CervicalCheck review: 12 women die as chance to prevent their cancer was missed

UK experts say women can have confidence in cervical cancer screening programme

The Government also plans to publish new patient safety legislation after Cabinet today. Photograph: iStock
The Government also plans to publish new patient safety legislation after Cabinet today. Photograph: iStock

An opportunity to identify 159 women’s cervical cancers was missed by CervicalCheck, an independent review of tests carried out by the screening programme has found.

This represents 15 per cent of the 1,038 women who participated in the review led by the UK-based Royal College of Obstetricians and Gynaecologists (RCOG).

It also found that 12 women from this group died as an opportunity was missed to prevent their cancer or diagnose it earlier.

In a further 15 per cent of cases, involving 149 women, the review panel disagreed with the original CervicalCheck reading of smear tests but said they did not believe this had an adverse impact on their health outcome.

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In total, the review found a discordant result in one-third of case they reviewed, 308 out of 1,034 women.

However, the overall pattern of discordance found by the review is similar to that found in a much larger slide review of cervical cancer cases in England, according to RCOG.

The review also looked at colposocopy (examination of the neck of the cervix) management, and found this was sub-optimal in a quarter of cases, “such that an opportunity to prevent cancer or to diagnose it at an earlier stage was missed”.

Lead assessor Prof Henry Kitchener said it was important to recognise cervical screening cannot prevent all cases of the disease. “The findings of the slide review are in line with the patterns of discordance reported in the English audit of cervical cancer and are not in themselves a cause for concern.

“The detailed scrutiny of colposcopy did identify where management of abnormal smears could have been better, and this reinforces the need for vigilance adherence to CervicalCheck clinical practice guidelines.”

“There is clear evidence from falling death rates that the CervicalCheck programme is working effectively and women can have confidence in the CervicalCheck programme.”

The 221+ patient support group, which was set up last year to represent women affected by the controversy, said the report evoked “varying emotions” among its members.

“It is a relief firstly that there is now an outcome to this delayed process. For many personally, it answers questions and provides some closure. For others it doesn’t complete the story but gives more information which we hope will help lead them to something better. For a number regrettably it has not been a good experience.”

Reclassified

As previously reported by The Irish Times, the slides of hundreds of women have been reclassified in the review. In almost 30 per cent of cases, the re-examination of smear tests originally conducted under CervicalCheck by the RCOG panel has produced a different result.

The review, which was set up following the controversy over CervicalCheck last year, involved the re-examination of the slides of 1,038 women who had been tested for cancer under CervicalCheck, were given the all-clear and later developed cancer. Some of these were women who are part of the 221 group formed in the wake of last year’s controversy, but many had never previously had their smear tests re-examined.

The HSE has said that where there is discordance between a woman’s original smear tests and the review results, it will provide access to a package of State supports, including a medical card and counselling.

These are currently available only to the 221-plus group of women who were affected by the earlier review of tests.

Some affected women may also be entitled to make a claim under the tribunal being established by the Government in response to the controversy.

Some of the women have expressed concerns about issues that arose during the review process after some slides were mislabelled and confusion occurred in some cases over results and the availability of slides.

However, the review panel said this occurred in only three of the 1,038 cases.

The review was not blinded, as reviewers knew that the women whose slides they were re-examining had gone on to develop cervical cancer. This, in the view of many experts, gives rise to a “hindsight bias” that is likely to skew the result.

The Government also plans to publish new patient safety legislation after Cabinet today, which will provide for mandatory open disclosure of serious incidents in the health services, as well as the licensing of public and private hospitals.

Members of the RCOG review panel briefed some of the women affected this morning, as Minister for Health Simon Harris brought the report to Cabinet. Members of the media were later briefed by the main assessors on the panel at an afternoon briefing in the Royal Hibernian Academy.

The review takes in both the 221 group of women at the centre of last year's controversy over CervicalCheck and a separate cohort of women whose cancers were notified to the National Cancer Registry but were not audited.

It was commissioned in May 2018 with the aim of providing a comprehensive overview of the screening history of all women diagnosed with cervical cancer over the past decade.

It was supposed to report over a year ago, but there were delays in setting it up, and one-third of women declined to participate.

Another 60 women have already applied to join the 221 patient support group for those affected by the CervicalCheck controversy on foot of the RCOG review of their smear tests.

Paul Cullen

Paul Cullen

Paul Cullen is a former heath editor of The Irish Times.