Search

AIMS: Improving glycaemic control in people with Type 1 diabetes is known to reduce complications. Our aim was to compare glycaemic control among people with Type 1 diabetes using data gathered in regional or national registries.METHODS: Data were obtained for children and/or adults with Type 1 diabetes from the following countries (or regions): Western Australia, Austria, Denmark, England, Champagne-Ardenne (France), Germany, Epirus, Thessaly and Thessaloniki (Greece), Galway (Ireland), several Italian regions, Latvia, Rotterdam (The Netherlands), Otago (New Zealand), Norway, Northern Ireland, Scotland, Sweden, Volyn (Ukraine), USA and Wales) from population or clinic-based registries. The sample size with available data varied from 355 to 173 880. Proportions with HbA1c < 58 mmol/mol (< 7.5%) and ≥ 75 mmol/mol (≥ 9.0%) were compared by age and sex.RESULTS: Data were available for 324 501 people. The proportions with HbA1c 58 mmol/mol (< 7.5%) varied from 15.7% to 46.4% among 44 058 people aged < 15 years, from 8.9% to 49.5% among 50 766 people aged 15-24 years and from 20.5% to 53.6% among 229 677 people aged ≥ 25 years. Sex differences in glycaemic control were small. Proportions of people using insulin pumps varied between the 12 sources with data available.CONCLUSION: These results suggest that there are substantial variations in glycaemic control among people with Type 1 diabetes between the data sources and that there is room for improvement in all populations, especially in young adults.

Background: Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures.Methods: A nested case-control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates.Results: Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities.Conclusions: Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.

Purpose: Different strategies applicable to control for confounding by indication in observational studies were compared in a large population-based study regarding the effect of bisphosphonates (BPs) for secondary prevention of fractures. Methods: The cohort was drawn from healthcare utilization databases of 13 Italian territorial units. Patients aged 55years or more who were hospitalized for fracture during 2003-2005 entered into the cohort. A nested case-control design was used to compare BPs use in cohort members who did (cases) and who did not experience (controls) a new fracture until 2007 (outcome). Three designs were employed: conventional-matching (D1), propensity score-matching (D2), and user-only (D3) designs. They differed for (i) cohort composition, restricted to patients who received BPs straight after cohort entry (D3); (ii) using propensity score for case-control matching (D2); and (iii) compared groups of BPs users versus no users (D1 and D2) and long-term versus short-term users (D3). Results: Bisphosphonate users had odds ratios (95% confidence interval) of 1.20 (1.01 to 1.44) and 0.95 (0.74 to 1.24) by applying D1 and D2 designs, respectively. Statistical evidence that long-term BPs use protects the outcome onset with respect to short-term use was observed for user-only design (D3) being the corresponding odds ratio (95% confidence interval) 0.64 (0.44 to 0.93). Conclusions: User-only design yielded closer results to those seen in RCTs. This approach is one possible strategy to account for confounding by indication. © 2014 John Wiley & Sons, Ltd.

Background: Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures. Methods: A nested case-control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates. Results: Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities. Conclusions: Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.

The Observational Studies working group of the Italian Association of Medical Statistics and Clinical Epidemiology (SISMEC) has undertaken to study the impact of recent healthcare sector regulations on the legal and organisational aspects of managing all EMR databases with emphasis on Legislative Decree No. 196/2003 (the Italian Personal Data Protection Law). This paper examines six issues relating to theirs legal implications. The first section, "Confidentiality", provides definitions and the regulatory context for the terms confidentiality and personal data. In the second, "Nature of data held in electronic medical record archives", we discuss the problem of sensitive data and procedures to make the identification code anonymous. In "Data ownership" we highlight the difference between the data controller and the database controller. The fourth section, "Conditions for processing", discusses problems associated with using research data from one study in other investigations. In the fifth, "Patient consent", we address the problems related to patient consent. Finally in "Penalties" we outline the main civil and criminal liability issues applied in case of non-compliance with the provisions of the Personal Data Protection Code. Where possible, we provide suggestions on how to comply with the legal requirements of managing medical record archives in order to make it easier for researchers to remain in compliance with the relevant provisions.

INTRODUCTION. In recent years the evaluation of the ability of a diagnostic (prognostic) variable to distinguish a diseased (at risk) from a non-diseased patient (not at risk) has been widely discussed. In the presence of a continuous variable, the clinical decision-making process often uses for classification a cut-point value. From the statistical perspective the critical point arises as to how determine this threshold value. Two analytical methods are often used in order to categorize continuous variables: the minimum P-value [1] - based on the maximization of a chi-square statistic - and the Youden index [2] method. The performance of these approaches has so far not been extensively compared.OBJECTIVES. Aim of our work is to compare the performance of the minimum P-value and the Youden index methods through a simulation study. Indeed these approaches are mathematically related. The chi-square statistic of the minimum P-value approach is a transformation of the Youden index function, accounting for variance in parameter estimation. CONCLUSIONS. We have presented a simulation study aimed to compare two common methods used to define cut-points of new biomarkers: the minimum P-value and the Youden index approach. We have shown that under the biomarker normality distribution assumption the Youden index approach performs better than the minimum P-value approach. The difference in performance between the minimum P-value and the Youden approach is due to the variance component included in the chi-square statistic. This aspect, that could be intuitively thought as an advantage of the minimum P-value approach, refers to the null hypothesis of absence of association between the true disease status and the classification variable. However, the identification of cut-points for dichotomization has a start point the possible presence of some discrimination potential of the variable needing categorization.

Objective: To assess, by smoothness index (SI), distribution of the antihypertensive effect of extended-release (ER) felodipine over 24 hours in elderly patients with hypertension. Methods: After a 4-week washout phase, 35 elderly patients (mean age 69 ± 4 years) with mild-to-moderate hypertension received 2 weeks' treatment with ER felodipine 5mg once daily. The dosage of ER felodipine was doubled to 10 mg/day and given for a further 2 weeks in non-responders (sitting clinic blood pressure > 140/90mm Hg). The study had an open-label design with no placebo control. After each period, clinic and ambulatory blood pressures were measured. Trough-to-peak (T/P) ratio was computed by dividing the blood pressure (BP) change at trough (22 to 24 hours after drug intake) by the change at peak (2 adjacent hours with a maximal BP reduction between the second and eighth hour after drug intake). SI was calculated as the ratio between the average of the 24, hourly, treatment-induced BP changes and its standard deviation. Results: After the initial 2-week treatment period, clinic and 24-hour ambulatory BP values were higher in non-responders (145 ± 11/87 ± 8 and 135 ± 17/80 ± 6mm Hg, respectively) than in responders (133 ± 6/81 ± 3 and 130 ± 9/77 ± 7mm Hg). In non-responders, clinic and 24-hour BP values were lowered after a further 2 weeks of treatment with ER felodipine 10 mg/day (128 ± 11/78 ± 6 and 128 ± 12/75 ± 5mm Hg). SI was high in responders (0.8 ± 0.8/0.7 ± 0.7 for systolic/diastolic BP) and low in non-responders (0.5 ± 0.6/0.3 ± 0.6) during the first 2-week treatment period. It increased in non-responders after an additional 2 weeks of treatment with ER felodipine 10 mg/day (1.0 ± 0.8/0.7 ± 0.6). Median T/P ratios were 0.73 and 0.61 (systolic BP and diastolic BP) in responders and 0.41 and 0.61 in non-responders after 2 weeks of treatment. At variance with SI, T/P ratios did not increase in non-responders after doubling the dosage of ER felodipine (0.34 and 0.18). ER fel