Self-reported attitudes, knowledge and skills of using evidence-based medicine in daily health care practice: A national survey among students of medicine and health sciences in Hungary

In order to map attitudes, knowledge and skills related to evidence-based medicine (EBM) in students of medical and health sciences faculties, we performed an online survey during the spring semester 2019 in all medical and health sciences faculties in Hungary. In total, 1080 students of medicine and 911 students of health sciences completed the online questionnaire. The attitude towards EBM was generally positive; however, only a small minority of students rated their EBM-related skills as advanced. There were large differences in the understanding of different EBM-related terms, with 'sample size' as the term with the highest (65%) and 'intention-to-treat analysis' with the lowest (7%) proportion of medical students being able to properly explain the meaning of the expression. Medical students who already participated in some EBM training rated their skills in searching and evaluating medical literature and their knowledge of EBM-related terms significantly better and had a more positive attitude towards using EBM in the practice than students without previous EBM training. EBM trained medical students were more likely to choose online journals (17.5% compared to 23.9%, p<0.05) and professional guidelines (15.4% compared to 6.1%, p<0.001) instead of printed books (33.6% compared to 52.6, p<0.001) as the main source of healthcare information retrieval and used Pubmed/Medline, Medscape and the Cochrane Library to a significant higher rate than students without any previous EBM training. Healthcare work experience (OR = 1.59; 95% CI = 1.01-2.52), conducting student research (OR = 2.02; 95% CI = 1.45-2.82) and upper year university students (OR = 1.65; 95% CI = 1.37-1.98) were other factors significantly influencing EBM-related knowledge. We conclude that the majority of students of medical and health sciences faculties are keen to acquire EBM-related knowledge and skills during their university studies. Significantly higher EBM-related knowledge and skills among EBM trained students underline the importance of targeted EBM education, while parallel increase of knowledge and skills with increasing number of education years highlight the importance of integrating EBM terminology and concepts also into the thematic of other courses

A korszerű sugárterápiás kezelések mellékhatásainak metaanalízise prosztatarákos betegeknél

Absztrakt Bevezetés: A sugárterápia technológiai fejlődésének egyik célterülete a prosztatarák megfelelő sugaras ellátása. Célkitűzés: Az elemzés célja a normálfrakcionálású és a hipofrakcionált, illetve a konvencionális és a magas dózisú intenzitásmodulált sugárterápia biztonságosságának vizsgálata. Módszer: A sugárkezelés szövődményeinek gyakoriságát metaanalízissel elemezték. Eredmények: Magasabb dózisú intenzitásmodulált sugárterápiával sem a súlyos urogenitalis (akut: p = 0,9, késői: p = 0,95), sem a mérsékelt vagy súlyos gastrointestinalis (akut: N/A, késői: p = 0,08) mellékhatásokban nincs eltérés a hagyományos besugárzási eljárásokhoz képest. A mérsékelt akut (relatív kockázat = 1,39, 95%-os konfidenciaintervallum: 1,09–1,78, p = 0,008) és késői (relatív kockázat = 1,48, 95%-os konfidenciaintervallum: 1,26–1,75, p<0,00001) urogenitalis mellékhatások relatív kockázata magasabb. A hipofrakcionált besugárzás súlyos urogenitalis (akut: N/A, késői: p = 0,73) és mérsékelt vagy súlyos gastrointestinalis (akut p = 0,73, késői p = 0,55) mellékhatásrátája sem tér el a normálfrakcionálású kezeléstől, azonban a mérsékelt késői urogenitalis mellékhatás kockázata magasabb (relatív kockázat = 1,39, 95%-os konfidenciaintervallum: 1,00–1,94, p = 0,05). Következtetések: Intenzitásmodulált sugártervezés és képvezérelt kezeléskiszolgáltatás mellett a hipofrakcionált és az emelt dózisú protokoll egyaránt biztonságos. Orv. Hetil., 2016, 157(20), 776–788

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

BACKGROUND: All randomized-controlled trials (RCTs) are required to follow high methodological standards. In this study, we aimed to assess the methodological quality of published cardiovascular clinical research trials in a representative sample of RCTs published in 2017. METHODS: Cochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017. Overall, 250 (10%) RCTs were randomly selected from a total of 2,419 studies. Data on general trial characteristics were extracted and the risk of bias (RoB) was determined. RESULTS: Overall, 86% of RCTs have reported at least one statistically significant result, with the primary outcome significant in 69%, treatment favored in 55%, and adverse events reported in 68%. Less than one-third (29%) of trials were overall low RoB, while the other two-thirds were rated unclear (40%) or with high RoB (31%). Sequence generation, allocation concealment, and selective reporting were the domains most often rated with high RoB. Drug trials were more likely to have low RoB than non-drug trials. Significant differences were found in RoB for the allocation concealment and blinding of participants and personnel between industry-funded and non-industry-funded trials, with industry-funded trials more often rated at low RoB. CONCLUSION: Almost two-thirds of RCTs in the field of cardiovascular disease (CVD) research, were at high or unclear RoB, indicating a need for more rigorous trial planning and conduct. Prospective trial registration is a factor predicting a lower risk of bias

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Background: Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods: We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results: For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs

Effect of using knee valgus brace on pain and activity level over different time intervals among patients with medial knee OA : systematic review

Background: The Knee valgus brace is one of the accepted conservative interventions for patients with medial compartment knee osteoarthritis to correct the knee varus and increase functional activity level. Nevertheless, comprehensive overview of the effects of using this brace on self-reported pain activity level over time is not available. Thus, this study aimed to systematically review the effect of using this brace on pain and activity levels in the last 20 years in patients with medial compartment knee osteoarthritis. Methods: Five databases were searched to find articles from the year 2000 to the end of November 2020: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, PubMed, Web of Science, and Scopus. Two reviewers independently evaluated the available articles for eligibility and assessed quality. The risk of bias in each study was assessed by two reviewers independently according to the Strengthening the Reporting of Observational Studies in Epidemiology tool (STROBE) for the non-randomized controlled studies and the Cochrane risk-of-bias tool for the randomized controlled studies. Results: Seven randomized controlled studies and 17 cohort studies (in total 579 participants) were included in the systematic review. Most of these studies found using a knee valgus brace effective in reducing pain and improving activity level over different time intervals. The majority of the included studies (14 studies) evaluated the impact of the brace for a considerably short-term (less than 6 months). Thus, limited evidence is available on the long-term use of the knee valgus brace and its associated complications. Conclusion: The knee valgus brace is an effective conservative intervention to improve the quality of life and reduce pain during daily activities for some patients. However, the long term of using this brace is still not very convenient, and the patients who benefit most from using the brace should be identified with high methodological quality studies

Publication of Clinical Trials on Medicinal Products: A Follow-Up Study

Background: Clinical research should provide reliable evidence to clinicians, health policy makers and researchers, which is only possible once the results are made transparently available. The present research aims to investigate factors influencing publication rates, time and characteristics of clinical trials on medicinal products and to assess the degree of accessibility of trial results on a country level. Methods: Clinical trials authorized in Hungary in the year of 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, Pubmed (MEDLINE) and Google. Results: Out of 330 clinical trials authorized in 2012, a total of 232 trials were completed for more than 1 year in June 2020. The proportion of industry-initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (p<0.001), and when registered in both EU CTR and clinicaltrials.gov (p<0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. A total of 70.93% of available publications were published “open access”. Publications with domestic co-authors contribute to the research output of a country. In our study only 21.5% of the identified publications had a Hungarian author. Conclusions: We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trials results. Measurable domestic scientific impact of trials on medicinal products need further improvement

Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design

Background: The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial's impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. Methods: The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov . Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication's target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials. Results: We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36). Conclusions: The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved