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Identification and Comparison of Patient Characteristics for Those Hospitalized with COVID-19 versus Influenza Using Machine Learning in a Commercially Insured US Population. 在美国商业保险人群中使用机器学习识别和比较COVID-19和流感住院患者的患者特征
IF 8.9 Pub Date : 2021-04-23 eCollection Date: 2021-01-01 DOI: 10.2147/POR.S304220
Xiaoxue Chen, Zhi Wang, Samantha G Bromfield, Andrea DeVries, David Pryor, Vincent Willey
Background The novel severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019 (COVID–19), continues to spread in the US through the 2020–2021 influenza season and beyond. Approaches to identify those most at risk for poor outcomes for the two viral infections are needed for future planning. As influenza is a well-known respiratory disease sharing some similarities to COVID-19, such comparison will aid physicians and health systems to predict disease trajectory and allocate health resources most efficiently. A retrospective cohort study using a French national administrative database found that patients hospitalized with COVID-19 were more frequently obese or overweight, diabetic, and hypertensive. 1 Patients hospitalized with influenza more frequently had heart failure, chronic respiratory disease, and cirrhosis. 1 Similar observations were reported in an international network study that included US, South Korea, and Spain. 2 While this information provides useful context to the current understanding of characteristics of patients hospitalized with COVID-19 in several countries, understanding of the overall risk profile for the two viral infections is lacking in a broad US population. Advanced modelling, machine learning, and artificial intelligence (AI) techniques have been employed to detect, diagnose, evaluate, and prioritize for Examples include laboratory examination frameworks to prioritize patients with COVID-19, AI techniques in the detection and classification of COVID-19 medical images, and models to predict the spread of disease. An increasing number of severe COVID-19 outcome risk assessment studies found that demographic factors, comorbidities, radiographic findings, and laboratory markers may individually or collectively predict worse outcomes. 3 deepen the understanding of COVID-19,
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引用次数: 1
Clinicians' Attitude Toward Computer-Guided Implant Surgery Approach: Survey in Saudi Arabia. 临床医生对计算机引导种植手术方法的态度:沙特阿拉伯的调查。
IF 8.9 Pub Date : 2021-04-01 eCollection Date: 2021-01-01 DOI: 10.2147/POR.S243623
Linah M Ashy

Purpose: To investigate the attitude of clinicians in Saudi Arabia towards dental implant treatment using different implant surgery approaches.

Materials and methods: This cross-sectional observational study was conducted using a web-based questionnaire wherein 56 clinicians ranked their attitude toward computer-guided implant surgery (CGIS) and conventional non-computer-guided surgery (non-CGIS) in terms of advantages, disadvantages and clinical indications. Statistical analysis was conducted by the Spearman correlation test, Kruskal-Wallis test, and Wilcoxon rank sum tests, at a significance level of P<0.05.

Results: The survey results indicated that the most significant advantages of CGIS from the participants' perspective were low levels of stress during surgery (P = 0.003) and minimal requirement of surgical skills (P = 0.04). Notably, the advantages of accurate outcome and predictable flapless surgery were not considered significantly higher for CGIS than for non-CGIS (P = 0.2 and 0.7, respectively). The high treatment cost was the most significant disadvantage of CGIS when compared to non-CGIS (P = 0.002), and complete edentulism was the most recommended clinical condition for CGIS.

Conclusion: Clinicians acknowledged the advantages of CGIS over non-CGIS, especially in complete edentulism. The significant advantages of CGIS were the clinician's state of low stress and minimal skills required rather than the patient's interest in treatment predictability. CGIS is an attractive approach for most participants, in spite of the low rate of actual use.

目的:了解沙特阿拉伯临床医生对采用不同种植方式进行种植治疗的态度。材料和方法:本研究采用基于网络的横断面观察性调查问卷,对56名临床医生对计算机引导种植手术(CGIS)和常规非计算机引导手术(non-CGIS)的优缺点和临床指征进行排名。采用Spearman相关检验、Kruskal-Wallis检验和Wilcoxon秩和检验进行统计分析,在显著性水平上为results:调查结果显示,从参与者的角度来看,CGIS最显著的优势是术中应激水平低(P = 0.003),对手术技能要求低(P = 0.04)。值得注意的是,CGIS的准确结果和可预测的无瓣手术的优势并没有被认为比非CGIS高(P分别= 0.2和0.7)。与非CGIS相比,CGIS最大的缺点是治疗费用高(P = 0.002),全牙治疗是CGIS最推荐的临床条件。结论:临床医生承认CGIS优于非CGIS,特别是在全牙治疗中。CGIS的显著优势是临床医生的低压力状态和所需的最低技能,而不是患者对治疗可预测性的兴趣。尽管实际使用率较低,但CGIS对大多数参与者来说是一种有吸引力的方法。
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引用次数: 0
Acceptability of Vaccination Against COVID-19 Among Healthcare Workers in the Democratic Republic of the Congo. 刚果民主共和国医护人员对接种 COVID-19 疫苗的接受程度。
IF 8.9 Pub Date : 2020-10-29 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S271096
Michel Kabamba Nzaji, Leon Kabamba Ngombe, Guillaume Ngoie Mwamba, Deca Blood Banza Ndala, Judith Mbidi Miema, Christophe Luhata Lungoyo, Bertin Lora Mwimba, Aimé Cikomola Mwana Bene, Elisabeth Mukamba Musenga

Purpose: This study aims to estimate the acceptability of a future vaccine against COVID-19 and associated factors if offered in Congolese health-care workers (HCWs), since they have the highest direct exposure to the disease.

Patients and methods: We conducted an analytical cross-sectional study among 23 Congolese referral hospitals, including three university hospitals, located in three towns from March through 30 April 2020. The main outcome variable was healthcare workers' acceptance of a future vaccine against COVID-19. The associated factors of vaccination willingness were identified through a logistic regression analysis.

Results: A sample of 613 HCWs participated in the study and completed the study questionnaire, including 312 (50.9%) men and 301 (49.1%) women. Only 27.7% of HCWs said that they would accept a COVID-19 vaccine if it was available. From the logistic regression analysis, male healthcare workers (ORa=1.17, 95% CI: 1.15-2.60), primarily doctors (ORa=1.59; 95% CI:1.03-2.44) and having a positive attitude towards a COVID-19 vaccine (ORa=11.49; 95% CI: 5.88-22.46) were significantly associated with reporting willingness to be vaccinated.

Conclusion: For acceptability of vaccination against COVID-19 among others education among HCWs is crucial because health professionals' attitudes about vaccines are an important determinant of their own vaccine uptake and their likelihood of recommending the vaccine to their patients.

目的:本研究旨在估算刚果医护人员(HCWs)未来接种 COVID-19 疫苗的可接受性及相关因素,因为他们是直接接触该疾病最多的人群:我们于 2020 年 3 月至 4 月 30 日在位于三个城镇的 23 家刚果转诊医院(包括三家大学医院)开展了一项横断面分析研究。主要结果变量是医护人员对未来接种 COVID-19 疫苗的接受程度。通过逻辑回归分析确定了疫苗接种意愿的相关因素:613名医护人员参与了研究并填写了研究问卷,其中男性312人(50.9%),女性301人(49.1%)。只有 27.7% 的医护人员表示,如果有 COVID-19 疫苗,他们会接受。从逻辑回归分析来看,男性医护人员(ORa=1.17,95% CI:1.15-2.60)、主要是医生(ORa=1.59;95% CI:1.03-2.44)和对 COVID-19 疫苗持积极态度(ORa=11.49;95% CI:5.88-22.46)与表示愿意接种疫苗有显著关系:结论:对医护人员进行 COVID-19 疫苗接种教育对于其他疫苗的可接受性至关重要,因为医护人员对疫苗的态度是决定其自身疫苗接种率以及向患者推荐疫苗可能性的重要因素。
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引用次数: 0
Patients with Sore Throat: A Survey of Self-Management and Healthcare-Seeking Behavior in 13 Countries Worldwide. 喉咙痛患者:全球13个国家自我管理和医疗保健寻求行为的调查
IF 8.9 Pub Date : 2020-09-10 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S255872
Alike W van der Velden, Aurelio Sessa, Attila Altiner, Antonio Carlos Campos Pignatari, Adrian Shephard

Background: Acute sore throat is one of the most common problems for which patients consult their general practitioner and is a key area for inappropriate antibiotic prescribing. The objective of this study was to investigate patients' attitudes related to healthcare-seeking behavior and self-management of sore throat.

Methods: We conducted an observational, questionnaire-based study across 13 countries (Australia, Brazil, China, France, Germany, Italy, the Philippines, Russia, Saudi Arabia, South Africa, Thailand, the UK and the USA) on respondents who reported having had a sore throat in the previous 12 months. Data were collected on their experiences, contact with healthcare professionals, treatment practices and opinions about antibiotics.

Results: A total of 5196 respondents (approximately 400 per country) completed the survey. Over 80% of respondents sought advice for a sore throat, with 30% consulting a general practitioner. The desire to limit the worsening of symptoms was the main reason for seeking treatment. Other reasons concerned resolving persistent symptoms and reducing the impact on daily life/sleep. Self-management for sore throat was mainly medicated sore throat remedies. "Wanting an antibiotic" was rated much lower (55%) than most other reasons for visiting a doctor, but this differed greatly between countries. The percentage of respondents using antibiotics varied widely, for example, 10% in the UK and 45% in Saudi Arabia. There was considerable variation in the proportion of respondents who thought that antibiotics would be effective against sore throat (from 24% in France to 94% in Saudi Arabia).

Conclusions: Our findings suggest that knowledge of effective treatments for sore throat varied widely. The results of this study should enable healthcare professionals to better anticipate patients' needs. This will support healthcare professionals in their role as antibiotic stewards, helping to reduce the misuse of antibiotics, and further guiding patients towards symptomatic self-management of sore throat.

背景:急性喉咙痛是最常见的问题之一,患者咨询他们的全科医生,是一个关键领域不适当的抗生素处方。摘要本研究的目的在于探讨病患对咽喉痛的就诊态度及自我管理。方法:我们在13个国家(澳大利亚、巴西、中国、法国、德国、意大利、菲律宾、俄罗斯、沙特阿拉伯、南非、泰国、英国和美国)对报告在过去12个月内有喉咙痛的受访者进行了一项观察性、基于问卷的研究。收集了他们的经历、与卫生保健专业人员的接触、治疗做法和对抗生素的意见的数据。结果:共有5196名受访者(每个国家约400人)完成了调查。超过80%的受访者因喉咙痛寻求建议,30%的人咨询全科医生。希望限制症状恶化是寻求治疗的主要原因。其他原因涉及解决持续症状和减少对日常生活/睡眠的影响。咽喉痛的自我管理主要是药物治疗。“需要抗生素”的比例远低于大多数其他看医生的原因(55%),但这在各国之间差异很大。答复者使用抗生素的百分比差别很大,例如,英国为10%,沙特阿拉伯为45%。认为抗生素对喉咙痛有效的答复者比例差异很大(从法国的24%到沙特阿拉伯的94%)。结论:我们的研究结果表明,有效治疗喉咙痛的知识差异很大。这项研究的结果应该使医疗保健专业人员能够更好地预测患者的需求。这将支持卫生保健专业人员发挥抗生素管理员的作用,帮助减少抗生素的滥用,并进一步指导患者对喉咙痛的症状进行自我管理。
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引用次数: 9
The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results. 美国成人亚临床重症哮喘 CHRONICLE 研究:目标、设计和初步结果。
IF 8.9 Pub Date : 2020-07-16 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S251120
Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri

Background: Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.

Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.

Study design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.

Initial results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m2; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.

Conclusion: CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.

背景:约有 5-10% 的哮喘患者病情严重。需要进行高质量的真实世界研究,以确定需要改进管理的领域:与国际严重哮喘登记处保持一致,CHRONICLE 研究(ClinicalTrials.gov: NCT03373045)旨在满足美国的这一需求:研究设计:从之前的研究中汲取经验,针对美国确诊重症哮喘患者开展一项真实世界、前瞻性、非介入性研究,这些患者接受亚专科医生治疗,需要生物制剂或维持性全身免疫抑制剂治疗,或使用大剂量吸入皮质类固醇和其他控制剂仍无法控制病情。目标是招募 4000 名患者,观察期≥3 年。过敏症/免疫科医生和肺科医生会在不同的地理位置抽取样本,与他们护理的所有符合条件的患者接触,每 6 个月报告一次患者特征、治疗情况和健康结果。患者每 1-6 个月完成一次在线调查:从 2018 年 2 月到 2019 年 2 月,102 个研究点筛选了 1428 名符合条件的患者;936 名患者注册。研究地点(40% 为过敏/免疫科医生,42% 为肺科医生,18% 两者皆有)与美国其他哮喘亚专科样本相似。入组患者中 67% 为女性,入组和确诊时的中位年龄分别为 55 岁(18-89 岁)和 26 岁(0-80 岁)。体重指数中位数为 31 kg/m2;目前或曾经吸烟的患者分别占 3% 和 29%,超过 60% 的患者在过去一年中病情恶化≥1 次,症状控制不理想:CHRONICLE将提供由医疗服务提供者和患者报告的高质量数据,这些数据来自于一个大型的、真实世界的美国成年重症哮喘患者队列。
{"title":"The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results.","authors":"Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri","doi":"10.2147/POR.S251120","DOIUrl":"10.2147/POR.S251120","url":null,"abstract":"<p><strong>Background: </strong>Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.</p><p><strong>Objective: </strong>Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.</p><p><strong>Study design: </strong>Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.</p><p><strong>Initial results: </strong>From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m<sup>2</sup>; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.</p><p><strong>Conclusion: </strong>CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":8.9,"publicationDate":"2020-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b2/64/por-11-77.PMC7371434.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38239305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CPAP Therapeutic Options for Obstructive Sleep Apnea. 阻塞性睡眠呼吸暂停的CPAP治疗选择。
IF 8.9 Pub Date : 2020-07-13 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S258632
Robert G Hooper

Introduction: There are many options available to patients who are placed on constant positive airway pressure (CPAP) for obstructive sleep apnea. Despite the success of CPAP in correcting apnea, a significant number of patients have difficulty with the therapy. A large number of those patients who have difficulty stop therapy and are often labeled as "CPAP Failure". Non-sleep specialists may view CPAP therapy as a singular course of treatment, but there are many ways CPAP may be ordered for a patient. Each patient experiences a unique set of options that constitute a unique order set.

Methods: In order to demonstrate the magnitude of the possible options, estimates of the number of unique order sets were calculated. The author chose individual order options and the number of selections possible within each option. The calculated sets included a "Generous, Limited and Minimal" number of selections for each option. Calculations were done separately for standard CPAP and for auto-adjusting CPAP. Additional calculations were performed using the number of commercially available masks in the United States.

Results: The maximum number of unique order sets was seen using a standard CPAP combined with commercially available masks: 49,152 unique order sets. The fewest number of unique order sets were seen with the auto-adjusting CPAP and the "Minimal" selections: 288 unique order sets.

Discussion: There are a large number of unique CPAP orders that a patient may experience. CPAP treatment is not a singular or simple therapy. When evaluating obstructive sleep apnea patients with histories of CPAP failure or prior difficulty with CPAP, paying close attention to the patient's treatment experiences may help explain a significant number of those patients' CPAP therapy problems.

导读:阻塞性睡眠呼吸暂停患者采用持续气道正压通气(CPAP)治疗有多种选择。尽管CPAP在纠正呼吸暂停方面取得了成功,但仍有相当数量的患者难以接受该治疗。大量有困难的患者停止治疗,通常被标记为“CPAP失败”。非睡眠专家可能认为CPAP治疗是一个单一的治疗过程,但有许多方法可以为患者订购CPAP。每个病人都经历了一组独特的选择,这些选择构成了一个独特的顺序集。方法:为了证明可能的选项的大小,估计的唯一订单集的数量进行了计算。作者选择了单独的订单选项和选择的数量可能在每个选项。计算集包括每个选项的“慷慨,有限和最小”数量的选择。分别对标准CPAP和自动调节CPAP进行计算。使用美国市售口罩的数量进行了额外的计算。结果:使用标准CPAP与市售口罩相结合的最大唯一订单集数量:49152个唯一订单集。使用自动调节CPAP和“Minimal”选项可以看到最少数量的唯一订单集:288个唯一订单集。讨论:患者可能会遇到大量独特的CPAP医嘱。CPAP治疗不是单一或简单的治疗。在评估有CPAP失败史或既往CPAP治疗困难的阻塞性睡眠呼吸暂停患者时,密切关注患者的治疗经历可能有助于解释大量患者的CPAP治疗问题。
{"title":"CPAP Therapeutic Options for Obstructive Sleep Apnea.","authors":"Robert G Hooper","doi":"10.2147/POR.S258632","DOIUrl":"https://doi.org/10.2147/POR.S258632","url":null,"abstract":"<p><strong>Introduction: </strong>There are many options available to patients who are placed on constant positive airway pressure (CPAP) for obstructive sleep apnea. Despite the success of CPAP in correcting apnea, a significant number of patients have difficulty with the therapy. A large number of those patients who have difficulty stop therapy and are often labeled as \"CPAP Failure\". Non-sleep specialists may view CPAP therapy as a singular course of treatment, but there are many ways CPAP may be ordered for a patient. Each patient experiences a unique set of options that constitute a unique order set.</p><p><strong>Methods: </strong>In order to demonstrate the magnitude of the possible options, estimates of the number of unique order sets were calculated. The author chose individual order options and the number of selections possible within each option. The calculated sets included a \"Generous, Limited and Minimal\" number of selections for each option. Calculations were done separately for standard CPAP and for auto-adjusting CPAP. Additional calculations were performed using the number of commercially available masks in the United States.</p><p><strong>Results: </strong>The maximum number of unique order sets was seen using a standard CPAP combined with commercially available masks: 49,152 unique order sets. The fewest number of unique order sets were seen with the auto-adjusting CPAP and the \"Minimal\" selections: 288 unique order sets.</p><p><strong>Discussion: </strong>There are a large number of unique CPAP orders that a patient may experience. CPAP treatment is not a singular or simple therapy. When evaluating obstructive sleep apnea patients with histories of CPAP failure or prior difficulty with CPAP, paying close attention to the patient's treatment experiences may help explain a significant number of those patients' CPAP therapy problems.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":8.9,"publicationDate":"2020-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S258632","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38239304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Adequacy of Therapy for People with Both COPD and Heart Failure in the UK: Historical Cohort Study. 英国COPD和心力衰竭患者治疗的充分性:历史队列研究
IF 8.9 Pub Date : 2020-06-02 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S250451
Konstantinos Kostikas, Chin Kook Rhee, John R Hurst, Piergiuseppe Agostoni, Hui Cao, Robert Fogel, Rupert Jones, Janwillem W H Kocks, Karen Mezzi, Simon Wan Yau Ming, Ronan Ryan, David B Price

Purpose: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) often occur concomitantly, presenting diagnostic and therapeutic challenges for clinicians. We examined the characteristics of patients prescribed adequate versus inadequate therapy within 3 months after newly diagnosed comorbid COPD or HF.

Patients and methods: Eligible patients in longitudinal UK electronic medical record databases had pre-existing HF and newly diagnosed COPD (2017 GOLD groups B/C/D) or pre-existing COPD and newly diagnosed HF. Adequate COPD therapy was defined as long-acting bronchodilator(s) with/without inhaled corticosteroid; adequate HF therapy was defined as beta-blocker plus angiotensin-converting enzyme inhibitor and/or angiotensin receptor blocker.

Results: Of 2439 patients with HF and newly diagnosed COPD (mean 75 years, 61% men), adequate COPD therapy was prescribed for 726 (30%) and inadequate for 1031 (42%); 682 (28%) remained untreated for COPD. Adequate (vs inadequate) COPD therapy was less likely for women (35%) than men (45%), smokers (36%) than ex-/non-smokers (45%), and non-obese (41%) than obese (47%); spirometry was recorded for 57% prescribed adequate versus 35% inadequate COPD therapy. Of 12,587 patients with COPD and newly diagnosed HF (mean 75 years, 60% men), adequate HF therapy was prescribed for 2251 (18%) and inadequate for 5332 (42%); 5004 (40%) remained untreated for HF. Adequate (vs inadequate) HF therapy was less likely for smokers (27%) than ex-/non-smokers (32%) and non-obese (30%) than obese (35%); spirometry was recorded for 65% prescribed adequate versus 39% inadequate HF therapy.

Conclusion: Many patients with comorbid COPD/HF receive inadequate therapy after new diagnosis. Improved equity of access to integrated care is needed for all patient subgroups.

目的:慢性阻塞性肺疾病(COPD)和心力衰竭(HF)经常同时发生,给临床医生的诊断和治疗带来了挑战。我们检查了新诊断为COPD或HF合并症的患者在3个月内接受适当治疗与不适当治疗的患者的特征。患者和方法:英国纵向电子病历数据库中符合条件的患者患有先前存在的HF和新诊断的COPD (2017 GOLD组B/C/D)或先前存在的COPD和新诊断的HF。适当的COPD治疗被定义为长效支气管扩张剂加/不加吸入皮质类固醇;适当的HF治疗被定义为β受体阻滞剂加血管紧张素转换酶抑制剂和/或血管紧张素受体阻滞剂。结果:2439例HF合并新诊断COPD患者(平均75岁,61%男性)中,726例(30%)接受了适当的COPD治疗,1031例(42%)接受了不适当的COPD治疗;682人(28%)仍未接受COPD治疗。女性(35%)比男性(45%),吸烟者(36%)比戒烟/不吸烟(45%),非肥胖(41%)比肥胖(47%)更不可能接受充分(vs不充分)的COPD治疗;肺量测定记录显示,57%的患者接受了适当的COPD治疗,35%的患者接受了不适当的COPD治疗。在12587例COPD合并新诊断HF患者(平均75岁,60%男性)中,2251例(18%)患者接受了适当的HF治疗,5332例(42%)患者接受了不适当的HF治疗;5004例(40%)仍未接受HF治疗。充分(vs不充分)心衰治疗对于吸烟者(27%)比戒烟/不吸烟(32%)和非肥胖(30%)比肥胖(35%)的可能性要小;65%的患者接受了适当的心力衰竭治疗,39%的患者接受了不适当的心力衰竭治疗。结论:许多合并COPD/HF的患者在新诊断后治疗不足。需要改善所有患者亚群获得综合护理的公平性。
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引用次数: 3
Real-World Safety and Effectiveness of Tadalafil in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Japanese Post-Marketing Surveillance Study. 他达拉非治疗继发于良性前列腺增生的下尿路症状的安全性和有效性:一项日本上市后监测研究
IF 8.9 Pub Date : 2020-05-04 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S237821
Hiroyoshi Yamazaki, Naoto Tsujimoto, Momoha Koyanagi, Megumi C Katoh, Koyuki Tajima, Mika Komori

Objective: To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥75 years.

Patients and methods: This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.

Results: Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged <75 and ≥75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (P < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (P < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was -9.8 mL at 18 months (P < 0.001); there were no significant differences from baseline in maximum urinary flow rate.

Conclusion: This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥75 years were similar to patients aged <75 years.

目的:评价他达拉非治疗日本男性良性前列腺增生继发下尿路症状的长期安全性和有效性;并调查≥75岁患者的安全性。患者和方法:这是一项前瞻性、非介入性、多中心、上市后监测研究,在开始他达拉非治疗后长达18个月的时间里,观察了日本患者继发于良性前列腺增生的下尿路症状。真实世界的安全性和有效性结果在基线和治疗后1、3、6、12和18个月或治疗最后一天进行评估。结果:大部分患者在整个观察期内给予他达拉非5mg / d。在1393例安全性分析患者中,药物不良反应的总发生率为8.3%。这些药物不良反应与他达拉非已知的安全性基本一致,长期使用未发现新的安全风险。两组患者药物不良反应发生频率差异无统计学意义(P < 0.001), IPSS-quality life评分提高1.5分(P < 0.001)。排尿后残余尿量与基线相比在每个时间点的平均变化都很显著,在18个月时为-9.8 mL (P < 0.001);最大尿流率与基线无显著差异。结论:这项监测表明,他达拉非在日本男性良性前列腺增生继发的下尿路症状中长期使用具有良好的安全性和有效性。此外,≥75岁患者的安全性与老年患者相似
{"title":"Real-World Safety and Effectiveness of Tadalafil in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Japanese Post-Marketing Surveillance Study.","authors":"Hiroyoshi Yamazaki,&nbsp;Naoto Tsujimoto,&nbsp;Momoha Koyanagi,&nbsp;Megumi C Katoh,&nbsp;Koyuki Tajima,&nbsp;Mika Komori","doi":"10.2147/POR.S237821","DOIUrl":"https://doi.org/10.2147/POR.S237821","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the long-term safety and effectiveness of tadalafil in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in real-world clinical practice; and to investigate the safety profile in patients aged ≥75 years.</p><p><strong>Patients and methods: </strong>This was a prospective, non-interventional, multicenter, post-marketing surveillance study in which Japanese patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia were observed for up to 18 months after initiating tadalafil treatment. The real-world safety and effectiveness outcomes were assessed at baseline and at 1, 3, 6, 12, and 18 months post-treatment or the last day of treatment.</p><p><strong>Results: </strong>Most patients received tadalafil 5 mg per day throughout the observation period. Among 1393 patients analyzed for safety, the overall incidence of adverse drug reactions was 8.3%. These adverse drug reactions were generally consistent with the known safety profile of tadalafil and no new safety risks were identified in long-term use. There was no statistical difference in the frequency of adverse drug reactions between patients aged <75 and ≥75 years. The mean change in total International Prostate Symptom Score (IPSS) and IPSS-quality of life subscore was significantly improved at each timepoint. At 18 months, IPSS had improved by 5.0 points (<i>P</i> < 0.001) and IPSS-quality of life subscore had improved by 1.5 points (<i>P</i> < 0.001). The mean change in post-voiding residual urine volume from baseline was significant at each time point and was -9.8 mL at 18 months (<i>P</i> < 0.001); there were no significant differences from baseline in maximum urinary flow rate.</p><p><strong>Conclusion: </strong>This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. In addition, safety profiles in patients aged ≥75 years were similar to patients aged <75 years.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":8.9,"publicationDate":"2020-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S237821","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37964248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States. 美国新近批准的晚期胃癌药物的真实世界数据早期分析结论的可靠性
IF 8.9 Pub Date : 2020-04-30 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S241427
Lisa M Hess, Michael Grabner, Liya Wang, Astra M Liepa, Xiaohong Ivy Li, Zhanglin Lin Cui, Lee Bowman, William R Schelman

Background: As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.

Methods: This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.

Results: Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).

Conclusion: Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.

背景:随着现实世界数据资源的扩展和完善,将有越来越多的机会研究干预措施的有效性。有必要确保研究设计探索潜在的偏见来源,并承认或减轻它们,以提高研究结果的准确性。本研究的目的是了解新批准的药物使用模式,在现实世界的临床设置随着时间的推移。方法:这项回顾性研究包括三个真实数据来源(索赔、电子健康记录和质量护理计划的重新编码数据),这些数据来自于曲妥珠单抗或拉穆单抗治疗的胃癌患者。线性回归用于调查自美国食品和药物管理局(FDA)批准以来这些药物用于胃癌患者护理的趋势。结果:符合条件的患者(n=1700)随时间的推移具有一致的人口统计学和临床特征。在获得监管批准后,曲妥珠单抗被用于较晚的治疗线,然后转移到较早的治疗线(p=0.002),而在FDA批准后,ramucirumab的使用一直保持一致(p=0.49)。Ramucirumab增强,定义为在开始一系列治疗后添加药物,随着时间的推移而减少(p=0.03),而曲妥珠单抗增强随时间保持一致(p=0.58)。结论:由于治疗效果可能在治疗线之间发生变化,如果在使用真实数据分析的时间段内药物使用发生变化(如线迁移),则可能产生偏倚。
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引用次数: 1
Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers. 使用医疗保险索赔来识别无铅起搏器植入后的急性临床事件。
IF 8.9 Pub Date : 2020-02-28 eCollection Date: 2020-01-01 DOI: 10.2147/POR.S240913
Kael Wherry, Kurt Stromberg, Jennifer A Hinnenthal, Lisa A Wallenfelsz, Mikhael F El-Chami, Lindsay Bockstedt

Background: There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study.

Methods: Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources.

Results: There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type.

Conclusion: Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.

背景:如何使用真实世界数据(RWD)来补充或取代收集临床信息的传统机制,引起了人们的高度兴趣。评估RWD的效用的一个关键组成部分是评估事件测量的有效性和可靠性。只有两项研究通过临床研究中收集的医生裁决数据验证了医疗保险索赔,而没有一项研究是在起搏器患者群体中进行的。本研究比较了Micra批准后注册(PAR)中收集的医生裁定的临床注册数据中确定的事件与Micra覆盖证据(CED)研究中通过医疗保险行政索赔确定的事件。方法:纳入2017年3月9日至2017年12月1日期间Micra CED和Micra PAR双入组的患者进行验证分析。所有打算植入Micra设备的患者都有资格参加Micra PAR。所有符合12个月连续登记标准的植入Micra设备的医疗保险服务收费受益人都包括在Micra CED中。我们比较了医疗保险索赔中确定的急性(30天)并发症的数量和医生判定的PAR数据,以评估数据源之间的一致性。结果:在研究期间,有230名患者双入组Micra CED和Micra PAR研究。总体而言,在Micra CED或Micra PAR中报告了17个急性事件,研究之间在事件识别和事件缺失方面的一致性为95%。两项研究报告的事件之间的研究差异各不相同:动静脉瘘(50%)、肺栓塞(67%)、出血/血肿(75%)和深静脉血栓形成(100%)。在医生判定的事件中,Micra CED和Micra PAR研究在任何事件类型上都没有差异。结论:本研究结果表明,对于植入Micra无铅起搏器的患者,医疗保险索赔数据和登记之间的事件识别高度一致。
{"title":"Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers.","authors":"Kael Wherry,&nbsp;Kurt Stromberg,&nbsp;Jennifer A Hinnenthal,&nbsp;Lisa A Wallenfelsz,&nbsp;Mikhael F El-Chami,&nbsp;Lindsay Bockstedt","doi":"10.2147/POR.S240913","DOIUrl":"https://doi.org/10.2147/POR.S240913","url":null,"abstract":"<p><strong>Background: </strong>There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study.</p><p><strong>Methods: </strong>Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources.</p><p><strong>Results: </strong>There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type.</p><p><strong>Conclusion: </strong>Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":8.9,"publicationDate":"2020-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/POR.S240913","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37748483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
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Pragmatic and Observational Research
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