Evidence Grading Research Articles

Initial CT Imaging Predicts Mortality in Severe Traumatic Brain Injuries in Pediatric Population-A Systematic Review and Meta-Analysis.

The purpose of this systematic review was to analyze evidence based on existing studies on the ability of initial CT imaging to predict mortality in severe traumatic brain injuries (TBIs) in pediatric patients. An experienced librarian searched for all existing studies based on the inclusion and exclusion criteria. The studies were screened by two blinded reviewers. Of the 3277 studies included in the search, data on prevalence of imaging findings and mortality rate could only be extracted from 22 studies. A few of those studies had patient-specific data relating specific imaging findings to outcome, allowing the data analysis, calculation of the area under the curve (AUC) and receiver operating characteristic (ROC), and generation of a forest plot for each finding. The data were extracted to calculate the sensitivity (SN), specificity (SP), positive predictive value (PPV), negative predicted value (NPV), AUC, and ROC for extradural hematoma (EDH), subdural hematoma (SDH), traumatic subarachnoid hemorrhage (tSAH), skull fractures, and edema. There were a total of 2219 patients, 747 females and 1461 males. Of the total, 564 patients died and 1651 survived; 293 patients had SDH, 76 had EDH, 347 had tSAH, 244 had skull fractures, and 416 had edema. The studies included had high bias and lower grade of evidence. Out of the different CT scan findings, brain edema had the highest SN, PPV, NPV, and AUC. EDH had the highest SP to predict in-hospital mortality.

The effects of whole-body muscle stimulation on body composition and strength parameters: A PRISMA systematic review and meta-analysis.

This systematic review and meta-analysis set out to determine the efficacy of whole-body muscle electrostimulation on body composition, strength, and muscle power in active and non-active adults (aged ≥18 years). This review was reported in accordance with the Protocol Statement of Preferred Reporting Element Guidelines for Systematic Reviews and Meta-Analysis included controlled trials; whole-body electromyostimulation trials with at least 1 exercise and control group; participants >18 years old. Outcome measures were defined as standardized mean differences for muscle mass, body fat mass, strength, and power. Studies were searched in the following electronic databases: PubMed, Web of Science, Scopus, SPORTDiscus, and EMBASE for all articles published up to July 30, 2021. The risk of bias was assessed by 2 independent researchers using the Physiotherapy Evidence Database scale and Grading of Recommendations, Assessment, Development and Evaluations approach. Analyses were performed using the metafor package of the statistical software R (version 4.0.3; R Core Team, 2020). Random effects models, forest, and funnel plots to quantify the asymmetry associated with publication bias were fitted using the metafor library in R. Statistical heterogeneity was assessed using I2 statistics. In total, 26 studies representing 1183 participants were included (WB-electromyostimulation: n = 586 and control group: n = 597). The mean age of the participants ranged from a minimum of 20.4 to a maximum of 77.4 years old. Interventions lasted a minimum of 4 and a maximum of 54 weeks. Standardized mean difference was 0.36 (95% confidence interval [CI]: 0.16-0.57) for muscle mass, -0.38 (95% CI: -0.62-0.15) for body fat, 0.54 (95% CI: 0.35-0.72) for strength, and 0.36 (95% CI: 0.02-0.71) for power with significant differences between groups (all P < .04). I2 revealed low heterogeneity of muscle mass (15%) and power (0%) between trials and medium heterogeneity of body fat (45%) and strength (55%). We concluded that WB-electromyostimulation has significant positive effects on muscle mass, body fat, strength, and power.

The association between low virulence organisms in different locations and intervertebral disc structural failure: A meta-analysis and systematic review.

Many factors may trigger intervertebral disc (IVD) structural failure (intervertebral disc degeneration (IDD) and endplate changes), including inflammation, infection, dysbiosis, and the downstream effects of chemical factors. Of these, microbial diversity in the IVD and elsewhere in the body has been considered as one of the potential reasons for disc structural failure. The exact relationships between microbial colonization and IVD structural failure are not well understood. This meta-analysis aimed to investigate the impact of microbial colonization and its location (such as skin, IVD, muscle, soft tissues, and blood) on IVD structural failure and corresponding low back pain (LBP) if any. We searched four online databases for potential studies. The potential relationships between microbial colonization in different sample sources (such as skin, IVD, muscle, soft tissues, and blood) and IDD and endplate change were considered as primary outcomes. Odds ratio (OR) and 95% confidence intervals (CI) for direct comparisons were reported. Grading of Recommendations Assessment, Development and Evaluation (GRADE) scale was used to assess the quality of evidence. Twenty-five cohort studies met the selection criteria. Overall pooled prevalence of microbial colonization in 2419 patients with LBP was 33.2% (23.6%-43.6%). The pooled prevalence of microbial colonization in 2901 samples was 29.6% (21.0%-38.9%). Compared with the patients without endplate change, the patients with endplate changes had higher rates of microbial colonization of disc (OR=2.83; 95% CI=1.93-4.14; I 2=37.6%; p=0.108). The primary pathogen was Cutibacterium acnes which was present in 22.2% of cases (95% CI=13.3%-32.5%; I 2=96.6%; p=0.000). This meta-analysis and systematic review found low-quality grade evidence for an association between microbial colonization of disc with endplate changes. The primary pathogen was C. acnes. Due to lack of enough high-quality studies and methodological limitations of this review, further studies are required to improve our understanding of the potential relationships and mechanisms of microbiota, dysbiosis, IVD colonization and IVD structural failure.

Re-evaluation of systematic reviews of acupuncture and moxibustion for childhood autism

To re-evaluate the systematic review/Meta-analysis of acupuncture and moxibustion for childhood autism (CA), aiming to provide decision-making basis for clinical diagnosis and treatment. The systematic review and/or Meta-analysis of acupuncture and moxibustion for CA were searched in PubMed, EMbase, Cochrane Library, SinoMed, CNKI and Wanfang databases. The retrieval time was from the database establishment to May 5th, 2022. PRISMA (preferred reporting items for systematic reviews and Meta-analyses) was used to evaluate the report quality, and AMSTAR 2 (a measurement tool to assess systematic reviews 2) was used to evaluate the methodological quality, bubble map was used to construct the evidence map and GRADE was used to evaluate the quality of evidence. A total of 9 systematic reviews were included. The PRISMA scores ranged from 13 to 26. The report quality was low, and there was a serious lack in the aspects of program and registration, search, other analysis and funding. The main problems in methodology included not making prespecified protocol, incomplete retrieval strategy, not providing a list of excluded literatures, and incomplete explanation on heterogeneity analysis and bias risk. The evidence map showed that 6 conclusions were valid, 2 conclusions were possible valid and 1 conclusion was uncertain valid. The overall quality of evidence was low, and the main factors leading to the downgrade were limitations, followed by inconsistency, imprecision and publication bias. Acupuncture and moxibustion has a certain effect for CA, but the quality of reporting, methodology and evidence in included literature need to be improved. It is suggested to perform high-quality and standardized research in the future to provide evidence-based basis.

Expanded carrier screening for reproductive risk assessment: An evidence-based practice guideline from the National Society of Genetic Counselors.

Expanded carrier screening (ECS) intends to broadly screen healthy individuals to determine their reproductive chance for autosomal recessive (AR) and X-linked (XL) conditions with infantile or early-childhood onset, which may impact reproductive management (Committee Opinion 690, Obstetrics and Gynecology, 2017, 129, e35). Compared to ethnicity-based screening, which requires accurate knowledge of ancestry for optimal test selection and appropriate risk assessment, ECS panels consist of tens to hundreds of AR and XL conditions that may be individually rare in various ancestries but offer a comprehensive approach to inherited disease screening. As such, the term "equitable carrier screening" may be preferable. This practice guideline provides evidence-based recommendations for ECS using the GRADE Evidence to Decision framework (Guyatt et al., BMJ, 2008, 336, 995; Guyatt et al., BMJ, 2008, 336, 924). We used evidence from a recent systematic evidence review (Ramdaney et al., Genetics in Medicine, 2022, 20, 374) and compiled data from peer-reviewed literature, scientific meetings, and clinical experience. We defined and prioritized the outcomes of informed consent, change in reproductive plans, yield in identification of at-risk carrier pairs/pregnancies, perceived barriers to ECS, amount of provider time spent, healthcare costs, frequency of severely/profoundly affected offspring, incidental findings, uncertain findings, patient satisfaction, and provider attitudes. Despite the recognized barriers to implementation and change in management strategies, this analysis supported implementation of ECS for these outcomes. Based upon the current level of evidence, we recommend ECS be made available for all individuals considering reproduction and all pregnant reproductive pairs, as ECS presents an ethnicity-based carrier screening alternative which does not rely on race-based medicine. The final decision to pursue carrier screening should be directed by shared decision-making, which takes into account specific features of patients as well as their preferences and values. As a periconceptional reproductive risk assessment tool, ECS is superior compared to ethnicity-based carrier screening in that it both identifies more carriers of AR and XL conditions as well as eliminates a single race-based medical practice. ECS should be offered to all who are currently pregnant, considering pregnancy, or might otherwise biologically contribute to pregnancy. Barriers to the broad implementation of and access to ECS should be identified and addressed so that test performance for carrier screening will not depend on social constructs such as race.

Representation of evidence-based clinical practice guideline recommendations on FHIR

BackgroundVarious formalisms have been developed to represent clinical practice guideline recommendations in a computer-interpretable way. However, none of the existing formalisms leverage the structured and computable information that emerge from the evidence-based guideline development process. Thus, we here propose a FHIR-based format that uses computer-interpretable representations of the knowledge artifacts that emerge during the process of evidence-based guideline development to directly serve as the basis of evidence-based recommendations. MethodsWe identified the information required to represent evidence-based clinical practice guideline recommendations and reviewed the knowledge artifacts emerging during the evidence-based guideline development process. We then conducted a consensus-based design process with domain experts to develop an information model for guideline recommendation representation that is structurally aligned to the evidence-based guideline recommendation development process and a corresponding representation based on FHIR resources developed for evidence-based medicine (EBMonFHIR). The resulting recommendations were modelled and represented in conformance with the FHIR Clinical Guidelines (CPG-on-FHIR) implementation guide. ResultsThe information model of evidence-based clinical guideline recommendations and its EBMonFHIR-/CPG-on-FHIR-based representation contain the clinical contents of individual guideline recommendations, a set of metadata for the recommendations, the ratings for the recommendations (e.g., strength of recommendation, certainty of overall evidence), the ratings of certainty of evidence for individual outcomes (e.g., risk of bias) and links to the underlying evidence (systematic reviews based on primary studies). We created profiles and an implementation guide for all FHIR resources required to represent the knowledge artifacts generated during evidence-based guideline development and their re-use as the basis for recommendations and used the profiles to implement an exemplary clinical guideline recommendation. ConclusionsThe FHIR implementation guide presented here can be used to directly link the evidence assessment process of evidence-based guideline recommendation development, i.e. systematic reviews and evidence grading, and the underlying evidence from primary studies to the resulting guideline recommendations. This not only allows the evidence on which recommendations are based on to be evaluated transparently and critically, but also enables guideline developers to leverage computable evidence in a more direct way to facilitate the generation of computer-interpretable guideline recommendations.

American Society of Transplant Surgeons recommendations on best practices in donation after circulatory death organ procurement.

The American Society of Transplant Surgeons supports efforts to increase the number of organs that are critically needed for patients desperately awaiting transplantation. In the United States, transplantation using organs procured from donation after circulatory death (DCD) donors has continued to increase in number. Despite these increases, substantial variability in the utilization and practices of DCD transplantation still exists. To improve DCD organ utilization, it is important to create a set of best practices for DCD recovery. The following recommendations aim to provide guidance on contemporary issues surrounding DCD organ procurement in the United States. A work group was composed of members of the American Society of Transplant Surgeon Scientific Studies Committee and the Thoracic Organ Transplantation Committee. The following topics were identified by the group either as controversial or lacking standardization: prewithdrawal preparation, definition of donor warm ischemia time, DCD surgical technique, combined thoracic and abdominal procurements, and normothermic regional perfusion. The proposed recommendations were classified on the basis of the grade of available evidence and the strength of the recommendation. This information should be valuable for transplant programs as well as for organ procurement organizations and donor hospitals as they develop robust DCD donor procurement protocols.

Impact of breastfeeding on the incidence and severity of respiratory syncytial virus (RSV)-associated acute lower respiratory infections in infants: a systematic review highlighting the global relevance of primary prevention

BackgroundRespiratory syncytial virus (RSV) is the principal cause of acute lower respiratory infections (ALRI) among infants worldwide, and an important cause of morbidity, hospitalisation and mortality. While infants are universally...

Analysis of the AUA Guidelines: Strength of Evidence Correlates With Recommendation Levels.

As part of its mission to provide the highest standards of clinical care, the AUA publishes guidelines on numerous urological topics. We sought to evaluate the caliber of evidence used establish the currently available AUA guidelines. All available AUA guideline statements in 2021 were reviewed for their level of evidence and recommendation strength. Statistical analysis was performed to identify differences between oncological and nononcologic topics, and statements pertinent to diagnosis, treatment, and follow-up. A multivariate analysis was utilized to identify factors associated with strong recommendations. A total of 939 statements across 29 guidelines were analyzed; 39 (4.2%) were backed by Grade A evidence, 188 (20%) Grade B, 297 (31.6%) Grade C, 185 (19.7%) Clinical Principle, and 230 (24.5%) Expert Opinion. There was a significant association of oncology guidelines (6% vs 3%, P = .021) with more grade A evidence and less Grade C Evidence (24% vs 35%, P = .002). Statements pertaining to diagnosis and evaluation were more likely backed by Clinical Principle (31% vs 14% vs 15%, P < .01), treatment statements backed by B (26% vs 13% vs 11%, P < .01) and C (35% vs 30% vs 17%, P < .01) grade evidence, and follow-up statements backed by Expert Opinion (53% vs 23% vs 24%, P < .01). On multivariate analysis, strong recommendations were more likely supported by high-grade evidence (OR = 12, P < .01). The majority of evidence for the AUA guidelines is not high grade. Additional high-quality urological studies are needed to improve evidence based urological care.

The Role of Induction Therapy for Sinonasal Cancers.

The role of induction chemotherapy in sinonasal cancers is promising; however, prospective studies with higher grades of evidence are needed. With the currently available literature, the authors would advocate for the use of induction chemotherapy (IC) in locally advanced sinonasal squamous cell carcinoma (T3-T4) for organ preservation and potentially for improved survival outcomes. In sinonasal undifferentiated carcinoma (SNUC), IC should be considered in all patients given its tendency for aggressive invasion and poor outcomes. In SNUC, response to IC may direct the modality of definitive treatment to follow. In responders (partial or complete), chemoradiation therapy should be strongly considered. In non-responders or in those with progression of disease, surgical therapy is favored. For esthesioneuroblastoma, surgical resection with negative margins and adjuvant radiation therapy remains the gold standard. However, IC may be considered for locally advanced disease especially with orbital invasion or in recurrent/distant disease. There is no definite indication for IC in sinonasal adenoid cystic carcinoma or sinonasal adenocarcinoma. Recommendations are summarized in Table 1.

The new guideline "Diagnosis and therapy of female urinary incontinence" AWMF register no.: 015-091-important to know

The new interdisciplinary S2k guideline "Female urinary incontinence" has been online since December31, 2021 under the AWMF register number: 015-091. The guideline combines the two previously separately published guidelines "Urinary stress incontinence in women" and "Overactive bladder in women" and integrates the previously independent guideline "Sonography in the context of urogynaecological diagnostics". The focus is on the identification of the three most common types of urinary incontinence in women "stress incontinence", "urge incontinence" and "mixed incontinence" through appropriate diagnostics and their conservative and surgical therapy. In addition, achapter on the management of extraurethral urinary incontinence in urogenital fistulas has been included. The guideline was created under the leadership of the "German Society for Gynecology and Obstetrics" (DGGG) and the Working Group for Urogynecology and Pelvic Floor Reconstruction e. V. (AGUB). In the interdisciplinary guideline group, six urologists from the working group "Urological functional diagnostics and female urology" were also involved as elected representatives of the German Society for Urology (DGU). For the validity in German-speaking areas, mandate holders from Austria and Switzerland were present. The clinically and practically relevant and new consensus recommendations for diagnostics and therapy were approved after systematic research, selection, evaluation and synthesis of the evidence base. Evidence grading was not intended as the S2k guideline. The individual statements and recommendations were differentiated linguistically-not symbolically. For acomplete overview, we recommend studying the long version "Diagnostics and Therapy of Female Urinary Incontinence" at www.AWMF.org or the short version in two parts by Naumann G. etal. in Obstetrics and Women's Health (in press), which will be published soon.

Effectiveness and safety of Inclisiran in hyperlipidemia treatment: An overview of systematic reviews.

This paper aimed to comprehensively evaluate the effectiveness and safety of Inclisiran in treating hyperlipidemia through an overview of systematic reviews (SRs). The Cochrane Library, EMBASE, PubMed, CNKI, WANGFANG database, VIP database, ClinicalTrials.gov, and ICRT were searched electronically to collect SRs and meta-analysis of Inclisiran in hyperlipidemia treatment from the establishment of the database till May 2022. Two researchers independently screened the relevant literature, then the assessment of multiple systematic reviews tool was made into assess the methodological quality of the included studies. Data extracted were used to perform the study through RevMan5.3 software. The grading of recommendations assessment, development, and evaluation tool was used to grade the quality of the evidence of the outcomes included in the SRs. Prospero ID: CRD 42022326845. A total of 10 relevant SRs were included, involving 7 randomized controlled trials. The assessment results of the assessment of multiple systematic reviews tool suggested that the quality of the SRs included needed to be improved. The reduced level of low-density lipoprotein cholesterol of the experimental group was lower than the control group, and the difference in the amount of effectiveness was statistically significant (MD = -50.13, 95%CI: -56.2 to -44.06, P < .00001). The grading of recommendations assessment, development, and evaluation results showed that out of 27 outcomes, 8 were high-quality, 3 were of medium quality, 6 were of low quality, and 10 were of the most inferior quality. 300mg Inclisiran with 2 injections a year has the best therapeutic effect, which can significantly reduce low-density lipoprotein cholesterol and total cholesterol, and increase high-density lipoprotein cholesterol levels in patients with hyperlipidemia. Inclisiran has a favorable safety profile, with no significant difference in the incidence of adverse reactions compared to a placebo. Most of the adverse effects were associated with the reaction on the injection site.

What's New in Hand and Wrist Surgery.

What's New in Hand and Wrist Surgery.

ESPEN guideline on Clinical Nutrition in inflammatory bowel disease

The present guideline is an update and extension of the ESPEN scientific guideline on Clinical Nutrition in Inflammatory Bowel Disease published first in 2017. The guideline has been rearranged according to the ESPEN practical guideline on Clinical Nutrition in Inflammatory Bowel Disease published in 2020. All recommendations have been checked and, if needed, revised based on new literature, before they underwent the ESPEN consensus procedure. Moreover, a new chapter on microbiota modulation as a new option in IBD treatment has been added. The number of recommendations has been increased to 71 recommendations in the guideline update. The guideline is aimed at professionals working in clinical practice, either in hospitals or in outpatient medicine, and treating patients with IBD. General aspects of care in patients with IBD, and specific aspects during active disease and in remission are addressed. All recommendations are equipped with evidence grades, consensus rates, short commentaries and links to cited literature.

Exposure to Commonly Used Drugs and the Risk of Gastric Cancer: An Umbrella Review of Meta-Analyses.

Recently, attention has been paid to some medications and gastric cancer (GC) risk. This review aimed to evaluate associations between commonly used drugs and GC risk and to grade evidence from published systematic reviews and meta-analyses. This umbrella review was registered in PROSPERO (CRD42022320276). The systematic reviews and meta-analyses of observational studies were retrieved by searching Embase, PubMed, and Web of Science. The evidence strength of commonly used drugs and GC risk was categorized into four grades: weak, suggestive, highly suggestive, and strong. Of 19 associations between commonly used drugs and GC risk and its subtypes, none was supported by convincing or highly suggestive evidence. The risk of GC related to non-steroidal anti-inflammatory drugs (NSAIDs), non-aspirin NSAIDs, and acid-suppressive drugs, as well as the risk of non-cardia GC related to NSAIDs and aspirin, was supported by suggestive evidence. The results showed that a reduced GC risk was associated with two drug types (NSAIDs and non-aspirin NSAIDs), and an increased GC risk was associated with acid-suppressing drugs at the suggestive evidence level. Moreover, NSAIDs and aspirin reduced non-cardia GC risk as supported by suggestive evidence. However, the evidence supporting statins or metformin in reducing GC risk was weak, and thus future studies are required to clarify these associations.

Efficacy of a Mulligan Concept Sustained Natural Apophyseal Glide Technique for Cervicogenic Headache: A Critically Appraised Topic

Clinical Question: In adults with cervicogenic headache (CGH), what are the effects of a clinician-applied Mulligan Concept C1–C2 rotational sustained natural apophyseal glide on cervicogenic symptomology? Clinical Bottom Line: Both Level 2b and Level 4 evidence of Grade B quality exists to support using the C1–C2 rotational sustained natural apophyseal glide to decrease CGH severity and participant-reported neck disability immediately posttreatment, while also increasing cervical range of motion in adult patients with CGH headaches and a positive flexion–rotation test. Further research should examine the long-term effects of the C1–C2 rotational sustained natural apophyseal glide technique on cervical range of motion, flexion–rotation test results, and CGH frequency and severity. In addition, the flexion–rotation test should be explored as a standard diagnostic assessment in CGH cases.

ESPEN practical guideline: Home enteral nutrition

This ESPEN practical guideline will inform physicians, nurses, dieticians, pharmacists, caregivers and other home enteral nutrition (HEN) providers in a concise way about the indications and contraindications for HEN, as well as its implementation and monitoring. This guideline will also inform interested patients requiring HEN. Home parenteral nutrition is not included but will be addressed in a separate ESPEN guideline. The guideline is based on the ESPEN scientific guideline published before, which consists of 61 recommendations that have been reproduced and renumbered, along with the associated commentaries that have been shorted compared to the scientific guideline. Evidence grades and consensus levels are indicated. The guideline was commissioned and financially supported by ESPEN and the members of the guideline group were selected by ESPEN.

Efficacy and safety of levamisole in childhood nephrotic syndrome: A meta-analysis.

Present evidence regarding the efficacy and safety of levamisole in childhood nephrotic syndrome (NS), particularly the steroid-sensitive NS (SSNS), is limited. We searched relevant databases such as PubMed/MEDLINE, Embase, Google Scholar, and Cochrane CENTRAL till June 30, 2020. We included 12 studies for evidence synthesis (5 were clinical trials that included 326 children). The proportion of children without relapses at 6-12 months was higher in the levamisole group as compared to steroids (relative risk [RR]: 5.9 [95% Confidence interval (CI): 0.13-264.8], I2 = 85%). Levamisole as compared to the control increased the proportion of children without relapses at 6-12 months (RR: 3.55 [95% CI: 2.19-5.75], I2 = 0%). The GRADE evidence was of "very-low certainty" except for the comparison of levamisole with control, the latter being of "moderate certainty." To conclude, levamisole given to children with SSNS is beneficial in preventing relapses and achieving remission as compared to placebo or low-dose steroids. Good-quality trials are needed to provide a robust evidence in this regard. PROSPERO Registration number: CRD42018086247.

Заключение совета экспертов «Роль витамина D в профилактике острых респираторных инфекций»

Acute respiratory viral infections (ARVIs) are the most common respiratory tract diseases that can reduce the quality of life of patients and aggravate bronchopulmonary and cardiovascular diseases. All ARVIs annually lead to a total economic damage of approximately 758 billion rubles, which corresponds to 80% of the damage from all infectious diseases. Due to a relatively limited number of non-specific causal therapy options, specific and non-specific prevention of ARVIs becomes extremely important. However, no specific vaccines against ARVIs, except influenza, have been developed so far. The majority of drugs for ARVI prevention have suboptimal efficacy and weak evidence (grade C). Given the pronounced economic damage from ARVIs (reaching 40 billion rubles annually), as well as the need for effective non-specific preventive agents, it is important to analyze the evidence base of new drugs for non-specific ARVI prevention, assess their cost-effectiveness, and availability for most patients. This can contribute to reducing ARVI incidence and both direct and indirect healthcare costs. Objective. Present the main provisions of the Council of Experts "The role of vitamin D in the prevention of acute respiratory infections" (February 18, 2023, Moscow, Russia) and assess the prospects for using in routine practice for improving the quality of patients life and optimize the costs of health care system. Main points. Preventive doses of colecalciferol (vitamin D3) is associated with a low risk of ARVI with daily or weekly intake lasting from 6 months. Vitamin D3 supplementation of 6 to 12 months should be recommended for people without obesity (BMI&lt;30 kg / m2) in a dose of 2000 IU / day or 10,000 IU / week, and with obesity (BMI&gt;30 kg / m2) in doses from 3000 IU / day to 6,000 IU / day for a long time. Long-term using of preventive doses of vitamin D3 is associated with a necessary maintain its target level throughout the year. Conclusions. In Russian Federation there is a high prevalence of deficiency and insufficiency of colecalciferol (vitamin D3) among the population, regardless of region and age group. According to the results of randomized clinical studies and metaanalyses, daily or weekly intake of vitamin D3 is associated with a low risk of ARVI. At the same time, vitamin D3 has a high therapeutic range, which makes its using more safe. Experts consider it it important to include colecalciferol (vitamin D3) in Russian clinical guidelines "Acute respiratory viral infections (ARVI) in adults" as part of their next revision as a means of non-specific prevention of ARVI. Level of evidence A (higher quality of evidence- 1). Key words: acute respiratory viral infections, influenza, COVID-19, nonspecific prevention, vitamin D3, colecalciferol

Efficacy and safety of lobeglitazone, a new Thiazolidinedione, as compared to the standard of care in type 2 diabetes mellitus: A systematic review and meta-analysis

AimThis systematic review and meta-analysis was conducted to evaluate the efficacy and safety of lobeglitazone as compared to the standard of care (SOC) in patients with type 2 diabetes mellitus (T2DM). MethodsDatabases were searched for relevant randomized controlled trials. The primary outcome was the comparison of the glycated hemoglobin (HbA1C) level after 24 weeks. Pooled mean differences and odds ratios were calculated using random-effects models. ResultsOf 267 studies that were screened, four were included. Treatment with adjunct lobeglitazone showed a reduction in the HbA1C level [mean difference: −0.23% (95% CI: −0.62 to 0.16); p = 0.24; i2: 87%; moderate GRADE (Grading of Recommendations Assessment, Development and. Evaluation) of evidence], fasting blood glucose level [mean difference: −7.12 mg/dl (95% CI: −20.09 to 5.85); p = 0.28; i2: 87%; moderate GRADE of evidence], and lipid profile as compared to those following treatment with the SOC; however, the changes were not statistically significant. The risk of hypoglycemia was significantly lower [odds ratio: 0.24 (95% CI: 0.08 to 0.70); p < 0.05; i2: 0%; moderate GRADE of evidence] without any significant difference in the risk of drug-related adverse events [odds ratio: 1.59 (95% CI: 0.87 to 2.93); p = 0.13; i2: 0%; moderate GRADE of evidence] following treatment with lobeglitazone as compared to those following treatment with the SOC. ConclusionTreatment with adjunct lobeglitazone showed changes in the blood glycemic status and lipid profile similar to SOC in patients with T2DM, and the results were not statistically significant. Lobeglitazone was well tolerated; its safety profile was comparable to SOC.