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CervicalCheck controversy
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The risk factors apply equally to women up and down the country. There is no assumption being made, it's apparent to anyone with an ounce of commonsense. Do you ever wonder why this is never brought up by any of the experts / media / HSE / Cervicalcheck / Head of QA
The National Cancer Registry of Ireland would disagree: https://www.ncri.ie/sites/ncri/files/pubs/cancer-inequality-report-summary-2016.pdfIncidence
By urban/rural status: Age-standardised incidence for six of the cancer types examined (stomach, lung, melanoma, male
colorectal, female breast and cervical), and for cancer as a whole, was significantly higher among urban populations
(defined on the basis of average population density ≥1 person/hectare) than among rural populations. For these cancers,
urban rates were 13-38% higher, most notably for lung cancer (36-38% higher). For all cancers combined, urban rates
were 10% (95% confidence interval 8-12%) higher for males and 11% (95% CI 8-12%) higher for females. For prostate
cancer, lymphoma, leukaemia and female colorectal cancer there was no significant variation between urban and rural
populations
You are more likely to develop cervical cancer if you live in an urban environment in Ireland, that's just a statistical fact. There can be population differences in testing.0 -
The National Cancer Registry of Ireland would disagree: https://www.ncri.ie/sites/ncri/files/pubs/cancer-inequality-report-summary-2016.pdf
You are more likely to develop cervical cancer if you live in an urban environment in Ireland, that's just a statistical fact. There can be population differences in testing.
12 per 100,000 in rural areas versus 14 per 100,000 in urban areas. Yet, living in an urban area is not a risk factor for cervical cancer - funny that.
Even if you make the assumption that the US lab received samples from women in rural areas only, this does not explain why Quest has half the positive rate of Irish labs.0 -
12% in rural areas versus 14% in urban areas. Yet, living in an urban area is not a risk factor for cervical cancer - funny that.
Even if you make the assumption that the US lab received samples from women in rural areas only, this does not explain why Quest has half the positive rate of Irish labs.
I agree, and it would a big and unjustified assumption to make given the information we have.
Realistically it's most likely there aren't significant differences in populations being tested in the labs. It is a possibility that there could be some impact and I'm sure it will be questioned during the inquiry.0 -
Even if you make the assumption that the US lab received samples from women in rural areas only, this does not explain why Quest has half the positive rate of Irish labs.
I would agree that differences in incidence would not appear to explain all of the differences in detection rates (in as much as an internet forum can serve as a basis for evidence), but I would like to know other aspects of the data before I drew firm conclusions. Do the labs calling more high grades have worse specificity etc.
I'm honestly open minded and keen to see the data. If the differences are as stark as described then I would like to hear from CervicalCheck what their QA processes are in detail.0 -
If the HSE didn't know which smear tests went to which labs, surely it's unlikely they were knowingly allocated in any particular way?
Any way, adds little to:The settlement was reached in the case following the evidence by an expert witness called by Ms Phelan’s legal team.
Is his evidence to the court on Tuesday, Professor John Shepherd a retired consultant gynecological oncologist said he had reviewed the case history and written a report.
From his examination of the records, he was aware that a review which uncovered the false negative result of Ms Phelan’s smear test was undertaken by the CervicalCheck screening programme in 2014, but this was not communicated to Ms Phelan until 2017.
Professor Shepherd said in his opinion this delay was "most irregular" and absolutely should not happen.
He said from his review of the records of this case, Ms Phelan’s test was "one of a number of smears that had been reviewed and found to be wanting".
https://www.rte.ie/news/courts/2018/0425/957122-vicky-phelan/0 -
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I haven't thrown insults. I have had insults thrown at me.
Misinformation?
A false positive can only be given as a result of a misdiagnoses
Lets try this one more time.
Screening is not a diagnostic tool. it never was and never will be. its not designed to be.
It therefore cannot make a false diagnosis.
Screening lacks the sensitivity of a diagnostic tool. Its a crude test to screen an at risk population and will always have false positives and false negatives..
It has saved thousands of lives but it has also missed cases and caused women to undergo further testing that did not have cancer.
There appears to me a misunderstanding as to what a screening program does and how it works..
If you sue for every single false negative or false positive all you will achieve is to ensure that all screening programs are closed or that the health service will go bust..0 -
Where are you getting your information? There was screening labs in Ireland. If there is no incompetence why is the US lab settling litigation for 2.5m? Best intentions? - the only intention was to limit litigation. Again, sharing the fact that tests were unreliable (over and above normal false results) would encourage patients to seek more reliable tests elsewhere (as opposed to not getting tested at all) - non-disclosure of the extent of false results has most likely cost lives.
Is Dr Gibbons (Quality Assurance chair of the Quality Assurance committee) not a reliable source? Suggest reading this article:
https://www.independent.ie/irish-new...-36858027.html
I never said there were no screening labs in Ireland.
I said there was no lab in Ireland capable of handling the quantity of smear tests. I also said that there was no Irish lab with the internationally recognised accreditation standard that would be required.
The testing for the pilot program was done in Ireland but the lab (run by Dr Gibbons) couldn't deal with the volume of even the pilot program and subcontracted out some of the testing.
When the screening program went nationwide it went to tender to which Irish and international labs were invited to apply.
No Irish lab met the required standard including the one run by Dr Gibbons.
I don't know if there was incompetence in the US lab. That is what the investigation will discover. However there would have or at least should have been a quality control process in the Ireland monitoring all subcontractors which should have spotted any issues. They didn't.
As I have said on more than one occasion I will wait for the results of the investigation before commenting on the standard of testing..0 -
I keep hearing mention of seventeen women who have died.
Did they all die from cervical cancer.
Its looking increasingly now like Governments should not offer free smear testing at all as errors in the results are then leaving the taxpayer liable for millions of euros in damages.
Will the money to pay people affected by the cervicalcheck tests be taken from the general Health budget.
The increase in cervical cancer would cost more than any saving obviously0 -
The increase in cervical cancer would cost more than any saving obviously
While screening is cost-effective it is net costly. It would be cheaper to abandon screening. I would not advocate this though.
I do think it's interesting to consider the implications of big payouts for every false negative. Quite aside from the human benefit of avoiding more painful screen failures.0 -
While screening is cost-effective it is net costly. It would be cheaper to abandon screening. I would not advocate this though.
I do think it's interesting to consider the implications of big payouts for every false negative. Quite aside from the human benefit of avoiding more painful screen failures.
If you pay out for every false negative, screening becomes prohibitively expensive and would not be cost-effective. It would have to be dropped.0 -
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If you pay out for every false negative, screening becomes prohibitively expensive and would not be cost-effective. It would have to be dropped.
I'd require screenes to sign a disclaimer saying damages are only payable in cases that can be demonstrated to be negligence (according to strict creteria, not the typical judicial rubber stamp). If people don't want to sign the disclaimer they have to purchase insurance against false negative outcome.0 -
Pretty much.While screening is cost-effective it is net costly. It would be cheaper to abandon screening. I would not advocate this though.
I do think it's interesting to consider the implications of big payouts for every false negative. Quite aside from the human benefit of avoiding more painful screen failures.
If you pay out for every false negative, screening becomes prohibitively expensive and would not be cost-effective. It would have to be dropped.
The net effect of this whole affair could easily be an abandonment of screening programs altogether, to the detriment of general population health.
It's worth remembering, that without Cervical Check, the poor women who got false negatives would still have gotten cancer, but the multitudes of women whose abnormalities for caught would also be dying. The program as a whole has been very successful. Making such a program politically dangerous by ignoring the potential for erroneous results and pretending it's as accurate as a diagnostic test is the real disgrace imo.
But the papers got a few headlines, and the mob got a few heads, so it's all justified.0 -
Pretty much.
The net effect of this whole affair could easily be an abandonment of screening programs altogether, to the detriment of general population health.
It's worth remembering, that without Cervical Check, the poor women who got false negatives would still have gotten cancer, but the multitudes of women whose abnormalities for caught would also be dying. The program as a whole has been very successful. Making such a program politically dangerous by ignoring the potential for erroneous results and pretending it's as accurate as a diagnostic test is the real disgrace imo.
But the papers got a few headlines, and the mob got a few heads, so it's all justified.
It should not be ignored either, regardless of overreaction in certain quarters. There are real people who have to deal with the failures of the service. To some people it's just about money and costs. At the very least after the exposure of the failings of the service, maybe such a screening service will be better for the future, better staff, procedures and safeguards. That can't be a bad thing.0 -
It should not be ignored either, regardless of overreaction in certain quarters. There are real people who have to deal with the failures of the service. To some people it's just about money and costs. At the very least after the exposure of the failings of the service, maybe such a screening service will be better for the future, better staff, procedures and safeguards. That can't be a bad thing.
There has been no evidence or even suggestion that there was core issues with the screening program in place. We know that there was \ is a process in place to move to a different, more sensitive screening process so there was some element of continuous improvement in place.
I have not seen any evidence of incompetence or a systemic issue with the screening that was done. An investigation may well show that the screening performed by one particular lab was substandard and that it was due to incompetence by an individual, or the lab, or it may show that there was no systemic issue or that the lab was screening using method A but has since moved to method B which shows less false negatives.
I don't know, and to my knowledge no one does.
But to listen to certain elements the labs were incompetence, screens were begin read by untrained illegal immigrants from Mexico all so the HSE could save enough money to get gold plated pens for the 50,000 desk jockeys
And then they allowed women to develop cancer and die even though they knew all along that the screens were wrong and could have prevented the women from getting sick or enabled them to start their treatment months it not years earlier.
Reality and whats been reported \ commented don't match.0 -
Bear in mind that the figures which are being used as evidence of inferior standards and testing date from 2008, and are based on a US standard. It has not been demonstrated that there was a higher rate of erroneous results from the US labs than the Irish during the period for Cervical Check, where they were contracted to Irish standards.Pretty much.
The net effect of this whole affair could easily be an abandonment of screening programs altogether, to the detriment of general population health.
It's worth remembering, that without Cervical Check, the poor women who got false negatives would still have gotten cancer, but the multitudes of women whose abnormalities for caught would also be dying. The program as a whole has been very successful. Making such a program politically dangerous by ignoring the potential for erroneous results and pretending it's as accurate as a diagnostic test is the real disgrace imo.
But the papers got a few headlines, and the mob got a few heads, so it's all justified.
It should not be ignored either, regardless of overreaction in certain quarters. There are real people who have to deal with the failures of the service. To some people it's just about money and costs. At the very least after the exposure of the failings of the service, maybe such a screening service will be better for the future, better staff, procedures and safeguards. That can't be a bad thing.
Money and costs are always going to play a part. Budgets are finite, and if we were to spend the money required to make the checks 100% accurate[by giving free diagnostic checks], we'd have to cut back other programs to pay for it. The improvement in cervical cancer results could thus potentially be more than wiped out by the detrimental effects of cancelling another program.
The women who received false results are at the receiving end of a tragedy, but it's not a failure of the screening service[unless standards weren't being followed, of which there is no evidence during the lifetime of the program], it's an accepted part of what is an effective program for protecting women's health. However, this doesn't in any way lessen their tragedy, and their reaction is 100% understandable.0 -
Another ad on RTE radio there, Ray Darcy is covering it again today with the daughter of a woman whos test was misread in '08 I think.0
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Pretty much.
The net effect of this whole affair could easily be an abandonment of screening programs altogether, to the detriment of general population health.
It's worth remembering, that without Cervical Check, the poor women who got false negatives would still have gotten cancer, but the multitudes of women whose abnormalities for caught would also be dying. The program as a whole has been very successful. Making such a program politically dangerous by ignoring the potential for erroneous results and pretending it's as accurate as a diagnostic test is the real disgrace imo.
But the papers got a few headlines, and the mob got a few heads, so it's all justified.
That's dismissive. There are genuine people with valid genuine concerns. The lab made errors. They tried to cover up the errors. That alone, is worthy of revisiting the current outsourcing process....
The women who received false results are at the receiving end of a tragedy, but it's not a failure of the screening service[unless standards weren't being followed, of which there is no evidence during the lifetime of the program], it's an accepted part of what is an effective program for protecting women's health. However, this doesn't in any way lessen their tragedy, and their reaction is 100% understandable.
Just because the process isn't 100% accurate does not mean we should shrug it off either. I'd rather we were overly cautious and arguably hyped up about it than have a few politicians remark on how terrible the deaths and dying are and continue as is.0 -
Matt Barrett wrote: »That's dismissive. There are genuine people with valid genuine concerns. The lab made errors. They tried to cover up the errors. That alone, is worthy of revisiting the current outsourcing process.
Can we even be sure the lab made errors yet?0 -
Topgear on Dave wrote: »Can we even be sure the lab made errors yet?
Yes, they gave people the all clear, who it turned out had cancer. It was in all the papers.0 -
Topgear on Dave wrote: »Can we even be sure the lab made errors yet?
Yes . They failed to see CIN which is pre cancerous and so the women were not treated in time to avoid the cells becoming cancerous0 -
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Probably asked before but how did no Minister of Health have any idea about this before the story was broken. Find it hard to believe, I believe they might not have got a memo but surely they heard it.0
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Matt Barrett wrote: »That's dismissive. There are genuine people with valid genuine concerns. The lab made errors. They tried to cover up the errors. That alone, is worthy of revisiting the current outsourcing process.
Just because the process isn't 100% accurate does not mean we should shrug it off either. I'd rather we were overly cautious and arguably hyped up about it than have a few politicians remark on how terrible the deaths and dying are and continue as is.
The HSE discovered the false positives and arranged the audit.
What has outsourcing begin highlighted ??? There is zero evidence to highlight that this in any way contributed to the problem, the same issue could easily happen in an Irish lab,.
You do realise that the taking of the smears was also outsourced by the HSE to multiple private companies ??
Pilot program was done in the Midwest. Testing for the program was done in an Irish lab. The Irish lab couldn't handle the volume of tests so they outsourced some of the samples. I would assume that they also set the standard to which the smears should tested etc.
It appears that there was a variation in results between one US based lab and the Irish lab but it also appears that both were testing smear tests to a different standard.
In 2009 the smear test program was announced to be extended nationwide. A tender process was opened for the laboratory testing of the smears. it was tendered internationally open to Irish, European and International labs. As part of the tender spec, standards were set that would have to be met by all labs.
From memory no Irish lab met the standard.
The tender was won by, from memory, a US lab which completed (or should have) the testing to the standard set out in the tender. The HSE (or what ever dept in the HSE was responsible) should (and probably did) have had a quality assurance set in place.
I am not sure what the duration of the tender was but I would suspect that it was re tendered since.
When the investigation is completed it may be found that the lab did everything exactly as they were asked. it may be found that when the tender spec didn't request the correct level of testing. It may be found that a lab took shortcuts it may be found that one employee of the lab was at fault.
We don't know and any attempt to appropriate blame now is a mistake..0 -
Matt Barrett wrote: »Yes, they gave people the all clear, who it turned out had cancer. It was in all the papers.
You are assuming that the smear test is 100% accurate and that all false negatives are as a result of incompetence.
Unfortunately that is not the case.
Have read of the below
http://www.thejournal.ie/smear-tests-hse-3990242-May2018/0 -
drunkmonkey wrote: »Probably asked before but how did no Minister of Health have any idea about this before the story was broken. Find it hard to believe, I believe they might not have got a memo but surely they heard it.
Harris is investigating who knew what and when. It seems correspondence was sent but not acted on or deemed worthy of action.The HSE discovered the false positives and arranged the audit.
What has outsourcing begin highlighted ??? There is zero evidence to highlight that this in any way contributed to the problem, the same issue could easily happen in an Irish lab,.
You do realise that the taking of the smears was also outsourced by the HSE to multiple private companies ??
Pilot program was done in the Midwest. Testing for the program was done in an Irish lab. The Irish lab couldn't handle the volume of tests so they outsourced some of the samples. I would assume that they also set the standard to which the smears should tested etc.
It appears that there was a variation in results between one US based lab and the Irish lab but it also appears that both were testing smear tests to a different standard.
In 2009 the smear test program was announced to be extended nationwide. A tender process was opened for the laboratory testing of the smears. it was tendered internationally open to Irish, European and International labs. As part of the tender spec, standards were set that would have to be met by all labs.
From memory no Irish lab met the standard.
The tender was won by, from memory, a US lab which completed (or should have) the testing to the standard set out in the tender. The HSE (or what ever dept in the HSE was responsible) should (and probably did) have had a quality assurance set in place.
I am not sure what the duration of the tender was but I would suspect that it was re tendered since.
When the investigation is completed it may be found that the lab did everything exactly as they were asked. it may be found that when the tender spec didn't request the correct level of testing. It may be found that a lab took shortcuts it may be found that one employee of the lab was at fault.
We don't know and any attempt to appropriate blame now is a mistake..
They did an audit but didn't inform Vicky Phelan for example. She went and had another test years later under her own initiative in 2011. That's when she discovered she had cancer. Then in 2017 when that cancer returned she happened to find note of the cancer being missed due to an audit held back in 2014.
https://www.irishtimes.com/news/health/cervicalcheck-10-year-timeline-1.3482051Smear issues are detected more widely by Irish labs
The two laboratories in Ireland that screen cervical smear tests consistently found a higher rate of abnormalities than a US laboratory used by the HSE.https://www.thetimes.co.uk/article/smear-issues-are-detected-more-widely-by-irish-labs-3mmt6mlb0
The points of concern are the standards adhered to by the contractor, the attempt to cover up the errors, (as to any conflicts of interest on tendering, another matter).
It was not a case of everyone having cancer and then an audit and no test is 100% accurate, so it didn't matter anyway. There should be no need to justify a look into this process and set of incidents.You are assuming that the smear test is 100% accurate and that all false negatives are as a result of incompetence.
Unfortunately that is not the case.
Have read of the below
http://www.thejournal.ie/smear-tests-hse-3990242-May2018/
For the third/fourth time. No I am not. People keep putting that up like it's an answer to the whole quandary those critical have missed, despite several comments by myself and others on here accepting no tests are 100% accurate.0 -
Matt Barrett wrote: »
They did an audit but didn't inform Vicky Phelan for example. She went and had another test years later under her own initiative in 2011. That's when she discovered she had cancer. Then in 2017 when that cancer returned she happened to find note of the cancer being missed due to an audit held back in 2014.
https://www.irishtimes.com/news/health/cervicalcheck-10-year-timeline-1.3482051
No argument..
The audit was carried out only after she was diagnosed with cancer. The audit was carried out by the HSE and the results were known by the HSE. There is no indication that the lab tried to hide the false positive, didn't assist with the audit or anything like that.
There is no indication of a coverup or attempted coverup by the lab.
The article you liked to refers to a period of testing pre 2008 and pre tender. There is some discussion in the media that testing was done in the lab to a US standard but in Ireland to a Irish standard". I would assume that when the tender was completed that the standard of testing required was outlined in the tender. But again I am commenting on third hand info so I don't know.Matt Barrett wrote: »
The points of concern are the standards adhered to by the contractor, the attempt to cover up the errors, (as to any conflicts of interest on tendering, another matter).
It was not a case of everyone having cancer and then an audit and no test is 100% accurate, so it didn't matter anyway. There should be no need to justify a look into this process and set of incidents.
100% there should be an investigation but you are even in the paragraph above predisposing the fault lies with the contractor. Quite possibly is does but we cannot know until after the investigation.
The investigation should start at the initial outsourcing during the pilot program, the period between then and the tender for the national program the tender spec and move forward from there.
As we need the feedback from this quickly and with the minimum of fuss (its essentially a technical audit) so that the findings can be used to improve the system. I think this should be done on its own.
A separate (parallel if you like ) investigation should be done into the decision not to disclose to the affected patients and who knew what and what was being done to address the issues raised.Matt Barrett wrote: »For the third/fourth time. No I am not. People keep putting that up like it's an answer to the whole quandary those critical have missed, despite several comments by myself and others on here accepting no tests are 100% accurate.
If you accept that then why is every false negative the fault of the lab ? Should liability for false negatives rest wit the lab ??0 -
Matt Barrett wrote: »Yes, they gave people the all clear, who it turned out had cancer. It was in all the papers.
Sorry I wrote that quickly and phrased it badly.
I meant that we don't have the error rates from individual labs yet so we don't know if any of them were giving unusually high number false negative results.
Its the overall quality control operation that I can see that needs the biggest investigation rather than the labs.
Id love to say the more audits the better but after last week who is gonna want to put their neck on the line if bad results come out from one.0 -
No argument..
The audit was carried out only after she was diagnosed with cancer. The audit was carried out by the HSE and the results were known by the HSE. There is no indication that the lab tried to hide the false positive, didn't assist with the audit or anything like that.
There is no indication of a coverup or attempted coverup by the lab.
The article you liked to refers to a period of testing pre 2008 and pre tender. There is some discussion in the media that testing was done in the lab to a US standard but in Ireland to a Irish standard". I would assume that when the tender was completed that the standard of testing required was outlined in the tender. But again I am commenting on third hand info so I don't know.
100% there should be an investigation but you are even in the paragraph above predisposing the fault lies with the contractor. Quite possibly is does but we cannot know until after the investigation.
The investigation should start at the initial outsourcing during the pilot program, the period between then and the tender for the national program the tender spec and move forward from there.
As we need the feedback from this quickly and with the minimum of fuss (its essentially a technical audit) so that the findings can be used to improve the system. I think this should be done on its own.
A separate (parallel if you like ) investigation should be done into the decision not to disclose to the affected patients and who knew what and what was being done to address the issues raised.
If you accept that then why is every false negative the fault of the lab ? Should liability for false negatives rest wit the lab ??
There was an attempt by the company to not let the findings of errors go public and possibly by members of the HSE and Health Department. Harris is looking into it. This has been covered numerous times in the media and in this thread.
Yes, liability is with the lab. Of course it is. Why bother checking any at all if it doesn't matter? You are going back to this no test is 100% accurate thing. We know. The point is how often, at what rates, what happens when you find out? Keeping it quiet and trying to silence those who found out is not best practice IMO.0 -
I never said there were no screening labs in Ireland.
I said there was no lab in Ireland capable of handling the quantity of smear tests. I also said that there was no Irish lab with the internationally recognised accreditation standard that would be required.
The testing for the pilot program was done in Ireland but the lab (run by Dr Gibbons) couldn't deal with the volume of even the pilot program and subcontracted out some of the testing.
When the screening program went nationwide it went to tender to which Irish and international labs were invited to apply.
No Irish lab met the required standard including the one run by Dr Gibbons.
I don't know if there was incompetence in the US lab. That is what the investigation will discover. However there would have or at least should have been a quality control process in the Ireland monitoring all subcontractors which should have spotted any issues. They didn't.
As I have said on more than one occasion I will wait for the results of the investigation before commenting on the standard of testing..
Or far more likely the quality control process just ignored the bare facts in front of them which included the following:
In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.
Most of your posts indicate you haven't been keeping up with this story.0 -
Thanks Kaymin, I hadn't seen those numbers.
They're well out for quest. How the hell was that allowed to run?0 -
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In 2013-14, the laboratory at Coombe found more than twice the percentage of abnormalities in smear tests as Quest. Coombe logged 14.1 per cent of its smear tests with abnormalities and MedLab logged 12.46 per cent. Quest logged 5.8 per cent.
In fairness those numbers are meaningless without also knowing what the criteria for a negative was and the test methodology.0
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