Active surveillance is an established practice for managing certain low-risk cancers that are unlikely to cause harm. It is an increasingly common and effective way to manage certain early-stage cancers, including those in the prostate, thyroid and kidney. However, adoption of active surveillance in practice has been hit-and-miss for several reasons. Among them, according to multiple studies, is a perceived increased risk of malpractice among physicians, stemming from unease that the window for a cure may unexpectedly close.

In a new study, Cedars-Sinai Cancer investigators explored malpractice trends related to active surveillance as a treatment strategy across cancers. They found that to date, there has been no successful litigation related to active surveillance. Their research was recently published in the peer-reviewed journal Annals of Surgery.

BACKGROUND  

Cancer clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) consider active surveillance an effective strategy for managing low-risk prostate, kidney and thyroid cancers. Active surveillance is also considered standard of care for certain lymphomas and an emerging option for managing stage 0 breast cancer. This less-invasive approach reserves surgery for cases in which the cancer progresses. In doing so, it avoids the adverse side effects of treatment when the benefit of that treatment (surgery, chemotherapy) is unclear.

Because some cases do progress, physicians have indicated a reluctance to use active surveillance for fear of malpractice lawsuits. However, data on malpractice trends across cancers had previously been lacking.

METHODS

Cedars-Sinai Cancer investigators analyzed comprehensive data from Westlaw Edge and LexisNexis Advance databases between 1990 and 2022 and examined federal and civil medical malpractice cases in all 50 states involving active surveillance for lymphoma and thyroid, prostate, kidney and breast cancer.

They found five prostate cancer cases related to active surveillance; no pertinent cases were found regarding active surveillance in any other cancers. In two of the five prostate cancer cases, the court defended the practice of active surveillance, determining that it was in accordance with national standards of “sound clinical judgment” and “accepted medical practices.” The other cases involved alleged physician negligence for not having recommended active surveillance as a treatment option, after the patients had complications from surgery. All cases were ruled in favor for the physicians, who had documented informed consent for active surveillance.

IMPACT

The authors concluded that given the legal precedent detailed in the identified cases—and increasing support across national guidelines—active surveillance is a sound management option in appropriate low-risk cancers and appears to present no increased risk of malpractice litigation.

“Our team previously published research showing that active surveillance is an effective treatment for many low-risk thyroid cancer patients,” said Allen Ho, MD, lead author of the study and co-director of the Thyroid Cancer Program at Cedars-Sinai Cancer. “These latest findings show no increased risk of medical malpractice with active surveillance across multiple cancer types.”  

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” said Timothy Daskivich, MD, co-author of the study and assistant professor of Surgery at Cedars-Sinai. “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study. In fact, in some cases, physicians were sued because they didn’t offer active surveillance.”

The authors added that failure to discuss an NCCN-recommended approach as a treatment option with patients could be considered just as prone to litigation. Their recommendations to strengthen patient communication and guard against malpractice include thoroughly explaining active surveillance to patients, engaging with the institution’s compliance officers or legal counsel to develop standardized consent templates, and integrating patient preferences and personal values when proposing the treatment option. 

AUTHORS 

Other Cedars-Sinai authors include Missael Vasquez, Wendy Sacks, MD, and Zachary Zumsteg, MD.

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While lower-income communities had lower vaccination rates than higher-income communities, the impact of vaccination on disease incidence was larger in lower-income communities. As a result, investigators say, vaccination led to reduced income-related disparities in COVID-19 incidence. 

The findings were published today in the Morbidity and Mortality Weekly Report, a publication of the Centers for Disease Control and Prevention (CDC).

“This study is a unique demonstration of how vaccination promotes health equity,” said Timothy Daskivich, MD, assistant professor of Surgery at Cedars-Sinai and senior author of the study. “Through this investigation, we also found that disparities in COVID-19 incidence between low- and high-income communities in the first two surges in Los Angeles were not observed in the first surge that occurred after vaccines were widely distributed.” 

The findings also serve as a model for future pandemics and mass vaccination needs across the country, said Daskivich.

“This study shows the benefit of prioritizing vaccine efforts in underserved communities to reduce disparities and improve overall population health,” Daskivich said.

The analysis included vaccination and reported COVID-19 illness data from 81 Los Angeles communities, representing more than 5 million people.

Community-level COVID-19 vaccination coverage and incidence data from April 2020 through September 2021 was obtained from the Los Angeles Times COVID-19 data repository, which is populated with California Department of Public Health data.

Key findings from the Cedars-Sinai analysis include:

• In 81 assessed Los Angeles communities, COVID-19 incidence during two surges before the availability of vaccines—July 2020 and January 2021—was higher in lower-income communities relative to higher-income communities.
• During the first surge after vaccines became available—September 2021—the disparity in COVID-19 incidence between the highest- and lowest-income communities disappeared.
• The impact of vaccination on COVID-19 incidence was highest in the lowest-income communities despite lower vaccination coverage.

Study authors point to public health programs that helped reduce disease incidence disparities. For instance, efforts in California included allocating 40% of vaccination appointments to communities in the lowest quartile of the California Healthy Places Index early in the vaccine rollout.

“Our study, alongside California's initiative to target vaccine rollouts, highlight the importance of improving vaccination access and reducing vaccine hesitancy in underserved communities to reduce disparities in COVID-19 incidence,” said Brennan Spiegel, MD, MSHS, director of Health Services Research at Cedars-Sinai and an author of the study. “Reducing barriers to vaccination in lower-income communities, including providing updated COVID-19 vaccine boosters, is critical to reducing disparities in disease burden and decreasing COVID-19–related illness in the United States.”

Other Cedars-Sinai authors involved in the study include John Masterson, MD, and Michael Luu, MPH.

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