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An opt-out breast cancer screening outreach approach did not improve mammography completion rates compared with an opt-in approach, a randomized trial of veterans found.

In the intention-to-treat analysis involving 883 veterans due for mammography, there was no significant difference in the primary outcome of completed mammography at 100 days between the opt-out arm who received an automatic referral or the opt-in arm who received an automated telephone call with an option for mammography referral (15.2% vs 14.9%, P=0.90), reported Leah Marcotte, MD, of the University of Washington in Seattle, and colleagues.

There was also no difference in the secondary outcome of completed or scheduled mammography at 100 days (19% vs 24%, respectively, P=0.07), they noted in.

In addition, a significantly higher number of referrals were canceled in the opt-out group compared with the opt-in group (23.6% vs 5.4%, P<0.001).

"The administrative burden of the opt-out approach, including medical record review of all veterans prior to outreach to confirm breast cancer screening eligibility, at least 1 telephone call to eligible veterans, and an increased number of canceled referrals following outreach, likely outweighs any potential added benefit," the authors wrote. "The findings suggest that health systems should consider both potential effects and excess administrative burden when deciding between opt-out and opt-in outreach strategies."

Marcotte and colleagues also conducted a restricted analysis that excluded veterans who could not be reached by phone or who otherwise were found to be ineligible after randomization based on medical record review, which showed that results were comparable in terms of completed mammography (16.5% in the opt-out arm vs 14.9% in the opt-in arm, P=0.50). However, more veterans in the opt-out arm either completed or scheduled mammography compared with the opt-in arm (26.3% vs 19.3%, P=0.02).

In explaining the rationale behind the study, Marcotte and colleagues pointed out that of the 280,000 individuals who receive care from the Veterans Health Administration and are eligible for breast cancer screening, only 66% are up to date with mammography.

"The current default option for cancer screening is to not participate unless a patient opts in. In contrast, changing the default framing to opt out, which assumes participation, has been associated with significantly increased influenza vaccination, hepatitis C screening, and colorectal cancer screening rates in randomized clinical trials," they noted. "Opt-out strategies for breast cancer screening outreach may help to decrease access barriers for patients and improve reach by making screening the default option."

In a , Kimberly Waddell, PhD, MSc, and Shivan Mehta, MD, both of the University of Pennsylvania in Philadelphia, said that an opt-out approach "is not a universal solution to low cancer screening rates."

While they will be most effective in improving behaviors that aren't too complex or intensive, Waddell and Mehta noted that in this case, the study location did not offer onsite mammogram screening and had to coordinate scheduling with non-VA healthcare facilities.

"One can imagine that scheduling and completing a mammogram in a different health system creates additional steps on the behavioral pathway that can hinder mammogram completion," they observed.

"Making it easier for patients to complete the required steps of preventive cancer screenings deserves as much attention as simply shifting the default option," Waddell and Mehta concluded.

This pragmatic randomized study was conducted at a single VA medical center from April 2022 to January 2023, and included female veterans ages 45 to 75 due for breast cancer screening and enrolled in VA primary care. They were randomized 1:1 to the opt-out arm or opt-in arm.

The mean age of the study participants was 59 years, 68.8% were white, and about three-quarters had received prior mammography.

After adjusting for age, race and ethnicity, comorbidities, and prior breast cancer screening, there was no significant difference in the odds of mammography completion between the opt-out and opt-in groups, or in the odds of scheduled or completed screening within 100 days.

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