Santa Mina Daniel, Sellers Daniel, Au Darren, Alibhai Shabbir M H, Clarke Hance, Cuthbertson Brian H, Darling Gail, El Danab Alaa, Govindarajan Anand, Ladha Karim, Matthew Andrew G, McCluskey Stuart, Ng Karen A, Quereshy Fayez, Karkouti Keyvan, Randall Ian M
Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.
Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Front Oncol. 2021 Mar 10;11:629207. doi: 10.3389/fonc.2021.629207. eCollection 2021.
Experimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies.
This is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation (., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced.
This pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.
实验数据凸显了手术前预康复的潜在益处及对卫生系统成本的节约；然而，有充足样本量的随机对照试验（RCT）数据仍很欠缺。早期的RCT数据可为新兴的术前预康复服务提供参考，但在为现实世界中的项目开发提供信息方面可能存在局限性。实用性试验强调外部有效性和可推广性，以了解并指导临床环境中干预措施的开发与实施。本文介绍了一项实用性术前预康复试验的方法，以补充新兴的III期临床试验，并为实施策略提供依据。
这是一项在加拿大安大略省多伦多市一家大型学术医院进行的实用性临床试验试点，旨在评估临床实施的可行性并得出有效性估计值。可行性数据包括项目转诊率、入组和失访情况、干预依从性和安全性、参与者满意度以及项目实施的障碍和促进因素。该研究旨在接收150例符合条件的转诊患者，这些患者为成年、说英语、术前患有肿瘤且有明确的术前预康复指征（如虚弱、身体机能下降、营养不良、心理困扰）。研究参与者需接受基线评估，并就干预方式进行共同决策：即基于机构的术前预康复或居家术前预康复。在这两种情况下，参与者都会收到个性化的运动处方、减压心理支持、营养咨询和蛋白质补充，如有需要，还会收到戒烟项目转诊。次要目标包括估计术前一周以及术后30天和90天的干预效果。结局指标包括手术并发症、术后住院时间、死亡率、再次入院情况、体能、心理健康状况和生活质量。拒绝干预但同意研究相关的健康记录访问的参与者的数据将作为对照。由于2019冠状病毒病大流行，引入了仅使用电话或基于互联网的通信进行筛查、评估或干预的“虚拟项目”。
这项实用性试验将为在常规临床条件下提供术前预康复服务的可行性和可行性提供证据。介绍了因2019冠状病毒病大流行而进行的研究修正，作为维持术前预康复研究和服务的策略，以潜在减轻手术等待时间延长的后果。
