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SAN ANTONIO -- The Bedside Pediatric Early Warning System (PEWS) was found to be no more effective than usual care for preventing deaths among hospitalized children in a randomized, clinical trial, researchers reported here.

The study, conducted to determine whether the severity of illness score improved patient outcomes, included 21 hospitals in seven countries, with approximately 144,500 patients included in the analysis.

The findings do not support the use of the BedsidePEWS tool to reduce hospital mortality, said Christopher Parshuram, MBChB, DPhil, of the Hospital for Sick Children in Toronto, who was the study's lead researcher and a co-creator of the scoring system.

He presented the EPOCH (Evaluating Processes of Care & the Outcomes of Children in Hospital) trial results at the Society of Critical Care Medicine (SCCM) Critical Care Congress, which were published simultaneously in .

"BedsidePEWS versus usual care did improve processes of care, and early detection of critical illness aligned with the notion of providing the right care right now," he said. "However, when we looked further, there was no difference in hospital mortality nor [intensive care unit (ICU)] resource utilization."

The BedsidePEWS system includes five validated, age-based severity-of-illness scores based on seven bedside vital signs and clinical observations, including heart rate, systolic blood pressure, capillary refill time, respiratory rate, respiratory effort, transcutaneous oxygen saturation, and oxygen therapy.

Key components of the scoring system include a validated severity-of-illness score from 0 to 26, a documentation record of the score calculation to enable decision support and multi-domain care recommendations.

All hospitals included in the trial had a pediatric ICU, and the average bed size was 1,000, Parshuram said. Hospitals were ineligible if they were already using a severity-of-illness score. The hospitals were located in Belgium, Canada, England, Ireland, Italy, New Zealand, and the Netherlands and had a total of 2,085 eligible inpatient unit beds.

Patient enrollment began in late February 2011 and ended in mid-June 2015. Follow-up ended in July 2015.

The primary study outcome was all-cause hospital mortality, and the secondary outcome was significant clinical deterioration, defined as a composite outcome reflecting late ICU admission.

Ten of the selected hospitals adopted the BedsidePEWS, with a 6-month run-in before assessment to allow system implementation. Eleven hospitals continued usual care with no severity-of-illness scoring.

The main study findings were as follows:

• All-cause hospital mortality was 1.93 per 1,000 patient discharges at hospitals with BedsidePEWS and 1.56 per 1,000 patient discharges at hospitals with usual care (adjusted between-group rate difference 0.01, 95% CI −0.80 to 0.81 per 1,000 patient discharges; adjusted OR 1.01, 95% CI 0.61-1.69; P=0.96)
• Significant clinical deterioration events occurred during 0.50 per 1,000 patient-days at hospitals with BedsidePEWS versus 0.84 per 1,000 patient-days at hospitals with usual care (adjusted between-group rate difference −0.34, 95% CI −0.73 to 0.05 per 1,000 patient-days; adjusted RR 0.77, 95% CI 0.61-0.97; P = 0.03)
• There were no significant differences in the rates of cardiac arrest, potentially preventable cardiac arrest, unplanned ICU readmission, or hospital readmission

In his presentation at the SCCM meeting, Parshuram noted that hospital mortality during the 18-month trial was 60% lower than had been anticipated -- "leading to questions about the power of this study, the interpretation of the outcome, or whether or not we were powered for a difference that is relevant to the current context."

Other study limitations, he said, included the inclusion of only large, academic hospitals, reducing the generalizability of the findings to smaller, non-academic centers; the unblinded nature of the study; and the inclusion of deaths with do-not-resuscitate (DNR) orders.

The reliance on a static paper-based system, manual data entry and calculations, isolated use of bedside vital signs, and exclusion of other data documented in the electronic medical record were also cited as study limitations in an editorial published with the study in JAMA.

Neil Halpern, MD, director of the Critical Care Center and medical director of Respiratory Therapy at Memorial Sloan Kettering Cancer Center in New York City, wrote that the failure of the BedsidePEWS intervention to reduce mortality rates "may be difficult to reconcile with the expectation that outcomes can be improved if early clinical changes are identified."

The secondary outcome finding of a decrease in significant clinical events with BedsidePEWS "implies that early warning systems advance the transfer of sick patients from the ward to the ICU," he noted.

"The limitations of the study should give clinicians pause as to what approaches should not be performed or studied going forward. With the endless stream of big data in the clinical setting, future studies of early warning systems should incorporate informatics based on deep learning technologies. Clinical inpatient early warning systems should accommodate the available big data, evolve the early warning system models, provide automated notification to physicians and nurses with clear-cut clinical recommendations, track all transactions, and monitor outcomes."

Halpern concluded by writing that stakeholders should embrace informatics systems now being developed, "which are broad in their data capture, analysis, learning, and therapeutic recommendations.

"These programs should be welcomed into inpatient and ICU care to allow investigations to move away from single intervention-based studies, with simplistic but easily accessible primary outcome measures such as mortality, to be a more technologically based approach to understanding healthcare data and studying therapeutic interventions."