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Critical appraisal of a statistical analysis: A novel visual guide 统计分析的批判性评估:新颖的视觉指南
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-27 DOI: 10.1111/jebm.12585
Lisa Kuramoto, Mike Marin, Jacquelyn J. Cragg
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引用次数: 0
Clinical practice guidelines for prevention and treatment of postoperative gastrointestinal disorder with Integrated Traditional Chinese and Western Medicine (2023) 中西医结合防治术后胃肠功能紊乱临床实践指南(2023 年)》。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-26 DOI: 10.1111/jebm.12587
Jianjun Xue, Ziqing Xu, Qiang Wang, Huaijing Hou, Lili Wei, Jie Zhang, Xiaohong Zhao, Liping Chen, Fanfan Ding, Li Ma, Yongqiang Zhao, Yingbin Wang, Daqing Ma, Tianjun Wang, Renyu Liu, Tong J Gan, Nicky Robinson, Yurasek Frank, Fan Su, Yongliang Chi, Dianhui Yang, Shujuan Liu, Suyang Cui, Yousong Wei, Zhiqiang Chen, You Qin, Lixing Cao, Guiping Chen, Kuanyong Shu, Zhongqing Xiao, Hui Zhang, Jianbo Yu, Zhiqian Hu, Huakun Cheng, Wuhua Ma, Guokai Liu, Xiuli Wang, Xinghua Cao, Ju Gao, Gaoyin Kong, Qing Tao, Baohua Wang, Junlu Wang, Hong Li, Cuixia Lyu, Zhiming Zhang, Tianzuo Li, Kehu Yang

Postoperative gastrointestinal disorder (POGD) was a common complication after surgery under anesthesia. Strategies in combination with Traditional Chinese Medicine and Western medicine showed some distinct effects but standardized clinical practice guidelines were not available. Thus, a multidisciplinary expert team from various professional bodies including the Perioperative and Anesthesia Professional Committees of the Chinese Association of Integrative Medicine (CAIM), jointly with Gansu Province Clinical Research Center of Integrative Anesthesiology/Anesthesia and Pain Medical Center of Gansu Provincial Hospital of Traditional Chinese Medicine and WHO Collaborating Center for Guideline Implementation and Knowledge Translation/Chinese Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Center/Gansu Provincial Center for Medical Guideline Industry Technology/Evidence-based Medicine Center of Lanzhou University, was established to develop evidence-based guidelines. Clinical questions (7 background and 12 clinical questions) were identified through literature reviews and expert consensus meetings. Based on systematic reviews/meta-analyses, evidence quality was analyzed and the advantages and disadvantages of interventional measures were weighed with input from patients’ preferences. Finally, 20 recommendations were developed through the Delphi-based consensus meetings. These recommendations included disease definitions, etiologies, pathogenesis, syndrome differentiation, diagnosis, and perioperative prevention and treatment.

术后胃肠功能紊乱(POGD)是麻醉手术后常见的并发症。中西医结合的策略显示出一些明显的效果,但却没有标准化的临床实践指南。因此,由中国中西医结合学会围术期专业委员会和麻醉专业委员会等多个专业机构组成的多学科专家团队,联合甘肃省中西医结合麻醉学临床研究中心/甘肃省中医院麻醉与疼痛医学中心、世界卫生组织指南实施与知识翻译合作中心/中国建议分级、甘肃省中医院麻醉与疼痛医学中心与世界卫生组织指南实施与知识翻译合作中心/中国推荐、评估、发展与评价(GRADE)中心/甘肃省医学指南产业技术中心/兰州大学循证医学中心共同成立了甘肃省中医院麻醉与疼痛医学中心,以制定循证指南。通过文献综述和专家共识会议,确定了临床问题(7 个背景问题和 12 个临床问题)。在系统综述/荟萃分析的基础上,对证据质量进行分析,并根据患者的偏好权衡介入措施的利弊。最后,通过德尔菲共识会议提出了 20 项建议。这些建议包括疾病定义、病因、发病机制、综合征鉴别、诊断以及围手术期预防和治疗。
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引用次数: 0
Polypharmacy and risk of fractures in older adults: A systematic review 多种药物治疗与老年人骨折风险:系统综述。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-22 DOI: 10.1111/jebm.12593
Marie-Eve Gagnon, Denis Talbot, Florence Tremblay, Katherine Desforges, Caroline Sirois

Background

Fractures have serious health consequences in older adults. While some medications are individually associated with increased risk of falls and fractures, it is not clear if this holds true for the use of many medications (polypharmacy). We aimed to identify what is known about the association between polypharmacy and the risk of fractures in adults aged ≥65 and to examine the methods used to study this association.

Methods

We conducted a systematic review with narrative synthesis of studies published up to October 2023 in PubMed, Embase, CINAHL, PsychINFO, Cochrane Library, Web of Science, and the grey literature. Two independent reviewers screened titles, abstracts, and full texts, then performed data extraction and quality assessment.

Results

Among the 31 studies included, 11 different definitions of polypharmacy were used and were based on three medication counting methods (concurrent use 15/31, cumulative use over a period 6/31, daily average 3/31, and indeterminate 7/31). Overall, polypharmacy was frequent and associated with higher fracture risk. A dose–response relationship between increasing number of medications and increased risk of fractures was observed. However, only seven studies adjusted for major confounders (age, sex, and chronic disease). The quality of the studies ranged from poor to high.

Conclusions

Polypharmacy appears to be a relevant modifiable risk factor for fractures in older individuals that can easily be used to identify those at risk. The diversity of medication calculation methods and definitions of polypharmacy highlights the importance of a detailed methodology to understand and compare results.

背景:骨折对老年人的健康有着严重的影响。虽然某些药物单独使用会增加跌倒和骨折的风险,但使用多种药物(多种药物治疗)是否会增加跌倒和骨折的风险,目前尚不清楚。我们的目的是确定已知的多种药物治疗与年龄≥65 岁的成年人骨折风险之间的关系,并研究用于研究这种关系的方法:我们对截至 2023 年 10 月在 PubMed、Embase、CINAHL、PsychINFO、Cochrane Library、Web of Science 和灰色文献中发表的研究进行了系统性综述。两位独立审稿人筛选了标题、摘要和全文,然后进行了数据提取和质量评估:在纳入的 31 项研究中,有 11 种不同的多重用药定义是基于三种药物计数方法(同时用药 15/31、一段时间内累计用药 6/31、日均用药 3/31、不确定用药 7/31)。总体而言,多药治疗是一种常见现象,与较高的骨折风险相关。研究发现,药物数量增加与骨折风险增加之间存在剂量反应关系。然而,只有七项研究对主要混杂因素(年龄、性别和慢性疾病)进行了调整。这些研究的质量从低到高不等:结论:多药治疗似乎是老年人骨折的一个相关可调整风险因素,可轻松用于识别高危人群。用药计算方法和多重用药定义的多样性凸显了详细方法对于理解和比较结果的重要性。
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引用次数: 0
Rapid review: A review of methods and recommendations based on current evidence 快速审查:基于现有证据的方法和建议回顾。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-21 DOI: 10.1111/jebm.12594
Qiong Guo, Guiyu Jiang, Qingwen Zhao, Youlin Long, Kun Feng, Xianlin Gu, Yihan Xu, Zhengchi Li, Jin Huang, Liang Du

Rapid review (RR) could accelerate the traditional systematic review (SR) process by simplifying or omitting steps using various shortcuts. With the increasing popularity of RR, numerous shortcuts had emerged, but there was no consensus on how to choose the most appropriate ones. This study conducted a literature search in PubMed from inception to December 21, 2023, using terms such as “rapid review” “rapid assessment” “rapid systematic review” and “rapid evaluation”. We also scanned the reference lists and performed citation tracking of included impact studies to obtain more included studies. We conducted a narrative synthesis of all RR approaches, shortcuts and studies assessing their effectiveness at each stage of RRs. Based on the current evidence, we provided recommendations on utilizing certain shortcuts in RRs. Ultimately, we identified 185 studies focusing on summarizing RR approaches and shortcuts, or evaluating their impact. There was relatively sufficient evidence to support the use of the following shortcuts in RRs: limiting studies to those published in English-language; conducting abbreviated database searches (e.g., only searching PubMed/MEDLINE, Embase, and CENTRAL); omitting retrieval of grey literature; restricting the search timeframe to the recent 20 years for medical intervention and the recent 15 years for reviewing diagnostic test accuracy; conducting a single screening by an experienced screener. To some extent, the above shortcuts were also applicable to SRs. This study provided a reference for future RR researchers in selecting shortcuts, and it also presented a potential research topic for methodologists.

快速综述(RR)可以利用各种捷径简化或省略步骤,从而加快传统的系统综述(SR)过程。随着 RR 的日益普及,出现了许多捷径,但如何选择最合适的捷径却没有达成共识。本研究使用 "快速综述"、"快速评估"、"快速系统综述 "和 "快速评价 "等术语在 PubMed 上进行了文献检索,检索时间从开始到 2023 年 12 月 21 日。我们还扫描了参考文献目录,并对纳入的影响研究进行了引文追踪,以获得更多的纳入研究。我们对所有 RR 方法、捷径以及评估其在 RR 各阶段有效性的研究进行了叙述性综合。根据现有证据,我们提出了在 RR 中使用某些捷径的建议。最终,我们确定了 185 项研究,重点是总结 RR 方法和捷径,或评估其影响。相对而言,有足够的证据支持在RR中使用以下捷径:仅限于以英文发表的研究;进行简略的数据库检索(如仅检索PubMed/MEDLINE、Embase和CENTRAL);省略灰色文献检索;将医疗干预的检索时间限制在最近20年,将诊断测试准确性的审查时间限制在最近15年;由经验丰富的筛选员进行单一筛选。在某种程度上,上述捷径也适用于SR。本研究为未来的 RR 研究人员选择捷径提供了参考,同时也为方法学家提出了一个潜在的研究课题。
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引用次数: 0
A data-driven newsvendor model for elective-emergency admission control under uncertain inpatient bed capacity 在住院床位容量不确定的情况下,用于控制择期急诊入院的数据驱动新闻供应商模型。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-20 DOI: 10.1111/jebm.12599
Wenwu Shen, Le Luo, Li Luo, Lin Zhang, Ting Zhu

Objective

Elective-emergency admission control referred to allocating available inpatient bed capacity between elective and emergency hospitalization demand. Existing approaches for admission control often excluded several complex factors when making decisions, such as uncertain bed capacity and unknown true probability distributions of patient arrivals and departures. We aimed to create a data-driven newsvendor framework to study the elective-emergency admission control problem to achieve bed operational efficiency and effectiveness.

Methods

We developed a data-driven approach that utilized the newsvendor framework to formulate the admission control problem. We also created approximation algorithms to generate a pool of candidate admission control solutions. Past observations and relevant emergency demand and bed capacity features were modeled in a newsvendor framework. Using approximation algorithmic approaches (sample average approximation, separated estimation and optimization, linear programing-LP, and distribution-free model) allowed us to derive computationally efficient data-driven solutions with tight bounds on the expected in-sample and out-of-sample cost guaranteed.

Results

Tight generalization bounds on the expected out-of-sample cost of the feature-based model were derived with respect to the LP and quadratic programing (QP) algorithms, respectively. Results showed that the optimal feature-based model outperformed the optimal observation-based model with respect to the expected cost. In a setting where the unit overscheduled cost was higher than the unit under-scheduled cost, scheduling fewer elective patients would replace the benefit of incorporating related features in the model. The tighter the available bed capacity for elective patients, the bigger the difference of the schedule cost between the feature-based model and the observation-based model.

Conclusions

The study provides a reference for the theoretical study on bed capacity allocation between elective and emergency patients under the condition of the unknown true probability distribution of bed capacity and emergency demand, and it also proves that the approximate optimal policy has good performance.

目的:非急诊入院控制是指在非急诊和急诊住院需求之间分配可用的住院床位。现有的入院控制方法在决策时往往排除了一些复杂因素,如不确定的床位容量和未知的病人到达和离开的真实概率分布。我们的目标是创建一个数据驱动的新闻供应商框架来研究择期急诊入院控制问题,以实现床位运营的效率和效益:我们开发了一种数据驱动方法,利用新闻供应商框架来制定入院控制问题。我们还创建了近似算法,以生成候选入院控制解决方案库。过去的观察结果以及相关的急诊需求和床位容量特征都在新闻供应商框架中进行了建模。利用近似算法方法(样本平均近似、分离估计和优化、线性编程-LP 和无分布模型),我们得出了计算效率高的数据驱动解决方案,并对样本内和样本外的预期成本保证了严格的约束:分别针对 LP 算法和二次编程(QP)算法,得出了基于特征模型的预期样本外成本的严格广义界限。结果表明,就预期成本而言,基于特征的最优模型优于基于观测的最优模型。在单位超计划成本高于单位计划不足成本的情况下,安排较少的择期病人将取代在模型中加入相关特征的好处。择期病人的可用床位越紧张,基于特征的模型与基于观察的模型之间的排班成本差异就越大:该研究为在床位容量和急诊需求真实概率分布未知的条件下,选科病人和急诊病人之间床位容量分配的理论研究提供了参考,同时也证明了近似最优策略具有良好的性能。
{"title":"A data-driven newsvendor model for elective-emergency admission control under uncertain inpatient bed capacity","authors":"Wenwu Shen,&nbsp;Le Luo,&nbsp;Li Luo,&nbsp;Lin Zhang,&nbsp;Ting Zhu","doi":"10.1111/jebm.12599","DOIUrl":"10.1111/jebm.12599","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Elective-emergency admission control referred to allocating available inpatient bed capacity between elective and emergency hospitalization demand. Existing approaches for admission control often excluded several complex factors when making decisions, such as uncertain bed capacity and unknown true probability distributions of patient arrivals and departures. We aimed to create a data-driven newsvendor framework to study the elective-emergency admission control problem to achieve bed operational efficiency and effectiveness.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We developed a data-driven approach that utilized the newsvendor framework to formulate the admission control problem. We also created approximation algorithms to generate a pool of candidate admission control solutions. Past observations and relevant emergency demand and bed capacity features were modeled in a newsvendor framework. Using approximation algorithmic approaches (sample average approximation, separated estimation and optimization, linear programing-LP, and distribution-free model) allowed us to derive computationally efficient data-driven solutions with tight bounds on the expected in-sample and out-of-sample cost guaranteed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Tight generalization bounds on the expected out-of-sample cost of the feature-based model were derived with respect to the LP and quadratic programing (QP) algorithms, respectively. Results showed that the optimal feature-based model outperformed the optimal observation-based model with respect to the expected cost. In a setting where the unit overscheduled cost was higher than the unit under-scheduled cost, scheduling fewer elective patients would replace the benefit of incorporating related features in the model. The tighter the available bed capacity for elective patients, the bigger the difference of the schedule cost between the feature-based model and the observation-based model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The study provides a reference for the theoretical study on bed capacity allocation between elective and emergency patients under the condition of the unknown true probability distribution of bed capacity and emergency demand, and it also proves that the approximate optimal policy has good performance.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 1","pages":"78-85"},"PeriodicalIF":7.3,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140175067","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}
引用次数: 0
An evidence-based guideline on treating lumbar disc herniation with traditional Chinese medicine 中药治疗腰椎间盘突出症循证指南
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-19 DOI: 10.1111/jebm.12598
Xiaokuan Qin, Kai Sun, Weiguo Xu, Jinghua Gao, Hong Jiang, Wei Chen, Ling Zhang, Zhenhua Li, Wuyin Li, Puwei Yuan, Kexin Yang, Peijian Tong, Yuanming Zhong, Xiaofeng Zhu, Xiaoming Wan, Chengjian He, Yanguo Wang, Xilin Xu, Yong Huang, Zhihai Zhang, Yifei Huang, Wei Guo, Junling Cao, Tianxiao Feng, Xu Wang, Yuhui Yin, Hao Wang, Chuanrui Sun, Xiangyu Xiao, Xu Wei, Liguo Zhu

Background

Lumbar disc herniation (LDH), as one of the most common causes of lower back pain, imposes a heavy economic burden on patients and society. Conservative management is the first-line choice for the majority of LDH patients. Traditional Chinese medicine (TCM) is an important part of conservative treatment and has attracted more and more international attention.

Study design

Evidence-based guideline.

Methods

We formed a guideline panel of multidisciplinary experts. The clinical questions were identified on the basis of a systematic literature search and a consensus meeting. We searched the literature for direct evidence on the management of LDH and assessed its certainty-generated recommendations using the grading of recommendations, assessment, development, and evaluation (GRADE) approach.

Results

The guideline panel made 20 recommendations, which covered the use of Shentong Zhuyu decoction, Shenzhuo decoction, Simiao San decoction, Duhuo Jisheng decoction, Yaobitong capsule, Yaotongning capsule, Osteoking, manual therapy, needle knife, manual acupuncture, electroacupuncture, Chinese exercise techniques (Tai Chi, Baduanjin, or Yijinjing), and integrative medicine, such as combined non-steroidal anti-inflammatory drugs, neural nutrition, and traction. Recommendations were either strong or weak, or in the form of ungraded consensus-based statement.

Conclusion

This is the first LDH treatment guideline for TCM and integrative medicine with a systematic search, synthesis of evidence, and using the GRADE method to rate the quality of evidence. We hope these recommendations can help support healthcare workers caring for LDH patients.

背景腰椎间盘突出症(LDH)是导致下背部疼痛的最常见原因之一,给患者和社会造成了沉重的经济负担。保守治疗是大多数腰椎间盘突出症患者的一线选择。研究设计基于证据的指南方法我们成立了一个由多学科专家组成的指南小组。在系统性文献检索和共识会议的基础上确定了临床问题。我们检索了有关 LDH 管理的直接证据文献,并采用建议、评估、发展和评价分级法(GRADE)对其确定性进行了评估。结果指南专家组提出了20条建议,涵盖了神通竹茹汤、神效汤、四妙散、独活寄生汤、瑶必通胶囊、瑶通宁胶囊、Osteoking、手工疗法、针刀、手工针灸、电针治疗等、针刀、手工针灸、电针、中医运动技术(太极拳、八段锦或易筋经),以及综合医学,如联合非甾体抗炎药、神经营养和牵引。结论:这是第一份通过系统检索、证据综述和使用 GRADE 方法对证据质量进行评级的中医和中西医结合 LDH 治疗指南。我们希望这些建议能为医护人员治疗 LDH 患者提供帮助。
{"title":"An evidence-based guideline on treating lumbar disc herniation with traditional Chinese medicine","authors":"Xiaokuan Qin,&nbsp;Kai Sun,&nbsp;Weiguo Xu,&nbsp;Jinghua Gao,&nbsp;Hong Jiang,&nbsp;Wei Chen,&nbsp;Ling Zhang,&nbsp;Zhenhua Li,&nbsp;Wuyin Li,&nbsp;Puwei Yuan,&nbsp;Kexin Yang,&nbsp;Peijian Tong,&nbsp;Yuanming Zhong,&nbsp;Xiaofeng Zhu,&nbsp;Xiaoming Wan,&nbsp;Chengjian He,&nbsp;Yanguo Wang,&nbsp;Xilin Xu,&nbsp;Yong Huang,&nbsp;Zhihai Zhang,&nbsp;Yifei Huang,&nbsp;Wei Guo,&nbsp;Junling Cao,&nbsp;Tianxiao Feng,&nbsp;Xu Wang,&nbsp;Yuhui Yin,&nbsp;Hao Wang,&nbsp;Chuanrui Sun,&nbsp;Xiangyu Xiao,&nbsp;Xu Wei,&nbsp;Liguo Zhu","doi":"10.1111/jebm.12598","DOIUrl":"10.1111/jebm.12598","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Lumbar disc herniation (LDH), as one of the most common causes of lower back pain, imposes a heavy economic burden on patients and society. Conservative management is the first-line choice for the majority of LDH patients. Traditional Chinese medicine (TCM) is an important part of conservative treatment and has attracted more and more international attention.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study design</h3>\u0000 \u0000 <p>Evidence-based guideline.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We formed a guideline panel of multidisciplinary experts. The clinical questions were identified on the basis of a systematic literature search and a consensus meeting. We searched the literature for direct evidence on the management of LDH and assessed its certainty-generated recommendations using the grading of recommendations, assessment, development, and evaluation (GRADE) approach.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The guideline panel made 20 recommendations, which covered the use of Shentong Zhuyu decoction, Shenzhuo decoction, Simiao San decoction, Duhuo Jisheng decoction, Yaobitong capsule, Yaotongning capsule, Osteoking, manual therapy, needle knife, manual acupuncture, electroacupuncture, Chinese exercise techniques (Tai Chi, Baduanjin, or Yijinjing), and integrative medicine, such as combined non-steroidal anti-inflammatory drugs, neural nutrition, and traction. Recommendations were either strong or weak, or in the form of ungraded consensus-based statement.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This is the first LDH treatment guideline for TCM and integrative medicine with a systematic search, synthesis of evidence, and using the GRADE method to rate the quality of evidence. We hope these recommendations can help support healthcare workers caring for LDH patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":"17 1","pages":"187-206"},"PeriodicalIF":7.3,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12598","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140165797","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}
引用次数: 0
Handling time-varying treatments in observational studies: A scoping review and recommendations 在观察性研究中处理时变治疗:范围界定审查和建议
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-19 DOI: 10.1111/jebm.12600
Jiayue Xu, Qiao He, Mingqi Wang, Mei Liu, Qianrui Li, Yan Ren, Minghong Yao, Guowei Li, Kevin Lu, Kang Zou, Wen Wang, Xin Sun

Objective

Time-varying treatments are common in observational studies. However, when assessing treatment effects, the methodological framework has not been systematically established for handling time-varying treatments. This study aimed to examine the current methods for dealing with time-varying treatments in observational studies and developed practical recommendations.

Methods

We searched PubMed from 2000 to 2021 for methodological articles about time-varying treatments, and qualitatively summarized the current methods for handling time-varying treatments. Subsequently, we developed practical recommendations through interactive internal group discussions and consensus by a panel of external experts.

Results

Of the 36 eligible reports (22 methodological reviews, 10 original studies, 2 tutorials and 2 commentaries), most examined statistical methods for time-varying treatments, and only a few discussed the overarching methodological process. Generally, there were three methodological components to handle time-varying treatments. These included the specification of treatment which may be categorized as three scenarios (i.e., time-independent treatment, static treatment regime, or dynamic treatment regime); definition of treatment status which could involve three approaches (i.e., intention-to-treat, per-protocol, or as-treated approach); and selection of analytic methods. Based on the review results, a methodological workflow and a set of practical recommendations were proposed through two consensus meetings.

Conclusions

There is no consensus process for assessing treatment effects in observational studies with time-varying treatments. Previous efforts were dedicated to developing statistical methods. Our study proposed a stepwise workflow with practical recommendations to assist the practice.

目标时变治疗在观察性研究中很常见。然而,在评估治疗效果时,尚未系统地建立处理时变治疗的方法框架。本研究旨在考察目前在观察性研究中处理时变治疗的方法,并提出切实可行的建议。方法我们检索了 2000 年至 2021 年在 PubMed 上发表的有关时变治疗的方法学文章,并对目前处理时变治疗的方法进行了定性总结。结果在 36 篇符合条件的报告(22 篇方法学综述、10 篇原创研究、2 篇教程和 2 篇评论)中,大多数报告都研究了时变治疗的统计方法,只有少数报告讨论了总体方法过程。一般来说,处理时变处理的方法有三个组成部分。其中包括治疗的具体化,可分为三种情况(即与时间无关的治疗、静态治疗制度或动态治疗制度);治疗状态的定义,可涉及三种方法(即意向治疗、按方案治疗或按治疗方法);以及分析方法的选择。根据审查结果,通过两次共识会议提出了方法学工作流程和一系列实用建议。以前的研究致力于开发统计方法。我们的研究提出了一个循序渐进的工作流程和实用建议,以协助实践。
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引用次数: 0
Risk of myocarditis after three doses of COVID-19 mRNA vaccines in the United States, 2020–2022: A self-controlled case series study 2020-2022 年美国接种三剂 COVID-19 mRNA 疫苗后患心肌炎的风险:一项自控病例系列研究。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-17 DOI: 10.1111/jebm.12595
Daoyuan Lai, Dickson Lim, Junfeng Lu, Han Wang, Tao Huang, Yan Dora Zhang

Aim

Myocarditis is a recognized safety concern following COVID-19 mRNA vaccination. However, there is limited research quantifying the risk associated with the third dose or comparing the risk between the three doses. The US Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system that monitors rare adverse events after US-licensed vaccination. However, studies analyzing VAERS data have often faced criticism for underreporting cases and lacking a control group to assess the increase in baseline risk.

Methods

The temporal association between myocarditis onset and COVID-19 vaccination was studied. To overcome limitations, a novel modified self-controlled case series method was employed, explicitly modeling the case reporting process in VAERS data.

Results

We found an increased risk of myocarditis during the 1- to 3-day period following the second and third doses of both the BNT162b2 vaccine and the mRNA-1273 vaccine. Following the second dose, the relative incidence (RI) was 4.89 (95% confidence interval (CI), 2.39–10.08) for the BNT162b2 vaccine and 2.86 (95% CI: 1.18–7.03) for the mRNA-1273 vaccine. Similarly, following the third dose, the RI was 9.04 (95% CI: 2.79–40.99) for the BNT162b2 vaccine and 4.71 (95% CI: 1.42–19.09) for the mRNA-1273 vaccine. No significant increase in risk was observed during other periods. Notably, our analysis also identified a similar increased risk of myocarditis among individuals aged below 30.

Conclusions

These findings raise safety concerns regarding COVID-19 mRNA vaccines, provide insights into the quantification of myocarditis risk at different postvaccination periods, and offer a novel approach to interpreting passive surveillance system data.

目的:COVID-19 mRNA 疫苗接种后,心肌炎是公认的安全问题。然而,量化第三剂疫苗相关风险或比较三剂疫苗之间风险的研究十分有限。美国疫苗不良事件报告系统 (VAERS) 是一个被动监测系统,用于监测美国许可疫苗接种后的罕见不良事件。然而,分析 VAERS 数据的研究常常受到批评,因为这些研究低报了病例,而且缺乏对照组来评估基线风险的增加:方法:研究了心肌炎发病与接种 COVID-19 疫苗之间的时间关联。结果:我们发现心肌炎发病与接种 COVID-19 疫苗之间存在时间关联:结果:我们发现,在接种第二剂和第三剂 BNT162b2 疫苗和 mRNA-1273 疫苗后的 1-3 天内,心肌炎的风险增加。接种第二剂后,BNT162b2 疫苗的相对发病率 (RI) 为 4.89(95% 置信区间 (CI):2.39-10.08),mRNA-1273 疫苗的相对发病率 (RI) 为 2.86(95% 置信区间 (CI):1.18-7.03)。同样,接种第三剂后,BNT162b2 疫苗的 RI 为 9.04(95% CI:2.79-40.99),mRNA-1273 疫苗的 RI 为 4.71(95% CI:1.42-19.09)。其他时期的风险没有明显增加。值得注意的是,我们的分析还发现年龄在 30 岁以下的人患心肌炎的风险也有类似的增加:这些发现引起了人们对 COVID-19 mRNA 疫苗安全性的关注,为量化接种后不同时期的心肌炎风险提供了见解,并为解释被动监测系统数据提供了一种新方法。
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引用次数: 0
Osteopathic manipulative treatment for chronic inflammatory diseases 针对慢性炎症性疾病的整骨疗法。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-15 DOI: 10.1111/jebm.12590
Ross Gillan, Gabrielle Bachtel, Kassidy Webber, Yasmine Ezzair, Nicole E. Myers, Anupam Bishayee

Chronic inflammatory diseases (CIDs) are debilitating and potentially lethal illnesses that affect a large proportion of the global population. Osteopathic manipulative treatment (OMT) is a manual therapy technique developed and performed by osteopathic physicians that facilitates the body's innate healing processes. Therefore, OMT may prove a beneficial anti-inflammatory modality useful in the management and treatment of CIDs. This work aims to objectively evaluate the therapeutic benefits of OMT in patients with various CIDs. In this review, a structured literature search was performed. The included studies involving asthma, chronic obstructive pulmonary disease, irritable bowel syndrome, ankylosing spondylitis, and peripheral arterial disease were selected for this work. Various OMT modalities, including lymphatic, still, counterstain, and muscle energy techniques, were utilized. Control treatments included sham techniques, routine care, or no treatment. OMT utilization led to variable patient outcomes in individuals with pathologies linked to CID.

慢性炎症性疾病(CID)是一种使人衰弱并可能致命的疾病,影响着全球大部分人口。骨科手法治疗(OMT)是由骨科医生开发和实施的一种手法治疗技术,可促进人体的内在愈合过程。因此,整骨疗法可能被证明是一种有益的抗炎方式,可用于 CID 的管理和治疗。本研究旨在客观评估 OMT 对各种 CID 患者的治疗效果。在本综述中,我们进行了结构化文献检索。本研究选择了涉及哮喘、慢性阻塞性肺病、肠易激综合征、强直性脊柱炎和外周动脉疾病的研究。研究中使用了各种 OMT 方式,包括淋巴、静止、反沾和肌肉能量技术。对照治疗包括假技术、常规护理或不治疗。对于患有与 CID 相关病症的患者来说,使用 OMT 可带来不同的治疗效果。
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引用次数: 0
Effects of folic acid supplementation on cognitive impairment: A meta-analysis of randomized controlled trials 叶酸补充剂对认知障碍的影响:随机对照试验荟萃分析。
IF 7.3 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-03-11 DOI: 10.1111/jebm.12588
Manru Xu, Yue Zhu, Jinxin Chen, Jie Li, Jingbo Qin, Yiran Fan, Pan Ren, Huixue Hu, Wenbin Wu
<div> <section> <h3> Objective</h3> <p>With the increasing number of patients with cognitive impairment, nonpharmacological ways to delay cognitive impairment have attracted people's attention, such as lifestyle changes and nutritional supplementation. Folic acid supplementation appears to be a promising treatment option. However, it remains controversial whether folic acid supplementation is effective in delaying adult's cognitive impairment. Therefore, we conducted a meta-analysis to analyze the effects of folic acid supplementation on different cognitive impairments.</p> </section> <section> <h3> Methods</h3> <p>We systematically searched PubMed, Web of Science, EMbase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), WanFang and VIP databases for randomized controlled trials on January 22, 2024. The included population comprised those diagnosed with cognitive impairment. We included trials that compared folic acid treatment with placebo, other dosing regimens, or other intervention controls. Conducting quality evaluation of included studies according to the Cochrane Risk of Bias tool. Statistical analyses were performed using Review Manager software.</p> </section> <section> <h3> Results</h3> <p>Twenty-two trials, including 3604 participants, met inclusion criteria. Compared with controls, the cognitive function of Alzheimer's disease (AD) patients showed improvement with folic acid supplementation: supplementation with < 3 mg (standardized mean differences (SMD) = 0.15, 95% confidence interval (CI) –0.10 to 0.41), and supplementing with ≥ 3 mg folic acid could improve cognitive function in AD patients (SMD = 1.03, 95% CI 0.18 to 1.88). Additionally, it reduced homocysteine (HCY) levels (mean differences (MD) = –4.74, 95% CI –8.08 to –1.39). In mild cognitive impairment (MCI) patients, cognitive function improved with folic acid supplementation: supplementation with > 400 μg (SMD = 0.38, 95% CI 0.13 to 0.63), and supplementation with ≤ 400 μg (SMD = 1.10, 95% CI 0.88 to 1.31). It also reduced HCY levels at intervention ≤ 6 months (MD = –3.93, 95% CI –5.05 to –2.82) and intervention > 6 months (MD = –4.38, 95% CI –5.15 to –3.61). However, supplementing with folic acid did not improve cognitive function in vascular cognitive impairment (VCI) patients, with folic acid supplements < 3 mg (SMD = –0.07, 95% CI –0.23 to –0.08), folic acid supplements ≥ 3 mg (SMD = 0.46, 95% CI –0.57 to 1.49), however, it reduced HCY levels at intervention > 6 months (MD = –5.91, 95% CI –7.13 to –4.69) and intervention ≤ 6 months (MD = –11.15, 95% CI –12.35 to –9.95).</p> </section> <section> <h3> Conclusions</h3>
目的:随着认知障碍患者人数的不断增加,延缓认知障碍的非药物方法引起了人们的关注,如改变生活方式和补充营养。补充叶酸似乎是一种很有前景的治疗方法。然而,补充叶酸是否能有效延缓成人认知功能障碍仍存在争议。因此,我们进行了一项荟萃分析,分析补充叶酸对不同认知障碍的影响:2024年1月22日,我们系统地检索了PubMed、Web of Science、EMbase、Cochrane Central Register of Controlled Trials、中国国家知识基础设施(CNKI)、万方数据库和VIP数据库中的随机对照试验。纳入人群包括确诊为认知障碍的患者。我们纳入了将叶酸治疗与安慰剂、其他剂量方案或其他干预对照进行比较的试验。根据 Cochrane 偏倚风险工具对纳入的研究进行质量评估。使用Review Manager软件进行统计分析:22项试验(包括3604名参与者)符合纳入标准。与对照组相比,补充叶酸可改善阿尔茨海默病(AD)患者的认知功能:补充 400 μg(SMD = 0.38,95% CI 0.13 至 0.63),补充 ≤ 400 μg(SMD = 1.10,95% CI 0.88 至 1.31)。它还能降低干预≤6个月时的HCY水平(MD = -3.93,95% CI -5.05至-2.82)和干预>6个月时的HCY水平(MD = -4.38,95% CI -5.15至-3.61)。然而,补充叶酸并不能改善血管性认知障碍(VCI)患者的认知功能,叶酸补充6个月(MD = -5.91,95% CI -7.13至-4.69)和干预≤6个月(MD = -11.15,95% CI -12.35至-9.95):补充叶酸对MCI患者的认知状况有益,补充≥3毫克叶酸可改善AD患者的认知功能。
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引用次数: 0
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Journal of Evidence‐Based Medicine
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