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A multicomponent smoking cessation program for adults with Type 2 Diabetes Mellitus (DiMe-SALUD2 project): A study protocol of a randomized controlled trial 针对 2 型糖尿病成人的多成分戒烟计划(DiMe-SALUD2 项目):随机对照试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-28 DOI: 10.1016/j.conctc.2024.101361
Carla López-Núñez , Sergio Fernández-Artamendi , Desirée Ruiz-Aranda , Davinia María Resurrección , Desirée Navas-Campaña

Background

Tobacco use represents a significant public health burden, being especially harmful for smokers with Type 2 Diabetes Mellitus (T2DM). Effective smoking cessation interventions are required for this vulnerable population. The goal is to describe a study protocol of a randomized controlled trial (RCT) aimed at analyzing the effectiveness and efficiency of a multicomponent smoking cessation intervention for T2DM smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM (DiMe-SALUD2 project).

Methods

This RCT will assign participants to: (1) Control Group (n = 30), including a brief psychoeducation advice about smoking cessation; (2) Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), based on a multicomponent program implemented in group-based sessions over an eight-week period; and (3) CBT plus DiMeSALUD2 protocol (n = 30), which will develop an additional psychoeducational protocol specifically designed to improve healthy lifestyle habits. Participants will be assessed at baseline, post-treatment and several follow-ups (1-, 6- and 12-months). Primary outcomes will include smoking abstinence (24-h point prevalence abstinence at post-treatment and 7-day point prevalence at follow-ups) and smoking continuous abstinence. Secondary outcomes will include treatment retention, changes in smoking patterns and nicotine dependence, as well as the impact on T2DM clinical variables, mental health, and quality of life.

Discussion

The DiMeSALUD2 program could assist T2DM smokers in quitting tobacco use and improving their overall quality of life. This project will help incorporating improvements in routine clinical practice with T2DM patients, offering a smoking cessation program adapted to their specific needs.

Trial registration

ClinicalTrials.gov. Identifier: NCT05885659. Date of registration: June 2nd, 2023.

背景吸烟是一项重大的公共卫生负担,对患有 2 型糖尿病(T2DM)的吸烟者危害尤其严重。对于这一弱势群体,需要采取有效的戒烟干预措施。本研究旨在描述一项随机对照试验(RCT)的研究方案,旨在分析针对 T2DM 吸烟者的多成分戒烟干预措施的有效性和效率,包括健康生活习惯和 T2DM 自我管理的培训方案(DiMe-SALUD2 项目)。方法这项 RCT 将把参与者分配到:(1)对照组(n = 30),包括关于戒烟的简短心理教育建议;(2)戒烟认知行为治疗(CBT)(n = 30),基于在为期八周的小组会议中实施的多组分方案;(3)CBT 加 DiMeSALUD2 方案(n = 30),该方案将制定专门用于改善健康生活习惯的额外心理教育方案。参与者将在基线、治疗后和多次随访(1 个月、6 个月和 12 个月)时接受评估。主要结果包括戒烟率(治疗后 24 小时点戒烟率和随访时 7 天点戒烟率)和持续戒烟率。次要结果将包括治疗保持率、吸烟模式和尼古丁依赖的变化,以及对T2DM临床变量、心理健康和生活质量的影响。讨论DiMeSALUD2项目可帮助T2DM吸烟者戒烟并改善他们的整体生活质量。该项目将有助于改善T2DM患者的常规临床实践,提供适合其特殊需求的戒烟计划。标识符:NCT05885659。注册日期:注册日期:2023 年 6 月 2 日。
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引用次数: 0
Study protocol for a randomized controlled trial of neurofeedback mindfulness in chronic migraines 慢性偏头痛神经反馈正念随机对照试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-28 DOI: 10.1016/j.conctc.2024.101362
Faly Golshan , Rachel Lysenko , Monika Nabi Zade , Parham Alibolandi , Haley Block , Paul Masiowski , Megan E. O'Connell , Gloria Sun , Marla Mickleborough

Chronic migraine is a debilitating headache disorder that is associated with excessive analgesic use. As the long-term use of analgesics could cause additional headaches due to medication overuse, there is a need to probe efficient nonprophylactic alternatives and migraineurs’ long-term adherence to such possible treatments. This protocol investigates the integration of neurofeedback and mindfulness which are the two common nonpharmacological therapies for migraines. We offer the use of portable EEG headbands for easy home-based data collection and consistent data access from researchers. In order to evaluate the efficacy of this recommended intervention, this is a protocol for a randomized control trial with a waitlisted group and an intervention group consisting of a daily attention task. The protocol presents important criteria which should be checked for consistency in longitudinal data collection from adults with chronic migraine.

慢性偏头痛是一种使人衰弱的头痛疾病,与过度使用镇痛药有关。由于长期使用镇痛药可能会因用药过度而导致更多头痛,因此有必要研究高效的非预防性替代疗法以及偏头痛患者对这些可能疗法的长期依从性。本方案研究了神经反馈和正念这两种常见的偏头痛非药物疗法的整合。我们提供便携式脑电图头带,方便研究人员在家收集数据并持续访问数据。为了评估这种推荐干预方法的疗效,我们制定了随机对照试验方案,其中包括候补组和干预组,干预组包括每日注意力任务。该方案提出了一些重要标准,在对患有慢性偏头痛的成年人进行纵向数据收集时,应检查这些标准是否一致。
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引用次数: 0
Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial 创伤性脑损伤后护理者健康(CG-Well):随机临床试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101356
Natalie Kreitzer , Stephanie Fink , Opeolu Adeoye , Brad Kurowski G , Shari Wade , Heidi Sucharew , Tamilyn Bakas

Introduction

After injury, survivors of moderate to severe traumatic brain injury (msTBI) depend on informal family caregivers. Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. The majority of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information to either survivors only, or to long-term caregivers, rather than to the new caregiver. This manuscript describes the protocol of an ongoing randomized control trial, Caregiver Wellness after TBI (CG-Well), developed to provide education, support, and skill-building to caregivers of adults with msTBI, beginning when the survivor is early in the clinical course.

Methods

Within two weeks of admission to the ICU, participants are randomized to CG-Well online modules (intervention group, n = 50 dyads) or information, support, and referral (ISR) e-bulletins that exist in the public domain (control group, n = 50 dyads) over the first six months after their family member's msTBI. Both groups receive regular phone calls. The primary outcome is intervention satisfaction at six months.

Results

Enrollment began in March 2022 and is projected to complete October 2024. We have enrolled approximately 70 % of participants at this time. Primary analysis completion is anticipated April 2025.

Discussion

This RCT is designed to evaluate caregiver satisfaction by addressing the need for tailored supportive care for caregivers of msTBI beginning during the ICU admission.

Trial registration

Clinicaltrials. gov Registration Number: NCT05307640.

导言中重度创伤性脑损伤(msTBI)幸存者在受伤后主要依靠非正式的家庭照顾者。多达 77% 的家庭照护者经历了不良后果,如不利的生活变化、与健康相关的生活质量低下以及抑郁症状加重。照护者经常报告说,对他们的支持或培训少之又少,无法让他们为自己的新角色做好准备。之前开发的大多数毫秒创伤性脑损伤后照护者和照护者/幸存者组合干预措施都侧重于仅向幸存者或长期照护者提供信息,而不是向新的照护者提供信息。本手稿介绍了一项正在进行中的随机对照试验 "TBI 后照顾者健康"(CG-Well)的方案,该方案旨在为患有毫秒创伤性脑损伤的成人照顾者提供教育、支持和技能培训,从幸存者的早期临床病程开始。方法在重症监护室入院两周内,参与者被随机分配到 CG-Well 在线模块(干预组,n = 50 对)或信息、支持和转介(ISR)电子公告(对照组,n = 50 对),这些电子公告存在于公共领域(对照组,n = 50 对)。两组都会定期接到电话。主要结果是六个月后的干预满意度。结果招募工作于 2022 年 3 月开始,预计于 2024 年 10 月结束。目前,我们已招募了约 70% 的参与者。讨论该研究旨在评估护理人员的满意度,方法是满足毫秒创伤性脑损伤护理人员在入住重症监护室期间对量身定制的支持性护理的需求:NCT05307640。
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引用次数: 0
Increasing participation in resistance training using outdoor gyms: A study protocol for the ecofit type III hybrid effectiveness implementation trial 利用户外健身房提高阻力训练的参与度:生态健身房 III 型混合效果实施试验的研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101358
Anna K. Jansson , David R. Lubans , Mitch J. Duncan , Jordan J. Smith , Adrian Bauman , John Attia , Sara L. Robards , Emily R. Cox , Sam Beacroft , Ronald C. Plotnikoff

Background

In this paper we outline the protocol for an implementation-effectiveness trial of ecofit, a multi-component mHealth intervention aimed at increasing participation in resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the ecofit program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., ‘Low’ versus ‘Moderate’) on the reach (primary outcome), uptake, dose received, impact and fidelity of the ecofit program.

Research design and methods

This hybrid type III implementation-effectiveness study will be evaluated using a two-arm randomized controlled trial, including 16 outdoor gym locations in two large regional municipalities in New South Wales, Australia. Outdoor gym locations will be pair-matched, based on an established socio-economic status consensus-based index (high versus low), and randomized to the ‘Low’ (i.e., ecofit app only) or ‘Moderate’ (i.e., ecofit app, face-to-face workout sessions and QR codes) implementation support group. The primary outcome of ‘reach’ will be measured using a modified version of the ‘System for Observing Play and Recreation in Communities’, capturing outdoor gym use amongst community members.

Conclusion

This implementation-effectiveness trial will evaluate the effects of different levels of implementation support on participation in resistance-focused physical activity using mHealth and outdoor gyms across the broader community. This may guide widespread dissemination for councils (municipalities) nation-wide wanting to promote outdoor gym usage.

Trial registry

This trial was preregistered with the Australian and New Zealand Clinical Trial Registry (ACTRN12624000261516).

背景在本文中,我们概述了 ecofit 的实施效果试验方案,这是一项多成分移动保健干预措施,旨在利用户外建筑环境(即户外健身房)和社会支持来提高阻力和有氧体育活动的参与率。此前,我们已分别在活动量不足的 2 型糖尿病患者(或高风险患者)和居住在社区的成年人中证实了 ecofit 计划的有效性和有效性。本试验的目的是比较两种实施支持模式(即 "低度 "与 "中度")对 ecofit 计划的覆盖率(主要结果)、吸收率、接受剂量、影响和忠实度的影响。研究设计与方法这项混合 III 型实施效果研究将采用双臂随机对照试验进行评估,包括澳大利亚新南威尔士州两个大型地区城市的 16 个户外健身房地点。户外健身房地点将根据既定的社会经济地位共识指数(高与低)进行配对,并随机分配到 "低度"(即仅使用 ecofit 应用程序)或 "中度"(即使用 ecofit 应用程序、面对面锻炼课程和二维码)实施支持组。主要结果 "覆盖范围 "将使用 "社区游戏和娱乐观察系统 "的修订版进行测量,以了解社区成员使用户外健身房的情况。 结论这项实施效果试验将评估不同程度的实施支持对在更广泛的社区内使用移动医疗和户外健身房参与抗阻力体育活动的影响。该试验已在澳大利亚和新西兰临床试验登记处(ACTRN12624000261516)进行了预先登记。
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引用次数: 0
Comparing different session regimens of electroacupuncture for chronic plantar fasciitis: Study protocol for a randomized clinical trial 比较电针治疗慢性足底筋膜炎的不同疗程:随机临床试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101355
Jiaxiang Shi , Ruimin Jiao , Yan Liu , Xinkun Liu , Yingxin Sun , Hangyu Shi , Ning Gao , Zhishun Liu , Jun Liang , Weiming Wang

Background

Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials.

Methods/design

This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the P value < 0.05 on a two-sided basis.

Discussion

This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of different electroacupuncture sessions (one session per week versus three sessions per week) for chronic PF. This study aims to contribute in produce up-to-date, rigorous evidence on the most effective frequency of electroacupuncture in managing chronic PF.

Trial registration Clinicaltrials.gov Identifier: NCT06284993. Registered on February 17, 2024.

背景足底筋膜炎(PF)是足跟痛最常见的原因之一,以往的研究发现针灸能有效缓解足底筋膜炎患者的疼痛。然而,不同疗程的电针治疗对足底筋膜炎的影响尚未通过随机对照试验进行研究。方法/设计这是一项两组平行、评估者盲法随机对照试验,包括为期四周的治疗阶段和为期 12 周的随访。将招募 80 名慢性前列腺增生症患者,按 1:1 的比例随机分配接受 12 个疗程(每周 3 个疗程;每周多次电针治疗组(M 组))或 4 个疗程(每周 1 个疗程;每周单次电针治疗组(S 组))的电针治疗。研究的主要结果是应答率,即与基线相比,早晨迈出第一步时最严重的疼痛强度至少改善 50%。我们将根据意向治疗原则进行所有分析,在双侧基础上,当 P 值为 0.05 时,则认为差异显著。讨论这项前瞻性试验将为评估不同电针疗程(每周一个疗程与每周三个疗程)治疗慢性前列腺增生症的疗效和安全性提供高质量的证据。该研究旨在为电针治疗慢性脚气的最有效频率提供最新、最严谨的证据。试验注册 Clinicaltrials.gov Identifier:NCT06284993。注册日期:2024 年 2 月 17 日。
{"title":"Comparing different session regimens of electroacupuncture for chronic plantar fasciitis: Study protocol for a randomized clinical trial","authors":"Jiaxiang Shi ,&nbsp;Ruimin Jiao ,&nbsp;Yan Liu ,&nbsp;Xinkun Liu ,&nbsp;Yingxin Sun ,&nbsp;Hangyu Shi ,&nbsp;Ning Gao ,&nbsp;Zhishun Liu ,&nbsp;Jun Liang ,&nbsp;Weiming Wang","doi":"10.1016/j.conctc.2024.101355","DOIUrl":"10.1016/j.conctc.2024.101355","url":null,"abstract":"<div><h3>Background</h3><p>Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials.</p></div><div><h3>Methods/design</h3><p>This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the <em>P</em> value &lt; 0.05 on a two-sided basis.</p></div><div><h3>Discussion</h3><p>This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of different electroacupuncture sessions (one session per week versus three sessions per week) for chronic PF. This study aims to contribute in produce up-to-date, rigorous evidence on the most effective frequency of electroacupuncture in managing chronic PF.</p><p>Trial registration Clinicaltrials.gov Identifier: NCT06284993. Registered on February 17, 2024.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101355"},"PeriodicalIF":1.4,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001029/pdfft?md5=09f202974de9c3e5ec9ed7df509d221d&pid=1-s2.0-S2451865424001029-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142076956","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
The digital MySteps intervention for abused women at risk for firearm-related injuries and homicides: Findings from the feasibility, acceptability and preliminary efficacy trial 针对有枪支相关伤害和杀人风险的受虐妇女的数字 MySteps 干预措施:可行性、可接受性和初步疗效试验结果
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101357
Bushra Sabri, Theresa Mata, Jian Li, Sara Butter, Jacquelyn C. Campbell, Chakra Budhathoki

Background

Firearms are the leading cause of victimization of abused women by intimate partner homicide and intimate partner homicide-suicides in the US. This calls for evidence-based intervention strategies to prevent firearm-related injuries or mortality and address the firearms-related safety needs of women in abusive relationships. My Safety Steps (MySteps) was designed to comprehensively assess women's firearm-related risks, and current safety needs and to prevent women's harm from their abuser's access or ownership of a firearm through a digitally delivered firearm-focused safety planning intervention. This paper describes the development, feasibility, acceptability, and preliminary evaluation of the digital BSHAPE intervention among women survivors of intimate partner violence (IPV).

Methods

Using a pretest post-test control group design, the study was conducted with 103 participants with 55 women randomly assigned to the MySteps arm and 48 women to the standard of care control arm. The feasibility and acceptability outcomes assessed were enrollment, adherence, and perceptions of the intervention. Preliminary evaluation outcomes included the partner's access to a firearm, women's self-efficacy beliefs, and empowerment. Further, qualitative follow-up interviews were conducted with 30 survivors of IPV in the MySteps arm to follow up on the use and helpfulness of safety strategies provided in MySteps.

Results and conclusion

The intervention was found to be feasible, and acceptable and demonstrated improved outcomes for survivors of IPV at risk from their partner's firearm. Women provided feedback for further refinement. The findings of this study will be useful in further refining MySteps and testing it in a full-scale randomized controlled trial.

背景在美国,枪支是亲密伴侣凶杀案和亲密伴侣凶杀-自杀案中受虐妇女受害的主要原因。这就要求我们采取循证干预策略,防止与枪支有关的伤害或死亡,并满足受虐待妇女在枪支安全方面的需求。我的安全步骤(MySteps)旨在全面评估女性与枪支相关的风险和当前的安全需求,并通过数字交付的以枪支为重点的安全规划干预措施,防止女性因施虐者获得或拥有枪支而受到伤害。本文介绍了数字 BSHAPE 干预措施在亲密伴侣暴力(IPV)女性幸存者中的开发、可行性、可接受性和初步评估情况。研究方法采用前测后测对照组设计,有 103 名参与者参加,其中 55 名女性被随机分配到 MySteps 组,48 名女性被分配到标准护理对照组。可行性和可接受性的评估结果包括注册、坚持和对干预的看法。初步评估结果包括伴侣获得枪支的机会、妇女的自我效能信念和赋权。此外,还对参加 MySteps 小组的 30 名 IPV 幸存者进行了定性跟踪访谈,以跟踪了解 MySteps 所提供的安全策略的使用情况和有用性。妇女们提供了进一步改进的反馈意见。本研究的结果将有助于进一步完善 MySteps,并在全面的随机对照试验中进行测试。
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引用次数: 0
Novel approach for oligospermia (NAPO) - Protocol for a randomized controlled trial 治疗少精症的新方法(NAPO)--随机对照试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-22 DOI: 10.1016/j.conctc.2024.101352
Sam Kafai Yahyavi , Mads Joon Jorsal , Rune Holt , Bugge Nøhr , Martin Blomberg Jensen

Background

Infertility affects millions of couples globally, with up to 40–50 % of cases linked to impaired semen quality. Insemination or in vitro fertilization are used frequently, regardless of the cause of infertility due to the lack of specific medical interventions for male infertility. Denosumab, an antibody blocking RANKL signaling, may enhance semen quality in infertile men. This randomized controlled trial evaluates if denosumab improves spermatogenesis in men with severely impaired semen quality identified by serum AMH levels as a predictive marker.

Methods

NAPO is a single-center, sponsor-investigator-initiated, placebo-controlled, double-blinded randomized trial. Subjects will be randomized in a 2:1 fashion to receive either denosumab 60 mg subcutaneously or a placebo. The study will be carried out at the Division of Translational Endocrinology, Copenhagen University Hospital, Herlev, Denmark. The primary outcome of the study is defined as the difference in sperm concentration (millions/mL) at one spermatogenesis (80 days) after inclusion.

Discussion

An important step in addressing infertility is establishing a viable treatment option for male infertility. With this study, we describe the protocol for a planned RCT aimed at evaluating whether treatment with denosumab can improve sperm concentration in men with severely impaired semen quality. The results of this study will provide evidence crucial for future treatment in a patient group where treatment options are minimal at best.

Trial registration

Clinical Trials: NCT06300229. Registered on March 12, 2024. Clinical Trials Information System (CTIS): 2023-508325-27-00. Approved on December 19, 2023.

背景全球有数百万对夫妇患有不育症,其中高达 40-50% 的病例与精液质量受损有关。由于缺乏针对男性不育症的特殊医疗干预措施,无论不育的原因是什么,授精或体外受精都被频繁使用。地诺单抗是一种阻断 RANKL 信号传导的抗体,可提高不育男性的精液质量。这项随机对照试验将评估地诺单抗是否能改善以血清AMH水平为预测指标的精液质量严重受损男性的生精功能。方法NAPO是一项由赞助商-调查员发起的单中心、安慰剂对照、双盲随机试验。受试者将按 2:1 的比例随机接受皮下注射 60 毫克地诺单抗或安慰剂。研究将在丹麦赫勒夫的哥本哈根大学医院转化内分泌科进行。研究的主要结果是纳入研究后一次精子生成(80 天)时精子浓度(百万/毫升)的差异。通过这项研究,我们描述了一项计划中的 RCT 方案,该方案旨在评估使用地诺单抗治疗是否能改善精液质量严重受损的男性的精子浓度。这项研究的结果将为这一患者群体未来的治疗提供至关重要的证据:NCT06300229。注册日期:2024 年 3 月 12 日。临床试验信息系统(CTIS):2023-508325-27-00。批准日期:2023 年 12 月 19 日。
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引用次数: 0
Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial 传统中医手法治疗颈源性头晕的安全性和有效性:随机对照多中心试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-18 DOI: 10.1016/j.conctc.2024.101349
Yunfan Zhan , Yujie Zhang , Kaoqiang Liu , Ye Zhao , Jiawei Ning , Yongli Chai , Lingjun Kong , Weian Yuan

Background

Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.

Methods

A multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.

Discussion

This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.

Trial registration

Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.

Protocol version

1.0, November 20, 2022.

背景颈源性头晕是一种以颈部疼痛和头晕为特征的临床综合征,近年来发病率呈上升趋势。在中国,手法治疗已被广泛用于颈源性头晕的治疗,但目前尚无高质量的医学证据支持其有效性和安全性。本研究的目的是评估施氏手法疗法(SMT)治疗颈源性头晕的安全性和有效性。方法将对106名符合颈源性头晕诊断标准的患者(18≤年龄≤65岁)进行多中心随机对照试验(RCT)。患者将按 1:1 的比例随机分配到干预组和对照组。对照组患者将接受美利曲隆(甲磺酸倍他司汀片)治疗。干预组的参与者将接受 SMT 治疗。主要结果是第 2 周的应答率,即通过头晕障碍量表 (DHI) 评分衡量的残疾程度相对于基线有所减轻的患者比例。主要次要结果包括第 1、2 和 6 周的 DHI 评分以及与基线相比的变化、头晕症状消失时间和头晕症状复发率。安全性将通过不良事件、体格检查和生命体征进行评估。讨论本试验旨在提供高质量的循证医学数据,证明SMT能有效、安全地减轻颈源性头晕患者的头晕症状。注册日期:2022年11月3日。协议版本1.0,2022年11月20日。
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引用次数: 0
Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide 通过标记化将临床试验参与者与他们在美国真实世界的数据联系起来:实用指南
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-17 DOI: 10.1016/j.conctc.2024.101354
Michael J. Eckrote , Carrie M. Nielson , Mike Lu , Tyler Alexander , Rikisha Shah Gupta , Kim Wah Low , Zhiwei Zhang , Austin Eliazar , Reyna Klesh , Andrew Kress , Matt Bryant , Alex Asiimwe , Nicolle M. Gatto , Nancy A. Dreyer

In drug development, the use of real-world data (RWD) has augmented our understanding of patients’ health care experiences and the effects of treatments beyond clinical trials. Although electronic health record (EHR) data integration at clinical trial sites is a widely adopted practice, primarily for recruitment and data capture, a challenge to data utility is the fragmentation of health data across different sources.

Linking RWD sources to each other and to trial data -- while preserving patient privacy through tokenization -- aids in filling evidence gaps with outcome data and facilitates the generalization of effects from controlled trial environments to real-world settings. This paper describes the applications of RWD linkage and how they benefit both clinical development and real-world decision-making. Trial benefits include improving interpretability and generalizability (e.g., by remediating missing data or losses to follow-up), extending follow-up beyond trial closeout, and characterizing the applicability of trial results to under-represented groups.

The operational aspects of linking trial data to RWD are addressed, emphasizing the importance of using privacy-preserving record linking systems with established metrics of accuracy and precision, managing consent, and providing the necessary training and resources at trial sites to inform participants about providing access to their RWD through data linkage.

在药物开发过程中,真实世界数据(RWD)的使用增强了我们对患者医疗保健经历和临床试验之外的治疗效果的了解。虽然临床试验机构广泛采用了电子健康记录(EHR)数据整合的做法,主要用于招募和数据采集,但数据实用性面临的一个挑战是不同来源的健康数据支离破碎。将 RWD 数据源相互连接并与试验数据相连接--同时通过标记化保护患者隐私--有助于填补结果数据的证据缺口,并促进将对照试验环境中的效果推广到真实世界环境中。本文介绍了 RWD 链接的应用,以及它们如何使临床开发和实际决策受益。本文讨论了将试验数据与 RWD 链接的操作方面,强调了使用具有既定准确性和精确性指标的隐私保护记录链接系统、管理同意书以及在试验点提供必要的培训和资源以告知参与者通过数据链接访问其 RWD 的重要性。
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引用次数: 0
Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language 患者参与由讲一种或多种英语以外语言的主要研究者进行的临床试验:探索作为语言替代物的种族
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-17 DOI: 10.1016/j.conctc.2024.101353
Anne Rivelli , Osondi Ozoani-Lohrer , Cheryl Lefaiver , Maureen Shields , Andy Marek , Mercedes Robaina , Veronica Fitzpatrick

Background

To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.

Methods

This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.

Results

Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).

Conclusions

Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.

背景探讨作为语言替代物的种族与除英语外还会讲一种或多种语言的主要研究者(PI)参与临床试验(CT)之间的关联。方法这项回顾性、描述性研究利用了 2019 年 1 月 1 日至 2021 年 12 月 31 日期间从中西部最大的非营利性医疗保健系统中提取的 CT 参与者人口统计数据。为便于比较,对 CT 参与者样本(N = 4308)进行了划分:西班牙裔或拉丁裔 CT 参与者(N = 254;5.90%)和非西班牙裔或拉丁裔 CT 参与者(N = 4054;94.10%)。结果粗略分析显示,西班牙裔或拉丁裔患者参加由除英语外还会讲其他语言的主治医师主持的 CT 的几率是参加由除英语外还会讲其他语言的主治医师主持的 CT 的几率的 2.04 (1.58, 2.64) 倍(<0.结论总体研究结果表明,西班牙裔或拉丁裔患者更有可能讲西班牙语,他们参与由讲英语以外另一种语言的主治医师进行的 CT 的几率更大。这可能意味着,CT 研究团队高层的文化敏感性(除英语外还会讲另一种语言的 PI 可能会表现出这种敏感性)可能是减少基于种族和语言的 CT 多样性障碍的重要因素,这种关系值得进一步探讨。
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引用次数: 0
期刊
Contemporary Clinical Trials Communications
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