PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia.
PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia.
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DOI：
10.1136/bmjopen-2023-072745
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发表时间：
2023-08-24
期刊：
影响因子：
2.9
通讯作者：
PROGRAM
中科院分区：
文献类型：
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作者：
Zapf, Matthew;Patel, Dev;Henson, Patrick;Mcevoy, Matthew D.;Huang, Eunice;Wanderer, Jonathan P.;Fowler, Leslie;Mccarthy, Karen;Freundlich, Robert;Eden, Svetlana;Shotwell, Matthew S.;Kertai, Miklos D.;PROGRAM
研究发现围手术期高血糖与外科手术患者不良预后相关，这促使许多机构制定了血糖指南。在这项试验中，我们将评估临床决策支持工具的实施情况，该工具集成到我们的电子健康记录的术中部分，并为高血糖高风险手术患者的术中胰岛素剂量提供实时最佳实践建议。我们将在机构层面使用连续和重复的交叉设计来评估这种干预措施，并有一段时间用于洗脱、对照和研究干预。分析的单位将是外科病例。主要结果将是术后第一次麻醉护理单位测量时高血糖的频率（>180 mg/dL (10 mmol/L)）。有几个预先指定的次要分析侧重于围手术期血糖控制。本方案和统计分析计划描述了方法、主要分析和次要分析。围手术期葡萄糖实用（PROGRAM）试验由美国田纳西州纳什维尔范德比尔特大学医学中心范德比尔特大学机构审查委员会（IRB, 220991）批准。研究结果将在同行评议的期刊上发表，并在国家科学会议上发表。PROGRAM试验的结果将为高血糖高危外科患者围手术期标准化胰岛素给药提供最佳实践。NCT05426096。
Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrated into the intraoperative portion of our electronic health record and provides real-time best practice recommendations for intraoperative insulin dosing in surgical patients at high risk for hyperglycaemia. We will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash-out, control and study intervention. The unit of analysis will be the surgical case. The primary outcome will be the frequency of hyperglycaemia (>180 mg/dL (10 mmol/L)) at first postoperative anaesthesia care unit measurement. There are several prespecified secondary analyses focused on perioperative glycaemic control. This protocol and statistical analysis plan describes the methodology, primary and secondary analyses. The PeRiOperative Glucose PRAgMatic (PROGRAM) trial was approved by the Vanderbilt University Institutional Review Board (IRB), Vanderbilt University Medical Center, Nashville, Tennessee, USA (IRB, 220991). The study results will be disseminated via publication in a peer-reviewed journal and presented at national scientific conferences. The results of PROGRAM trial will inform best practice for perioperative standardised insulin administration in surgical patients at high risk of hyperglycaemia. NCT05426096.
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影响因子：
5.3
作者：
Li G;Dietz CJK;Freundlich RE;Shotwell MS;Wanderer JP
通讯作者：
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14.6
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