When , saw a friend rushed to the hospital "with shaking and chills" one day after his colonoscopy a few years ago, he wondered how often this procedure results in such scary, adverse events.
"For about 12 hours he was very, very sick," Krumholz recalled. And it seemed "a bit much to think the colonoscopy was unrelated; maybe there was a micro-perforation, or a contaminant in the IV" used to administer sedation during the procedure.
It struck Krumholz, director of the Yale Center for Outcomes Research and Evaluation (CORE), that the frequency and severity of harm from this common cancer screening, performed in roughly 14 million people each year, were poorly quantified. It probably varies widely among facilities, depending not just on the skill of their clinicians, but on many other factors related to how the facility functions, he thought.
So Krumholz, whose team has multiple Medicare contracts to develop pay for performance measures for healthcare settings, went to work.
"I came back to my group and said, 'We need a measure for this,'" he said. "How often does this happen and how much does it vary among the outpatient centers? Probably the people who performed his colonoscopy didn't even know he showed up in the emergency department. Because today, there's no feedback to let them know.'"
The Yale team developed a risk-adjusted measure that now has been incorporated in two Centers for Medicare & Medicaid Services quality reporting programs. It provides a count of all healthy fee-for-service Medicare beneficiaries 65 and older who, for any reason, experienced an unplanned visit to the hospital within 7 days of their outpatient colonoscopy -- regardless of whether a polyp was removed or biopsy performed.
As a kind of test, Krumholz and colleagues applied the measure, which factors in the patients' procedures and conditions in the prior year, to Medicare claims databases in four states (New York, California, Florida, and Nebraska) that track unique patient identifiers. With that, they could see what care patients required within 7 days of their colonoscopies.
Two of Every 125 Patients
What they found might surprise many, although it's not out of line with the literature: 1.6% of 325,000 otherwise low-risk healthy patients who had a colonoscopy in the year 2010 experienced a complication serious enough to send them to a hospital or emergency department within 7 days.
For some, "that 1.6% may not seem high," , director of quality measurement programs at the Yale center, said in an phone interview. "But not when you think of how so many healthy people have these procedures. It's important for us to know how many could be having a bad result."
The Yale team's as the lead article in the January issue of the journal Gastroenterology, accompanied by a .
What's more, the team found wide variation in the rates of emergency visits and hospitalizations across facilities, from 8.4 per 1,000 up to 20, she said.
Extrapolating to a national population of 1.7 million Medicare fee for service beneficiaries undergoing colonoscopies each year, Drye and colleagues estimated about 27,000 would have an unplanned hospital visit within 7 days. That does not include Medicare Advantage enrollees or younger patients 50 to 64 who have an adverse reaction from their colonoscopy bad enough to send them to the hospital.
A lot of things can go wrong even after colonoscopy in an outpatient setting, such as a hospital outpatient department or an ambulatory surgery center.
Perforations or lacerations can cause bleeding and hemorrhage or even infections that don't show up for a day or more; sedative drugs can cause reactions resulting in hypoxia, aspiration pneumonia, and cardiac arrhythmias. Abdominal pain or nausea can also result, possibly from preparation, Drye said.
As early as next year, all Medicare-approved outpatient facilities will have their scores for the measure -- "ASC-12" or "OP-32" as it is now called -- publicly reported on .
CMS said in its that such transparency "will reduce adverse patient outcomes associated with preparation for colonoscopy, the procedure itself, and follow-up care by capturing and making more visible to providers and patients all unplanned hospital visits following the procedure." Eventually the measure will probably be used to determine amount of Medicare reimbursement to those facilities.
It also will provide "transparency for patients on the rates and variation across facilities in unplanned hospital visits after colonoscopy," CMS said in its .
The intent is "not to put a label on a facility that looks better or worse," she emphasized. "What we're doing is making this visible to doctors, to gastroenterologists and surgeons and their facilities, so they know what is happening to the patient ... something they don't know now."
When the data becomes public, it will also help physicians determine where to refer their patients.
Beyond 7 Days
Most colonoscopy adverse events occur within 7 days, but even more occur beyond the 7-day period. In a mid-2014 handout, the agency said: "Hospital visit rates after outpatient colonoscopy range from 0.8 to 1.0 percent at 7-14 days." And in its , it estimated the range of hospital visits is between "2.4 to 3.8% at 30 days post procedure."
But Drye noted also that the risk is even higher on a per-person basis, because one must consider that patients who undergo colonoscopies at recommended intervals -- every 10 years, or every 5 years if polyps are found -- would have from three to six colonoscopies before age 76.
Additionally, the measure also only captures the risk for healthier patients; Those with conditions such as diverticulitis or inflammatory bowel disease, and those with serious chronic illnesses are more likely to experience complications from colonoscopy were excluded from this measure's denominator.
"We were very conservative," Drye said. Also, the 1.6% meshed more or less with what they found in medical literature, where a variety of studies using different time frames and definitions of "hospitalization" found rates of colonoscopy complications ranging from .8 to 3.8%.
Rates were somewhat different between hospital outpatient departments and ambulatory surgical centers, Drye added. Their study found that the ASC measure scores "ranged from a minimum of 6.5 per 1,000 procedures to a maximum of 13 per 1,000." Hospital outpatient department averages were slightly higher "with a minimum of 7.3 and a maximum of 16.6 per 1,000."
Public reporting will be a good thing, said , a quality measurement expert referred by the American Gastroenterological Association.
"This forces, or at least helps to begin a dialogue of what percentage of the endoscopists' (and facility's) patients actually have an emergency department or hospital visit within the week," said Brill, of Predictive Health LLC in Phoenix. "Ideally, it should be zero."
And if it isn't, he said, "you need to look at the root causes of why that would occur, and would you could do to bring it down."
Providers should be asking, "what kind of preparation was used, what type of scope did you use, what were the comorbid conditions, what type of sedation or anesthesia – ask all those questions first to find out what's going on. And if there's something there, we need to modify or change our practices," Brill said.
The measure is part of the movement toward value, Brill acknowledged. "We clearly have to move toward avoiding potentially avoidable complications, and that includes avoiding unnecessary services that could have been prevented up front. This could be tipping us off to that."
CMS began collecting this data early last year, and in recent months outpatient surgical centers received their first confidential reports to show how they measure up. Those numbers are not being publicly reported, to give centers a chance to compare themselves and improve before the data go live next year with updates for 2016.
Gastroenterology groups seem comfortable with the new transparency, even though some proceduralists will need to change their practices.
Disbelief Common
Though still, some physicians expressed skepticism, saying they don't see such high rates of complications. Brill thought the actual complication rates are much lower than what Drye found. "It's still a very low risk procedure," he said.
Some emergency room physicians concur.
"(It's) very unusual in my practice at UCSD [University of California San Diego]," said , a long-time emergency room physician who now serves as medical director for the city's fire and rescue department. "I know of one case in the past couple of years, and naturally it happened to an MD during a routine screening exam."
Drye acknowledged widespread disbelief that complications are that common. "These outcomes really aren't visible to anyone right now, just like hospital readmissions weren't visible until we started reporting them."
But others say those numbers are quite plausible. , an emergency physician in Lexington, Ky., said he was "not surprised. The most common complications I see are perforations that are usually small, diverticulitis and bleeding."
, an emergency physician in New Orleans, wrote that she has not seen "a lot" of patients in the ED with complications, although, she added, she has "seen some with massive GI bleeds after polypectomy."
For Krumholz, the numbers will tell an important story about quality in outpatient settings that has for too long gone unreported. "It's a big area of growth, but a largely invisible area with regard to performance. It's important for us to have a sense of what is being achieved."