Complications related to endoscopies and colonoscopies could be three times more common than previously thought, according to a new study, contributing possibly hundreds of millions of dollars to the nation's health care costs.

The study, published Monday in the Archives of Internal Medicine, also showed the potential promise of electronic medical records in helping physicians better understand patient outcomes.

For the study, the researchers used an EMR system to automatically track hospital visits following outpatient endoscopy procedures with doctors affiliated with Beth Israel Deaconness Medical Center in Boston.

The researchers said this new method found around five times more complications, such as pain and GI bleeding, than voluntary physician reporting, relied on for earlier estimates and known from some studies to miss as many as 15 to 45 percent of adverse events, according to the paper.

"The standard physician reporting greatly underestimated the burden of medical care related to endoscopic procedures and unexpected hospital utilization, which adds considerably to the cost of our screening or surveillance colonoscopy program," wrote the authors, led by Dr. Daniel A. Leffler, a gastroenterologist with Beth Israel.

In the study, the EMR system automatically recorded visits to the emergency room within two weeks of an endoscopy. Doctors evaluated cases and determined if they were "related" to the procedure based on certain criteria. For instance, "abdominal pain" could be classified as related if it followed a screening colonoscopy, typically done on healthy adults, but not if it was the reason the patient sought an endoscopy in the first place.

Using the medical records to record more than 6,000 esophagogastroduodenoscopies and almost 12,000 colonoscopies (almost two-thirds for screening or surveillance), the doctors recorded 419 emergency room visits and 266 hospitalizations following a procedure.

Of these, 134 of the ER visits and 76 hospitalizations were classified as procedure-related. In contrast, physician reporting only turned up 31 complications.

Although the overall endoscopy complication rate was very low, at less than 1 percent, the rate was still several times higher than many earlier estimates, the researchers said. A widely relied-on 1976 survey conducted by the American Society for Gastrointestinal Endoscopy found complication rates between one out of 1,000 for upper endoscopy and one out of 285 for colonoscopies, the authors said.

"Although the overall rate of severe complications, including perforation, myocardial infarction and death remained low, the true range of adverse events is much greater than typically appreciated, and the overall rate of one in 127 patients visiting the hospital due to an outpatient endoscopic procedure is a cause for concern, especially in the setting of screening and surveillance when otherwise healthy individuals are subjected to procedural risks," the authors said.

Around half of ER visits in the study were due to abdominal pain, and about one out of 10 to GI tract bleeding, the authors said. Only one death was judged linked to the procedures - a 75-year-old whose heart stopped eight days after stopping an aspirin regimen before getting an endoscopy for surveillance of Barrett esophagus. (ASGE no longer recommends stopping aspirin for routine endoscopies, the organization said.)

Millions more

A big concern of the hospital visits was their cost: they added around $48 on average to a colonoscopy screening program, increasing its cost around 4 percent, the researchers said. The total costs to the hospital from procedure-related visits reached around $1.4 million.

"Although on an individual basis this cost is relatively low, projected nationwide, this is a considerable and underreported cost to the medical system, which could exceed $650 million per year in the United States," the researchers said.

Still, the doctors said it's possible their numbers could be off. They might have underestimated complications by missing patients visiting other hospitals. To control for this, the researchers said they captured data from physician reports from outside hospitals and called 200 patients several weeks after the procedure. Only around 6 percent of the total events were recorded at outside hospitals, the doctors said, and only one patient called by the researchers went to the ER within the first two weeks of the procedure, when the medical literature shows most complications are likely to occur.

However, it's also possible the classification scheme might have roped in unrelated hospital visits. But the doctors say "related"-type reasons for hospital visits declined within two weeks of endoscopic procedures, as expected, while conditions obviously unrelated to the procedure remained level.

First step

"This is a good first step," Dr. Brian C. Jacobson, chair of the Health & Public Policy Committee, with the American Society for Gastrointestinal Endoscopy, told DOTmed News about the study. "It's evidence that proper use of electronic health records to track patient outcomes can potentially be very fruitful in helping inform physicians about the care we give."

Still, Jacobson said it wasn't the "final word." He said the researchers admitted they erred on the side of ascribing hospital visits to endoscopies if the cases were ambiguous.

"Some of these things are a little hard to be sure that it's accurate," he said, such as a patient falling a week after the procedure.

"Like they said, a day after, you could say, maybe it was an elderly person under the influence of sedation, but a week after, someone falls, I'm not sure that was appropriate," he said.

"If you take a lot of these other ones out, the overall complication rate drops a sizable amount," Jacobson added. "That said, if people are coming to the emergency room and we can even think it's related to the endoscopy, the question is what else can we do to prevent that from happening."

The results could suggest systemic problems - not necessarily with procedures, but with helping patients know when their problems are serious enough to warrant visiting the hospital, as only around of half of ER visits resulted in hospitalizations.

"[It] points to system changes in terms of what can we do to give patients a way of getting care without necessarily utilizing health care dollars," Jacobson said.

He said at his medical center, "We have nurses call the day after the procedure, and if there [are] any symptoms or anything, we call patients directly. And that may be one way of heading off some emergency room visits for things that may not be a complication."