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
Background
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.
Methods
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.
Results
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 m2/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 (β = −0.097, 95% CI, –0.178 to –0.016, p = 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 m2 per week (95% CI, –0.74 to –0.43), which was marginally associated with a reduced risk of composite renal outcome (β = 0.290, 95% CI, 0.000 to 0.581, p = 0.050), but was not associated with the risks of MACE or all-cause mortality.
Conclusions
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.
{"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
Aim
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.
Methods
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.
Results
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.
Conclusions
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.
{"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}
This study aimed to evaluate whether integrated traditional Chinese medicine (TCM) and Western medicine (WM) is more effective than WM for acute pancreatitis (AP).
Methods
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.
Results
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 (n = 734), the TCM&WM group (n = 2096) had lower overall mortality rate (1.7% vs. 3.4%; risk ratio, 0.482; 95% confidence interval, 0.286–0.810; p = 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.
Conclusion
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.
目的：本研究旨在评估中西医结合治疗急性胰腺炎（AP）是否比中西医结合治疗更有效：方法：在真实的临床环境中招募急性胰腺炎患者，根据治疗方案将其分为中西医结合组（TCM&WM）和中西医结合组（WM）。我们采用1:3倾向评分匹配，以调整混杂因素。主要结果是死亡率，次要结果是器官衰竭、器官支持疗法、局部并发症、住院费用和住院时间。同时还进行了敏感性分析和亚组分析：在5442例AP患者中，4691例和751例分别被纳入中西医结合组和WM组。PSM 后，患者的基线特征非常均衡。与 WM 组（n = 734）相比，中西医结合组（n = 2096）的总死亡率较低（1.7% vs. 3.4%；风险比，0.482；95% 置信区间，0.286-0.810；p = 0.005）。中西医结合组发生持续性肾功能衰竭、多器官功能衰竭和感染的风险较低，器官支持疗法的使用率较低，住院时间和重症监护室住院时间缩短，住院费用降低。敏感性分析显示了类似的结果。亚组分析显示，中西医结合治疗对老年患者更有利：与 WM 治疗相比，中西医结合治疗 AP 患者的死亡率和器官衰竭风险更低，经济效益更好。这项研究为在现实世界中采用中医和中西医结合治疗 AP 提供了一个很有前景的选择。
{"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
Objective
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.
Methods
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.
Results
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.
Conclusions
As diabetes mellitus severity increases, the risk of acute pancreatitis increases.
{"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}
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.
Methods
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.
Results
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.
Conclusions
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.
{"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
<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
{"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}
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.
Methods
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.
Results
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.
Conclusions
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.
目的：关于新辅助治疗对食管切除术后吻合口漏（AL）的影响，目前的报道结果不一。我们旨在通过网络荟萃分析揭示新辅助治疗对食管切除术后吻合口漏的潜在影响：我们从 PubMed、EMbase、The Cochrane Library 和 Web of Science Core Collection 中检索了相关文献，进行了贝叶斯网络荟萃分析。研究纳入了比较以下治疗方式的随机临床试验（RCT）和回顾性研究（RS）：新辅助化放疗（nCRT）、新辅助化疗（nCT）、新辅助放疗（nR）、新辅助免疫化疗（nICT）和单纯手术（SA）。此外，还按放射剂量、检查淋巴结（ELN）、重建途径、吻合部位和手术方法进行了分组分析：本研究共纳入 62 项研究，12746 名患者，其中 17 项为研究性临床试验。在两项 RCT 中，AL 的五种治疗方式之间没有观察到明显的统计学差异（nCRT-nICT：风险比 1.51，95% 置信区间 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）和 RS（nCRT-nICT：风险比 1.53，95% 置信区间 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）。亚组分析显示，除了nCRT与nCT（0.21，0.05-0.73）对放射剂量≥41.4 Gy的AL的影响外，其他五种治疗方式的AL没有明显差异：结论：新辅助治疗不会明显增加食管切除术后 AL 的发生率。结论：新辅助治疗不会明显增加食管切除术后 AL 的发生率，中等剂量的照射与 AL 风险升高无关。临床医生在开具新辅助治疗处方时可以不必过于担心。
{"title":"Does neoadjuvant therapy contribute to increased risk in anastomotic leakage of esophageal cancer? A network meta-analysis","authors":"Da Zhou, Donglai Chen, Peidong Song, Zihao Hu, Sukai Xu, Rongying Zhu, 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}
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