Comparison of Electronic Record Types Concerning the Applicability for Patient Recruitment (Preprint)

Background Clinical trials constitute an important pillar in medical research. It is beneficial to support recruitment for clinical trials using software tools, so-called patient recruitment support systems; however, such information technology systems have not been frequently used to date. Because medical information systems' underlying data collection methods strongly influence the benefits of implementing patient recruitment support systems, we investigated patient recruitment support system requirements and corresponding electronic record types such as electronic medical record, electronic health record, electronic medical case record, personal health record, and personal cross-enterprise health record. Objective The aim of this study was to (1) define requirements for successful patient recruitment support system deployment and (2) differentiate and compare patient recruitment support system-relevant properties of different electronic record types. Results Patient recruitment support system requirements (n=16) were grouped into 4 categories (consent management, patient recruitment management, trial management, and general requirements). All 16 requirements could be partially met by at least 1 type of electronic record. Only 1 requirement was fully met by all 5 types. According to our analysis, personal cross-enterprise health records fulfill most requirements for patient recruitment support systems. They demonstrate advantages especially in 2 domains (1) supporting patient empowerment and (2) granting access to the complete medical history of patients. Conclusions In combination with patient recruitment support systems, personal cross-enterprise health records prove superior to other electronic record types, and therefore, this integration approach should be further investigated

Prediction of postoperative pain after radical prostatectomy

<p>Abstract</p> <p>Background</p> <p>There is a belief that the amount of pain perceived is merely directly proportional to the extent of injury. The intensity of postoperative pain is however influenced by multiple factors aside from the extent of trauma. The purpose of the study was to evaluate the relationship between preoperative factors that have been shown to predict postoperative pain and the self-reports of pain intensity in a population of 155 men undergoing radical prostatectomy (RP), and also to investigate if previous pain score could predict the subsequent pain score.</p> <p>Methods</p> <p>The correlation between potential pain predictors and the postoperative pain experiences during three postoperative days was tested (Pitmans' test). By use of a logistic regression analysis the probability that a Visual Analogue Scale (VAS) score at one occasion would exceed 30 mm or 70 mm was studied, depending on previous VAS score, age, depression and pain treatment method.</p> <p>Results</p> <p>Age was found to be a predictor of VAS > 30 mm, with younger patients at higher risk for pain, and preoperative depression predicted VAS > 70 mm. The probability that VAS would exceed 30 mm and 70 mm was predicted only by previous VAS value. Day two however, patients with epidural analgesia were at higher risk for experiencing pain than patients with intrathecal or systemic opioid analgesia.</p> <p>Conclusion</p> <p>The results show that it would be meaningful to identify RP patients at high risk for severe postoperative pain; i.e. younger and/or depressive patients who might benefit from a more aggressive therapy instituted in the very early postoperative period.</p

О причине возникновения неоднородности структуры экструзионных полимерных листов

Тез. докл. VII Междунар. науч.-техн. конф. (науч. чтения, посвящ. П. О. Сухому), Гомель, 23–24 окт. 2008 г

Architecture of a consent management suite and integration into IHE-based regional health information networks

<p>Abstract</p> <p>Background</p> <p>The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment.</p> <p>Methods</p> <p>Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR.</p> <p>Results</p> <p>The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents.</p> <p>Conclusions</p> <p>Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.</p

Complete Epstein-Barr virus seropositivity in a large cohort of patients with early multiple sclerosis

OBJECTIVE: To determine the prevalence of antibodies to Epstein-Barr virus (EBV) in a large cohort of patients with early multiple sclerosis (MS). METHODS: Serum samples were collected from 901 patients with a clinically isolated syndrome (CIS) or early relapsing-remitting multiple sclerosis (RRMS) participating in the German National MS cohort, a prospective cohort of patients with early MS with stringent inclusion criteria. Epstein-Barr nuclear antigen (EBNA)-1 and viral capsid antigen (VCA) antibodies were measured in diluted sera by chemiluminescence immunoassays (CLIAs). Sera of EBNA-1 and VCA antibody-negative patients were retested undiluted by an EBV IgG immunoblot. For comparison, we retrospectively analysed the EBV seroprevalence across different age cohorts, ranging from 0 to >80 years, in a large hospital population (N=16 163) from Berlin/Northern Germany. RESULTS: EBNA-1 antibodies were detected by CLIA in 839 of 901 patients with CIS/RRMS. Of the 62 patients without EBNA-1 antibodies, 45 had antibodies to VCA as detected by CLIA. In all of the remaining 17 patients, antibodies to EBV were detected by immunoblot. Altogether, 901 of 901 (100%) patients with CIS/RRMS were EBV-seropositive. EBV seropositivity increased with age in the hospital population but did not reach 100% in any of the investigated age cohorts. CONCLUSION: The complete EBV seropositivity in this large cohort of patients with early MS strengthens the evidence for a role of EBV in MS. It also suggests that a negative EBV serology in patients with suspected inflammatory central nervous system disease should alert clinicians to consider diagnoses other than MS

Treatment choices and neuropsychological symptoms of a large cohort of early MS

Objective To assess clinical characteristics, distribution of disease-modifying treatments (DMTs), and neuropsychological symptoms in a large cohort of patients with early-stage MS. Methods The German National MS Cohort is a multicenter prospective longitudinal cohort study that has recruited DMT-naive patients with clinically isolated syndrome (CIS) and relapsing-remitting MS (RRMS) since 2010. We evaluated their baseline characteristics and the prevalence of neuropsychological symptoms. Results Of 1,124 patients, with a 2.2: 1 female-to-male ratio and median age at onset of 31.71 years (interquartile range [IQR]: 26.06-40.33), 44.6% and 55.3% had CIS and RRMS, respectively. The median Expanded Disability Status Scale (EDSS) score at baseline was 1.5 (IQR: 1.0-2.0). A proportion of 67.8% of patients started DMT after a median time of 167.0 days (IQR 90.0-377.5) since the first manifestation. A total of 64.7% and 70.4% of the 762 patients receiving early DMT were classified as CIS and RRMS, respectively. Fatigue, depressive symptoms, and cognitive dysfunction were detected in 36.5%, 33.5%, and 14.7% of patients, respectively. Conclusion Baseline characteristics of this large cohort of patients with early, untreated MS corroborated with other cohorts. Most patients received early DMT within the first year after disease onset, irrespective of a CIS or RRMS diagnosis. Despite the low EDSS score, neuropsychological symptoms affected a relevant proportion of patients

Novel multiple sclerosis susceptibility loci implicated in epigenetic regulation.

We conducted a genome-wide association study (GWAS) on multiple sclerosis (MS) susceptibility in German cohorts with 4888 cases and 10,395 controls. In addition to associations within the major histocompatibility complex (MHC) region, 15 non-MHC loci reached genome-wide significance. Four of these loci are novel MS susceptibility loci. They map to the genes L3MBTL3, MAZ, ERG, and SHMT1. The lead variant at SHMT1 was replicated in an independent Sardinian cohort. Products of the genes L3MBTL3, MAZ, and ERG play important roles in immune cell regulation. SHMT1 encodes a serine hydroxymethyltransferase catalyzing the transfer of a carbon unit to the folate cycle. This reaction is required for regulation of methylation homeostasis, which is important for establishment and maintenance of epigenetic signatures. Our GWAS approach in a defined population with limited genetic substructure detected associations not found in larger, more heterogeneous cohorts, thus providing new clues regarding MS pathogenesis