What do international ethics guidelines say in terms of the scope of medical research ethics?

BACKGROUND: In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. METHODS: We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. RESULTS: We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. CONCLUSION: There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences

Нарушение репродуктивной функции при простатите/синдроме хронической тазовой боли

Показано, что нелеченное хроническое воспаление предстательной железы приводит к нарушению показателей спермограммы и в ряде случаев к бесплодию при нормальном развитии половых желез и достаточном гормональном обеспечении организма. Бактерии, вирусы, лейкоциты, свободные радикалы, цитокины, иммунологические изменения и обструкция семявыводящих путей при простате являются кофакторами в развитии бесплодия.It is shown that untreated chronic inflammation of the prostate gland causes disturbances of spermogram count and strility in a number of cases at normal development of sex glands and sufficient hormone supply of the organism. Bacteria, viruses, leukocytes, free radicals, cytokines, immunological changes and obstruction of the deferent ducts in prostatitis are co−factors of sterility development

Patients' and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence.

INTRODUCTION: International sharing of health data opens the door to the study of the so-called 'Big Data', which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a 'social license' is identifying the views patients and the public may hold with regard to data sharing for health research. METHODS: We performed a narrative review of the empirical evidence addressing patients' and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed (MEDLINE), Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients' and public attitudes were extracted from selected references and thematically categorised. RESULTS: Twenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread-though conditional-support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability. CONCLUSIONS: Our results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests

The social licence for data-intensive health research: towards co-creation, public value and trust

BACKGROUND: The rise of Big Data-driven health research challenges the assumed contribution of medical research to the public good, raising questions about whether the status of such research as a common good should be taken for granted, and how public trust can be preserved. Scandals arising out of sharing data during medical research have pointed out that going beyond the requirements of law may be necessary for sustaining trust in data-intensive health research. We propose building upon the use of a social licence for achieving such ethical governance. MAIN TEXT: We performed a narrative review of the social licence as presented in the biomedical literature. We used a systematic search and selection process, followed by a critical conceptual analysis. The systematic search resulted in nine publications. Our conceptual analysis aims to clarify how societal permission can be granted to health research projects which rely upon the reuse and/or linkage of health data. These activities may be morally demanding. For these types of activities, a moral legitimation, beyond the limits of law, may need to be sought in order to preserve trust. Our analysis indicates that a social licence encourages us to recognise a broad range of stakeholder interests and perspectives in data-intensive health research. This is especially true for patients contributing data. Incorporating such a practice paves the way towards an ethical governance, based upon trust. Public engagement that involves patients from the start is called for to strengthen this social licence. CONCLUSIONS: There are several merits to using the concept of social licence as a guideline for ethical governance. Firstly, it fits the novel scale of data-related risks; secondly, it focuses attention on trustworthiness; and finally, it offers co-creation as a way forward. Greater trust can be achieved in the governance of data-intensive health research by highlighting strategic dialogue with both patients contributing the data, and the public in general. This should ultimately contribute to a more ethical practice of governance

Комбинированные гестаген/эстрогенные препараты в лечении гиперандрогении

Рассмотрены биохимические механизмы действия гестаген/эстрогенных препаратов при лечении синдрома гиперандрогении. Описаны преимущества комбинации дроспиренона с этинидэстрадиолом для лечения акне, себореи и гирсутизма у женщин, одновременно нуждающихся в контрацепции.The biochemical mechanisms of action of gestagen/estrogen drugs in treatment for syndrome of hyperandrogeny are featured. The advantages of Drospirenon and Etinidestradiol combination in treatment of acne, seborrhea and hirsutism in women simultaneously requiring contraception are described

Alertness, movement, and affective behaviour of people with profound intellectual and multiple disabilities (PIMD) on introduction of a playful interactive product:Can we get your attention?

Background: New technology may stimulate active leisure activities for people with profound intellectual and multiple disabilities (PIMD). We conducted a study of an interactive ball that responded to gross body movement, focus of attention, and vocalisations of users with PIMD. The aim was to increase alertness and body movement and elicit more expressions of positive, or fewer of negative affect.Method: Nine participants with PIMD played during 8–10 sessions. The movement was analysed automatically. Alertness and affective behaviour were coded manually. We analysed the last 5 sessions for each participant and compared 15 min of interaction with 15 min of rest.Results: Clearly positive effects were seen for three participants. Effects were seen in the unexpected direction for four participants. No strong effects were found for the remaining three participants.Conclusions: Interactive technologies may provide suitable activities for people with PIMD but individual differences play an important role

Визначення вальпроєвої кислоти у крові методом реакційної високоефективної рідинної хроматографії

Здійснена взаємодія вальпроєвої кислоти з 3-(2'-бромацетил)-7-метоксикумарином і розроблено її визначення у крові методом реакційної високоефективної рідинної хроматографії. Вивчений вплив різних методів депротоїнізації на вивільнення вальпроєвої кислоти та оптимізовані умови пробопідготовки.Осуществлено взаимодействие вальпроевой кислоты с 3-(2'-бромацетил)-7-метоксикумарином и разработано ее определение в крови методом реакционной высокоэффективной жидкостной хроматографии. Изучено влияние различных методов депротеинизации на выходы вальпроевой кислоты и оптимизированы условия пробоподготовки.The interaction of the valproic acid with 3-(2'-bromoacetyl)-7-methoxicoumarin has been carried out and its determination in blood by the reaction high performance liquid chromatography method has been developed. The influence of various methods of deproteinization on the yields of the valproic acid has been studied and the conditions of the sample preparing has been optimized

Minimally invasive image-guided therapy for inoperable hepatocellular carcinoma: What is the evidence today?

Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10–15% of HCC patients are suitable candidates for hepatic resection and liver transplantation due to the advanced stage of the disease at time of diagnosis and shortage of donors. Therefore, several minimally invasive image-guided therapies for locoregional treatment have been developed. Tumor ablative techniques are either based on thermal tumor destruction, as in radiofrequency ablation, cryoablation, microwave ablation, laser ablation and high-intensity focused ultrasound, or chemical tumor destruction, as in percutaneous ethanol injection. Image-guided catheter-based techniques rely on intra-arterial delivery of embolic, chemoembolic or radioembolic agents. These minimally invasive image-guided therapies have revolutionized the management of inoperable HCC. This review provides a description of all minimally invasive image-guided therapies currently available, an up-to-date overview of the scientific evidence for their clinical use, and thoughts for future directions