住院新生儿的医源性事件：一项前瞻性队列研究。

Iatrogenic events in admitted neonates: a prospective cohort study.

作者信息

Ligi Isabelle, Arnaud Frédérique, Jouve Elisabeth, Tardieu Sophie, Sambuc Roland, Simeoni Umberto

机构信息

Division of Neonatology, La Conception Hospital, EA 3279, Assistance Publique-Hôpitaux de Marseille, Faculté de Médecine, Université de la Méditerranée, Marseille, France.

出版信息

Lancet. 2008 Feb 2;371(9610):404-10. doi: 10.1016/S0140-6736(08)60204-4.

DOI:10.1016/S0140-6736(08)60204-4

PMID:18242414

Abstract

BACKGROUND

Iatrogenic events are increasingly recognised as an important problem in all people admitted to hospital. However, few epidemiological data are available for iatrogenic events in neonatal high-risk units. We aimed to assess the incidence, nature, preventability, and severity of iatrogenic events in a neonatal centre and to establish the association of patient characteristics with the occurrence of iatrogenic events in neonates.

METHODS

We undertook an observational, prospective study from Jan 1, 2005, to Sept 1, 2005, including all neonates admitted in the Division of Neonatology of an academic, tertiary neonatal centre in southern France. Iatrogenic events were defined as any event that compromised the safety margin for the patient, in the presence or absence of harm. The report of an iatrogenic event was voluntary, anonymous, and non-punitive. The primary outcome was the rate of iatrogenic events per 1000 patient days.

FINDINGS

A total of 388 patients were studied during 10 436 patient days. We recorded 267 iatrogenic events in 116 patients. The incidence of iatrogenic events was 25.6 per 1000 patient days. 92 (34%) were preventable and 78 (29%) were severe. Two iatrogenic events (1%) were fatal, but neither was preventable. The most severe iatrogenic events were nosocomial infections (49/62 [79%]) and respiratory events (nine of 26 [35%]). Cutaneous injuries were frequent (n=94) but generally minor (89 [95%]), as were medication errors (15/19 [76%]). Most medication errors occurred during administration stage (12/19 [63%]) and were ten-fold errors (nine of 19 [47%]). The major risk factors were low birthweight and gestational age (both p<0.0001), length of stay (p<0.0001), a central venous line (p<0.0001), mechanical ventilation (p=0.0021), and support with continuous positive airwary pressure (p=0.0076).

INTERPRETATION

Iatrogenic events occur frequently and are often serious in neonates, especially in infants of low birthweight. Improved knowledge of the incidence and characteristics of iatrogenic events, and continuous monitoring could help to improve quality of health care for this vulnerable population.

摘要

背景

医源性事件日益被视为所有住院患者面临的一个重要问题。然而，关于新生儿高危病房中医源性事件的流行病学数据却很少。我们旨在评估一家新生儿中心中医源性事件的发生率、性质、可预防性和严重程度，并确定患者特征与新生儿医源性事件发生之间的关联。

方法

我们于2005年1月1日至2005年9月1日进行了一项观察性前瞻性研究，纳入了法国南部一家学术性三级新生儿中心新生儿科收治的所有新生儿。医源性事件被定义为任何损害患者安全边际的事件，无论是否造成伤害。医源性事件报告是自愿、匿名且非惩罚性的。主要结局是每1000患者日的医源性事件发生率。

结果

在10436个患者日期间共研究了388例患者。我们在116例患者中记录了267起医源性事件。医源性事件的发生率为每1000患者日25.6起。92起（34%）是可预防的，78起（29%）是严重的。两起医源性事件（1%）是致命的，但均不可预防。最严重的医源性事件是医院感染（49/62 [79%]）和呼吸事件（26起中的9起 [35%]）。皮肤损伤很常见（n = 94），但一般较轻（89起 [95%]），用药错误也是如此（15/19 [76%]）。大多数用药错误发生在给药阶段（12/19 [63%]），且为十倍剂量错误（19起中的9起 [47%]）。主要危险因素是低出生体重和孕周（均p < 0.0001）以及住院时间（p < 0.0001）、中心静脉置管（p < 0.0001）、机械通气（p = 0.0021）和持续气道正压通气支持（p = 0.0076）。