Being given the all clear for any cancer screening test is an incredible relief. But what if the results are wrong? And what if you have been diagnosed with cancer but it turns out it should have been detected earlier?
The HSE has confirmed that 208 women diagnosed with cervical cancer had earlier incorrectly been given the all-clear and this is at the core of the current controversy. But the problem is compounded because even though the HSE became aware of the “false negatives” in 2014 – when it audited the test results of women who developed cancer after getting the all-clear – it did not automatically tell all the women their smear test result was incorrect. Seventeen of these women are now dead.
Understandably there is now much confusion, worry and indeed misinformation in the public domain about what has happened and the role of cervical cancer screening.
Public health experts have pointed out that cervical cancer is a slow developing disease, and that screening can prevent it and help pick it up, but it is not a diagnostic test. The screening process is complex and not infallible with false negatives a part of every screening programme.
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Revelations
These facts have been lost somewhat in the cascade of revelations since Vicky Phelan, a woman now terminally ill with cervical cancer, revealed that she only learned about the audit’s findings on the incorrect results of her 2011 smear test last September.
While a range of remedial actions has now been taken, including the launch of an external review to internationally benchmark CervicalCheck, and a statutory investigation to be conducted by Hiqa, how reliable is our cervical cancer screening programme and how does it compare with other countries?
A number of gynaecology staff warned the government a decade ago about moving testing to private companies overseas, as they feared cancer cases would be missed
CervicalCheck has detected almost 1,500 cases of cervical cancer since 2008.
Currently, the programme screens women aged between 25 to 60 years every three to five years using a smear test to check for changes in the cells of the cervix, a process comparable to similar screening programmes in many countries internationally.
Three laboratories
The HSE has contracts with three laboratories to process these tests, two of which are located in Ireland, the other in the US. It says there is insufficient capacity in the Republic of Ireland to process all the cervical screening samples needed for CervicalCheck to provide free screening to all eligible women.
However, a number of gynaecology healthcare staff warned the government a decade ago about moving testing to private companies overseas, as they feared cancer cases would be missed.
One of these, Dr David Gibbons told RTÉ’s Morning Ireland programme this week that he resigned his position on the quality assurance committee of the cervical screening programme after his warnings were ignored. He said figures from the US showed a one-third lower detection rate of high-grade dysplasias (pre-cancerous cells) compared to Irish labs, with a “mismatch” of systems because Ireland tests for cervical cancer every three years while the US tests smear samples annually.
The reviews now ordered by Minister for Health Simon Harris will assess the quality and accuracy of the current Irish cervical cancer screening test process and whether the outsourcing of the tests to international laboratories will continue.
As this scandal has shown, no matter how high quality or accurate a health service is, trust is at the absolute core of its success
Ireland is not alone in having an issue with false negative cancer screening results and open disclosure. A 2014 English audit of 5,480 earlier smears of women with cervical cancer originally deemed to be negative, found on review that half had changes that should have warranted a repeat smear or referral for colposcopy; which appears to be a similar finding to the Irish review.
Reviews
A separate 2013 survey of UK colposcopists on whether their patients were being invited to discuss the results of an invasive cervical cancer review found that only 53 per cent had invited their patients for review of their findings, despite UK cancer screening guidelines that all affected women should be offered a review. Lack of knowledge on the guidelines, fear of litigation or unduly worrying the women, and workload were among the reasons cited for not contacting women.
Vicky Phelan herself has consistently highlighted the importance of women continuing to have smear tests. About 50,000 women have been detected with precancerous cells since CervicalCheck commenced and the incidence of cervical cancer has reduced by approximately 7 per cent a year since 2010. Screening saves lives and thus restoring confidence in our cervical cancer screening programme is vital.
As this scandal has shown, no matter how high quality or accurate a health service is, trust is at the absolute core of its success and the patient is the most important person in any health service “transaction”.
Not telling patients when something has gone wrong has long been a feature of Ireland’s paternalistic health services and is simply unacceptable.
The HSE’s Open Disclosure Policy 2013 was designed specifically to deal with adverse healthcare events in a transparent and open manner but it is sadly clear that it is not working and that mandatory disclosure must now be brought in.
Priscilla Lynch is a medical journalist