Journal of Evidence‐Based Medicine最新文献

{"title":"Does neoadjuvant therapy contribute to increased risk in anastomotic leakage of esophageal cancer? A network meta-analysis","authors":"Da Zhou,&nbsp;Donglai Chen,&nbsp;Peidong Song,&nbsp;Zihao Hu,&nbsp;Sukai Xu,&nbsp;Rongying Zhu,&nbsp;Yongbing Chen","doi":"10.1111/jebm.12634","DOIUrl":"10.1111/jebm.12634","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>Conflicting results have been reported about the impact of neoadjuvant therapy on anastomotic leakage (AL) after esophagectomy. We aimed to unravel the potential effect of neoadjuvant therapy on AL after esophagectomy through a network meta-analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A Bayesian network meta-analysis was performed by retrieving relevant literature from PubMed, EMbase, The Cochrane Library and Web of Science Core Collection. Randomized clinical trials (RCTs) and retrospective studies (RS) comparing the following treatment modalities were included: neoadjuvant chemoradiation (nCRT), neoadjuvant chemotherapy (nCT), neoadjuvant radiotherapy (nR), neoadjuvant immunochemotherapy (nICT), and surgery alone (SA). Subgroup analyses by radiation dose, examined lymph nodes (ELN), route of reconstruction, site of anastomosis, and surgical approach were also conducted.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 62 studies with 12,746 patients were included for the present study, among which 17 were RCTs. There were no significantly statistical differences observed among the five treatment modalities in AL for both RCTs (nCRT-nICT: risk ratio 1.51, 95% confidence interval 0.52–4.4; nCT-nICT: 1.71, 0.56–5.08; nICT-nR: 0.79, 0.12–8.02; nICT-SA: 0.59, 0.2–1.84) and RS (nCRT-nICT: odds ratio 1.53, 95% confidence interval 0.84–2.84; nCT-nICT: 1.56, 0.87–2.88; nICT-SA: 0.6, 0.31–1.12; nICT-nR: 1.08, 0.09–36.02). Subgroup analysis revealed that no significant difference in AL was observed among the five treatment modalities except for the impact of nCRT versus nCT (0.21, 0.05–0.73) on AL with a radiation dose ≥41.4 Gy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Neoadjuvant therapy do not significantly increase the incidence of AL after esophagectomy. Administration of irradiation with a moderate dose is not associated with elevated risk in AL. Clinicians can be less apprehensive about prescribing nCRT.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"559-574"},"PeriodicalIF":3.6,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12634","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142004397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Bayesian bias-adjusted random-effects model for synthesizing evidence from randomized controlled trials and nonrandomized studies of interventions","authors":"Minghong Yao,&nbsp;Fan Mei,&nbsp;Kang Zou,&nbsp;Ling Li,&nbsp;Xin Sun","doi":"10.1111/jebm.12633","DOIUrl":"10.1111/jebm.12633","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>An important consideration when combining RCTs and NRSIs is how to address their potential biases in the pooled estimates. This study aimed to propose a Bayesian bias-adjusted random effects model for the synthesis of evidence from RCTs and NRSIs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We present a Bayesian bias-adjusted random effects model based on power prior method, which combines the likelihood contribution of the NRSIs, raised to the power parameter of alpha, with the likelihood of the RCT data, modeled with an additive bias. The method was illustrated using a meta-analysis on the association between low-dose methotrexate exposure and melanoma. We also combined RCTs and NRSIs using the naïve data synthesis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The results including only RCTs has a posterior median and 95% credible interval (CrI) of 1.18 (0.31–4.04), the posterior probability of any harm (&gt; 1.0) and a meaningful association (&gt; 1.15) were 0.61 and 0.52, respectively. The posterior median and 95% CrI based on the naïve data synthesis resulted in 1.17 (0.96–1.47), and the posterior probability of any harm and a meaningful association were 0.96 and 0.60, respectively. For the Bayesian bias-adjusted analysis, the median OR was 1.16 (95% CrI: 0.83–1.71), and the posterior probabilities of any and a meaningful clinical association were 0.88 and 0.53, respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The results indicated that integrating NRSIs into meta-analysis could increase the certainty of the body of evidence. However, directly combining RCTs and NRSIs in the same meta-analysis without distinction may lead to misleading conclusions.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"550-558"},"PeriodicalIF":3.6,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of the eMCI-CHD tool: A multivariable prediction model for the risk of mild cognitive impairment in patients with coronary heart disease","authors":"Qing Wang,&nbsp;Yanfei Liu,&nbsp;Shihan Xu,&nbsp;Fenglan Liu,&nbsp;Luqi Huang,&nbsp;Fengqin Xu,&nbsp;Yue Liu","doi":"10.1111/jebm.12632","DOIUrl":"10.1111/jebm.12632","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This study aimed to develop and validate an eMCI-CHD tool based on clinical data to predict mild cognitive impairment (MCI) risk in patients with coronary heart disease (CHD).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This cross-sectional study prospectively collected data from 400 patients with coronary heart disease (aged 55–90 years, 62% men) from July 2022 to September 2023 and randomized (7:3 ratio) them into training and validation sets. After determining the modeling variables through least absolute shrinkage and selection operator regression analysis, four ML classifiers were developed: logistic regression, extreme gradient boosting (XGBoost), support vector machine, and random forest. The performance of the models was evaluated using area under the ROC curve, accuracy, sensitivity, specificity, and F1 score. Decision curve analysis was used to assess the clinical performance of the established models. The SHapley Additive exPlanations (SHAP) method was applied to determine the significance of the features, the predictive model was visualized with a nomogram, and an online web-based calculator for predicting CHD-MCI risk scores was developed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 400 CHD patients (average age 70.86 ± 8.74 years), 220 (55%) had MCI. The XGBoost model demonstrated superior performance (AUC: 0.86, accuracy: 78.57%, sensitivity: 0.74, specificity: 0.84, F1: 0.79) and underwent validation. An online tool (https://mr.cscps.com.cn/mci/index.html) with seven predictive variables (<i>APOE</i> gene typing, age, education, TyG index, NT-proBNP, C-reactive protein, and occupation) assessed MCI risk in CHD patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study highlights the potential for predicting MCI risk among CHD patients using an ML model-driven nomogram and risk scoring tool based on clinical data.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"535-549"},"PeriodicalIF":3.6,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of testosterone replacement therapy on lower urinary tract symptoms: A systematic review and network meta-analysis","authors":"Xiang Yuan,&nbsp;Xingyu Xiong,&nbsp;Jianxin Xue","doi":"10.1111/jebm.12628","DOIUrl":"10.1111/jebm.12628","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>In this study, we aimed to perform a network meta-analysis (NMA) to investigate the effects of different testosterone replacement therapy (TRT) administration routes on lower urinary tract symptoms (LUTS) in aging men with late-onset hypogonadism (LOH).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A systematic search of PubMed, Embase, The Cochrane Library, CNKI, WanFang Data, and VIP was conducted to identify randomized controlled trials (RCTs) reporting data on International Prostate Symptom Score (IPSS), prostate-specific antigen (PSA) level, or prostate volume. NMA was performed, and subgroup analysis was conducted to assess the impact of TRT duration on outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 21 RCTs involving 2453 participants were included. For pairwise meta-analysis, <i>p</i> values for TRT delivered by transdermal, intramuscular, and oral routes were as follows: IPSS: 0.93, 0.20, and 0.76; PSA level: 0.20, 0.27, and 0.98; prostate volume: 0.18, 0.04, and 0.16. There were no significant differences in IPSS, PSA level, or prostate volume between TRT routes. In subgroup analysis, long-term intramuscular TRT significantly decreased IPSS (<i>p</i> = 0.03), short-term transdermal TRT increased PSA levels (<i>p</i> &lt; 0.001), and short-term intramuscular TRT increased the prostate volume (<i>p</i> = 0.04). Other forms of TRT showed no significant change in IPSS, PSA level, and prostate volume compared with the placebo. Indirect comparison of the three administration routes demonstrated no significant differences in IPSS, PSA level, and prostate volume. Nevertheless, surface under the cumulative ranking curve analysis indicated that intramuscular TRT had an 83% probability of being the best method for decreasing IPSS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The results demonstrate that TRT does not worsen LUTS regardless of the administration route. Intramuscular TRT may be the preferred treatment for aging men with LOH and LUTS. Intramuscular TRT may be the preferred treatment for men with LOH and LUTS. Further research is warranted to validate these findings and optimize TRT management strategies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"490-502"},"PeriodicalIF":3.6,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling the detrimental vicious cycle linking skeletal muscle and COVID-19: A systematic review and meta-analysis","authors":"Qin Wang,&nbsp;Peipei Shi,&nbsp;Lu Cao,&nbsp;Haoran Li,&nbsp;Xiankai Chen,&nbsp;Peiyu Wang,&nbsp;Jianjiang Zhang","doi":"10.1111/jebm.12629","DOIUrl":"10.1111/jebm.12629","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Skeletal muscle catabolism supports multiple organs and systems during severe trauma and infection, but its role in COVID-19 remains unclear. This study investigates the interactions between skeletal muscle and COVID-19.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The PubMed, EMbase, and The Cochrane Library databases were systematically searched from January 2020 to August 2023 for cohort studies focusing on the impact of skeletal muscle on COVID-19 prevalence and outcomes, and longitudinal studies examining skeletal muscle changes caused by COVID-19. Skeletal muscle quantity (SMQN) and quality (SMQL) were assessed separately. The random-effect model was predominantly utilized for statistical analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Seventy studies with moderate to high quality were included. Low SMQN/SMQL was associated with an increased risk of COVID-19 infection (OR = 1.62, <i>p</i> &lt; 0.001). Both the low SMQN and SMQL predicted COVID-19-related mortality (OR = 1.53, <i>p</i> = 0.016; OR = 2.18, <i>p</i> = 0.001, respectively). Mortality risk decreased with increasing SMQN (OR = 0.979, <i>p</i> = 0.009) and SMQL (OR = 0.972, <i>p</i> = 0.034). Low SMQN and SMQL were also linked to the need for intensive care unit/mechanical ventilation, increased COVID-19 severity, and longer hospital stays. Significant skeletal muscle wasting, characterized by reduced volume and strength, was observed during COVID-19 infection and the pandemic.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study reveals a detrimental vicious circle between skeletal muscle and COVID-19. Effective management of skeletal muscle could be beneficial for treating COVID-19 infections and addressing the broader pandemic. These findings have important implications for the management of future virus pandemics.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Systematic review registration</h3>\u0000 \u0000 <p>PROSPERO CRD42023395476.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"503-525"},"PeriodicalIF":3.6,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Baduanjin for ischemic heart failure with mildly reduced/preserved ejection fraction (BEAR Trial): A randomized controlled trial","authors":"Jingen Li,&nbsp;Meili Yu,&nbsp;Yanhui Wang,&nbsp;Siming Li,&nbsp;Siwei Li,&nbsp;Xue Feng,&nbsp;Ruijie Li,&nbsp;Keji Chen,&nbsp;Hao Xu","doi":"10.1111/jebm.12631","DOIUrl":"10.1111/jebm.12631","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>While Baduanjin, a traditional Chinese mind-body exercise, has shown potential health benefits, its efficacy in improving outcomes for heart failure patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) has not been well documented. We aimed to investigate the adjunctive impact of Baduanjin on exercise capacity and quality of life for HFmrEF/HFpEF.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Patients with HFmrEF/HFpEF were enrolled in this multicenter randomized clinical trial. All participants were randomized to conventional cardiac rehabilitation with or without an additional 12-week Baduanjin exercise. The primary endpoint was the distance covered in a 6-min walk test (6MWD), while key secondary outcomes included quality of life measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and cardiopulmonary function including anaerobic threshold (VO₂ AT).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 120 patients were enrolled, and 109 completed all session and tests. The mean age of the 120 patients was 60.5 years (SD, 9.21 years), and 23 (19.2%) were women. The Baduanjin group exhibited a 6.14% improvement in 6MWD compared to a 1.32% improvement in the control group (median improvement, 25.0 vs. 5.0 m; <i>p </i>&lt; 0.001) at 12th week. The VO₂ AT increased by 25.87% in the Baduanjin group versus 3.94% in the control group (<i>p </i>&lt; 0.001). Quality of life also significantly improved in the Baduanjin group as indicated by MLHFQ score changes (–16.8% vs. –3.99%; <i>p </i>&lt; 0.001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Adding Baduanjin to exercise-based cardiac rehabilitation for patients with ischemic HFmrEF or HFpEF are generally safe and could provide significant improvements in exercise capacity and quality of life.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"526-534"},"PeriodicalIF":3.6,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12631","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation and management of knee osteoarthritis","authors":"Siyi Zhu,&nbsp;Wenchun Qu,&nbsp;Chengqi He","doi":"10.1111/jebm.12627","DOIUrl":"10.1111/jebm.12627","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <p>Knee osteoarthritis (KOA) significantly contributes to the global disability burden, with its incidence expected to escalate by 74.9% by 2050. The urgency to comprehend and tackle this condition is critical, necessitating an updated and thorough review of KOA. A systematic review up to February 26, 2024, has elucidated the principal aspects of KOA's pathogenesis, risk factors, clinical manifestations, and contemporary management paradigms. The origins of KOA are intricately linked to mechanical, inflammatory, and metabolic disturbances that impair joint function. Notable risk factors include age, obesity, and previous knee injuries. Diagnosis predominantly relies on clinical assessment, with radiographic evaluation reserved conditionally. The significance of rehabilitation assessments, informed by the International Classification of Functioning, Disability, and Health framework, is highlighted. Treatment strategies are diverse, prioritizing nonpharmacological measures such as patient education, exercise, and weight management, with pharmacological interventions considered adjuncts. Intra-articular injections and surgical options are contemplated for instances where conventional management is inadequate. KOA stands as a predominant disability cause globally, characterized by a complex etiology and profound effects on individuals’ quality of life. Early, proactive management focusing on nonpharmacological interventions forms the cornerstone of treatment, aiming to alleviate symptoms and enhance joint function. This comprehensive review underscores the need for early diagnosis, individualized treatment plans, and the integration of rehabilitation assessments to optimize patient outcomes. Further research is needed to refine prevention strategies and improve management outcomes for KOA patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"675-687"},"PeriodicalIF":3.6,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis and management of inflammatory bowel disease","authors":"Lili Li,&nbsp;Rui Cheng,&nbsp;Yushan Wu,&nbsp;Hao Lin,&nbsp;Huatian Gan,&nbsp;Hu Zhang","doi":"10.1111/jebm.12626","DOIUrl":"10.1111/jebm.12626","url":null,"abstract":"<p>Inflammatory bowel disease (IBD) is a chronic and relapsing immune-mediated disease of the gastrointestinal tract with a gradually increasing global incidence and prevalence. A prolonged course of IBD leads to a decline in patient quality of life and the creation of a substantial economic burden on society. Owing to the lack of specific diagnostic markers, the diagnosis of IBD still needs a gold standard based on a combination of clinical manifestations, imaging, laboratory, and endoscopic results. Accordingly, the current goals of IBD treatment are to alleviate clinical symptoms and reduce recurrence rates. Therefore, it is imperative to develop a standard set of procedures to diagnose and treat IBD. In this review, we summarize prominent and emerging studies, outline classical and contemporary approaches to diagnosing and managing IBD, and integrate multiple guidelines. Furthermore, we propose the possibility of establishing an early and comprehensive diagnostic workflow and personalized management strategy in the future. We aim to enhance the quality and standardization of diagnostic and treatment procedures for IBD.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 2","pages":"409-433"},"PeriodicalIF":3.6,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141457339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Guidelines for use and promotion of low sodium salt in China","authors":"Yifang Yuan,&nbsp;Chao Gao,&nbsp;Xuejun Yin,&nbsp;Xianghui Zhang,&nbsp;Yufei Ji,&nbsp;Xizi Zheng,&nbsp;Qi Zhou,&nbsp;Yangfeng Wu","doi":"10.1111/jebm.12621","DOIUrl":"10.1111/jebm.12621","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>Both excessive intake of sodium and inadequate intake of potassium are associated with blood pressure elevation and subsequent increase in the risk of cardiovascular disease, which accounts for the largest number of deaths in China and worldwide. Low sodium salt, a mixture of mainly sodium chloride and potassium chloride, has shown its great potential as a promising population strategy for sodium intake reduction through multiple large-scale, multicenter, randomized controlled trials among populations including patients with cardiovascular disease, individuals with and without hypertension, older and younger adults, and men and women in China and other countries. This Guidelines aims to provide expert recommendations for promotion and use of low sodium salt in China, based on the current available scientific evidence regarding the effectiveness, safety, cost-effectiveness, and acceptability of low sodium salts in various population groups and different application scenarios. The suggestions to key stakeholders are also made.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A working group, an expert review committee and an advisory committee were established to be responsible for formulating the guidelines’ scope and key questions to be addressed, for searching, synthesizing, and evaluating research evidence, proposing and reviewing the recommendations. The consensus on the final recommendations was reached using the GRADE grid method.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The working group summarized current available evidence of salt substitution regarding its effectiveness, safety, cost-effectiveness, acceptability, availability, suitability, etc. The Guidelines provided six recommendations advising different populations how to use low sodium salt, four recommendations on the application of low sodium salts in different scenarios, and five suggestions for key stakeholders to promote salt substitution.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The first evidence-based guidelines on promotion and use of low sodium salts covers all key questions in relevance and would play a critical role in prevention and control of hypertension and cardiovascular disease in China and worldwide.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 2","pages":"454-467"},"PeriodicalIF":3.6,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141457340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The ethics of some placebo-controlled randomized controlled trials","authors":"Elliot M. Levine,&nbsp;Carlos M. Fernandez","doi":"10.1111/jebm.12625","DOIUrl":"10.1111/jebm.12625","url":null,"abstract":"&lt;p&gt;It has been well-recognized that a randomized controlled trial (RCT) represents the best investigative format to establish medical evidence. In an RCT, essential variables can be controlled and bias minimized. When testing for the efficacy and safety of a medication, it is often compared to a blinded placebo. There is little argument to challenge the role of an RCT in this regard. When a subject is enrolled in an RCT investigating the therapeutic value of a medication for the treatment of a condition, it is often compared to a placebo, so as to best measure whatever benefit this new medication can have, independent of a possible placebo or contextual effect.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; There are many examples of RCTs performed for the testing of a medication being measured for its efficacy in treating a condition when compared to a placebo. However, when there is a known effective medication that can be used with which that comparison can be made, it may be difficult to justify the use of a placebo in that instance, and there are many examples of this circumstance in all medical specialties, including as referenced in these gynecologic examples.&lt;span&gt;&lt;sup&gt;2, 3&lt;/sup&gt;&lt;/span&gt; The putative medications that can be used for such a comparison (instead of placebo), have themselves been compared with placebo in prior Investigational New Drug (IND) trials performed for Federal Drug Administration (FDA) approval.&lt;/p&gt;&lt;p&gt;It is fair to recognize that the ethical principle of nonmaleficence (“first, do no harm”) may be violated by the physicians involved in that RCT.&lt;span&gt;&lt;sup&gt;4&lt;/sup&gt;&lt;/span&gt; Simply put, if the comparison being made in this sort of a study was between a standard medication and a newer medication (possibly being better), then that would certainly be acceptable. Many studies are not performed in that way, however. As a physician-scientist, duty-bound to provide standard-of-care medications to patients and also to see innovative medical treatment be properly tested in order to advance evidence-based medical science, a placebo-controlled investigation fails in this regard, especially for conditions with currently available therapies of proven medical benefit. To not provide available therapy to a patient presenting with a properly documented condition may be an example of harm to that patient.&lt;/p&gt;&lt;p&gt;According to a principle of Logic (Transitive Property of Equality), if A = B, and B = C, then A = C.&lt;span&gt;&lt;sup&gt;5&lt;/sup&gt;&lt;/span&gt; While that tenet may refer to an objective mathematical concept, it may still be useful to apply to the circumstance being described, in that if a FDA-approved medication was objectively found to be efficacious for treating a particular condition in a placebo-controlled investigation, it can itself be used (rather than a placebo) in future studies. Of course, this logical principle may only apply for those investigations showing a medication found to be either more effective or noninferior when compared with that same FDA-approve","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 2","pages":"267-268"},"PeriodicalIF":3.6,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12625","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}