Iatrogenic events in admitted neonates: a prospective cohort study

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

The Lancet

Volume 371, Issue 9610, 2–8 February 2008, Pages 404-410

https://doi.org/10.1016/S0140-6736(08)60204-4 Get rights and content

Summary

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.

Introduction

During the past few decades, rapid advances in neonatal medicine have caused a substantial reduction in neonatal mortality, especially in premature infants. However, new therapeutic strategies might result in adverse side-effects or cause iatrogenic damage. Iatrogenic injury is defined as an unintended harm or suffering arising from any aspect of health-care management.¹ The report To Err Is Human² has shown the serious problem of medical errors and estimated that more than 44 000 deaths were caused by medical errors in the USA every year. Since this report, control of iatrogenesis has become an important challenge for public health and patient safety. However, available reports have focused primarily on adult and paediatric care.3, 4, 5, 6 Although newborn babies represent a high-risk population, data are still scarce. The Harvard Medical Practice Study4, 6 and the Health Cost and Utilization Project (HCUP) study,⁷ have estimated that between 1·2% and 1·4% of neonates admitted to hospital have been affected by medical errors at discharge. However, these studies described retrospectively rates of medical error on the basis of the International Classification of Diseases (ICD)-9 and possibly underestimated the incidence of iatrogenic events in neonates.

There is general agreement that the incidence of the most common complications of care in high-risk nurseries needs to be precise, but methodology is crucial in obtaining accurate information about the issue of iatrogenesis. Reporting systems are a key strategy for learning from errors, as emphasised by the Institute of Medecine.² Mandatory reporting systems, on the basis of retrospective chart reviews, focus on errors associated with serious injuries or death. But errors resulting in serious harm are only part of the problem, and iatrogenesis is certainly underestimated by these systems. By contrast, voluntary reporting systems, which are widely used in aviation, focus on incidents that often result in slight injury or no harm (so-called near misses). The intent is to identify and remedy vulnerabilities in systems to improve patients' safety. Leape and colleagues⁸ reported the importance of a non-punitive, anonymous, and timely reporting system to effectively monitor adverse events, which seems to be more efficient than medical chart review.⁹ Thus, to improve understanding of the nature and importance of iatrogenesis in neonatal units and to improve the quality of care, we undertook a prospective study with a voluntary, non-punitive, and anonymous reporting system. We aimed to define the epidemiological characteristics (incidence, severity, preventability, and risk factors) of iatrogenesis in neonates admitted to hospital in a high-risk neonatal centre.

Section snippets

Setting and patients

The study was done in a 54-bed (15 beds in intensive-care unit) level 3 neonatal centre in a university hospital in Marseille (southern France), from Jan 1, 2005, to Sept 1, 2005. All neonates admitted in the centre were included in the study. The clinical risk index for babies was used to assess illness severity.¹⁰ Patients who had just had surgery or those requiring extracorporeal membrane oxygenation were excluded from the study. The medical staff consisted of nine neonatologists and eight

Results

388 neonates were admitted to the study, with a total of 10 436 patient days. Table 1 shows the characteristics of the study population. Of the 388 patients admitted, 116 had one or more iatrogenic event, and 56 of these 116 patients had more than one event. In total, 267 iatrogenic events were detected. The incidence of iatrogenic events was 25·6 per 1000 patient days. 92 (34%) were preventable, resulting in a preventable iatrogenic event incidence of 8·8 per 1000 patient days. 78 (29%)

Discussion

Our study has shown that a substantial proportion of neonates admitted to hospital had iatrogenic events, a significant proportion of which were preventable. The most severe iatrogenic events were nosocomial infections and respiratory events. Cutaneous injuries and medication errors were common, but generally minor. We identified the major risk factors of iatrogenic events as low birthweight and gestational age, use of a central venous line, and mechanical ventilation.

Kanter and colleagues'⁷

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ArticlesIatrogenic events in admitted neonates: a prospective cohort study

Summary

Background

Methods

Findings

Interpretation

Introduction

Section snippets

Setting and patients

Results

Discussion

Am J Infect Control

Lancet

Early Hum Dev

Semin Fetal Neonatal Med

A comparison of iatrogenic injury studies in Australia and the USA. I: Context, methods, casemix, population, patient and hospital characteristics

Int J Qual Health Care

Adverse events and preventable adverse events in children

Pediatrics

Incidence of adverse events and negligence in hospitalized patients

N Engl J Med

Medication errors and adverse drug events in pediatric inpatients

JAMA

The nature of adverse events in hospitalized patients

N Engl J Med

Hospital-reported medical errors in premature neonates

Pediatr Crit Care Med

Reporting of adverse events

N Engl J Med

Evaluation of two methods for quality improvement in intensive care: facilitated incident monitoring and retrospective medical chart review

Crit Care Med

The CRIB (clinical risk index for babies) score: a tool for assessing initial neonatal risk and comparing performance of neonatal intensive care units

Lancet

Articles
Iatrogenic events in admitted neonates: a prospective cohort study