Viewpoint Of Evidence-based Medicine Research Articles

Minimally invasive surgery in advanced gastric cancer

Since Dr. Kitano introduced laparoscopic distal gastrectomy for early gastric cancer in 1994, there have been remarkable advances in minimally invasive surgery (MIS) for gastric cancer, including robotic surgery. With the efforts of many clinical researchers and consenting patients, medical knowledge and evidence for laparoscopic surgery in gastric cancer have accumulated. Although many gastric surgeons are comfortable with the clinical application of laparoscopic surgery for early gastric cancer, the adoption of MISs for advanced gastric cancer remains controversial. In this review article, we describe the current status and evidence of MIS from an evidence‐based medicine viewpoint and explore the feasibility and effectiveness of MIS for advanced gastric cancer in the real world.

Treatment of macular diseases: an overview of key randomized clinical trials

Macular diseases are traditionally a serious issue in ophthalmology, which has great social impact due to widespread occurrence and significant vision loss, often irreversible. Over the past few decades, the possibilities for the diagnosis and treatment of pathologies of the retina and choroid have been significantly expanded. Randomized clinical trials provided ophthalmologists with valuable information on the natural course and treatment strategies of common retinal diseases from the viewpoint of evidence-based medicine. However, due to the large number of trials conducted, it is often difficult to make an adequate choice of data to be used in daily practice. In this review, we systematize the most valuable randomized clinical trials. To this end, we selected 42 randomized clinical studies conducted between 1979 and 2019 and focused on the treatment of age-related macular degeneration (AREDS 1, AREDS 2, ANCHOR, MARINA, PrONTO, CATT, IVAN, VIEW 1, VIEW 2, EVEREST II, PLANET, SEVEN-UP, ALTAIR, HAWK, HARRIER), choroidal neovascularization of multiple etiology (myopic, post-inflammatory, angioid-streak-related, etc. — RADIANCE, REPAIR, MYRROR, MINERVA), diabetic eye lesions (diabetic retinopathy and diabetic macular edema — ETDRS, DRCR.net Protocols B, I, S and T, RISE, RIDE, VIVID-DME, VISTA-DME, MEAD, FAME), retinal vein occlusions (BVOS, CVOS, SCORE-CRVO, SCORE-BRVO, BRAVO, CRUISE, GALILEO, COPERNICUS, VIBRANT), as well as retinopathy of prematurity (CRYO-ROP, ETROP, RAINBOW). The review summarizes the main results of these studies, which confirm the effectiveness and safety of such treatment methods as antiVEGF and photodynamic therapy, retinal laser photocoagulation, cryotherapy, corticosteroids and nutraceuticals from the viewpoint of evidence-based medicine. For greater clarity, we provide a table summarizing information on each of the randomized clinical trials considered.

Место ингибиторов натрий-глюкозного ко-транспортера 2 в лечении сахарного диабета 2 типа и его осложнений с позиции доказательной медицины

Место ингибиторов натрий-глюкозного ко-транспортера 2 в лечении сахарного диабета 2 типа и его осложнений с позиции доказательной медицины

Response to Journal Club: Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Evidence-based Medicine Viewpoint

Response to Journal Club: Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Evidence-based Medicine Viewpoint

Computed tomography in diagnosis of silicosis

Respiratory system diseases are one of the main problems in contemporary occupational medicine and exceed one fifth of all occupational diseases. Objective of the review was search and analysis of literature on diagnosis of silicosis as an important occupational disease of respiratory organs, by computed tomography and high-resolution computed tomography, from evidence-based medicine viewpoint.

Анализ схем лечения полипозного риносинусита в Российской Федерации

Chronic polypous rhinosinusitis does not subject to complete medicinal control; it is difficult to predict the prospects of the pathology development in each individual patient. Therefore, the search of new regimens of treatment of these patients is still in progress. An international consensus published in 2016, considers, inter alia, various groups of drugs for conservative treatment of polypous rhinosinusitis from the viewpoint of evidence-based medicine. We conducted a retrospective analysis of outpatient records and personal data of 1059 patients with polypous rhinosinusitis who underwent outpatient and inpatient treatment at the period from February 2016 to March 2018 in Moscow, Moscow Region and 26 regions of Russia. According to the results, in outpatient treatment, the basic therapy with intranasal glucocorticosteroids was performed in 92.4%, irrigation therapy – in 82.2% of cases, antihistamines were recommended in 79.4%. In case of hospitalization for surgical treatment, 16.6% of patients in Russian regions and 24% in Moscow Region had received no preliminary therapy for 6 months before hospitalization. In general, analyzing the management and treatment regimens of the patients with polypous rhinosinusitis, we found almost no deviations from the present-day domestic and foreign clinical guidelines. However, we observed prescription of some intranasal glucocorticosteroids, the leaflets of which contain no indications for polypous rhinosinusitis treatment.

Epidemiological features of occupational chronic obstructive lung disease

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality all over the world. Tobacco smoking is a main risk factor, but nearly 15–20% of COPD cases are caused by occupational exposure (to dust, gases, vapors, fibers). The review is aimed to search and analysis of literature on occupational COPD from evidencebased medicine viewpoint. Systemic search of literature covered databases of PubMed, Google Scholar, Cyberleninka, using a key word “occupational COPD”. As a result of the search, the authors selected 6 systematic reviews and 9 clinical studies for further analysis, proved cause-effect relationship between exposure to occupational factors at workplace and COPD. With that, occupational exposure contributes more significantly into formation and peculiarities of COPD course, than tobacco smoking does. Topics of phenotyping, early diagnosis, treatment peculiarities and pulmonary rehabilitation for occupational COPD patients remain unresolved.

Campaign Mode MMR Vaccination to Control Outbreak of Mumps in a Highly Vaccinated Population: Evidence-based Medicine viewpoint.

This study evaluated the effectiveness of a third dose of MMR vaccine for outbreak control, and assessed for waning immunity. Of 20,496 university students who were enrolled during the 2015–2016 academic year, mumps was diagnosed in 259 students. Fisher’s exact test was used to compare unadjusted attack rates according to dose status and years since receipt of the second MMR vaccine dose, and multivariable time-dependent Cox regression models were used to evaluate vaccine effectiveness, according to dose status (3 doses vs 2 doses, and 2 doses vs 0 dose) after adjustment for the number of years since the second dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs 14.5 cases per 1000 population, P<0.001). Students had more than 9-times the risk of mumps if they had received the second MMR dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% CI 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. The authors concluded that students who had received a third dose of MMR vaccine had a lower risk of mumps than those who had received two doses. Students who had received a second dose of MMR vaccine 13 years or more before the outbreak had an increased risk of mumps.

Evaluation and Validation of a Model for Identifying Serious Bacterial Infections among Children Presenting to the Emergency: Evidence-based Medicine Viewpoint.

In this diagnostic accuracy study of clinical and biomarker variables in the diagnosis of serious bacterial infections (SBIs), including pneumonia, in febrile children (age <16 y), a diagnostic model was derived by using multinomial logistic regression and internal validity. External validation of a published model was undertaken, followed by model updating and extension by the inclusion of procalcitonin and resistin. There were 1101 children studied, of whom 264 had a SBI. A diagnostic model discriminated well between pneumonia and no SBI (concordance statistic 0.84, 95% CI 0.78–0.90) and between other SBIs and no SBI (0.77, 95% CI 0.71–0.83) on internal validation. A published model discriminated well on external validation. Model updating yielded good calibration with good performance at both high-risk (positive likelihood ratios 6.46 and 5.13 for pneumonia and other SBI, respectively) and low-risk (negative likelihood ratios 0.16 and 0.13, respectively) thresholds. Extending the model with procalcitonin and resistin yielded improvements in discrimination. The authors concluded that diagnostic models discriminated well between pneumonia, other SBIs, and no SBI in febrile children in the emergency department.

Reply: ECHM Consensus Conference and levels of evidence

Dr Sherlock asks for clarification on the approach adopted by the European Committee on Hyperbaric Medicine (ECHM) to assessing evidence for establishing indications for hyperbaric oxygen treatment (HBOT). Firstly, regardless of the strict process of editing and proof-reading of tables included in the above-mentioned publication, we received comments from some readers that identified imperfect layout of Table 1 and incorrect layout of Table 2 which significantly changed the conclusions to be drawn from them. This concerned both the details of the methodology used and description of the ECHM recommendations and associated levels of evidence. Therefore, those tables are republished in their correct forms in this issue, hoping that this will explain at least some of the doubts and misunderstandings. Both the Editor and ourselves apologise for these errors of publication. Secondly, in the ECHM Consensus Conference methodology, we scored the evidence for clinical studies requiring double-blind randomised controlled trials (RCT) as Level A and B when, at the same time, some scoring scales require simply 'RCT', as correctly pointed out by Dr Sherlock. Long experience in organising evidence based medicine (EBM) meetings and discussions has taught us that RCTs that are not double blinded are often criticised as having serious potential bias and so are denied as level A evidence. Although we acknowledge that double blinding a clinical study in HBOT is a source of difficulty, we chose a priori to consider only double-blinded RCTs in our grading scale to avoid endless discussions about this potential bias. We are well aware that doing so means that Level A evidence is a difficult target for the hyperbaric community. We agree that many evidence scoring systems have a low level of inter-observer agreement. This is why we treat the Consensus Conference as a valuable tool that provides a better opportunity for discussing the evidence than analysis by a small group of 'experts'. This is because the whole process is transparent and available to all participants' comments and input. The final process of voting by the audience after the general discussion thus truly reflects the position of the professional hyperbaric community in Europe on the issued recommendations. By these two mechanisms, the blind application of disputable evidence scoring systems may be avoided or, at least, decreased. Thirdly, the problem of 'sham' treatments in hyperbaric research has been raised. While this has been discussed many times in the past, hyperbaric research is not the sole field where such sham treatment raises some difficulty. Surgery is probably the best example where RCTs with control arms utilising sham surgical procedures (possibly including the administration of anaesthesia) are rare and can raise major ethical problems. Nevertheless, from an EBM viewpoint, the difficulty of designing a double-blind study is never taken into account during evaluation of clinical studies. Finally, Dr Sherlock pointed out her doubts on the recommendations issued by the ECHM on idiopathic sudden sensorineural hearing loss (ISSHL). While there is no possibility to cite here the full experts' report on that issue presented during the conference, we understand that a detailed report from the Conference is being prepared for publication. In brief, the strength of evidence has been scored as Level B, in general agreement with the last Cochrane review and the UHMS Committee report. Based on this level of evidence, the Type 1 recommendation was issued with the agreement of the large majority of the Consensus Conference participants.

Randomized Controlled Trial Evaluating Probiotics in Children with Severe Acute Malnutrition: Evidence-based Medicine Viewpoint.

This randomized, double-blind, placebo-controlled trial was conducted involving 400 children hospitalized with severe acute malnutrition (SAM). Patients received one daily dose of a blend of Bifidobacterium animalis subsp lactis and Lactobacillus rhamnosus (10 billion colony-forming units, 50:50) or placebo during hospitalization followed by an 8- to 12-week outpatient treatment period, depending on patients’ recovery rate. The primary outcome was number of days with diarrhea during hospitalization. Secondary outcomes included other diarrhea outcomes, pneumonia, weight gain, and recovery. There was no difference in number of days with diarrhea between the probiotic (n=200) and placebo (n=200) groups during inpatient treatment (adjusted difference +0.2 days, 95% confidence interval -0.8 to 1.2, P=0.69); however, during outpatient treatment, probiotics reduced days with diarrhea (adjusted difference -2.2 days 95% confidence interval -3.5 to -0.3, P=0.025). Twenty-six patients died in the probiotic versus 20 in the placebo group (P=0.38). The authors concluded that these probiotics had no effect on diarrhea in children with SAM during hospitalization, but reduced the number of days with diarrhea in outpatient treatment by 26%.

Comparison of Lung Ultrasonography and Chest Radiography for Diagnosis of Childhood Pneumonia: Evidence based Medicine Viewpoint.

Comparison of Lung Ultrasonography and Chest Radiography for Diagnosis of Childhood Pneumonia: Evidence based Medicine Viewpoint.

Efficacy of a Mobile based Application on Quality of Care and Perinatal Mortality: Evidence based Medicine Viewpoint.

Efficacy of a Mobile based Application on Quality of Care and Perinatal Mortality: Evidence based Medicine Viewpoint.

Can We Predict Antibiotic-resistance in Urinary Tract Infection: Evidence-based Medicine Viewpoint.

Can We Predict Antibiotic-resistance in Urinary Tract Infection: Evidence-based Medicine Viewpoint.

Oral Azithromycin for Acute Episodic Airway Symptoms in Young Children: Evidence-based Medicine Viewpoint.

Oral Azithromycin for Acute Episodic Airway Symptoms in Young Children: Evidence-based Medicine Viewpoint.

Age of Introduction of Complementary Feeding and Iron Deficiency Anemia in Breastfed Infants: Evidence-based Medicine Viewpoint.

Age of Introduction of Complementary Feeding and Iron Deficiency Anemia in Breastfed Infants: Evidence-based Medicine Viewpoint.

Maternal Mild Thyroid Insufficiency and Risk of Attention Deficit Hyperactivity Disorder: Evidence-based Medicine Viewpoint.

This study was embedded within the Generation R, a population-based birth cohort in the Netherlands where children were followed up from birth until young adulthood. Of the 4997 eligible mother-child pairs with data on maternal thyroid levels (excluding twins), 3873 pairs of children and caregivers (77.5%) were included in the main analyses. Maternal hypothyroxinemia, characterized by low levels of free thyroxine coexisting with reference thyrotropin levels, and children’s symptoms of attention-deficit hyperactivity disorder (ADHD) were the main outcome measures. Maternal thyroid hormone levels (thyrotropin, free thyroxine, thyroid peroxidase antibodies) were measured at a mean (SD) of 13.6 (1.9) weeks of gestation. Children’s ADHD symptoms were assessed at 8 years of age using the Conners’ Parent Rating Scale-Revised Short Form; higher scores indicate more ADHD symptoms (possible range, 0–36). Maternal hypothyroxinemia (n=127) in early pregnancy was associated with higher scores for ADHD symptoms in children at 8 years of age after adjustments for child and maternal factors (increase in ADHD scores, 7% [95% CI, 0.3%, 15%]). The results remained essentially unchanged when women with elevated levels of thyroid peroxidase antibodies were excluded. The authors concluded that children exposed to maternal hypothyroxinemia in early pregnancy had more ADHD symptoms, independent of confounders. This finding suggests that intrauterine exposure to insufficient thyroid hormone levels influences neurodevelopment in offspring.

Intermittent Short Course Rifapentine-Isoniazid Combination for Preventing Tuberculosis in Children: Evidence based Medicine Viewpoint.

Intermittent Short Course Rifapentine-Isoniazid Combination for Preventing Tuberculosis in Children: Evidence based Medicine Viewpoint.

Effective messages in vaccine promotion: a randomised trial: evidence based medicine viewpoint.

Effective messages in vaccine promotion: a randomised trial: evidence based medicine viewpoint.

CTOs: what is the state of the evidence?

Community Treatment Orders (CTOs) require outpatients to adhere to treatment and permit rapid hospitalisation when necessary. They have become a clinical and policy solution to repeated hospital readmissions despite some strong opposition and the contested nature of published evidence. In this article, we appraise the current literature on CTOs from the viewpoint of Evidence-Based Medicine and discuss the way forward for using and researching CTOs. Non-randomised outcome studies show conflicting results, but their lack of standardisation of methods and measures makes it difficult to draw conclusions. In contrast, all three randomised controlled trials (RCTs) conducted concur in their findings that CTOs do not impact on hospital outcomes. No systematic review or meta-analysis has identified any clear clinical advantage to CTOs. The evidence-base does not support the use of CTOs in their current form. Involuntary clinical interventions must conform to the highest standard of evidence-based care. To enable clinicians to take an evidence-based approach and to settle remaining uncertainties about the current evidence, high-quality RCTs should be designed and undertaken, using standardised outcome measures.