可变手术室可用性的集群随机对照试验的随机化策略

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-28 DOI:10.1016/j.cct.2025.108057

Sheau-Chiann Chen , Heidi Chen , Rafael Paez , Cheryl L. Gatto , Robert James Lentz , Fabien Maldonado

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引用次数: 0

摘要

进行了一项单中心、开放标签、实用、非劣效性的聚类随机对照试验，比较两种诊断性支气管镜入路A平台和b平台的临床结果。聚类定义为手术室（OR）日。在集群级别上，平台A和平台B之间的预期分配比例为1:1。本试验可用的资源包括一个平台A，一个平台B，每周两天可用两个OR，另外三天可用一个OR。当一个平台被随机分配到一个手术室时，另一个平台被放置在另一个手术室。由于手术室和支气管镜平台可用性的限制，无法对个体患者进行随机化，因此提出了一种分层策略，将手术室随机化到给定的平台。使用不平衡（定义为A平台和B平台之间入组患者数量的差异/不平衡）及其标准差作为评估指标，进行了1000个重复的模拟以评估分配的平衡。在第150天（210个任务），与排列块随机化方法（平均值= - 0.238,SD = 7.064，中位数= 0，范围=(- 24,22)）相比，采用按工作日分层的排列块随机化方法减少了不平衡和变异(平均值= 0.044，标准差（SD) = 1.110，中位数= 0，范围=(- 4,4)）。我们进一步探索了另一种策略：按OR可用性分层。该评价分析显示不平衡的减少更大，范围为- 2和2（平均值= - 0.006,SD = 0.690，中位数= 0）。我们创新的研究设计，结合了按OR可用性分层的排列块随机化方法，有效地减少了分配的不平衡，优化了资源分配。临床试验注册：RELIANT于201月30日在clinicaltrials .gov注册（NCT05705544）； RELIANT 2于2024年1月12日在clinicaltrials .gov注册（NCT06654271）。

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A randomization strategy for a cluster-randomized controlled trial with variable operating room availability

A single-center, open-label, pragmatic, non-inferiority, cluster randomized controlled trial was conducted to compare the clinical outcomes of two diagnostic bronchoscopy approaches, Platform A and Platform B. A cluster was defined as an operating room (OR) day. The expected allocation ratio at the cluster level was 1:1 between Platform A and Platform B. The resources available for this trial included one Platform A, one Platform B, two ORs available for two days a week, and one OR available for the other three days. When one platform was randomly assigned to one OR, the other platform was placed in the other OR.

Due to limitations in OR and bronchoscopy platform availability precluding individual patient randomization, a stratification strategy was proposed to randomize ORs to a given platform. A simulation with 1000 replicates was performed to assess balance of assignments, using imbalance (defined as the difference/imbalance in the number of patients enrolled between Platform A and Platform B) and its standard deviation as evaluation metrics.

At day 150 (210 assignments), a permuted-block randomization method, incorporating stratification by weekdays, reduced both imbalance and variation (mean = 0.044, standard deviation (SD) = 1.110, median = 0, range = (−4, 4)), compared to a permuted-block randomization method (mean = −0.238, SD = 7.064, median = 0, range = (−24, 22)). We further explored an alternative strategy: stratification by OR availability. This evaluation analysis revealed a greater reduction in imbalance, with a range of −2 and 2 (mean = −0.006, SD = 0.690, median = 0).

Our innovative study designs, incorporating a permuted-block randomization method stratified by OR availability, effectively reduced the imbalance assignments and optimized allocation of resources.

Trial registration

ClinicalTrials.gov registration (NCT05705544) for RELIANT on January 30, 2023.

ClinicalTrials.gov registration (NCT06654271) for RELIANT 2 on January 12, 2024.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.