Medical professionals' agency and pharmaceuticalization: Physician-industry relations in Russia.

In the contemporary world pharmaceuticals have become a go-to answer to a growing number of questions. This process of pharmaceuticalization gives rise to a concern with the increasing influence of the pharmaceutical industry on physicians' decision-making. Critics suggest that companies' for-profit-interests might compromise the integrity of medical practice. This article employs qualitative research methodology to explore how Russian physicians deal with the industry's efforts to expand and shape the use of pharmaceuticals. By bridging perspectives of social studies of science and sociology of professions, we offer a contextualized account of physicians' daily practices and interpretations related to pharmaceuticalization. The findings question conventional assumptions of physician-industry relations and allow to delineate a new form of medical professionalism that emerges in the context of pharmaceuticalization and cannot be reduced to either "resisting" industry marketing activities or "giving in" to them and thus corrupting biomedical expertise. Instead, the ways in which physicians navigate abundant sources of knowledge and use industry resources to overcome constraints of their organizational environment attest to mundane forms of agency exercised by physicians in their relations with industry.

Patients' work and fluid trajectories: Access to medicines for oncological and rare diseases in Russia.

Health policy studies usually conceptualise access to medicines as a result of the institutional configuration of policies, legislation, and pharmaceutical markets. This study adopts a different approach that stems from the sociology of health and Science and Technology Studies (STS). Based on an ethnographically inspired qualitative research of access practices of patients with oncological and rare diseases in Russia, we argue that access to medicines is a fluid and unstable trajectory constructed by the everyday practices of patients. Instead of seeing patients as passive recipients of institutionally arranged access, we focus on their practices of building access and identify four types of work they do to steer their access trajectories in the desired direction. These types of work include persisting work, complying work, adjusting work, and knowing work. In many studies of access, these types of work remain invisible, and thus the efforts and skills that patients need to make access possible remain unnoticed, undervalued, and unaccounted for.

Practices of patient engagement in drug development: a systematic scoping review.

BACKGROUND: During the past decade, patient engagement (PE) has attracted significant attention in the field of drug development. Readiness to accept the central importance of patients' knowledge and contributions has become evident. This study aimed to synthesize evidence on the current state of PE in drug development: what is actually being done and how. METHODS: A systematic scoping review was conducted based on a PRISMA-informed protocol. Search was performed in PubMed, EMBASE and Web of Science, covering the period between 2011 and 2021. For analysis of extracted data, we developed a framework for analyzing PE in Drug Development. The Framework distinguishes a number of different PE types that take place at different stages of drug development and are characterized by the different degrees of power patients have in the process. It allowed us to assess depth and intensity of PE initiatives included in this review. RESULTS: Most included PE initiatives took place at the stage of designing studies (40 in total). At this stage drug development goals are already set, but the mode of reaching them has not yet been fully determined. PE initiatives on the finetuning details stage followed (16 in total). The finetuning details stage covers the last parts of the drug development trajectory, when only relatively minor issues are still open for patients' contributions. The least numerous were PE initiatives on the stage of setting up R&D program (13 in total). This stage refers to the early steps in drug development where PE has the potential to make the most impact on shaping the subsequent process. In terms of intensity of engagement, most PE initiatives included in this review align with consultation and involvement types, 26 and 30 initiatives, respectively. Partnership was less frequent in the published accounts of PE (13 initiatives). CONCLUSIONS: This review delineated a contemporary landscape of PE in drug development. Although attention to PE in drug development is relatively recent, a wide range of PE practices has already been initiated. The results indicate the necessity of distinguishing between different types of PE in order to understand consequences of choices regarding depth and intensity of PE.

This article summarizes what is publicly found in scientific papers about patient engagement in drug development initiatives between 2011 and 2021. It also introduces a new Framework to use to look at these patient engagement efforts. The Framework breaks these efforts down based on the depth of patient engagement in the drug development process and different degrees of influence or power patients have or intensity of engagement. In terms of depth of patient engagement in the process of drug development, most patient engagement initiatives described efforts involved in designing studies where goals were already set. Next were patient engagement efforts related to finetuning details where patients could make minor contributions. The fewest efforts were found related to setting up a research and development program where patients potentially could make significant impact. In terms of intensity of patient engagement, most initiatives aligned with consultation and involvement intensities, and few examples aligned with the highest intensity of patient engagement that was considered partnership. While patient engagement in drug development is becoming more common, the approaches to doing so vary widely. We have developed a new Framework to help characterize these efforts related to patient influence in the process as well as depth of their engagement.

Adolescents in a tuberculosis hospital: Qualitative study of how relationships with doctors, caregivers, and peers mediate their mental wellbeing.

Lengthy hospitalization can impact adolescents' mental wellbeing in a number of negative ways. Scholarship has indicated that a young patient's relationships play an important role in reducing the amount of stress felt and in improving emotional state. In this article we turn to the experiences of adolescents with tuberculosis [TB] in Russia to explore how exactly hospitalization together with the TB diagnosis itself impact their mental wellbeing and how relationships with others mediate these impacts. We conducted a qualitative, interview-based study in Tomsk pediatric TB clinic. Interviews were conducted with three groups relevant for reaching the aim of this research: adolescent patients, their adult caregivers, and their treating physicians [17 informants in total]. Interview data were complemented with prolonged observations in the same clinic. The results of our study highlight that threats to mental wellbeing of adolescents with TB are multiple. Adolescents who are about to enter the in-patient treatment feel apprehensive and anxious about their future. They tend to have a hard time accepting their diagnosis, which they often feel is something shameful, and, consequently, may develop a negative attitude towards themselves. Most importantly, many undergo painful loss of personal relationships and expect or actually experience rejection by peers because of having tuberculosis. However, relationships with physicians, caregivers, and other patients in the clinic mediate negative impacts of TB diagnosis and hospitalization on adolescents' mental wellbeing and can open ways for providing support. Supportive practices include physicians leaving it up to adolescents to decide what they want to discuss and when, caregivers remaining available for contact and keeping regular communication, and other adolescents with TB proactively seeking contact with the newcomers and behaving in a non-judgmental way. These results can inform design of adolescent-friendly TB services.

Opisthorchis felineus infection, risks, and morbidity in rural Western Siberia, Russian Federation.

BACKGROUND: The liver fluke, Opisthorchis felineus, is widely distributed throughout Europe and large parts of the Russian Federation. In Western Siberia, information about opisthorchiasis is lacking although infection may lead to severe liver and bile duct diseases. We aimed to assess the current prevalence of O. felineus infection along with associated risk factors and morbidity in rural Western Siberia. METHODS: We conducted a community-based, cross-sectional study in the rural Shegarskiy district, Tomsk Oblast, Russian Federation. All household members (≥ 7 years) present on the survey day were enrolled (n = 600). Two stool samples per person were examined for helminth eggs, using PARASEP (DiaSys Ltd, UK). The number of eggs per gram (EPG) of feces was recorded. Each study participant was interviewed to determine risk factors, using a pre-tested questionnaire. An abdominal ultrasonography examination of liver and bile ducts was performed with a mobile, high resolution ultrasound device. In total, 488 persons completed assessments (two stool samples, completed questionnaires); of those, 436 individuals had an ultrasonography (US) examination. RESULTS: We observed a prevalence of O. felineus infection of 60.2%. Significant risk factors for infection were the consumption of river fish (odds ratio from adjusted analysis [aOR] 2.4, 95% CI 1.52-3.95, p<0.001), particularly stock fish (OR from multivariable analysis [mOR] 3.2, 95% CI 2.63-3.80, p<0.001), smoked fish (mOR 1.5, 95% CI 1.24-1.72, p<0.001), frozen fish (mOR 1.6, 95% CI 1.29-2.02, p<0.001), and raw fish (mOR 1.4, 95% CI 1.05-1.84, p = 0.02); and fishing activities (mOR 1.2, 95% CI 1.03-1.43, p = 0.019). Women had a higher risk of infection than men. Infection was associated positively with age and negatively with socio-economic status. The respondents' general awareness of opisthorchiasis was quite high (93.2%), but their knowledge about infection transmission and prevention was insufficient. Children aged 7-18 years old had a lower level of awareness compared to adults. The abdominal ultrasonography results demonstrated a strong association between O. felineus infection and gallbladder stones (mOR 2.8, 95% CI 1.33-6.04, p = 0.007) and periductal fibrosis of intrahepatic bile ducts (mOR 1.9, 95% CI 1.08-3.46, p = 0.026). CONCLUSION: O. felineus infection is highly prevalent in rural regions of Western Siberia, and associated with severe hepatobiliary pathology. Identified risk factors will be used to develop a comprehensive targeted O. felineus infection control program.

Informal professionalization of healthy participants in phase I clinical trials in Russia.

BACKGROUND: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term "professionalization" has been used to denote this phenomenon. PURPOSE: We aim to examine a component of healthy trial participants' professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials. METHODS: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff. RESULTS: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators. LIMITATIONS: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics. CONCLUSIONS: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants' work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

EXPERIENCING SYNDEMIC: DISENTANGLING THE BIOSOCIAL COMPLEXITY OF TUBERCULOSIS THROUGH QUALITATIVE RESEARCH.

Tuberculosis (TB) remains a major global public health problem that has become a crisis fuelled by HIV and the increasing occurrence of antimicrobial resistance. What has been termed the biosocial nature of TB challenges effective control of the disease. Yet, biosocial interactions involved in the persistence of TB in diverse settings are difficult to systematically account for. The recently developed framework of syndemics provides a way to capture how complex health problems result from the interactions between diseases such as HIV and TB, and harmful social conditions such as unemployment, malnutrition and substance abuse. This article advances the syndemics scholarship by examining health conditions that cluster together with TB in the Russian Federation, by eliciting a set of social processes that precipitate this clustering and exacerbate health outcomes, and by analysing interactions between these health conditions and social processes. To provide an account of this complexity, the article takes a qualitative approach and draws on the perspectives and experiences of people with TB. The results demonstrate emergence of a syndemic of stress, substance abuse, TB and HIV that is sustained by poverty, occupational insecurity, marginalization and isolation. Frictions between the narrow focus of the health care system on TB and the wider syndemic processes in which the lives of many persons with TB are embedded, contribute to poorer health outcomes and increase the risks of developing drug resistance. Finally, the article argues that the large-scale and impersonal forces become embodied as individual pathology through the crucial interface of the ways in which persons experience and make sense of these forces and pathologies. Qualitative research is needed for the adequate analysis of this biosocial complexity in order to provide a solid basis for responses to TB-centred syndemics in various settings.

Risks and benefits of trial participation: A qualitative study of participants' perspectives in Russia.

BACKGROUND: The Russian Federation is one of the emerging clinical trial regions where the numbers of international clinical trials have been significantly rising over the course of recent years. PURPOSE: Our aims were to describe and explain risk-benefit calculus by clinical trial participants in Russia and to analyse the significance of the results for the ethical regulation of globalizing clinical trials. METHODS: In-depth semi-structured interviews were conducted with 21 individuals participating in trials for cardiovascular disease. Analysis was based on the inductive constant comparative method. RESULTS: Interviewed participants perceived multiple benefits in trial enrolment including regular check-ups, provision and explanation of individual test results, the opportunity to ask investigators for advice and the provision of treatment recommendations for those with limited access to a physician outside of the trial. Participants tried to manage risks of trial enrolment by paying attention to how they felt and reporting changes to investigators. Regular monitoring, the opportunity to drop out of the trial and health insurance provision in case of adverse events were viewed as further minimizing individual risks. Importantly, interviewed trial participants did not assess the risks and benefits of a single trial independently of wider social situation or particularities of their own health condition. Value of trial enrolment benefits for participants was enhanced by the healthcare system that was viewed as being unresponsive to the needs of people with cardiovascular disease. Therefore, in their risk-benefit assessment, participants weighed enrolment risks against the risks of dealing with their fragile health without continuous contact with a medical professional. LIMITATIONS: A relatively small number of interviews was conducted, only participants of cardiovascular disease trials were interviewed and the extent to which the described perspectives are generalizable is not established. CONCLUSION: The risk-benefit assessment as performed by most interviewed trial participants involved multiple components, including the ones unrelated to the trial itself, and was largely context-dependent. Perspectives of research participants can enrich frameworks for the evaluation of trial risks and benefits.

International clinical trials, cardiovascular disease and treatment options in the Russian Federation: research and treatment in practice.

The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the therapeutic misconception. However, it has also been questioned whether research can and should always be separated from medical care provision. In this paper we analyze how these concerns played out in practice settings of the three trial sites in Russia, specialized in trials in cardiovascular diseases. Using in-depth interviews with participants of phase II and III trials (n = 21) and discussions with physician-investigators (n = 7), we found that trial enrollment allowed participants to establish continuous supportive relationships with the physician-investigators. In the context of unresponsive health care, chronically ill participants received regular monitoring, treatment recommendations and help in case of problems and emergencies through such relationships. The trial designs in the three sites did not preclude the provision of individualized treatment. We suggest that debates about the research/treatment interface in trials need to become more attuned to the conditions in locations of their conduct, views and experiences of actors involved and evolving trial methodologies. Too much focus on categorical differentiation of research and treatment may obscure the fact that globalizing clinical trials proceed amidst profound health disparities, dismiss diverse concerns of people on the ground and risk attenuating responsibilities of trial organizers, sponsors and investigators towards research participants.

Developing Clinical Research Relationship: Views from Within.

The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted in Ghana and South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator-participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long-term public trust, crucial for the continuous operation of clinical research.

Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.