Digital literacy linked to engagement and psychological benefits among breast cancer survivors in Internet-based peer support groups

© 2019 John Wiley & Sons Ltd Objective: Internet-based peer support groups (ISGs) represent an innovative, scalable approach to addressing information and support needs of cancer survivors. However, this innovation may not benefit survivors equally due to population variance in digital literacy. This study examined how digital literacy influences level of engagement in and psychological benefits from participating in ISGs for breast cancer (N = 183). Methods: Secondary analysis of data from a randomised trial of ISGs that included behavioural measures of engagement, subjective ratings and psychological distress symptoms. Results: Digital literacy was positively related to education level (p =.005). Relative to women with high digital literacy, those with lower digital literacy were more likely to report difficulties using the ISG and to value the user's guide and facilitator assistance (all p's <.05). Digital literacy was negatively correlated with computer anxiety pre-intervention, distress before and after online chat during the intervention and post-intervention depressive symptoms (all p's <.05). Conclusion: Low digital literacy is associated with computer anxiety and barriers to ISG use, as well as distress during and after ISG use. Digital literacy must be taken into account when designing or delivering innovative digital interventions for cancer survivors

Collisional cross sections and momentum distributions in astrophysical plasmas: dynamics and statistical mechanics link

We show that, in stellar core plasmas, the one-body momentum distribution function is strongly dependent, at least in the high velocity regime, on the microscopic dynamics of ion elastic collisions and therefore on the effective collisional cross sections, if a random force field is present. We take into account two cross sections describing ion-dipole and ion-ion screened interactions. Furthermore we introduce a third unusual cross section, to link statistical distributions and a quantum effect originated by the energy-momentum uncertainty owing to many-body collisions, and propose a possible physical interpretation in terms of a tidal-like force. We show that each collisional cross section gives rise to a slight peculiar correction on the Maxwellian momentum distribution function in a well defined velocity interval. We also find a possible link between microscopical dynamics of ions and statistical mechanics interpreting our results in the framework of non-extensive statistical mechanics.Comment: 8 page

Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials

Tapinarof cream 1% (VTAMA(®); Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) to treat plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age, and for atopic dermatitis in adults and children down to 2 years of age. The PSOARING phase 3 clinical trial program evaluated tapinarof cream 1% once daily (QD) in adults with mild to severe plaque psoriasis for up to 52 weeks (NCT03956355, NCT03983980, NCT04053387). Here we present case photography documenting outcomes in the PSOARING trials. Cases illustrate various outcomes across different body areas, including responses meeting the formal FDA-mandated regulatory endpoint of a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points from baseline at week 12, meaningful clinical improvement not meeting this formal endpoint, patient-reported outcomes, and pre-specified adverse events of special interest (AESIs). Tapinarof cream 1% QD demonstrated rapid and highly statistically significant efficacy, with improvements in disease activity and quality of life. In addition, a high rate (40.9%; n = 312/763) of complete disease clearance (PGA = 0) was achieved, and improvements exceeding National Psoriasis Foundation treatment goals were demonstrated. After first achieving complete disease clearance (PGA = 0), patients treated with tapinarof experienced an approximately 4-month remittive effect off therapy. Incidence and severity of folliculitis and contact dermatitis AESIs were generally mild or moderate, localized to the site of application, and associated with low discontinuation rates. Medical images are of importance in trials of dermatologic therapies to inform clinical decision-making and enhance patient assessment. Tapinarof cream 1% QD is efficacious and well tolerated in patients with mild to severe plaque psoriasis, with clinically relevant improvements seen early in the course of treatment. Clinicaltrials.gov numbers: NCT03956355, NCT03983980, NCT04053387

Исследование методов государственного регулирования цен и издержек системы здравоохранения на лекарственные препараты в Великобритании

Objective: analysis of state regulation of prices and costs for the purchase of medicines (drugs) in the United Kingdom (UK), and proposal development to improve the processes of state regulation of manufacturers’ marginal registered prices of medicines included in the list of vital and essential drugs approved in the Russian Federation.Material and methods. Analysis of the structure of state regulation of prices and costs for the procurement of drugs was carried out based on information contained in the regulatory legal documents of the UK Government, health services and technical regulation, and data provided in systematic reviews and articles.Results. A key feature of regulation in the UK is maximizing the efficiency of health care costs based on the principles of digitization, long-term planning and health technology assessment in pricing. Government regulation of costs is focused on the patent-protected drug segment. Providers of such medicines fall under the Voluntary or Statutory Scheme and are required to make payments in the form of a fixed percentage of sales to the Department of Health and Social Care. Certain drug segments are exempt from payments to stimulate innovative development of the pharmaceutical industry and accelerate market access for new therapies. As practice shows, the Voluntary Scheme is more profitable for most companies. Regulation in the segment of reproduced drugs is carried out by free-market mechanisms and the antimonopoly service.Conclusion. The analysis revealed the mechanisms and key features of the methods of state regulation of prices and costs of the health care system for the procurement of drugs, identified best practices that are promising for adaptation to improve the state regulation of prices in the Russian Federation. Цель: анализ государственного регулирования цен и издержек на закупку лекарственных препаратов (ЛП) в Великобритании, а также разработка предложений по совершенствованию процессов государственного регулирования предельных зарегистрированных цен производителей на препараты, включенные в перечень жизненно необходимых и важнейших ЛП, утвержденный в Российской Федерации.Материал и методы. Анализ структуры государственного регулирования цен и издержек на закупку ЛП проведен на основании сведений, содержащихся в нормативных правовых документах Правительства Великобритании, служб здравоохранения и технического регулирования, а также информации, представленной в систематических обзорах и статьях.Результаты. Ключевой особенностью регулирования в Великобритании является максимизация эффективности издержек здравоохранения на основе принципов цифровизации, долгосрочного планирования и оценки технологий здравоохранения при ценообразовании. Государственное регулирование издержек сконцентрировано на сегменте ЛП, находящихся под патентной защитой. Поставщики таких препаратов подпадают под действие Добровольной или Принудительной схемы доступа на рынок и обязаны осуществлять платежи в виде фиксированного процента продаж в пользу Департамента здравоохранения и социального обеспечения. Отдельные сегменты лекарств освобождены от платежей с целью стимулирования инновационного развития фармацевтической отрасли и ускорения доступа на рынок новых видов терапии. Как показывает практика, Добровольная схема выгоднее для большинства компаний. Регулирование в сегменте воспроизведенных ЛП осуществляется механизмами свободного рынка и антимонопольной службой.Заключение. В результате анализа выявлены механизмы и ключевые особенности методов государственного регулирования цен и издержек системы здравоохранения на закупку ЛП, определены лучшие практики, перспективные для адаптации с целью совершенствования подходов государственного регулирования цен в Российской Федерации

Обзор методик расчета, процедуры регистрации и перерегистрации цен производителей лекарственных препаратов в странах Евразийского экономического союза

Aim. To analyze the methods of the state regulation of prices for the manufacturers of pharmaceutical drugs in the Eurasian Economic Community counties (EAEC).Materials and Methods. The comparison of the aspects of the price regulation was presented as short characteristics of the regulating impact of the key normative legal acts (NLA) in the sphere of price formation on pharmaceutical drugs in the EAEC. The study included the following stages: the analysis of NLA in the Russian Federation, Republic of Belarus, Republic of Kazakhstan, Republic of Moldova, Republic of Armenia, and the Kyrgyz Republic, the comparison of the list of reference countries, and decreasing coefficients.Results. The authors revealed the differences in the procedure of the registration, re-registration, referencing of prices, and decreasing coefficients for the generics. The authors highlighted the drawbacks of the existing procedure of the registration of prices in Russia in terms of the formation of the list of the referent countries, the re-registration of drugs with an increase in price, and limited economic efficiency.Conclusion. The performed analysis showed that the differences in the methods of the state regulation of prices on pharmaceutical drugs in the EAEC countries do not allow for the formation of a unified approach. However, the creation of supranational method of price formation is an essential condition for the functioning of the united market of pharmaceutical drugs.Цель. Анализ методов государственного регулирования цен производителей лекарственных препаратов в странах-участницах Евразийского экономического союза (далее – ЕАЭС, Союз).Материалы и методы. Сопоставление аспектов ценового регулирования представлено в виде краткой характеристики регулирующего воздействия ключевых статей нормативных правовых актов (далее – НПА) в сфере ценообразования на лекарственные препараты в странах ЕАЭС. Исследование включало следующие этапы: анализ НПА в Российской Федерации, Республике Беларусь, Республике Казахстан, Республике Молдова, Республике Армения, Киргизской Республике; сравнение перечня референтных стран, понижающих коэффициентов.Результаты. Выявлены различия в процедурах регистрации, перерегистрации, реферирования цен, величине понижающих коэффициентов для воспроизведенных препаратов, выделены недостатки существующего порядка регистрации цен в России в части формирования перечня референтных стран, перерегистрации цены производителя в сторону увеличения, ограничения рентабельности.Заключение. По результатам анализа сделан вывод о том, что различия в методах государственного  регулирования цен на лекарственные препараты в странах ЕАЭС на данный момент не позволяют  сформировать универсальный подход, однако создание наднациональной методики ценообразования  является необходимым условием для функционирования единого рынка лекарственных средств

Bridging the gap between global models and full fluid models : a fast 1D semi-analytical fluid model for electronegative plasmas

Analytical and numerical models allow investigation of complicated discharge phenomena and the interplay that makes plasmas such a complex environment. Global models are quick to implement and can have almost negligible computation cost, but provide only bulk or spatially averaged values. Full fluid models take longer to develop, and can take days to solve, but provide accurate spatio-temporal profiles of the whole plasma. The work presented here details a different type of model, analytically similar to fluid models, but computationally closer to a global model, and able to give spatially resolved solutions for the challenging environment of electronegative plasmas. Included are non-isothermal electrons, gas heating, and coupled neutral dynamics. Solutions are reached in seconds to minutes, and spatial profiles are given for densities, fluxes, and temperatures. This allows the semi-analytical model to fill the gap that exists between global and full fluid models, extending the tools available to researchers. The semi-analytical model can perform broad parameter sweeps that are not practical with more computationally expensive models, as well as exposing non-trivial trends that global models cannot capture. Examples are given for a low pressure oxygen CCP. Excellent agreement is shown with a full fluid model, and comparisons are drawn with the corresponding global model

Особенности механизмов защиты прав на интеллектуальную собственность на примере лекарственных средств, применяемых для лечения редких (орфанных) заболеваний

Objective: to study features of intellectual property protection mechanisms on the example of drugs for the treatment of rare (orphan) diseases.Material and methods. Analysis of pharmaceutical market data was performed with the DSM Group analytical database. The approach proposed by the Russian Federal Industrial Property Service was used for creating patent landscape. The method supposes conducting a patent search and analysis of the documents found for date of filing, office (country) of filing, applicant, as well as analysis of the patent activity (dynamics) for the subject, in this case, for orphan drugs having a defined structure.Results. We proposed the complex conclusions to increase national drug safety. Intellectual property limitations for importing countries such as data exclusivity, do not allow to reproduce clinical trials, which leads to non-disclosure of medical data to all parties – medical society and patients, all other market participants, including local pharmaceutical producers. Current intellectual property restrictions conceal crucial data from medical and patient society and other market players and affect accuracy of diagnosis and treatment. Along with outstanding cost of new therapies it causes enormous budget burden for the healthcare system and prevents the introduction of objective criteria in the appointment and use of medicines. Prior to the approval and submission of the registration certificate by the regulatory authority, it is necessary to establish reasonable marginal prices, to form a sufficient set and volume of clinical guidelines and to determine in advance the sources of financing and mechanisms of integration into the national system of drug provision.Conclusion. The introduction of drugs for the treatment of rare diseases into circulation leads to a sharp increase in the burden on the budgets of the healthcare system at all levels. Current restrictions and obligations in the field of intellectual property rights protection, the degree of disclosure of medical data in the process of registration and admission to the market require significant changes to the traditional system of drug provision and the system of placing state orders, as well as the introduction of new regulatory mechanisms (for example, compulsory licensing or producing individual dosage forms in pharmacy organizations), contributing to the development of the local pharmaceutical industry and providing the national health system with the necessary volume of drugs with a sufficient level of quality and safety.Цель: изучение особенностей обеспечения защиты прав на интеллектуальную собственность на примере лекарственных средств, применяемых для лечения редких (орфанных) заболеваний.Материал и методы. Анализ данных фармацевтического рынка выполнен с использованием аналитических баз данных DSM Group. Для построения патентного ландшафта применена методика, предложенная Федеральной службой по интеллектуальной собственности. Методика предполагает проведение патентного поиска и анализ найденных документов по датам подачи, ведомству (стране) подачи и заявителю, а также анализ патентной активности (динамики) в отношении объекта, в данном случае препаратов определенной структуры для лечения орфанного заболевания.Результаты. Сформулированы выводы комплексного характера, которые направлены на повышение национальной лекарственной безопасности. Ограничения, связанные с защитой прав на интеллектуальную собственность для стран-импортеров, в частности режим эксклюзивности данных, не позволяют странам-импортерам воспроизводить клинические исследования и приводят к сокрытию таких данных от медицинских, пациентских сообществ и других участников рынка. Существующие ограничения затрудняют научный обмен между медицинскими организациями и регуляторами, влияют на точность диагностики и лечения, что в случае высокой стоимости новых методов терапии создает огромную бюджетную нагрузку на систему здравоохранения и препятствует внедрению объективных критериев при назначении и применении лекарственных средств. До момента утверждения и предоставления регистрационного удостоверения регулирующим органом необходимо устанавливать обоснованные предельные цены, формировать достаточный комплект и объем клинических рекомендаций, а также заранее определять источники финансирования и механизмы интеграции в национальную систему лекарственного обеспечения.Заключение. Введение в оборот препаратов для терапии редких заболеваний приводит к резкому увеличению нагрузки на бюджеты системы здравоохранения всех уровней. Существующие ограничения и обязательства в области защиты прав на интеллектуальную собственность, степень раскрытия медицинских данных в процессе регистрации и допуска на рынок требуют существенных изменений традиционной системы лекарственного обеспечения и системы размещения государственного заказа, а также внедрения новых регуляторных механизмов (например, принудительного лицензирования или изготовления отдельных лекарственных форм в условиях аптечных организаций), способствующих развитию локальной фармацевтической отрасли и обеспечивающих национальную систему здравоохранения необходимым объемом лекарственных средств с достаточным уровнем качества и безопасности

Is concern about young people's anti-social behaviour associated with poor health? cross-sectional evidence from residents of deprived urban neighbourhoods

&lt;p&gt;&lt;b&gt;Background:&lt;/b&gt; Young people in disadvantaged neighbourhoods are often the focus of concerns about anti-social behaviour (ASB). There is inconsistent evidence to support the hypothesis that perceptions of ASB (PASB) are associated with poor health. We ask whether perceptions of young people's ASB are associated with poor health; and whether health, demographic and (psycho)social characteristics can help explain why PASB varies within disadvantaged neighbourhoods (Glasgow, UK).&lt;/p&gt; &lt;p&gt;&lt;b&gt;Methods:&lt;/b&gt; Regression analysis of survey data exploring associations between perceiving teenagers hanging around to be a serious neighbourhood problem and SF-12v2 mental and physical health scores (higher = better), including adjustment for demographic characteristics. Further analysis explored associations with self-reported measures of health service use, psychosocial characteristics of homes and neighbourhoods and social contacts.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Results:&lt;/b&gt; 6008 adults participated (50% response) and 22% (n = 1,332) said teenagers were a serious neighbourhood problem (the most frequently reported local problem). Demographic characteristics associated with perceiving serious teenager problems included regular health service use, age (inverse relationship), financial problems and living with children. Lower SF-12v2 physical health scores were associated with perceiving teenager problems after adjustment for demographic variables (OR 0.98; 95%CI 0.97,0.99; p = &#60; 0.001), whilst adjusted findings for mental health scores were less conclusive (OR 0.99; 95%CI 0.98,1.00; p = 0.103). Further analysis suggested that perceiving teenager problems was more strongly associated with a number of self-reported psychosocial factors: e.g. lacking social support, &#60; weekly family contacts, poor neighbourhood safety, low trust in neighbours, neighbourhood perceived to be a barrier to self-esteem, and neighbourhood decline.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Conclusions:&lt;/b&gt; Given the evidence we found of weak and small associations between PASB and health, we caution against assuming that tackling concern about teenagers' ASB will lead to substantial public health gains in disadvantaged areas. Although the findings do not present a compelling case for making PASB a public health priority, it is still important to address concerns about young people's ASB. Reasons for doing so may include improving social cohesion, reducing fear and isolation, and improving the general quality of people's lives - particularly in neighbourhoods burdened by multiple disadvantages. Future research should evaluate interventions that attempt to reduce PASB in disadvantaged areas. Findings from this study could help inform the targeting of such interventions.&lt;/p&gt

Нормативное правовое регулирование изготовления лекарственных препаратов аптечными организациями: опыт североамериканского фармацевтического рынка

In order to improve regulation of socially significant type of activity in the field of compounding pharmacy production, the review summarizes the technological, organizational and regulatory requirements for ensuring quality and safety of compounding drugs, as well as historical and technical analysis of the compounding pharmacy regulation in North American pharmaceutical market. The main imperatives are identified and the best practices recommended for implementation into the current state of the pharmaceutical market in the Russian Federation. С целью совершенствования подходов к регулированию особого и социально значимого вида деятельности – изготовления лекарственных препаратов (ЛП) аптечными организациями – в обзоре обобщены технологические, организационные и регуляторные требования по вопросам обеспечения качества и безопасности изготовления экстемпоральных ЛП, а также проведен историкотехнический анализ развития регулирования изготовления ЛП аптечными организациями на примере североамериканского фармацевтического рынка. Выявлены основные императивы и описана система надлежащих практик, элементы которой могут быть рекомендованы для внедрения в текущую систему регулирования деятельности аптечных организаций по изготовлению ЛП на территории Российской Федерации.