May 20, 2022

Appendicitis or antibiotics? A great trial helps with decision making

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

The presence of mineralized stool, known as an appendicolith, was associated with an almost doubled risk of suffering appendectomy within 30 days of starting antibiotics, write David Flum, MD, of the University of Washington and co-authors of a paper published in JAMA surgery January 12.

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

Doctors have had their own ideas about what factors make a patient more likely to need an appendectomy after a first round of antibiotic treatment, such as a high white blood cell count or a perforation seen on CT scans, Flum said. . Medscape Medical News in an interview. But research has not supported some of these theories.

“That’s why we do studies,” Flum said. “Sometimes we discover that our intuitions were wrong.”

Flum and his co-authors measured the association between different patient factors and disease severity and the need for appendectomy after a course of antibiotics. They used adjusted odds ratios (aOR) 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 this factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest that the factor was associated with appendectomy.

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

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

The OR was 1.09 (95% CI, 1.00, 1.18) for radiographic finding of a larger appendix, 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 an increase of 1000 cells/μL.

Apply or not?

This article is based on the CODA (Comparison of Outcomes of Antibiotic Drugs and Appendectomy) trial (NCT02800785), for which the main results were published in 2020 in The New England Journal of Medicine. In this article, Flum and colleagues reported the results of 1552 adults (414 with an appendicolith) who were equally randomized to receive either antibiotic treatment or appendectomy. After 30 days, antibiotics were found to be non-inferior to appendectomy, as reported Medscape Medical News.

The federal Patient-Centered Outcomes Research Institute (PCORI) funded CODA research. Flum said the National Institutes of Health (NIH) didn’t seem interested in funding a review of the different options available for patients with 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 head-to-head comparisons. Her support has been essential for Flum and her colleagues as they seek to help people weigh their options for treating appendicitis.

The CODA study “models what the patient experience looks like, and that hasn’t been the focus of NIH as much,” Flum said.

The CODA team sought to make it easy for patients to consider what their findings and other appendicitis research mean to them. They have created an online decision support tool, available on the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patient options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose treatment based on their individual circumstances.

Moving away from the “paternalistic framework”

In the past, surgeons focused on the risk to patients from procedures, deciding for them whether or not to proceed. There is now a drive to move away from this “paternalistic framing” toward shared decision-making, Flum said.

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

Flum said his fellow surgeons have generally responded well to the work of the CODA team.

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

the guidelines from 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 before 90 days, 75% of those without appendicolitis, and 59% of those with appendicolith).

“Based on surgeon judgment, patient preferences, and local resources (e.g., hospital staff, bed, and availability of PPE supply), antibiotics are an acceptable first-line treatment, with a appendectomy offered to people with worsening or recurring symptoms,” according to the ACS guidelines. to say.

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

CODA research, including the new article in JAMA surgerymakes it easier for doctors to work with patients and their families to make decisions about how to treat appendicitis, Fakhry said.

These important discussions take time, he said, and patients need to have that time. Patients may feel misled, for example, if a surgeon insists on an appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery immediately, especially in cases of appendicoliths, to avoid the risk of repeated bouts of medical care, he said.

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

This study was supported by a grant from the Patient-Centered Outcomes Research Institute. The authors have reported serving as consultants or reviewers or receiving honoraria for work outside of this article 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 responsible for the central theme of patient safety issues for the Association of Health Care Journalists. Young previously 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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