THE UNITED KINGDOM’S Royal College of Obstetricians and Gynaecologists have completed a year-long review into Ireland’s smear screening programme, following some problems with the CervicalCheck programme.
In short, these problems were caused when at least 221 women who received a cervical cancer diagnosis weren’t told that their smear tests were reviewed, and the results of those reviews found that a different action should have been taken.
Due to a concern among the public on whether women could trust their smear test results, Health Minister Simon Harris announced in May 2018 that anyone who had a smear test taken could get a repeat for free.
He also announced that an independent review would be conducted into Ireland’s cervical smear programme, in order to ensure the public could have confidence in it.
The results of this were published this week; it reviewed 1,659 smear slides from 1,038 women who had developed cervical cancer since the CervicalCheck programme was first introduced in 2008.
Although it disagreed on diagnoses in 30% of smear tests, lead assessor of the report Professor Henry Kitchener said the CervicalCheck programme was “performing effectively” and in line with cervical smear programmes in the UK and elsewhere.
Before resigning as CEO of the HSE in the wake of the CervicalCheck controversy, Tony O’Brien told the Oireachtas Health Committee in May 2018 that public confidence in the CervicalCheck programme had been “shaken” which was the “most tragic thing”, as they could forsee rates of cervical cancer increasing as a result.
The CervicalCheck programme was introduced in September 2008, and aimed “to reduce the incidence and the death rate from cervical cancer in Ireland”.
It offers a free smear test to all women aged 25 to 60 who live in Ireland. These are offered through GP clinics, where nurses carry out the test. A laboratory then examines the smears, and indicates if there are any abnormalities.
If no abnormalities are found, the woman will be booked in for a smear test three years later (if they’re aged between 25-44), unless she wants an additional smear test, which will cost around €80. If the woman is aged between 45-60, the smear is carried out every five years.
Dr Caroline Mason Mohan, Director of Public Health at the National Screening Service, said that even if your smear test is clear, it’s important to go to the doctor if you experience any of the following symptoms:
A pain in your pelvis – that’s between the belly button and the top of your thigh; bleeding between periods; vaginal spotting or discharge; or pain during sex or bleeding during sex.
If abnormalities are found, the woman is called in for a colposcopy examination to categorise the type of abnormality, and a number of things might happen depending on that abnormality.
If it’s a low-grade HPV abnormality, the woman will be told to come back for a second smear after 6-12 months. This is because the body is constantly ridding itself different strains of HPV, so the abnormality might go away by itself.
If the abnormality is of high-risk, or hasn’t gone away within a certain amount of time, the cells can be burned off during a visit to a colposcopy clinic – all costs are covered under the CervicalCheck programme.
If the abnormality is high-risk or precancerous, further treatment would be needed. It usually takes 10-15 years for an abnormality to develop into cervical cancer, which is why the smears are carried out at 3- or 5-year intervals.
“Generally in screening,” Dr Mohan said, “we take a population who are most at risk of a condition, you have a test, and you get everyone to take that test. Out of that, you pick those whose risk is higher than the normal, and you send them for diagnostic testing.
So if there’s something on your smear, you’re sent to a colposcopy for a further diagnostic test, and the colposcopist test decides what happens now. [Screening has] done it’s job if it gets you to colposcopy: we’re not looking for cancer, we’re looking for changes in the cells.
For every 1,000 women, there will be 20 women who’ve got an abnormalities that could develop into cancer. Of those 20 abnormalities, smear test screening will pick up 15.
“Obviously you don’t want to be in those 5,” Dr Mohan says, “but women who are in the programme early, chances are it will be picked up by the next smear test in time.”
Next year, the smear test programme will change to a HPV smear test, which will pick up 18 out of 20 rather than 15 out of 20, Dr Mohan says.
The HPV is a different test to do the same thing. We know from the research that it’s better at picking up the women who have abnormalities.
The smear test does not test for cervical cancer.
It found that in the cases of 308 women diagnosed with cervical cancer, it disagreed with the diagnoses given by the CervicalCheck programme – meaning it spotted indications of abnormalities where CervicalCheck gave the all-clear.
This 308 was out of 1,038 women who agreed to take part, and that was out of over 1,700 women eligible to take part.
In 159 cases out of the 308, the report found that had the abnormalities on the smear test been found, it had the potential to “prevent or to detect cancer at an earlier stage”.
For the other 149 cases, the review disagreed with the original CervicalCheck slide diagnosis, but said that it didn’t believe this had an “adverse effect on their outcome”.
Despite these findings, lead assessor of the report Professor Kitchener said that the error rate of 30% here would “in no way apply to normal screening – it only applies to women who have been diagnosed with cancer”.
Health Minister Simon Harris welcomed the report, saying that it sought to answer women’s questions on whether they could trust the government’s screening programme.
“The answer is clear, and thankfully, is yes,” he said. He added that the fact that some abnormalities in smear tests are missed is “extremely painful and devastating on a human level”, but added that “no screening programme in the world will detect all cancers. And that is the difficult, painful reality.”
The CervicalCheck scandal came into the public eye when Vicky Phelan, a Limerick mother-of-two whose whose cervical cancer is terminal, settled a High Court action against a US laboratory for €2.5 million over incorrect smear test results from 2011.
In 2014, Phelan received another smear test that indicated she had cervical cancer. An audit of Phelan’s 2011 smear tests were conducted in 2014, but Phelan wasn’t told about the audit or the results of the audit, until 2016.
Vicky Phelan, the lead CervicalCheck campaigner who first brought these issues to light, has said that she doesn’t have confidence in the RCog report.
It is notable that the focus by the government was on RCOG’s endorsement of the screening programme rather than on the impact of the findings for those women and families, which was actually the purpose of the review.
Emma Mhic Mathúna, another prominent campaigner who died earlier this year, had three smears incorrectly diagnosed in 2010, 2011 and 2013. The 2011 result was a false negative, while the 2010 and 2013 slides were both misread and came back as negative.
Ruth Morrissey, a woman who was diagnosed with terminal cervical cancer, was awarded €2.1 million in damages in the High Court in June.
The judge in that case found that the lab where the Limerick woman’s 2009 smear was read were negligent and in breach of duty. He also found that the lab that handled her 2012 slide failed to test it for adequacy before examining it, and said laboratories should have “absolute confidence” in their decision if they are to give a slide the all-clear.
This is being appealed by two laboratories and the HSE; medical professionals have argued that no screening programme cannot offer “absolute confidence”.
In January this year, Phelan urged women to continue to get their smear tests:
“Please, please continue going for smears and bear with the screening programme. We will get there and we will have a programme that we can trust and one which will be on a par with the best in the world.”
In any well-run programme you can’t eliminate all errors, Dr Mohan says.
“It’s a quality assured programme, we bring human error down to a minimum, but no programme can get rid of it completely.”
She adds that Scally looked at whether the rate of error, and found that it was in line with international standards.
“One of the big things that has happened since the Scally report,” she continues, “is the involvement of the patients, they’re involved in testing of materials, and we’ve been working with a group to develop a patient-public partner strategy for next year.”
She says that since she’s come into the role, there’s been work going on in the background to enact the Scally report: “You can always improve things, you can always make it better.”
People are in the job they’re in because they believe in screening, and they know it saves lives.
Since 2008, CervicalCheck has carried out more than 3 million screening tests and detected and treated over 100,000 cases of abnormal cervical cells.
Figures indicate that there was a 4% increase in the number of people being diagnosed with cervical cancer from 2003/2004 to 2008. After this, the year CervicalCheck was introduced, there was a 6.9% decrease in incidents of cervical cancer.
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