CervicalCheck review skewed results, patient advocate claims

Process set up to verify women’s review report ‘thorough and essential’, HSE says

The Royal College of Obstetricians and Gynaecologists (RCOG) has been accused of “skewing” the results of its review of CervicalCheck by including cases where a woman’s full slide history was not available.

Patient advocate Lorraine Walsh, one of the women whose tests were misread by the screening programme, said where the RCOG review panel was unable to locate a woman's smear test prior to diagnosis with cancer, it categorised the case as concordant.

Concordant means the result of the review agreed with the original test finding by CervicalCheck. Discordance occurs where the RCOG reviewers came back with a different result from the original one.

Ms Walsh said she learned of RCOG’s approach after receiving her own report, which initially said her pre-cancer diagnosis slide was not available but listed her result as concordant. After she pointed out that her slide was available, RCOG provided her with a second, updated report listing her result as discordant.

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Ms Walsh said she has since been contacted by another woman in the review whose slide was missing and was similarly categorised as concordant.

The review published on Tuesday found a discordant result in a third of cases reviewed – 308 out of 1,034 women. But the level of discordance would have been higher if cases involving missing slides had been excluded from the review, as Ms Walsh maintains they should have been.

Partial reports

A spokeswoman for RCOG said the aim of the review was to identify cases of discordance.

“A case can only be classified as discordant if there is evidence of disagreement in available slides. In cases where there was an unavailable slide this was classified as a ‘partial report’ where the narrative would include reference to the limitations of any possible conclusion in the case.

“In the absence of positive evidence of discordance it would be grouped with the concordant cases if there was a concordant slide in her history,” she confirmed.

Ms Walsh resigned from the CervicalCheck steering committee in late October due in part to her concerns about errors in the process of validating women’s reports, which were sent by RCOG to the Health Service Executive before being passed on.

In one batch of 581 reports sent to Ireland by RCOG, “half of them had to be returned because the detail in them was inaccurate”, she claimed.

The HSE said the process set up to verify each woman’s report from RCOG was “thorough and essential”. “References to certain numbers of slides seem to refer to the position at a certain point in time rather than the completed verification process.”

RCOG said date discrepancies occurred in a small number of cases and some “clerical updates” had been made to reports.

“To date, it has been necessary to issue fewer than five supplementary reports because new information came to light, in two of these cases the conclusion was updated.

Ms Walsh found out she and Vicky Phelan, whose court case led to the original revelations about a botched audit at CervicalCheck, were two of three women affected by labelling errors. This was the "final straw" leading to her resignation.

The RCOG spokeswoman said mislabelling occurred “after completion of the slide review and therefore had no bearing on any individual report”.

The review found an opportunity to identify 159 women’s cervical cancers was missed by CervicalCheck, but it also said the overall pattern of discordance is similar to that found in a larger slide review of cervical cancer cases in England.

The RCOG review team is expected to appear before the Oireachtas health committee later this month.

Paul Cullen

Paul Cullen

Paul Cullen is Health Editor of The Irish Times