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Characteristics of Vaccine Safety Observational Studies and Authors' Attitudes: A Systematic Review. 疫苗安全性观察研究的特点与作者的态度:系统回顾。
IF 4.6 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-16 DOI: 10.1016/j.amjmed.2024.10.007
Mariana Barosa, Vinay Prasad

Background: Postlicensure observational studies are the mainstay of vaccine safety evaluation. However, these studies have well-known methodological limitations, rendering them particularly vulnerable to unmeasured confounding. We sought to describe high-impact observational studies of vaccine safety, investigate the authors' attitudes toward their study's findings and limitations, and report on spin practices.

Methods: We conducted a PubMed systematic review of comparative observational studies of vaccine safety published in the 6 top medical journals from inception to March 2024.

Results: Thirty-seven studies were included, spanning publications from 1995 to 2024. Most studies focused on COVID-19 and influenza vaccines (n = 11, 30%, and n = 10, 27%, respectively). Study designs and methodologies varied. Electronic health records (54%), passive surveillance databases (32%), and national registries (27%) were the most common data sources. Negative control outcomes were used in a single study. Residual confounding was conceded in 54% of studies, and an additional 24% did so implicitly. Spin was noted in 48.6% of the studies. This systematic review found that authors of observational vaccine safety studies in high-impact medical journals often acknowledge residual confounding, but rarely use methods like negative control outcomes to better detect unmeasured confounding. Furthermore, spin is common, occurring in approximately 50% of the studies.

Conclusions: Although our findings are somewhat limited by subjectivity in study assessments, they suggest that editors and reviewers of high-impact journals should ensure that the language used in reporting observational studies accurately reflects the findings and their limitations.

背景:许可后观察研究是疫苗安全性评估的主要方法。然而,这些研究在方法上存在众所周知的局限性,因此特别容易受到未测量混杂因素的影响。我们试图描述对疫苗安全性影响较大的观察性研究,调查作者对其研究结果和局限性的态度,并报告具体做法:我们在 Pubmed 上对六种顶级医学期刊上发表的疫苗安全性比较观察研究进行了系统综述,研究时间从开始到 2024 年 3 月:结果:共纳入 37 项研究,发表时间跨度为 1995 年至 2024 年。大多数研究侧重于 COVID19 和流感疫苗(分别为 11 项,占 30% 和 10 项,占 27%)。研究设计和方法各不相同。电子健康记录(54%)、被动监测数据库(32%)和国家登记处(27%)是最常见的数据来源。有一项研究使用了阴性对照结果。54%的研究承认存在残余混杂因素,另有24%的研究默认存在残余混杂因素。48.6%的研究注意到了旋转。本系统综述发现,在影响力较大的医学期刊上发表的观察性疫苗安全性研究报告的作者通常承认存在残余混杂因素,但很少使用阴性对照结果等方法来更好地检测未测量的混杂因素。此外,自旋现象也很常见,约有 50%的研究出现了这种情况:尽管我们的研究结果在一定程度上受到了研究评估主观性的限制,但它们表明,影响力大的期刊的编辑和审稿人应确保在报道观察性研究时使用的语言能准确反映研究结果及其局限性。
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引用次数: 0
In the Pursuit of Immortality, Who is Sitting at the Table? 在追求永生的过程中,谁坐在桌边?
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-16 DOI: 10.1016/j.amjmed.2024.09.015
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引用次数: 0
The Burden of Heart Failure in the Obese Patient 肥胖患者心力衰竭的负担。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-16 DOI: 10.1016/j.amjmed.2024.05.019
Oscar M.P. Jolobe MRCP(UK)
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引用次数: 0
The Reply 答复是
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-16 DOI: 10.1016/j.amjmed.2024.08.030
Harpreet Singh MD, Deba Prasad Dhibar MD
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引用次数: 0
Disseminated Herpes Zoster in an Immunocompromised Patient: Challenges for Preventing Transmission Before Diagnosis. 免疫力低下患者的播散性带状疱疹:诊断前预防传播的挑战。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-15 DOI: 10.1016/j.amjmed.2024.10.010
Shiori Kitaya, Reina Iyobe, Hajime Kanamori
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引用次数: 0
Unraveling Tuberculosis: An Atypical Tuberculous Presentation. 揭开结核病的神秘面纱:非典型肺结核表现。
IF 4.6 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-15 DOI: 10.1016/j.amjmed.2024.10.014
Genevieve M Y Tan, Ying Na Ho, Glenn K W Yong
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引用次数: 0
Effectiveness of Audit and Feedback and Academic Detailing Interventions to Support Safer Opioid Prescribing in Primary Care. 审计与反馈和学术细化干预措施在支持基层医疗机构更安全地开具阿片类药物处方方面的效果。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-15 DOI: 10.1016/j.amjmed.2024.09.017
Meagan Lacroix, Fred Abdelmalek, Karl Everett, Monica Taljaard, Lena Salach, Lindsay Bevan, Victoria Burton, Hui Jia, Jennifer Shuldiner, Celia Laur, Emily Nicholas Angl, Noah M Ivers, Mina Tadrous

Background: Opioids, prescribed to manage pain, are associated with safety risks. Quality improvement strategies such as audit and feedback and academic detailing may improve prescribing in primary care.

Methods: We used a matched-cohort design with claims databases. Participants were family physicians practicing in Ontario, Canada. The interventions were a voluntary audit and feedback report with or without academic detailing sessions. Physicians in the control group received neither intervention. The primary outcome was mean rate of high-risk opioid prescriptions per 100 patients per month. Data were analyzed comparing monthly percentage change in slope over 12 months before and 18 months after the intervention. Additional analyses considered only the subgroup of higher-prescribing physicians.

Results: There were 1469 (25%) physicians in the audit and feedback group, 245 (4%) in the audit and feedback + academic detailing group, and 4211 (71%) matched controls. All groups showed a significant preintervention decline in opioid prescribing. There were no significant between-group differences in opioid prescribing postintervention. Among high-prescribing physicians, there was a significant reduction in the audit and feedback group (% change in slope = -0.37, 95% CI = -0.65 to -0.09, P < .01), but not in the academic detailing group (% change in slope = 0.19, 95% CI = -0.52 to 0.91, P = .59).

Conclusions: This study demonstrated declining secular trends in prescribing and suggests that two large-scale initiatives had limited additional benefits. We found some additional reductions after audit and feedback among the highest-volume opioid prescribers. Future interventions should focus on these physicians for the greatest benefit.

背景:阿片类药物是用于控制疼痛的处方药,存在安全风险。质量改进策略(如审计和反馈以及学术细节)可改善初级医疗处方:方法:我们利用索赔数据库进行了匹配队列设计。方法:我们利用索赔数据库进行了配对队列设计,参与者为在加拿大安大略省执业的家庭医生。干预措施包括自愿审计和反馈报告,以及或不包括学术详述课程。对照组的医生没有接受任何干预。主要结果是每月每 100 名患者的高风险阿片类药物处方平均率。对数据进行了分析,比较了干预前 12 个月和干预后 18 个月的每月百分比变化。附加分析仅考虑了处方量较高的医生亚组:审计和反馈组有 1469 名医生(25%),审计和反馈+学术细节组有 245 名医生(4%),匹配对照组有 4211 名医生(71%)。所有组的阿片类药物处方量在干预前都有明显下降。干预后阿片类药物处方量在组间无明显差异。在高处方量医生中,审计和反馈组的处方量明显减少(斜率变化百分比 = -0.37,95%CI = -0.65 至 -0.09,p < 0.01),但学术细节组的处方量没有明显减少(斜率变化百分比 = 0.19,95%CI = -0.52 至 0.91,p = .59):本研究显示了处方量下降的长期趋势,并表明两项大规模举措带来的额外益处有限。我们发现,在对阿片类药物处方量最大的医生进行审核和反馈后,处方量有了一定程度的减少。未来的干预措施应侧重于这些医生,以获得最大收益。
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引用次数: 0
Rethinking Our Roots: The Ground-Up Approach to Heart Health & Planetary Sustainability. 反思我们的根源:从根本上实现心脏健康和地球的可持续发展。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-09 DOI: 10.1016/j.amjmed.2024.09.028
Ali Saad, Eric J Brandt, Kamil F Faridi, Jeremy W Paster, Sohum Sheth, Andrew M Freeman, Verity Ramirez, Monica Aggarwal

Cardiovascular disease is the leading cause of death in the United States. Poor dietary habits are not only a major modifiable risk factor for cardiovascular disease and other chronic illnesses, but they also harm planetary health. Our food system is complex, shaped by agricultural practices and human behaviors. To change it, we need to understand why current agricultural practices exist and address nutrition education, food insecurity, and nutritional security. There are effective ways to make our food system healthier, more equitable, and more sustainable. The best available evidence points to plant-forward diets as the keystone to this complex issue. This manuscript reviews how human and planetary health are connected through our food system and suggests solutions for diets that prevent and treat cardiovascular disease while promoting planetary health.

心血管疾病是美国人的主要死因。不良的饮食习惯不仅是心血管疾病和其他慢性疾病的主要可改变风险因素,而且还会损害地球健康。我们的食物系统非常复杂,是由农业实践和人类行为形成的。要改变它,我们需要了解当前农业实践存在的原因,并解决营养教育、粮食不安全和营养安全问题。有一些有效的方法可以让我们的粮食系统更健康、更公平、更可持续。现有的最佳证据表明,植物性饮食是解决这一复杂问题的关键。本手稿回顾了人类健康和地球健康是如何通过我们的食物系统联系在一起的,并提出了既能预防和治疗心血管疾病,又能促进地球健康的饮食解决方案。
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引用次数: 0
The Four Ts of Mentoring Minorities. 指导少数族裔的四个T。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-05 DOI: 10.1016/j.amjmed.2024.10.001
Smita Pakhale
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引用次数: 0
Increased Risk of Chronic Respiratory Disease among Individuals with Inflammatory Bowel Disease in a Prospective Cohort Study. 在一项前瞻性队列研究中,炎症性肠病患者罹患慢性呼吸道疾病的风险增加。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-05 DOI: 10.1016/j.amjmed.2024.09.001
Lintao Dan, Ying Xie, Tian Fu, Yuhao Sun, Xuejie Chen, Xiaoyan Wang, Chenkai Wu, Jie Chen, Xue Li

Background: Cross-sectional evidence suggests a higher burden of chronic respiratory diseases in people with inflammatory bowel disease, but there is a lack of prospective evidence to clarify the direction of their associations. We aimed to investigate the association of inflammatory bowel disease with the risk of 2 major chronic respiratory diseases, chronic obstructive pulmonary disease, and asthma.

Methods: We included 430,414 participants from UK Biobank and followed them from recruitment (2006-2010) to 2021. Chronic obstructive pulmonary disease and asthma cases were obtained from inpatient data and death register. Using Cox proportional hazards models, we estimated the multivariable-adjusted hazard ratios (HR) of developing chronic obstructive pulmonary disease and asthma in participants with inflammatory bowel disease compared with inflammatory bowel disease-free groups. We also investigated the association among Crohn's disease and ulcerative colitis with the risk of chronic obstructive pulmonary disease and asthma.

Results: Over a median follow-up of 11.9 years, there were 11,196 incidents of chronic obstructive pulmonary disease and 9831 asthma cases. The adjusted HRs of developing chronic obstructive pulmonary disease (HR 1.54; 95% confidence interval [CI], 1.33-1.79) and asthma (HR 1.52; 95% CI, 1.29-1.79) were higher for those with inflammatory bowel disease when compared with inflammatory bowel disease-free participants. Participants with Crohn's disease and ulcerative colitis were also found to have a higher risk of chronic obstructive pulmonary disease (Crohn's disease: HR 1.71; 95% CI, 1.36-2.15; ulcerative colitis: HR 1.45; 95% CI, 1.20-1.75) and asthma (Crohn's disease: HR 1.73; 95% CI, 1.33-2.25; ulcerative colitis: HR 1.41; 95% CI, 1.15-1.73) when compared with those free of inflammatory bowel disease.

Conclusions: This study suggested that individuals with inflammatory bowel disease have a higher risk of developing chronic obstructive pulmonary disease and asthma, highlighting the importance of preventing chronic respiratory diseases among inflammatory bowel disease patients.

背景:横断面证据表明,炎症性肠病患者的慢性呼吸道疾病负担较重,但缺乏前瞻性证据来明确两者之间的关联方向。目的:研究炎症性肠病与慢性阻塞性肺病和哮喘这两种主要慢性呼吸道疾病风险之间的关联:我们纳入了英国生物库中的 430,414 名参与者,并对他们进行了从招募(2006-2010 年)到 2021 年的跟踪调查。慢性阻塞性肺病和哮喘病例来自住院病人数据和死亡登记。我们使用 Cox 比例危险模型估算了与无炎症性肠病组相比,患有炎症性肠病的参与者罹患慢性阻塞性肺病和哮喘的多变量调整危险比 (HR)。我们还调查了克罗恩病和溃疡性结肠炎与慢性阻塞性肺病和哮喘风险之间的关系:在中位 11.9 年的随访期间,共有 11196 例慢性阻塞性肺病和 9831 例哮喘。与无炎症性肠病的参与者相比,患有炎症性肠病的参与者罹患慢性阻塞性肺病(HR=1.54,95% CI:1.33-1.79)和哮喘(HR=1.52,95% CI:1.29-1.79)的调整后HR值更高。研究还发现,患有克罗恩病和溃疡性结肠炎的参与者罹患慢性阻塞性肺病的风险更高(克罗恩病:HR=1.71;95% CI:1.29-1.79):HR=1.71;95% CI:1.36-2.15;溃疡性结肠炎:HR=1.45;95% CI:1.20-1.75)和哮喘(克罗恩病:与无炎症性肠病的人相比,哮喘(克罗恩病:HR=1.73;95%CI:1.33-2.25;溃疡性结肠炎:HR=1.41;95%CI:1.15-1.73)的发病率更高:这项研究表明,炎症性肠病患者罹患慢性阻塞性肺病和哮喘的风险较高,这凸显了炎症性肠病患者预防慢性呼吸系统疾病的重要性。
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American Journal of Medicine
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