Yuxin Li, Jun Xiong, Zheng Zhang, Kai Liao, Xiaohong Zho, Jun Li, Jie Xiang, Lingling Xu
{"title":"Efficacy and safety of various corticosteroids in the treatment of children with allergic rhinitis: A systematic review and network meta-analysis","authors":"Yuxin Li, Jun Xiong, Zheng Zhang, Kai Liao, Xiaohong Zho, Jun Li, Jie Xiang, Lingling Xu","doi":"10.1111/jebm.12645","DOIUrl":"10.1111/jebm.12645","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Intranasal corticosteroids were recommended as first-line drugs for the treatment of allergic rhinitis (AR) children. A variety of corticosteroids were available for clinical choice; however, which could relieve the clinical symptoms of patients to the greatest extent was currently unknown. Thus, we performed a network meta-analysis (NMA) to systematically evaluate the effectiveness and safety of different corticosteroids in treating children with AR, which might provide a basis for more rational clinical treatment decisions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Seven electronic databases were searched, and the retrieval time range was the time from their inception to November 2023. The literature screening, data extraction, and assessment of the risk of bias of included studies were completed independently by two reviewers. A frequentist NMA was performed with Stata17.0 software.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 43 RCTs covering 10,897 participants were included. In the improvement of reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS), fluticasone furoate nasal spray (FFNS) and beclomethasone dipropionate (BDP) nasal aerosol presented the best efficacy. Regarding the incidence of adverse reactions, mometasone furoate aqueous nasal spray (MFANS) and BDP showed a good safety profile. In terms of the influence of cortisol (urinary free cortisol, plasma cortisol) and growth, no significant difference was observed between the different groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The results showed that BDP nasal aerosol and FFNS had best efficacy; MFANS and BDP had the best safety profile. However, this conclusion was less convincing because of the limited numbers of patients/controls and study quality.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"626-642"},"PeriodicalIF":3.6,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307925","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}
Jiayue Xu, Wenkai Wu, Jundi Jia, Liang Du, Wen Wang, Xin Sun
{"title":"Methodology quality was inadequate for observational studies investigating drug safety of Chinese patent medicine using real-world data: A cross-sectional survey","authors":"Jiayue Xu, Wenkai Wu, Jundi Jia, Liang Du, Wen Wang, Xin Sun","doi":"10.1111/jebm.12648","DOIUrl":"10.1111/jebm.12648","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"483-485"},"PeriodicalIF":3.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289283","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":"Association between duration of action of benzodiazepine hypnotic drugs and blepharospasm: A disproportionality analysis study using FDA Adverse Events Reporting System","authors":"Yoshihiro Noguchi, Rikuto Masuda, Masataka Shishido, Tomoaki Yoshimura","doi":"10.1111/jebm.12647","DOIUrl":"10.1111/jebm.12647","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"480-482"},"PeriodicalIF":3.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289281","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}
Shuzhen Bai, Chu Lin, Xiaoling Cai, Han Wu, Ruoyang Jiao, Suiyuan Hu, Fang Lv, Wenjia Yang, Linong Ji
{"title":"The association between the eGFR slope and cardiorenal prognosis in patients with renoprotective treatments: A systematic review and meta-analysis","authors":"Shuzhen Bai, Chu Lin, Xiaoling Cai, Han Wu, Ruoyang Jiao, Suiyuan Hu, Fang Lv, Wenjia Yang, Linong Ji","doi":"10.1111/jebm.12646","DOIUrl":"10.1111/jebm.12646","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The associations between the estimated glomerular filtration rate (eGFR) slope and the cardiorenal prognosis in patients with renoprotective drugs have not been well characterized yet.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>PubMed, Medline, Embase, The Cochrane Library, CNKI, WanFang, Weipu databases and Clinicaltrial.gov were searched from inception to April 2023. Event-driven randomized controlled trials (RCTs) investigating renoprotective drugs and reporting eGFR slopes in patients with atherosclerotic cardiovascular disease, heart failure, type 2 diabetes, or chronic kidney disease were included.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In all, 25 RCTs with 179,893 participants were included. The preservation of eGFR was observed in patients with renoprotective drugs, with a comparator-adjusted total eGFR slope of 0.51 mL/min per 1.73 m<sup>2</sup>/year (95% CI, 0.31 to 0.70). It was indicated that the eGFR preservation reflected by the positive comparator-adjusted total eGFR slope was associated with a reduced risk of composite renal outcome (<i>β</i> = −0.097, 95% CI, –0.178 to –0.016, <i>p</i> = 0.022), but was not associated with the risks of major adverse cardiovascular events (MACE) or all-cause mortality. In patients with SGLT2i, MRA, or RAASi treatments, the placebo-adjusted acute eGFR slope was –0.59 mL/min per 1.73 m<sup>2</sup> per week (95% CI, –0.74 to –0.43), which was marginally associated with a reduced risk of composite renal outcome (<i>β</i> = 0.290, 95% CI, 0.000 to 0.581, <i>p</i> = 0.050), but was not associated with the risks of MACE or all-cause mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The eGFR preservation reflected by the positive comparator-adjusted total eGFR slope was associated with a reduced risk of composite renal outcome in patients receiving renoprotective agents. Greater acute decline in eGFR during the initiation of the treatment might confer a trend of fewer renal events in patients receiving SGLT2i, MRA, or RAASi.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"643-653"},"PeriodicalIF":3.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289284","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}
Mengshu Wang, Xufei Luo, Janne Estill, Karen Spruyt, Ryo Kurokawa, Nav Persaud, Yasuteru Shimamura, Holly Raison, Paolo Niccolò Franco, Cesare Maino, Hussein Elkhayat, Rehab A. Galal, Daisuke Kimura, Shingo Omata, Sergey A. Ryzhkin, Timur R. Izmailov, Rustem A. Bashirov, Zhaoxiang Bian, Jinhui Tian, Junqiang Lei
{"title":"Evaluation of the reliability and usability of CARE-Radiology: A descriptive-analytic study","authors":"Mengshu Wang, Xufei Luo, Janne Estill, Karen Spruyt, Ryo Kurokawa, Nav Persaud, Yasuteru Shimamura, Holly Raison, Paolo Niccolò Franco, Cesare Maino, Hussein Elkhayat, Rehab A. Galal, Daisuke Kimura, Shingo Omata, Sergey A. Ryzhkin, Timur R. Izmailov, Rustem A. Bashirov, Zhaoxiang Bian, Jinhui Tian, Junqiang Lei","doi":"10.1111/jebm.12638","DOIUrl":"10.1111/jebm.12638","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>The study aimed to evaluate the reliability and usability of the CARE-Radiology checklist in assessing radiological case reports and provide a basis for its broader adoption and optimization.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Ten randomly selected radiological case reports published in scientific journals in 2020 were evaluated using the CARE-Radiology checklist. Twenty-six experts from 10 countries were invited to independently assess all ten reports. The reliability of the checklist was measured using Fleiss' Kappa, and Cronbach's alpha coefficient. Usability was evaluated by recording the time taken to complete the assessments and requesting the evaluators to rate each item on a Likert scale for its easiness of use.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The median time for evaluating one radiological case report was 15 min. The overall agreement among evaluators showed moderate reliability with a Kappa value of 0.47 and a Cronbach's alpha of 0.51. The mean compliance rate for the items of CARE-Radiology was 61.8%, with some items exceeding 90% compliance. Items related to abstracts and keywords had the lowest compliance rates. The evaluators found most items easy to understand, with a few exceptions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The CARE-Radiology checklist is relatively easy for researchers to use and understand. Continuous feedback is necessary for future revisions and updates, to enhance the effectiveness of the checklist, and to improve user experience.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"597-603"},"PeriodicalIF":3.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142261065","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":"Effects of integrated traditional Chinese and Western medicine for acute pancreatitis: A real-world study in a tertiary teaching hospital","authors":"Lihui Deng, Zhiyao Chen, Ping Zhu, Cheng Hu, Tao Jin, Xinwei Wang, Lan Li, Ziqi Lin, Jia Guo, Xiaonan Yang, Na Shi, Xiaoxin Zhang, Xinmin Yang, Kun Jiang, Yun Ma, Qingyuan Tan, Ling Li, Wen Wang, Wei Huang, Xin Sun, Qing Xia","doi":"10.1111/jebm.12635","DOIUrl":"10.1111/jebm.12635","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>This study aimed to evaluate whether integrated traditional Chinese medicine (TCM) and Western medicine (WM) is more effective than WM for acute pancreatitis (AP).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Patients with AP were enrolled and divided into the TCM and WM (TCM&WM) and WM groups according to the therapeutic protocol in real clinical settings. We applied 1:3 propensity score matching, which was to adjust confounding factors. The primary outcome was mortality, whereas the secondary outcomes were organ failure, organ supportive therapies, local complications, hospitalization cost, and length of hospital stay. Sensitivity and subgroup analyses were also performed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 5442 patients with AP, 4691 and 751 were included in the TCM&WM and WM groups, respectively. After PSM, patient baseline characteristics were well balanced. Compared with the WM group (<i>n</i> = 734), the TCM&WM group (<i>n</i> = 2096) had lower overall mortality rate (1.7% vs. 3.4%; risk ratio, 0.482; 95% confidence interval, 0.286–0.810; <i>p </i>= 0.005). The TCM&WM group was associated with lower risk of persistent renal failure, multiple organ failure, and infection, lower utilization of organ supportive therapies, shortened lengths of hospital and intensive care unit stay, and lower hospital costs. Sensitivity analyses showed similar results. Subgroup analysis favored TCM&WM treatment for patients aged < 60 years, with hypertriglyceridic etiology, and with admission interval between 24 and 48 h.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>TCM&WM treatment can achieve lower risks of mortality and organ failure and better economic effectiveness in patients with AP than WM treatment. This study provides a promising alternative of TCM&WM treatment for AP in the real-world setting.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"575-587"},"PeriodicalIF":3.6,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12635","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289282","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}
José Nunes de Alencar, Gabriel Gonçalves da Costa, Vitor Borin Pardo de Souza, Felipe Nogueira Barbara, Yung Gonzaga, Arn Migowski
{"title":"Evaluating clinical utility in diagnostic tests: Likelihood ratios confidence intervals and proposal of a simple index","authors":"José Nunes de Alencar, Gabriel Gonçalves da Costa, Vitor Borin Pardo de Souza, Felipe Nogueira Barbara, Yung Gonzaga, Arn Migowski","doi":"10.1111/jebm.12641","DOIUrl":"10.1111/jebm.12641","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"477-479"},"PeriodicalIF":3.6,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142177409","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}
Kwang Hyun Chung, In Rae Cho, Young Hoon Choi, Young Deok Cho, Ji Kon Ryu, Sang Hyub Lee, Kyungdo Han
{"title":"Association between diabetic status and risk of acute pancreatitis: A nationwide population-based study","authors":"Kwang Hyun Chung, In Rae Cho, Young Hoon Choi, Young Deok Cho, Ji Kon Ryu, Sang Hyub Lee, Kyungdo Han","doi":"10.1111/jebm.12637","DOIUrl":"10.1111/jebm.12637","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>There have been several epidemiologic studies on the association between diabetes mellitus and acute pancreatitis. However, there is no solid evidence, and the effect of diabetes mellitus severity on acute pancreatitis incidence is not well known. This study aimed to evaluate the association between diabetic status and the risk of acute pancreatitis in a nationwide population-based cohort.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Among the participants who underwent national health examinations between 2009 and 2012, patients with diabetes mellitus were included. Patients diagnosed with acute pancreatitis before the health examination or diagnosed with pancreatitis within 1 year following the examination were excluded. The association between the number of oral hypoglycemic agents (<3 or ≥3) or insulin use during examination and acute pancreatitis occurrence was analyzed after follow-up until December 31, 2018.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Overall, 2,444,254 patients were included in the final analysis. During the follow-up period, acute pancreatitis occurred in 10,360 patients with an incidence ratio of 0.585 per 1,000 person-years, and it was observed that the risk of acute pancreatitis sequentially increased between patients taking oral hypoglycemic agents <3 (incidence ratio = 0.546), those taking ≥3 (incidence ratio = 0.665), and those using insulin (incidence ratio = 0.872). The adjusted hazard ratios of patients taking three or more hypoglycemic agents and those using insulin were 1.196 (95% confidence interval (CI) 1.123–1.273) and 1.493 (95% CI 1.398–1.594), respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>As diabetes mellitus severity increases, the risk of acute pancreatitis increases.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"588-596"},"PeriodicalIF":3.6,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140277","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":"Ontology of clinical practice guidelines for Integrated Traditional Chinese and Western Medicine","authors":"Yongbo Wang, Xiangying Ren, Kuang Gao, Mukun Chen, Qiao Huang, Siyu Yan, Yan Zhu, Xin Sun, Yaolong Chen, Long Ge, Jinguang Gu, Feng Gao, Wenbin Hu, Liang Hong, Chen Zhao, Hongcai Shang, Yinghui Jin","doi":"10.1111/jebm.12639","DOIUrl":"10.1111/jebm.12639","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Clinical practice guidelines (CPGs) for Integrated Traditional Chinese and Western Medicine (TCM and WM) are important medical documents used to assist medical decision-making and are of great significance for standardizing clinical pathways. However, due to the constraints of text format, it is difficult for Integrated TCM and WM CPGs to play a real role in medical practice. In addition, how to standardize the structure and semantic relationships between Integrated TCM and WM CPG knowledge, and realize the construction of computable, sharable and reliable CPGs, remains an urgent issue to be addressed. Therefore, we are proposing an ontology of CPGs for Integrated TCM and WM.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We first initialized domain concepts and relationships to ensure the accuracy of the ontology knowledge structure. We then screened CPGs that meet the standards for Integrated TCM and WM, analyzed and classified the contents, and extracted the common structures. Based on the seven-step ontology construction method combined with inference-complement, referring to the representation methods and hierarchical relationships of terms and concepts in MeSH, ICD-10, SNOMED-CT, and other ontologies and terminology sets, we formed the concept structure and semantic relationship tables for the ontology. We also achieved the matching and mapping between the ontology and reference ontologies and term sets. Next, we defined the aspects and constraints of properties, selected multiple Integrated TCM and WM CPGs as instances to populate, and used ontology reasoning tools and formulated defined inference rules to reason and extend the ontology. Finally, we evaluated the performance of the ontology.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The content of the Integrated TCM and WM CPGs is divided into nine parts: basic information, background, development method, clinical question, recommendation, evidence, conclusion, result, and reason for recommendations. The Integrated TCM and WM CPG ontology has 152 classes and defines 90 object properties and 114 data properties, with a maximum classification depth of 4 layers. The terms of disease, drug and examination item names in the ontology have been standardized.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study proposes an Integrated TCM and WM CPG ontology. The ontology adopts a modular design, which has both sharing and scaling ability, and can express rich guideline knowledge. It provides important support for the semantic processing and computational application of guideline documents.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"604-614"},"PeriodicalIF":3.6,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140278","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}
Ilari Kuitunen, Ville T. Ponkilainen, Mikko Uimonen
{"title":"Incorrect blinding assessments are common in meta-analyses published in high impact journals","authors":"Ilari Kuitunen, Ville T. Ponkilainen, Mikko Uimonen","doi":"10.1111/jebm.12636","DOIUrl":"10.1111/jebm.12636","url":null,"abstract":"<p>Guidelines and best practices emphasize the importance of blinding to mitigate potential biases in clinical studies.<span><sup>1</sup></span> Randomized controlled trials are considered the be the highest form of evidence and typically the goal has been to conduct a placebo controlled double-blinded trial.<span><sup>2</sup></span> Risk of bias (RoB) assessment is a crucial part of evidence synthesis.<span><sup>3</sup></span> Typically, this evaluation is carried out using tools such as Cochrane's original RoB tool and the revised RoB 2.0 tool.<span><sup>4, 5</sup></span> The original RoB tool explicitly assesses blinding through separate domains for blinding of participants and personnel (performance bias), as well as blinding of outcome assessment (detection bias).<span><sup>4</sup></span> In RoB 2.0, blinding assessment is part of the measurement of the outcome domain.<span><sup>5</sup></span> However, both tools consider blinding within the context of the outcome's nature, whether it is objective for the patient, treating personnel, the outcome assessor, all of these, or none.</p><p>The objectivity of the outcome plays a pivotal role in assessing bias risk when evaluating blinding, especially concerning subjective outcomes where the absence of blinding could significantly affect effect sizes.<span><sup>6</sup></span> Previous meta-epidemiological studies have mostly reported that the blinding has influence only on subjective outcomes.<span><sup>6, 7</sup></span> Interestingly, one of the latest and largest meta-epidemiological studies did not find evidence that blinding would even have an influence on subjective outcomes neither.<span><sup>8</sup></span> Thus, it is plausible to assume that the effect of blinding on objective outcomes is either negligible or even nonexistent in medicine.</p><p>A key part of the evidence synthesis is to appraise the evidence certainty. The most widely used method is to assess the evidence certainty according to the Grading and Recommendations (GRADE).<span><sup>9</sup></span> GRADE rates each outcome according to different domains, of which one is risk of bias.<span><sup>10</sup></span> Thus, to make an accurate judgment on evidence certainty, risk of bias in studies should be adequately assessed. A previous meta-epidemiological study of neonatal meta-analyses showed evidence certainties were often downgraded due to lack of blinding even in the objective outcomes.<span><sup>11</sup></span> Thus, inadequate downgrading of evidence certainty may have direct influence to treatment guidelines and patient care.<span><sup>12</sup></span> The aim of this study was to investigate how the authors of systematic reviews and meta-analyses published in top level journals and Cochrane have estimated the risk of bias due to blinding and have they noted the objectivity of the outcomes in their assessments.</p><p>We conducted a systematic meta-epidemiological review of systematic reviews and meta-analyses. As the RoB 2.0 too","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 3","pages":"471-473"},"PeriodicalIF":3.6,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12636","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108119","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}