The Irish government runs two screening programmes – CervicalCheck and BreastCheck – designed to benefit the country’s women. In 2009, Ruth Morrissey had a routine pap smear test and the result came back negative – i.e. nothing to worry about. The same outcome was reported in 2012. However, the health authorities conducted an audit in 2014 and established that both smears had been inaccurately read, and in 2015 Ms Morrissey was diagnosed with advanced cervical cancer. Now terminally ill, she and her husband were recently awarded €2.1 million in damages by the High Court of Ireland.
In his ruling, Mr Justice Cross held that “absolute confidence” is the screener’s practical duty in relation to his or her analysis of the slide. It is this wording that concerns Irish radiologists who have the responsibility of reading the mammographic images in BreastCheck. One expert, who requested anonymity told AuntMinnie.com: “This seems an unattainable goal, but if it becomes a legal standard, it may make screening impossible to sustain. The judge has subsequently explained that his judgement relied upon a standard already in existence and was not intended to be applied more broadly. Nonetheless, it has spooked many professionals involved in screening work.”
While radiologists are not involved in reading pap smear images – that’s the domain of pathologists – they are worried that a woman diagnosed with breast cancer, who had a previous false negative result, may choose to sue the clinician who read the earlier mammogram. Another medical imaging specialist commented: “It could be the death knell for screening, certainly from a financial point of view,” and said that the impact of such judgements is often lost on the general public.
When a woman has a screening mammogram and receives a negative report, there are three possible outcomes. First, it is a true negative and no cancer is present. Second, it is a false negative, but there is no evidence of cancer in the mammogram. Third, it is a false negative, and there is evidence of cancer that was not detected by the radiologist. In the first outcome, an interval cancer may develop between screening mammograms through no fault of the radiologist. In the second outcome, dense breast tissue can mask the cancer and that is why CapeRay has developed the Aceso system that integrates ultrasound with mammography.
In the third outcome, the radiologist could be found liable for negligence, but evidence suggests the number of cases is exceedingly small. It would be a travesty if the threat of litigation prevented Irish women from access to a life-saving service like BreastCheck.
Indeed an unfortunate result; the medicolegal system is so often misaligned with real world practice realities, and generates unintended consequences.
Will AI and machine learning systems in the near future reduce the number of false negatives and protect radiologists from lawsuits? Or will they generate more false positives, cost and anxiety? We’ll have to see what data the prospective studies produce. And perhaps Aceso will integrate these algorithms into image output?
I believe you’re right, Gary, that new technologies like AI, and our dual-modality Aceso system, will reduce the number of false negatives. While more false positives may occur, with the attendant increase in anxiety for the affected women, some would argue that’s a risk worth taking.
Unfortunately, many women (and some doctors) do not fully grasp the devastating implications of receiving a false negative diagnosis. It happened to me many years ago.
The magistrate is not well informed. If “absolute confidence” in the screener’s practical duty is wanted, we should stop screening. Both exclude each other. Apparently it is not enough to be a native speaker to understand the etymology of the word “screening”.
Perhaps “scagadh” (google translate) might get him (or her) on the right track.
Thank you for your comment, Ard, with which I fully agree. I also used Google Translate to discover that “scagadh” is an Irish word that means “filtering.” Well said!