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Financial conflicts of interest during meetings of the cardiovascular and renal drugs advisory committee 心血管和肾脏药物咨询委员会会议期间的财务利益冲突
Pub Date : 2022-04-21 DOI: 10.1515/jom-2021-0226
Blake Bertolino, N. Kinder, Craig M. Cooper, Harrison M Gray, Wade Arthur, Joseph Ahlander, A. Simpson, M. Vassar
Abstract Context The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the Food and Drug Administration (FDA) reviews safety and efficacy data for cardiovascular and renal drugs, ultimately making recommendations to the Commissioner of Food and Drugs for approval. The Open Public Hearing segment of these meetings allows for patients, advocates, healthcare professionals, clinical trialists, and members of the public to provide testimony, which often results in expressing their preference for, or against, drug approval. Prior to providing testimony, the public speakers are highly encouraged to disclose any financial conflicts of interest (FCOIs) with the sponsor or other groups. Given the potential influence of these speakers on drug approval recommendations, we investigated the industry associations disclosed by public speakers in the Open Public Hearing section of the CRDAC meetings. Previous studies, such as one done by Lurie et al. indicated that positive testimony is tied to a higher likelihood of drug approval, and because drug companies provide financial compensation for speakers to provide testimony in general, we wanted to determine the likelihood with which speakers who have an FCOI provided a positive testimony vs. those without any FCOI. Objectives The purpose is to evaluate whether public speakers with an FCOI are more likely to provide positive testimony regarding the drug in question during the CRDAC of the FDA between February 2009 and December 2019 through the use of publicly available transcripts. Methods Independent researchers investigated public transcripts and minutes of the CRDAC meetings with public speakers (n=20). We identified all speakers, along with characteristics such as an FCOI, and classified statements utilizing a pilot-tested Google form. The data collected were analyzed utilizing Stata. The speaker’s testimony was then compared with their FCOI. An ordered logistic regression was performed utilizing the speaker’s testimony regarding the drug as the dependent variable. Results Of the 88 speakers represented in our sample, 35 (35/88, 39.8%) disclosed an FCOI, most commonly regarding travel cost. Among speakers with an FCOI, 30 (30/35, 85.7%) spoke positively. Speakers with an FCOI were 4.96 times more likely to provide positive testimony (OR=4.96, 95% CI 1.67–14.78). Speakers with the disease were also more likely to provide positive testimony (OR=13.05, 95% CI 2.84–59.93). Conclusions Public speakers often play a role during meetings, and they may also have an FCOI, most commonly related to travel expenses. Our study shows that speakers with an FCOI are more likely to provide positive testimony. Stipulations, such as requiring disclosure of FCOI and randomizing the selection process of speakers, can help ensure the integrity of the drug approval process.
美国食品和药物管理局(FDA)的心血管和肾脏药物咨询委员会(CRDAC)审查心血管和肾脏药物的安全性和有效性数据,最终向食品和药物管理局局长提出批准建议。这些会议的公开听证会部分允许患者、倡导者、医疗保健专业人员、临床试验人员和公众成员提供证词,这通常导致表达他们对药物批准的偏好或反对。在提供证词之前,强烈鼓励公众演讲者披露与赞助商或其他团体的任何财务利益冲突(FCOIs)。鉴于这些演讲者对药物批准建议的潜在影响,我们调查了在CRDAC会议公开听证会部分公开演讲者披露的行业协会。先前的研究,如Lurie等人所做的研究表明,积极的证词与更高的药物批准可能性有关,并且由于制药公司通常会为提供证词的演讲者提供经济补偿,因此我们想确定具有FCOI的演讲者与没有FCOI的演讲者提供积极证词的可能性。目的是评估在2009年2月至2019年12月FDA CRDAC期间,通过使用公开的转录本,具有FCOI的公开演讲者是否更有可能提供有关药物的正面证词。方法独立研究者调查了公开的CRDAC会议记录和公开演讲者会议记录(n=20)。我们确定了所有的发言者,以及FCOI等特征,并使用经过试点测试的谷歌表单对陈述进行分类。使用Stata分析收集的数据。然后将演讲者的证词与他们的FCOI进行比较。利用说话人关于药物的证词作为因变量,进行了有序逻辑回归。在我们的样本中,88位发言者中有35位(35/88,39.8%)披露了FCOI,最常见的是差旅费用。在有FCOI的发言者中,30人(30/35,85.7%)积极发言。具有FCOI的讲话者提供正面证词的可能性高出4.96倍(OR=4.96, 95% CI 1.67-14.78)。患有该疾病的讲话者也更有可能提供积极的证词(OR=13.05, 95% CI 2.84-59.93)。公众演讲者经常在会议中发挥作用,他们也可能有FCOI,最常见的是与差旅费有关。我们的研究表明,有FCOI的说话者更有可能提供积极的证词。规定,如要求披露FCOI和随机选择发言者的过程,可以帮助确保药品审批过程的完整性。
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引用次数: 1
Investigating the safety and feasibility of osteopathic medicine in the pediatric oncology outpatient setting 探讨骨科药物在儿科肿瘤科门诊的安全性和可行性
Pub Date : 2022-04-15 DOI: 10.1515/jom-2021-0246
J. Belsky, J. Stanek, M. Rose
Abstract Context Pediatric patients receiving chemotherapy experience unwanted therapy-induced side effects, commonly constipation and pain that diminish quality of life. To date, few studies have investigated the safety and feasibility of osteopathic manipulative treatment (OMT) in pediatric oncology. Objectives The primary objective of this study is to investigate the safety and feasibility of OMT in pediatric oncology outpatient clinics. Methods This is a single institutional pilot study evaluating children aged ≥2–21 years receiving chemotherapy for an oncological diagnosis at Nationwide Children’s Hospital (NCH). Permission was obtained from the NCH Institutional Review Board. Participants were enrolled for 8 weeks and received weekly OMT. OMT was deemed feasible by participating in six out of eight weekly treatments, and safety was assessed through adverse event grading per Common Terminology Criteria for Adverse Events (CTCAE). During the clinic visit, patients answered validated surveys on constipation (Bristol Stool Scale) and pain (FACES Scale) pre/post-OMT. Feasibility was analyzed utilizing a one-sided exact binomial test while validated tools and adverse events were summarized descriptively. Results A total of 23 patients were enrolled, with 21 included in feasibility analyses. The majority of the patients were female (n=13, 61.9%), with a median age of 12 years at enrollment (range, 2.7–20.8 years). There were no serious adverse events attributed to OMT intervention, and among the patients assessed for feasibility, 100% of them participated in at least two-thirds of their weekly OMT treatments, meeting our defined feasibility criteria. The intervention lasted an average of 14.2 min (range, 7.2–19.2 min). There were no FACES or Bristol Stool Scale scores that correlated with worsening pain on constipation post-OMT intervention. Conclusions Pediatric oncology patients were feasibly and safely able to receive OMT during a regularly scheduled chemotherapy visit. The limitations include the small sample size. These findings support the need to further investigate the safety and feasibility, as well as efficacy, of OMT in the pediatric oncology clinical setting.
接受化疗的儿科患者会经历意想不到的治疗引起的副作用,通常是便秘和疼痛,从而降低生活质量。迄今为止,很少有研究调查骨科手法治疗(OMT)在小儿肿瘤学中的安全性和可行性。本研究的主要目的是探讨OMT在儿科肿瘤门诊的安全性和可行性。方法:这是一项单一机构的试点研究,评估≥2-21岁的儿童在全国儿童医院(NCH)接受肿瘤诊断的化疗。已获得NCH机构审查委员会的许可。参与者入组8周,每周接受OMT治疗。通过参加每周8次治疗中的6次,OMT被认为是可行的,并且通过不良事件通用术语标准(CTCAE)的不良事件分级来评估安全性。在门诊访问期间,患者回答了omt前后便秘(Bristol大便量表)和疼痛(FACES量表)的有效调查。利用单侧精确二项检验分析可行性,同时描述性地总结验证工具和不良事件。结果共纳入23例患者,其中21例纳入可行性分析。大多数患者为女性(n=13,占61.9%),入组时中位年龄为12岁(范围为2.7-20.8岁)。没有严重的不良事件归因于OMT干预,在可行性评估的患者中,100%的患者参加了每周至少三分之二的OMT治疗,符合我们确定的可行性标准。干预时间平均为14.2 min (7.2-19.2 min)。没有面部或布里斯托大便量表评分与omt干预后便秘疼痛加重相关。结论儿科肿瘤患者在定期化疗期间接受OMT是可行且安全的。局限性包括样本量小。这些发现支持了进一步研究OMT在儿科肿瘤学临床环境中的安全性、可行性和有效性的必要性。
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引用次数: 0
The psychological burden associated with Ehlers-Danlos syndromes: a systematic review 与Ehlers-Danlos综合征相关的心理负担:一项系统综述
Pub Date : 2022-04-14 DOI: 10.1515/jom-2021-0267
M. Kennedy, Katherine Loomba, Hira Ghani, B. Riley
Abstract Context Ehlers-Danlos syndromes (EDS) are disorders of connective tissue that lead to a wide range of clinical presentations. While we are beginning to understand the association between EDS and psychological manifestations, it is critical that we further elucidate the relationship between the two. Understanding the correlation between EDS and mental health will better ensure swift diagnosis and effective treatment for patients. Objectives This study aims to systematically examine and report the prevalence of psychiatric disorders in the EDS population. Methods The PubMed database was searched on June 14, 2021 for articles published from January 2011 to June 2021. We included original, evidence-based, peer-reviewed journal articles in English that reported information on psychiatric disorders among EDS patients. Psychiatric disorders and psychological conditions were limited to those included in the “psychology” and “mental disorders” Medical Subject Headings (MeSH) search terms defined by the National Library of Medicine. Publications identified utilizing this search strategy by M.K. were imported into the Covidence system, where they first underwent a title and abstract screening process by three independent reviewers (M.K., K.L., H.G.). During the full-text review, two independent reviewers read the full text of the questionable articles to assess their eligibility for inclusion. Studies were excluded if they did not meet our target objective or if they were not in English or if they were opinion pieces, conference abstracts, or review articles. Data were extracted from the shortlisted studies by reviewers. During the data extraction phase, the quality and risk of publication bias were assessed by two independent reviewers utilizing the National Institutes of Health (NIH) Study Quality Assessment Tools. Any disagreements in study selection, data extraction, or quality assessment were adjudicated via discussion between the two reviewers, utilizing a third reviewer as a decider if necessary. Results Out of 73 articles identified, there were no duplicates. A total of 73 records were screened, but only 40 articles were assessed in full text for eligibility. A total of 23 articles were ultimately included, which collectively discussed 12,298 participants. Ten (43.5%) of the included studies were cross-sectional in design, three (13.0%) were case reports, and three (13.0%) were retrospective chart reviews. The remaining seven (30.4%) articles were either case-control, cohort, qualitative, controlled observational, or validation studies. Twelve (52.2%) of the studies reported data on depression disorders, six of which reported prevalence data. Nine (39.1%) of the studies reported data on anxiety disorders, five of which reported prevalence data. Studies that reported nonprevalence data presented odds-ratio, mean scores on psychiatric evaluations, and other correlation statistics. Psychiatric disorders that were most reported in these article
ehers - danlos综合征(EDS)是一种导致广泛临床表现的结缔组织疾病。当我们开始了解EDS和心理表现之间的联系时,进一步阐明两者之间的关系是至关重要的。了解EDS与心理健康之间的关系将更好地确保对患者的快速诊断和有效治疗。目的本研究旨在系统地调查和报告EDS人群中精神疾病的患病率。方法于2021年6月14日检索PubMed数据库,检索2011年1月至2021年6月发表的文章。我们收录了原创的、循证的、同行评议的英文期刊文章,这些文章报道了EDS患者的精神疾病信息。精神障碍和心理状况仅限于国家医学图书馆定义的“心理学”和“精神障碍”医学主题标题(MeSH)搜索词中包含的那些。M.K.利用该搜索策略确定的出版物被导入到covid系统中,首先由三位独立审稿人(M.K.、k.l.、H.G.)对其进行标题和摘要筛选。在全文审查期间,两名独立审稿人阅读了有问题文章的全文,以评估其纳入资格。如果研究不符合我们的目标目标,或者它们不是英文的,或者它们是评论文章、会议摘要或评论文章,我们将其排除在外。数据由审稿人从入围研究中提取。在数据提取阶段,由两名独立审稿人利用美国国立卫生研究院(NIH)研究质量评估工具评估论文的质量和发表偏倚风险。在研究选择、数据提取或质量评估方面的任何分歧均通过两位审稿人的讨论来裁决,必要时可以利用第三位审稿人作为决定者。结果共鉴定73篇文献,无重复。总共筛选了73份记录,但只有40篇文章的全文被评估为合格。最终共收录了23篇文章,共讨论了12298名参与者。纳入的研究中有10项(43.5%)为横断面设计,3项(13.0%)为病例报告,3项(13.0%)为回顾性图表回顾。其余7篇(30.4%)文章为病例对照、队列、定性、对照观察性或验证性研究。12项(52.2%)研究报告了抑郁症的数据,其中6项报告了患病率数据。9项(39.1%)研究报告了焦虑症的数据,其中5项报告了患病率数据。报告非流行数据的研究呈现了优势比、精神病学评估的平均得分和其他相关统计。这些文章中报道最多的精神疾病是情绪障碍(n=11)、焦虑症(n=9)和神经发育障碍(n=7)。尽管报告各不相同,EDS患者中最高的精神病学患病率报告包括语言障碍(63.2%)、注意缺陷/多动障碍(ADHD)(52.4%)、焦虑(51.2%)、学习障碍(42.4%)和抑郁(30.2%)。结论:虽然情绪障碍在更多的文章中被引用,但据报道患病率最高的是语言障碍和多动症。这种差异凸显了开展更多研究以更好地理解EDS与精神疾病之间关系的重要性。
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引用次数: 2
Addressing disparities in medicine through medical curriculum change: a student perspective 通过医学课程改革解决医学差异:学生视角
Pub Date : 2022-04-13 DOI: 10.1515/jom-2021-0033
Amina Kureshi, Scott Landman, M. Ahmed, O. Savinova, Diane Becker
Abstract Cultural competency training has been a focus of medical schools for some time. An essential step in developing culturally competent physicians, effective cultural competency training has previously been researched at medical schools. Before forming a diversity task force to head cultural competency training, one medical school utilized medical student volunteers to review current teaching material and provide suggestions to increase cultural competency training. A study group consisting of three faculty members and 29 medical students was formed on a voluntary basis during the summer of 2020. Based on medical student opinion and reviewed teaching materials, learning tools were created to guide medical curricular updates. This experience resulted in the formation of four teaching tools: a didactic lecture checklist to include more diverse patient populations; case-based learning objectives that focus on social determinants of health; a facilitator question script to encourage group discussion and student feedback on the given clinical cases; and a student reflection form on the effects of race, gender, and socioeconomic status on patients and medical professionals in the clinical setting. Updating the medical school curriculum is a constant and ongoing process. Forming a diversity task force to guide these changes and regularly review medical teaching materials will help train physicians ready to care for a diverse patient population. In addition, the use of the suggested teaching tools may help guide the review process for such committees at other medical schools.
摘要文化能力培养一直是医学院校关注的焦点。在培养具有文化能力的医生方面,有效的文化能力培训是必不可少的一步,此前曾在医学院进行过研究。在成立一个领导文化能力培训的多元化工作组之前,一所医学院利用医学生志愿者审查当前的教材,并提出加强文化能力培训的建议。2020年夏季,在自愿的基础上成立了一个由三名教员和29名医学生组成的研究小组。根据医学生的意见和经审查的教材,创建了学习工具来指导医学课程的更新。这一经验导致了四种教学工具的形成:一种教学讲座清单,包括更多样化的患者群体;注重健康的社会决定因素的基于案例的学习目标;一个引导者问题脚本,以鼓励小组讨论和学生对给定临床病例的反馈;以及学生关于种族、性别和社会经济地位对患者和临床医疗专业人员的影响的反思形式。医学院课程的更新是一个持续不断的过程。组建一个多元化工作组来指导这些变化,并定期审查医学教材,这将有助于培训准备好照顾不同患者群体的医生。此外,使用建议的教学工具可能有助于指导其他医学院此类委员会的审查过程。
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引用次数: 1
Response to “Standardization of osteopathic manipulative treatment in telehealth settings to maximize patient outcomes and minimize adverse effects” 对“远程医疗环境中骨科手法治疗标准化以最大限度提高患者疗效和减少不良反应”的回应
Pub Date : 2022-04-13 DOI: 10.1515/jom-2022-0055
Joanna L. Kramer, Kathleen de Asis
We appreciate the authors’ interest [1] and enthusiasm for osteopathic interventions via telehealth and agree with their call for standardized guidelines to help improve the delivery of virtual osteopathic care. When these visits began [2], we were pivoting quickly from in-person to telehealth visits and trying to determine if osteopathic interventions via telehealth would be feasible. Given our early results, we absolutely recognize the need for more study of standardization and quality tools to assist patients and families with such visits. This need is highlighted by a systematic review conducted by Mani et al. [3] which revealed discrepancies in validity for certain musculoskeletal assessments conducted over telehealth. Cottrell and Russell [4] suggest several considerations for standardizing musculoskeletal therapy via telehealth including the use of frameworks and theories, clinical factors like physical location, clinician skill and experience, and systematic evaluations of the treatments. The study and development of such standardized protocols could allow for a better understanding of the efficacy of osteopathic interventions for specific musculoskeletal complaints. Additionally, consistent methods would lead to broader and safer application of osteopathic principles through a telehealth platform. We would be eager to collaborate in the future with any osteopathic leaders who might be interested in developing these tools.
我们赞赏作者对通过远程医疗进行整骨疗法干预的兴趣[1]和热情,并同意他们对标准化指南的呼吁,以帮助改善虚拟整骨疗法的提供。当这些访问开始[2]时,我们迅速从面对面访问转向远程医疗访问,并试图确定通过远程医疗进行整骨疗法干预是否可行。鉴于我们的早期结果,我们绝对认识到有必要对标准化和质量工具进行更多的研究,以帮助患者和家庭进行此类访问。Mani等人进行的一项系统综述强调了这一需求[3],该综述揭示了远程医疗中某些肌肉骨骼评估的有效性差异。Cottrell和Russell[4]提出了通过远程医疗标准化肌肉骨骼治疗的几个考虑因素,包括框架和理论的使用、物理位置等临床因素、临床医生的技能和经验,以及对治疗的系统评估。这种标准化方案的研究和发展可以让我们更好地了解骨科干预对特定肌肉骨骼疾病的疗效。此外,一致的方法将导致通过远程医疗平台更广泛和更安全地应用整骨疗法原理。我们渴望在未来与任何可能对开发这些工具感兴趣的整骨疗法领导者合作。
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引用次数: 0
Overcoming reward deficiency syndrome by the induction of “dopamine homeostasis” instead of opioids for addiction: illusion or reality? 通过诱导“多巴胺稳态”而不是阿片类药物成瘾来克服奖励缺乏症:幻觉还是现实?
Pub Date : 2022-04-12 DOI: 10.1515/jom-2021-0026
K. Blum, Diwanshu Soni, R. Badgaiyan, D. Baron
Abstract Many individuals in the United States are plagued by addiction, and the rate at which it is affecting people in the United States only seems to be increasing. Research shows that addiction is a preventable disorder rather than a flaw in one’s moral fiber. It is driven by the imbalance of dopamine and the brain’s reward system. Although medication-assisted treatment (MAT), the most common treatment for addiction, are effective in reducing harm, they provide minimal aid in addressing the root cause of this preventable disorder. The authors aim to convey that the proper treatment should help restore dopamine balance so the quality of life can be improved in the recovering community. Osteopathic principles emphasize the importance of homeostasis and allostasis in allowing the body to heal itself. Viewing reward deficiency syndrome (RDS) through this osteopathic lens can bring about treatments that aim to restore the dopamine homeostasis. The article discusses various potential therapeutic modalities that can provide dopamine homeostasis via activation of dopaminergic pathways.
在美国,许多人都受到成瘾的困扰,而且它影响美国人的速度似乎只会增加。研究表明,成瘾是一种可预防的疾病,而不是一个人道德品质的缺陷。它是由多巴胺和大脑奖励系统的不平衡所驱动的。虽然药物辅助治疗(MAT)是最常见的成瘾治疗方法,在减少伤害方面是有效的,但它们在解决这种可预防疾病的根本原因方面提供的帮助微乎其微。作者的目的是传达适当的治疗应该有助于恢复多巴胺平衡,从而改善康复社区的生活质量。整骨疗法的原理强调体内平衡和不平衡在让身体自愈中的重要性。通过这种整骨镜观察奖励缺乏症(RDS)可以带来旨在恢复多巴胺稳态的治疗。本文讨论了各种潜在的治疗方式,可以通过激活多巴胺能途径提供多巴胺稳态。
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引用次数: 4
Xeroderma pigmentosum presenting in two siblings from Uganda 来自乌干达的两个兄弟姐妹出现色素性干皮病
Pub Date : 2022-04-01 DOI: 10.1515/jom-2022-0039
Austin B. Ambur, Timothy A. Nyckowski
A 10-year-old female presented to our global health outreach clinic in Uganda in May 2018 for evaluation of progressive pigmentary changes on the face and severe visual impairment. Cutaneous examination revealed a large area of mottled hypopigmentation involving the central nose and upper cutaneous lip (Figure 1). Ocular examination revealed corneal opacities involving the bilateral eyes (Figure 1). The dyspigmentation began during infancy and her vision progressively worsened since age 6. Her 3-year-old brother accompanied her and was noted to have similar dyspigmentation involving the face that had been present since 1 year of age (Figure 2).
2018年5月,一名10岁女性来到我们在乌干达的全球健康外展诊所,接受面部进行性色素变化和严重视力障碍的评估。皮肤检查显示大面积斑点状低色素沉着,累及中央鼻和上皮唇(图1)。眼部检查显示双侧眼角膜混浊(图1)。色素沉着始于婴儿期,6岁后视力逐渐恶化。她3岁的弟弟陪同她,并注意到自1岁起就有类似的面部色素沉着(图2)。
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引用次数: 0
The impact of COVID-19 on otolaryngology research: a cross-sectional analysis of discontinued trials COVID-19对耳鼻喉科研究的影响:对已停止试验的横断面分析
Pub Date : 2022-04-01 DOI: 10.1515/jom-2021-0278
Brayden Rucker, Nicholas B. Sajjadi, L. Brame, M. Vassar, M. Hartwell
Abstract Context The COVID-19 pandemic has reduced the capacity to conduct medical research due to recruitment difficulties, supply chain shortages, and funding deficits. The clinical practice of otolaryngology was especially impacted due to a reduction in elective procedures, such as facial plastic surgeries and vocal fold injections. Objectives The primary objective was to examine the extent of clinical trial (CTs) disruption secondary to the COVID-19 pandemic in the field of otolaryngology. Methods On August 1, 2021, we conducted a systematic search utilizing ClinicalTrials.gov for CTs related to common otolaryngology disorders. We utilized the date range January 1, 2020 through August 1, 2021 to identify all trials potentially affected by the COVID-19 pandemic. Investigators performed screening and data extraction in a duplicate, masked fashion. Trials resulting from the search were extracted for trial status, condition treated, enrollment number, funding, study type, study design, last update posted date, and trial location. Trials that explicitly mentioned COVID-19 as a reason for discontinuation or suspension were coded as such. For trials that did not explicitly mention COVID-19, we coded the reason provided from ClinicalTrials.gov. The Oklahoma State University Center for Health Science Institutional Review Board determined that this project did not qualify as human subject research. Results A total of 1,777 CTs met the inclusion criteria, and 223 CTs were discontinued between January 1, 2020 and August 1, 2021. Thirty-three (14.8%) of the 223 CTs reported discontinuation explicitly due to the COVID-19 pandemic. The 33 studies had 1,715 participants enrolled in total. Among the primary interventions, 11 (33.3%) were devices, 10 (30.3%) were drugs, 5 (15.2%) were behavioral, 4 (12.1%) were diagnostic tests, 1 (3.0%) was dietary, and 2 (6.1%) were labeled as “other.” Regarding the CT location, 20 (60.6%) were conducted in the United States, and 13 (39.4%) were conducted internationally. Of the 33 CTs, 19 (57.6%) were suspended, 9 (27.3%) were terminated, and 5 (15.2%) were withdrawn. The overall most common reason for trial disruption was recruitment difficulties (24.2%). Median enrollment for discontinued trials due to COVID-19 was 37 (interquartile range [IQR], 19–71) and for other reasons was 6 (IQR, 0–27), for which the Mann–Whitney test showed a statistically significant difference between the two (z=−3.913, p<0.001). There were no significant associations between trial location, funding source, randomization, or whether a study involved masked vs unmasked participants. Conclusions The COVID-19 pandemic has incited an impact on clinical research in the field of otolaryngology. To preserve trial continuation amid future threats to participant interaction and communication, we recommend further exploration of remote monitoring practices and virtual procedures—those that will maintain the effectiveness and accuracy needed to establish no
新冠肺炎疫情导致科研人员招聘困难、供应链短缺、经费短缺等,降低了医学研究能力。耳鼻喉科的临床实践尤其受到影响,因为选择性手术的减少,如面部整形手术和声带注射。本研究的主要目的是研究2019冠状病毒病(COVID-19)大流行对耳鼻喉科临床试验(ct)中断的程度。方法于2021年8月1日,我们在ClinicalTrials.gov网站上对常见耳鼻喉科疾病相关的ct进行了系统检索。我们利用2020年1月1日至2021年8月1日的日期范围来确定所有可能受COVID-19大流行影响的试验。调查人员以重复的蒙面方式进行筛选和数据提取。从检索中提取试验状态、治疗条件、入组编号、资助、研究类型、研究设计、最后更新发布日期和试验地点。明确将COVID-19作为终止或暂停原因的试验被编码为此类试验。对于没有明确提到COVID-19的试验,我们编码了ClinicalTrials.gov提供的原因。俄克拉荷马州立大学健康科学中心机构审查委员会决定,该项目不符合人体实验研究的资格。结果共有1777例ct符合纳入标准,其中223例在2020年1月1日至2021年8月1日期间停用。223个ct中有33个(14.8%)报告明确因COVID-19大流行而中断。这33项研究共纳入了1715名参与者。在主要干预措施中,11项(33.3%)为设备,10项(30.3%)为药物,5项(15.2%)为行为,4项(12.1%)为诊断测试,1项(3.0%)为饮食,2项(6.1%)为“其他”。CT定位方面,20例(60.6%)在美国进行,13例(39.4%)在国际进行。33例ct中,19例(57.6%)被停职,9例(27.3%)被终止,5例(15.2%)被撤销。总体而言,试验中断最常见的原因是招聘困难(24.2%)。因COVID-19而中断的试验中位入组人数为37人(四分位数间距[IQR], 19-71),因其他原因而中断的试验中位入组人数为6人(四分位数间距[IQR], 0-27), Mann-Whitney检验显示两者之间存在统计学差异(z= - 3.913, p<0.001)。试验地点、资金来源、随机分组或研究是否涉及蒙面受试者与未蒙面受试者之间没有显著关联。结论新冠肺炎疫情对耳鼻喉科临床研究产生了影响。为了在未来对参与者互动和沟通的威胁中保持试验的继续,我们建议进一步探索远程监测实践和虚拟程序——这些将保持建立新疗法所需的有效性和准确性。我们鼓励未来的试验来衡量哪些远程评估显示出最大的有效性,其长期目标是建立能够抵御未来流行病的创新研究设计。
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引用次数: 2
Idiopathic linear IgA bullous dermatosis with mucosal involvement 特发性线状IgA大疱性皮肤病伴粘膜受累
Pub Date : 2022-04-01 DOI: 10.1515/jom-2022-0036
Austin B. Ambur, Timothy A. Nyckowski
{"title":"Idiopathic linear IgA bullous dermatosis with mucosal involvement","authors":"Austin B. Ambur, Timothy A. Nyckowski","doi":"10.1515/jom-2022-0036","DOIUrl":"https://doi.org/10.1515/jom-2022-0036","url":null,"abstract":"","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"11 1","pages":"375 - 376"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88396803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prevention of external auditory canal exostosis in the Colorado whitewater community 科罗拉多州白水社区外耳道外生性增生的预防
Pub Date : 2022-03-31 DOI: 10.1515/jom-2021-0252
Annalise E. Wille, V. Pazdernik, Nicole Sassounian, K. Glaser
Abstract Context External auditory canal exostoses (EACE) are bony formations that develop insidiously in the auditory meatus from chronic exposure to cold water and, in severe cases, require surgery. This condition has been understudied in the whitewater kayakers and not yet studied in the riverboarding population. Precautions such as earplugs are thought to prevent the formation of EACE because they mechanically block cold water from contacting the sensitive skin in the external auditory canal; however, earplugs are not commonly utilized by athletes. Inquiring about hobbies and the use of protective equipment can be done during osteopathic physicians’ preventive care visits. Objectives This article aims to determine the prevalence of EACE in Colorado whitewater athletes and their attitudes about wearing ear protection before and after an educational intervention directed at increasing awareness and prevention of EACE. Methods In July 2020, participants of this cross-sectional study completed a 10-min survey that collected demographics, whitewater experience, and perceptions of EACE, followed by an educational intervention. Participant ears were photographed utilizing a digital otoscope to assess EACE, and severity ratings were categorized into one of four occlusion levels: none (0%), mild (<25%), moderate (25–75%), or severe (>75%). Spearman correlation coefficients and Wilcoxon signed-rank tests were utilized to assess changes in attitudes before and after the educational intervention. Results Eighty-one participants (mean [SD] age = 36.3 [12.6] years, 25.9% female) completed the study: 74 kayakers and seven riverboarders. After the intervention, 60.5% (49/81) (p<0.001) reported greater understanding of EACE and 75.0% (60/80) were more likely to wear ear protection (p<0.001). Most (58.0%, 47/81) never wore ear protection. Of the 61 (75.0%) participants with at least one ear severity rating, most (55.7%, 34/61) had moderate EACE, 29.5% (18/61) had no to mild EACE, and 14.8% (9/61) had severe EACE (p<0.001). Impaired hearing was the biggest barrier to utilizing ear protection (51.6%, 33/64). Conclusions Our results suggested that the educational intervention improved understanding of EACE and may increase utilization of ear protection in this population. Such prevention efforts may lead to better health of whitewater paddlers by reducing the incidence of EACE. Encouraging osteopathic physicians to inquire about hobbies and protective equipment during primary care preventive visits is essential to help keep athletes in the river doing what they love for longer, contributing to a healthier and happier whole person.
摘要背景外耳道外露(EACE)是由于长期暴露在冷水中而在听道中隐性发展的骨形成,严重者需要手术治疗。这种情况在激流皮划艇运动员中尚未得到充分研究,而在河板人群中尚未得到研究。耳塞等预防措施被认为可以防止EACE的形成,因为它们可以机械地阻止冷水接触外耳道敏感的皮肤;然而,运动员通常不使用耳塞。在骨科医生的预防性护理访问期间,可以询问爱好和防护设备的使用情况。本文旨在确定科罗拉多州激流运动员中EACE的患病率,以及他们在旨在提高EACE意识和预防的教育干预前后对佩戴耳罩的态度。在2020年7月,这项横断面研究的参与者完成了一项10分钟的调查,收集了人口统计数据、白水经历和对EACE的看法,然后进行了教育干预。使用数字耳镜对参与者的耳朵进行拍照以评估EACE,并将严重程度分为四种闭塞程度之一:无(0%),轻度(75%)。采用Spearman相关系数和Wilcoxon符号秩检验评估教育干预前后态度的变化。81名参与者(平均[SD]年龄= 36.3[12.6]岁,25.9%为女性)完成了研究:74名皮划艇运动员和7名河板运动员。干预后,60.5% (49/81)(p<0.001)表示对EACE有了更深入的了解,75.0%(60/80)表示更有可能佩戴耳罩(p<0.001)。大多数(58.0%,47/81)从未戴过护耳。在61名(75.0%)至少有一个耳朵严重程度评分的参与者中,大多数(55.7%,34/61)为中度EACE, 29.5%(18/61)为无至轻度EACE, 14.8%(9/61)为重度EACE (p<0.001)。听力受损是使用护耳的最大障碍(51.6%,33/64)。结论教育干预提高了该人群对EACE的认识,并可能增加耳部保护的使用。这种预防措施可以通过减少EACE的发病率来改善激流桨手的健康状况。鼓励骨科医生在初级保健预防性访问期间询问他们的爱好和防护装备,这对于帮助运动员在河里做他们喜欢的事情更长时间是至关重要的,有助于成为一个更健康、更快乐的人。
{"title":"Prevention of external auditory canal exostosis in the Colorado whitewater community","authors":"Annalise E. Wille, V. Pazdernik, Nicole Sassounian, K. Glaser","doi":"10.1515/jom-2021-0252","DOIUrl":"https://doi.org/10.1515/jom-2021-0252","url":null,"abstract":"Abstract Context External auditory canal exostoses (EACE) are bony formations that develop insidiously in the auditory meatus from chronic exposure to cold water and, in severe cases, require surgery. This condition has been understudied in the whitewater kayakers and not yet studied in the riverboarding population. Precautions such as earplugs are thought to prevent the formation of EACE because they mechanically block cold water from contacting the sensitive skin in the external auditory canal; however, earplugs are not commonly utilized by athletes. Inquiring about hobbies and the use of protective equipment can be done during osteopathic physicians’ preventive care visits. Objectives This article aims to determine the prevalence of EACE in Colorado whitewater athletes and their attitudes about wearing ear protection before and after an educational intervention directed at increasing awareness and prevention of EACE. Methods In July 2020, participants of this cross-sectional study completed a 10-min survey that collected demographics, whitewater experience, and perceptions of EACE, followed by an educational intervention. Participant ears were photographed utilizing a digital otoscope to assess EACE, and severity ratings were categorized into one of four occlusion levels: none (0%), mild (<25%), moderate (25–75%), or severe (>75%). Spearman correlation coefficients and Wilcoxon signed-rank tests were utilized to assess changes in attitudes before and after the educational intervention. Results Eighty-one participants (mean [SD] age = 36.3 [12.6] years, 25.9% female) completed the study: 74 kayakers and seven riverboarders. After the intervention, 60.5% (49/81) (p<0.001) reported greater understanding of EACE and 75.0% (60/80) were more likely to wear ear protection (p<0.001). Most (58.0%, 47/81) never wore ear protection. Of the 61 (75.0%) participants with at least one ear severity rating, most (55.7%, 34/61) had moderate EACE, 29.5% (18/61) had no to mild EACE, and 14.8% (9/61) had severe EACE (p<0.001). Impaired hearing was the biggest barrier to utilizing ear protection (51.6%, 33/64). Conclusions Our results suggested that the educational intervention improved understanding of EACE and may increase utilization of ear protection in this population. Such prevention efforts may lead to better health of whitewater paddlers by reducing the incidence of EACE. Encouraging osteopathic physicians to inquire about hobbies and protective equipment during primary care preventive visits is essential to help keep athletes in the river doing what they love for longer, contributing to a healthier and happier whole person.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"12 1","pages":"431 - 437"},"PeriodicalIF":0.0,"publicationDate":"2022-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76949335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of Osteopathic Medicine Journal of Osteopathic Medicine
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