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Syrian refugee young adults as community mental health workers implementing problem management plus: Protocol for a pilot randomized controlled trial to measure the mechanisms of effect on their own wellbeing, stress and coping 叙利亚青年难民作为社区心理健康工作者实施问题管理加:试点随机对照试验协议,以衡量对其自身福祉、压力和应对的影响机制
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-28 DOI: 10.1016/j.conctc.2024.101325
Rima Nakkash , Lilian Ghandour , Grant Brown , Catherine Panter-Brick , Hailey Bomar , Malak Tleis , Hanan Al Masri , Marwa Fares , Fadi Al Halabi , Yamen Najjar , Bayan Louis , Maha Hodroj , Yara Chamoun , Myriam Zarzour , Rima A. Afifi

This pilot randomized controlled trial protocol aims to (1) assess the impact on the wellbeing of Syrian refugee young adults (18–24 years) of being a community mental health worker (CMHW) implementing WHO's evidence-based psychosocial intervention - Problem Management Plus (PM+) - with adults in their community, and (2) identify the mechanisms associated with the outcomes of enhanced wellbeing and coping, and reduced stress among these CMHWs. Over 108 million people have been forcibly displaced as of the end of 2022. Mental health consequences of these displacements are significant, yet human resources for health are not sufficient to meet the needs. A large proportion of refugee populations are youth and young adults (YA). Evidence indicates their engagement in supporting their communities leads to their own enhanced wellbeing and that of their community. This trial trains Syrian refugees to serve their communities as CMHW (n=19) or tutors (n=19) and compare wellbeing, stress and coping outcomes between these two groups and a control group (n = 40). We will also assess 7 mechanisms as potential pathways for the interventions to influence outcomes. Surveys will assess outcomes and mechanisms, hair samples will measure stress cortisol. The primary analysis will use a Bayesian Hierarchical Model approach to model the trajectories of the mechanisms and primary study endpoints over time for individuals in each of the arms. Our results will elucidate critical mechanisms in which engagement of young adults to support their community enhances their own wellbeing.

Trial registration

National Institutes of Mental Health, NCT05265611, Registered prospectively in 2021.

Lebanon clinical trials registry #

LBCTR2023015206, Registered in 2023.

这项试点随机对照试验方案旨在:(1)评估作为社区心理健康工作者(CMHW)对叙利亚难民中的年轻成年人(18-24 岁)实施世界卫生组织的循证社会心理干预措施--问题管理+(PM+)--对其社区中成年人的幸福感的影响;(2)确定与这些社区心理健康工作者的幸福感和应对能力增强以及压力减轻的结果相关的机制。截至 2022 年底,已有超过 1.08 亿人被迫流离失所。这些流离失所现象对心理健康造成了严重后果,但卫生方面的人力资源却不足以满足这些需求。难民人口中有很大一部分是青年和年轻成年人(YA)。有证据表明,他们参与支持自己的社区可提高自身和社区的福祉。本试验将培训叙利亚难民作为社区医疗卫生工作者(19 人)或辅导员(19 人)为社区服务,并比较这两组与对照组(40 人)之间的福利、压力和应对结果。我们还将评估 7 种机制,作为干预措施影响结果的潜在途径。调查将评估结果和机制,头发样本将测量压力皮质醇。主要分析将使用贝叶斯层次模型方法来模拟每组个体的机制和主要研究终点随时间变化的轨迹。我们的研究结果将阐明年轻成年人参与支持社区提高自身幸福感的关键机制。试验注册美国国家心理卫生研究所,NCT05265611,2021 年进行前瞻性注册。黎巴嫩临床试验注册 #LBCTR2023015206,2023 年注册。
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引用次数: 0
Three steps toward dose optimization for oncology dose finding 实现肿瘤剂量优化的三个步骤
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-24 DOI: 10.1016/j.conctc.2024.101329
Jason J.Z. Liao , Ekaterine Asatiani , Qingyang Liu , Kevin Hou

Background

Traditional dose selection for oncology registration trials typically employs a one- or two-step single maximum tolerated dose (MTD) approach. However, this approach may not be appropriate for molecularly targeted therapy, which tends to have toxicity profiles that are markedly different than cytotoxic agents. The US Food and Drug Administration launched Project Optimus to reform dose optimization in oncology drug development and has recently released a related guidance for industry.

Methods

We propose a “three steps toward dose optimization” procedure, in response to these initiatives, and discuss the details in dose-optimization designs and analyses. The first step is dose escalation to identify the MTD or maximum administered dose with an efficient hybrid design, which can offer good overdose control and increases the likelihood of the recommended MTD being close to the true MTD. The second step is the selection of appropriate recommended doses for expansion (RDEs), based on all available data, including emerging safety, pharmacokinetics, pharmacodynamics, and other biomarker information. The third step is dose optimization, which uses data from a randomized fractional factorial design with multiple RDEs explored in multiple tumor cohorts during the expansion phase to ensure a feasible dose is selected for registration trials, and that the tumor type most sensitive to the investigative treatment is identified.

Conclusion

We believe using this three-step approach can increase the likelihood of selecting an optimal dose for a registration trial that demonstrates a balanced safety profile while retaining much of the efficacy observed at the MTD.

背景传统的肿瘤登记试验剂量选择通常采用一步或两步单一最大耐受剂量(MTD)法。然而,这种方法可能不适合分子靶向治疗,因为分子靶向治疗的毒性特征往往与细胞毒性药物明显不同。美国食品和药物管理局发起了 Optimus 项目,旨在改革肿瘤药物开发中的剂量优化,最近还发布了一份相关的行业指南。第一步是剂量升级,通过有效的混合设计确定 MTD 或最大给药剂量,这可以提供良好的过量控制,并增加推荐 MTD 接近真实 MTD 的可能性。第二步是根据所有可用数据,包括新出现的安全性、药代动力学、药效学和其他生物标志物信息,选择适当的推荐扩大剂量(RDEs)。第三步是剂量优化,即在扩增阶段利用随机分因子设计的数据,在多个肿瘤队列中探索多个 RDEs,以确保为注册试验选择可行的剂量,并确定对研究性治疗最敏感的肿瘤类型。结论我们相信,采用这种三步法可以增加为注册试验选择最佳剂量的可能性,从而在保留 MTD 观察到的大部分疗效的同时,展示均衡的安全性。
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引用次数: 0
Global trends in clinical trials and interventions for the metabolic syndrome: A comprehensive analysis of the WHO International Clinical Trials platform 代谢综合征临床试验和干预措施的全球趋势:世界卫生组织国际临床试验平台综合分析
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-22 DOI: 10.1016/j.conctc.2024.101330
Ndivhuwo Muvhulawa , Phiwayinkosi V. Dludla , Musawenkosi Ndlovu , Yonela Ntamo , Asanda Mayeye , Nomahlubi Luphondo , Nokulunga Hlengwa , Albertus K. Basson , Sihle E. Mabhida , Sidney Hanser , Sithandiwe E. Mazibuko-Mbeje , Bongani B. Nkambule , Duduzile Ndwandwe

Metabolic syndrome has emerged as a significant global public health concern, necessitating comprehensive examination alongside cardiovascular diseases (CVDs) and type 2 diabetes mellitus (T2D). This study provides a comprehensive analysis of clinical trials, drawing upon data sourced from the International Clinical Trials Registry Platform (ICTRP), until April 2023. Information pertaining to trial attributes and intervention features was gathered and subsequently summarized. Among the 2379 studies found on ICTRP from 18 clinical registries, ClinicalTrials.gov was the most popular with 55 % of the studies, based on data emerging from the United States. Most trials were for treatment (44 %) and prevention (17 %), with fewer focused on basic science, and diagnostic purposes. Diet and exercise were the most prominent, with 710 and 247 studies, respectively. Metformin and statins emerge as leading pharmacological therapies, reflecting the prevalence of CVD and T2D in the context of metabolic syndrome. However, there is growing recognition of other promising interventions, such as Glucagon-Like Peptide-1 agonists and Dipeptidyl Peptidase IV inhibitors, which offer potential in slowing the progression of metabolic syndrome-related conditions. Notably, clinical trials primarily assessed diagnostic markers like lipid profiles, insulin, and blood pressure, rather than body mass and body mass index. These parameters are crucial for evaluating the effectiveness and safety of interventions for metabolic syndrome due to its multi-condition nature. Most studies aimed to address general symptom relief, while highlighting a need for additional well-designed treatment trials with rigorous methodologies in accordance with the World Health Organization's guidance for consistent evaluation and treatment.

代谢综合征已成为全球关注的重大公共卫生问题,需要与心血管疾病(CVD)和 2 型糖尿病(T2D)一起进行全面检查。本研究利用国际临床试验注册平台(ICTRP)提供的数据,对截至 2023 年 4 月的临床试验进行了全面分析。研究人员收集了与试验属性和干预特点相关的信息,随后进行了总结。在国际临床试验注册平台上发现的来自 18 个临床注册机构的 2379 项研究中,ClinicalTrials.gov 最受欢迎,占 55% 的研究,数据来自美国。大多数试验是用于治疗(44%)和预防(17%),较少的试验侧重于基础科学和诊断目的。饮食和运动是最主要的研究,分别有 710 项和 247 项研究。二甲双胍和他汀类药物成为主要的药物疗法,反映了代谢综合征背景下心血管疾病和 T2D 的发病率。然而,越来越多的人认识到其他有前景的干预措施,如胰高血糖素样肽-1激动剂和二肽基肽酶IV抑制剂,它们在减缓代谢综合征相关疾病的进展方面具有潜力。值得注意的是,临床试验主要评估血脂、胰岛素和血压等诊断指标,而不是体重和体重指数。由于代谢综合征的多病因性质,这些参数对于评估代谢综合征干预措施的有效性和安全性至关重要。大多数研究旨在缓解一般症状,同时强调需要根据世界卫生组织的一致评估和治疗指南,采用严格的方法进行更多精心设计的治疗试验。
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引用次数: 0
The Tandem VR™ protocol: Synchronized nature-based and other outdoor experiences in virtual reality for hospice patients and their caregivers Tandem VR™ 协议:在虚拟现实中为安宁疗护患者及其护理人员同步提供基于自然的体验和其他户外体验
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-22 DOI: 10.1016/j.conctc.2024.101318
O. McAnirlin , J. Thrift , F. Li , J.K. Pope , M.H.E.M. Browning , P.P. Moutogiannis , G. Thomas , E. Farrell , M.M. Evatt , T. Fasolino

Background

Nature-based and other outdoor virtual reality (VR) experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.

Methods

Our study uses the synchronized Tandem VR TM approach where patient-caregiver dyads experience immersive nature-based and other outdoor VR content. This mixed methods study will recruit 20 patient-caregiver dyads (N = 40) enrolled in home hospice services nearing EOL. Dyads will experience a personalized nature-based and other outdoor VR experience lasting 5–15 min. Self-reported questionnaires and semi-structured interviews will be collected pre/post the VR intervention to identify the impacts of Tandem VR TM experiences on the QOL, pain, and fear of death in patient-caregiver dyads enrolled with hospice services. Additionally, this protocol will determine the acceptance of Tandem VR TM experiences by dyads as a non-pharmacological modality for addressing patient and caregiver needs. Acceptance will be quantified by the number of dyads accepting or declining the VR experience during recruitment.

Discussion

Using personalized, nature-based and other outdoor VR content, the patient-caregiver dyads can simultaneously engage in an immersive encounter may help alleviate symptoms associated with declining health and EOL phases for the patient and the often overburdened caregiver. This protocol focuses on meeting the need for person-centered, non-pharmacological interventions to reduce physical, psychological, and spiritual distress.

Trial registration

NCT06186960.

背景头戴式显示器(HMD)中基于自然的虚拟现实(VR)体验和其他户外虚拟现实(VR)体验为临终关怀团队提供了强大的非药物工具,可帮助正在经历生命末期(EOL)转变的患者。然而,患者-护理者二元组合的心理困扰是相互关联的,突出了作为一个单元的相互依存性和对困扰的反应能力。我们的研究采用同步串联 VR TM 方法,让患者-护理者二人组体验身临其境的自然和其他户外 VR 内容。这项混合方法研究将招募 20 个病人-护理人员二人组(N = 40),他们都参加了临终关怀服务。二人组将体验 5-15 分钟的个性化自然和其他户外 VR 体验。将在 VR 干预前后收集自我报告问卷和半结构式访谈,以确定 Tandem VR TM 体验对接受临终关怀服务的患者-护理人员二人组的 QOL、疼痛和死亡恐惧的影响。此外,该方案还将确定患者和护理人员对串联 VR TM 体验作为一种非药物治疗方式的接受程度,以满足患者和护理人员的需求。讨论利用个性化、基于自然和其他户外 VR 内容,患者和护理人员可以同时进行身临其境的体验,这可能有助于减轻患者和往往负担过重的护理人员与健康衰退和临终关怀阶段相关的症状。该方案侧重于满足对以人为本的非药物干预的需求,以减轻生理、心理和精神痛苦。
{"title":"The Tandem VR™ protocol: Synchronized nature-based and other outdoor experiences in virtual reality for hospice patients and their caregivers","authors":"O. McAnirlin ,&nbsp;J. Thrift ,&nbsp;F. Li ,&nbsp;J.K. Pope ,&nbsp;M.H.E.M. Browning ,&nbsp;P.P. Moutogiannis ,&nbsp;G. Thomas ,&nbsp;E. Farrell ,&nbsp;M.M. Evatt ,&nbsp;T. Fasolino","doi":"10.1016/j.conctc.2024.101318","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101318","url":null,"abstract":"<div><h3>Background</h3><p>Nature-based and other outdoor virtual reality (VR) experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.</p></div><div><h3>Methods</h3><p>Our study uses the synchronized <em>Tandem VR</em> <sup><em>TM</em></sup> approach where patient-caregiver dyads experience immersive nature-based and other outdoor VR content. This mixed methods study will recruit 20 patient-caregiver dyads (<em>N</em> = 40) enrolled in home hospice services nearing EOL. Dyads will experience a personalized nature-based and other outdoor VR experience lasting 5–15 min. Self-reported questionnaires and semi-structured interviews will be collected pre/post the VR intervention to identify the impacts of <em>Tandem VR</em> <sup><em>TM</em></sup> experiences on the QOL, pain, and fear of death in patient-caregiver dyads enrolled with hospice services. Additionally, this protocol will determine the acceptance of <em>Tandem VR</em> <sup><em>TM</em></sup> experiences by dyads as a non-pharmacological modality for addressing patient and caregiver needs. Acceptance will be quantified by the number of dyads accepting or declining the VR experience during recruitment.</p></div><div><h3>Discussion</h3><p>Using personalized, nature-based and other outdoor VR content, the patient-caregiver dyads can simultaneously engage in an immersive encounter may help alleviate symptoms associated with declining health and EOL phases for the patient and the often overburdened caregiver. This protocol focuses on meeting the need for person-centered, non-pharmacological interventions to reduce physical, psychological, and spiritual distress.</p></div><div><h3>Trial registration</h3><p>NCT06186960.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000656/pdfft?md5=84f862dee4cdabeeeda8e0d2c4bc6af2&pid=1-s2.0-S2451865424000656-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141486767","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
Effectiveness and mechanism of Huoxin pill on heart failure after percutaneous coronary intervention: Study protocol for a double-blind, randomised, placebo-controlled parallel trial 藿香正气丸对经皮冠状动脉介入治疗后心力衰竭的疗效和机制:双盲、随机、安慰剂对照平行试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-19 DOI: 10.1016/j.conctc.2024.101328
Bo-yong Qiu , Bai-rong Xu , Yan-kun Song, Yu-cai Hu, Hong-jie Ren, Jia Zheng, Peng Chen, Yong-xia Wang

Background

Coronary heart disease (CHD) is the most common cardiovascular disease facing human beings. Cardiac remodelling is an important pathological factor for the progression of heart failure (HF) after CHD. At present, Chinese medicine is widely used in the treatment of HF, but there are still some drugs lack of evidence-based and mechanism evidence. Multi-omics techniques can deep explore candidate pathogenic factors and construct gene regulatory networks.This trial is intended to evaluate the effect on Huoxin pill (HXP) in the treatment of HF after programmable communication interface (PCI). Meantime, multi-omics analysis technique will be used to target the fundamental pathological links of cardiac remodelling, so as to study the mechanism of HXP in the treatment of HF after PCI.

Methods

This study is a randomized, double-blind, placebo-controlled trial. Sixty patients with HF undergoing PCI are recruited from the First Affiliated Hospital of Henan University of CM. All selected patients will be randomly attributed to receive conventional treatment + HXP or placebo. The packaging, dosage and smell of placebo and heart activating pill were identical. The primary outcome is NYHA cardiac function grade, while the secondary outcomes included Lee's HF score, exercise tolerance test, and quality of life evaluation. Additional indicators include cardiac ultrasound, electrocardiogram, 24-h dynamic electrocardiogram, myocardial injury indicators, and energy metabolism indicators.

Discussion

This study may provide a new treatment option for patients with HF after PCI and provide evidence for the treatment of CHD and HF with HXP.

Trial registration

2023-10-08 registered in China Clinical Trial Registry, registration number ChiCTR2300076402.

背景冠心病(CHD)是人类最常见的心血管疾病。心脏重塑是冠心病后心力衰竭(HF)进展的重要病理因素。目前,中医药在心力衰竭的治疗中应用广泛,但仍有部分药物缺乏循证和机理证据。本试验旨在评估藿香正气丸(HXP)治疗可编程通信接口(PCI)后心力衰竭的效果。本试验旨在评估藿香正气丸(HXP)治疗可编程通信接口(PCI)术后心房颤动的效果,同时采用多组学分析技术,针对心脏重构的基本病理环节,研究HXP治疗PCI术后心房颤动的机制。本研究为随机、双盲、安慰剂对照试验,从河南中医药大学第一附属医院招募 60 名接受 PCI 治疗的心房颤动患者。所有入选患者将被随机分配接受常规治疗 + HXP 或安慰剂治疗。安慰剂和活心丸的包装、剂量和气味完全相同。主要结果为 NYHA 心功能分级,次要结果包括李氏高频评分、运动耐量测试和生活质量评估。讨论本研究可为PCI术后HF患者提供一种新的治疗选择,并为HXP治疗CHD和HF提供证据。
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引用次数: 0
Effect of trehalose on mortality and disease severity in ICU-admitted patients: Protocol for a triple-blind, randomized, placebo-controlled clinical trial 曲哈洛糖对重症监护病房住院病人死亡率和疾病严重程度的影响:三盲、随机、安慰剂对照临床试验方案
IF 1.5 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-06-18 DOI: 10.1016/j.conctc.2024.101324
Mehrdad Sahranavard , Hesamoddin Hosseinjani , Maryam Emadzadeh , Tannaz Jamialahmadi , Amirhossein Sahebkar

Background

Improvement in organ failure in intensive care unit (ICU) patients is accompanied by lower mortality rate. A disaccharide, trehalose is a candidate to improve organ failure and survival by autophagy induction and enhancing oxidative stress defense. The aim of this study is to assess the effectiveness of trehalose in improving clinical outcome and reducing mortality in ICU patients.

Methods

a triple-blind, randomized, placebo-controlled, two arm, parallel-group, superiority clinical trial will enroll 200 ICU-admitted patients at Imam Reza hospital, Mashhad, Iran. The patients will be randomly allocated to receive either a 100 ml solution of 15 % trehalose or normal saline intravenously. Primary outcomes include ICU mortality and 60-day mortality, while secondary outcomes focus on blood parameters on day 5 and length of hospital/ICU stay.

Conclusion

Trehalose has demonstrated beneficial effects in diverse patients; however, no study has evaluated its effect in all ICU-admitted patients. Consequently, this study provides an opportunity to investigate whether trehalose's anti-inflammatory effects, mediated by inducing autophagy and enhancing oxidative stress defense, can play a role in reducing mortality and improving clinical outcomes in the critically ill patients. If successful, trehalose could offer a potential therapeutic approach in the ICU setting.

背景重症监护室(ICU)患者器官衰竭的改善伴随着死亡率的降低。一种双糖--曲哈洛糖是通过诱导自噬和增强氧化应激防御来改善器官衰竭和存活率的候选物质。本研究的目的是评估曲哈洛糖在改善 ICU 患者临床疗效和降低死亡率方面的有效性。方法一项三盲、随机、安慰剂对照、双臂、平行组、优效临床试验将在伊朗马什哈德的伊玛目礼萨医院招募 200 名 ICU 住院患者。患者将被随机分配静脉注射 100 毫升 15% 曲哈洛糖溶液或生理盐水。主要结果包括重症监护室死亡率和 60 天死亡率,次要结果侧重于第 5 天的血液参数和住院时间/重症监护室住院时间。因此,本研究提供了一个机会,以探讨曲哈洛糖通过诱导自噬和增强氧化应激防御所介导的抗炎作用是否能在降低重症患者死亡率和改善临床预后方面发挥作用。如果研究成功,则可为重症监护病房提供一种潜在的治疗方法。
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引用次数: 0
Publication of observational studies making claims of causation over time 发表观察性研究报告,声称存在长期因果关系
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-17 DOI: 10.1016/j.conctc.2024.101327
Alyson Haslam , Vinay Prasad

To examine methodology characteristics over time and investigate research impact before and after the start of the COVID-19 era, we analyzed original articles published in The New England Journal of Medicine between October 26, 2017 and August 27, 2022. April 1, 2020 was used as the defining date dividing before and after the COVID-19 era. Out of 1051 original articles, 515 (49 %) were before and 536 (51 %) were after the COVID-19 era. Two independent reviewers categorized and reconciled methodology into groups: “randomized trial” (715 articles), “uncontrolled experimental study” (128), “descriptive observational study” (168), and “observational study making a causal claim” (40). We extracted subsequent citations and Altmetric data for each article to assess impact.

The median number of social media shares was 2272 (IQR: 743–7821) for observational studies making a causal conclusion, compared to 306 (IQR: 70–606) for randomized trials (p-value=<0.001). The median Altmetric score for randomized COVID-19 trials (2421, IQR: 1063–3920) was not significantly different than that of COVID-19 observational studies making a causal claim (2583, IQR: 1513–6197, p-value = 0.42), but it was significantly lower than descriptive observational COVID-19 studies (4093, IQR: 2545–6823, p-value = 0.04).

We conclude that there has been a steady increase in the number and percentage of observational studies that make causal conclusions about the efficacy of an intervention. Research concerning COVID-19, regardless of methodology, has seen a sharp rise in dissemination as measured through Altmetric's social media score and subsequent citations.

为了研究不同时期的研究方法特点,并调查 COVID-19 时代开始前后的研究影响,我们分析了 2017 年 10 月 26 日至 2022 年 8 月 27 日期间发表在《新英格兰医学杂志》上的原创文章。2020年4月1日被作为COVID-19时代前后的分界日期。在1051篇原创文章中,515篇(49%)在COVID-19时代之前,536篇(51%)在COVID-19时代之后。两位独立审稿人将研究方法分为以下几组并进行了核对:"随机试验"(715 篇)、"非对照实验研究"(128 篇)、"描述性观察研究"(168 篇)和 "提出因果关系主张的观察研究"(40 篇)。我们提取了每篇文章的后续引用和 Altmetric 数据,以评估其影响力。得出因果结论的观察性研究的社交媒体分享次数中位数为 2272 次(IQR:743-7821),而随机试验的社交媒体分享次数中位数为 306 次(IQR:70-606)(P 值=<0.001)。COVID-19随机试验的Altmetric得分中位数(2421,IQR:1063-3920)与COVID-19提出因果关系结论的观察性研究的Altmetric得分中位数(2583,IQR:1513-6197,p值=0.我们的结论是,对干预措施的疗效做出因果性结论的观察性研究的数量和比例一直在稳步上升。通过 Altmetric 的社交媒体评分和随后的引用情况可以看出,有关 COVID-19 的研究,无论采用何种方法,其传播量都急剧上升。
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引用次数: 0
Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses 针对轻度认知障碍患者的集体非药物多模式干预计划的疗效:单臂干预研究,前后期和外部对照分析
IF 1.4 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-06-14 DOI: 10.1016/j.conctc.2024.101326
Satoshi Nakagawa , Hisatomo Kowa , Yumi Takagi , Yasumasa Kakei , Tatsuo Kagimura , Shoji Sanada , Yoji Nagai

Aim

This study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI).

Methods

A single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores.

Results

Twenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI.

Conclusion

A non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.

目的 本研究旨在评估由体育锻炼、认知刺激和健康教育组成的非药物多模式干预计划对减缓轻度认知障碍(MCI)进展的疗效。方法 对 27 名 MCI 患者进行了单臂干预研究。为了评估干预计划的疗效,研究人员在为期 8 个月的干预前后,使用欧洲量表 5 维度(EQ-5D)、迷你精神状态检查(MMSE)、认知功能测试(CFI)、5 Cog 测试、抑郁和体能表现进行了前后分析。此外,还利用外部对照组患者的 MMSE 评分数据进行了倾向得分和半贝叶斯分析,以比较干预计划和标准医疗护理。在研究期间,虽然 EQ-5D 和 MMSE 分数保持不变(平均变化为 0.02 [95 % 置信区间 (CI):-0.004, 0.04]、0.5 [-0.2, 1.3]),但 CFI 和 5Cog 的子类别(注意力和推理能力)有所改善(平均变化为-1.23 [-2.24, -0.21], 4.3 [0.9, 7.7]、3.0 [0.4, 5.6])。在比较 MMSE 评分变化的附加分析中,接受干预计划的患者比外部对照组患者的评分下降幅度要小(平均变化-1.7 [-2.1, -1.3]),观察到的平均差异为 2.25 [1.46, 3.03],倾向得分调整后的差异为 2.26 [1.46, 3.05]。半贝叶斯方法也表明,干预措施减缓了MCI的进展。
{"title":"Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses","authors":"Satoshi Nakagawa ,&nbsp;Hisatomo Kowa ,&nbsp;Yumi Takagi ,&nbsp;Yasumasa Kakei ,&nbsp;Tatsuo Kagimura ,&nbsp;Shoji Sanada ,&nbsp;Yoji Nagai","doi":"10.1016/j.conctc.2024.101326","DOIUrl":"10.1016/j.conctc.2024.101326","url":null,"abstract":"<div><h3>Aim</h3><p>This study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI).</p></div><div><h3>Methods</h3><p>A single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores.</p></div><div><h3>Results</h3><p>Twenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI.</p></div><div><h3>Conclusion</h3><p>A non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000735/pdfft?md5=759ffd8e4f8aaf04cf854ce7639bb5bd&pid=1-s2.0-S2451865424000735-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141390511","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
Detailed description of multidisciplinary prehabilitation in patients admitted to nerve sparring radical prostatectomy – A randomized feasibility study protocol 神经疏导根治性前列腺切除术入院患者多学科预康复的详细描述--随机可行性研究方案
IF 1.5 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-06-10 DOI: 10.1016/j.conctc.2024.101319
Malene Blumenau Pedersen , John M. Saxton , Brigitta Rasmussen Villumsen , Jørgen Bjerggaard Jensen , Sara Birch

Background

Localized prostate cancer treated with radical prostatectomy is highly effective, though severe side-effects are common after the surgery. Prehabilitation is an approach to optimize patient's physical and mental resources before surgery, to improve postoperative outcomes. The feasibility of a multi-modal home-based prehabilitation program, delivered using telehealth in patients awaiting radical prostatectomy is unknown. This paper describes the development of a prehabilitation program for patients awaiting radical prostatectomy.

Method

A model by The Medical Research Council for developing and evaluating complex interventions (MRC Framework) was used in the development process. The Template for Intervention Description and Replication (TIDieR) checklist was applied for ensuring sufficient description of the interventions. A total of 40 patients will be randomized to either intervention or control group. Patients in the control group will follow standard care. The 4-week prehabilitation programme consists of exercise, pelvic floor exercise, sexual counseling, stress management and nutritional support. The interventions are home-based and delivered using telehealth. Feasibility outcomes will include recruitment, attrition rates, adherence, safety and suitability.

Conclusion

We have developed a multimodal prehabilitation programme, which has the potential to bring tangible health benefits to men with prostate cancer awaiting radical prostatectomy. The results of the feasibility study will inform the design of a fully powered randomized controlled trial.

背景采用根治性前列腺切除术治疗局部前列腺癌疗效显著,但术后常见严重的副作用。术前康复是一种在手术前优化患者身心资源,以改善术后效果的方法。利用远程医疗技术为等待前列腺癌根治术的患者提供多模式家庭康复计划的可行性尚不清楚。本文介绍了为等待前列腺癌根治术的患者制定康复计划的过程。方法在制定过程中使用了医学研究委员会制定和评估复杂干预措施的模型(MRC 框架)。为确保对干预措施进行充分描述,采用了干预措施描述和复制模板(TIDieR)核对表。共有 40 名患者将被随机分配到干预组或对照组。对照组患者将接受标准护理。为期 4 周的预康复计划包括运动、盆底肌锻炼、性咨询、压力管理和营养支持。干预措施以家庭为基础,通过远程医疗提供。可行性结果将包括招募率、减员率、依从性、安全性和适用性。结论我们开发了一种多模式康复前计划,它有可能为等待前列腺癌根治术的男性患者带来切实的健康益处。可行性研究的结果将为设计完全有效的随机对照试验提供参考。
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引用次数: 0
Protocol for a feasibility randomized controlled trial of gentle yoga in older patients discharged from phase II cardiac rehabilitation 针对从第二阶段心脏康复出院的老年患者开展的轻柔瑜伽可行性随机对照试验方案
IF 1.5 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-06-04 DOI: 10.1016/j.conctc.2024.101320
Geunyeong Cha , Misook L. Chung , Nicholas R. Heebner , Ulf G. Bronas , Martha J. Biddle , Chin-Yen Lin , JungHee Kang , Jia-Rong Wu , Jessica H. Thompson , Ashmita Thapa , Debra K. Moser

Background

Physical activity (PA) is essential following an acute cardiac event. Cardiac rehabilitation (CR) is commonly prescribed, and PA after CR is recommended. Because of age-related changes in functional ability and multi-comorbidity, many older cardiac patients struggle to continue performing PA at home after CR. Depressive symptoms and anxiety are prevalent in cardiac patients and associated with poor self-care, including lack of daily PA. Yoga has been demonstrated to improve psychological and physical health outcomes in cardiac patients, but it is unknown whether yoga, modified for older CR patients – Gentle Yoga – is beneficial in managing psychological distress and maintaining PA following phase II CR. Our specific aims are to:1) determine the feasibility and acceptability of a modified gentle yoga intervention delivered via video conferencing for older cardiac patients; 2) compare, at 3-month follow-up, the effects and determine effect sizes of a gentle yoga intervention versus control on psychological health and physical health.

Methods

We are conducting a 2-group (intervention versus control) randomized controlled pilot study. The intervention is a 12-week gentle yoga program delivered via video conference. Short-term effects will be evaluated at 3-month.

Conclusion

This study is designed to be suited for older cardiac patients who would not have access to supervised PA opportunities after facility-based CR to enhance PA. This study will provide data about the feasibility and acceptability of the protocol for older cardiac patients and will offer effect sizes to determine sample size for a fully powered randomized controlled trial.

背景急性心脏事件发生后,体力活动(PA)至关重要。心脏康复(CR)是常见的处方,建议在心脏康复后进行体力活动。由于与年龄相关的功能变化和多病并发症,许多老年心脏病患者在心脏康复后难以在家中继续进行体力活动。心脏病患者普遍存在抑郁症状和焦虑,这与自我护理能力差有关,包括缺乏日常 PA。瑜伽已被证明能改善心脏病患者的心理和生理健康状况,但针对老年 CR 患者改良的瑜伽--轻柔瑜伽--是否能在第二阶段 CR 后对控制心理压力和维持 PA 有益,目前还不得而知。我们的具体目标是:1)确定通过视频会议为老年心脏病患者提供改良的温和瑜伽干预的可行性和可接受性;2)在 3 个月的随访中,比较温和瑜伽干预与对照对心理健康和身体健康的影响,并确定影响大小。干预措施是通过视频会议进行的为期 12 周的温和瑜伽课程。结论这项研究的目的是为老年心脏病患者设计的,因为他们在以医院为基础的康复治疗后无法获得有监督的体育锻炼机会,以加强体育锻炼。这项研究将为老年心脏病患者提供有关该方案的可行性和可接受性的数据,并将提供效应大小,以确定全面随机对照试验的样本大小。
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引用次数: 0
期刊
Contemporary Clinical Trials Communications
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