N. P. Kutishenko

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.

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.

THE LIS STUDY (LYUBERTSY STUDY OF MORTALITY IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION). EVALUATION OF THE PHARMACOTHERAPY. PART 1. TREATMENT OF PATIENTS BEFORE MYOCARDIAL INFARCTION AND ITS INFLUENCE ON HOSPITAL MORTALITY RATE

Aim. To assess the patients’ pharmacotherapy preceding the acute myocardial infarction (AMI) and to assess the effects of this therapy on hospital mortality. Material and methods. 1133 patients were enrolled into the LIS AMI register . All these patients experienced AMI leading to hospital admitting in the territory of one of the districts of the Moscow Region during 3 years. The pharmacotherapy that patients received before AMI was analyzed as well as the influence of different drugs on the hospital mortality risk. Results. 172 of 1133 patients (15.2%) died in hospital. Before admission 21.4% of patients received β-blockers, 35.3% — ACE inhibitors, 15.7% — antiplatelet drugs, 1.9% — statins. Reduction in the hospital mortality rate was shown for β-blockers [relative risk (RR)=0.542, confidence interval (CI) =0.357–0.824] and ACE inhibitors (RR=0.710, CI=0.512–0.986). Conclusion. A significant part of patients with high risk of AMI does not receive drugs with proven positive effect on the life prognosis.

ASSESSING FACTORS THAT FORM PATIENT’S ATTITUDE TO TREATMENT PRECEDING HOSPITALIZATION FOR ACUTE CORONARY SYNDROM (DATA OF QUESTIONNAIRE WITHIN THE LIS REGISTER)

Aim. To determine the most significant factors forming patient’s attitude to treatment and factors of adherence to treatment preceding hospitalization in patients with acute coronary syndrome (ACS). Material and methods. A register of patients admitted to Lyubertsy Regional Hospital №2 for ACS from 01.12.2011 to 01.12.2012 was used in the study. A total of 272 patients (men – 157, women – 115) were enrolled into the study. Age range was between 31 and 89 years, mean age was 63.6±12.6 years. Acute myocardial infarction was diagnosed in 181 patients, unstable angina pectoris – in 91 patients. While in hospital all the patients had filled out the questionnaire on therapy adherence. Results. Half of the 272 patients (133 persons) enrolled into the study had regularly been followed-up for chronic diseases in different medical centers; 138 patients (50.7%) had not been followed-up before the reference hospitalization. According to the valid Morisky-Green test results 120 patients (44.1%) were adherent to treatment, in 141 (51.8%) patients the adherence was unsatisfactory, 11 persons (4.1%) did not answer the test questions. Younger patients adhered to doctors’ recommendations better. According to the patients (125 patients – 46%) the most effective strategy to improve treatment adherence was the obtaining of detailed information about their disease and methods of its treatment provided by the doctor. 32 patients (11.8%) pointed out the importance of lowering drug costs. 11 patients of 272 respondents demanded more care from their doctor; 4 persons suggested that better quality of medical care organization would help to ameliorate treatment adherence. Regular follow-up for chronic diseases with detailed informing about the condition by a physician positively influences adherence to recommended therapy. Patients of commercial medical centers and patients without any medical follow-up least of all adhered to treatment. Conclusion. Specially designed questionnaire allowed to determine the most significant factors that form patients’ attitude to therapy preceding the reference hospitalization and factors of adherence to treatment prescribed before the hospitalization. All the significant factors were related to the physician-patient relationships, what emphasizes the important role of both doctors and patients in improvement of treatment adherence.

PROSPECTIVE OUTPATIENT REGISTRY OF MYOCARDIAL INFARCTION PATIENTS (PROFILE-MI): STUDY DESIGN AND FIRST RESULTS

Aim. To characterize patients included to the registry PROFILE-MI; to present data reflecting the condition of patients before the onset of acute myocardial infarction (MI). Material and methods. Totally, 160 patients included: 106 males, 54 females — 66,2%/33,8%, respectively, consequently visited cardiologist in the City Polyclinics №9 of Moscow or one of two its branches, after hospitalization for MI. Results. Mean age of patients 70,4±10,8 (39-87) y.o., males were in average 10 years younger than women. About 40% were >60 y.o., about a half were retired, and of those most were women, ~1/3 of patients were already disabled; in ~3/4 there was arterial hypertension. For smoking and lipid disorders, in most patients there was no data: only for 29,4 and 46,9%, respectively; diabetes was found in 28,1%. Anamnesis of coronary heart disease (CHD) had been registered in anamnesis of 47 (29.4%), and most of those already experienced myocardial infarction (MI). Half of the included patients had had visited medical institutions during 2 year period before the MI event, most of them — local outpatient institutions (polyclinics), but 1/3 of patients did not request for medical help during last ≥2 years. Conclusion. Patients included to PROFILE-MI registry, had in general similar demographic and clinical parameters with other registries of MI in Russia. Most post MI patients already had cardiovascular diseases of atherosclerotic origin, or a combination of traditional CHD risk factors, so MI onset was quite predictable. Most of them were not under the coverage of primary and secondary CHD preventions before MI event.

ONCE AGAIN ABOUT THE HIERARCHY OF EVIDENCES IN MEDICINE OR WHETHER IT IS POSSIBLE TO CHOOSE THE MOST EFFECTIVE AND SAFE DRUG WITH THE HELP OF OBSERVATIONAL STUDIES

The role of randomized controlled trials (RCTs) and observational studies in evaluation of the efficacy and safety of drugs in cardiology is discussed. The possibility of using the results of non-interventional studies in accepting the decision to choose the most effective and safe drug is presented in more detail.

ASSESSMENT OF CHANGES IN QUALITY OF PREHOSPITAL TREATMENT OF PATIENTS WITH ACUTE CORONARY SYNDROME IN THE LAST FEW YEARS: LIS-1 VS LIS-3 REGISTRIES

Aim. To assess the changes in prehospital treatment of patients with acute coronary syndrome during the last years on the basis of the LIS-3 registry data. Material and methods . Data of acute coronary syndrome hospital registry LIS-3 (2013-2015, n=397) and acute myocardial infarction hospital registry LIS-1 (2005-2007, n=1133) were used. To assess quality of prehospital treatment the fact of taking specific pharmacological groups of medications for primary and secondary cardiovascular diseases prevention was taken into consideration. Results. Patients in the LIS-3 registry, in comparison with patients in the LIS-1 registry, more often took antiplatelet drugs (23.2% vs 15.7%, respectively; p 0.05). The quality of prehospital treatment did not differ significantly in survived and deceased patients of LIS-3 registry (p>0.05). Conclusion. Only slight improvement in the quality of prehospital therapy in patients with acute coronary syndrome was revealed, mainly due to more frequent use of antiplatelet drugs and statins. It may be explained by poor detection of early forms of ischemic heart disease and underestimation of the importance of risk factors correction, both on the part of patients and on the part of physicians.

Assessment of patients’ attendance at outpatient clinics and prehospital therapy: Russian acute coronary syndrome registry LISS-3 data

Attendance prior to ACS was generally higher in patients with established CVD and in patients with evident risk factors. The overall quality of prehospital therapy was better in patients with higher attendance rate, however, even in attendants it was far from that recommended by current clinical guidelines. Objective: Despite greater use of modern medication therapy, effective reperfusion therapy and primary percutaneous coronary interventions, mortality following acute coronary syndrome (ACS) remains substantial [1,2]. Prehospital therapy is one of the components that influences outcomes of a disease [3]. Its quality may depend on different factors: quality of identification of high risk patients, physicians’ adherence to use of clinical guidelines in their practice, patients’ adherence to doctors’ recommendations [4]. The aim of the present study was to analyze patients’ attendance at outpatient clinics (OC) prior to the development of ACS and its influence on the quality of their prehospital therapy.

EVALUATION OF THE CONFORMITY OF CARDIOVASCULAR THERAPY TO CURRENT CLINICAL GUIDELINES IN THE IMPROVEMENT OF OUTCOMES IN PATIENTS AFTER STROKE (ACCORDING TO THE LIS-2 REGISTER)

Aim. To study the conformity of preventative therapy prescribed to patients during a hospital stay and at a discharge to clinical guidelines using a special algorithm, and to assess the impact of the results on a long-term mortality based on the LIS-2 register (Lyubertsy study of mortality in patients after cerebral stroke). Material and methods. The scales to assess the quality of cardiovascular care for the prevention of recurrent stroke along with the prevention of recurrent ischemic attacks index (PRIA index) for this assessment were developed according to current clinical guidelines. Analysis of the therapy was performed using PRIA index on survived hospital patients from LIS-2 register (N=753). The impact of PRIA index results on a long-term mortality (Me=2.3 years) was studied. Results. Based upon the results of the assessment obtained with PRIA index, higher treatment conformity to clinical guidelines resulted in a significantly better long-term survival. Non-conformity to clinical guidelines was due to the lack of prescription of drugs with proven efficacy and irrational choice of preventive therapy. Median of treatment quality assessment was 44.4% (22.2; 44.4). Conclusion. Low conformity of preventive therapy to clinical guidelines is found in the LIS-2 register. The algorithm for the assessment of preventive cardiovascular therapy quality allows identifying limitations in the prevention of recurrent stroke, and can serve as an example of implementation of evidence-based medicine in clinical practice.

РЕГИСТРЫ В КАРДИОЛОГИИ. ОСНОВНЫЕ ПРАВИЛА ПРОВЕДЕНИЯ И РЕАЛЬНЫЕ ВОЗМОЖНОСТИ

The article presents the main goals, tasks, principles, and methodological aspects of the cardiology register development. The authors describe the main types of registers, provide the examples, and specify the key principles of the register development and maintenance. In addition, they discuss the role of both long- and short-term registers in solving a wide range of important research tasks, particularly in the areas of effectiveness and safety of cardiovascular pharmacotherapy and the survival prognosis for specific nosological forms. The task-specific limitations of registers are also discussed.