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。
{"title":"Financial conflicts of interest during meetings of the cardiovascular and renal drugs advisory committee","authors":"Blake Bertolino, N. Kinder, Craig M. Cooper, Harrison M Gray, Wade Arthur, Joseph Ahlander, A. Simpson, M. Vassar","doi":"10.1515/jom-2021-0226","DOIUrl":"https://doi.org/10.1515/jom-2021-0226","url":null,"abstract":"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.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"30 1","pages":"445 - 451"},"PeriodicalIF":0.0,"publicationDate":"2022-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84356928","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}
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。
{"title":"Investigating the safety and feasibility of osteopathic medicine in the pediatric oncology outpatient setting","authors":"J. Belsky, J. Stanek, M. Rose","doi":"10.1515/jom-2021-0246","DOIUrl":"https://doi.org/10.1515/jom-2021-0246","url":null,"abstract":"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.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"5 1","pages":"423 - 429"},"PeriodicalIF":0.0,"publicationDate":"2022-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74543216","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}
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
{"title":"The psychological burden associated with Ehlers-Danlos syndromes: a systematic review","authors":"M. Kennedy, Katherine Loomba, Hira Ghani, B. Riley","doi":"10.1515/jom-2021-0267","DOIUrl":"https://doi.org/10.1515/jom-2021-0267","url":null,"abstract":"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","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"5 1","pages":"381 - 392"},"PeriodicalIF":0.0,"publicationDate":"2022-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79984722","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}
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.
{"title":"Addressing disparities in medicine through medical curriculum change: a student perspective","authors":"Amina Kureshi, Scott Landman, M. Ahmed, O. Savinova, Diane Becker","doi":"10.1515/jom-2021-0033","DOIUrl":"https://doi.org/10.1515/jom-2021-0033","url":null,"abstract":"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.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"470 1","pages":"353 - 357"},"PeriodicalIF":0.0,"publicationDate":"2022-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73421646","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}
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.
{"title":"Response to “Standardization of osteopathic manipulative treatment in telehealth settings to maximize patient outcomes and minimize adverse effects”","authors":"Joanna L. Kramer, Kathleen de Asis","doi":"10.1515/jom-2022-0055","DOIUrl":"https://doi.org/10.1515/jom-2022-0055","url":null,"abstract":"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.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"119 1","pages":"379 - 379"},"PeriodicalIF":0.0,"publicationDate":"2022-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77483246","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}
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.
{"title":"Overcoming reward deficiency syndrome by the induction of “dopamine homeostasis” instead of opioids for addiction: illusion or reality?","authors":"K. Blum, Diwanshu Soni, R. Badgaiyan, D. Baron","doi":"10.1515/jom-2021-0026","DOIUrl":"https://doi.org/10.1515/jom-2021-0026","url":null,"abstract":"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.","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"8 1","pages":"333 - 337"},"PeriodicalIF":0.0,"publicationDate":"2022-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85358506","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}
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).
{"title":"Xeroderma pigmentosum presenting in two siblings from Uganda","authors":"Austin B. Ambur, Timothy A. Nyckowski","doi":"10.1515/jom-2022-0039","DOIUrl":"https://doi.org/10.1515/jom-2022-0039","url":null,"abstract":"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).","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"13 1","pages":"487 - 488"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79277569","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}
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
{"title":"The impact of COVID-19 on otolaryngology research: a cross-sectional analysis of discontinued trials","authors":"Brayden Rucker, Nicholas B. Sajjadi, L. Brame, M. Vassar, M. Hartwell","doi":"10.1515/jom-2021-0278","DOIUrl":"https://doi.org/10.1515/jom-2021-0278","url":null,"abstract":"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","PeriodicalId":16639,"journal":{"name":"Journal of Osteopathic Medicine Journal of Osteopathic Medicine","volume":"10 1","pages":"393 - 399"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90046026","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}
{"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}
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.
{"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}