Школа охорони здоров’я
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- ItemThe development and initial validation of the Russian version of the BASIS-24(2022) Madden, Lynn; Farnum, Scott; Bromberg, Daniel; Barry, Declan; Mazhnaya, Alyona; Fomenko, Tetiana; Meteliuk, Anna; Marcus, Ruthanne; Rozanova, Julia; Poklad, Iurii; Dvoriak, Sergii; Altice, FrederickBackground: Efficient and linguistically appropriate instruments are needed to assess response to addiction treatment, including severity of addiction/mental health status. This is critical for Russian-speaking persons in Eastern Europe and Central Asia (EECA) where Medications for Opioid Use Disorder (MOUD) remain underscaled to address expanding and intertwined opioid, HIV, HCV and tuberculosis epidemics. We developed and conducted a pilot validation of a Russian version of the 24-item Behavior and Symptom Identification Scale (BASIS-24), an addiction/mental health severity instrument with six subscales, previously validated in English. Methods: Using the Mapi approach, we reviewed, translated, and back-translated the content to Russian, pilot-tested the Russian-version (BASIS-24-R) among new MOUD patients in Ukraine (N = 283). For a subset of patients (n = 44), test-rest was performed 48 h after admission to reassess reliability of BASIS-24-R. Exploratory principal component analysis (PCA) assessed underlying structure of BASIS-24-R. Results: Cronbach alpha coefficients for overall BASIS-24-R and 5 subscales exceeded 0.65; coefficient for Relationship subscale was 0.42. The Pearson correlation coefficients for overall score and all subscales on the BASIS-24-R exceeded 0.8. Each item loaded onto factors that corresponded with English BASIS-24 subscales ≥ 0.4 in PCA. Conclusion: Initial version of BASIS-24-R appears statistically valid in Russian. Use of the BASIS-24-R has potential to guide MOUD treatment delivery in the EECA region and help to align addiction treatment with HIV prevention goals in a region where HIV is concentrated in people who inject opioids and where healthcare professionals have not traditionally perceived MOUD as effective treatment, particularly for those with mental health co-morbidities.
- ItemThe influence of the regulatory system on the study design and data management practices in clinical trials(2022) Yashchenko, Mariia; Yurochko, Tetiana; Soroka, IvanThe aim: To review real-life regulatory-dependent study design and data management practices of post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and Poland. Materials and methods: This article presents the case study of 4 post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and European Union. Results: The case study presented effective cross-border cooperation between Ukrainian and European actors. Despite the gaps in Ukrainian legislative framework on medical devices, complex solutions on employment of the most stringent regulatory provisions led to appropriate study design. Usage of the highly compliant electronic data capture led to fast-track study start-up and solid clinical data collection. Conclusions: Publications on real-life regulatory-dependent clinical trials conduct might be essential to innovate the regulatory system in Ukraine. The cross-border cooperation might assist the advancement of clinical trials industry in Ukraine. Gaps in medical devices regulations in Ukraine impede the context-specific clinical trials solutions for biotech industry in Ukraine. The regulatory framework and practice in Ukraine may be perceived as externally driven due to gaps in medical devices regulations, lack of capacities of domestic notified bodies and business interests of Sponsors.
- ItemManaging opioid agonist therapy in the post-soviet limbo [electronic resourse](2022) Dmitrieva, Alexandra; Stepanov, Vladimir; Mazhnaya, AlyonaAccording to Dante, "Limbo" is the first circle of Hell located at its edge. Unlike other residents of Hell, the Limbo population suffers no torment other than their lack of hope. We argue that a lack of hope in post-Soviet Ukraine is expressed by a lack of conditions for a better future since the past is overrepresented in the present. Therefore, every movement transforms under the past’s pressure, changing its course in order to reproduce and perpetuate ghosts of what is long gone. We argue that the current state of Ukraine can be framed as "post-Soviet limbo". If the great stability of the Soviet regime was a result of overregulation and extensive control, or of "uncertainty avoidance", then a post-Soviet limbo is a result of "managing uncertainty" simultaneously influenced by Soviet legacies and neoliberal promises of growth, calculability, and deregulation on the part of the State. "Soviet legacies" are dominant and represent a mix of formal overregulation explicitly presented through laws and policies and informality which, according to some authors, became even more widespread in the post- Soviet period than it used to be under the Soviet rule. We do not aim to consider the past legacies as being opposite to neoliberal features and futures, but negotiate the way the two are interrelated and mutually reinforced in the present to produce the post-Soviet limbo. Ukraine’s performance of Opioid Agonist Therapy (OAT) coverage is consistently estimated as insufficient and needing further improvement. However, we argue that that there are two modes of OAT implementation in Ukraine: state-funded (formal) and privately-funded (informal). The latter’s size does not fall into official estimates since the national reports on OAT performance never include the numbers of patients involved in informal treatment. We suggest, that the informal mode of OAT implementation appeared as a result of contrasting efforts towards intensive regulation and extensive growth. To understand how these two modes are produced in the context of post-Soviet narcology, how they differ and where their paths cross, we analyze two types of texts: legal and policy documents regulating substance use disorder (SUD) treatment, mainly OAT; and qualitative data, including interviews with OAT patients and field notes reflecting the environment of OAT programs. Finally, the presented article seeks to answer how the state’s contrasting efforts to manage the uncertainty of SUD treatment through OAT regulation and implementation reproduce the post-Soviet limbo and, thus, people with SUD as "patients of the state" who are frozen in a hopeless wait for changes.
- ItemA qualitative exploration of daily path and daily routine among people in Ukraine who inject drugs to understand associated harms(2022) Owczarzak, Jill; Chien, Jessie; Tobin, Karin; Mazhnaya, Alyona; Chernova, Olena; Kiriazova, TetianaBackground: Patterns of movement, heterogeneity of context, and individual space-time patterns affect health, and individuals’ movement throughout the landscape is shaped by addiction, meeting basic needs, and maintaining relationships. Place and social context enable or constrain behavior and individuals use social networks and daily routines to accomplish individual goals and access resources. Methods: This article explores drug use as part of daily routines and daily paths among people who inject drugs in Dnipro City, Ukraine. Between March and August 2018, we interviewed 30 people who inject drugs living in Dnipro City, Ukraine. Study participants completed a single interview that lasted between 1 and 2 hours. During the interview, participants described their daily routine and daily path using a printed map of Dnipro as a prompt. Participants were asked to draw important sites; give time estimates of arrival and departure; and annotate on the map the points, paths, and areas most prominent or important to them. Participants also described to what extent their daily routines were planned or spontaneous, how much their daily path varied over time, and how drug use shaped their daily routine. Results: We identified 3 major types of daily routine: unpredictable, predictable, and somewhat predictable. Participants with unpredictable daily routines had unreliable sources of income, inconsistent drug suppliers and drug use site, and dynamic groups of people with whom they socialized and used drugs. Participants with predictable daily routines had reliable sources of income, a regular drug dealer or stash source, and a stable group of friends or acquaintances with whom they bought and/or used drugs. Participants with somewhat predictable daily routines had some stable aspects of their daily lives, such as a steady source of income or a small group of friends with whom they used drugs, but also experienced circumstances that undermined their ability to have a routinized daily life, such as changing drug use sites or inconsistent income sources. Conclusions: Greater attention needs to be paid to the daily routines of people who use drugs to develop and tailor interventions that address the place-based and social contexts that contribute to drug-use related risks.
- ItemСоціально-економічні наслідки коронакризи : інформаційно-аналітична доповідь(2021) Пищуліна, Ольга; Юрчишин, Василь; Юрочко, ТетянаУ виданні міститься інформаційно-аналітична доповідь, що складається з п’яти розділів. У кожному розділі наведені результати дослідження впливу пандемії COVID-19 на різні соціально-економічні та інституційні процеси в Україні, аналіз прямих та опосередкованих наслідків пандемії на рівень життя населення, вплив на систему охорони здоров’я, сферу соціального захисту та ринок праці. Крім того, окремо аналізується вплив пандемії на соціальне самопочуття громадян. У дослідженні також розглядаються інструменти державної політики та ефективність державних антикризових заходів, спрямованих на підтримку населення України в період карантинних обмежень (особливо соціально вразливих груп населення).