Medical Technology

Appendectomy or Antibiotics? Large-scale trial aids in decision making

A new analysis of data from a major US trial comparing antibiotics to surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington and co-authors in a paper published in JAMA Surgery on January 12.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Flum told Medscape Medical News in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Flum said. “Sometimes we find out that our hunches were wrong.”

Flum and co-authors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios (aORs) to describe these relationships while accounting for other differences.

An OR of 1.0 — or when the confidence interval around an OR crosses 1 — signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28 to 3.10. The OR was 1.53 (95% CI, 1.01 – 2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66 – 1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00 – 1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98 – 1.09) for having a higher white blood cell count, as measured by a 1000-cells/μL increase.

Appy or Not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which topline results were published in 2020 in The New England Journal of Medicine. In that paper, Flum and colleagues reported on results for 1552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by Medscape Medical News.

The federal Patient-Centered Outcomes Research Institute (PCORI) funded the CODA research. Flum said the National Institutes of Health (NIH) had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.

Shift Away From “Paternalistic Framing”

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision making, Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment, he said. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Flum said.

The guidelines of the American College of Surgeons (ACS) state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (eg, hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview arranged for Medscape by ACS, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, agreed with Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care, he said.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from the Patient-Centered Outcomes Research Institute. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, Tetraphase Pharmaceuticals Stryker.

JAMA Surg. Published online January 12, 2022. Abstract

Kerry Dooley Young is a freelance journalist based in Washington, DC. She is the core topic leader on patient safety issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.

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