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经验性临床数据在不稳定型心绞痛实践指南评估中的应用。

The use of empiric clinical data in the evaluation of practice guidelines for unstable angina.

作者信息

Katz D A, Griffith J L, Beshansky J R, Selker H P

机构信息

Divisions of Clinical Decision Making, New England Medical Center, Boston, MA 02111, USA.

出版信息

JAMA. 1996 Nov 20;276(19):1568-74.

PMID:8918854
Abstract

OBJECTIVE

To determine the applicability to emergency department (ED) clinical practice of a nationally disseminated practice guideline on the disposition of patients with a diagnosis of unstable angina, and to determine the potential impact of the guideline on hospital admissions and demand for intensive care beds.

DESIGN

Application of guideline criteria for ED disposition decisions to a validation sample derived from a prospective clinical trial.

SETTING

Five hospitals, including 2 urban general teaching hospitals, 2 urban tertiary care university hospitals, and 1 suburban university-affiliated community hospital.

PATIENTS

A consecutive sample of 457 patients who presented with symptoms suggestive of acute cardiac ischemia and who had "unstable angina" or "rule out unstable angina" diagnosed by ED physicians. Greater than 90% of eligible patients were enrolled in the clinical trial; follow-up data sufficient for assignment of a definitive diagnosis were obtained for 99% of subjects.

MAIN OUTCOME MEASURES

Acute myocardial infarction and unstable angina, based on blind review of initial and follow-up clinical data, including cardiac enzyme levels and electrocardiograms. After completion of the trial, without knowledge of final diagnosis or outcome, the investigators classified patients into risk groups specified by the unstable angina guideline.

RESULTS

Of subjects with an ED diagnosis of unstable angina, only 6% (n=28) met the guideline's criteria corresponding to low risk for adverse events and were therefore suitable for discharge directly to home. Fifty-four percent (n=247) met the intermediate-risk criteria; 40% (n=182) met the high-risk criteria and were identified as requiring admission to an intensive care unit. Actual ED disposition differed from guideline recommendations in 2 major areas: only 4% (1/28) of low-risk patients were discharged to home with outpatient follow-up, and only 40% (72/182) of high-risk patients were admitted to an intensive care unit.

CONCLUSIONS

Although the guideline was intended to reduce hospitalization by identifying a low-risk group, the small size of this group among ED patients suggests that little reduction in hospitalization can be expected. Indeed, the guideline may increase demand for the limited number of intensive care beds to accommodate patients with unstable angina considered high-risk but currently placed elsewhere. These results emphasize the need to use empiric data from target clinical settings to assess the likely actual impact of guidelines on clinical care prior to national dissemination.

摘要

目的

确定一项在全国推广的关于不稳定型心绞痛患者处置的实践指南在急诊科临床实践中的适用性,并确定该指南对医院入院情况及重症监护床位需求的潜在影响。

设计

将指南中关于急诊科处置决策的标准应用于来自一项前瞻性临床试验的验证样本。

地点

五家医院,包括2家城市综合教学医院、2家城市三级大学医院和1家郊区大学附属社区医院。

患者

连续选取457例出现提示急性心肌缺血症状且被急诊科医生诊断为“不稳定型心绞痛”或“排除不稳定型心绞痛”的患者。超过90%的符合条件患者纳入了该临床试验;99%的受试者获得了足以进行明确诊断的随访数据。

主要观察指标

基于对初始及随访临床数据(包括心肌酶水平和心电图)的盲法审查确定急性心肌梗死和不稳定型心绞痛。在试验完成后,在不了解最终诊断或结果的情况下,研究人员将患者分为不稳定型心绞痛指南规定的风险组。

结果

在急诊科诊断为不稳定型心绞痛的患者中,仅6%(n = 28)符合指南中对应不良事件低风险的标准,因此适合直接出院回家。54%(n = 247)符合中度风险标准;40%(n = 182)符合高风险标准并被确定需要入住重症监护病房。急诊科的实际处置在两个主要方面与指南建议不同:低风险患者中只有4%(1/28)通过门诊随访出院回家,高风险患者中只有40%(72/182)入住重症监护病房。

结论

尽管该指南旨在通过识别低风险组来减少住院率,但急诊科患者中这一组规模较小,表明住院率降低的幅度可能很小。实际上,该指南可能会增加对数量有限的重症监护床位的需求,以容纳被认为是高风险但目前安置在其他地方的不稳定型心绞痛患者。这些结果强调了在全国推广之前,需要利用目标临床环境中的经验数据来评估指南对临床护理可能产生的实际影响。

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