2.32, 1.16–4.89) and 2 or more (OR: 27.8, 14.8–56.4), MDW 22 (OR: 3.73, 2.46–5.70), smoking (OR: 3.0, 1.22–7.31), end stage renal function (OR: 2.3, 1.25–4.22), neurodegenerative disease (OR: 2.2, 1.31–3.68), Neutrophils ≥ 8.9 × 10 3 /µL (OR: 2.73, 1.82–4.11), Lymphocytes 1.3 × 10 3 /µL (OR: 1.72, 1.17–2.53) and CRP ≥ 19.1 mg/L (OR: 2.57, 1.63–4.08). A risk score derived from predictive models achieved high accuracy by using an optimal threshold (AUC: 95% 93–97%). The study suggests that incorporating MDW in the clinical decision process may improve the early identification of sepsis, with minimal additional effort on the standard procedures adopted during emergency care.
Publisher: American Psychiatric Association Publishing
Date: 02-2018
DOI: 10.1176/APPI.PS.201600460
Abstract: Patients with schizophrenia have a high prevalence of diabetes, but data on diabetes care quality for these patients are limited. This nationwide study compared the quality of diabetes care among in iduals with and without schizophrenia and identified predictors of care quality. In a population-based cohort study, 83,813 in iduals with diabetes seen at hospital outpatient clinics between 2005 and 2013, including 669 with comorbid schizophrenia, were identified from Danish registries. High-quality diabetes care was defined as having received ≥80% of guideline-recommended process performance measures. Variables assessed as predictors of diabetes care included patient-specific (sex, age, smoking, substance abuse, Global Assessment of Functioning score, and duration of schizophrenia), provider-specific (quality of schizophrenia care), and system-specific (annual patient contact volume of the diabetes clinic) factors. Compared with in iduals with diabetes only, those with diabetes and schizophrenia were less likely to receive high-quality diabetes care (relative risk [RR]=.91, 95% confidence interval [CI]=.88-.95) and less likely to receive several in idual process performance measures of diabetes care, including blood pressure monitoring (RR=.98, CI=.96-.99), treatment with antihypertensive drugs (RR=.83, CI=.70-.97) and angiotensin-converting enzyme/angiotensin II receptor inhibitors (RR=.72, CI=.55-.93), screening for albuminuria (RR=.96, CI=.93-.99), eye examination at least once every second year (RR=.97, CI=.94-.99), and foot examination (RR=.96, CI=.93-.99). Predictors of poor diabetes care among in iduals with schizophrenia included documented drug abuse and low contact volume of the diabetes clinic. In iduals with schizophrenia received lower-quality diabetes care compared with those without schizophrenia. However, absolute differences in care were modest.
Publisher: Oxford University Press (OUP)
Date: 23-07-2011
Publisher: Cold Spring Harbor Laboratory
Date: 24-11-2021
DOI: 10.1101/2021.11.23.21266747
Abstract: Governments across the WHO European Region prioritized dashboards for reporting COVID-19 data. The ubiquitous use of dashboards for public reporting is novel. This study explores the development of COVID-19 dashboards during the pandemic’s first year and common barriers, enablers and lessons from the experiences of teams responsible for their development. Multiple methods were applied to identify and recruit COVID-19 dashboard teams using a purposive, quota s ling approach. Semi-structured group interviews were conducted between April– June 2021. Using elaborative coding and thematic analysis, descriptive and explanatory themes were derived from interview data. A validation workshop with study participants was held in June 2021. Eighty informants, representing 33 national COVID-19 dashboard teams across the WHO European Region participated. Most dashboards were launched swiftly in the first months of the pandemic, between February–May 2020. The urgency, intense workload, limited human resources, data and privacy constraints, and public scrutiny were common to the initial development stage. Themes related to barriers or enablers were identified pertaining to the pre-pandemic context, pandemic itself, people and processes, software, data, and users. Lessons emerged around the themes of simplicity, trust, partnership, software and data, and change. COVID-19 dashboards were developed in a learning-by-doing approach. The experiences of teams signal initial under-preparedness was compensated by high-level political endorsement, the professionalism of teams, accelerated data improvements, and immediate support of commercial software solutions. To leverage the full potential of dashboards, investments are needed at team-, national- and pan-European-level.
Publisher: Wiley
Date: 20-05-2021
DOI: 10.1111/HEX.13231
Abstract: Patient‐centredness has been targeted by the Italian government as a key theme for the future development of health services. Measuring patient‐centred health services in partnership with citizens, health professionals and decision makers. National participatory survey in a large test set of hospitals at national level. A total of 387 hospital visits conducted in 16 Italian regions by over 1,500 citizens and health professionals during 2017‐2018. An ad hoc checklist was used to assess person‐centredness in hospital care through 243 items, grouped in 4 main areas, 12 sub‐areas and 29 person‐centred criteria (scored 0‐10). GEE linear multivariate regression was used to explore the relation between hospital characteristics and person‐centredness. Person‐centred scores were moderately high, with substantial variation overall (median score: 7.0, range: 3.2‐9.5) and by area (Care Processes: 6.8, 2.0‐9.8 Access: 7.4, 2.7‐9.7 Transparency: 6.7, 3.4‐9.5 and Relationship: 7.3, 0.8‐10.0). Multivariate regression found higher scores for increasing volumes of activity (quartile increase: +0.21 95% CI: 0.13, 0.29) and lower scores in the south and islands (−1.03 −1.62,‐0.45). The checklist has been applied successfully by over 1,500 collaborators who assessed hospitals in 16 distinct Regions and Autonomous Provinces of Italy. Despite an overall positive mark, all scores were highly variable by location and hospital characteristics. A national participatory programme to improve patient‐centredness in Italian hospitals highlighted critical areas with the direct input of citizens.
Publisher: SAGE Publications
Date: 2022
DOI: 10.1177/20552076221121154
Abstract: Governments across the World Health Organization (WHO) European Region have prioritised dashboards for reporting COVID-19 data. The ubiquitous use of dashboards for public reporting is a novel phenomenon. This study explores the development of COVID-19 dashboards during the first year of the pandemic and identifies common barriers, enablers and lessons from the experiences of teams responsible for their development. We applied multiple methods to identify and recruit COVID-19 dashboard teams, using a purposive, quota s ling approach. Semi-structured group interviews were conducted from April to June 2021. Using elaborative coding and thematic analysis, we derived descriptive and explanatory themes from the interview data. A validation workshop was held with study participants in June 2021. Eighty informants participated, representing 33 national COVID-19 dashboard teams across the WHO European Region. Most dashboards were launched swiftly during the first months of the pandemic, February to May 2020. The urgency, intense workload, limited human resources, data and privacy constraints and public scrutiny were common challenges in the initial development stage. Themes related to barriers or enablers were identified, pertaining to the pre-pandemic context, pandemic itself, people and processes and software, data and users. Lessons emerged around the themes of simplicity, trust, partnership, software and data and change. COVID-19 dashboards were developed in a learning-by-doing approach. The experiences of teams reveal that initial underpreparedness was offset by high-level political endorsement, the professionalism of teams, accelerated data improvements and immediate support with commercial software solutions. To leverage the full potential of dashboards for health data reporting, investments are needed at the team, national and pan-European levels.
Publisher: Swansea University
Date: 22-02-2018
Abstract: Information is increasingly digital, creating opportunities to respond to pressing issues about human populations in near real time using linked datasets that are large, complex, and erse. The potential social and in idual benefits that can come from data-intensive science are large, but raise challenges of balancing in idual privacy and the public good, building appropriate socio-technical systems to support data-intensive science, and determining whether defining a new field of inquiry might help move those collective interests and activities forward. A combination of expert engagement, literature review, and iterative conversations led to our conclusion that defining the field of Population Data Science (challenge 3) will help address the other two challenges as well. We define Population Data Science succinctly as the science of data about people and note that it is related to but distinct from the fields of data science and informatics. A broader definition names four characteristics of: data use for positive impact on citizens and society bringing together and analyzing data from multiple sources finding population-level insights and developing safe, privacy-sensitive and ethical infrastructure to support research. One implication of these characteristics is that few people possess all of the requisite knowledge and skills of Population Data Science, so this is by nature a multi-disciplinary field. Other implications include the need to advance various aspects of science, such as data linkage technology, various forms of analytics, and methods of public engagement. These implications are the beginnings of a research agenda for Population Data Science, which if approached as a collective field, can catalyze significant advances in our understanding of trends in society, health, and human behavior.
Publisher: Springer Science and Business Media LLC
Date: 10-06-1999
Abstract: To assess the efficacy, safety and extent of perceived indications of acarbose, a new antidiabetic agent, under routine clinical practice conditions in an unselected Northern Italian population of type II diabetic patients. The study population was assigned to three different groups according to the physician's clinical judgement: group A (acarbose considered as an elective treatment) group B (acarbose considered to be of uncertain benefit): group C (acarbose deemed not to be appropriate). Group B patients were randomized either to continue their standard treatment or to add acarbose to it. Patients with type II diabetes mellitus were recruited from 17 diabetes outpatient clinics from one Italian region (Lombardy). A total of 1027 patients were recruited (group A: 283 group C: 494 group B: 250, of whom 124 were randomly assigned to standard treatment + acarbose and 126 to standard treatment alone). Acarbose was administered for 1 year at a median dose of 100 mg 3 times daily. Drug efficacy was evaluated in terms of mean HbAlc, pre- and post-prandial glycaemic values. Additional endpoints were the proportion of patients with HbA1c levels below 8% at the end of the study period and the proportion of subjects who needed a modification in the standard treatment. The safety and tolerability profiles of the drug were also investigated. Data on HbA1c, fasting and post-prandial blood glucose levels were analysed over time using repeated-measures analysis [Generalized Estimating Equation (GEE) models]. The analysis of Group B showed that, after treatment for 1 year, the mean reduction in HbA1c levels in the acarbose group with respect to the control group was 0.30% (95% confidence limits -0.60 +0.02 P = 0.07), while the mean reduction in post-prandial glycaemia was 17 mg-dl(-1) (95% c.l. -33.5 -0.8 P = 0.04). No difference resulted for fasting blood glucose levels. When looking at the baseline HbA1c levels, it emerged that the mean benefit associated with the use of acarbose was 0.14% (95% c.l. -0.6 +0.28 P = 0.5) in patients with HbAlc levels below 8%, 0.28% (95% c.l. -0.6 +0.05 P = 0.09) in those with values between 8% and 9.9% and 0.65% (95% c.l. -1.36 +0.06 P = 0.07) in those with values > or =10%. Only patients treated with diet+/-oral anti-diabetic agents (OAA) benefited from acarbose treatment (mean benefit = 0.37%, 95% c.l. -0.65 -0.08), while no effect was shown for insulin-treated subjects. The proportion of patients with HbA1c below 8% increased from 31% to 44% in the acarbose group and from 40% to 45% in the control group (absolute difference between baseline and end-of-study values = 8.0% in favour of acarbose-treated patients P = 0.058). Patients treated with acarbose were significantly more likely to undergo a dose reduction in concomitant diabetic treatments compared with the control group they were also less likely to require an increase in the dose of standard treatment and to start insulin during the study period. One third of the patients could not assume the drug for the whole study period, mainly due to gastrointestinal side-effects. The design adopted in this study allowed an integrated evaluation of the overall effectiveness of acarbose in clinical practice. The benefits of the drug in an unselected population of non-insulin-dependent diabetes mellitus (NIDDM) patients are significant but of marginal clinical relevance. Only a better definition of the subgroups of patients who are more likely to benefit from long-term treatment, particularly through possible postponement of secondary OAA failure, will allow a reliable definition of the cost-effectiveness of this complementary component of anti-diabetic strategy.
Publisher: Wiley
Date: 20-03-2020
DOI: 10.1111/DME.14286
Publisher: BMJ
Date: 27-03-2020
DOI: 10.1136/MEDETHICS-2019-105948
Abstract: Data processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union (EU) General Data Protection Regulation (GDPR). We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health. Computerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results. A total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage (median, range of adoption: 45%, 30%–80%), access and accuracy of personal data (50%, 0%–100%) and anonymisation procedures (56%, 11%–100%). A high variability was noted in the application of privacy principles. A comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy.
Publisher: Hindawi Limited
Date: 14-06-2022
DOI: 10.1155/2022/7414258
Abstract: Aims. To compare different packages of care across care providers in Scotland on foot-related outcomes. Methods. A retrospective cohort study with primary and secondary care electronic health records from the Scottish Diabetes Registry, including 6,845 people with type 2 diabetes and a first foot ulcer occurring between 2013 and 2017. We assessed the association between exposure to care processes and major lower extremity utation and death. Proportional hazards were used for time-to-event univariate and multivariate analyses, adjusting for case-mix characteristics and care processes. Results were expressed in terms of hazard ratios with 95% confidence intervals. Results. 2,243 (32.7%) subjects had a major utation or death. Exposure to all nine care processes at all ages ( HR = 0.63 95% CI: 0.58-0.69 p .001 ) and higher foot care attendance in people aged years ( HR = 0.88 0.78-0.99 p = .03 ) were associated with longer major utation-free survival. Waiting time ≥ 12 weeks between ulceration and clinic attendance was associated with worse outcomes ( HR = 1.59 1.37-1.84 p .001 ). In people 70 years, minor utations were associated with improved major utation-free survival ( HR = 0.69 0.52-0.92 p = .01 ). Conclusions. Strict adherence to a standardised package of general diabetes care before foot ulceration, timely foot care after ulceration, and specific treatment pathways were associated with longer major utation-free survival among a large cohort of people with type 2 diabetes in Scotland, with a larger impact on older age groups.
Publisher: Oxford University Press (OUP)
Date: 10-03-2015
Abstract: To review and update the conceptual framework, indicator content and research priorities of the Organisation for Economic Cooperation and Development's (OECD) Health Care Quality Indicators (HCQI) project, after a decade of collaborative work. A structured assessment was carried out using a modified Delphi approach, followed by a consensus meeting, to assess the suite of HCQI for international comparisons, agree on revisions to the original framework and set priorities for research and development. International group of countries participating to OECD projects. Members of the OECD HCQI expert group. A reference matrix, based on a revised performance framework, was used to map and assess all seventy HCQI routinely calculated by the OECD expert group. A total of 21 indicators were agreed to be excluded, due to the following concerns: (i) relevance, (ii) international comparability, particularly where heterogeneous coding practices might induce bias, (iii) feasibility, when the number of countries able to report was limited and the added value did not justify sustained effort and (iv) actionability, for indicators that were unlikely to improve on the basis of targeted policy interventions. The revised OECD framework for HCQI represents a new milestone of a long-standing international collaboration among a group of countries committed to building common ground for performance measurement. The expert group believes that the continuation of this work is paramount to provide decision makers with a validated toolbox to directly act on quality improvement strategies.
Publisher: Springer Science and Business Media LLC
Date: 27-06-2007
Abstract: On a regional level, our aims were to describe rehabilitation patterns for elderly patients with stroke and hip fracture and to investigate mortality risk during the 6-month post acute period. Data sources included administrative data relative to patients aged 65+ resident in Tuscany admitted in hospital for stroke or hip fracture between 2001 and 2003, traced up to 3 years before and 6 months following index admission. The study design involves computerized linkage of administrative data, and an exploratory analysis of the association between rehabilitation patterns and 6-month mortality, adjusting for clinical, demographic, and acute-related care characteristics using multivariate Cox regression. Rehabilitation patterns vary greatly across Tuscany with considerable cost implications. Six month mortality risk for stroke patients is significantly lower among residents of Local Health Authorities where patients are more frequently rehabilitated, specifically in extra-hospital settings. Our study, targeting two crucial conditions for elderly patients, found a high variability of rehabilitation patterns across a region, albeit coherent between the two pathologies, associated with remarkable differences in average expenditure. Differences in hazard rates for 6-month mortality after stroke at population level were also found. These results need to be confirmed and further investigated through a more robust information framework.
Publisher: Springer Science and Business Media LLC
Date: 22-11-2021
DOI: 10.1186/S12873-021-00521-4
Abstract: Monocyte Distribution Width (MDW), a simple proxy marker of innate monocyte activation, can be used for the early recognition of sepsis along with Procalcitonin. This study explored the added value of MDW as an early predictor of ensuing sepsis in patients hospitalised in an Intensive Care Unit. We performed an observational prospective monocentric study to estimate the analytical performance of MDW in detecting ensuing sepsis in a s le of consecutive patients assisted in an Intensive Care Unit for 48 h for any reason. Demographic and clinical characteristics, past medical history and other laboratory measurements were included as potential predictors of confirmed sepsis in multivariate logistic regression. A total of 211 patients were observed, 129 of whom were included in the final s le due to the suspect of ensuing sepsis of these, 74 (57%) had a confirmed diagnosis of sepsis, which was best predicted with the combination of MDW 23.0 and PCT 0.5 ng/mL (Positive Predictive Value, PPV: 92.6, 95% CI: 82.1–97.9). The best MDW cut-off to rule out sepsis was ≤20.0 (Negative Predictive Value, NPV: 86.4, 95% CI: 65.1–97.1). Multivariate analyses using both MDW and PCT found a significant association for MDW 23 only (OR:17.64, 95% CI: 5.53–67.91). We found that values of MDW 23 were associated with a high PPV for sepsis, whereas values of MDW ≤ 20 were associated with a high NPV. Our findings suggest that MDW may help clinicians to monitor ICU patients at risk of sepsis, with minimal additional efforts over standard of care.
Publisher: Elsevier BV
Date: 10-1996
DOI: 10.1016/S0168-8227(96)01343-5
Abstract: The aim of this study was to describe the epidemiology of self-monitoring of blood glucose and to identify specific characteristics of those subgroups of diabetic patients treated with insulin that are most likely to monitor their blood glucose according to medical recommendations. Data were collected on 1384 insulin-treated patients, enrolled from 35 diabetic outpatient clinics and 49 general practitioners' offices between December 1993 and June 1994. Seventeen Italian regions out of 20 were included in the study. Our data show that 418 (31%) diabetic patients treated with insulin had never practised blood glucose self-monitoring. In addition, only 242 patients (18.2%) self-monitored their glycemia with a mean frequency of at least once a day (29.7% among insulin-dependent diabetes mellitus (IDDM) and 13.9%, among insulin-treated non-insulin-dependent diabetes mellitus (NIDDM-IT) patients). Patients' characteristics associated with a higher probability of practising blood glucose self-monitoring were age below 50 years, being treated at a diabetic outpatient clinic, hypertension, need of three or more insulin injections per day, history of hypoglycemic episodes, ability to self-manage insulin doses. Our study calls for vigorous efforts aimed at promoting the incorporation of clearly-defined educational programs at each level of care, in order to improve the motivation and self-care of diabetic patients. Furthermore, studies are necessary to identify subgroups of diabetic patients that truly need to self-monitor blood glycemia, and to assess the efficacy of the practice of self-monitoring of blood glucose in improving metabolic control and reducing acute and long-term diabetic complications.
Publisher: American Medical Association (AMA)
Date: 10-06-1996
Location: United Kingdom of Great Britain and Northern Ireland
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