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CervicalCheck chief responds to test criticism: 'I’d be surprised if women didn’t have questions'

The screening programme said that it had received a slight increase in calls after the Vicky Phelan High Court case settlement.

shutterstock_631110185 Source: Shutterstock/Iryna Inshyna

THE CLINICAL DIRECTOR of CervicalCheck has said that she’d be surprised if women didn’t have questions after Vicky Phelan’s court case over an incorrect smear test made headlines yesterday.

Phelan, who’s a 43-year-old Limerick mother-of-two, was awarded €2.5 million over a missed abnormality in a smear test in 2011.

When she returned for a routine smear test three years later in 2014, she was told she had cervical cancer. After a number of tests, she was told she had between six and 12 months to live.

In a statement to TheJournal.ie, the screening programme said “a small additional number of women” had been in touch yesterday after widespread publicity of the case, and that it was committed to answering women’s questions so that they’d have confidence in the smear programme.

Questions were raised about CervicalCheck’s process after it emerged that a 2014 qualitative review of the 2011 smear test showed that abnormalities in her smear test had been missed. Despite this, Phelan was not told about the missed abnormality until 2017.

Speaking to TheJournal.ie, CervicalCheck director Professor Grainne Flannelly said that she empathised with Vicky Phelan’s situation.

I can understand her frustration, I honestly can. It took time and you think, ‘How could it take so long to do that?’
It did take a long time, we deeply regret that it took a long time for this lady to be told.
Having a cervical cancer diagnosis is a very difficult thing and has a big impact on the woman and her family. We profoundly regret that this has happened.

She added that at the time, they were implementing a new process of reviewing historical smears. She said that since then, the process of reviewing smear tests, informing clinicians and their patients has since been “smoothened out”.

Late last night the HSE said that since 2008, a total 1,482 cases of cervical cancer have been notified to the CervicalCheck programme.

In 442 cases, a review was warranted and of those cases, 206 cytology reviews suggested a different result that would have recommended an investigation to occur at an earlier stage.

This broke down as 173 cytology reviews suggesting that a referral to colposcopy might have been recommended earlier and for 33 cases a repeat smear might have been recommended to occur earlier.

The Minister for Health Simon Harris and the Director General of the HSE Tony O’Brien met today and agreed that an international peer review of the CervicalCheck programme would be undertaken in order to ensure ongoing confidence in the programme.

The Director of the National Cancer Control Programme has been ordered to establish this review as a matter of urgency.

Missed abnormalities vs misdiagnosis

Flannelly said that after headlines about the case, there was a need to clarify and highlight certain aspects of the screening programme.

The first thing to say is that cervical screening programmes aim to prevent many cancers developing – that’s why we get up in the morning.

“We cannot prevent all cancers, but the smear test works really well in intervals – that’s not to say that it’s the perfect test.”

The average gap between smear tests depends on the age of the person: for younger women, incidents of pre-cancers are higher, so they need to be done every three years. For older women it’s every 5 years. There’s no need for smears more often than that based as those times are based on how fast pre-cancers develop.

Another important distinction is that these screenings are not designed to diagnose. They select women who would benefit from further examination. It actually works better if you have a pre-cancerous abnormality rather than a cancerous problem.

She said that in relation to the 2014 review of Phelan’s smear, when a woman who has received a smear test is later diagnosed with cancer, the screening programme reviews those initial tests to inform their process.

“We control the quality of the test as much as we can. Quality control reviews are embedded at all levels of the programme and we think that’s really important part of the process.

We need to learn from patients and women who develop cancer by looking at those smear tests and by looking back at their cancer and how they were diagnosed. This is not so much a review because there is a problem, but a quality assurance approach that was put into place in 2010. It’s a continuous process – it happens all the time.

It’s been suggested that there are other women whose smear tests were incorrectly interpreted and who weren’t informed.

In an interview on RTÉ Morning Ireland yesterday, the head of the National Cancer Control Programme Dr Jerome Coffey  said that the decision on whether doctors should tell their patients the result of a review was “between the physician and the patient”.

Speaking to reporters yesterday, Minister for Health Simon Harris said that “it’s absolutely essential that we establish that those doctors told their patients of the outcomes of those audits”.

“So today, Cervical Check will write to those doctors to confirm that they have informed their patients.

We can’t just presume they did, or expect or hope that they did, we have to make it absolutely sure that they did so that women can have absolute confidence in relation to that.

Responding to reports that clinicians had been told to withhold information of incorrect smears from patients, Flannelly said that their direction to clinicians was that whatever the outcome of the qualitative review was, women needed to be given the option of knowing the results of their smear test reviews.

She added that in around half of similar cases in the UK where women receive serious cervical cancer diagnoses, women don’t want to know the results of those reviews.

Women who have had a cervical cancer diagnosis can want to focus on their treatment – not everyone wants to have the results of a review after a diagnosis.

Battling cervical cancer

She said that as it stands, one in 5 women haven’t had their smear test, “so it’s very important that the message gets out that women should be a part of this programme”.

She added that the CervicalCheck programme compared favourably to the NHS, and is still one of the most effective ways of preventing cervical cancer.

Every year around 250,000 women have smear tests through Cervical Check and that the programme has found over 50,000 women with pre-cancerous changes.

“It’s really important that women are reassured by our programme. They need to know that we take our quality metrics seriously and it’s maintained within a very narrow target.

“We’re trying to reassure women that quality underpins every aspect of the screening programme and that it holds its head high in context of other screening programmes around the world. It’s not perfect but we’re constantly trying to make it better.”

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