scholarly journals Specialized nutrition for athletes: evaluation of ergogenic action using the principles of evidence-based medicine

Pharmacia ◽  
2022 ◽  
Vol 69 (1) ◽  
pp. 37-44
Author(s):  
L. M. Gunina ◽  
Ye. B. Shustov ◽  
I. F. Belenichev ◽  
N. L. Vysochina ◽  
R. V. Golovashchenko ◽  
...  
Keyword(s):  
Evidence Based Medicine ◽  
Food Additives ◽  
Sports Nutrition ◽  
Laboratory Animals ◽  
Control Group ◽  
Placebo Control ◽  
Evidence Based ◽  
Mental Performance ◽  
Based Medicine ◽  
Positive Effect

The aim is to form a balanced position regarding the ergogenic characteristics of new sports food products in the modern practice of training highly qualified athletes on the basis of clinical-experimental evaluation of the effectiveness of special purpose real food additives. Materials and methods. Studies were carried out on laboratory animals (36 Wistar rats at the age of 3 months weighing 150–200 g and 16 Svetlogorsk mini-pigs) as well as on 102 high-qualified representatives of cyclic sports (all men aged 19–26) − members of national teams such as swimming (25), cross-country athletics (53), and skiing (24). As a control group, we studied 25 athletes of the same gender (all men), age and qualifications who received a placebo (starch capsules) for a long time during exercise. Placebo-controlled studies have been conducted on laboratory animals and athletes in compliance with the principles of bioethics. Results. It has been established that in the experiment the application of a new specialized food product MioActiv has a positive effect on the physical performance of animals and delays the onset of fatigue, which significantly exceeds the corresponding characteristics in the placebo group. Athletes also showed an increase in speed when passing competitive distances by 18.7–21.4% (p < 0,05), as well as a significant increase in mental endurance indicators (p < 0,05). The approbation of the innovative pre-workout pharmacological nutrient complex Pre-Fuse also showed the high efficacy and safety of this product with a positive effect of increasing the performance and endurance of animals, as well as the parameters of mental performance of athletes in the main groups, in contrast to the data in the placebo control groups. Conclusions. An analysis of the prescription components of new types of ergogenic sports nutrition and the presented results of preclinical and clinical studies conducted on the basis of the evidence-based medicine paradigm regarding the effectiveness of specialized products indicate the complex action of these funds on various aspects of both physical and mental performance. From the materials presented in the article, it can be seen that specialized sports nutrition products of an ergogenic orientation can provide significant assistance in increasing sports results.

scholarly journals Efficacy of a complex intervention comprising the guideline evidence-based health information and a training programme on the quality of health information: study protocol of a randomised controlled trial

2020 ◽  
Author(s):  
Julia Lühnen ◽  
Birte Berger-Höger ◽  
Burkhard Haastert ◽  
Jana Hinneburg ◽  
Jürgen Kasper ◽  
...  
Keyword(s):  
Health Information ◽  
Evidence Based Medicine ◽  
Information Quality ◽  
Controlled Trial ◽  
Training Programme ◽  
Control Group ◽  
Evidence Based ◽  
Study Results ◽  
Based Medicine

Abstract Background Evidence-based health information (EBHI) is a prerequisite for informed and shared decision-making. The criteria for EBHI have been described comprehensively but the implementation in practice is still insufficient. The guideline evidence-based health information addresses providers of health information. Its goal is to improve the quality of health information. The evidence-based guideline emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. In addition, the competences of providers of health information were explored and a training programme was developed. Aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expect the intervention to improve the quality of health information in comparison to provision of the guideline only. Methods The trial uses a superiority randomised control group design with ten months follow-up. 26 providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline & training programme) with usual care (guideline publicly available). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline’s recommendations. Each provider will prepare a single health information informing a health-related decision on a freely chosen topic. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) checklist. An accompanying process evaluation will then be conducted. Discussion The study results will show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers’ competences in evidence-based medicine and to ensure high quality EBHI in the long-term. Trial registration ISRCTN registry, registration number: ISRCTN96941060, Date: 7 March 2019, URL: http://www.isrctn.com/ISRCTN96941060

scholarly journals A Study on How Using an Interactive Multimedia E-Book Improves Teachers’ Ability to Teach Evidence-Based Medicine, Depending on Their Seniority

2021 ◽  
Author(s):  
Yu-Hsuan Liao ◽  
Kuo-Shu Tang ◽  
Chih-Jen Chen ◽  
Ying-Hsien Huang ◽  
Mao-Meng Tiao
Keyword(s):  
Evidence Based Medicine ◽  
Clinical Teaching ◽  
Teaching Method ◽  
Control Group ◽  
Study Group ◽  
Evidence Based ◽  
Fresno Test ◽  
Before And After ◽  
Study Type ◽  
Based Medicine

Abstract Background Teaching evidence-based medicine (EBM) is not an easy task. The role of the electronic book (e-book) is a useful supplement to traditional methods for improving skills. Our aim is to use an e-book or PowerPoint to evaluate instructors’ teaching effects. Methods Our study group was introduced to learning evidence-based medicine (EBM) using an interactive e-book available on the Internet, while the control group used a PowerPoint presentation. We adopted the Modified Fresno test to assess EBM skills before and after their learning. EBM teaching sessions via e-book or PowerPoint were 20–30 minutes long, followed by students’ feedback. We adopted the Mann-Whitney U tests to compare teachers’ evaluation of their EBM skills and the students’ assessment of the teachers’ instruction. Results We found no difference of EBM skills between the two groups prior to their experimental learning. Physicians in the study group ranked higher in “Choose a case to explain which kind of research design is used for the study type of the question and explain your choice” (P = 0.011) and “How are the important results expressed in the articles found” (P = 0.023), which was assessed by the Modified Fresno test. Teaching effect was better in the e-book group than in the control group for the items, “I am satisfied with this lesson,” “The teaching was of high quality,” “This was a good teaching method,” and “It aroused my interest in EBM.” No difference was observed between the two groups in the physicians with more than 10 years’ experience. Conclusions The use of interactive e-books in clinical teaching can enhance teachers’ EBM skills and teaching and is thus clinically useful.

scholarly journals How to Design the Control Group in Randomized Controlled Trials of Acupuncture?

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Jaung-Geng Lin ◽  
Chao-Hsun Chen ◽  
Yu-Che Huang ◽  
Yi-Hung Chen
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Control Group ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Based Medicine

In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.” We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field.

scholarly journals Development and evaluation of an evidence-based medicine module in the undergraduate medical curriculum

2020 ◽  
Author(s):  
Abeer Salem Al Shahrani
Keyword(s):  
Medical Students ◽  
Study Design ◽  
Evidence Based Medicine ◽  
Clinical Decision Making ◽  
Medical Curriculum ◽  
Control Group ◽  
Evidence Based ◽  
Fresno Test ◽  
Post Test ◽  
Based Medicine

Abstract Background: Evidence-based medicine (EBM) is a core competence in both undergraduate and postgraduate medical curricula. However, its integration into curricula varies widely. Our study will help medical colleges develop, implement and evaluate their EBM courses. We assessed the effectiveness of workshops in improving critical appraisal skills among medical students.Methods: A before-and-after study design without a control group was used. A 5-week short EBM module including lectures, workshops, and online search sessions was conducted with 52 fourth-year medical students during their primary healthcare course at the College of Medicine, Princess Nourah bint Abdulrahman University. Statistical analysis was performed using SPSS statistical software (version 20, SPSS Inc., Chicago, US). Parametric tests as well as Student’s paired t-test for pre- and post-test comparisons were used.Results: Forty-nine (49) participants completed the pre- and post-training Fresno tests, and 44.9% of the participants had a GPA of 4.0 or higher. The mean Fresno test score increased from 45.63 (SD 21.89) on the pre-test to 64.49 (SD 33.31) on the post-test, with significant improvements in the following items: search strategies, relevance, internal validity, magnitude and significance of results, statistical values of diagnosis studies (sensitivity, specificity, and LR), statistical values of therapy studies (ARR, RRR, and NNT), and best study design for diagnosis and prognosis (P<0.05).Conclusion: This study supports that a short course in EBM that is incorporated into the undergraduate curriculum, especially in the clinical years, might be effective in improving medical students’ knowledge and skills in EBM. However, prospective studies are necessary to assess the long-term impact of these interventions and ultimately their effectiveness for clinical decision making. Trial registration: not applicable

Evidence-based medicine in otolaryngology journals

2002 ◽  
Vol 126 (4) ◽  
pp. 371-376 ◽  
Author(s):  
Boris L. Bentsianov ◽  
Marina Boruk ◽  
Richard M. Rosenfeld
Keyword(s):  
Clinical Research ◽  
Internal Control ◽  
Evidence Based Medicine ◽  
Research Articles ◽  
Control Group ◽  
Evidence Based ◽  
Supporting Evidence ◽  
Level Of Evidence ◽  
Therapeutic Recommendations ◽  
Based Medicine

OBJECTIVE: We set out to assess, within the context of evidence-based medicine, the levels of supporting evidence for therapeutic recommendations made in leading otolaryngology journals. DESIGN: We used a cross-sectional survey of clinical research articles published in 1999 in 4 high-circulation otolaryngology journals. OUTCOME MEASURES: We used study design methodology and level of evidence for clinical research articles with therapeutic recommendations. Outcomes were stratified by type of recommendation (positive vs negative) and by study focus (medical vs surgical therapy). RESULTS: Of the 1019 articles identified, 737 (72%) were clinical research and 268 (36%) made therapeutic recommendations. Median sample size was modest (27 subjects), with only 38% of studies reflecting planned research and 22% including an internal control or comparison group. positive studies were 20 times more prevalent than negative ones, but were 69% less likely to have an internal control group ( P = .042) and 93% less likely to include confidence intervals ( P = .020). Moreover, the level of evidence for positive studies was lower than for negative studies ( P = .037), with twice as many negative recommendations supported by analytic research. Similarly, the level of evidence for operation was lower than for medical therapy ( P < .001), with 3 times as many medical recommendations supported by analytic research. CONCLUSIONS: Most therapeutic recommendations in otolaryngology journals are on the basis of descriptive case series (80%) and least often on randomized controlled trials (7%). A dual standard appears to exist for negative versus positive studies and for medical versus surgical recommendations. Greater scrutiny of the breadth and quality of evidence levels supporting therapeutic recommendations is likely to occur as the popularity of—and demand for—evidence-based medicine increases. SIGNIFICANCE: Evaluation of levels of evidence in otolaryngology decision making.

Calculation of sample size when planning a clinical study of the Bovhyaluronidaze azoximer preparation in companion animals urological practice

2020 ◽  
Vol 1 ◽  
pp. 140-144
Author(s):  
A.V. Nazarova ◽  
Keyword(s):  
Veterinary Medicine ◽  
Clinical Study ◽  
Sample Size ◽  
Evidence Based Medicine ◽  
Statistical Significance ◽  
Companion Animals ◽  
Control Group ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Based Medicine

Nowadays both international and Russian medical sciences are actively working to improve the methods of evidence and the formation of standards of research and treat-ment. The necessity to develop common criteria for evaluating the effectiveness of methods of diagnosis, treatment and prevention of diseases exists in veterinary medicine. To achieve this goal, both general veterinary medicine and scientific research in the field of veterinary medicine, must reach the level of evidence that answers the requirements of Evidence Based Medicine. In accordance with the current require-ments of Evidence Based Medicine and Good Clinical Practice, at the stage of plan-ning a clinical study of the use of Bovhyalu-ronidaze azoximer preparations in the com-panion animals urological treatment, we have calculated the required sample size. In the calculation, we used the results of a pilot study, in which the incidence of post-operative complications in the experimental group was 0.10, in the control group — 0.55. We calculated that for statistical significance testing with significance level α = 0.05 and power β = 0.80 in a clinical trial of the use of bovhyaluronidaze azoximer prepara-tion in the urological practice of companion animals, the sample size should be at least 22 animals in each group (taking into ac-count the possible retirement of patients from the clinical study). And the groups must be equal in volume to achieve the max-imum test power.

scholarly journals Development and evaluation of an evidence-based medicine module in the undergraduate medical curriculum

2020 ◽  
Author(s):  
Abeer Salem Al Shahrani
Keyword(s):  
Medical Students ◽  
Study Design ◽  
Evidence Based Medicine ◽  
Clinical Decision Making ◽  
Medical Curriculum ◽  
Control Group ◽  
Evidence Based ◽  
Fresno Test ◽  
Post Test ◽  
Based Medicine

Abstract Background: Evidence-based medicine (EBM) is a core competence in both undergraduate and postgraduate medical curricula. However, its integration into curricula varies widely. Our study will help medical colleges develop, implement and evaluate their EBM courses. We assessed the effectiveness of workshops in improving critical appraisal skills among medical students. Methods A before-and-after study design without a control group was used. A 5-week short EBM module including lectures, workshops, and online search sessions was conducted with 52 fourth-year medical students during their primary healthcare course at the College of Medicine, Princess Nourah bint Abdulrahman University. Statistical analysis was performed using SPSS statistical software (version 20, SPSS Inc., Chicago, US). Parametric tests as well as Student’s paired t-test for pre- and post-test comparisons were used. Results Forty-nine (49) participants completed the pre- and post-training Fresno tests, and 44.9% of the participants had a GPA of 4.0 or higher. The mean Fresno test score increased from 45.63 (SD 21.89) on the pre-test to 64.49 (SD 33.31) on the post-test, with significant improvements in the following items: Searching strategies, Relevance, Internal validity, Magnitude & significance of results, Statistical values of diagnosis studies (sensitivity, specificity, and LR), Statistical values of therapy studies (ARR, RRR, and NNT), and Best study design for diagnosis and prognosis (P < 0.05). Conclusion This study supports that short course in EBM that is incorporated into the undergraduate curriculum especially in the clinical years might be effective in improving medical students’ knowledge and skills in EBM. However, prospective studies are necessary to assess the long-term impact of these interventions and ultimately their effectiveness for clinical decision making.

scholarly journals Practising evidence-based medicine in an era of high placebo response: number needed to treat reconsidered

2016 ◽  
Vol 208 (5) ◽  
pp. 416-420 ◽  
Author(s):  
Steven P. Roose ◽  
Bret R. Rutherford ◽  
Melanie M. Wall ◽  
Michael E. Thase
Keyword(s):  
Evidence Based Medicine ◽  
Clinical Management ◽  
Clinical Decision Making ◽  
Placebo Response ◽  
Clinical Decision ◽  
Placebo Control ◽  
Number Needed To Treat ◽  
Therapeutic Effects ◽  
Evidence Based ◽  
Based Medicine

SummaryThe number needed to treat (NNT) statistic was developed to facilitate the practice of evidence-based medicine. Placebo was assumed to be therapeutically inert when the NNT was originally conceived, but more recent data for conditions such as major depressive disorder (MDD) suggest that the placebo control condition can have considerable therapeutic effects. Complications arise because the NNT calculated from randomised controlled trials (RCTs) reflects a comparison between medication plus clinical management and placebo plus clinical management, whereas, in the clinical setting, physicians choose between prescribing open medication, observing a patient over time with a supportive approach, and doing nothing. Thus, NNTs derived from clinical trials are not directly relevant to clinical decision-making, because they are based on control conditions that do not exist in standard practice. Additional difficulties may arise when using NNTs to compare alternative treatments for MDD, such as medication and psychotherapy, since these comparisons require the control conditions upon which the respective NNTs are based to be similar. Whereas pill placebo conditions include intensive clinical management and elicit expectations of improvement, attention control conditions for psychotherapy research are less well developed. Often the effects of psychotherapy are gauged against a wait-list control condition, which has substantially fewer therapeutic components than a pill placebo control condition. To improve the clinical utility of NNTs for the treatment of MDD, we advocate effectiveness studies that include treatment conditions resembling actual clinical practice, rather than using placebo-controlled RCTs for this purpose. Until such studies are performed, the effect of bias in comparing NNTs across treatments can be controlled by ensuring that the RCT control conditions upon which the NNTs are based are comparable.

scholarly journals Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial

2020 ◽  
Author(s):  
Julia Lühnen ◽  
Birte Berger-Höger ◽  
Burkhard Haastert ◽  
Jana Hinneburg ◽  
Jürgen Kasper ◽  
...  
Keyword(s):  
Health Information ◽  
Evidence Based Medicine ◽  
Information Quality ◽  
Guideline Implementation ◽  
Training Programme ◽  
Control Group ◽  
Evidence Based ◽  
Study Results ◽  
Based Medicine

Abstract Background The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. Aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own. Methods The trial uses a superiority randomised control group design with ten months follow-up. 26 providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline & training programme) with usual care ( a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline’s recommendations. Each provider will prepare a single health information informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) checklist. An accompanying process evaluation will then be conducted. Discussion The study results will show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers’ competences in evidence-based medicine and to ensure high-quality EBHI in the long-term. Trial registration ISRCTN registry, registration number: ISRCTN96941060, Date: 7 March 2019, URL: http://www.isrctn.com/ISRCTN96941060 Keywords health information; guideline implementation, training programme; evidence-based medicine; guideline evidence-based health information

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