Jessica Wright

Strategies for health data exchange for secondary, cross-institutional clinical research

Secondary use of health data has a vital role in improving and advancing medical knowledge. While digital health records offer scope for facilitating the flow of data to secondary uses, it remains essential that steps are taken to respect wishes of the patient regarding secondary usage, and to ensure the privacy of the patient during secondary use scenarios. Consent, together with depersonalisation and its related concepts of anonymisation, pseudonymisation, and data minimisation are key methods used to provide this protection. This paper gives an overview of technical, practical, legal, and ethical aspects of secondary data use and discusses their implementation in the multi-institutional @neurIST research project.

Risk of Rupture of Small Anterior Communicating Artery Aneurysms Is Similar to Posterior Circulation Aneurysms

Background and Purpose— According to the International Study of Unruptured Intracranial Aneurysms (ISUIA), anterior circulation (AC) aneurysms of <7 mm in diameter have a minimal risk of rupture. It is general experience, however, that anterior communicating artery (AcoA) aneurysms are frequent and mostly rupture at <7 mm. The aim of the study was to assess whether AcoA aneurysms behave differently from other AC aneurysms. Methods— Information about 932 patients newly diagnosed with intracranial aneurysms between November 1, 2006, and March 31, 2012, including aneurysm status at diagnosis, its location, size, and risk factors, was collected during the multicenter @neurIST project. For each location or location and size subgroup, the odds ratio (OR) of aneurysms being ruptured at diagnosis was calculated. Results— The OR for aneurysms to be discovered ruptured was significantly higher for AcoA (OR, 3.5 [95% confidence interval, 2.6–4.5]) and posterior circulation (OR, 2.6 [95% confidence interval, 2.1–3.3]) than for AC excluding AcoA (OR, 0.5 [95% confidence interval, 0.4–0.6]). Although a threshold of 7 mm has been suggested by ISUIA as a threshold for aggressive treatment, AcoA aneurysms <7 mm were more frequently found ruptured (OR, 2.0 [95% confidence interval, 1.3–3.0]) than AC aneurysms of 7 to 12 mm diameter as defined in ISUIA. Conclusions— We found that AC aneurysms are not a homogenous group. Aneurysms between 4 and 7 mm located in AcoA or distal anterior cerebral artery present similar rupture odds to posterior circulation aneurysms. Intervention should be recommended for this high-risk lesion group.

Regulating tissue research: do we need additional rules to protect research participants?

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.