Criteria Of Evidence-based Medicine Research Articles

Adhesion barriers in gynecologic surgeries and cesarean section: An Asia-Pacific expert panel consensus recommendation.

Adhesions arising from gynecologic surgeries and cesarean sections pose substantial clinical, social, and economic challenges, leading to issues like pelvic pain, infertility, bowel obstruction, and recurring surgeries. Preventing adhesions is a pressing unmet need, hindered by difficulties in assessing postoperative adhesions and understanding barriers. To bridge adhesion prevention gaps, statements on clinical practices were synthesized to present Asia-Pacific expert perspectives on gynecologic surgery and cesarean section adhesion prevention. An expert panel of eight physicians from various healthcare settings in the Asia-Pacific region was convened and a comprehensive literature search on topics related to adhesion prevention in gynecologic surgeries and cesarean sections was performed. Information from full-text publications was used to develop draft consensus statements, with each statement assigned the highest available evidence level based on a systematic literature review and graded using the Oxford Center for Evidence-based Medicine criteria. A modified Delphi process, involving two rounds of online voting and discussions with an extended group of 109 experts, was employed to reach a consensus on six topics related to adhesion barriers. A set of 15 consensus statements were synthesized. Key topics include adhesion incidence in Asia, cesarean section complications, barrier application status, adhesion formation and prevention, absorbable barriers' effectiveness, recommendations, and future considerations. The statements provide guidance for healthcare professionals, especially in the Asia-Pacific region, to tackle the challenges posed by postoperative adhesions and improve patient outcomes. Further research is needed to enhance understanding and prevention of adhesions in this region.

Dynamics of indicators of the state of health and lifestyle of students in the process of studying at a social college

An anonymous survey was conducted on the author’s questionnaire of students of the social college of Moscow. The questionnaire included 26 questions related to health, complaints about well-being, fatigue, lifestyle, attitude to the chosen specialty. The study was cross-sectional. 289 people aged 15 to 19 were interviewed. Data processing was performed with the assessment of average values and the use of evidence-based medicine criteria and the calculation of health risks. The purpose of the research is to study the influence of health and lifestyle on the wellbeing of students and orientation to the chosen profession. The results showed that one in five had a chronic pathology with a predominance of diseases of the gastrointestinal tract and 20 % had reduced vision. 41.2 % of students were often ill in the first year, and by the third year their number was decreasing. Bad habits were common among students: 38.8 smoked in the first year, and half as much in the last. one in five people consumed alcoholic beverages. Good nutrition is important, but 13.8 %- 20 %., students rated their nutrition as poor. 20 % had a hot meal three times a day, and 30 % had it only once. The results indicate the need for classes with students on the basics of proper nutrition. Students with chronic diseases were more tired after classes, which teachers need to take into account. Among the students, the number of those who liked the profession increased in the dynamics of learning, which indicates the importance of practice.

Chinese expert consensus on off-label use of Tocilizumab in rheumatic diseases

The interleukin-6 (IL-6) pathway plays a crucial role in various rheumatic diseases. Tocilizumab, a biologic targeting IL-6 receptor, has been widely used in clinical practice, though it's officially approved in China for only three indications. To address clinical challenges associated with the off-label use of tocilizumab in treating rheumatic diseases, the Committee of Chinese Primary Health Care Foundation for Rheumatologists and Immunologists engaged multidisciplinary experts and highlight 12 related clinical issues. We aggregated the drug specifications, the guidelines for clinical management of rheumatic diseases and the evidence from clinical research. Recommendations were formed through voting with the consensus conference method incorporating the Oxford evidence-based medicine criteria to evaluate the strength of evidence and recommendations. We have formulated 10 recommendations for off-label use of tocilizumab related to giant cell arteritis, polymyalgia rheumatica, Takayasu arteritis, systemic sclerosis, adult-onset Still's disease, rheumatoid arthritis, and juvenile idiopathic arthritis. This consensus aims to provide references for the rational use of tocilizumab in clinical practice and enhance pharmacovigilance monitoring.

Thrombectomy vs Medical Management for Posterior Cerebral Artery Stroke: Systematic Review, Meta-Analysis, and Real-World Data.

There is a paucity of high-level evidence for endovascular thrombectomy (EVT) in posterior cerebral artery (PCA) strokes. The MEDLINE, Embase, and Web of Science databases were queried for well-conducted cohort studies comparing EVT vs medical management (MM) for PCA strokes. Outcomes of interest included 90-day functional outcomes, symptomatic intracranial hemorrhage (sICH), and death. The level of evidence was determined per the Oxford Centre for Evidence-Based Medicine criteria. We also conducted a propensity score matched (PSM) analysis of the 2016-2020 National Inpatient Sample (NIS) to provide support for our findings with real-world data. A total of 2,095 patients (685 EVT and 1,410 MM) were identified across 5 well-conducted cohort studies. EVT was significantly associated with higher odds of no disability at 90 days (odds ratio [OR] 1.25, 95% CI 1.04-1.50, p = 0.015) but not functional independence (OR 0.87, 95% CI 0.72-1.07, p = 0.18). EVT was also associated with higher odds of sICH (OR 2.48, 95% CI 1.55-3.97, p < 0.001) and numerically higher odds of death (OR 1.32, 95% CI 0.73-2.38; p = 0.35). PSM analysis of 95,585 PCA stroke patients in the NIS showed that EVT (n = 1,540) was associated with lower rates of good discharge outcomes (24.4% vs 30.7%, p = 0.037), higher rates of in-hospital mortality (8.8% vs 4.9%, p = 0.021), higher rates of ICH (18.2% and 11.7%, p = 0.008), and higher rates of subarachnoid hemorrhage (3.9% vs 0.6%, p < 0.001). Among patients with moderate to severe strokes (NIH Stroke Scale 5 or greater), EVT was associated with significantly higher rates of good outcomes (21.7% vs 13.8%, p = 0.023) with similar rates of mortality (7.6% vs 6.6%, p = 0.67) and ICH (17.8% vs, 13.1%, p = 0.18). Our meta-analysis revealed that while EVT may be effective in alleviating disabling deficits due to PCA strokes, it is not associated with different odds of functional independence and may be associated with higher odds of sICH. These findings were corroborated by our large propensity score matched analysis of real-world data in the United States. Thus, the decision to pursue PCA thrombectomies should be carefully individualized for each patient. Future randomized trials are needed to further explore the efficacy and safety of EVT for the treatment of PCA strokes. This study provides Class III evidence that in patients with acute PCA ischemic stroke, treatment with EVT compared with MM alone was associated with higher odds of no disabling deficit at 90 days and higher odds of sICH.

Total Hip Arthroplasty in Human Immunodeficiency Virus Positive Patients: A Systematic Review of Outcomes

BackgroundTotal hip arthroplasty (THA) has become a common intervention for human immunodeficiency virus (HIV)–positive patients who have osteonecrosis of the femoral head. This paper provides a systematic review to assess survivorships, patient-reported outcomes (PROMs), infection rates, other complications, and immune competence for patients who had THAs who did and did not have HIV. MethodsA comprehensive and systematic review of published studies investigating the outcomes of THA in HIV-positive patients (osteonecrosis and non-osteonecrosis patients) was performed adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 10 studies with 9,534 HIV-positive patients fulfilled the inclusion and exclusion criteria. Manuscript quality was assessed on 2 scales: the Coleman Methodology Score and the level of evidence derived from Center for Evidence-Based Medicine criteria. Data were extracted from studies in the 5 key areas of interest: survivorships, PROMs, infection rates, complications, and clusters of differentiation-4 (CD4+) counts and viral loads. ResultsImplant survivorship was between 95% and 100%. Postoperative Harris Hip Scores were significantly improved from preoperative values in HIV-positive patients. Postoperative PROMs and infections did not appear to be different between HIV-positive and HIV-negative patients. Many of the cohort studies demonstrate comparable complication rates to matched controls. Where described (7 reports), mean CD4+ counts ranged from 425 to 646 cells/mm3, with low viral loads (3 reports) and variations not found to influence outcomes. ConclusionsTHA is an effective treatment for HIV-positive patients, many of whom suffer from osteonecrosis of the femoral head. The results demonstrate excellent implant survivorship, improved quality of life, and a low risk of infections and complications.

Effect of Face Masking on Transmission of SARS-CoV-2.

The efficacy of face masking for the public is not convincing to preventthe transmission of respiratory tract viruses such as SARS-CoV-2 when the criteria of evidence-based medicine are applied. This finding is mainly explained by the results from randomized-controlled trials (RCTs)when a high prevalence of the infection and a high compliance in mask wearingwas assured. Throughout these studies no significant protective effect was observed. Observational studies with surgical masks describe a significant protective effect, but are prone to confounders such as physical distance. Respirators do not provide an additional health benefit compared to surgical or medical masks (RCTs). Community masks can even increase the risk of infection (RCTs). Based on the categories of evidence-based medicine, the efficacy results can best be categorized as conflicting evidence. Many relevant adverse events are described when masks are worn for hours such as dyspnea (12.2-52.8%), headache (3.9-73.4%), pruritus (0.0-60.0%), and skin reactions (0.0-85.0%). Their frequency is often higher with respirators. In future pandemics, masks should only be recommended or mandated for settings in which a clinically relevant health benefitcan be expected, defined as theprevention of severe, critical or fatal disease, thatclearly outweighs the expectable associated adverse reactions.

Evidence-Based Application of the Plasma Exchange to Improve Muscle Power and Disability Grade in Patients with Guillain-Barré Syndrome

&lt;p&gt;格林-巴利症候群是罕見且病程進展快速的急性周邊神經系統病變，未及時治療，將導致四肢癱瘓及呼吸衰竭。本文描述一位71歲男性，接種AstraZeneca（AZ）疫苗後，出現對稱性肢體無力及右側顏面麻痺，經檢查確診為AZ疫苗誘發格林-巴利症候群的急性發炎性脫髓鞘多發性神經病變合併右側貝爾氏麻痺。筆者以神經科專科護理師角度，評估病人與家屬對治療方案之選擇呈現意見分歧，故運用實證方法探討血漿置換術對改善肌肉力量與殘疾程度之成效。 於Cochrane、Embase、MEDLINE、PubMed、 CINAHL及華藝等資料庫，使用&amp;ldquo;Guillain-Barre Syndrome&amp;rdquo;、&amp;ldquo;plasma exchange&amp;rdquo;、&amp;ldquo;intravenous immunoglobulin&amp;rdquo;、&amp;ldquo;muscle power&amp;rdquo;及&amp;ldquo;disability grade&amp;rdquo;之關鍵字，搜尋2013 年1月至2023 年2月之中英文文獻。經篩選後共計納入3篇研究進行分析，使用OCEBM評讀文獻，結果顯示治療第2週後，接受血漿置換術之介入措施對於殘疾等級和肌肉力量之改善高於靜脈注射免疫球蛋白。本實證應用結果，病人於住院期間確實恢復肌肉力量及改善殘疾程度。希冀藉由此案例分享，做為爾後照護之參考。&lt;/p&gt; &lt;p&gt;&amp;nbsp;&lt;/p&gt;&lt;p&gt;Guillain-Barr&amp;eacute; syndrome is a rare and rapidly progressing disease characterized by acute peripheral neuropathy. If left untreated, it can lead to quadriplegia and respiratory failure. In this case, a 71-year-old male developed symmetric limb weakness and right facial palsy after receiving the AstraZeneca (AZ) vaccine. The case was diagnosed with acute inflammatory demyelinating polyneuropathy, a form of Guillain-Barr&amp;eacute; syndrome, along with right Bell&amp;rsquo;s palsy. The author, a neurological nurse practi-tioner, was trying to resolve the differences in treatment preferences between the patient and his fami-ly members. Therefore, an evidence-based approach was employed to explore the effectiveness of plas-ma exchange in improving muscle strength and disability grade. An electronic literature search was conducted in databases including Cochrane, Embase, MEDLINE, PubMed, CINAHL, and Airiti Li-brary. Keywords such as &amp;ldquo;Guillain-Barr&amp;eacute; Syndrome,&amp;rdquo; &amp;ldquo;Plasma Exchange,&amp;rdquo; &amp;ldquo;Intravenous Immunoglob-ulin,&amp;rdquo; &amp;ldquo;Muscle Power,&amp;rdquo; and &amp;ldquo;Disability Grade&amp;rdquo; were applied. Studies in Chinese or English published between January 2013 and February 2023 were screened and three relevant studies were included in the analysis. The Oxford Centre for Evidence-Based Medicine criteria were further applied to review the literature. The results showed that plasma exchange intervention resulted in a greater improvement in disability grade and muscle power compared to intravenous immunoglobulin after the second week of treatment. Empirical evidence indicated that the patient indeed regained muscle strength and im-proved their disability grade during hospitalization. This case is shared as a reference for future care considerations.&lt;/p&gt; &lt;p&gt;&amp;nbsp;&lt;/p&gt;

A Mixed-Methods Systematic Review of Group Reflective Practice in Medical Students.

Used primarily as a pedagogical evaluation tool for didactic teaching and skill development, reflective practice (RP) for its own merits is poorly understood. This study aimed to systematically review the literature regarding the role of group RP in fostering empathy, wellbeing, and professionalism in medical students. Electronic searches of empirical studies published between 1 January 2010 and 22 March 2022 from Medline, Embase, and PsychINFO databases were conducted. Empirical studies of any design (qualitative or quantitative) which included RP (1) involving medical students; (2) with a focus on fostering empathy, or professionalism, or personal wellbeing; and (3) provided in a group setting were included. Duplicates, non-English articles, grey literature and articles using RP to examine pedagogy and specific technical skills were excluded. Both authors screened articles independently to derive a final list of included studies, with any discrepancies resolved by discussion, until consensus reached. Articles were rated for methodological quality using the Attree and Milton checklist for qualitative studies; the Oxford Centre for Evidence-Based Medicine criteria, and the Alberta Heritage Foundation for Medical Research Standard Quality Assessment Criteria for quantitative studies. Of 314 articles identified, 18 were included: 9 qualitative; 4 quantitative and 5 mixed methodology. Settings included United States (6), United Kingdom (3), Australia (3), France (2), Taiwan (2), Germany (1), and Ireland (1). Themes were (i) professionalism: bridging theoretical paradigms and practice; (ii) halting empathy decline; (iii) wellbeing: shared experience. Additional themes regarding the "successful" delivery of RP groups in facilitating these outcomes also emerged. This first systematic review of group RP in medical students shows that RP may bring theory to life in clinical dilemmas, while fostering collegiality and mitigating against isolation amongst students, despite the absence of studies directly examining wellbeing. These findings support the value of RP integration focusing on emotive and humanitarian processes into contemporary medical education for medical students. PROSPERO CRD42022322496.

СРАВНИТЕЛЬНАЯ ОЦЕНКА ТЕЧЕНИЯ И ИСХОДОВ БЕРЕМЕННОСТИ У ПАЦИЕНТОК С НЕДИФФЕРЕНЦИРОВАННОЙ ДИCПЛАЗИЕЙ СОЕДИНИТЕЛЬНОЙ ТКАНИ ПРИ ИСПОЛЬЗОВАНИИ ОБЩЕПРИНЯТОЙ И ПЕРСОНАЛИЗИРОВАННОЙ ПРЕГРАВИДАРНОЙ ПОДГОТОВКИ

Background. Preparation for pregnancy in patients with extragenital pathology is an important problem of current obstetrics. Purpose. To perform comparative assessment of the course and outcomes of pregnancy in patients with undifferentiated connective tissue dysplasia (UCTD) after using conventional and personalized preconception preparation. Material and methods. A total of 262 patients were examined, including 159 with UCTD. Group I (the main group) included 125 patients with minor heart abnormalities and at least 4 signs of undifferentiated connective tissue dysplasia, who underwent the generally accepted preconception preparation: folic acid – 400 μg/day, potassium iodide – 200 μg/day orally for 3 months. Group II (the intervention group) consisted of 34 patients who received personalized preconception preparation: folic acid – 400 μg/day orally, potassium iodide – 200 μg/day orally for 3 months, Mg2+ preparations at a dose of 300 mg/day, glycine –400 mg/day, multivitamin complex containing vitamin B1 (10 mg/day), vitamin B2 (10 mg/day), vitamin B6 (10 mg/day), vitamin E (400 mg/day) for 3 months. Group III (the control group) included 103 patients without signs of UCTD who received a standard amount of preconception preparation. The evaluation of the effectiveness of personalized preconception preparation was carried out according to the criteria of evidence-based medicine. Relative risk (RR), relative risk reduction (RRR), absolute risk reduction (ARR), the number of patients who needed treatment to prevent 1 adverse outcome (NNT), the odds ratio (OR) for a particular outcome were calculated. Results of the study. In the intervention group, statistically significant results were obtained in terms of reducing the risk of developing a threatened miscarriage and preterm birth in patients with undifferentiated connective tissue dysplasia, as well as reducing the absolute risk of developing isthmic-cervical isufficiency. Conclusions. Identification of signs of UCTD at the preconception stage and the use of personalized preconception preparation in this group of patients contributes to the improvement of perinatal outcomes.

Clinico–anatomical characteristic of the traffic trauma in the megapolis environment. The fourth report: estimation of clinical risks

Objective. Establishment and verification of clinical definite risks in the injured persons, in whom trauma have occurred as a consequence of the traffic accidents in environment of megapolis.&#x0D; Materials and methods. The pattern of a nature type was used, formatted in accordance to the big numbers law and following the demands and the evidence–based medicine criteria. The investigation volume, which was presented by 1139 observations of trauma as a consequence of the traffic accidents in period 2019–2020 yrs, and formatted using method of a reverse randomization in accordance to the damage signs and the random numbers method.&#x0D; Results. In general massive of the injured persons the clinical resultant risk index have constituted 0.05 and was verified as a minimal one in accordance to qualitative characteristic. The risk–creating factor, named “gender” in the injured persons has been situated in range of minimal qualitative characteristic in both genders, but its quantitative values were bigger in men by 66.67 %. Here exist a pronounced dependence of clinical resultant risk index from the age sign of the injured persons, and in the age groups up to 70 yrs old it is minimal, while after 70 years old – nonessential. This index was characterized in all participants of the traffic as a minimal, but the biggest risk of the negative result occurrence concerning the traumatic process course have had the pedestrians. The death risk in the injured person has been raised accurately along with enhancement of the injury severity index, ranging from the minimal to catastrophic one. The negative result risk for the traumatic course has been depended probably on the affection volume: the death probability in the injured person raising accurately with the affection volume enhancement. The damage of 4 anatomic–functional portions was considered as a critical.&#x0D; Conclusion. The clinic–epidemiological risk–creating factors have got qualitative characteristic “minimal”– from 0.02 to 0.09, excluding persons of a senile age, for whom they were nonessential (0.2). The biggest risk of the death was revealed in the injured active participants of traffic – drivers (0.03) and pedestrians (0.08). For clinic–nosological risk–creating factors a quite certain trend for the death risk enhancement oi the injured person with enhancement of volume and severity of the damage was depicted in detail, and qualitatively were characterized from minimal (0.01) to catastrophic (0.82). The impact of the risk–creating factors owes a complex character.

External Auditory Canal Cholesteatoma after Radiation Therapy for Nasopharyngeal Cancer: Case Series and Systematic Review

The authors performed a systematic review, in accordance with the PRISMA guidelines, across multiple databases, including all original studies published until November 2022, focusing on External auditory canal cholesteatoma (EACC) after radiation therapy (RT) for nasopharyngeal cancer (NC). Inclusion criteria were original articles reporting on secondary EACC after RT for NC. Articles were critically appraised to assess level of evidence using the Oxford Center for Evidence-Based Medicine criteria. Overall, 138 papers were identified and after duplicate removal (34 papers) and excluding papers not in English, 93 papers were assessed for eligibility; finally, only five papers were included and summarized with the three cases coming from our institution. These mainly involved the anterior and the inferior part of the EAC. The mean time of diagnosis after RT was the largest series of 6.5 years (with a range from 0.5 to 15.4 years). Patients undergoing RT for NC have 18 times a higher risk of developing EACC compared to the normal population. EACC is probably one of the most underreported side effects, because patients may present variable clinical findings, which could lead to misdiagnosis. Early diagnosis of RT related EACC is advised to enable conservative treatment.

Evaluation of the toxicity and hepatoprotective properties of new s-substituted pteridins

Abstract Liver damage is a common problem around the world, and pharmacocorrection of such disease is carried out by administration of various drugs. Natural and synthetic thio-containing compounds are important in this respect. Most of these, however, have side effects and do not always meet the criteria of evidence-based medicine. Therefore, the search for new drugs with hepatoprotective properties, characterized by high efficiency and low toxicity, is an urgent problem of current pharmacology and biochemistry. The purpose of this study was to assess the acute toxicity of new potentially bioactive S-substituted pteridinones, to select the least toxic substance, to improve the pharmaco-technological characteristics, and to study the hepatoprotective properties in an experimental model of tetrachloromethane hepatitis in rats. Herein, comparison of the hepatoprotective properties of compound 4.1 and the reference drug "Thiotriazoline" is based on biochemical studies. The research results showed that sub-stance 4.1 had a positive effect on biochemical processes by increasing the compensatory mechanisms of antioxidant systems, while reducing the infiltrative, destructive and inflamma-tory process in the liver, evoking decreases in the cytolytic process, restoring the structure of the components of the membrane of hepatocytes, stabilizing and enhancing the functional activity of the liver, restoring the liver’s protein-synthesizing function and increasing the abil-ity to restore metabolic disorders in the liver. As a result of the biochemical study of the hepa-toprotective effect of compound 4.1, it was found that the studied substance is a non-toxic compound with antioxidant properties.

ED visits, hospital admissions and treatment breaks in head/neck cancer patients undergoing radiotherapy.

Radiation therapy (RT) is an integral part of treatment of head/neck cancer (HNC) but is associated with many toxicities. We sought to evaluate sociodemographic, pathologic, and clinical factors associated with emergency department (ED) visits, hospital admissions (HA), and RT breaks in HNC patients undergoing curative-intent RT. We completed a Level 3 (Oxford criteria for evidence-based medicine) analysis of a cohort of HNC patients who underwent curative-intent RT at our institution from 2013 to 2017. We collected demographic characteristics and retrospectively assessed for heavy opioid use, ED visits or HA during RT as well as RT breaks. Treatment breaks were defined as total days to RT fractions ratio ≥1.6. Multivariable stepwise logistic regression analyses were done to determine the association of various sociodemographic, pathologic, and clinical characteristics with ED visits, HA and RT treatment breaks. The cohort included 376 HNC patients (294 male, 82 female, median age 61). On multivariable analysis, significant factors associated with ED visits during RT were heavy opioid use and black race. Receipt of concomitant chemotherapy was the only factor associated with hospital admissions during RT. Advanced age, lower socioeconomic class, glandular site, and receipt of chemotherapy were all independently associated with RT breaks. Lower cancer stage and lack of substance abuse history were independently associated with lack of treatment breaks. HNC patients with factors such as heavy opioid use, Black race, receipt of concomitant chemotherapy, and lower socioeconomic class may require closer monitoring during RT.

The use of IncobotulinumtoxinA in spastic forms of cerebral palsy: a review of randomized clinical trials

Botulinum therapy has been used to treat increased muscle tone and spasticity in cerebral palsy (CP) over almost 30 years. Despite this, every year a large number of published scientific articles present new clinical studies devoted to various aspects of the use of botulinum toxin type A (BTA) products in children. The article discusses in detail the results of three major international randomized clinical trials concerning determination the efficacy and safety of the product Xeomin (IncobotulinumtoxinA) in spastic forms of cerebral palsy. All these studies were performed in accordance with the criteria of evidence-based medicine - randomized, prospective, multicenter, comparative, and longitudinal with a large number of patients, clear inclusion and exclusion criteria. The TIM (Treatment with incobotulinumtoxinA in Movement) study demonstrated the effectiveness of the treatment of spasticity of the lower extremities muscles when using different doses of IncobotulinumtoxinA (8, 6 and 2 units/kg of body weight to correct one pathological pattern) in a double-blind study. The TIMO (Treatment with IncobotulinumtoxinA in Movement Open Label) study showed the efficacy and safety of high doses of IncobotulinumtoxinA (total doses of 16-20 units/kg of body weight) in the treatment of spasticity of the lower and upper extremities with prolonged use. The XARA study (IncobotulinumtoxinA in Arm Treatment in Cerebral Palsy) presented data on the high efficacy of IncobotulinumtoxinA when using a multi-level approach for the treatment of lower and upper limb spasticity in CP children and adolescents, which reflects the real clinical needs of a large number of patients. In each of these studies, the safety of the use of IncobotulinumtoxinA was also evaluated. Good tolerability of therapy was demonstrated (84.1% of patients completed all visits in total according to three studies - TIM, TIMO and XARA) and its safety (the frequency of adverse events associated with therapy was observed in less than 2% of cases). Treatment with IncobotulinumtoxinA was characterized by the lack of an immunologic response - Xeomin as a starting therapy provides a stable effect without fading associated with the development of neutralizing antibodies.

Synovectomy in juvenile idiopathic arthritis: A systematic review and meta-analysis.

Juvenile idiopathic arthritis (JIA) is an inflammatory arthropathy with onset in children younger than 16 years. Treatment is primarily medical; however, surgical interventions, such as arthroscopic or open synovectomy, can be beneficial. Many studies have investigated synovectomy in JIA, but the results of these studies have not been synthesized to our knowledge. Therefore, we performed a systematic review of the literature reporting synovectomy as a treatment for JIA to provide clinical recommendations regarding its risks and benefits. On March 8, 2022, we searched the Cochrane Library, Embase, PubMed, Scopus, and Web of Science for studies evaluating clinical outcomes of open or arthroscopic synovectomy to treat JIA in patients younger than 18 years. We included only studies published in English and excluded studies of synovectomy to treat other arthropathies, septic arthritis, hemophilia, or foreign body arthropathy. The level of evidence for included studies was determined by using the Oxford Centre for Evidence-Based Medicine criteria. We qualitatively analyzed clinical outcomes data, including patient-reported pain relief, rates of symptom recurrence, and postoperative complications. Of 428 articles assessed, 14 were included in our analysis. One was a randomized trial, 1 was a case-control study, and all others were case-series. Studies consistently reported that synovectomy was associated with improved function and decreased pain postoperatively. However, comparisons with modern medical therapy were lacking. Rates of arthritis recurrence varied, with increasing symptom recurrence with longer follow-up and re-synovectomy rates up to 15%. Oligoarticular disease and early disease course were associated with better response to synovectomy, whereas systemic and polyarticular disease were associated with poor response. Stiffness requiring manipulation under anesthesia was the most common complication (4% of all included patients). Although synovectomy is associated with positive functional outcomes and pain reduction postoperatively, there was inadequate comparison thus inadequate evidence to recommend it over modern medical therapy. The current literature suggests that synovectomy should be offered only to patients for whom medical management has failed, while noting the risks of decreased range of motion and symptom recurrence over time.

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature.

Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional studies. The evidence base and features of ADR reports that are used to support signals remain to be comprehensively described. To this end, we have undertaken a scoping review. We searched the following databases: PubMed, EMBASE, PsycINFO, Web of Science, and Google Scholar, without language or time restrictions. We also hand searched the bibliographies of relevant studies. We included studies of any design if the results were described as signals. We assessed the levels of evidence using the Oxford Centre for Evidence-Based Medicine (OCEBM) criteria and coded features of reports of ADRs using the Bradford Hill guidelines. Overall, 1974 publications reported 2421 studies of signals; 1683/2421 were clinical assessments of anecdotal reports of ADRs, but only 225 (13%) of these included explicit judgments on which features of the ADR reports were supportive of a signal. These 225 studies yielded 228 signals; these were supported by features, which were: 'experimental evidence' (i.e., positive dechallenge or rechallenge, 154 instances [68%]), 'temporality' (i.e., time to onset, 130 [57%]), 'exclusion of competing causes' (49 [21%]), and others (40 [17%]). Positive dechallenge/rechallenge often co-occurred with temporality (77/228). OCEBM 4 (i.e., case series and case-control studies) was the most frequent level of evidence (2078 studies). Between 2013 and 2019, there was a three-fold increase in clinical assessments of reports of ADRs compared with a less than two-fold increase in studies supported by higher levels of evidence (i.e., OCEBM 1-3). We identified an increased rate between 2013 and 2019 in disproportionality analyses (about 15 studies per year), mostly from academia. Most signals were supported by temporality and dechallenge/rechallenge, but clear reporting of judgments on causality remains infrequent. The number of studies supported only by anecdotal reports of ADRs increased from year to year. The impact of a growing number of signals of disproportionate reporting communicated without an accompanying clinical assessment should be evaluated.

ODP185 Diabetic Retinopathy Prevalence in Pediatric Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

Abstract Type 2 diabetes mellitus (T2DM) is on the rise in children and adolescents. Diabetic retinopathy (DR) is a leading cause of blindness in adult patients with diabetes. However, the exact prevalence of DR and its determinants in pediatric patients with T2DM are unknown. Understanding the burden of DR in pediatric T2DM can help inform screening and management clinical practice guidelines. This systematic review and meta-analysis aimed to determine the prevalence and determinants of DR in pediatric T2DM. The main outcome was the pooled prevalence of DR in pediatric T2DM. Other important outcomes included the assessment of the impact of diabetes duration, method of retinopathy diagnosis, sex, race, and obesity on prevalence. We searched MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, and the grey literature from inception until April 4, 2021 for relevant data. No language restrictions were applied, and searches were limited to human studies. Two reviewers independently screened for studies of T2DM patients diagnosed &amp;lt;21 years of age with observational study design and ≥10 participants. Risk of bias evaluation was performed and level of evidence analysis was conducted using the Oxford Centre for Evidence-Based Medicine criteria. A random-effects meta-analysis was used to pool the results. Out of 1849 screened studies, 24 studies met the inclusion criteria. The overall prevalence of DR in pediatric T2DM was 6.58% (95%CI 3.46-10.46, I 2 =96%,n=9026). Most cases were classified as minimal or mild non-proliferative DR. Six cases were sight-threatening. Prevalence was higher in studies using fundoscopy than fundus photography to evaluate DR (0.47% [95%CI 0. 00-3.30, I 2 =0%,n=135] vs. 18.20% [95%CI 7.92-31.28, I 2 =89%,n=718]), suggesting that fundus photography was more sensitive in detecting DR than fundoscopy. The risk of DR rose progressively post-diagnosis; while1.25% (95%CI 0. 00-4. 01, I 2 =13%,n=213) of patients had DR &amp;lt;3 years post T2DM diagnosis, this figure rose to33. 03% (95%CI 25.79-40.66, I 2 =0%,n=162) &amp;gt;5 years after diagnosis. Obesity and sex did not impact DR prevalence. White/Middle Eastern patients had a DR prevalence of 7.43% (95%CI 0. 00-31.37; I 2 =97%,P &amp;lt;0. 001, n=4419),while Asians had a higher prevalence of 14.85% (95%CI 0.91-39.16; I 2 =93%,P &amp;lt;0. 001, n=501). In conclusion, DR is a frequent complication in children and adolescents in the early years post T2DM diagnosis. Screening for DR at diagnosis and annually thereafter using fundus photography is critical to allow early detection and management to prevent visual impairment in these patients. Presentation: No date and time listed

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: "Miscellaneous Therapies". Animals 2021, 11, 3356.

Simple SummaryAccording to the simile principle (Similia similibus curentur, or ‘Let like be cured by like’), classical (=individualized) homeopathic therapy is based on the individual and not on the indication. Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in methodologically high-quality studies. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine (a combination of patient-oriented conventional and complementary veterinary medicine) and the integration of complementary medicine including homeopathy at the universities seems a necessary consequence and requirement in the interests of the patient.(1) Background: Classical (=individualized) homeopathic therapy is based on the individual and not on the indication. (2) Methods: The prerequisite for conducting methodologically high-quality studies on indvidualized homeopathy is that the principles of homeopathy are considered, since the selection of the simile (the individually appropriate homeopathic medicinal product) is decisive for the effectiveness of the homeopathic treatment, because only an application lege artis can be effective for the respective patient. Apart from this, criteria for evidence-based medicine must be considered for design, conduction, documentation, and rating of studies in homeopathy. (3) Results: When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in the methodologically high-quality studies. (4) Conclusions: Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle (Similia similibus curentur, or ‘Let like be cured by like’) is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine and the integration of complementary medicine including homeopathy at universities seems a necessary consequence and requirement in the interests of the patient, which is already expressed in the American consensus guidelines for an integrative veterinary medicine curriculum and is legally anchored in Switzerland by the Medical Professions Act for university teaching and research.

Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis.

IntroductionThe Chinese National Medical Products Administration (NMPA) has emphasized proactive pharmacovigilance throughout the product life cycle in recent years. However, the safety-related withdrawal of drugs from the Chinese market has received less attention.ObjectivesThe primary aim of the study was to investigate the context of withdrawing a drug for safety reasons in China (between 1999 and 2021).MethodsWithdrawn drugs were first identified from the Chinese NMPA and United States (US) Food and Drug Administration websites and the World Health Organization’s (WHO’s) consolidated list of products, WHO Drug Information, and WHO Pharmaceuticals Newsletter. We then searched the China National Knowledge Internet database, Chongqing VIP information database, Wanfang database, PubMed, and Google Scholar for drug withdrawal details. We used the Oxford Centre for Evidence-Based Medicine criteria to assess the levels of evidence that support withdrawing a drug.ResultsA total of 30 drugs were withdrawn from the Chinese market between 1999 and 2021. The number of withdrawals increased during the stable Chinese drug surveillance period (2012–2021). Evidence from case-series or case–control studies was primarily used to determine the withdrawals of 16 drugs (53.3%). Fifteen drugs were withdrawn from the markets of China and the US, including five drugs (5/15, 33.3%) that were withdrawn in the same year in China and the US.ConclusionsThe promulgation of regulations and development of advanced passive and active systems have enhanced pharmacovigilance in China. High-quality evidence, coordination with other regulatory authorities, and communication and information sharing should be strengthened to optimize drug safety surveillance and risk management.

A scoping systematic assessment for post-marketing abuse drug withdrawal

Abstract Objectives The aim of this study was to identify the post-marketing withdrawal of medicines due to their adverse drug reactions (ADRs)-related abuse effects and to examine the types of evidence, mechanisms and patterns for the withdrawal decisions after their approval across different geographical regions. Methods By searching through different databases that focused on withdrawn drugs due to their ADRs-related abuse effects between 1930 and 2021 that could provide findings of evidence used in making withdrawal decisions based on the tools of the Oxford Centre for Evidence-Based Medicine (OCEBM) criteria alongside sources derived from authorities based on their withdrawal. The outcomes were categorized, and the average time between the launch date of exposure and withdrawal was calculated and stratified. Key findings A total of 33 abused withdrawn drugs. The withdrawals occurred between 1961 and 2007. Psychostimulant drugs accounted for most of the abuse withdrawals (42.4%). Most of the withdrawals occurred between 1981 and 1990 (n = 18, 54.5%). Most withdrawn drugs were in Europe (41, 46.6%) with a minimum withdrawal period of 5 years and an average time of withdrawal of 28.8 years. Conclusions Psychostimulant drugs presented the most abuse withdrawals based on the evidence of case–control studies, and the most withdrawals were in Europe. The duration of withdrawn drugs was different from region to region in different continents. More intensive research is required to further reduce the time duration between drug marketing and withdrawal, which will help improve decision-making processes with favourable benefit-risk ratio outcomes.