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Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials 筛查日志:妇科肿瘤临床试验社区患者招募面临的挑战
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-29 DOI: 10.1016/j.conctc.2024.101379
Rubina Ratnaparkhi , Gary C. Doolittle , Hope Krebill , Michelle Springer , Elizabeth Calhoun , Andrea Jewell , Dinesh Pal Mudaranthakam

Background

Clinical trial participation can improve overall survival and mitigate healthcare disparities for gynecologic cancer patients in low-volume community centers. This study aimed to assess the effectiveness of a centrally regulated but administratively decentralized electronic screening log system to identify eligible patients across a large catchment area for a National Cancer Institute (NCI)-designated cancer center's open clinical trials.

Methods

Electronic screening log data collected between 2014 and 2021 from ten community partner sites in a single NCI-designated cancer center's catchment area were reviewed retrospectively. Clinical factors assessed included cancer site, primary versus recurrent disease status, and histology. Identification efficiency (the ratio of patients screened identified with an available trial) was calculated. Identification inefficiencies (failures to identify patients with a potentially relevant trial) were assessed, and etiologies were characterized.

Results

Across ten community partner sites, 492 gynecologic cancer patients were screened for seven open clinical trials during the study period. This included 170 (34.5 %) ovarian cancer patients, 156 (31.7 %) endometrial cancer patients, and 119 (24.2 %) cervical cancer patients. Over 40 % had advanced stage disease, and 10.6 % had recurrent disease. Only three patients were identified as having a relevant open trial; none ultimately enrolled due to not meeting trial eligibility criteria. An additional 2–52 patients were retrospectively found to have a relevant trial available despite not being identified as such within the electronic screening log system. Up to 14.4 % of patients had one or more missing minimum data elements that hindered full evaluation of clinical trial availability. Re-screening patients when new trials open may identify 12-15 additional patients per recurrent disease trial.

Conclusions

An electronic screening log system can increase awareness of gynecologic oncology clinical trials at a NCI-designated cancer center's community partner sites. However, it is inadequate as a single intervention to increase clinical trial enrollment. Providing adequate support staff, documenting clinical factors consistently, re-screening patients at relevant intervals, and coordinating with central study personnel may increase its utility.
背景参与临床试验可以提高低容量社区中心妇科癌症患者的总生存率,并减少医疗保健方面的差异。本研究旨在评估一个集中管理但行政分散的电子筛查日志系统的有效性,该系统可在一个大的覆盖区内识别符合美国国家癌症研究所(NCI)指定的癌症中心开放临床试验条件的患者。方法回顾性审查了2014年至2021年期间从一个NCI指定的癌症中心覆盖区内的10个社区合作站点收集的电子筛查日志数据。评估的临床因素包括癌症部位、原发性与复发性疾病状态以及组织学。计算了识别效率(筛查出的患者中获得可用试验的比例)。结果在研究期间,10 个社区合作机构共为 492 名妇科癌症患者筛查了 7 项公开临床试验。其中包括 170 名(34.5%)卵巢癌患者、156 名(31.7%)子宫内膜癌患者和 119 名(24.2%)宫颈癌患者。超过 40% 的患者处于晚期,10.6% 的患者病情复发。只有 3 名患者被认定接受过相关的公开试验,但由于不符合试验资格标准,最终无一人入选。另外有 2-52 名患者被回顾性地发现有相关试验,尽管在电子筛选记录系统中并未被识别为相关试验。多达 14.4% 的患者缺少一个或多个最低数据元素,这阻碍了对临床试验可用性的全面评估。结论电子筛查日志系统可以提高NCI指定癌症中心的社区合作机构对妇科肿瘤临床试验的认识。然而,仅靠该系统不足以提高临床试验的注册率。提供足够的支持人员、持续记录临床因素、在相关时间间隔重新筛查患者,以及与中央研究人员协调,都可以提高该系统的效用。
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引用次数: 0
A character-strengths based coaching intervention to improve wellbeing of rural community health workers in Madhya Pradesh, India: Protocol for a single-blind randomized controlled trial 基于性格力量的辅导干预,改善印度中央邦农村社区卫生工作人员的福祉:单盲随机对照试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-27 DOI: 10.1016/j.conctc.2024.101377
Ameya P. Bondre , Azaz Khan , Abhishek Singh , Spriha Singh , Ritu Shrivastava , Narendra Verma , Aashish Ranjan , Jyotsna Agrawal , Seema Mehrotra , Rahul Shidhaye , Anant Bhan , John A. Naslund , Steve D. Hollon , Deepak Tugnawat

Background

There is scarce knowledge on the use of structured positive psychology interventions for reducing work-stress and improving wellbeing of rural community health workers in India, particularly the Accredited Social Health Activists (ASHAs) who are village-level (resident women, incentivised) lay health workers. This trial will test the effectiveness of a ‘character-strengths’ based coaching intervention compared to routine supervision on wellbeing (‘authentic happiness’) of ASHAs.

Methods

This protocol is for a single-blind, parallel group randomized controlled trial comparing the effectiveness of a five-day residential workshop focusing on the use of character-strengths and subsequent 8- to 10-week remote telephonic coaching (weekly) to individually support ASHAs to improve their wellbeing, against routine health system support. The arms are intervention added to routine ASHA supervision (weekly, by the ASHA supervisor), and routine supervision alone (control arm). The target sample comprises 330 rural ASHAs in Madhya Pradesh, India. The primary outcome of mean Authentic Happiness Inventory (AHI) scores will be compared between arms at 3-month follow-up. Secondary outcomes will include an assessment of ASHA's self-reported affect, self-efficacy, flourishing, burnout, motivation, physical health symptoms, quality of life, and routine work performance indicators, and the consequent patient-level outcomes [e.g., service satisfaction and depression remission rates after receiving brief psychological treatment by trained ASHAs]. We will also evaluate the costs of developing and delivering the intervention.

Discussion

This trial will determine whether a character-strengths based coaching intervention is an effective and scalable approach for reducing work-stress and improving wellbeing of rural ASHAs in low-resource settings.
背景关于使用结构化积极心理学干预措施来减轻印度农村社区卫生工作者的工作压力并提高其幸福感的知识很少,尤其是作为村级(常驻妇女、受激励)非专业卫生工作者的认可社会卫生活动家(ASHAs)。本试验将测试基于 "性格优势 "的辅导干预与常规监督相比,对 ASHAs 的幸福感("真实的幸福感")的有效性。方法本方案是一项单盲、平行分组随机对照试验,将为期五天的住宿研讨会(侧重于性格优势的使用)和随后 8 到 10 周的远程电话辅导(每周一次)与常规卫生系统支持进行比较,以单独支持 ASHAs 改善其幸福感。两组分别是在日常 ASHA 督导(每周一次,由 ASHA 督导员进行)的基础上进行干预,以及单独进行日常督导(对照组)。目标样本包括印度中央邦的 330 名农村 ASHA。两组的主要结果是在 3 个月的随访中比较真实幸福感量表 (AHI) 的平均得分。次要结果将包括对 ASHA 自我报告的情感、自我效能、蓬勃发展、职业倦怠、动力、身体健康症状、生活质量和日常工作绩效指标的评估,以及随之而来的患者层面的结果[例如,接受训练有素的 ASHA 简短心理治疗后的服务满意度和抑郁症缓解率]。我们还将评估制定和实施干预措施的成本。讨论这项试验将确定基于性格力量的辅导干预措施是否是一种有效且可扩展的方法,可用于减轻低资源环境下农村助理健康与护理人员的工作压力并改善其健康状况。
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引用次数: 0
Recruitment issues in a multicenter randomized controlled trial about the effect of the Cultural Formulation Interview on therapeutic working alliance 关于文化构思访谈对治疗工作联盟影响的多中心随机对照试验中的招募问题
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-27 DOI: 10.1016/j.conctc.2024.101373
Alma M. Brand , Simon P.N. Groen , Samrad Ghane , Nathalie Destoop , Hannah E. Jongsma , Bernard G.C. Sabbe , Özlem Becan , Dhiya Alyan , Mario H. Braakman
This short communication concerns recruitment issues in a multicenter randomized controlled trial. An overview of anticipated and unexpected recruitment issues at various organizational levels is discussed as encountered in this trial. These experiences are shared to assist researchers in avoiding similar experiences, prevent wasting valuable research resources, and justify the time and energy committed by enrolled participants.
这篇简短的通讯涉及一项多中心随机对照试验中的招募问题。文中概述了在该试验中遇到的不同组织层面的预期和意料之外的招募问题。分享这些经验是为了帮助研究人员避免类似的经历,防止浪费宝贵的研究资源,并证明招募参与者所投入的时间和精力是合理的。
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引用次数: 0
Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study 同时使用肝素可通过碱性成纤维细胞生长因子促进皮肤移植供体部位的愈合:前瞻性随机对照试验研究
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-24 DOI: 10.1016/j.conctc.2024.101375
Keishi Kohyama , Hisakazu Kato , Hideshi Okada , Takuma Ishihara , Yuji Yasue , Ryo Kamidani , Kodai Suzuki , Takahito Miyake , Hiroshi Okuda , Hirofumi Shibata , Hiroyuki Tomita , Takenori Ogawa
Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.
由于碱性成纤维细胞生长因子(bFGF)具有促有丝分裂和血管生成的特性,人们一直在研究如何使用它来促进伤口愈合。然而,由于其不稳定性,其临床疗效并未达到预期。有报道称肝素能稳定碱性成纤维细胞生长因子。因此,我们假设,与单独使用 bFGF 相比,联合使用这两种药物能更有效地促进伤口愈合;因此,我们进行了一项单中心、双臂、平行、单盲、前瞻性随机对照试验研究,涉及 12 名接受分层厚皮移植术的患者。为确保临床治疗模式的可行性,研究使用了市售药物。患者按 1:1 的比例被随机分配到使用 bFGF 的对照组(n = 6)或使用 bFGF 和肝素的干预组(n = 6)。术后每周评估伤口面积和伤口面积变化,以及上皮化所需天数。作为补充分析,使用线性混合效应模型计算了最小二乘均值。本研究结果表明,与单独使用 bFGF 相比,联合使用 bFGF 和肝素能更有效地促进伤口愈合,这与我们的假设一致。基于这些数据的多中心试验正在进行中。
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引用次数: 0
A roadmap for improving representation in clinical trials 提高临床试验代表性的路线图
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-23 DOI: 10.1016/j.conctc.2024.101374
Amanda F. Petrik , Nora B. Henrikson , Gloria D. Coronado , Erin Keast , Matthew P. Banegas
Clinical trials continue to struggle with recruiting diverse participants that include historically underrepresented and minoritized patients, who are typically patients in non-white racial and ethnic groups and have low income (Medicaid). Enrolling diverse participants will benefit the health sciences by providing more generalizable findings. The Cancer Financial Experience project (CAFÉ) study sought to improve financial distress by providing financial navigation for newly diagnosed cancer patients, and intentionally recruited diverse participants. All diverse participants consented at slightly higher rates than non-diverse participants (21.3 % vs. 20.1 %). Spanish-speaking patients consented at a much higher rate than non-Spanish speakers (36.4 % vs. 20.2 % respectively). Here we discuss how we increased our recruitment of diverse participants. Obtaining diverse participation is achievable and will provide more meaningful findings.
临床试验在招募多元化参与者方面仍有困难,这些参与者包括历来代表性不足的少数群体患者,他们通常是非白人种族和民族群体的患者以及低收入者(医疗补助)。招募多样化的参与者将有利于健康科学的发展,提供更具普遍性的研究结果。癌症财务体验项目(CAFÉ)研究旨在通过为新诊断的癌症患者提供财务指导来改善财务困境,并有意招募了不同的参与者。所有多元化参与者的同意率略高于非多元化参与者(21.3% 对 20.1%)。西班牙语患者的同意率远远高于非西班牙语患者(分别为 36.4% 对 20.2%)。在此,我们将讨论如何增加对不同参与者的招募。多元化参与是可以实现的,并将提供更有意义的研究结果。
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引用次数: 0
The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol 经颅直流电刺激联合保守治疗颈源性头痛患者的安全性和可行性:双盲随机对照研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-19 DOI: 10.1016/j.conctc.2024.101370
K. Jobin , C. Campbell , S.M. Schabrun , K.J. Schneider , A. Smith , C.T. Debert

Background

Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH.

Methods

Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life.

Conclusions

This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients.

Registration

ClinicalTrials.gov-NCT05582616.
背景颈源性头痛(CGH)是脑震荡和鞭打伤后的常见病,严重降低了患者的生活质量。ET和物理疗法等保守疗法结合注射疗法是治疗颈源性头痛的基础,但疗效有限。对初级运动皮层(M1)的经颅直流电刺激(tDCS)已显示出治疗其他慢性疼痛病症的前景。本试验的主要目的是评估经颅直流电刺激(tDCS)与ET联合治疗CGH的可行性和安全性。方法成人(18-65岁)将被随机分为两组:主动经颅直流电刺激组(active tDCS)和假经颅直流电刺激组(sham tDCS)。经颅直流电刺激将应用于 M1,每周三次,持续 6 周,ET 将每天进行。本试验的主要结果是干预的可行性和安全性。可行性的定义是招募率超过 30%,方案遵守率超过 70%,保留率超过 80%。安全性的定义是无严重不良事件发生。次要探索性结果将评估疼痛、力量、功能和生活质量的改善情况。结论这项试验旨在证明 tDCS 联合 ET 治疗颈源性头痛的安全性和可行性。颈源性头痛很难治疗,会严重影响患者的功能和生活质量。经颅直流电刺激是一种潜在的新型疗法,可改善这些患者的健康状况。RegistrationClinicalTrials.gov-NCT05582616.
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引用次数: 0
Constricting Gaps: Protocol development, implementation challenges and lessons learned for the reality map of unmet needs for Palliative Care Interventions in advanced cancer patients study in Romania and Switzerland 缩小差距:罗马尼亚和瑞士晚期癌症患者姑息关怀干预未满足需求现实图研究的协议制定、实施挑战和经验教训
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-17 DOI: 10.1016/j.conctc.2024.101360
Kalbermatten Natalie , Curca Razvan , Grigorescu Alexandru , Mosoiu Daniela , Pop Florina , Poroch Vladimir , Rosiu Ariana , Achimas-Cadariu Patriciu , Strasser Florian , Swiss-Romanian Partnership IZERZO

Background

Patients with advanced cancer experience many symptoms and needs requiring a Palliative Care Intervention (PCI). Identifying gaps between needs for PCIs and experienced delivery may improve health care, furthermore the association of gaps with quality indicators (QI). The multicentre Romanian (RO)-Swiss (CH) reality map study implemented a novel protocol based on needs concepts and culturally adapted quality indicators (QI).

Methods

An interactive mapping guide measuring unmet needs for PCIs monthly over six months, patient characteristics (cognition, EAPC basic data set, Cofactors) and QI (Inappropriate Anticancer Treatment, High Symptom Burden [IPOS, EQ5D], Repeated ER Admissions, Aggressive End-of-Life Care, and Quality of Death-and-Dying) were developed, applying swiss standards for quality assurance. A composite endpoint (QI, cofactors) was planned. Finally, local solutions responding to gaps were piloted.

Results

From 308 patients (RO: 262, CH: 46, age 62j [mean], 74 % ECOG PS 1&2, 81 % current anticancer treatment) baseline and first follow-up data revealed main gaps (symptom management, spiritual needs, family support), country differences (e.g. illness understanding, spiritual needs) and a significant association of the number of gaps with depression. Later data become less, and data quality on QI variable, revealing gaps in research conduct competences, resources, and applicability of over-sophisticated quality assurance tools. Nevertheless, the unmet needs data promoted local initiatives, 81 patients participated in feasibility studies. Finally, the joint experience stimulated academic developments and national integration of palliative care into oncology.

Conclusions

Pairing motivation and enthusiasm with more modest aims, feasibility testing of all outcomes and investment in research competences may disperse gaps.

背景晚期癌症患者有许多症状和需求,需要姑息治疗干预(PCI)。找出PCI需求与经验提供之间的差距可以改善医疗服务,并将差距与质量指标(QI)联系起来。罗马尼亚(RO)-瑞士(CH)多中心现实地图研究根据需求概念和文化适应性质量指标(QI)实施了一项新方案。方法应用瑞士的质量保证标准,开发了一个交互式绘图指南,用于测量未满足的六个月内每月 PCIs 需求、患者特征(认知、EAPC 基本数据集、Cofactors)和 QI(不恰当的抗癌治疗、高症状负担 [IPOS、EQ5D]、重复急诊入院、积极的生命末期护理和临终质量)。还规划了一个综合终点(质量指标、辅助因素)。结果从 308 名患者(瑞士:262 人,中国:46 人,平均年龄 62 岁,74% ECOG PS 1&2,81% 正在接受抗癌治疗)的基线和首次随访数据中发现了主要差距(症状管理、精神需求、家庭支持)、国家差异(如对疾病的理解、精神需求)以及差距数量与抑郁的显著关联。后来的数据变得越来越少,有关质量保证的数据质量也参差不齐,显示出在研究能力、资源和过于复杂的质量保证工具的适用性方面存在差距。尽管如此,未满足需求的数据促进了当地的主动行动,81 名患者参与了可行性研究。最后,联合经验促进了学术发展和国家将姑息关怀纳入肿瘤学的进程。结论将积极性和热情与更适度的目标相结合,对所有结果进行可行性测试,并对研究能力进行投资,可以消除差距。
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引用次数: 0
Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach COACH 协议,这是一项以证据为基础的干预措施,旨在通过社区参与的方式改善青少年美式橄榄球的头部撞击安全。
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-17 DOI: 10.1016/j.conctc.2024.101371
Jillian E. Urban , Justin B. Moore , Madison E. Marks , Ty D. Holcomb , Robert Patterson , Alexis McCoy , Christopher M. Miles , Joel D. Stitzel , Kristie L. Foley

Subconcussive, repetitive head impacts sustained in collision sports may negatively affect brain health. American football practices are controlled environments amenable to intervention. Engaging community members is essential for successful development, implementation, and sustainability of viable interventions. The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American football (i.e., football), using a community-engaged approach. This manuscript describes the co-design of the intervention and associated implementation plan and the study protocol for evaluating the effectiveness and feasibility of the intervention and implementation plan. In the first part of this study, focus groups with parents and coaches, and individual interviews with organizational leaders associated with two teams at the middle school level were conducted. An anonymous survey assessing beliefs and perceptions of non-concussive head impacts was given to parents, coaches, and organizational leaders within the local youth football league. Following the football season, qualitative and quantitative data describing determinants of head acceleration events in football were shared with 12 stakeholders of coaches, league and school administrators, parents, an athletic trainer, and local university player development director. Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic planning approach. The preliminary effectiveness and feasibility were assessed in the second part of this study. Youth football players participating on the teams in year 1 (control teams) were fitted with mouthpiece-based head kinematic sensors which measure head acceleration events (HAEs). HAEs were collected and quantified during team activities. Preliminary effectiveness of the intervention to reduce HAEs was measured among two new teams pilot testing COACH with mouthpiece-based sensors, while simultaneously monitoring implementation of the intervention. We report our study design and evaluation, and opportunities and challenges with our approach. The results will inform a future full-scale pragmatic trial to assess the implementation and effectiveness of the intervention program.

NCT04908930.

碰撞运动中头部受到的次撞击和重复撞击可能会对大脑健康产生负面影响。美式橄榄球训练是一种可控环境,适合采取干预措施。社区成员的参与对于可行干预措施的成功开发、实施和可持续性至关重要。本研究的目的是采用社区参与的方法,开发并试点测试一种循证干预措施,以减少青少年美式橄榄球(即足球)运动中的头部撞击。本手稿介绍了干预措施和相关实施计划的共同设计,以及评估干预措施和实施计划的有效性和可行性的研究方案。在研究的第一部分,对家长和教练进行了焦点小组讨论,并对与中学两支球队相关的组织领导进行了个别访谈。此外,还向当地青少年足球联赛的家长、教练和组织领导者发放了一份匿名调查问卷,评估他们对非撞击性头部撞击的信念和看法。足球赛季结束后,我们与教练、联赛和学校管理人员、家长、运动训练师和当地大学球员发展主任等 12 名利益相关者分享了描述足球运动中头部加速事件决定因素的定性和定量数据。我们采用战略规划方法,共同设计了 COACH(减少脑震荡和头部撞击的社区联盟)和实施计划。本研究的第二部分对初步的有效性和可行性进行了评估。参加第一年级球队(对照组)的青少年足球运动员都安装了口罩式头部运动传感器,用于测量头部加速度事件(HAE)。在球队活动中收集并量化 HAEs。在两支新队伍中,对使用口罩式传感器的 COACH 进行了试点测试,同时对干预措施的实施情况进行了监测,以衡量干预措施在减少 HAE 方面的初步效果。我们报告了我们的研究设计和评估,以及我们的方法所面临的机遇和挑战。研究结果将为未来的全面务实试验提供参考,以评估干预计划的实施情况和有效性。
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引用次数: 0
Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial 两种药物护肤霜对糖尿病患者脚部干燥症的治疗效果:双臂双盲随机对照试验的原理与设计
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-16 DOI: 10.1016/j.conctc.2024.101372
Anna Ericsson , Karin Borgström , Christine Kumlien , Magdalena Gershater Annersten , Tautgirdas Ruzgas , Johan Engblom , Petri Gudmundsson , Victoria Lazer , Skaidre Jankovskaja , Eva Lavant , Sophia Ågren-Witteschus , Sebastian Björklund , Saman Salim , Mikael Åström , Stefan Acosta

Introduction

To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator creams.

Methods

Two-armed double-blind RCT, registered in ClinicalTrials.gov Identifier: NCT06427889. With 80 % power, two-tailed significance of 2.5 % in each arm, 39 study persons is needed in each arm, total 78 persons, 98 including dropouts, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal®lipid cream), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28.

Discussion

This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes.

导言:为了最大限度地降低患足部溃疡的风险,糖尿病患者被建议每天检查足部并使用护肤配方。然而,市面上很少有专门针对糖尿病足护理而开发和评估的护肤产品。这项随机对照试验(RCT)的主要目的是评估使用两种含有不同保湿剂的护肤霜(干预措施)和一种不含保湿剂的护肤霜(对比试验)对减轻无足部溃疡的糖尿病患者足部干燥症的效果。次要结果是评估干预药膏与对比药膏之间在皮肤屏障完整性、低分子量生物标志物和皮肤微生物群、微循环(包括经皮氧压)、神经病变程度和 HbA1c 方面的差异:NCT06427889。在80%的功率下,每组的双尾显著性为2.5%,每组需要39名研究人员,共78人(包括退出者98人),才能证明干预药膏与对比药膏相比,在 "角化严重程度量表"(Xerosis Severity Scale)中至少降低了一个等级。在一个治疗组中,每位受试者的一只脚使用一种干预药膏(Oviderm® 或 Canoderm®),另一只脚使用对比药膏(Decubal® 脂质药膏),每天两次。如有需要,参与者可在两周的冲洗期后参加治疗。本研究评估了护肤霜中的保湿剂对糖尿病患者足部干燥症的潜在作用。
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引用次数: 0
Feasibility and effectiveness of cardiac telerehabilitation for older adults with coronary heart disease: A pilot randomized controlled trial 为患有冠心病的老年人提供心脏远程康复服务的可行性和有效性:随机对照试验
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-12 DOI: 10.1016/j.conctc.2024.101365
Jing Jing Su , Arkers Kwan Ching Wong , Xi-Fei He , Li-ping Zhang , Jie Cheng , Li-Juan Lu , Lan Lan , Zhaozhao Wang , Rose S.Y. Lin , Ladislav Batalik

Background

Cardiac rehabilitation is a beneficial multidisciplinary treatment of exercise promotion, patient education, risk factor management, and psychosocial counseling for people with coronary heart disease (CHD) that is underutilized due to substantial disparities in access, referral, and participation. Empirical studies suggest that cardiac telerehabilitation (CTR) have safety and efficacy comparable to traditional in-person cardiac rehabilitation, however, older adults are under-reported with effectiveness, feasibility, and usability remains unclear.

Methods

The study randomized 43 older adults (84 % males) to the 12-week CTR intervention or standard of care. Guided by Social Cognitive Theory, participants received individualized in-person assessment and e-coaching sessions, followed by CTR usage at home. Data were collected at baseline (T0), six-week (T1), and 12-week (T2).

Results

Participants in the CTR intervention group showed significant improvement in daily steps (T1: β = 4126.58, p = 0.001; T2: β = 5285, p = 0.01) and health-promoting lifestyle profile (T1: β = 23.26, p < 0.001; T2: β = 12.18, p = 0.008) across study endpoints. Twenty participants completed the intervention, with 40 % used the website for data-uploading or experiential learning, 90 % used the pedometer for tele-monitoring. Improving awareness of rehabilitation and an action focus were considered key facilitators while physical discomforts and difficulties in using the technology were described as the main barriers.

Conclusions

The CTR is feasible, safe and effective in improving physical activity and healthy behaviors in older adults with CHD. Considering the variation in individual cardiovascular risk factors, full-scale RCT with a larger sample is needed to determine the effect of CTR on psychological symptoms, body weight and blood pressure, and quality of life.

背景心脏康复是一种有益的多学科治疗方法,包括运动促进、患者教育、危险因素管理和冠心病患者的心理咨询,但由于在获取、转诊和参与方面存在巨大差异,因此未得到充分利用。经验性研究表明,心脏远程康复(CTR)的安全性和有效性可与传统的面对面心脏康复相媲美,但是,老年人对其有效性、可行性和可用性的报告不足,目前仍不清楚。方法该研究将 43 名老年人(84% 为男性)随机分配到为期 12 周的 CTR 干预或标准护理中。在社会认知理论的指导下,参与者接受了个性化的面对面评估和电子辅导课程,随后在家中使用 CTR。在基线(T0)、6 周(T1)和 12 周(T2)收集数据。结果CTR 干预组的参与者在各研究终点的每日步数(T1:β = 4126.58,p = 0.001;T2:β = 5285,p = 0.01)和促进健康的生活方式(T1:β = 23.26,p < 0.001;T2:β = 12.18,p = 0.008)方面均有显著改善。20名参与者完成了干预,其中40%的人使用网站上传数据或进行体验式学习,90%的人使用计步器进行远程监测。提高康复意识和行动重点被认为是主要的促进因素,而身体不适和使用技术的困难被认为是主要障碍。考虑到个体心血管风险因素的差异,需要进行更大规模的样本研究,以确定 CTR 对心理症状、体重和血压以及生活质量的影响。
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引用次数: 0
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Contemporary Clinical Trials Communications
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