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.

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.

0Effects of the COVID-19 Pandemic on Treatment Adherence in Patients with Chronic Heart Failure.

Background: To assess the influence of the COVID-19 (Coronavirus Disease 2019) pandemic on treatment adherence by patients with CHF (Chronic heart failure) and to determine the factors associated with changing adherence during home-isolation. Methods: The survey was conducted in patients participating in the COMPLIANCE study (ClinicalTrials.gov. NCT04262583). Thirty-one patients, included into in the COMPLIANCE study before March 1, 2020, were interviewed through phone calls. A modified adherence scale of the National Society for Evidence-Based Pharmacotherapy was used, which permits to assess of overall adherence, adherence to particular drugs and the main causes for non-adherence. Results: In the whole group of patients, only a tendency to reduced overall adherence was registered during the COVID-19 pandemic (р=0,256). Significant differences in the rate of adherence deterioration were revealed for angiotensin-converting enzyme (ACE) inhibitors (p=0.031) and for statins (p=0.002). The reasons for non-adherence were lack of opportunity to contact with a physician, inability to perform investigations necessary for correcting prescribed pharmacotherapy, and side effects. Conclusion: A tendency to deterioration of adherence to prescribed pharmacotherapy was revealed during the COVID-19 pandemic. A significant decline in adherence was registered to ACE inhibitors and statins.

Analysis of Adverse Events in the Treatment of Patients with Non-Valvular Atrial Fibrillation with Oral Anticoagulants: Data from the "ANTEY" Observational Study.

Rationale. Therapy with oral anticoagulants (OACs) in patients with atrial fibrillation (AF) is based on finding the optimal balance of efficacy and safety of these drugs. Data from observational studies are an additional source of information for the adverse events (AEs) of pharmacotherapy. Objective: To investigate pharmacotherapy AEs with OACs in the "ANTEY" prospective observational study in patients with non-valvular atrial fibrillation (AF). Material and Methods: A total of 201 people were enrolled (83 (41.3%) were women). The age of subjects was 71.1 ± 8.7 years (data presented as mean with standard deviation). The study protocol included two face-to-face visits (contacts V0 and V1) and one follow-up (FU) phone contact which were made with the patient at an interval of 6 months. At V0, all patients were recommended to take one of the non-vitamin K antagonist oral anticoagulants (NOACs); starting from V1, warfarin could have been prescribed or NOAC could have been changed. Information about AEs and OACsadministration was collected at V0, V1, and FU. Results. During 1 year of observation, 15 out of 201 patients refused to take OACs, and 186 initiated the recommended drug. Rivaroxaban was initiated in 93 patients, dabigatran in 46, apixaban in 40, and warfarin in 7 patients. There were 55 AEs, 25 of which were serious (SAEs), including 4 deaths. Of the 30 AEs, there were 18 bleedings: eight (8.6%) occurred with the administration of rivaroxaban; four (8.5%) with dabigatran, three (7.5%) with apixaban, and three (42.9%) with warfarin. Differences in the incidence of bleeding events between NOACs and warfarin are statistically significant (p = 0.025). Any AEs increased the chance of nonadherence to treatment nine-fold: OR = 9.2 (CI95%: 3.6−23.5), p < 0.0001. Conclusions. The most typical and common AEs in real-world clinical practice settings treatment with OACs were bleedings, the incidence of which was approximately 8% to 9% in the treatment with NOACs and was much higher with warfarin, bleedings in the treatment with OACs are statistically significantly associated with nonadherence to the use of these drugs in the future.

Awareness of cardiovascular disease, its risk factors, and its association with attendance at outpatient clinics in acute coronary syndrome patients.

BACKGROUND: The objective was to assess patients' awareness of cardiovascular disease, its risk factors, and its association with attendance at outpatient clinics in patients with acute coronary syndrome (ACS). METHODS: All patients of the Lyubertsy Infarct Survival Study-3 registry hospitalized with ACS from November 1, 2013, to July 31, 2015, were included (n = 397). We used medical histories and specifically designed checklists. Awareness was assessed in survived patients (n = 320) for dyslipidemia, diabetes, arterial hypertension, and previous myocardial infarction. Patients were divided into three groups depending on their attendance at outpatient clinics prior to ACS: attendants, partially compliant to attendance, and nonattendants. RESULTS: Our study showed several differences between medical history data received from patients and data obtained from objective examination, which was true for arterial hypertension (p < 0.05) and particularly for dyslipidemia (p < 0.01). The majority of patients were aware of diabetes. All patients knew about previous myocardial infarction. Awareness of arterial hypertension slightly increased with increasing attendance (p > 0.05), whereas awareness of dyslipidemia increased dramatically (p < 0.01). CONCLUSION: Our study showed significant differences between medical history data received from patients and data obtained from objective examination for several cardiovascular disease risk factors in patients with ACS. Awareness of dyslipidemia was very low. It increased dramatically with increasing attendance. At the same time, there was only a slight increase in awareness of arterial hypertension with increase of attendance.