17 November 2011 : Two papers in Lancet Oncology add more evidence supporting the long term efficacy of HPV vaccination programmes. This may reduce the need for screening to just a once-in-a-lifetime test, according to the author of one of the papers, Prof Matti Lehtinen.
http://www.sciencedirect.com/science/article/pii/S1470204511702868
06 November 2011 : A Mexican study reported in The Lancet has found that HPV testing on self-collected vaginal samples is 3.4 times more sensitive than cytology. Despite its lower specificity, the authors conclude that HPV testing might be preferred in low-resource settings where restricted infrastructure reduces the effectiveness of cytology screening programmes.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61522-5/abstract
14 June 2011 : When women with human papilloma virus (HPV) have low-grade cytology findings but a normal colposcopy, they can be followed at routine intervals, a UK team has shown.
The cumulative rate of CIN2+ at 3 years in HPV+ve/Colp -ve women was 4.4% at 27 months, considered as sufficiently low to justify return to routine recall.
http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.2011.02970.x/abstract
28 May 2011 : An analysis of HPV primary screening trials suggests that cut-off values for the HC2 test could be safely increased to 10rlu. False positive results would be greatly reduced without significantly compromising sensitivity.
http://www.bmj.com/content/342/bmj.d2757.short?etoc
10 March 2011 : Up to £775 million of government funding is to be made available over the next five years for research aimed at delivering benefits to NHS patients.
http://info.cancerresearchuk.org/news/archive/cancernews/2011-03-08-Government-announces-...
05 March 2011 : "The logical and inevitable move to HPV-based cervical cancer prevention strategies will require longer screening intervals that will disrupt current gynecologic and cytology laboratory practices built on frequent screening."
http://jnci.oxfordjournals.org/content/103/5/368.short?rss=1
17 January 2011 : Academy of Medical Sciences press release.
Urgent changes are required to the regulation and governance of health research in the UK because unnecessary delays, bureaucracy and complexity are stifling medical advances, without additional benefits to patient safety. A report by the Academy of Medical Sciences sets out a new regulatory and governance pathway that will increase the speed at which healthcare innovations become available to patients, whilst eliminating unnecessary bureaucracy.
Professor Sir Michael Rawlins FMedSci, Chair of the Academy of Medical Sciences working group that prepared the report, said:
“A fertile research environment is vital for the health
and wealth of the UK. The current system of regulation is making it increasingly difficult to initiate health research in the UK and is preventing patients from participating in studies.
This is ultimately denying patients early access to new drugs and hindering improvements to public health for the wider society.
“We have found unequivocal evidence that health research in this country is being jeopardised by a regulatory and governance framework that has become unnecessarily
complex and burdensome. Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in research. The
changes we propose will streamline and improve the process to create a better environment for research, while protecting the interests of patients and the public.”
The report recommends the establishment of a new independent Health Research Agency (HRA) to bring together existing approval processes. The Agency would work with regulatory and governance bodies in the devolved nations to develop an integrated approvals system
for the UK. The report recommends that the Department of Health should establish a new National Research Governance Service (NRGS) for England, to be housed within the HRA.
The NRGS would facilitate rapid approval of research studies conducted in single or multiple NHS sites by assuming responsibility for all study-wide checks that are currently duplicated by each participating NHS Trust.
Sir Michael added, “The delay in obtaining NHS permissions is a major failure of the current pathway and is the biggest single barrier to all types of health research studies. There is a
highly inefficient emphasis on process rather than outcomes, which has led to delays of over a year to gain permissions for simple studies. The UK has created nearly a quarter of the world’s top 100 medicines and its share of world citations in both the clinical and health sciences is currently second only to the US. However, recent data show a decline in the UK’s global share of clinical research activity. There is widespread agreement that the regulatory and governance framework is one of the main contributing factors to this decline. Implementing the changes outlined in the Academy’s
report will allow the UK to realise the health and wealth benefits of our world class health research base and maximise the value of our public, charitable and commercial investment.
Sir Michael Rawlins concluded, “It is vital that the HRA is established as soon as possible. To achieve its goals it will have to be a genuine single regulator and not a mere façade hiding the continuation of many separate existing bodies. We recommend that it is established as soon as possible to start making necessary changes to start making necessary changes right away and then confirmed in primary legislation in due course.”
On publication of the report, Professor Sir John Bell FRS FREng PMedSci, President of the Academy of Medical Sciences, said, “The UK has historically supported vibrant research intensive medical science industries and world-renowned academic medical science centres, but a cumbersome regulatory and governance environment is driving this work abroad. Health research must be subject to robust regulation that both protects patients and
facilitates globally-competitive research. This report sets out a realistic and achievable framework by which this can be achieved.”
http://www.acmedsci.ac.uk/index.php?pid=47&prid=88
28 December 2010 : Hot on the heels of the MAVARIC trial showing no benefit of automation-assisted cervical cytology, a large RCT from Finland involving more than half a million cases has reached the same conclusion.
http://onlinelibrary.wiley.com/doi/10.1002/ijc.25677/abstract
26 December 2010 : An analysis of over 50,000 slides pre- and post-conversion to liquid based cytology shows that rapid prescreening by LBC is significantly more sensitive for detecting cervical abnormalities (58.7 vs. 68.7%, p<0.001) than conventional cytology.
Acta Cytologica 201155:54–56
DOI: 10.1159/000320906
12 December 2010 : Reporting rates for glandular neoplasia in 464,754 cervical samples reported at six UK laboratories in 12-month periods before and after the implementation of SurepathTM LBC processing are compared. The introduction of LBC processing is seen to have resulted in a significant increase in the detection rate for endocervical glandular neoplasia while maintaining high levels of reporting specificity. The authors suggest the following underlying reasons for the observed improvement in detection of endocervical glandular neoplasia:
1. More effective sampling of the endocervical canal as a result of changed sampling devices (from wooden spatulae to broom style samplers)
2. More representative transfer of cells from the sampling device to the liquid medium used for processing
3. Improved morphological presentation of endocervical abnormalities particularly evident with Surepath samples.
http://onlinelibrary.wiley.com/doi/10.1002/dc.21471/full
11 December 2010 : MAVARIC was a randomised controlled trial designed to investigate the utility of automation-assisted reading of cervical cytology slides.
73 266 liquid-based cytology samples were obtained from women aged 25–64 years undergoing primary cervical screening in the UK. Women were randomly assigned to receive either manual reading only or paired reading (automation-assisted reading and manual reading). In the paired arm, two automated systems were used—the ThinPrep Imaging System and the FocalPoint GS Imaging System. The primary outcome was sensitivity of automation-assisted reading relative to manual reading for the detection of underlying CIN2+ in the paired arm.
Automation-assisted reading was 8% less sensitive than manual reading and specificity increased by 0·6%. The inferior sensitivity of automation-assisted reading for the detection of CIN2+, combined with an inconsequential increase in specificity, suggests that automation-assisted reading cannot be recommended for primary cervical screening.
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(10)70264-3/fulltext
18 November 2010 : A study published in the International Journal of Cancer, an HPV RNA assay provided a better combination of sensitivity and specificity than HPV DNA- or cytology-based tests for cervical cancer screening.
The French APTIMA Screening Evaluation (FASE) study is the first screening study to compare liquid-based cytology, a Pap test widely used in cervical cancer screening, with the new RNA-based APTIMA HPV test and the DNA-based Hybrid Capture 2 test (HC2).
Commenting on the implications of the trial, Eric Lai, PhD, Gen-Probe’s senior vice president of Research and Development, said: “DNA tests detect the presence of the HPV virus, whereas APTIMA HPV targets biologically relevant markers active in transforming cervical cells. DNA tests are therefore more likely to pick up transient infections and lead to false positive results with respect to disease. This study showed that in a routine screening population, APTIMA HPV had the same sensitivity as a HPV DNA test, with the low false positive rate of cytology. This means women at risk of cervical cancer could be more accurately identified. At the same time, unnecessary colposcopies, office visits, over-treatment and the associated costs could be reduced. In addition, APTIMA HPV could decrease the patient anxiety caused by inappropriate diagnostic procedures.”
http://onlinelibrary.wiley.com/doi/10.1002/ijc.25726/abstract
14 November 2010 : A pooled analysis of primary HPV testing in over 30,000 women from 17 studies across China, concludes that HPV testing is significantly more sensitivie for the detection of CIN3 or worse than either cytology or visual inspection with acetic acid. By adopting a cutoff point for HPV positivity of 10pg/ml for women under the age of 35, instead of the manufacturer's recommendation of 1-2pg/ml, specificity was increased and a high sensitivity was maintained.
http://www.lancet.com/journals/lanonc/article/PIIS1470-2045(10)70256-4/fulltext
29 October 2010 : A massive multinational study reported in Lancet Oncology has shown that HPV types 16, 18, 45, 33, 31, 52, 58, and 35 account for 91% of all cases of cervical cancer. It is likely that the next generation of cervical cancer vaccines will specifically include each of the 8 HPV types noted in this paper, since this will cover 90% of the cases of cervix cancer.
http://www.ncbi.nlm.nih.gov/pubmed/20952254
28 October 2010 : Conventional cytology apparently! Human papillomavirus testing and liquid-based cytology increases costs, but not effectiveness, compared with traditional approaches, according to a paper in the current issue of Obstet Gynecol
http://www.ncbi.nlm.nih.gov/pubmed/20966702?dopt=Abstract
28 October 2010 : The use of p16INK4a immunohistochemistry significantly improves the accuracy of grading CIN lesions by a single pathologist, equalling an expert consensus diagnosis.
http://jcp.bmj.com/content/63/11/972.short?rss=1
21 October 2010 : A randomized trial in a resource-limited setting has shown that an HPV test-and-treat policy is more effective than visual inspection-and-treat in reducing the incidence of high grade CIN.
http://jnci.oxfordjournals.org/content/102/20/1557.short?rss=1
20 September 2010 : A randomised study from Finland comparing automation-assisted screening and conventional cytology hs shown no difference in cervical cancer risk between the two groups after six years of follow up. The authors suggest that both methods are valid for screening.
http://onlinelibrary.wiley.com/doi/10.1002/ijc.25677/abstract
26 August 2010 : Controversy has arisen over the potential impact on cervical cancer rates of reduced screening in a population vaccinated against HPV. A recent modeling study reported in The Lancet Infectious Diseases suggests that introduction of the vaccine is unlikely to lead to an increased incidence of cervical cancer as a result of diminished screening. However, a Finnish group disputes this conclusion by claiming that vaccinations alone will not prevent cervical cancer unless their efficacy is longer than 15 years. If the duration of efficacy is shorter and efficient boostering is not organised, the onset of the cancer in women is merely postponed and rates of cervical cancer will ultimately increase.
26 August 2010 : This study challenges the claim that LBC improves the sensitivity for detection of CIN2+ compared with conventional cytology. A random sample of 818 LBC cases originally reported in the NTCC trial were blindly reviewed by three international cytology exerts.There was no significant difference between the accuracy of the experts and the original interpreters.
http://onlinelibrary.wiley.com/doi/10.1002/cncy.20081/abstract