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Personalized tourniquet pressure versus uniform tourniquet pressure in orthopedic trauma surgery of extremities: A prospective randomized controlled study protocol 四肢创伤骨科手术中的个性化止血带压力与统一止血带压力:前瞻性随机对照研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-26 DOI: 10.1016/j.conctc.2024.101376

Background

In the field of orthopedic surgery, tourniquets are often used to achieve a clear operative field, expedite operations, and minimize hemorrhagic events. However, determining the optimal tourniquet inflation pressure is a topic of debate. The current approach involves using a constant tourniquet pressure, although this is associated with the potential to augment the risk of tourniquet-associated complications. The Association of Surgical Technologists recommends a tourniquet pressure of systolic blood pressure plus 50 mm Hg for the upper limb and 100 mm Hg for the lower limb. Nevertheless, this method lacks robust support from high-quality medical literature. Therefore, the study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method. The findings might outline the theoretical framework necessary for advocating for tourniquet pressure setups guided by systolic blood pressure.

Methods/design

This randomized controlled study classified the tourniquet pressure regimen into two groups: one based on the patient's systolic blood pressure (the study group) and the other using a constant pressure (the control group). The study included patients aged between 16 and 70 who presented with fresh fractures (less than 3 weeks) of the lower and upper limbs. All the included patients required surgical treatment involving the intraoperative use of a tourniquet and had no contraindications to this surgery. Our primary outcome was to assess the surgeon's satisfaction with the hemostasis achieved in the operative field. We also examined the changes in the circumference of the limb where the tourniquet was applied and tracked any postoperative complications and their incidence. The study ultimately encompassed 144 patients.

Discussion

Despite the prevalent use of tourniquets in surgical operations related to limb fractures, conflicting viewpoints persist concerning the adjustments in pressure and other elements. The study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method.

Study registration

The study was duly recorded in the Chinese Clinical Trial Registry on May 13, 2022 (Registration number: ChiCTR2200059867).

Registration website

https://www.chictr.org.cn/showproj.aspx?proj=162504.
背景在骨科手术领域,止血带常用来获得清晰的手术视野、加快手术进程并最大限度地减少出血事件。然而,如何确定最佳止血带充气压力一直是个争论不休的话题。目前的方法是使用恒定的止血带压力,但这有可能增加止血带相关并发症的风险。外科技师协会建议上肢使用收缩压加 50 mm Hg 的止血带压力,下肢使用 100 mm Hg 的止血带压力。然而,这种方法缺乏高质量医学文献的有力支持。因此,本研究旨在比较根据收缩压设定止血带压力与使用恒压法设定止血带压力的止血效果和差异。方法/设计这项随机对照研究将止血带压力方案分为两组:一组基于患者的收缩压(研究组),另一组使用恒定压力(对照组)。研究对象包括年龄在 16 岁至 70 岁之间、上下肢有新鲜骨折(不足 3 周)的患者。所有患者都需要进行手术治疗,包括术中使用止血带,并且没有手术禁忌症。我们的主要结果是评估外科医生对术野止血效果的满意度。我们还检查了使用止血带的肢体周长的变化,并跟踪了术后并发症及其发生率。讨论尽管止血带在与四肢骨折相关的外科手术中得到了普遍使用,但关于压力和其他因素的调整仍存在相互矛盾的观点。该研究旨在比较基于收缩压的止血带压力设置与恒压法止血带压力设置的止血效果和差异。研究注册该研究于2022年5月13日在中国临床试验注册中心正式注册(注册号:ChiCTR2200059867)。注册网站https://www.chictr.org.cn/showproj.aspx?proj=162504。
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引用次数: 0
Adapting the design of the ongoing RAMPART trial in response to external evidence: An example for trials which take many years to run and report 根据外部证据调整正在进行的 RAMPART 试验的设计:历时多年的试验和报告范例
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-18 DOI: 10.1016/j.conctc.2024.101381
Clinical trials to establish the efficacy of new agents in the adjuvant cancer setting typically take many years to complete. During that time, external factors can impact recruitment and reporting plans. An example is a new standard of care becoming available during the recruitment period.
In this paper we describe how we modified the design of the RAMPART trial (NCT03288532) which was set up to investigate immune checkpoint inhibitor therapy in the adjuvant renal cancer setting. The trial had been initiated when no globally accepted adjuvant strategy after nephrectomy existed. A subsequent change in the standard of care for many patients with early renal cancer meant it was no longer feasible to continue to recruit. We needed to find a way to maximise the contribution that RAMPART participants could make to the evidence base for immune checkpoint inhibitor therapy without introducing bias or detriment to the integrity of the trial results. We describe how we agreed and incorporated all design and timeline changes while remaining blinded to accumulating data within the trial, thus protecting the reliability of the future results. We share details of our design modifications to guide others who may have similar experiences, particularly as more agents and combinations of agents are developed and investigated in similar adjuvant settings.
确定新药在癌症辅助治疗中疗效的临床试验通常需要多年才能完成。在此期间,外部因素可能会影响招募和报告计划。本文介绍了我们如何修改 RAMPART 试验(NCT03288532)的设计,该试验旨在研究肾癌辅助治疗中的免疫检查点抑制剂疗法。该试验是在肾切除术后尚无全球公认的辅助治疗策略时启动的。随后,许多早期肾癌患者的治疗标准发生了变化,这意味着继续招募患者已不再可行。我们需要找到一种方法,既能最大限度地发挥 RAMPART 参与者对免疫检查点抑制剂疗法证据基础的贡献,又不会引入偏见或损害试验结果的完整性。我们介绍了如何在对试验中积累的数据保持盲法的同时,商定并纳入所有设计和时间安排上的变更,从而保护未来结果的可靠性。我们分享设计修改的细节是为了给其他可能有类似经历的人提供指导,尤其是当更多的药物和药物组合被开发出来并在类似的辅助环境中进行研究时。
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引用次数: 0
Optimization the design of fixed and group sequential three-arm non-inferiority trials with dichotomous endpoints of risk difference and odds ratio 优化设计以风险差异和几率比二分法为终点的固定和分组顺序三臂非劣效性试验
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-18 DOI: 10.1016/j.conctc.2024.101383
Although the risk difference (RD) is the most common and well explored functional form for testing efficacy with dichotomous endpoint, odds ratio (OR) is also suggested and well applied measure for non-inferiority (NI) trials. Since the construction and interpretation of these function forms are quite different, this study aims to provide detailed discussions and comprehensive comparisons on the design and testing approach for RD and OR scales for the fixed and group sequential three-arm NI trials under various of situations. The sample size determinations and testing approaches for assessing NI of a new treatment in three-arm clinical trials for RD and OR scales were reviewed comprehensively. Simulation studies are conducted for hundreds of scenarios with parameter configurations of the response rates, randomized allocations, NI margins and interim analysis. The operating characteristic (OC) of RD and OR scales based on the MLE and RMLE methods were thoroughly investigated. A trial example was designed and analyzed to demonstrate the methodologies. It is found that sample size determination on OR scale gives smaller sample size and robust procedure compared to RD scale in the majority of situations. When evaluating the behaviors of the attained power, the RMLE methods based on OR scale outperforms the MLE method and tend to have more power to reject the null hypothesis especially under the small sample size situations. Compared to the fixed design, the group sequential design has better OC, which provides a comparable power while needing smaller total average sample sizes for all cases. In addition, we suggest a lower significance level with a higher power for the sample size determination in the superiority test stage in the group sequential design, which can significantly reduce the total sample sizes while the number of subjects in the placebo group does not increase much. It can offer some recommendations for the investigators to choose the optimal endpoints and parameter configurations to design a three-arm NI trial under certain situations.
虽然风险差异(RD)是二分终点疗效测试中最常见、最受关注的函数形式,但在非劣效性(NI)试验中,几率比(OR)也是被建议和广泛应用的测量方法。由于这些函数形式的构建和解释有很大不同,本研究旨在详细讨论和全面比较在各种情况下固定和分组顺序三臂非劣效性试验中,RD 和 OR 的设计和测试方法。全面回顾了三臂临床试验中RD量表和OR量表评估新疗法NI的样本量确定和测试方法。通过对反应率、随机分配、净住院率和中期分析的参数配置,对数百种情况进行了模拟研究。深入研究了基于 MLE 和 RMLE 方法的 RD 和 OR 量表的运行特征(OC)。设计并分析了一个试验示例来演示这些方法。结果发现,在大多数情况下,与 RD 量表相比,用 OR 量表确定样本量的样本量更小,程序更稳健。在评估获得功率的行为时,基于 OR 标度的 RMLE 方法优于 MLE 方法,尤其是在样本量较小的情况下,往往具有更强的拒绝零假设的能力。与固定设计相比,分组序列设计具有更好的 OC,在所有情况下都需要较小的总平均样本量,但却能提供相当的功率。此外,我们还建议在分组序列设计中,在优效性检验阶段用较低的显著性水平和较高的功率来确定样本量,这样可以显著减少总样本量,而安慰剂组的受试者人数不会增加太多。这为研究者在特定情况下选择最佳终点和参数配置设计三臂 NI 试验提供了一些建议。
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引用次数: 0
A type 1 hybrid multi-site randomized controlled trial protocol for evaluating virtual interview training among autistic transition-age youth 评估自闭症过渡年龄青少年虚拟访谈培训的 1 类混合多站点随机对照试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-18 DOI: 10.1016/j.conctc.2024.101384
A number of policies mandate that autistic transition-age youth receive employment services to prepare for the workforce before high school graduation. A key limitation to these services is the job interview component, which relies on non-standardized, resource-intensive, staff-led role-plays to help autistic transition-age youth improve their interview skills. The autism community has called for better job interview preparation. To address this gap in services, our team, collaborated with the autism community to adapt the intervention, Virtual Reality Job Interview Training (VR-JIT; effective among adults with serious mental illness), into Virtual Interview Training for Transition Age Youth (VIT-TAY). This adapted intervention was tailored to meet the needs of autistic transition age youth while maintaining the core components of VR-JIT (i.e., an online job interview simulator with four levels of automated feedback and e-learning content). A pilot randomized controlled trial (RCT) demonstrated VIT-TAY's feasibility and initial effectiveness at improving job interview skills, reducing anxiety, and increasing employment rates within six months when added to transition services or pre-employment transition services (Pre-ETS). Thus, the overarching goal of this Hybrid Type 1 effectiveness-implementation study protocol is to conduct a fully-powered RCT of VIT-TAY across 16 schools in various geographical locations. Our specific aims are to 1) Evaluate whether Pre-ETS (or transition services) with VIT-TAY, as compared to Pre-ETS (or transition services) with an active control intervention (i.e., job interview didactics/e-learning with a series of 3–5 min videos of employed autistic adults talking about their career pathways) enhances employment outcomes; 2) Evaluate mechanisms of employment by nine months post-randomization; and 3) Conduct a multilevel, mixed-method process evaluation of the initial implementation of VIT-TAY across settings (e.g., acceptability, feasibility, and barriers and facilitators of implementation).
许多政策规定,患有自闭症的过渡适龄青少年必须接受就业服务,以便在高中毕业前为就业做好准备。这些服务的一个主要限制是求职面试部分,它依赖于非标准化、资源密集型、由工作人员主导的角色扮演来帮助自闭症过渡适龄青少年提高面试技巧。自闭症社区呼吁改善求职面试准备工作。为了填补服务方面的这一空白,我们的团队与自闭症社区合作,将虚拟现实求职面试培训(VR-JIT;对患有严重精神疾病的成年人有效)这一干预措施调整为过渡年龄青少年虚拟面试培训(VIT-TAY)。这种经过调整的干预措施是为满足自闭症过渡年龄青少年的需求而量身定制的,同时保留了 VR-JIT 的核心内容(即带有四级自动反馈和电子学习内容的在线求职面试模拟器)。一项试点随机对照试验(RCT)证明了 VIT-TAY 的可行性和初步有效性,即在过渡服务或就业前过渡服务(Pre-ETS)中加入 VIT-TAY,可在六个月内提高求职面试技能、减少焦虑并提高就业率。因此,本混合型 1 类效果-实施研究方案的总体目标是在不同地理位置的 16 所学校中对 VIT-TAY 进行全面的 RCT 研究。我们的具体目标是:1)评估采用 VIT-TAY 的预教育与培训服务(或过渡服务)与采用积极对照干预措施的预教育与培训服务(或过渡服务)(即:就业面试说教/电子学习)相比,是否更有效;2)评估采用 VIT-TAY 的预教育与培训服务(或过渡服务)是否更有效、2)评估随机化后九个月的就业机制;以及 3)对 VIT-TAY 在不同环境中的初步实施情况(如可接受性、可行性、实施障碍和促进因素)进行多层次、混合方法的过程评估。)
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引用次数: 0
Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial 评估改善烟草相关健康差异的慢性病方法:混合型 1 类实施效果试验研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-16 DOI: 10.1016/j.conctc.2024.101380

Background

Black, Indigenous, and People of Color (BIPOC) communities experience higher prevalence of cardiovascular disease and related chronic conditions compared to White communities due to disparities in tobacco exposure. Smoking can be effectively treated but evidence-based treatments are less likely to be offered to or used by BIPOC patients. We present the study protocol of the Smoking Cessation Outreach for Racial Equity (SCORE) trial that tests the effect of adding longitudinal care coordination to current standard of care for smoking cessation to promote health equity among BIPOC patients.

Methods

Longitudinal Proactive Outreach (LPO; 4 culturally tailored outreach call cycles over one year by motivational interviewing trained counselors to connect patients to cessation counseling and medication) will be added to the current standard of care, Ask-Advise-Connect (AAC; primary care providers asking all patients if they smoke, and if smoking, advising to quit and connecting to treatment). We will conduct a hybrid type 1 implementation-effectiveness trial to examine the direct effect of AAC + LPO (a multilevel health system intervention) vs. AAC on population-level combustible tobacco abstinence at 18 months and treatment utilization among 2000 BIPOC adults who smoke across two healthcare systems in Minnesota. Participants will be surveyed at 6, 12, and, 18 months post-enrollment to assess outcomes. The primary outcome is biochemically confirmed combustible cigarette abstinence at 18 months.

Discussion

LPO has potential to promote health equity by addressing barriers caused by structural racism, including access to care, care fragmentation, and provider racism, by systematically reaching out to all BIPOC patients who smoke.

Clinicaltrialsgov

NCT05671380.
背景黑人、原住民和有色人种(BIPOC)社区与白人社区相比,由于烟草接触方面的差异,心血管疾病及相关慢性病的发病率更高。吸烟可以得到有效治疗,但以证据为基础的治疗方法却较少提供给有色人种患者或被他们使用。我们介绍了 "促进种族公平的戒烟推广"(SCORE)试验的研究方案,该试验测试了在目前的戒烟标准护理中增加纵向护理协调以促进 BIPOC 患者健康公平的效果。方法将在现行标准护理 "询问-建议-连接"(AAC;初级保健提供者询问所有患者是否吸烟,如果吸烟,则建议戒烟并连接到治疗)的基础上增加 "纵向主动外展"(LPO;由受过动机访谈训练的咨询师在一年内进行 4 次文化定制的外展呼叫周期,为患者提供戒烟咨询和药物治疗)。我们将在明尼苏达州的两个医疗系统中对 2000 名吸烟的 BIPOC 成年人进行混合型 1 类实施效果试验,研究 AAC + LPO(多层次医疗系统干预)与 AAC 相比,对 18 个月后人群可燃烟草戒断率和治疗利用率的直接影响。参与者将在加入后 6 个月、12 个月和 18 个月接受调查,以评估结果。讨论LPO具有促进健康公平的潜力,它通过系统地接触所有BIPOC吸烟患者,解决了结构性种族主义造成的障碍,包括获得医疗服务、医疗服务的分散性和医疗服务提供者的种族主义。
{"title":"Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial","authors":"","doi":"10.1016/j.conctc.2024.101380","DOIUrl":"10.1016/j.conctc.2024.101380","url":null,"abstract":"<div><h3>Background</h3><div>Black, Indigenous, and People of Color (BIPOC) communities experience higher prevalence of cardiovascular disease and related chronic conditions compared to White communities due to disparities in tobacco exposure. Smoking can be effectively treated but evidence-based treatments are less likely to be offered to or used by BIPOC patients. We present the study protocol of the Smoking Cessation Outreach for Racial Equity (SCORE) trial that tests the effect of adding longitudinal care coordination to current standard of care for smoking cessation to promote health equity among BIPOC patients.</div></div><div><h3>Methods</h3><div>Longitudinal Proactive Outreach (LPO; 4 culturally tailored outreach call cycles over one year by motivational interviewing trained counselors to connect patients to cessation counseling and medication) will be added to the current standard of care, Ask-Advise-Connect (AAC; primary care providers asking all patients if they smoke, and if smoking, advising to quit and connecting to treatment). We will conduct a hybrid type 1 implementation-effectiveness trial to examine the direct effect of AAC + LPO (a multilevel health system intervention) vs. AAC on population-level combustible tobacco abstinence at 18 months and treatment utilization among 2000 BIPOC adults who smoke across two healthcare systems in Minnesota. Participants will be surveyed at 6, 12, and, 18 months post-enrollment to assess outcomes. The primary outcome is biochemically confirmed combustible cigarette abstinence at 18 months.</div></div><div><h3>Discussion</h3><div>LPO has potential to promote health equity by addressing barriers caused by structural racism, including access to care, care fragmentation, and provider racism, by systematically reaching out to all BIPOC patients who smoke.</div></div><div><h3>Clinicaltrialsgov</h3><div>NCT05671380.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142526879","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
Baseline-dependent improvement in CF studies, plausibility of bias 基于基线的 CF 研究改进,偏差的合理性
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-05 DOI: 10.1016/j.conctc.2024.101378

Background:

It has been commonly reported that therapeutic treatments in cystic fibrosis (CF) have ceiling effects, such that their efficacy is diminished for persons with high pre-treatment health (Montgomery et al., 2012 and Newsome et al., 2019). Floor effects have also been reported where decline is of lower magnitude in those with below-average pre-treatment health (Harun et al., 2016; Konstan et al., 2012 and Szczesniak et al., 2017). When measurement error is present, the statistical literature has warned of exaggerated or spurious associations between pre-treatment measures and subsequent change (Chambless and Davis, 2003 and Yanez et al., 1998). Measurement error, equivalently described as day-to-day variation, has been described to occur in CF outcome measurements such as forced expiratory volume in 1 s taken by spirometry (FEV1pp) (Magaret et al., 2024; Stanojevic et al., 2020 and Thornton et al., 2023).

Methods:

We conducted a simulation study to assess the potential for spurious floor or ceiling effects in studies of CF therapeutics. We considered uncontrolled or single-arm studies, and evaluated estimated association between pre-treatment FEV1pp and treatment-induced change: post-versus pre-treatment.

Results:

When day-to-day variation was present in FEV1pp, at levels equivalent to those reported in large studies measuring spirometry both at home and in clinic, naive analytic approaches found spurious associations of change with baseline (Paynter et al., 2022 and Saiman et al., 2003). Type I error ranged from 31.9% to 98.3% for day-to-day variation as high as 3% to 15% relative to biological variation. Incorporating known day-to-day variation, the regression calibration approach corrected bias and controlled type I error (Chambless and Davis, 2003).

Conclusion:

Exaggerated ceiling effects are possible. Further studies could provide meaningful confirmation of ceiling effects in CF, perhaps reducing day-to-day variation by incorporating multiple pre- and post-treatment measurements.
背景:据普遍报道,囊性纤维化(CF)的治疗方法具有天花板效应,即治疗前健康状况较好的患者的疗效会降低(Montgomery等人,2012年和Newsome等人,2019年)。也有报道称,在治疗前健康状况低于平均水平的人群中,地板效应的下降幅度较低(Harun等人,2016年;Konstan等人,2012年和Szczesniak等人,2017年)。如果存在测量误差,统计文献就会警告治疗前的测量结果与后续变化之间存在夸大或虚假的关联(Chambless 和 Davis,2003 年;Yanez 等人,1998 年)。方法:我们进行了一项模拟研究,以评估 CF 治疗药物研究中可能出现的虚假最低或最高效应。结果:当 FEV1pp 存在日间变化,且变化水平与在家庭和诊所测量肺活量的大型研究中报告的水平相当时,天真的分析方法会发现变化与基线之间存在虚假关联(Paynter 等人,2022 年;Saiman 等人,2003 年)。I型误差从31.9%到98.3%不等,日常变化相对于生物变化高达3%到15%。结合已知的日变化,回归校准方法纠正了偏差并控制了 I 类误差(Chambless 和 Davis,2003 年)。进一步的研究可以对 CF 中的上限效应进行有意义的确认,或许可以通过结合治疗前后的多次测量来减少日常变化。
{"title":"Baseline-dependent improvement in CF studies, plausibility of bias","authors":"","doi":"10.1016/j.conctc.2024.101378","DOIUrl":"10.1016/j.conctc.2024.101378","url":null,"abstract":"<div><h3>Background:</h3><div>It has been commonly reported that therapeutic treatments in cystic fibrosis (CF) have ceiling effects, such that their efficacy is diminished for persons with high pre-treatment health (Montgomery et al., 2012 and Newsome et al., 2019). Floor effects have also been reported where decline is of lower magnitude in those with below-average pre-treatment health (Harun et al., 2016; Konstan et al., 2012 and Szczesniak et al., 2017). When measurement error is present, the statistical literature has warned of exaggerated or spurious associations between pre-treatment measures and subsequent change (Chambless and Davis, 2003 and Yanez et al., 1998). Measurement error, equivalently described as day-to-day variation, has been described to occur in CF outcome measurements such as forced expiratory volume in 1 s taken by spirometry (FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp) (Magaret et al., 2024; Stanojevic et al., 2020 and Thornton et al., 2023).</div></div><div><h3>Methods:</h3><div>We conducted a simulation study to assess the potential for spurious floor or ceiling effects in studies of CF therapeutics. We considered uncontrolled or single-arm studies, and evaluated estimated association between pre-treatment FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp and treatment-induced change: post-versus pre-treatment.</div></div><div><h3>Results:</h3><div>When day-to-day variation was present in FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp, at levels equivalent to those reported in large studies measuring spirometry both at home and in clinic, naive analytic approaches found spurious associations of change with baseline (Paynter et al., 2022 and Saiman et al., 2003). Type I error ranged from 31.9% to 98.3% for day-to-day variation as high as 3% to 15% relative to biological variation. Incorporating known day-to-day variation, the regression calibration approach corrected bias and controlled type I error (Chambless and Davis, 2003).</div></div><div><h3>Conclusion:</h3><div>Exaggerated ceiling effects are possible. Further studies could provide meaningful confirmation of ceiling effects in CF, perhaps reducing day-to-day variation by incorporating multiple pre- and post-treatment measurements.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142438010","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
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

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

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
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
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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Contemporary Clinical Trials Communications
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