Ethical issues in biomedical research using electronic health records: a systematic review.

Digitization of a health record changes its accessibility. An electronic health record (EHR) can be accessed by multiple authorized users. Health information from EHRs contributes to learning healthcare systems' development. The objective of this systematic review is to answer a question: What are ethical issues concerning research using EHRs in the literature? We searched Medline Ovid, Embase and Scopus for publications concerning ethical issues of research use of EHRs. We employed the constant comparative method to retrieve common ethical themes. We descriptively summarized empirical studies. The study reveals the breadth, depth, and complexity of ethical problems associated with research use of EHRs. The central ethical question that emerges from the review is how to manage access to EHRs. Managing accessibility consists of interconnected and overlapping issues: streamlining research access to EHRs, minimizing risk, engaging and educating patients, as well as ensuring trustworthy governance of EHR data. Most of the ethical problems concerning EHR-based research arise from rapid cultural change. The framing of concepts of privacy, as well as individual and public dimensions of beneficence, are changing. We are currently living in the middle of this transition period. Human emotions and mental habits, as well as laws, are lagging behind technological developments. In the medical tradition, individual patient's health has always been in the center. Transformation of healthcare care, its digitalization, seems to have some impacts on our perspective of health care ethics, research ethics and public health ethics.

Selection of Endpoints in Clinical Trials: Trends in European Marketing Authorization Practice in Oncological Indications.

OBJECTIVES: To determine the types of endpoints that were the basis for efficacy assessment of medicines used in particular groups of oncological indications. Changes in the endpoints applied in marketing authorization practice were also considered. METHODS: The analysis included marketing authorization applications (MAAs) for medicines used in oncological indications that were first-time approved by the European Medicines Agency (EMA) between 2009 and 2017, and the extensions of the analyzed medicines. RESULTS: The analysis covered 125 MAAs: first-time approved (62%) and extensions (38%). In the analyzed trials, the endpoints that were reported most frequently included overall survival (OS), progression-free survival (PFS), and overall response rate (in 94.4%, 92.8%, 87.2% of MAAs, respectively). The following trends were observed: decreased significance of OS as a primary endpoint and increased significance of PFS as a primary endpoint (hematological indications). An analysis of MAAs for which the OS results were immature confirms the increased significance of PFS and new efficacy indicators (ie, pathological complete response). CONCLUSIONS: An analysis of EMA's marketing authorization practice proves that the use of surrogate endpoints is becoming increasingly common in evaluating oncological health technologies. EMA's guidelines underline the role played by surrogates in the process of assessing efficacy of new therapies. Results of an analysis demonstrate that protocols of clinical trials define surrogates as primary endpoints more and more often. Furthermore, a positive decision on granting marketing authorization is possible also in situations when only such clinical data are available.

Isolation frequency of Candida present on the surfaces of mobile phones and handsx.

BACKGROUND: It is known that mobile phones may play a role in microorganism transmission. The aim of this study was to analyze the relationship between the number of Candida genera/species isolated from samples collected from the surfaces of mobile phones and the hands of the staff as well as the preferred health-related behavior. METHODS: The mycological evaluation included 175 mobile telephones and the hands of staff members at the University Hospital in Bialystok, Poland. We used the Count-Tact(TM) applicator, with CandiSelect (Bio-Rad). Self-administered questionnaire was used to gather data on mobile phones disinfection practices. Assessment of the preferred health-related behavior was based on The Multidemensional Health Locus of Control Scale (MHLC). RESULTS: Out of 175 mobile phones, 131 (74.9 %) were colonized. Candida glabrata, C. albicans and C.krusei were isolated more frequently from the hand as well as phone surface. The mean number of Candida colonies was higher in samples collected from hand surfaces than mobile phone surfaces. No significant correlation was found between the preferred health-related behavior and the frequency of washing hands, the way of using a mobile phone, the number of colonies or the isolation frequency for the fungi collected from the surface of the phones and hands of their owners. Only 19.4 % of the participants cleaned the surface of their phones. CONCLUSION: The prevalence of mobile phone contamination by Candida is high in the University Hospital in Bialystok, Poland. Candida albicans, C. glabrata, and C. krusei were the dominant species in the samples collected from mobile phones and hands. These results pose the need to develop guidelines for mobile phone disinfection.

A Stepwise Screening Protocol for Multiple Myeloma.

BACKGROUND: Monoclonal gammopathies and multiple myeloma should be screened in the primary care setting. METHODS: The screening strategy consisted of an initial interview supported with the analysis of basic laboratory test results and the increasing laboratory workload in the following steps was developed based on characteristics of patients with multiple myeloma. RESULTS: The developed 3-step screening protocol includes evaluation of myeloma-related bone disease, two renal function markers, and three hematologic markers. In the second step, the erythrocyte sedimentation rate (ESR) and the level of C-reactive protein (CRP) were cross-tabulated to identify persons qualifying for confirmation of the presence of monoclonal component. Patients with diagnosed monoclonal gammopathy should be referred to a specialized center to confirm the diagnosis. The screening protocol testing identified 900 patients with increased ESR and normal level of CRP and 94 of them (10.4%) had positive immunofixation. CONCLUSIONS: The proposed screening strategy resulted in an efficient diagnosis of monoclonal gammopathy. The stepwise approach rationalized the diagnostic workload and cost of screening. The protocol would support primary care physicians, standardizing the knowledge about the clinical manifestation of multiple myeloma and the method of evaluation of symptoms and diagnostic test results.

Separation methods for isolation of human polymorphonuclear leukocytes affect their motile activity.

Five commonly used methods for the isolation of human polymorphonuclear leukocytes (PMNLs) from blood and their subsequent effect on cell motile activity were compared. Although all methods (isolation from blood clots, hemolysis of erythrocytes in hypotonic solutions, and sedimentation with the use of Percoll, Ficoll 400 or Dextran T 500 solutions) preserved cell viability, they demonstrated different effects on cell spreading and the speed of spontaneous cell movement. The highest motile activity was shown by PMNLs separated from blood clots and Percoll solutions. In the presence of formylated peptides, N-FMLP-mediated movement was markedly stimulated in PMNLs separated by all five methods, but cells isolated with the use of Dextran T 500 or Ficoll 400 were relatively slower than those isolated with other methods. This suggests that the cells had preserved the sensitivity of their receptors specific for ligands stimulating chemokinesis (chemotaxis) after all five methods of separation. Immunofluorescence observations showed that PMNLs isolated in the presence of FITC-Dextran exhibited polysaccharide-coated surfaces with receptor proteins extended above that coat - an observation which explains why cell coating with polysaccharides does not disturb cell phenotyping with flow cytometry and FACS methods.