Hutchison J, Ward R, Lacroix J, Hébert P, Skippen P, Barnes M, Meyer P, Morris K, Kirpalani H, Singh R, Dirks P, Bohn D, Moher D
Department of Critical Care Medicine, Hospital for Sick Children, and Interdepartmental Division of Critical Care, Faculty of Medicine, University of Toronto, Canada.
Dev Neurosci. 2006;28(4-5):291-301. doi: 10.1159/000094155.
The utility of a pretrial clinical evaluation or run-in phase prior to conducting trials of complex interventions such as hypothermia therapy following severe traumatic brain injury in children and adolescents has not been established.
The primary objective of this study was to prospectively evaluate the ability of investigators to adhere to the clinical protocols of care including the cooling and rewarming procedures as well as management guidelines in patients with severe traumatic brain injury (Glasgow Coma Scale<or=8) treated with 24 h of hypothermia therapy. A secondary objective was to evaluate the ability of study research assistants to complete the study case report form using a procedures manual. The study was conducted at 18 sites in Canada, the United Kingdom and France prior to proceeding to a randomized controlled trial (RCT). After 2 patients were enrolled at each center, an independent clinical evaluation committee examined the process of care and the completeness of data collection. Centers were permitted to enroll patients in the RCT once they met pre-established adherence criteria.
Seventeen of the 18 centers completed the pretrial clinical evaluation phase demonstrating compliance with study procedures and proceeded to an RCT of hypothermia therapy. One center enrolled only 1 patient in the pretrial clinical evaluation phase due to small numbers of patients with traumatic brain injury, and therefore, did not proceed to the RCT. Three centers were required to enroll more than 2 patients in the pretrial clinical evaluation phase prior to proceeding to the RCT because of problems with adherence to the clinical protocols at two centers and the training of new study personnel at another center. Of the 39 patients enrolled during the pretrial clinical evaluation phase, 8 (20.5%) died and 22 (62.9%) had a good outcome defined as normal, mild or moderate disability assessed using the Pediatric Cerebral Performance Category score at 6 months following injury.
The pretrial clinical evaluation phase was useful to ensure compliance with complex hypothermia therapy and consensus-based clinical management guidelines of care successfully implemented across 17 of 18 centers. This study maneuver allowed us to complete a subsequent RCT in 225 children following severe traumatic brain injury.
在开展诸如儿童和青少年重度创伤性脑损伤后低温治疗等复杂干预试验之前，尚未确定进行审前临床评估或导入期的效用。
本研究的主要目的是前瞻性评估研究人员遵循临床护理方案的能力，包括低温治疗和复温程序以及重度创伤性脑损伤（格拉斯哥昏迷量表≤8分）患者的管理指南，这些患者接受24小时低温治疗。次要目的是评估研究助理使用程序手册完成研究病例报告表的能力。在进行随机对照试验（RCT）之前，该研究在加拿大、英国和法国的18个地点开展。每个中心招募2名患者后，一个独立的临床评估委员会检查了护理过程和数据收集的完整性。一旦中心符合预先确定的依从性标准，就允许其在RCT中招募患者。
18个中心中的17个完成了审前临床评估阶段，表明符合研究程序，并进入了低温治疗的RCT。由于创伤性脑损伤患者数量较少，1个中心在审前临床评估阶段仅招募了1名患者，因此未进入RCT。由于两个中心在遵循临床方案方面存在问题，另一个中心在培训新的研究人员，3个中心在进入RCT之前需要在审前临床评估阶段招募超过2名患者。在审前临床评估阶段招募的39名患者中，8名（20.5%）死亡，22名（62.9%）预后良好，定义为损伤后6个月使用儿科脑功能表现类别评分评估为正常、轻度或中度残疾。
审前临床评估阶段有助于确保遵循复杂的低温治疗和基于共识的临床护理管理指南，18个中心中有17个成功实施。这项研究策略使我们能够在225名重度创伤性脑损伤儿童中完成后续的RCT。
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