International Journal of Risk & Safety in Medicine - Volume 27, issue s1

Article Type: Other

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S85-S85, 2015

Authors: Egorova, S.N. | Akhmetova, T.

Article Type: Abstract

Abstract: BACKGROUND: The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs. Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type …of work requires high level of professional training and appropriate ethics. OBJECTIVE: To explore the current status of pharmaceutical counseling in Russia. METHODS: Situation analysis, surveys of pharmacists. RESULTS: Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs. Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist : In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling. Contradiction between the pharmacist’s special functions and trade procedure with the lack of pharmaceutical counseling standards : Article 1.1 “Code of Ethics of the pharmaceutical worker of Russia” states: “The main task of the professional activity of the pharmaceutical worker - protection of human health ”, Article 1.3 states that a pharmaceutical worker must take professional decisions solely in the interests of a patient [1 ]. However, the pharmacy is a trade organization, thus as a retailer the pharmacy is directly interested in making profits and increasing sales of pharmaceutical products, including non-prescription medicines. Moreover, while the clinical medicine is monitored for unjustified prescribing and measures are being taken to prevent polypharmacy, for a pharmacist the growing sales of over-the-counter drugs, active promotion of dietary supplements, homeopathic medicines, medical devices, and, consequently, an increase of financial indicators (particularly “average purchase size”) – all are characteristics of success [2 ]. Rational use of over-the-counter medicines requires introduction of pharmaceutical counseling standards (pharmaceutical care) according to symptoms - major reasons to visit a pharmacy as part of responsible self-medication (cold, sore throat, headache, diarrhea, etc.). Standards of pharmaceutical counseling should be objective, reliable and up-to-date and contain recommendations for the rational use of over-the-counter drugs as well as indications requiring treatment to the doctor. Standardization of pharmaceutical counseling in terms of Evidence-based Pharmacy would enhance the efficiency, safety and cost-effectiveness of over-the-counter medicines. Currently, the lack of clinical component in the higher pharmaceutical education and the lack of approved standards of pharmaceutical counseling lead to the introduction of cross-selling technologies (which are broadly applied in other areas of trade, for example, the offer of a boot-polish during the sale of shoes) to the pharmaceutical practice [2 , 3 ]. However, drugs belong to a special group of products, proper selection of which requires special education, and the consumer is not always able to evaluate the quality of the recommendations. Marketing cross-selling recommendations are aimed at promotion of the over-the-counter medicines for customers buying prescription drugs. For example, business coaches recommend the pharmacists to make additional offers: with the purchase of physician-prescribed antibiotics - offer of vitamins, with prescribed nonsteroidal anti-inflammatory drugs – commercially available ointment with non-steroidal topical formulation (“to enhance the effect”) and others. These recommendations do not agree with evidence-based medicine and lead to inefficient use of over-the-counter drugs and unjustified financial expenses. CONCLUSIONS: Thus, to ensure the rational use of medicines permitted for free (non-prescription) dispensing at the pharmacies, pharmaceutical information needs standardization on the basis of evidence-based medicine as well as standardization of the pharmaceutical counseling service. The development of practical recommendations on the rational use of over-the counter medicines by doctors and pharmacists with further adoption at the state level, the recommendation of most secure, efficient and cost-effective over-the-counter medications during pharmaceutical counseling in pharmacies will contribute to the restoration and preservation of public health. Show more

Keywords: Pharmaceutical counseling, evidence-based medicine, profits, pharmacy, pharmacist

DOI: 10.3233/JRS-150701

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S87-S88, 2015

Authors: Verbitskaya, E.V.

Article Type: Abstract

Abstract: BACKGROUND: Meta-analysis is a powerful tool to identify Evidence Based medical technologies (interventions) for use in every day practice. Meta-analysis uses statistical approaches to combine results from multiple studies in an effort to increase power (over individual studies), improve estimates of the size of the effect and/or to resolve uncertainty when reports disagree. Meta-analysis is a quantitative, formal study design used to systematically assess previous research studies to derive conclusions from this research. Meta-analysis may provide more precise estimate of the effect of treatment or risk factor for a disease, or other outcomes, than any individual study contributing to the …pooled analysis. We have quite a substantial number of Russian medical publications, but not so many Meta-Analyses published in Russian. Russian publications are cited in English language papers not so often. A total of 90% of clinical studies included in published Meta-Analyses incorporate only English language papers. International studies or papers with Russian co-authors are published in English language. OBJECTIVE: The main question is: what is the problem with inclusion of Russian medical publications in Meta-Analysis? RESULTS: The main reasons for this are the following: 1) It is difficult to find Russian papers, difficult to work with them and to work with Russian journals: a. There are single Russian Biomedical Journals, which are translated into English and are included in databases (PubMed, Scopus and other), despite the fact that all of them have English language abstracts. b. The majority the meta-analyses authors use in their work different citation management software such as the Mendeley, Reference Manager, ProCite, EndNote, and others. These citation management systems allow scientists to organize their own literature databases with internet searches and have adds-on for the Office programs what makes process of literature citation very convenient. The Internet sites of the majority of International Journals have built-in tools for saving citations to reference manager software. The majority of articles in Russian journals cannot be captured by citation management systems: they do not have special coding of articles descriptors. c. Some journals still have PDF files of the whole journal issue without dividing it into articles and do not provide any descriptors, making manual time-consuming input of information the only possibility. Moreover the context search of the article content is unavailable for search engines. 2) The quality of research . This problem has been discussed for more than twenty years already. Still we have too many publications of poor quality of study design and statistical analysis. With the exception of pharmacological clinical tails, designed and supervised by international Pharma industry, many interventional studies, conducted in Russia, have methodological flaws inferring a high risk of bias: a. Absence of adequate control, b. No standard endpoints, duration of therapy and follow up, c. Absence of randomization and blinding, d. Low power of studies: sample sizes are calculated (if calculated at all) in such a way, that the main goal is to have as small sample size as possible. Very often statisticians have to solve the problem how to substantiate a small number of subjects, that sponsor could afford, instead of calculating the needed sample size to reach enough power. e. No standards of statistical analysis. f. Russian journals do not have standards for description and presentation of study results, in particular, results of statistical analysis (a reader even cannot see what is presented: standard deviation (SD) or standard error of the mean (SEM). We have a long standing experience in analysis of methodological and statistical quality of Russian biomedical publications and have found up to 80% publications with statistical and methodological errors and high risk of bias. In our practice, we had tried to perform two Meta-analyses for two local pharmaceutical products for prevention of stroke recurrence. For the first product, we did not found even two single Russian language studies suitable for the analysis (incomparable populations, different designs, endpoints, doses etc.). For the second product, only four studies had comparable populations and standard internationally approved scales for effectiveness analysis. However, the combinations of scales, the length of treatment and follow up differed widely, so that we could combine the results of only 2 or 3 studies for each end point. CONCLUSIONS: Russian researchers have to follow internationally recognised standards in study design, selection of endpoint, timelines and therapy regimens, data analysis and presentation of results. Russian journals need to develop consolidate rules for authors of clinical trials and epidemiological research of result reporting close to international standards. In this case the international Network EQUATOR (Enhancing the QUAlity and Transparency Of health Research http://www.equator-network.org/ ) is one to be taken into account. In addition, Russian Journals have to improve their online information for better interaction with search engines and citation managers. Show more

Keywords: Meta-analysis, evidence-based medicine, Russian publications, epidemiological research, clinical trials

DOI: 10.3233/JRS-150702

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S89-S90, 2015

Authors: Abakumova, T.R. | Safina, A.F. | Ziganshina, L.E.

Article Type: Abstract

Abstract: BACKGROUND: Clinical conferences are generally defined as scheduled events at which practicing physicians themselves present to their colleagues interesting clinical cases, share their new experiences and learn about the latest achievements of medical science and practice. The value of a clinical conference is thought to be in direct communication between physicians, in analysis of topical issues in a given specialty with the aim to improve the quality of care. Speakers based on their own observations and studies reveal the most urgent problems, analyze results and offer potential decisions to their colleagues interested in the same questions. The event format may …be different: workshops, highly specialized sections, round tables and seminars with participation of the leading specialists in a given field. These conferences are generally organised by the Ministries and Departments of Health, by leading research and/or educational institutions in the field, by recognised medical centres and other institutions. Recently pharmaceutical companies got actively involved in medical events, acting as sponsors of various scientific conferences and congresses, however threatening the mission of these events [1 ]. This brings up some uneasy questions: who are the medical conferences for? Who is in charge of setting the conference agenda? Do they contribute to evidence-based medicine; do they contribute to better health? Unfortunately, there is a trend to duplication or multiplication of conferences: various agencies and departments deliver the same conferences, presentations at which are often pre-arranged by pharmaceutical companies and do not have clear scientific novelty, while the conferences themselves have largely transformed into advertising of new pharmaceuticals or new technologies [2 ]. Pharmaceutical corporations sponsor invited speakers paying for their trips and paying honoraria, organising cocktail parties as part of medical activities. With the help of leading experts with impressive titles serving as speakers at the conferences, pharmaceutical companies are trying to be as close as possible to routine practice of prescribing of certain drugs, manipulating evidence, controlling scientific societies as well as the process of clinical guideline development and publication of research results [3 ]. The degree of expert involvement depends on their level of influence [4 ]. OBJECTIVE: We aimed to study how often regular medical practitioners attend these conferences; to analyse who were keynote speakers and where they were coming from; to identify which organizations were responsible for organisation of these conferences and for sending out invitations to these conferences and for disseminating information about them. METHODS:: We summarized all the invitations (printed on paper) received by one regular medical practitioner employed with the outpatient clinical of the city of Kazan for the period of two years (2012-2013). RESULTS: During the study period (2012-2013), a regular medical practitioner received 47 printed paper invitations to scientific conferences: 22 in 2012 and 25 in 2013. The conferences were not distributed evenly over the months of the years. November appeared to be the month with the highest density/number of medical conferences: 7 conferences in 2012 and 10 in 2013. If the distribution was even, then we could calculate the number per month dividing the number per year by 9 active months (excluding July, August and September). This resulted in 2.4 and 2.8 conferences per month. Among these studied conferences 4 were organized by public health agencies: invitation tickets were accompanied by the corresponding official order to organise a conference, issued by the Health Department. Noteworthy, that 2 of these conferences were held in conference rooms of the largest hotels of the city. Forty-one out of 47 medical conferences were sponsored by big pharma: either jointly with the major medical higher educational institutions of the city or plainly by pharmaceutical companies. Seventeen conferences were held during official working hours, in the first half of the day. Not only the logo of the pharmaceutical companies was printed on invitation tickets, but there was also an advert of the promoted pharmaceutical brand. Nine conference invitations contained invitation to dinner. In one of the invitations to a conference on neuroscience it was written: “dinner under the unforgettable music”. Two conference invitations contained invitation to a lunch. Programs of 20 conferences (which were included) listed guest lecturers, coming from the leading medical universities in Moscow and St. Petersburg. Opinion leaders’ involvement: some of the leading experts acted as speakers from 4 to 7 conferences a month in this sample conference invitations package of a regular polyclinic physician. CONCLUSIONS: In 2012-2013 health practitioners were invited to attend medical conferences regularly, at least 2 times a month, with November being the busiest month. The keynote speakers were the opinion leaders from the local medical educational institutions and visitors from Moscow and St. Petersburg; their involvement with the conferences was repetitive. Governmental institutions jointly with big pharma were responsible for organisation of these conferences and attracting audience. Limitations of these observations: Unfortunately, the information on printed-paper conference invitations was not complete because not all tickets have survived. From the interview with the physician we know that in addition to these printed on paper invitations there were many invitations and alerts sent out by e-mail, SMS messages and personal phone calls, making the regularity of these conferences much higher. The physician, who kindly provided this information to us, asked not to be named or thanked in any public presentation of the results of these analyses. Show more

Keywords: Conferences, opinion leaders, health practitioners, physicians, pharmaceutical companies

DOI: 10.3233/JRS-150703

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S91-S92, 2015

Authors: Nizamov, I.G. | Sadykova, T.I.

Article Type: Abstract

Abstract: BACKGROUND: In recent years, huge efforts to improve quality control process and efficiency of healthcare were put in advancing health systems in Russia. There are measurable and noteworthy achievements, there are unresolved issues. It’s impossible to manage the process of improving the quality and efficiency of care without high-quality training of respective troops. However, in the last decade a phrase about the poor quality of postgraduate medical education has been heard periodically in the speeches of the leaders at various levels. The source is unknown, but this information continues to be spread by word of mouth as a regular component …of speeches about health issues. Considering that the “poor quality” of postgraduate education has not been substantiated by solid evidence, this informational spam, of course, needs to be overcome. It is not only harmful to health system overall, it is harmful in particular for the process of formation of personnel reserve, but it also discredits the whole system of postgraduate education and a titanic work of thousands of teachers, who work as enthusiasts, most of them performing valuable research, teaching and organizational work. OBJECTIVE: To provide situation analysis in the field of postgraduate medical education. RESULTS: First of all, it begs the question - how and who measures the quality of education. What indicators in the evaluation process are key? As a rule, when assessing quality in any field, preference is given to the opinion of the consumer. Our direct customers are the heads of health organs and institutions who regularly undergo advanced training in the specialty “Public Health and Health Care” at sub-faculty. After the completion of each cycle of training and exams, each participant fills out a questionnaire, which points out the level of quality of pedagogical activity of the sub-faculty. The analysis of these questionnaires shows that the students generally give high assessment of the quality of pedagogical process. The health authorities of subjects of Russia that send the heads of their subordinate medical organizations to study public health and healthcare are satisfied with the work of sub-faculty, professorial teaching staff, they send thank-you letters to the educational organization. In this regard, natural questions related to the overall methodology for the assessment of the quality of education in the system of postgraduate training of doctors arise, which today is still very insufficiently developed. The quality of education in the system of continuous medical education of physicians can be assessed in the following levels with the help of quality indicators, which have to be developed appropriately for each particular level. In our opinion, the following levels should be included: 1) The level of the sub-faculty 2) The level of the faculty 3) The level of the medical organization 4) The level of the territorial health authority 5) The level of the subject of the federation. CONCLUSIONS: Multidimensional assessment of the results of evaluation in the mentioned levels will allow providing an integrated assessment system of quality of continuous medical education in the country. Show more

Keywords: Continuous medical education, quality control, assessments

DOI: 10.3233/JRS-150704

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S93-S94, 2015

Authors: Kamalbekova, G. | Kalieva, M.

Article Type: Abstract

Abstract: BACKGROUND: Understanding principles of evidence-based medicine is of vital importance for improving quality of care, promoting public health and health system development. Understanding principles of evidence-based medicine allows using the most powerful information source, which have ever existed in medicine. OBJECTIVE: To evaluate the effectiveness of teaching Evidence-Based Medicine, including long-term outcomes of training. METHODS: The study was conducted at the Medical University of Astana, where the Scientific and Educational Center of Evidence-Based Medicine was established in 2010 with the help of the corresponding project of the World Bank. The participants of the study were the …faculty trained in Evidence-Based Medicine at the workshop “Introduction to Evidence-Based Medicine” for the period of 2010–2015 years. There were a total of 16 workshops during the period, and 323 employees were trained. All participants were asked to complete our questionnaire two times: before the training - pre-training (to determine the initial level of a listener) and after the training – post-training (to determine the acquired level and get the feedback). Questionnaires were prepared in such a way, that the majority of questions before and after training were identical. Thus, it provided a clear picture of the effectiveness of training. Questions in the survey were open-ended so that the respondents had the opportunity to freely and fully express their views. The main part of the questionnaires included the following questions: “Do you understand what evidence-based medicine is”, “how do you understand what the study design means”, “what is randomization”, “how research is classified”, “do you know the steps of decision-making according to Evidence-Based Medicine, list them”, “what literature do you prefer to use when searching for information (print, electronic, etc.)”, “what resources on the Internet do you prefer to use”. RESULTS: Only 30–35% of respondents gave correct answers to the questions on understanding EBM, understanding study designs, randomization. There were no correct or complete answers to the question on study classification. Again, 35% of respondents provided correct answer to the question about the stages of decision-making process from the perspective of EBM, 65% - provided no answer. One fourth (25%) of the respondents preferred using printed literature. Only very few respondents indicated Cochrane Library, Medline (PubMed), Tripdatabasa as preferred Internet sources of information, with 40% indicating Google and 60% - other sources. The results of post-training survey showed that nearly 90% of the respondents gave correct answers to all the questions. With the aim to identify knowledge survival (the long-term training outcomes) we conducted the third survey in May 2014 in previously trained people at the seminar “Introduction to Evidence-Based Medicine”. The respondents were asked to answer 4 questions, and to assess previously obtained information on the basics of Evidence-Based Medicine on a 10-point scale. We found that 100% of the respondents answered «Yes» to the question: «Have you changed your behavior after the seminar?» To the question: «Have you encountered difficulties in implementing the principles of evidence-based medicine in the educational process?» 56% of the respondents answered that they had not encountered any difficulties. The other 44% faced the difficulties associated with implementation of Evidence-Based Medicine: lack of understanding by students, low knowledge survival rate among students, too many questions from the students, difficult disputes and discussions. To the question: «Have you encountered difficulties in implementing the principles of Evidence-Based Medicine in practical health-care?» only 37.5% of the respondents answered that they had not encountered difficulties. But the remaining 62.5% of the respondents faced the problems and difficulties in implementing the principles of evidence-based medicine in their practice. These were: failure in implementing, lack of understanding on the part of colleagues, commitment to traditional obsolete methods of treatment, discrepancy between some of the existing standards of diagnosis and treatment and principles of evidence-based medicine. To the question: «Are there any end products after listening to the seminar?» 67% of the respondents answered in affirmative. The end products were mainly marked by the publication of articles and abstracts, including international publications, and participation in the working group on the revision and development of clinical protocols. CONCLUSIONS: Barriers to implementation of Evidence-Based Medicine in education and practice are lack of funding to provide access to reliable sources of information, websites; outdated research methodology skills in medical education, lack of skills in critical evaluation of medical information; tradition of authoritarian relationships, use of past experience stencils; failure to comply with continuing education programs (“from training to professional development”). Knowledge of Evidence-Based Medicine, skills to perform searches for scientific data, to evaluate their validity and to transform scientific data into practical solutions are necessary for health workers in their daily activities. This culture needs to be rooted in modern medical education. Show more

Keywords: Evidence-based medicine, training, education, practice, survey, questionnaire

DOI: 10.3233/JRS-150705

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S95-S96, 2015

Authors: Sychev, D.A. | Malova, E.U.

Article Type: Abstract

Abstract: BACKGROUND: For improving quality, safety and efficiency of care, health systems perform a paradigm change towards personalized medicine, also referred to as genomic medicine. It uses combined knowledge (genomics, transcriptomics, proteomics, metabolomics) about a person to predict disease susceptibility, disease prognosis or treatment response and thereby to improve the person’s health. The last decade has witnessed a steady embrace of personalized medicine by senior government officials, industry leadership and health care providers [1 ]. On the 12th December of 2013 Russian President Vladimir Putin in his annual address to the Federal Assembly said: “The Ministry of Health and the Russian …Academy of Sciences must give priority to fundamental and applied research in medicine, including genomic studies” [2 ]. A year earlier, in 2012 the Ministry of Health of the Russian Federation, headed by Veronika Skvortsova established the strategy of personalized medicine development in Russia [3 ]. But still a lot of work is focused on using clinical research findings to aid the delivery of optimum clinical care to patients. Pharmacogenetic testing (using genetic information to guide drug therapy) is an actively developing field of personalized medicine and its current state indicates that it can be usefully introduced into clinical practice in the nearest future. In Russia pharmacogenetic testing is already used for personalizing prescription of certain drugs [4 ]. OBJECTIVE: To assess the extent of genetic testing use for improving use of medicines. METHODS: PubMed and E-Library searches for the period of 2004–2015. RESULTS: The number of publications retrieved in PubMed search for the term “pharmacogenetics” for 2004 year was 538 and was more than 15500 publications for 2015. 800 Russian-language publications in total were retrieved using a domestic scientific database E-Library search for the term “pharmacogenetics” for 2015 year. The sharp rise in the number of publications (including Russia) reflects growing interest not only among scientists, but also among practitioners. However evidence that is actually available on some key topics may not be of sufficiently high quality to support confident conclusions. As a rule, retrospective cohort studies, also known as historical cohort studies, are carried out. The number of randomized, prospective studies is not large, though in recent years, there has been an increase in their number. However, surrogate outcomes are commonly used in the mentioned studies as trial end points. The main reason for this is the lack of sponsorship. Quite often studies are not interesting for pharmaceutical companies and are carried out within the confines of the small grants. Nevertheless, systematic reviews and meta-analyses of some pharmacogenetic tests provide the high level of evidence (pharmacogenetic testing for clopidogrel, abacavir and antineoplastic drugs) so they appear even in clinical guidelines with the evidence level IIb. It is important to mention that for certain drugs FDA has already approved pharmacogenetic testing [5 ]. CONCLUSIONS: Evidence is often inconsistent. This leads to the fact that clinical use of pharmacogenetic testing seems to be most appropriate for the management of patients with high risk of adverse drug reactions. Show more

Keywords: Pharmacogenetics, evidence, personalized medicine

DOI: 10.3233/JRS-150706

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S97-S98, 2015

Authors: Faizullin, I. | Faizullina, E.

Article Type: Abstract

Abstract: BACKGROUND: Ankle sprain is a medical condition when ankle ligaments are totally or partially torn. The primary cause of ankle sprain is sharp movements like turning or rolling the foot [1 ]. The ankle sprain needs to be treated right after the trauma, because if not treated it could lead to decreased stability of the ankle joint and lead to chronic ankle instability, which is characterized by increased risk of the ankle sprain [2 ] . We suppose that rehabilitation after the ankle sprain could significantly increase the performance of sportsmen. OBJECTIVE: To investigate effects of balance exercise …training on instable ankle due to the previous ankle sprain injury. In addition, the secondary aim of this systematic review was to find the effectiveness of different balance training exercises on instable ankle in order to find better opportunities for rehabilitation of sportsmen. METHODS: The studies were selected from PubMed and Scopus using the library of the Friedrich-Alexander University of Erlangen-Nuremberg (further-UB FAU), we used full texts, and only texts in English were included in this review. The literature search was conducted at the end of December 2014. Texts included randomised controlled trials, which were published in the last 5 years (2009–2014). The literature was included in this review only if it was published in English and if the randomised controlled trial was conducted in the study and if the full text was available from UB FAU. The articles, which were found only in PubMed search, were excluded during Scopus search. PubMed search. First MeSH term was “Balance training for the ankle sprain” and 44 articles were found in PubMed. Then 29 articles were filtered by title and excluded from the study. Remaining 15 articles were assessed reading their abstracts, 6 of them were excluded and only 4 articles were left. The second MeSH term was “Balance training for ankle injury”. Four additional articles were found by initial search. Two of them were filtered by the title and 2 were excluded at the stage of reading abstracts. The third MeSH term was “Balance exercises for instable ankle”. One additional article was found by initial search and was excluded after reading the abstract. Scopus search. The same MeSH terms were used as in PubMed search. With the first MeSH term one article was found and filtered by the title. With the second MeSH term no results were found in the initial search and with the third term 2 articles were picked up by the initial search. One of these articles was filtered by the title. The other one was filtered after reading the abstract. Overall 8 articles were taken into consideration for conducting a systematic review. Nevertheless, three of them could not be downloaded for free even using UB FAU up to the 28th of December, 2014. Thus, five articles were taken for the systematic review. After reading all 5 articles, one article by Maraike Alice Wortmann and Carrie L. Docherty was excluded from the study because it was a systematic review per se and at the same time it was not mentioned neither in the article title, nor in the abstract that the current study was a systematic review [3 ]. Also the article by Borreani et al. 2014 [4 ] was excluded after reading the paragraph “Methods” as this was not an RCT but a descriptive study. Therefore, 3 articles were taken for conducting a systematic review. RESULTS: The first article by Janssen et al. 2011 [5 ] was a 3-way randomised controlled trial with 1 year follow-up. Participants aged from 12 to 70 years used this intervention. People with active participation in sports with a lateral ankle sprain during the last 2 months were eligible for inclusion in the study. Participants were divided into 3 groups. Group 1 undertook an 8 week neuromuscular training programme. Group 2 wore sports brace during their sport activities for the duration of 1 year, and group 3 was a control group and used the combination of neuromuscular training program and wore sports brace for 8 weeks. There were 122 participants in the neuromuscular training group, 126 in the brace group and 136 in combined group. The drawback of this intervention was that there was no control over the care provid. In the second study by Ben Moussa Zouita, A et al. 2013 [6 ] the objective was to investigate how the proprioceptive exercises effect the postural balance and isokinetic strength in athletes with ankle sprain. 16 participants were recruited in the study and divided into two groups. The experimental group consisted of 8 participants with unilateral ankle sprain symptoms. The control group included another 8 participants with bilateral non-injured ankles. The training programme included 24 sessions during 8 weeks, every session lasted between 20 and 30 minutes. Four prescribed exercises were used during the intervention: one exercise without any material, one exercise with a ball only, one exercise with a balance board only and one exercise with a ball and a balance board. As a result, after 8 weeks of proprioceptive rehabilitation a significant improvement in extensor and flexor strength of ankle at a speed of 60-deg/sec was registered. The third study by Emery, Meeuwisse 2010 [7 ] was aimed to examine the effectiveness of the neuromuscular prevention strategy in youth soccer players. The inclusion criteria were adolescents between 13 and 18 years of age. The exclusion criteria were injury within 6 weeks and the history of systemic disease in anamnesis (i.e. cerebral palsy, head injury). 82 soccer teams were invited to take part in the intervention. 12 trainers declined the invitation, other 10 teams declined participation. Overall 60 teams took part in the intervention programme. The teams were randomised by a club. 32 training group teams (n = 380 players) and 28 control group players (n = 364 players) took part in the intervention. The training programme included dynamic stretching exercises, agility, jumping and balance and eccentric strength. The control programme was a standardized warm-up including static, dynamic and aerobic components and home-based stretching programme using 16-inch diameter wobble board used for 15 minutes during exercises. The injury rate in the training group was 2.08 injuries/1000 player-hours, and in the control group 3.35 injuries/1000 player-hours. The neuromuscular training programme was protective in injuries of youth soccer players. CONCLUSIONS: Balance training is an effective training method for rehabilitation of instable ankle. Different approaches to balance training provide in general similar improvement for sprained ankle. Implications for future studies: More RCTs on chronic ankle instability are needed with large sample size and use of different intensities of exercises. It would be better for the UB FAU to provide access to articles so that students and researches could download articles for free from different electronic sources. Show more

Keywords: Ankle sprain, balance training, ankle injury, instable ankle

DOI: 10.3233/JRS-150707

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S99-S101, 2015

Authors: Mendelevich, V.D. | Zalmunin, K.Yu.

Article Type: Abstract

Abstract: BACKGROUND: For many years, clinical protocols for treatment of drug abuse patients and treatment standards in Russian Federation were not grounded on the principles of evidence-based medicine [1 ]. Recommendations for use of certain drugs were not accompanied by any indication of the level of credibility of the evidence supporting it. The appearance in 2014 of such indications in clinical recommendations can be considered a significant step forward for the science of addiction medicine [2 ]. OBJECTIVE: To compare Russian evidence and practice in addiction medicines with international standards. METHODS: Situation and literature analysis. …RESULTS: The analysis shows that in the wording of recommendations on the use of medicines, some were subject of serious methodological errors. For some drugs globally there is high quality evidence supporting effects of certain drugs globally, but this is not recognized in Russia. As a result, Russian standards of clinical care for the treatment of dependency syndrome are radically different to the standards of therapy, presented in the WHO recommendations. This is due both to the disregard of the meta-analyses presented in the Cochrane reviews and also to the specific bioethical preferences in drug treatment in Russia. It is known that there is no convincing data on the effectiveness and safety of antipsychotics in the treatment of alcohol dependence syndrome [3 ]. 13 randomized trials with a double blind placebo-controlled design involving 1593 patients assessing effects of amisulpride, aripiprazole, flupentixolum dekonoat, olanzapine, quetiapine, tiapride showed that antipsychotics do not result in abstinence, do not reduce abuse and do not stop craving in alcoholic patients: “Antipsychotics should not be used in patients with a primary diagnosis of dependence. Appointment of antipsychotics for the treatment of substance abuse disorders are contraindicated, since not only does it not improve the condition of patients, but it can even worsen the course of the disease, leading to a reduction in the duration and quality of the remission, and is fraught with serious side effects that threaten the health of patients .” SSRI antidepressants indirectly improve the results of treatment of comorbid alcoholism in depressed patients, without affecting alcohol dependence per se . Also, there is currently no convincing evidence of the efficacy of anticonvulsants in the treatment of dependence syndrome, particularly alcohol. Despite the fact that traditional psychotherapeutic interventions remain widespread in practice, and treatment of alcohol dependence syndrome showed high efficiency, there is no convincing evidence for long-term benefits as opposed to short-term benefits. The Cochrane Review with data based on 146 scientific studies involving 21,404 patients confirmed the effectiveness of opioid receptor agonists in treatment of opioid dependence. This therapy showed a statistically significant reduction in the use of illegal drugs, HIV transmission and risky sexual behavior, and was significantly more effective compared to the conventional maintenance therapy with opioid receptor antagonists. In countries, where law prohibits prescribing and use of opioid agonists for opioid dependence treatment, the drugs of choice are antagonists. A meta-analysis of thirteen randomized placebo-controlled trials of oral form of naltrexone (1158 subjects), did not show any advantages of this type of treatment both for management and prevention of relapse compared with placebo [4 ]. Special studies also showed no inclination to reduce the use of opiates in patients receiving naltrexone [5 ]. However, studies carried out in Russia, showed the best results for daily intake of naltrexone after detoxification, which increased the duration of remission [6 ]. It was noted that the effect is associated with higher levels of adherence and family support in the examined population. An overview based on controlled clinical studies on the use of antipsychotic drugs (neuroleptics) in patients dependent on opioids revealed no evidence of effectiveness of this approach. It was concluded that the use of antipsychotics is justified only in the presence of co-morbid psychiatric problems in patients [7 ]. In a recent meta-analytic review on the use of atypical antipsychotics for off-label indications (off-label), there was a lack of data to support the effectiveness of their use in substance abuse [8 , 9 ]. The effectiveness of anticonvulsants in the treatment of opioid dependence syndrome has not been proven. In connection with the above puzzling fact, for Russian standards of treatment (clinical guidelines) the level of credibility of the effectiveness of antipsychotics and antidepressants in treatment of substance abuse is assessed as A or B. This paradox raises the question of the methodology for determining the level of credibility of evidence. It should be noted that Russian recommendations for inclusion of certain drugs and therapies are based on sufficient consensus of experts rather than on the results of meta-analyses [2 ]. CONCLUSIONS: This fact casts doubt on credibility and validity of scientific recommendations. Thus, one may say that Russian addiction medicine is not based on evidence, which is, in our view, erroneous and may impair the quality of care. Show more

Keywords: Paradoxes, evidence-based medicine, addiction medicine

DOI: 10.3233/JRS-150708

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S102-S103, 2015

Authors: Nazarenko, G.I. | Kleymenova, E.B. | Payushik, S.A. | Otdelenov, V.A. | Sychev, D.A. | Yashina, L.P.

Article Type: Abstract

Abstract: BACKGROUND: Today medicine is facing a “knowledge crisis” in that explosively expanding medical knowledge encounters limited abilities to disseminate new practices [1 ]. Clinical practice guidelines (CPGs) are intended to promote high standards of care in specific areas of medicine by summarizing best clinical practice based on careful reviews of current research. However, doctors are often short of time to study these documents and check their updates, have little motivation for strict adherence to them. A systematic review of 11 studies reporting on 29 recommendations has found that median adherence to all recommendations was 34%, suggesting that potential benefits for …patients from health research may be lost [2 ]. Clinical decision support systems (CDSS) can serve as a knowledge translation tool, mediator between clinical guidelines and physicians by providing the right information to the right person at the right time. OBJECTIVE: To evaluate the effectiveness of implementation of international and national CPGs for venous thromboembolism (VTE) prevention with the help of CDSS in a general hospital. METHODS: A multifunctional CDSS based on national and international guidelines on the VTE prevention was developed and implemented in the Medical Center of the Bank of Russia (MC). The system has the following functionalities: 1) it supports the decision on the VTE prevention based on individual risk assessment of thrombosis (scales of Caprini, Rogers and Khorana, Padua Prediction Score, additional risk factors) and bleeding (IMPROVE scale for non-surgical patients, major bleeding scale for surgical patients and major orthopedic surgeries, hemorrhagic complications risk in cancer patients); 2) generates the summary containing the grade of recommendations and the level of evidence, personalized recommendations on regimen and duration of preventive antithrombotic therapy, dose correction according to creatinine clearance; 3) provides an audit form for and statistical analysis of VTE cases; 3) automatically generates a quality register for VTE prevention. CDSS was implemented in June 2014. We analyzed VTE cases identified by triggers (deep vein thrombosis diagnosed by Doppler ultrasound and pulmonary embolism at the chest CT) that occurred in 2014 before and after CDSS implementation, as well as in the first half of 2015. Patients with VTE diagnosed during the first 48 hours of hospitalization or receiving anticoagulants in therapeutic doses were excluded from the analysis. Chi-square test for linear trend and non-parametric methods of descriptive statistics were used for data analysis. RESULTS: CDSS utilization was regulated by a special hospital-wide policy; lectures were organized to educate doctors how to use the system. Although international recommendations require VTE risk assessment for all hospitalized patients (except those receiving anticoagulant in therapeutic doses), the doctors filled forms for only 306 patients during the first 6 months of CDSS functioning (14.1% of discharges with length of stay >48 hours during this period). In the first half of 2015 the coverage of VTE risk assessment with CDSS was 19% (n = 506). Correctness of filling out the forms was 78.4%, in the rest of cases doctors made mistakes in choosing patient's profile or when filling in risk scales. Doctors adhere to given recommendations in 85.4% of cases. Most often (47.5%) pharmacotherapy with low molecular weight heparin (LMWH), preventive doses, was recommended by the system, and in this category the adherence to recommended practice was the lowest (74.6%). Among patients who underwent pharmacoprophylaxis, in 21.1% cases the use of anticoagulants was inconsistent with clinical guidelines or drug package insert (typically inappropriate choice of LMWH prophylactic doses, delaying or reducing the duration of prophylaxis). The rate of hospital-acquired VTE significantly decreased after CDSS implementation and was 11.71, 8.28 and 4.84 per 1,000 hospitalizations in the first and second half of 2014 and in the first half of 2015, respectively (χ2 = 7.325, df = 1, p = 0.0068). The rate of postoperative VTE for the same period amounted to 8.76, 3.39 and 4.17 per 1,000 operations, respectively (χ2 = 7.266, df = 1, p = 0.007), reaching a level of the correspondent AHRQ safety indicator (4.99 per 1,000 operations) [3 ]. Deviations from clinical guidelines or anticoagulant package inserts were revealed in 74% of VTE cases; and more than 1/3 of deviations affected treatment outcomes. CONCLUSIONS: Coverage of hospitalized patients with documented VTE risk assessment gradually increased after the CDSS implementation, but remained at a low level (19% of eligible patients). Partly it may be attributed to the lack of CDSS integration in electronic health record or computerized physician order entry systems that would facilitate routine documentation of VTE and bleeding risks. However, the introduction of CDSS has allowed reducing significantly the rate of hospital-acquired VTE. This can be explained by drawing doctor’s attention to the VTE problem and by training effect of CDSS. After receiving appropriate recommendations doctors adhere to them, on average, in 85.4% of cases, although for LMWH pharmacoprophylaxis this level was lower (74.6%). Development of hospital-acquired VTE in most cases (74%) was accompanied by non-compliance with CPGs recommendations, emphasizing the importance of additional measures for better adherence to evidence-based clinical practices. Show more

Keywords: Decision support system, clinical practice guidelines, hospital-acquired, venous thromboembolism, prevention

DOI: 10.3233/JRS-150709

Citation: International Journal of Risk & Safety in Medicine, vol. 27, no. s1, pp. S104-S105, 2015