Orchestrating differential data access for translational research: a pilot implementation.

BACKGROUND: Translational researchers need robust IT solutions to access a range of data types, varying from public data sets to pseudonymised patient information with restricted access, provided on a case by case basis. The reason for this complication is that managing access policies to sensitive human data must consider issues of data confidentiality, identifiability, extent of consent, and data usage agreements. All these ethical, social and legal aspects must be incorporated into a differential management of restricted access to sensitive data. METHODS: In this paper we present a pilot system that uses several common open source software components in a novel combination to coordinate access to heterogeneous biomedical data repositories containing open data (open access) as well as sensitive data (restricted access) in the domain of biobanking and biosample research. Our approach is based on a digital identity federation and software to manage resource access entitlements. RESULTS: Open source software components were assembled and configured in such a way that they allow for different ways of restricted access according to the protection needs of the data. We have tested the resulting pilot infrastructure and assessed its performance, feasibility and reproducibility. CONCLUSIONS: Common open source software components are sufficient to allow for the creation of a secure system for differential access to sensitive data. The implementation of this system is exemplary for researchers facing similar requirements for restricted access data. Here we report experience and lessons learnt of our pilot implementation, which may be useful for similar use cases. Furthermore, we discuss possible extensions for more complex scenarios.

FDG-PET/CT in the Assessment of Treatment Response after Oncologic Treatment of Head and Neck Squamous Cell Carcinoma.

BACKGROUND: In many centers, (18)F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is used to monitor treatment response after definitive (chemo)radiotherapy [(C)RT] for head and neck squamous cell carcinoma (HNSCC), but its usefulness remains somewhat controversial. We aimed at assessing the accuracy of FDG-PET/CT in detecting residual disease after (C)RT. METHOD: All HNSCC patients with FDG-PET/CT performed to assess treatment response 10-18 weeks after definitive (C)RT at our institution during 2008-2010 were included. The patient charts were reviewed for FDG-PET/CT findings, histopathologic findings, and follow-up data. The median follow-up time for FDG-PET/CT negative patients was 26 months. RESULTS: Eighty-eight eligible patients were identified. The stage distribution was as follows: I, n = 1; II, n = 15; III, n = 17; IV, n = 55. The negative predictive value, positive predictive value, specificity, sensitivity, and accuracy of FDG-PET/CT in detecting residual disease were 87%, 81%, 94%, 65%, and 85%, respectively. The corresponding specific figures for the primary tumor site were 91%, 71%, 94%, 59%, and 86% and for the neck 93%, 100%, 100%, 75%, and 94%, respectively. CONCLUSIONS: In patients who have received definitive (C)RT for HNSCC, post-treatment FDG-PET/CT has good potential to guide clinical decision-making. Patients with negative scan can safely be followed up clinically only, while positive scan necessitates tissue biopsies or a neck dissection to rule out residual disease.

Subarachnoid hemorrhage in the subacute stage: elevated apparent diffusion coefficient in normal-appearing brain tissue after treatment.

PURPOSE: To prospectively evaluate whether subarachnoid hemorrhage (SAH) is associated with a change in the apparent diffusion coefficient (ADC) in normal-appearing brain parenchyma. MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained for all patient and volunteer studies. One hundred patients (48 men, 52 women; mean age, 52 years +/- 12 [standard deviation]) with aneurysmal SAH underwent conventional and diffusion-weighted magnetic resonance (MR) imaging at a mean of 9 days +/- 3 after SAH to evaluate possible lesions caused by SAH, treatment of SAH, and vasospasm. Aneurysms were treated surgically (n = 70) or endovascularly (n = 30) before MR imaging. Diffusion-weighted MR imaging was performed at 1-year follow-up in 30 patients (10 men, 20 women; mean age, 51 years +/- 11). Thirty healthy age-matched volunteers (11 men, 19 women; mean age, 54 years +/- 16) underwent MR imaging with an identical protocol. ADC values were measured bilaterally in the gray and white matter (parietal, frontal, temporal, occipital lobes; cerebellum; caudate nucleus; lentiform nucleus; thalamus; and pons) that appeared normal on T2-weighted and diffusion-weighted MR images. Linear mixed model was used for comparison of ADC values of supratentorial gray matter and white matter; general linear regression analysis was used for comparison of ADC values of cerebellum and pons. RESULTS: In patients with SAH, the ADC values in normal-appearing white matter, with a single exception in the frontal lobe (P = .091), were significantly higher than they were in healthy volunteers (P /= .121). CONCLUSION: SAH and its treatment may cause global mild vasogenic edema in white matter and deep gray matter that is undetectable on T2-weighted and diffusion-weighted MR images but is detectable by measuring the ADC value in the subacute stage of SAH.

Cerebral perfusion heterogeneity and complexity in patients with acute subarachnoid haemorrhage.

BACKGROUND: The pathophysiological mechanisms of impaired perfusion during acute subarachnoid haemorrhage (SAH) are incompletely understood. Cerebral perfusion at the micro vascular level can be assessed by single photon emission computed tomography (SPECT). We used a SPECT approach with 99mTc-ECD to measure the cerebral perfusion heterogeneity and complexity in patients with acute aneurysmal SAH or perimesencephalic non-aneurysmal SAH (PNSAH). METHODS: The perfusion SPECT data of 61 patients with aneurysmal SAH, 18 patients with PNSAH, and 20 healthy control subjects were analysed by dividing the brain into 384 regions of interest. The magnitude of spatial perfusion heterogeneity was assessed by calculating the relative dispersion (RD=coefficient of variation). The fractal dimension (FD) was used to describe the overall complexity of global cerebral perfusion. RESULTS: Patients with aneurysmal SAH (RD=11.30+/-2.17, P<0.001) and PNSAH (10.38+/-2.27, P=0.023) had a higher perfusion heterogeneity than control subjects (8.69+/-0.80). Patients with aneurysmal SAH tended to have a higher perfusion heterogeneity than patients with PNSAH (P=0.061). Also the overall complexity of cerebral perfusion was decreased in aneurysmal SAH (FD=1.11+/-0.06, P<0.001) and PNSAH (1.11+/-0.06, P=0.004) as compared with control subjects (1.17+/-0.06). Acute SAH causes increased regional cerebral perfusion heterogeneity and decreased overall complexity of global cerebral perfusion. CONCLUSION: Non-invasive assessment of cerebral perfusion characteristics is feasible with SPECT and fractal analysis in patients with acute SAH and may help evaluating micro vascular function in SAH.