STANFORD, Calif-- A study led by Paul Sharek, MD, Chief Clinical Patient Safety Officer for Lucile Packard Children’s Hospital at Stanford, indicates that adverse events in neonatal intensive care units across North America occur more frequently and are more severe than previously reported. The authors reviewed records from 15 NICUs across North America. The intent of the study — the largest of its kind — was not to cast blame, but rather to identify ways in which the naturally high-risk NICU environment can be made safer for patients through research and changes in clinical practice.
 
“Many of the harmful events we identified are not currently preventable,” said Sharek, who is also an Assistant Professor of Pediatrics at the Stanford University School of Medicine. As an example, Sharek cited a life-saving medicine with unavoidable adverse side effects. “But it’s still vitally important to document these events so we can establish future priorities.” In Sharek’s example, a lengthy rap sheet for a particular treatment or drug may spark physicians and drug developers to look for new alternatives.
 
Sharek and his colleagues were able to identify previously unreported adverse events—defined as harmful results of hospital care—by using a recently developed method of chart review known as the trigger tool method. In this method, trained medical staff scan patients’ charts for key events, medications, or labs — called triggers — that often occur in conjunction with an adverse event.

Despite their name, triggers aren’t necessarily the cause of the event; sometimes they are the result. For instance, the drug naloxone is used to rapidly reverse the respiratory depression that can occur as a result of the use of narcotics such as morphine. Its use, documented in an infant’s chart, triggered a more intensive review of that child’s NICU treatment that sometimes revealed an adverse event related to narcotic administration.
 
Participation in the study by the 15 NICUs was voluntary. The researchers limited their search to infants who spent at least two days in the NICU between November 2004 and January 2005. They found that about half of all the adverse events were preventable, and about 40 percent resulted in substantial and sometimes permanent harm. Only eight percent of the adverse events had been previously identified using traditional reporting methods. The frequency of adverse events in the NICU is similar to those found in recent studies of adult intensive care units, but in general the repercussions of the events were more severe.
 
“The NICU is a very high-risk environment,” explained Sharek. “These infants are exceptionally medically fragile.” The authors corrected the results for the infants’ birth weights and gestational age in an effort to take into account the fact that some institutions, like Packard Children’s, treat higher acuity cases that may require more sophisticated interventions. The research is published in the October issue of the journal Pediatrics.
 
Each institution received a report tallying its results. While nearly all struggled with similar issues, some inter-site variations were enlightening. For instance, although many physicians and NICU staff believe that hospital-bourne infections are inevitable in their highly fragile population, a few institutions had no hospital-bourne infections during the timeframe of the study.

“This doesn’t mean that some hospitals are inherently safer than others,” said Sharek, who cautions against any direct comparisons. “These data provide a starting point for local and national efforts to decrease those adverse events with the highest frequency and greatest risk through patient safety interventions in the NICU.”  A similar study among 21 pediatric intensive care units (PICUs), spearheaded by Sharek and Packard Children’s PICU fellow Swati Agarwal, MD, is presently underway.
 
Sharek’s collaborators on the NICU study included investigators from the Harvard University School of Medicine, Dartmouth University School of Medicine, the University of Vermont College of Medicine, Children’s Hospital Los Angeles, the Medical University of South Carolina, and the University of Utah School of Medicine.