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

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

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

BACKGROUND: To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). METHODS: Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. RESULTS: Recruitment was completed in December 2008 with 3994 evaluable patients. CONCLUSIONS: This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. TRIAL REGISTRATION: NCT00681850.

PCDD/F levels in plasma of a belgian population before and after the 1999 belgian PCB/DIOXIN incident.

We evaluated the impact of the 1999 Belgian dioxin incident on the blood plasma polychlorinated dibenzo-p-dioxin (PCDD) and polychlorinated dibenzofuran (PCDF) levels among 232 Belgian blood donors (74% men, mean age 47 years). The Red Cross made plasma samples from before the incident of these donors available. A second plasma sample was collected during the second half of 2000. The sum of the 17 PCDD/F congeners was significantly lower in 2000 compared to 1998 (417 pg/g fat versus 445 pg/g fat, respectively). This could be completely attributed to the significant decrease of OctaCDD (301 pg/g fat in 2000 versus 277 pg/g fat in 1998). Moreover a slight but significant decrease was observed for 2,3,7,8-TetraCDF and for 1,2,3,4,6,7,8-HeptaCDF. 1,2,3,7,8-PentaCDF and 2,3,4,7,8-PentaCDF however showed a slight but significant increase (respective levels in 1998 were 0.004 and 14.5 pg/g fat compared to 0.006 and 17.9 pg/g fat in 2000). Given their significantly higher presence in incident related food samples this increase can be attributed to the food contamination episode. However, the total toxicity remained unchanged (22.9 in 1998 versus 23.1 pg WHO-TEQ/g fat, p>0.05). Moreover the observed congener profiles and the total PCDD/F levels were similar to those of other European non-occupationally exposed populations. In conclusion, the 1999 PCB/dioxin incident was traceable in the plasma profiles (rise of the two specific PCDF congeners), but comparison of the results for both years indicates that the changes were too small to cause an adverse public health effect.