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Cost comparison analysis of laparoscopic versus open aortobifemoral bypass surgery: a randomized controlled trial 腹腔镜与开放式主动脉-股动脉旁路手术的成本比较分析:一项随机对照试验
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2019-06-19 DOI: 10.2147/OAJCT.S192552
M. Sahba, A. H. Krog, E. M. Pettersen, T. Wisløff, Kg Rogne, J. Sundhagen, Ssh Kazmi
1Department of Vascular Surgery, Ostfold Central Hospital, Grålum, Norway; 2Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, Norway; 3Department of Infectious Disease Epidemiology and Modelling, Norwegian Institute of Public Health, Oslo, Norway; 4Department of Health Management and Health Economics, University of Oslo, Oslo, Norway; 5Economy Department, Oslo University Hospital, Oslo, Norway; 6Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway; 7Faculty of Medicine, Oslo University, Oslo, Norway Background: Laparoscopic aortobifemoral bypass (LABFB) surgery has become an established treatment procedure for aortoiliac occlusive disease (AIOD), Trans-Atlantic Inter-Society Consensus II (TASC II), type D lesions. However, studies with an economic evaluation of this procedure are sparse. The main purpose of our study was to compare the costs of LABFB and open aortobifemoral bypass (OABFB) surgery. Patients and methods: This is a substudy of a larger randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Perioperative data were collected on 70 patients undergoing surgery for AIOD, TASC type D lesions. Thirty-four patients were randomized to LABFB and 36 patients to OABFB. Treatment costs were calculated for the two operative treatments until 30 postoperative days. In addition to fixed and variable costs, direct and indirect costs were also included. Results: The mean total cost of LABFB was 19,798 € and for OABFB 34,016 € until 30 postoperative days. Laparoscopic procedure was 14,218 € less costly than the open procedure. The main factor leading to less cost of LABFB was shorter length of hospital stay (mean 5.3 days, 95% CI 4.1–6.5) as compared to OABFB (mean 10.1 days, 95% CI 7.5–12.6). Ten patients, three in the LABFB and seven in the OABFB group, had complications that resulted in reoperations within the 30 postoperative days. The mean cost of treatment for the complicated patients was 49,349 € and 82,985 €, respectively, for LABFB and OABFB. Conclusion: Laparoscopic aortobifemoral bypass procedure costs less than open aortobifemoral bypass for the treatment of advanced aortoiliac occlusive disease.
1挪威Grålum Ostfold中央医院血管外科;2挪威克里斯蒂安桑瑟兰德HF医院血管外科;3挪威公共卫生研究所传染病流行病学和建模系,挪威奥斯陆;4挪威奥斯陆奥斯陆大学卫生管理和卫生经济学系;5经济科,奥斯陆大学医院,奥斯陆,挪威;6奥斯陆大学医院心血管和肺部疾病科血管外科,挪威奥斯陆;7奥斯陆大学医学院,奥斯陆,挪威背景:腹腔镜主动脉-双股旁路(LABFB)手术已成为主动脉-髂动脉闭塞性疾病(AIOD)、跨大西洋社会共识II(TASC II)和D型病变的既定治疗程序。然而,对该程序进行经济评估的研究很少。我们研究的主要目的是比较LABFB和开放性主动脉双股旁路(OABFB)手术的成本。患者和方法:这是一项更大的随机对照前瞻性多中心试验,挪威腹腔镜主动脉外科试验(NLAST)的子研究。收集了70名接受AIOD、TASC D型病变手术的患者的围手术期数据。34名患者被随机分配到LABFB,36名患者被分配到OABFB。计算两次手术治疗至术后30天的治疗费用。除了固定成本和可变成本外,还包括直接成本和间接成本。结果:术后30天,LABFB和OABFB的平均总费用分别为19798欧元和34016欧元。腹腔镜手术比开放式手术成本低14218欧元。与OABFB(平均10.1天,95%置信区间7.5-12.6)相比,导致LABFB费用降低的主要因素是住院时间更短(平均5.3天,95%可信区间4.1-6.5)。10名患者(LABFB组3名,OABFB组7名)出现并发症,导致术后30天内再次手术。LABFB和OABFB的复杂患者的平均治疗费用分别为49349欧元和82985欧元。结论:腹腔镜主动脉-双股动脉搭桥术治疗晚期主动脉-髂动脉闭塞性疾病的成本低于开放式主动脉-双足动脉搭桥术。
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引用次数: 3
Effects of pain on cognitive function and mobility 疼痛对认知功能和活动能力的影响
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2019-03-25 DOI: 10.2147/OAJCT.S182502
S. A. Moreira, P. Novak
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引用次数: 4
Selective enhancement of focused attention by Alpinia galanga in subjects with moderate caffeine consumption 高良姜选择性增强适度咖啡因摄入受试者的集中注意力
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2018-09-01 DOI: 10.2147/OAJCT.S164450
S. Srivastava
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引用次数: 3
Placebo-only-controlled versus active-controlled trials of new drugs for nine common life-threatening diseases 九种常见危及生命的疾病的新药安慰剂对照试验与活性对照试验
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2018-04-24 DOI: 10.2147/OAJCT.S156054
Sarah Sorscher, A. AbuDagga, Sammy Almashat, M. Carome, S. Wolfe
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引用次数: 1
Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial) 依维莫司联合内分泌治疗绝经后er阳性和her2阴性转移性乳腺癌的开放标签II期研究(Chloe试验)
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2018-02-16 DOI: 10.2147/OAJCT.S155706
T. Shimoi, A. Shimomura, T. Shien, Y. Uemura, H. Kato, M. Kitada, T. Toyama, T. Aihara, H. Mukai
Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.
背景:这是一项随机、多中心、开放标签的II期研究,旨在评估依维莫司在芳香化酶抑制剂(AI)连续给药中对至少5个月病情稳定或反应较好的患者的疗效。患者和方法:将患者随机分为依维莫司和标准治疗组(1:1比例)。在依维莫司组中,除了AI制剂外,患者还将接受依维莫斯治疗。标准治疗组将继续进行AI单独治疗。主要终点是无进展生存期。目标累积为130名患者,双侧I型错误率为10%,检测风险降低35%的能力为80%。结论:Chloe试验将为在AI中加入依维莫司治疗雌激素受体阳性和人表皮生长因子2阴性转移性癌症的有效性和安全性提供重要信息。
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引用次数: 1
Computerized Cognitive Training to Improve Mood in Senior Living Settings: Design of a Randomized Controlled Trial. 计算机化认知训练改善老年人生活环境中的情绪:一项随机对照试验的设计。
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2018-01-01 Epub Date: 2018-04-26 DOI: 10.2147/OAJCT.S154782
Marianne Smith, Michael P Jones, Megan M Dotson, Fredric D Wolinsky

Purpose: This two-arm, randomized controlled trial was designed to evaluate a computerized cognitive speed of processing (SOP) training known as Road Tour in the generally older group of adults residing in assisted living (AL) and related senior housing. Study aims focused on depression-related outcomes that were observed in earlier SOP studies using Road Tour with younger, home-dwelling seniors. Study design and baseline outcomes are discussed.

Participants and methods: A community-based design engaged AL and related senior living settings as partners in research. Selected staff served as on-site research assistants who were trained to recruit, consent, and train a target of 300 participants from AL and independent living (IL) programs to use the intervention and attention-control computerized training. Ten hours of initial computerized training was followed by two booster sessions at 5 and 11 months. Outcome measures included Useful Field of View (UFOV), 9-item Patient Health Questionnaire (PHQ-9), 12-item Centers for Epidemiological Studies Depression scale (CESD-12), 7-item Generalized Anxiety Disorders GAD-7), Brief Pain Inventory (BPI) and SF-36 Health Survey. Assessments occurred before randomization (pre-training), post-training, 26 and 52 weeks.

Results: A total of 351 participants were randomized to the intervention (n=173) and attention-control (n=178) groups. There were no significant differences between groups in demographic characteristics with the exception of education and reported osteoporosis. There were no significant differences in study outcomes between groups at baseline. Participants in AL had significantly lower SOP and self-rated health, and significantly higher depression, anxiety and pain when compared to those in IL programs on the same campus.

Conclusions: Compared to earlier SOP training studies using Road Tour, this sample of senior living participants were older, reported more health conditions and poorer overall health, had lower UFOV scores and greater depressive symptoms at baseline. Moreover, participants in AL had greater health challenges than those in IL.

目的:本两组随机对照试验旨在评估计算机化的认知处理速度(SOP)训练,称为Road Tour,用于居住在辅助生活(AL)和相关老年住房的一般老年人群体。研究的目的集中在早期的SOP研究中观察到的与抑郁相关的结果,这些研究使用Road Tour对年轻的居家老年人进行了研究。讨论了研究设计和基线结果。参与者和方法:基于社区的设计将人工智能和相关的老年生活环境作为研究的合作伙伴。选定的工作人员作为现场研究助理,接受培训,从人工智能和独立生活(IL)项目中招募、同意和培训300名参与者,以使用干预和注意力控制的计算机化培训。最初的10小时计算机化训练之后,在5个月和11个月时进行两次强化训练。结果测量包括有用视场(UFOV)、9项患者健康问卷(PHQ-9)、12项流行病学研究中心抑郁量表(csd -12)、7项广泛性焦虑障碍量表(GAD-7)、简短疼痛量表(BPI)和SF-36健康调查。评估在随机化前(训练前)、训练后、26周和52周进行。结果:351名参与者被随机分为干预组(n=173)和注意控制组(n=178)。除了受教育程度和骨质疏松报告外,两组间的人口统计学特征没有显著差异。在基线时,两组之间的研究结果无显著差异。与同一校区的IL项目相比,AL项目的参与者的SOP和自评健康显著降低,抑郁、焦虑和疼痛显著增加。结论:与早期使用Road Tour进行的SOP训练研究相比,该样本的老年生活参与者年龄更大,报告的健康状况更多,整体健康状况更差,基线时UFOV得分更低,抑郁症状更严重。此外,AL组的参与者比IL组有更大的健康挑战。
{"title":"Computerized Cognitive Training to Improve Mood in Senior Living Settings: Design of a Randomized Controlled Trial.","authors":"Marianne Smith,&nbsp;Michael P Jones,&nbsp;Megan M Dotson,&nbsp;Fredric D Wolinsky","doi":"10.2147/OAJCT.S154782","DOIUrl":"https://doi.org/10.2147/OAJCT.S154782","url":null,"abstract":"<p><strong>Purpose: </strong>This two-arm, randomized controlled trial was designed to evaluate a computerized cognitive speed of processing (SOP) training known as <i>Road Tour</i> in the generally older group of adults residing in assisted living (AL) and related senior housing. Study aims focused on depression-related outcomes that were observed in earlier SOP studies using <i>Road Tour</i> with younger, home-dwelling seniors. Study design and baseline outcomes are discussed.</p><p><strong>Participants and methods: </strong>A community-based design engaged AL and related senior living settings as partners in research. Selected staff served as on-site research assistants who were trained to recruit, consent, and train a target of 300 participants from AL and independent living (IL) programs to use the intervention and attention-control computerized training. Ten hours of initial computerized training was followed by two booster sessions at 5 and 11 months. Outcome measures included Useful Field of View (UFOV), 9-item Patient Health Questionnaire (PHQ-9), 12-item Centers for Epidemiological Studies Depression scale (CESD-12), 7-item Generalized Anxiety Disorders GAD-7), Brief Pain Inventory (BPI) and SF-36 Health Survey. Assessments occurred before randomization (pre-training), post-training, 26 and 52 weeks.</p><p><strong>Results: </strong>A total of 351 participants were randomized to the intervention (n=173) and attention-control (n=178) groups. There were no significant differences between groups in demographic characteristics with the exception of education and reported osteoporosis. There were no significant differences in study outcomes between groups at baseline. Participants in AL had significantly lower SOP and self-rated health, and significantly higher depression, anxiety and pain when compared to those in IL programs on the same campus.</p><p><strong>Conclusions: </strong>Compared to earlier SOP training studies using <i>Road Tour</i>, this sample of senior living participants were older, reported more health conditions and poorer overall health, had lower UFOV scores and greater depressive symptoms at baseline. Moreover, participants in AL had greater health challenges than those in IL.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"10 ","pages":"29-41"},"PeriodicalIF":1.2,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S154782","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37422026","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
Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention. 痴呆症患者家庭照顾者的生活增强活动:积极影响技能干预的随机对照试验方案。
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2018-01-01 Epub Date: 2018-02-07 DOI: 10.2147/oajct.s150597
Alice Verstaen, Judith T Moskowitz, Karin E Snowberg, Jennifer Merrilees, Glenna A Dowling

Given the increasing number of family caregivers of persons with dementia (PWD) and the associated burden and detriments to both physical and mental health, interventions that aim to improve such outcomes are important. Studies are increasingly demonstrating the unique importance of positive emotions in coping with stress, independent from the impact of negative emotions. However, none have examined the benefits of interventions that target positive emotions for caregivers of individuals with a chronic and debilitating disease such as dementia. This paper presents the design and methods for a randomized controlled trial (RCT) of a positive affect skills intervention for family caregivers of PWD. The RCT is of a skills-based intervention that seeks to increase the frequency and intensity of positive affect in order to improve outcomes such as well-being, coping, and physical and mental health. The skills are delivered by trained facilitators via five one-to-one Internet video sessions with family caregivers of persons diagnosed with dementia (eg, Alzheimer's disease, vascular dementia, unspecified). The control group is an emotion reporting/waitlist control. Follow-up assessments are conducted post-intervention and at 1, 3, and 6 months post-completion of the intervention. This study promises to be an important and needed step toward improving the lives of caregivers of PWD.

鉴于痴呆症患者的家庭照护者越来越多,以及相关的负担和对身心健康的损害,旨在改善这种结果的干预措施非常重要。越来越多的研究表明,积极情绪在应对压力方面的独特重要性,独立于消极情绪的影响。然而,没有人研究过以积极情绪为目标的干预措施对患有慢性和衰弱性疾病(如痴呆症)的患者的照顾者的好处。本文介绍了一项针对残疾家庭照顾者的积极影响技能干预的随机对照试验(RCT)的设计和方法。RCT是一种基于技能的干预,旨在增加积极影响的频率和强度,以改善幸福感、应对能力和身心健康等结果。这些技能由训练有素的辅导员通过与被诊断患有痴呆症(如阿尔茨海默病、血管性痴呆,未指明)的人的家庭照顾者进行的五次一对一互联网视频会议传授。控制组是情绪报告/等待列表控制组。在干预后以及干预完成后1、3和6个月进行随访评估。这项研究有望成为改善残疾患者护理人员生活的重要且必要的一步。
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引用次数: 6
Randomized response surface pathway design with odd response outcomes in a Latin Square designed study 拉丁方设计研究中随机反应面路径设计与奇数反应结果
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2017-09-01 DOI: 10.2147/OAJCT.S139884
T. Holand, K. Ellingsen, Sagita Dewi, S. Larsen
php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2017:9 75–84 Open Access Journal of Clinical Trials Dovepress
php,并包含知识共享署名-非商业(未启动,v3.0)许可证(http://creativecommons.org/licenses/by-nc/3.0/)。通过访问作品,您在此接受条款。作品的非商业用途是允许的,无需德芙医学出版社有限公司的任何进一步许可,前提是作品的归属正确。关于本作品的商业使用许可,请参阅我们的条款第4.2和第5段(https://www.dovepress.com/terms.php)。开放获取临床试验杂志2017:9 75–84开放获取临床实验杂志Dovepress
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引用次数: 6
A randomized controlled trial to improve heart failure disparities: the Mālama Puʻuwai (caring for heart) Study 一项改善心力衰竭差异的随机对照试验:Mālama Puïuwai(照顾心脏)研究
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2017-08-03 DOI: 10.2147/OAJCT.S136066
M. Mau, EunJung Lim, J. Kaholokula, Taylor Loui, Yongjun Cheng, T. Seto
php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2017:9 65–74 Open Access Journal of Clinical Trials Dovepress
php,并包含知识共享署名-非商业(未启动,v3.0)许可证(http://creativecommons.org/licenses/by-nc/3.0/)。通过访问作品,您在此接受条款。作品的非商业用途是允许的,无需德芙医学出版社有限公司的任何进一步许可,前提是作品的归属正确。关于本作品的商业使用许可,请参阅我们的条款第4.2和第5段(https://www.dovepress.com/terms.php)。开放获取临床试验杂志2017:9 65–74开放获取临床实验杂志Dovepress
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引用次数: 6
Informing primary care physicians of patients' involvement in clinical trials carried out at a specialist care level 告知初级保健医生患者参与在专科护理级别进行的临床试验
IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2017-07-27 DOI: 10.2147/OAJCT.S134555
J. A. Schoenenberger-Arnaiz, Montserrat Solanilla-Puertolas, M. Acer-Puig, J. Gómez-Arbonés
Background: Patients enrolled in clinical trials continue to have frequent contacts with primary care physicians because of comorbidities or toxicities. The aim of the present study was to analyze the information provided at different levels, when participants are included in clinical trials organized at a specialized care level. The purpose was to verify if informing the patient's primary care physician is contemplated in the inclusion process. Methods: The authors conducted a cross-sectional study that included the clinical trials approved in the last 2 years by the hospital's Institutional Review Board. In addition, some of the participants in the included clinical trials were interviewed in order to check their knowledge of the type of research taking place. Results: In total, 67 protocols and the accompanying informed consent documents were reviewed. Half of the reviewed protocols (48%) did not provide participants with an identification card. Regarding the role of the primary care physician, 68.6% of clinical trials (46/67) had taken it into account in different ways. In only four trials, the method used to contact the primary care physician was documented. In total, 20 participants were interviewed. Only 3 (15%) knew the title of the study in which they were participating, 14 (70%) were aware of their illness and 6 (30%) did not know how to answer any of these two questions. Almost all participants in the study knew the name of the physician who was the principal investigator in the trial. Conclusion: Information given to health care practitioners, who are not directly involved in clinical trials conducted by specialized medical staff, is still scarce. In our clinical setting, patients participating in clinical trials have a low awareness of such studies. Keywords: informed consent, clinical trials, family physician, wallet card
背景:由于合并症或毒性,参加临床试验的患者继续与初级保健医生频繁接触。本研究的目的是分析在不同级别提供的信息,当参与者被纳入在专业护理级别组织的临床试验时。目的是验证纳入过程中是否考虑通知患者的初级保健医生。方法:作者进行了一项横断面研究,包括医院机构审查委员会在过去两年中批准的临床试验。此外,还采访了纳入临床试验的一些参与者,以检查他们对正在进行的研究类型的了解。结果:总共审查了67个方案和随附的知情同意书文件。一半的审查方案(48%)没有向参与者提供身份证。关于初级保健医生的作用,68.6%的临床试验(46/67)以不同的方式考虑到了这一点。只有四项试验记录了联系初级保健医生的方法。总共采访了20名参与者。只有3人(15%)知道他们参与的研究的标题,14人(70%)知道自己的疾病,6人(30%)不知道如何回答这两个问题中的任何一个。几乎所有参与研究的人都知道作为试验主要研究者的医生的名字。结论:提供给没有直接参与由专业医务人员进行的临床试验的医护人员的信息仍然很少。在我们的临床环境中,参与临床试验的患者对此类研究的认识较低。关键词:知情同意书、临床试验、家庭医生、钱包卡
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引用次数: 3
期刊
Open Access Journal of Clinical Trials
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