Morris Alan H, Orme James, Truwit Jonathon D, Steingrub Jay, Grissom Colin, Lee Kang H, Li Guoliang L, Thompson B Taylor, Brower Roy, Tidswell Mark, Bernard Gordon R, Sorenson Dean, Sward Katherine, Zheng Hui, Schoenfeld David, Warner Homer
Pulmonary Division, Department of Medicine, LDS Hospital and the University of Utah School of Medicine, Salt Lake City, UT, USA.
Crit Care Med. 2008 Jun;36(6):1787-95. doi: 10.1097/CCM.0b013e3181743a5a.
To ensure interpretability and replicability of clinical experiments, methods must be adequately explicit and should elicit the same decision from different clinicians who comply with the study protocol.
The objective of this study was to determine whether clinician compliance with protocol recommendations exceeds 90%.
We developed an adequately explicit computerized protocol (eProtocol-insulin) for managing critically ill adult patient blood glucose. We monitored clinician compliance with eProtocol-insulin recommendations in four intensive care units in four hospitals and compared blood glucose distributions with those of a simple clinical guideline at one hospital and a paper-based protocol at another. All protocols and the guideline used intravenous insulin and 80 to 110 mg/dL (4.4-6.1 mmol/L) blood glucose targets.
The setting for this study was four academic hospital intensive care units.
This study included critically ill adults requiring intravenous insulin.
Intervention used in this study was a bedside computerized protocol for managing blood glucose.
The main outcome measure was clinician compliance with eProtocol-insulin recommendations.
The number of patients was 31 to 458 and the number of blood glucose measurements was 2,226 to 19,925 among the four intensive care units. Clinician compliance with eProtocol-insulin recommendations was 91% to 98%. Blood glucose distributions were similar in the four hospitals (generalized linear model p = .18). Compared with the simple guideline, eProtocol-insulin glucose measurements within target increased from 21% to 39%, and mean blood glucose decreased from 142 to 115 mg/dL (generalized linear model p < .001). Compared with the paper-based protocol, eProtocol-insulin glucose measurements within target increased from 28% to 42%, and mean blood glucose decreased from 134 to 116 mg/dL (generalized linear model p = .001).
The 91% to 98% clinician compliance indicates eProtocol-insulin is an exportable instrument that can establish a replicable experimental method for clinical trials of blood glucose management in critically ill adults. Control of blood glucose was better with eProtocol-insulin than with a simple clinical guideline or a paper-based protocol.
为确保临床试验的可解释性和可重复性，方法必须足够明确，并且应能使遵循研究方案的不同临床医生做出相同的决策。
本研究的目的是确定临床医生对方案建议的遵循率是否超过90%。
我们开发了一个足够明确的计算机化方案（电子方案 - 胰岛素）来管理重症成年患者的血糖。我们在四家医院的四个重症监护病房监测临床医生对电子方案 - 胰岛素建议的遵循情况，并将血糖分布与一家医院的简单临床指南和另一家医院的纸质方案进行比较。所有方案和指南均使用静脉胰岛素和80至110mg/dL（4.4 - 6.1mmol/L）的血糖目标。
本研究的地点是四家学术医院的重症监护病房。
本研究包括需要静脉注射胰岛素的重症成年患者。
本研究中使用的干预措施是一种用于管理血糖的床边计算机化方案。
主要观察指标是临床医生对电子方案 - 胰岛素建议的遵循情况。
四个重症监护病房的患者人数为31至458人，血糖测量次数为2226至19925次。临床医生对电子方案 - 胰岛素建议的遵循率为91%至98%。四家医院的血糖分布相似（广义线性模型p = 0.18）。与简单指南相比，电子方案 - 胰岛素使目标范围内的血糖测量从21%增加到39%，平均血糖从142mg/dL降至115mg/dL（广义线性模型p < 0.001）。与纸质方案相比，电子方案 - 胰岛素使目标范围内的血糖测量从28%增加到42%，平均血糖从134mg/dL降至116mg/dL（广义线性模型p = 0.001）。
91%至98%的临床医生遵循率表明电子方案 - 胰岛素是一种可推广的工具，可为重症成年患者血糖管理的临床试验建立可重复的实验方法。与简单临床指南或纸质方案相比，电子方案 - 胰岛素对血糖的控制更好。
