Pediatric Endoscopy Adverse Events Research

Background: Why we're studying adverse events after endoscopies

Pediatric patients with gastrointestinal symptoms often undergo an endoscopy for either diagnostic or treatment purposes. These procedures have become increasingly common over the years, but there remains a lack of published data on the rate, type and severity of adverse events (AEs) — undesirable experiences or harm associated with medical care, rather than the underlying disease — related to pediatric endoscopy procedures.

A digestive health research team within Children's Hospital Colorado's Digestive Health Institute was one of the first and only to study all common types of AEs in pediatric patients up to 72 hours after an endoscopic procedure. The study tracked all post-endoscopy complaints reported by parents or providers in order to identify procedure-specific rates.

The team expanded the clinical criteria for AEs and tracked common, delayed (and sometimes unclear) events, in addition to confirmed severe events. To do so, the team created a pediatric classification system to stratify and differentiate the most common types of AEs.

As a result of the data our team collected, the first-ever quality improvement guidelines for pediatric endoscopy were published in 2017 by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Collecting data for pediatric endoscopic adverse events

Due to the small amount of data available on pediatric patients, many pediatric endoscopy providers refer to adult data, which, like the limited pediatric data, focuses on confirmed cases of serious AEs.

The Pediatric Endoscopy Database System-Clinical Outcomes Research Initiative (Peds-CORI) database reports rates of AEs that take place during and immediately after endoscopy. However, to get a truly accurate picture of AEs related to endoscopy, researchers need data that tracks AEs before, during and after the procedure.

The Peds-CORI database shows rates for AEs in esophagogastroduodenoscopy, or EGD, at 2.3%, and rates with colonoscopy at 1.1%. Another often-cited study collected AE data for pediatric patients up to 30 days post-endoscopy. This study shows a rate of AEs at 42% after EGD.

Methods: How we gathered adverse event data

For a period of four years, we tracked important metrics for procedures that occurred at our hospital, including:

• Parental notifications of post-endoscopy symptoms
• Emergency department visits
• Hospital admissions
• Any AE (including abdominal pain, throat pain and fever) clinicians encountered during or after an endoscopy

Categorization methods

The team categorized events according to several significant criteria:

• Type of procedure performed
• Type of event
• Level of intervention needed

The team then categorized the procedures as either diagnostic or interventional/advanced, developing a two-character classification system to illustrate both the severity and type of AE.

The team included common, less significant AEs that do not require additional treatment in their tracking. Because these events are more common, their classification will allow clinical teams to offer parents more guidance in anticipating what their child might experience after undergoing endoscopy.

AEs that were assigned Level 2 or higher were considered "significant," because they led to increased medical costs and potential risks from unanticipated medical care.

Results: Key findings on pediatric endoscopy adverse events

Of 9,577 endoscopic procedures, 249 AEs accounted for 2.6% of total procedures. Of those 249, 160 resulted in medical evaluation and increased cost — 1.7% of the total procedures.

Advanced or interventional procedures experienced a higher AE rate of 65 of 1,167 events, or 5.6% total. There were 10 cases of confirmed bleeding and 13 perforations. These results were published in the June 2016 issue of the Journal of Pediatric Gastroenterology and Nutrition.

Setting a quality standard for pediatric endoscopy

Using data gathered in the study, the Digestive Health Institute worked with the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition to create the first quality improvement guidelines for pediatric endoscopy, published in 2017.

These guidelines, define quality indicators and provide pediatric endoscopy providers with a framework they can use to develop and implement a quality improvement program at their institutions.
As they establish relevant indicators and corresponding measures for every aspect of the endoscopy procedure — from informed consent to the delivery of biopsy results — these guidelines set quality benchmarks that not only help providers understand and target opportunities for improvement, but help parents make informed decisions about their child's care.

The quality improvement guidelines are designed to expand and evolve as new data becomes available, and the Digestive Health Institute continues to study AEs in pediatric endoscopy, toward a future of better, safer care.

Learn more about pediatric endoscopies at Children's Colorado.