Contemporary Clinical Trials Communications最新文献

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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
Contemporary Clinical Trials Communications Pub Date : 2024-08-28 DOI: 10.1016/j.conctc.2024.101362
{"title":"Study protocol for a randomized controlled trial of neurofeedback mindfulness in chronic migraines","authors":"","doi":"10.1016/j.conctc.2024.101362","DOIUrl":"10.1016/j.conctc.2024.101362","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001091/pdfft?md5=a8cce1d71923cf2506f491555867753c&pid=1-s2.0-S2451865424001091-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142094863","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101356
{"title":"Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial","authors":"","doi":"10.1016/j.conctc.2024.101356","DOIUrl":"10.1016/j.conctc.2024.101356","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Discussion</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Clinicaltrials. gov Registration Number: NCT05307640.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001030/pdfft?md5=ea07980888f5a551aae90fa55e58b462&pid=1-s2.0-S2451865424001030-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142076918","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101358
{"title":"Increasing participation in resistance training using outdoor gyms: A study protocol for the ecofit type III hybrid effectiveness implementation trial","authors":"","doi":"10.1016/j.conctc.2024.101358","DOIUrl":"10.1016/j.conctc.2024.101358","url":null,"abstract":"<div><h3>Background</h3><p>In this paper we outline the protocol for an implementation-effectiveness trial of <em>ecofit</em>, 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 <em>ecofit</em> 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 <em>ecofit</em> program.</p></div><div><h3>Research design and methods</h3><p>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., <em>ecofit</em> app only) or ‘Moderate’ (i.e., <em>ecofit</em> 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.</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Trial registry</h3><p>This trial was preregistered with the Australian and New Zealand Clinical Trial Registry (ACTRN12624000261516).</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001054/pdfft?md5=7d8bed7456e9d3efc06d5faf270a96d8&pid=1-s2.0-S2451865424001054-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142083994","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101355
{"title":"Comparing different session regimens of electroacupuncture for chronic plantar fasciitis: Study protocol for a randomized clinical trial","authors":"","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":null,"pages":null},"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
Contemporary Clinical Trials Communications Pub Date : 2024-08-24 DOI: 10.1016/j.conctc.2024.101357
{"title":"The digital MySteps intervention for abused women at risk for firearm-related injuries and homicides: Findings from the feasibility, acceptability and preliminary efficacy trial","authors":"","doi":"10.1016/j.conctc.2024.101357","DOIUrl":"10.1016/j.conctc.2024.101357","url":null,"abstract":"<div><h3>Background</h3><p>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).</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results and conclusion</h3><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001042/pdfft?md5=7163a101d6bfdae4b9e1d363e1548dd2&pid=1-s2.0-S2451865424001042-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142076954","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-22 DOI: 10.1016/j.conctc.2024.101352
{"title":"Novel approach for oligospermia (NAPO) - Protocol for a randomized controlled trial","authors":"","doi":"10.1016/j.conctc.2024.101352","DOIUrl":"10.1016/j.conctc.2024.101352","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Clinical Trials: NCT06300229. Registered on March 12, 2024. Clinical Trials Information System (CTIS): 2023-508325-27-00. Approved on December 19, 2023.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000991/pdfft?md5=9503e5920cc2499e0c3eab87f581b38c&pid=1-s2.0-S2451865424000991-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142076955","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-18 DOI: 10.1016/j.conctc.2024.101349
{"title":"Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial","authors":"","doi":"10.1016/j.conctc.2024.101349","DOIUrl":"10.1016/j.conctc.2024.101349","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.</p></div><div><h3>Protocol version</h3><p>1.0, November 20, 2022.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000966/pdfft?md5=0746cb8292b1b0a677d7c51adf67a5b1&pid=1-s2.0-S2451865424000966-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142049840","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-17 DOI: 10.1016/j.conctc.2024.101354
{"title":"Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide","authors":"","doi":"10.1016/j.conctc.2024.101354","DOIUrl":"10.1016/j.conctc.2024.101354","url":null,"abstract":"<div><p>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.</p><p>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.</p><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001017/pdfft?md5=b3417adeac61a9fbdd6d2870d5b20542&pid=1-s2.0-S2451865424001017-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142087771","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
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
Contemporary Clinical Trials Communications Pub Date : 2024-08-17 DOI: 10.1016/j.conctc.2024.101353
{"title":"Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language","authors":"","doi":"10.1016/j.conctc.2024.101353","DOIUrl":"10.1016/j.conctc.2024.101353","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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 (&lt;0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p &lt; 0.0001).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001005/pdfft?md5=bb106c2f0283635499325954e4a043f0&pid=1-s2.0-S2451865424001005-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142012855","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
Assessing core outcome set uptake in randomized controlled trials for chronic kidney disease: Cross-sectional analysis 评估慢性肾脏病随机对照试验中核心结果集的采用情况:横断面分析
IF 1.4
Contemporary Clinical Trials Communications Pub Date : 2024-08-15 DOI: 10.1016/j.conctc.2024.101347
{"title":"Assessing core outcome set uptake in randomized controlled trials for chronic kidney disease: Cross-sectional analysis","authors":"","doi":"10.1016/j.conctc.2024.101347","DOIUrl":"10.1016/j.conctc.2024.101347","url":null,"abstract":"<div><h3>Main problem</h3><p>Chronic kidney disease (CKD) is a progressive condition that affects millions of people worldwide. A standardized core outcome set (COS) was developed for CKD by the International Consortium for Health Outcomes and Measurements in 2019. This study aims to evaluate the frequency of measurement for these outcomes before and after the publication of the COS.</p></div><div><h3>Methods</h3><p>A literature search was done to gather the phase III/IV clinical trials evaluating chronic kidney disease through ClinicalTrials.gov. Data extraction of included studies was completed in a masked, duplicate fashion. The included studies were evaluated for characteristics such as survival, burden of disease, patient-reported health-related quality of life, and treatment modality-specific outcomes.</p></div><div><h3>Results</h3><p>Our results showed that the majority of all COS domains were inadequately measured in CKD clinical trials before and after publication of the COS. Despite the increase in COS measurements following publication, the average percent of COS outcomes measured was less than 40 % per year even after four years.</p></div><div><h3>Conclusion</h3><p>There is a notable deficiency in the complete measurement of COS among all domains both before and after COS publication. We suggest efforts be made to improve the adoption of consistent outcome measures that would benefit the growing population of patients affected by CKD.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000942/pdfft?md5=5bad43fdb5894cc82cad7e0b8b515896&pid=1-s2.0-S2451865424000942-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142040355","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
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