A new study by the American College of Surgeons, a professional organization, compared records for 75,000 patients who underwent surgery for GERD, or gastrointestinal esophageal reflux disease. The study looked at two different surgical procedures and found the less invasive one seemed equally effective, but kept patients in the hospital a shorter time with fewer complications. The news release did a good job of discussing surgical alternatives and costs, which were estimated to be $9,000 lower for the less invasive laparoscopic procedure.
The release would have been better had it spelled out some of the study limitations, the key one being that a retrospective, observational review of hospital records — as this study was — isn’t capable of supporting the cause and effect statements sprinkled throughout the release.
Millions of Americans complain of occasional heartburn, sometimes called a burning sensation in the throat from food coming back up from the stomach. But some estimates are that about 20 percent of US adults fit the definition of GERD, which means they suffer symptoms at least every week. If patients consider a surgical fix, this study shows that a less-invasive procedure could reduce their complications and shorten their hospital stay.
It’s hard to pin down stats on GERD prevalence. A 2014 review of 16 epidemiological studies of GERD prevalence published in the journal Gut suggest GERD prevalence ranges from “18.1%-27.8% in North America, 8.8%-25.9% in Europe, 2.5%-7.8% in East Asia, 8.7%-33.1% in the Middle East, 11.6% in Australia and 23.0% in South America.”
The story focused on costs, including information about the relative cost comparison between what are called “open” surgeries and those done laparoscopically (with a thin flexible tube.)
The release summarized how minimally invasive techniques reduced the length of hospital stay and complication rates for patients.
“Researchers also found that, on average, the minimally invasive approach reduced length of hospital stay by approximately two days, and open operations were more than $9,000 more expensive than minimally invasive procedures.
The researchers also found that laparoscopic procedures were better for patients in terms of fewer complications. Laparoscopic anti-reflux operations were less likely to result in postoperative blood clots, wound complications, surgical site infection, esophageal perforation (which can be life threatening), bleeding, cardiac failure, and death.”
We rate this satisfactory, but just barely, for citing cost differences between the two types of surgery and the average reduction in the number of days a patient must remain hospitalized. We do wish the release had delved more into the specifics of reduced complications. How common were the surgical complications in each surgical method?
The release names complications associated with both types of surgery for GERD, while stating that patients undergoing laparoscopic procedures encountered fewer of them: “postoperative blood clots, wound complications, surgical site infection, esophageal perforation (which can be life threatening), bleeding, cardiac failure, and death.”
The news release gave details about how the study examined records of about 75,000 patients from 1,000 hospitals to compare outcomes in the records for open vs. the minimally invasive laparoscopic surgeries. That’s all to the good.
However, the news release didn’t mention any of the study’s limitations.
The key one is that this is a retrospective, observational review of records that isn’t capable of supporting cause and effect statements such as the minimally invasive approach “reduced length of hospital stay by approximately two days.” Nor should this kind of evidence be used as the basis for statements such as laparoscopic procedures “were better for patients” and “should be the standard of care.” Patients receiving open vs. laparascopic procedures could differ in unknown ways, which is why the superiority of one approach over the other should ideally be established by a prospective, randomized controlled trial.
There were other limitations outlined in the journal article that were not mentioned in the release. Because the NIS database doesn’t link to hospital records, researchers weren’t able to track and measure outcomes “including complications, readmission, and mortality, occurring after the initial hospital discharge.” The researchers were also unable to determine which open surgeries were “re-dos” of previous surgeries. The potential for errors in coding which procedures were used was also cited as a possible limitation.
There was no disease mongering. The release also provided useful context on the prevalence of GERD and further specified that smaller group of patients, from the many heartburn suffers, might be candidates for the surgery. Well done.
The release does not list any funding source for the research and the published study notes that authors had “nothing to disclose.” We’ll rate this not applicable since this is an examination of existing data, and there may have been no additional outside funding.
The news release does a good job here. It compares different surgical methods and it also names alternatives for treating GERD such as medications and changes in the diet.
It also states which group of patients the surgery is aimed at: “Anti-reflux surgery should be considered in patients who do not achieve complete control of their symptoms [regurgitation or cough] with medications; who do not want to take medications for the rest of their lives; or who experience complications of medical therapy.”
It’s clear from the release that both methods of surgery have been widely available nationally and the outcomes of 75,000 surgeries were tracked by the National Inpatient Sample (NIS) database.
The release also notes that “urban academic or teaching hospitals” perform laparoscopic anti-reflux surgery more often than “open” procedures, 54.4 percent versus 45.6 percent. And it recommends that anti-reflux surgery should be performed laparoscopically in specialized centers.
The news release was not about a novel procedure and made no claim of novelty. However, this isn’t the first study to examine laparoscopic vs. open surgery. For example, the British Journal of Surgery published results of a randomized trial of the two methods and the Scandinavian Journal of Gastroenterology published research on long-term outcomes following laparoscopic and open procedures for GERD.
We did not observe any unjustifiable language.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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