Contemporary Clinical Trials Communications最新文献_第3页

Design of INSPIRE: Evaluation of the effectiveness of practice facilitation on implementation of screening, brief interventions, referral to treatment and medication for unhealthy alcohol use identification and treatment in primary care INSPIRE的设计：评估在实施筛查、简短干预、转诊治疗和初级保健中不健康酒精使用的药物治疗方面的实践促进的有效性。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101413

Jennifer Bannon , Justin D. Smith , Mark J. Van Ryzin , Megan McHugh , Jennifer Heinrich , Theresa L. Walunas , Abel N. Kho

Background

Unhealthy alcohol use is a leading cause of preventable mortality and a risk factor for an array of social and health problems. The Intervention in Small primary care Practices to Implement Reduction in unhealthy alcohol use (INSPIRE) study is part of a nationwide campaign to improve the identification and treatment of patients engaging in unhealthy alcohol use.

Methods

We conducted a single arm, pragmatic study consisting of seventeen primary care practices in the Chicago metropolitan area, Wisconsin, and California across two waves with a 6-month latent period, a 12-month intervention period, followed by a 6-month sustainability period. Enrolled practices were independent, Federally Qualified Health Centers, network-based, and academic health centers. INSPIRE utilized the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to examine implementation feasibility, fidelity, and performance of clinicians on practice adoption of screening, brief intervention, referral to treatment (SBIRT) and medication for unhealthy alcohol use (MAUD) activities in primary care clinics.

Results

Seventeen eligible primary care practices were enrolled over the course of 21 months beginning in March of 2020 through December of 2021. There was a pause in recruitment from March of 2020 through July of 2020 due to the Covid-19 pandemic. The majority of enrolled practices were small (<6 clinicians) and were part of a network. 57 % of clinicians completed the educational modules in part or in full.

This paper will outline the INSPIRE protocol and design. Additionally, we will present practice demographic data, recruitment data and results related to on-line learning module completion.

Conclusion

The INSPIRE study will evaluate the ability of primary care clinicians in small practices to participate in practice education programs and implement standard screening and treatment protocols, adapted for documentation in the electronic health record (EHR). The study will also identify the factors that facilitated or hindered improvement and sustainability using quantitative and qualitative analysis methods.

背景：不健康饮酒是可预防死亡的主要原因，也是一系列社会和健康问题的危险因素。对小型初级保健实践进行干预以实施减少不健康酒精使用（INSPIRE）研究是一项全国运动的一部分，目的是改进对不健康酒精使用患者的识别和治疗。方法：我们进行了一项单组实用研究，包括芝加哥大都会区、威斯康辛州和加利福尼亚州的17家初级保健诊所，分为两波，潜伏期为6个月，干预期为12个月，持续期为6个月。登记的诊所是独立的、联邦认证的健康中心、基于网络的和学术的健康中心。INSPIRE利用RE-AIM（覆盖范围、有效性、采用、实施、维持）框架来检查临床医生在初级保健诊所实践中采用筛查、短暂干预、转诊治疗（SBIRT）和不健康酒精使用药物（MAUD）活动的实施可行性、保真度和表现。结果：从2020年3月到2021年12月，在21个月的时间里，17个符合条件的初级保健实践被纳入研究。由于2019冠状病毒病大流行，从2020年3月到2020年7月，招聘暂停。大多数登记的诊所都是小型诊所(结论：INSPIRE研究将评估小型诊所的初级保健临床医生参与实践教育计划和实施标准筛查和治疗方案的能力，这些方案适用于电子健康记录（EHR）的记录。该研究还将利用定量和定性分析方法查明促进或阻碍改进和可持续性的因素。

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引用次数: 0

Tools to improve discharge equity: Protocol for the pilot TIDE trial 改善出院公平的工具：TIDE 试验方案。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101419

Kirsten Austad , Cecilia Thai , Alegna Zavatti , Nhi Nguyen , Diana Bautista-Hurtado , Patrick Kenney , Noelia Lugo , Joo H. Lee , Howard Lanney , Ziming Xuan , Erika G. Cordova-Ramos , Mari-Lynn Drainoni , Brian Jack

Background

Written discharge instructions after hospitalization promote patient understanding and positive clinical outcomes. Despite the rising prevalence of patients with non-English language preference (NELP) in the U.S., most hospitals do not routinely provide discharge instructions in their preferred language, thereby placing them at higher risk for medical errors and hospital readmission. Innovative solutions to close this implementation gap at hospital discharge for patients with NELP are needed. The Tools to Improve Discharge Equity (TIDE) intervention leverages communication practices proven effective in addressing communication barriers to create language concordant discharge tools from hospital discharge paperwork.

Methods

We present the protocol for a type I hybrid implementation-effectiveness pilot randomized trial. The TIDE intervention includes a translated medication calendar, pictographs, and an audio recording of the discharge instructions in the patient's preferred language. We will recruit an estimated 50 patient participants from the hospital's top four non-English language groups—Spanish, Haitian Creole, Cape Verdean Creole, and Vietnamese—as well as the nurse and in-person interpreter caring for them. Outcomes include patient recall of primary diagnosis and overall understanding of discharge instructions using a newly developed 24-point score, patient experience, implementation measures (acceptability, feasibility, and appropriateness), and clinical effectiveness (including hospital reutilization). A mixed methods evaluation will identify determinants of intervention uptake to guide selection of multi-level implementation strategies to test in a future hybrid type III trial.

Discussion

The TIDE intervention is the first hospital discharge intervention designed for patients with NELP. Result will inform future efforts to improve the safety and equity of the hospital discharge process.

Trial registration

clinicaltrials.gov NCT05988229 (August 14, 2023) https://classic.clinicaltrials.gov/ct2/show/NCT05988229.

背景：住院后书面出院说明促进患者理解和积极的临床结果。尽管非英语语言偏好（NELP）患者在美国越来越普遍，但大多数医院通常不会用他们首选的语言提供出院说明，从而使他们面临更高的医疗差错和再入院风险。需要创新的解决方案，以缩小NELP患者出院时的执行差距。改善出院公平的工具（TIDE）干预措施利用在解决沟通障碍方面被证明有效的沟通实践，从医院出院文书中创建语言一致的出院工具。方法：我们提出了一项I型混合实施-有效性试点随机试验的方案。TIDE干预包括翻译的用药日历、象形文字和患者首选语言的出院说明录音。我们将从医院最主要的四个非英语语言群体（西班牙语、海地克里奥尔语、佛得角克里奥尔语和越南语）中招募大约50名患者，以及照顾他们的护士和现场翻译。结果包括患者对初步诊断的回忆和出院指示的总体理解（采用新开发的24分制评分）、患者体验、实施措施（可接受性、可行性和适当性）和临床有效性（包括医院再利用率）。混合方法评估将确定干预措施的决定因素，以指导选择多层次实施策略，以在未来的混合III型试验中进行测试。讨论：TIDE干预是第一个为NELP患者设计的出院干预。结果将为今后提高医院出院过程的安全性和公平性提供信息。试验注册：clinicaltrials.gov NCT05988229（2023年8月14日）https://classic.clinicaltrials.gov/ct2/show/NCT05988229。

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引用次数: 0

Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer STRONG的可行性试验：数字干预改善食管癌和胃食管癌患者的营养管理。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101421

Yu Chen Lin , Jose M. Pimiento , Jeanine Milano , Diane Riccardi , Nakesha Mckinnie , Emma Hume , Olivia Sprow , Sophia Diaz-Carraway , Mara Budnetz , Ryan Hagen , Mohammed Al-Jumayli , Allan Lima Pereira , Andrew J. Sinnamon , Ashwin Somasundaram , Jennifer B. Permuth , Amir Alishahi Tabriz , Kea Turner

Introduction

Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.

Methods

Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.

Results

Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.

Conclusion

Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.

Clinical trial registration

The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.

食管癌和胃食管癌（GEJ）患者营养不良的风险特别高。然而，大多数营养不良患者没有得到足够的营养支持。我们进行了一项单臂试验，以测试远程观察和营养指导支持（STRONG）的实施情况，这是一种多级数字干预，可改善局部晚期食管癌和胃食管结癌患者的营养结局。方法：参与者接受营养师的五次营养咨询，通过Fitbit应用程序记录每日食物摄入量，并完成与患者营养不良、营养相关症状和生活质量结果相关的五项研究评估。我们根据先验基准评估了STRONG的可行性、可接受性和可用性。结果：参与者（N = 17）的中位年龄为68岁，71%为男性。参与者完成基线评估（94%）、完成五项评估中的四项（82%）和参与者保留率（85%）的可行性基准得到满足。在研究期间只接受口服饮食的参与者中，遵守饮食预约（89%）和食物摄入跟踪（78%）的比例很高。参与者招募率（47%）略低于基准（50%）。所有参与者都认为干预是可以接受的。干预的可用性很高，69%和92%的参与者分别对通过Fitbit和营养师主导的营养咨询会议跟踪食物摄入量表示高度满意。结论：我们的研究表明STRONG在食管癌和胃食管癌患者中具有较高的可行性、可接受性和可用性。本研究的结果可以指导未来的疗效研究，以评估STRONG对患者预后的影响。临床试验注册：通过远程观察和营养指导计划支持胃食管癌患者（STRONG-GEC）研究于参与者入组前的2022年6月在clinicaltrials.gov （NCT05438940）上注册。

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引用次数: 0

The hypotension prediction index in major abdominal surgery – A prospective randomised clinical trial protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101417

Jakub Szrama, Agata Gradys, Zuzanna Nowak, Ashish Lohani, Krzysztof Zwoliński, Tomasz Bartkowiak, Amadeusz Woźniak, Tomasz Koszel, Krzysztof Kusza

Background

Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.

Methods

and Analysis: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of <65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.

Ethics and dissemination

This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB–559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT06247384.

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引用次数: 0

Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals 开展自我收集药代动力学样本的临床试验：来自健康个体中西他那定SR的探索性1期开放标签试验的经验。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101396

Chelsea Ye , Tatiana Shablinski , Susan E. Shoaf , Chris Chung , Michelle Bullock

Background

The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.

Methods

Healthy adults (18–55 years) with a body mass index of 19.0–32.0 kg/m² were enrolled. The trial comprised a screening period, 2 clinic visits (visits 1, 2), 2 at-home visits (visits 3 and 4), and follow-up clinic visit (visit 5). Participants received a single 100-mg oral dose of centanafadine sustained release at visits 1, 2, and 4. Pharmacokinetic samples, electrocardiograms (ECGs; 6-lead [participant] and 12-lead [staff]), and vital signs were collected by clinical personnel (visit 1), under staff supervision (visit 2), and remotely (visit 4), facilitated by the Verily clinical trial application. Successful sample collection at visit 4 was reported descriptively. A survey assessed the utility of training, devices, and the Verily app, and ability to complete trial procedures.

Results

Among 20 participants enrolled, 90 % were female, mean (SD) age was 35.9 (11.1) years. Verily platform/procedures facilitated successful remote vital sign collection in at least 75 %, ECGs in at least 80 %, and blood microsamples in 65 %–70 % of participants at visit 4. Most agreed that training was adequate, and they were able to complete trial procedures on their own. Participants favored self-collection over staff collection, having visits in their own location, and would consider participation in similar future research.

Conclusions

Results from this decentralized PK trial, with remote, in-home sample collection and monitoring, demonstrated the potential feasibility of this study design.

背景：COVID-19大流行加速了向分散临床试验的转变。我们从1期药代动力学（PK）试验中提出了这种方法的潜在可行性。方法：健康成人（18-55岁），体重指数19.0 ~ 32.0 kg/m2。该试验包括筛选期，2次门诊就诊（就诊1、2次），2次家访（就诊3、4次）和随访门诊就诊（就诊5次）。参与者在就诊1、2、4次时接受单次100毫克口服西他那定缓释。药代动力学样品、心电图；6导联[参与者]和12导联[工作人员])，生命体征由临床人员收集（就诊1），在工作人员监督下（就诊2）和远程（就诊4），并通过Verily临床试验应用程序进行辅助。在第4次访问中成功的样本采集被描述性地报道。一项调查评估了培训、设备和Verily应用程序的效用，以及完成试验程序的能力。结果：入选的20名参与者中，90%为女性，平均（SD）年龄为35.9（11.1）岁。Verily平台/程序促进了至少75%的远程生命体征采集成功，至少80%的心电图采集成功，65% - 70%的参与者在就诊4时采集了血液显微样本。大多数人认为培训是充分的，他们能够自己完成试验程序。参与者更喜欢自己收集，而不是员工收集，在自己的地点进行访问，并会考虑参与类似的未来研究。结论：这项分散的PK试验的结果，远程、在家采样和监测，证明了这项研究设计的潜在可行性。

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引用次数: 0

Preschool and Me: Educational-clinical linkage to improve health equity for children with developmental delays and disabilities from historically marginalized communities 学前班和我：教育-临床联系，以改善来自历史边缘化社区的发育迟缓和残疾儿童的健康公平。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101412

Tina L. Schuh , Kathleen R. Diviak , Sarai Coba-Rodriguez , Emily Pela , Raphael Kinney , Michael L. Berbaum , Amanda Klemas , Kruti Acharya , Molly Martin , Reshma Shah

Societal and structural inequities have resulted in longstanding health care disparities among Black, Latino/a/e, and low-income preschool children with developmental delays and disabilities (PCw/DD), depriving them of educational and therapeutic services that improve future academic, economic, and health outcomes. To address this issue, we developed Preschool and Me (PreM), a community-clinical linkage (CCL) implemented within healthcare settings serving historically marginalized communities. This novel CCL, an educational-medical linkage model, aims to increase access to school-based services for PCw/DD. Combining key components of CCLs with a personalized medical-education care plan and remote navigator support, PreM targets multiple levels of influence impacting access to school-based therapeutic and educational services. We will utilize a hybrid effectiveness-implementation approach in two models of real-world service delivery conditions. Participants (n = 320) will be randomized to either 6 months of PreM or a waitlist control arm beginning the intervention after a 6-month delay. Our specific aims are to test the effectiveness of PreM on access to school-based services as well as health service outcomes; examine mediators of intervention effects using a mixed-methods approach; and explore social determinants of health as potential moderators. We will simultaneously conduct an implementation evaluation. The results of this study have the potential to support effective implementation of CCL models within pediatric clinical settings serving historically marginalized communities which can be utilized to improve health outcomes for families and their children with a range of health conditions.

社会和结构上的不平等导致了黑人、拉丁裔/黑人/黑人和低收入学龄前发育迟缓和残疾儿童（PCw/DD）之间长期存在的医疗保健差距，剥夺了他们获得教育和治疗服务的权利，而这些服务可以改善未来的学术、经济和健康成果。为了解决这个问题，我们开发了学前班和我（PreM），这是一个社区-临床联系（CCL），在医疗机构中实施，服务于历史上边缘化的社区。这种新颖的CCL是一种教育-医疗联动模式，旨在增加PCw/DD获得校本服务的机会。PreM将ccl的关键组成部分与个性化的医疗教育护理计划和远程导航员支持相结合，针对影响获得校本治疗和教育服务的多个层面的影响。我们将在现实世界的服务交付条件的两种模型中使用混合效率-实施方法。参与者（n = 320）将被随机分为6个月的PreM组或延迟6个月后开始干预的等候名单对照组。我们的具体目标是测试PreM在获得校本服务和保健服务成果方面的有效性；使用混合方法检查干预效果的中介；并探索健康的社会决定因素作为潜在的调节因素。我们将同时进行实施评估。本研究的结果有可能支持在儿科临床环境中有效实施CCL模式，服务于历史上边缘化的社区，可用于改善具有一系列健康状况的家庭及其儿童的健康结果。

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引用次数: 0

Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan 青少年强迫症患者的情绪失调及其治疗意义——TECTO试验的一项探索性研究：协议和统计分析计划。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101408

Christine Lykke Thoustrup , Camilla Uhre , Valdemar Uhre , Melanie Ritter , Signe Vangkilde , Janus Engstrøm , Jane Lindschou , Christian Gluud , Anne Katrine Pagsberg , Markus Harboe Olsen

Background

Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD.

Methods

Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses.

Conclusion

This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.

背景：改善青少年强迫症（OCD）心理治疗的研究，包括认知行为疗法（CBT），应该通过检查基线调节因子和潜在的改变机制来探索什么对谁有效以及如何有效。情绪失调被认为是跨诊断框架中的一个中间治疗因素。本研究探讨8-17岁青少年强迫症患者的情绪失调作为心理治疗的结果、机制和调节因素。方法：数据来自一项随机临床试验和一项健康对照平行前瞻性研究。患有强迫症的参与者(n = 130；在这项研究中，121名患者被随机分为14组，分别接受以家庭为基础的CBT治疗，包括暴露和反应预防，以及以家庭为基础的心理教育和放松训练。我们将;1)评估以情绪调节困难量表（DERS）衡量的情绪失调是否从基线到治疗结束有所减少；2)比较正常情绪调节的被试比例与健康对照的90%参考区间（n = 90）；3)采用线性回归检验基线情绪失调是否会调节儿童耶鲁-布朗强迫症量表测量的治疗效果；4)研究情绪失调的改变是否介导治疗效果；5)观察健康对照组情绪调节的时间稳定性。分析1-4将对所有强迫症参与者进行，并对两个治疗组分别进行。两名独立调查人员将进行分析。结论：本方案及统计分析方案可提高分析透明度，减少偏倚。

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引用次数: 0

Oral administration of hydrolyzed collagen alleviates pain and enhances functionality in knee osteoarthritis: Results from a randomized, double-blind, placebo-controlled study 一项随机、双盲、安慰剂对照研究结果显示，口服水解胶原蛋白可减轻膝关节骨性关节炎患者的疼痛并增强其功能。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101424

Juan Antonio Carrillo-Norte , Guillermo Gervasini-Rodríguez , María Ángeles Santiago-Triviño , Virginio García-López , Rafael Guerrero-Bonmatty

Osteoarthritis (OA) is a major source of chronic pain and disability, representing a significant global health concern that affects 10–15 % of individuals aged over 60, with a higher prevalence among females than males. This investigation aimed to evaluate the impact of a dietary supplement containing collagen peptides (MW 1–3 kDa) on knee OA symptoms and inflammatory biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Adults aged 30–81 years (50 % female) with grade II or III OA and a minimum pain score of 40 on the 0 to 100 visual analogue scale (VAS) were enrolled. Participants were randomly assigned to receive either 10 g of the test product (verum group) or placebo and were assessed at baseline (T0, pre-treatment) and after a six-month follow-up period (T6). Baseline characteristics were comparable between groups. At T6, the verum group exhibited significant reductions in VAS pain scores, Lequesne algofunctional index (LAI) scores, CRP levels (mg/L), and ESR (mm/h) compared to placebo (p < 0.001). No adverse effects were reported during the study, and the supplement demonstrated good tolerability and yielded satisfactory safety and acceptability. These findings suggest that the dietary supplement may serve as a complement to drug therapy for knee OA by alleviating osteoarticular pain, improving locomotor function and potentially reducing reliance on analgesic and anti-inflammatory medications. This study provides valuable insights into the efficacy and safety of collagen peptides in managing knee OA symptoms.

骨关节炎（OA）是慢性疼痛和残疾的主要来源，是一个重大的全球健康问题，影响了10- 15%的60岁以上老年人，女性患病率高于男性。本研究旨在评估含有胶原肽（MW 1-3 kDa）的膳食补充剂对膝关节OA症状和炎症生物标志物（如c反应蛋白（CRP）和红细胞沉降率（ESR））的影响。年龄30-81岁的成人（50%为女性）患有II级或III级OA，在0到100视觉模拟评分（VAS）中最低疼痛评分为40分。参与者被随机分配接受10克测试产品（verum组）或安慰剂，并在基线（T0，治疗前）和六个月随访期（T6）后进行评估。各组间基线特征具有可比性。T6时，与安慰剂相比，verum组VAS疼痛评分、Lequesne疼痛功能指数（LAI）评分、CRP水平（mg/L）和ESR （mm/h）均显著降低（p < 0.05）

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引用次数: 0

Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity 在涉及虚弱、多病或复杂患者的试验中，将目标设定作为一种结果衡量标准。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101411

Emma Tenison , Katherine Lloyd , Yoav Ben-Shlomo , Emily J. Henderson

Background/aims

In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism.

Methods

The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment.

Results

We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms.

Conclusion

We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.

背景/目的：在缺乏帕金森病的疾病改善疗法的情况下，许多研究集中在改善生活质量、健康和福祉上。以稳健和标准化的方式评估潜在的治疗方法和创新的护理模式非常重要。特定疾病的结果在老年人、有认知障碍、多病、残疾或预期寿命短的人群中存在局限性。我们的目的是选择并根据需要进行调整，以评估帕金森病患者的多组分干预的主要结果。方法：在英国的一项随机对照试验（RCT）中，对多组分主动和综合管理和授权（PRIME）护理模型进行了评估。我们需要一种有意义的结果测量方法，可以捕捉多种症状和领域的影响；适用于所有疾病阶段/表型，包括患有多种疾病和/或认知障碍的参与者。结果：我们选择了班戈目标设定访谈，并将其用于PRIME-UK随机对照试验。这包括4个步骤：参与者1)确定要工作的领域；2)描述具体的目标；3)评估当前的达成情况、改变的准备程度和目标的重要性；4)成绩随访3个月。在标准化量表上，三到五个个性化目标的评分变化可以在试验组之间进行比较。结论：我们展示了如何在一个复杂的帕金森病干预试验中实现目标导向的结果。帕金森病是一种典型的多系统、异质性疾病，主要影响老年人。在涉及体弱多病和/或临床复杂性患者的试验中，有更广泛地使用目标导向的结果测量的余地。

{"title":"Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity","authors":"Emma Tenison , Katherine Lloyd , Yoav Ben-Shlomo , Emily J. Henderson","doi":"10.1016/j.conctc.2024.101411","DOIUrl":"10.1016/j.conctc.2024.101411","url":null,"abstract":"<div><h3>Background/aims</h3><div>In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism.</div></div><div><h3>Methods</h3><div>The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment.</div></div><div><h3>Results</h3><div>We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms.</div></div><div><h3>Conclusion</h3><div>We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101411"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932928","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

Comorbidities And Reducing InEquitieS (CARES): Feasibility of self-monitoring and community health worker support in management of comorbidities among Black breast and prostate cancer patients 合并症和减少不公平（护理）：自我监测和社区卫生工作者支持黑人乳腺癌和前列腺癌患者合并症管理的可行性。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-02-01 DOI: 10.1016/j.conctc.2024.101387

Laura C. Schubel , Ana Barac , Michelle Magee , Mihriye Mete , Malinda Peeples , Mansur Shomali , Kristen E. Miller , Lauren R. Bangerter , Allan Fong , Christopher Gallagher , Jeanne Mandelblatt , Hannah Arem

Background

Black individuals with cancer have a higher prevalence of comorbidities and a worse cancer prognosis than other racial groups in the US. As part of a quality improvement project, we aimed to demonstrate feasibility of self-monitoring and community health worker (CHW) support among managing comorbidities for Black individuals with breast or prostate cancer.

Methods

In a single arm, pre-post study, we enrolled patients with diabetes and/or hypertension who identified as Black and were diagnosed with 1) stage 0-IV breast cancer, or 2) prostate cancer and on long-term androgen-deprivation therapy. Participants received a home-monitoring device linked to a mobile app and worked with a CHW over six months to track their blood pressure (BP) and/or blood glucose (BG). PROMIS surveys assessed support and self-efficacy.

Results

Between May 2021–December 2022, 61 patients with breast or prostate cancer comorbid with hypertension (79 %) or hypertension and diabetes (21 %) enrolled. Once weekly self-recording of BP and BG was achieved in 92 % of individuals (with hypertension) and 77 % of individuals (with diabetes and hypertension). Participants (n = 47) who reported ≥4 readings in Months 1 and 6 demonstrated improved BP control (mean reduction = 4.07 mmHg); too few BG readings were collected to assess change. We observed a slight decrease in PROMIS scores for informational (mean 3.2, sd 8.0) and instrumental support (mean 3.6, sd 8.3).

Conclusions

A self-monitoring and CHW intervention is a feasible approach to monitor hypertension among Black cancer patients. Modifications are needed to improve BG monitoring and patient reported outcomes.

背景：在美国，与其他种族相比，黑人癌症患者的合并症患病率更高，癌症预后更差。作为质量改进项目的一部分，我们旨在证明自我监测和社区卫生工作者（CHW）支持在管理黑人乳腺癌或前列腺癌合并症中的可行性。方法：在单组研究中，我们招募了患有糖尿病和/或高血压的患者，这些患者被诊断为1)0-IV期乳腺癌，或2)前列腺癌，并接受长期雄激素剥夺治疗。参与者收到了一个与移动应用程序相连的家庭监测设备，并与CHW一起工作了六个多月，以跟踪他们的血压（BP）和/或血糖（BG）。PROMIS调查评估了支持和自我效能。结果：在2021年5月至2022年12月期间，纳入了61例乳腺癌或前列腺癌合并高血压（79%）或高血压合并糖尿病（21%）的患者。92%的人（高血压患者）和77%的人（糖尿病和高血压患者）实现了每周一次的血压和BG自我记录。在第1个月和第6个月报告读数≥4的参与者（n = 47）表现出血压控制改善（平均降低= 4.07 mmHg）；收集到的BG读数太少，不足以评估变化。我们观察到信息支持（平均3.2,sd 8.0）和工具支持（平均3.6,sd 8.3）的PROMIS得分略有下降。结论：自我监测和CHW干预是监测黑人癌患者高血压的可行方法。需要修改以改善BG监测和患者报告的结果。

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引用次数: 0