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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 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.10.007
Mariana Barosa MD, MSc , Vinay Prasad MD, MPH

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
Fitz-Hugh–Curtis Syndrome 菲茨-休-柯蒂斯综合征
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.10.008
Kosuke Ishizuka MD, PhD, FHGM , Yoshiyuki Ohira MD, PhD , Mitsuyasu Ohta MD, PhD
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引用次数: 0
Progressive Nontraumatic Facial and Truncal Purpura 进行性非外伤性面部和躯干紫癜。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.10.013
Esther Choi BS , Simran Chadha MD , Lida Zheng MD
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引用次数: 0
Latin America's Battle Against Antibiotic Resistance and Cancer: A Call to Action. 拉丁美洲抗击抗生素耐药性和癌症的斗争:行动呼吁。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2025.01.027
Ismar A Rivera-Olivero, Nikolaos C Kyriakidis
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引用次数: 0
High Incidence of Autonomic Dysfunction and Postural Orthostatic Tachycardia Syndrome in Patients with Long COVID: Implications for Management and Health Care Planning 长COVID患者自主神经功能障碍和体位性心动过速综合征的高发:对管理和卫生保健计划的影响
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2023.06.010
Marie-Claire Seeley MNurs , Celine Gallagher PhD , Eric Ong BMedSci , Amy Langdon BHealthSci , Jonathan Chieng BHealthMedSci , Danielle Bailey BHealthMedSci , Amanda Page PhD , Han S. Lim MBBS, PhD , Dennis H. Lau MBBS, PhD

Background

Autonomic dysfunction, including postural orthostatic tachycardia syndrome (POTS), has been reported in individuals with post-acute sequelae of COVID-19 (PASC). However, the degree of dysautonomia in PASC has not been compared to those with POTS and healthy controls.

Methods

All participants were prospectively enrolled between August 5, 2021 and October 31, 2022. Autonomic testing included beat-to-beat hemodynamic monitoring to assess respiratory sinus arrhythmia, Valsalva ratio, and orthostatic changes during a 10-minute active standing test, as well as sudomotor assessment. The Composite Autonomic Symptom Score (COMPASS-31) was used to assess symptoms and the EuroQuol 5-Dimension survey (EQ-5D-5L) was used to assess health-related quality of life (HrQoL) measures.

Results

A total of 99 participants (n = 33 PASC, n = 33 POTS, and n = 33 healthy controls; median age 32 years, 85.9% females) were included. Compared with healthy controls, the PASC and POTS cohorts demonstrated significantly reduced respiratory sinus arrhythmia (P < .001), greater heart rate increase during 10-minute active standing test (P < .001), greater burden of autonomic dysfunction evidenced by higher COMPASS-31 scores across all subdomains (all P < .001), and poor HrQoL across all EQ-5D-5L domains (all P < .001), lower median EuroQol-visual analogue scale (P < .001), and lower utility scores (P < .001). The majority (79%) of those with PASC met the internationally established criteria for POTS.

Conclusion

The prevalence of autonomic symptomology for POTS was high in those with PASC, leading to poor HrQoL and high health disutility. Autonomic testing should be routinely undertaken in those with PASC to aid diagnosis and direct appropriate management to improve health outcomes.
背景:自主神经功能障碍,包括体位性站立性心动过速综合征(POTS),已在COVID-19急性后后遗症(PASC)患者中报道。然而,PASC患者的自主神经异常程度尚未与POTS患者和健康对照进行比较。方法:所有参与者在2021年8月5日至2022年10月31日期间前瞻性入组。自主神经测试包括搏动血流动力学监测,以评估呼吸窦性心律失常、Valsalva比率和10分钟主动站立测试期间的直立变化,以及压迫性运动评估。综合自主神经症状评分(COMPASS-31)用于评估症状,EuroQuol 5维调查(EQ-5D-5L)用于评估健康相关生活质量(HrQoL)措施。结果:共有99名参与者(n = 33 PASC, n = 33 POTS和n = 33健康对照);中位年龄32岁,85.9%为女性)。与健康对照组相比,PASC和POTS组呼吸窦性心律失常明显减少(P < 0.001), 10分钟活动站立试验期间心率增加(P < 0.001),自主神经功能障碍负担加重,所有子域的COMPASS-31评分较高(均P < 0.001),所有EQ-5D-5L域的HrQoL较差(均P < 0.001), euroqol -视觉模拟量表中位数较低(P < 0.001),效用评分较低(P < 0.001)。大多数PASC患者(79%)符合国际公认的POTS标准。结论:PASC患者盆腔自主神经症状的发生率高,导致HrQoL差,健康负效用高。在PASC患者中应常规进行自主神经测试,以帮助诊断和指导适当的管理,以改善健康结果。
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引用次数: 0
Association of Sedentary Lifestyle with Risk of Acute and Post-Acute COVID-19 Sequelae: A Retrospective Cohort Study 久坐不动的生活方式与 COVID-19 急性和急性后遗症风险的关系:回顾性队列研究
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2023.12.002
Chen Zheng PhD , Wendy Ya-Jun Huang PhD , Feng-Hua Sun PhD , Martin Chi-Sang Wong MD , Parco Ming-Fai Siu PhD , Xiang-Ke Chen PhD , Stephen Heung-Sang Wong PhD

Background

Evidence suggests that coronavirus disease 2019 (COVID-19) survivors could experience COVID-19 sequelae. Although various risk factors for COVID-19 sequelae have been identified, little is known about whether a sedentary lifestyle is an independent risk factor.

Methods

In this retrospective cohort study, 4850 participants self-reported their COVID-19 sequelae symptoms between June and August 2022. A sedentary lifestyle included physical inactivity (<150 min/week of moderate-to-vigorous intensity physical activity) and prolonged sedentary behavior (≥10 h/day) before the fifth COVID-19 wave was recorded. Logistic regression analysis was performed to determine the relationships between sedentary lifestyle and risk of acute and post-acute (lasting ≥2 months) COVID-19 sequelae.

Results

A total of 1443 COVID-19 survivors and 2962 non-COVID-19 controls were included. Of the COVID-19 survivors, >80% and >40% self-reported acute and post-acute COVID-19 sequelae, respectively. In the post-acute phase, COVID-19 survivors who were physically inactive had a 37% lower risk of insomnia, whereas those with prolonged sedentary behavior had 25%, 67%, and 117% higher risks of at least one symptom, dizziness, and “pins and needles” sensation, respectively. For the acute phase, prolonged sedentary behavior was associated with a higher risk of fatigue, “brain fog,” dyspnea, muscle pain, joint pain, dizziness, and “pins and needles” sensation. Notably, sedentary behavior, rather than physical inactivity, was correlated with a higher risk of severe post-COVID-19 sequelae in both acute and post-acute phases.

Conclusions

Prolonged sedentary behavior was independently associated with a higher risk of both acute and post-acute COVID-19 sequelae, whereas physical inactivity played contradictory roles in COVID-19 sequelae.
背景有证据表明,2019 年冠状病毒病(COVID-19)幸存者可能会出现 COVID-19 后遗症。方法在这项回顾性队列研究中,4850名参与者自我报告了他们在2022年6月至8月期间出现的COVID-19后遗症症状。研究记录了第五次COVID-19波前的久坐生活方式,包括缺乏运动(每周150分钟中等至剧烈运动)和长期久坐(每天≥10小时)。结果 共纳入了 1,443 名 COVID-19 存活者和 2,962 名非 COVID-19 对照者。在COVID-19幸存者中,分别有80%和40%的人自述患有COVID-19急性和急性期后遗症。在COVID-19后遗症的急性期,不运动的COVID-19幸存者出现失眠的风险降低了37%,而长期久坐的幸存者出现至少一种症状、头晕和 "针刺 "感的风险分别增加了25%、67%和117%。在急性期,长期久坐与疲劳、"脑雾"、呼吸困难、肌肉疼痛、关节疼痛、头晕和 "针刺 "感的风险较高有关。值得注意的是,无论是在急性期还是在急性期后,久坐行为而非不运动都与 COVID-19 后严重后遗症的更高风险相关。结论长期久坐行为与 COVID-19 急性期和急性期后后遗症的更高风险独立相关,而不运动则在 COVID-19 后遗症中起着相互矛盾的作用。
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引用次数: 0
Lipid Profiling in Obesity: The Limitations of the Friedewald Equation 肥胖症的血脂分析:弗里德瓦尔德方程的局限性
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.09.011
Haoyi Zheng MD, PhD
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引用次数: 0
Asymptomatic Eosinophilia in Travelers: Perseverance is Key! 旅行者中的无症状嗜酸性粒细胞增多症:坚持不懈是关键!
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.09.029
Oula Itani MD , Lucie Kuhmel MD , Nicolas Etienne MD , Paul Henri Consigny MD
{"title":"Asymptomatic Eosinophilia in Travelers: Perseverance is Key!","authors":"Oula Itani MD ,&nbsp;Lucie Kuhmel MD ,&nbsp;Nicolas Etienne MD ,&nbsp;Paul Henri Consigny MD","doi":"10.1016/j.amjmed.2024.09.029","DOIUrl":"10.1016/j.amjmed.2024.09.029","url":null,"abstract":"","PeriodicalId":50807,"journal":{"name":"American Journal of Medicine","volume":"138 2","pages":"Pages 214-216"},"PeriodicalIF":2.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142378549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Environmental Neurotoxins and a Neurodegenerative Outbreak: Diagnosis Requires Specific Sampling Knowledge 环境神经毒素与神经退行性疾病爆发:诊断需要特定的采样知识。
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.08.033
Arnold R. Eiser MD, MACP
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引用次数: 0
The Reply
IF 2.5 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-02-01 DOI: 10.1016/j.amjmed.2024.10.027
Tyler J. Albert MD , Paul B. Cornia MD
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引用次数: 0
期刊
American Journal of Medicine
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