User experience and workflow performance: a pilot evaluation of the Genius Digital Diagnostics System for screening cervical cytology samples

It is generally understood that the cytology work process can be stressful and fatiguing affecting technicians’ performance and job satisfaction on a day-to-day basis and in the longer term. The Genius Digital Diagnostics System (Genius DxS) is a new digital cytology platform with artificial intelligence (AI) offering a novel approach for reviewing liquid-based cytology samples within cervical screening programs. This study assessed the performance and user experience of cytotechnologists (CTs) using ‘Genius DxS’ benchmarked against ThinPrep Integrated Imager (I2), to understand the impact of perceived stress, fatigue, and decision-making processes.

This workflow and user experience pilot study with five CTs was conducted in Belgium (December 2020). Users reviewed 300 pre-selected retrospective ThinPrep slides first using I2. After a 2-week washout period, users reviewed the same cases using Genius DxS, using a high-definition monitor. The AI algorithm generates a gallery of clinically relevant objects; CTs review the gallery to render an interpretation.

Efficiency and accuracy were measured whilst reading slides using I2 and Genius DxS. A pragmatic literature search of user experience studies was performed to derive quantitative surveys measuring perceived stress and mental fatigue. CTs completed surveys at pre-determined times during the day. Semi-structured qualitative interviews explored their experiences.   

Results showed all CTs completed slide readings faster using Genius DxS, while achieving similar accuracy. Speed increases were not accompanied by reported increases in fatigue/stress.  CTs reported similar confidence in their ability to accurately interpret slides. Qualitative reports indicate the Genius DxS cell presentation enables easier and more immediate decision-making.

Efficiency gains with Genius DxS may be achievable without negative impacts on users’ experience. Differences in CTs’ reported mental processing of diagnostic information may partially account for these benefits. These findings merit further research alongside performance measurement within larger studies. The full text of the presentation is available online.

© Aquarius Population Health 2022. For commercial use or distribution, please contact info@aquariusph.com.

Evaluating the benefits and costs of using an mRNA versus DNA HR-HPV assay in the National Cervical Screening Programme in the Netherlands

Persistent infection with high-risk human papillomavirus (HR-HPV) is a leading cause of cervical cancer. The National Cervical Screening Programme (NCSP) implemented HR-HPV primary screening to detect HR-HPV infections in the Netherlands in 2017. The choice of HR-HPV test (mRNA or DNA) used in screening programmes can impact resource use and costs, follow-up testing and referral for colposcopy.

A decision tree model was adapted from a previously published model in England to represent the current cervical screening flowchart in the Netherlands. The model estimates the impact on costs, the number of colposcopies, HR-HPV and cytology tests of using an mRNA assay compared to a DNA assay for a cohort aged 30 to 65 years. Results found adopting an mRNA HR-HPV test instead of a DNA test as part of the NCSP in the Netherlands, gave an estimated €1.8M in total cost savings annually. The results from the model are comparable to results for other countries including England, Sweden, Denmark, Canada, and France.

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Dombrowski C, Weston G, Adams E. Evaluating the benefits and costs of using an mRNA versus DNA HR-HPV assay in the National Cervical Screening Programme in the Netherlands. Poster presented at: EUROGIN International Multidisciplinary HPV Congress; 2021 May 30 – June 1; Virtual

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Modelling the impact of using a DNA compared to mRNA HPV assay as part of the cervical screening programmes in Sweden and Denmark

Nearly all cases of cervical cancer are caused by 14 high-risk human papillomavirus (HR-HPV) genotypes. Denmark and Sweden are assessing the structure of their cervical cancer screening programmes and implementing HR-HPV screening in certain populations. While both DNA and mRNA assays have similar sensitivity, mRNA assays have been shown to have higher specificity resulting in fewer false-positive results.

We adapted a decision tree model from a previously published study in England to explore how the type of assay used to detect HR HPV infections in a screening programme may impact costs, patient follow-up, and resource use. The results showed the use of mRNA tests in cervical screening for women in Sweden or Denmark instead of DNA testing would result in cost savings and a decrease in the number of unnecessary cytology tests, unnecessary recall HR-HPV tests and unnecessary colposcopies compared to HR-HPV DNA testing and can be used to inform the implementation of screening programmes with benefits for health services and women.

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Dombrowski C, Weston G, Adams E. Modelling the impact of using a DNA compared to mRNA HPV assay as part of the cervical screening programmes in Sweden and Denmark. Poster presented at: EUROGIN International Multidisciplinary HPV Congress; 2021 May 30 – June 1; Virtual

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Evaluating the choice of HPV assay in the French cervical screening programme with a decision tree model

Persistent infection with high-risk human papillomavirus (HR-HPV) has been linked to precancerous lesions (cervical intraepithelial neoplasia (CIN)) which may progress to cervical cancer. Guidance was issued in 2020 in France to include the use of assays to detect HR-HPV infections in a national cervical screening programme.

A decision tree model was developed to evaluate the impact of using a similarly sensitive, but more specific, mRNA HR-HPV assay (Aptima HR-HPV assay) compared to a DNA HR-HPV test (cobas 4800 HPV assay) in the proposed cervical screening algorithm in France. Results showed using an mRNA assay could yield an estimated annual cost saving of €6.5 million and reduce the total number of colposcopies, HPV and cytology tests required. As mRNA and DNA assays have similar test sensitivity, true positives will not be missed, and total costs are reduced by eliminating unnecessary colposcopy referrals, HR-HPV and cytology tests.

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Dombrowski C, Weston G, Descamps P, Izopet J, Adams E. Evaluating the choice of HPV assay in the French cervical screening programme with a decision tree model. Poster presented at: EUROGIN International Multidisciplinary HPV Congress; 2021 May 30 – June 1; Virtual.

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A cost effectiveness analysis of repeat screening for syphilis in pregnancy as an alternative screening strategy in the UK

Syphilis is a treatable sexually transmitted infection (STI) which can be passed from mother to foetus during pregnancy resulting in congenital syphilis. Syphilis infection also increases the risk of adverse pregnancy outcomes such as stillbirth and pre-term delivery. Most cases of congenital syphilis and adverse pregnancy outcomes can be avoided if the infection is diagnosed and correctly treated during pregnancy.

In the UK, pregnant women are offered screening for syphilis, HIV and hepatitis at their first antenatal appointment, typically at or before 12 weeks gestation. Despite the very high coverage of these routine screens plus repeat screening in some higher risk women, a handful of congenital syphilis cases still occur each year, either in women who miss screening or in women who become infected with syphilis after their antenatal screen. For this reason, the UK National Screening Committee (UK NSC) commissioned Aquarius to assess the cost effectiveness of offering a repeat screen to all pregnant women later in pregnancy.

We worked closely with a small group of experts to compare the current strategy – screening in the first trimester only – with an alternative strategy – screening in the first trimester and a repeat screen later in pregnancy.  We developed a decision tree and model inputs which accounted for the sensitivity and specificity of the syphilis assay, the small number of women who do not attend antenatal care until their third trimester (thereby missing the opportunity for repeat screening) and the costs associated with screening, delivery and antenatal care for all women delivering in the UK in one year.

The model revealed that repeat screening would prevent 5.5 cases of congenital syphilis each year but at cost of £1.8 million per case avoided. When a lifetime horizon was considered, the incremental cost-effectiveness ratio (ICER) for the repeat screening strategy was £120,494 per QALY gained – well above the £20k-30k cost per QALY threshold that NICE uses to assess interventions.

The paper concludes that in the UK setting, where prevalence of syphilis is very low, repeat screening for syphilis in pregnancy would not be a cost-effective strategy and alternative strategies should be sought to prevent congenital syphilis.

This is the first published study from outside the US to compare these two screening strategies. The results will be used to inform national screening policy and are relevant countries with similar syphilis prevalence and healthcare costs. 

Huntington S, Weston G, Seedat F, et al Repeat screening for syphilis in pregnancy as an alternative screening strategy in the UK: a cost-effectiveness analysis BMJ Open 2020;10:e038505. doi: 10.1136/bmjopen-2020-038505

Examining the acceptability of offering STI screening in higher educational settings

Uptake of screening for STIs, such as chlamydia and gonorrhoea, is often inadequate in young people despite provision of open-access sexual health services. Offering STI tests outside medical settings is currently being explored as a way to increase uptake in this group.

In 2017, St George’s University of London ran the ‘Test n Treat’ feasibility trial where free, confidential on-site testing for chlamydia and gonorrhoea was offered to students at six higher-education colleges in South London. We have previously reported on the main results of the trial and the cost estimates of providing such a service .

As part of the trial, the research team wanted to understand the acceptability of this type of service among students as well as the barriers and facilitators to its use. They interviewed a small sample of students, some of whom used the service and some of whom did not, as well teachers and the research team. The results of this qualitative study, which Aquarius Population Health gave advisory support to, were published in August 2020.

The paper reports that students who used the service had a very positive opinion of it. There were a number of barriers to using the service identified, including embarrassment about STI testing and the perceived view that individuals would be viewed negatively by their peers if they had an STI test. On the flip side, peers also acted as facilitators to uptake, for example, if a group of friends encouraged each other to get tested. A lack of understanding of STIs was another major barrier, with many students lacking understanding about the long-term consequences of STIs or having the misconception that only people with symptoms should get tested.  Where a £5 honorarium was given to students using the service, this acted as a legitimate incentive for testing, mitigating the (perceived) social stigma of testing.

The paper concludes that if a similar service were provided in future, uptake could be improved if education about sexual health was offered alongside testing, if small cash incentives were given and if peer influencers were engaged to promote the service.

Fleming, C., Drennan, V.M., Kerry-Barnard, S. et al. Understanding the acceptability, barriers and facilitators for chlamydia and gonorrhoea screening in technical colleges: qualitative process evaluation of the “Test n Treat” trial. BMC Public Health 20, 1212 (2020). https://doi.org/10.1186/s12889-020-09285-1

Modelling the choice of high-risk human papillomavirus (HR-HPV) assay in the English cervical screening programme

Aquarius developed a decision tree model to compare the use of the Aptima mRNA HR-HPV assay to a DNA HR-HPV assay in the HPV primary screening algorithm in England. Robust results from the model demonstrate that using the mRNA HR-HPV assay is cost saving and avoids unnecessary HPV recall tests, cytology tests and colposcopies compared to using a DNA HR-HPV assay.

In England, women are invited for cervical cancer screening starting at age 25 and are recalled at regular intervals until age 64. In the HPV primary screening algorithm, cervical samples are tested first for HR-HPV. Positive HPV samples are then tested using liquid based cytology to identify abnormal cells.

Aquarius developed a cost consequence analysis decision tree taking the perspective of NHS England and modelling the HPV primary screening algorithm for one simulated cohort of 2,247,439 women aged 25-64 from baseline screen through recall visits. The model endpoint was discharge to routine recall, loss-to-follow up, or referral to colposcopy. A micro-costing approach was used to estimate costs for screening in England, using published data. Head-to-head comparison of mRNA to DNA tests at baseline and with follow-up was not available for the English population. Therefore, data from the HORIZON study in Denmark with similar positivity to that in England was used.

The model indicated that using an mRNA versus DNA assay in the HPV primary screening algorithm in England can save an estimated £15.4 million and require 28,009 fewer unnecessary colposcopies, 90,605 few HR-HPV tests and 253,477 fewer cytology tests.  Uncertainty and scenario analyses demonstrate cost and resource savings will almost certainly be achieved using the mRNA assay.

PublicationWeston G, Dombrowski C, Harvey MJ, et al Use of the Aptima mRNA high-risk human papillomavirus (HR-HPV) assay compared to a DNA HR-HPV assay in the English cervical screening programme: a decision tree model based economic evaluation BMJ Open2020; 10:e031303. doi: 10.1136/bmjopen-2019-031303

Rapid testing and treatment for sexually transmitted infections improve patient care and yield public health benefits

With collaborators at Chelsea and Westminster NHS Foundation Trust, we estimated the impact of a rapid testing and result notification service for patients testing for sexually transmitted infections at the Dean Street Express clinic. We found that a rapid testing service for asymptomatic infections resulted in 8 days’ faster time to result notification for CT and/or NG which enables faster treatment, thus reducing infectious periods and leading to fewer transmissions, unnecessary partner attendances and clinic costs, compared with those attending an existing ‘standard’ sexual health clinic.

PublicationWhitlock GG, Gibbons DC, Longford N, et al. Rapid testing and treatment for sexually transmitted infections improve patient care and yield public health benefits
International Journal of STD & AIDS. First Published October 23, 2017
https://doi.org/10.1177/0956462417736431

 

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Cost-effectiveness of antimicrobial resistance point-of-care testing for optimising gonorrhoea treatment

In July, Emma Harding-Esch spoke at the STI and HIV World Congress in Rio on how to best manage the increasing challenge of anti-microbial resistance (AMR). The research she presented was a collaboration between Aquarius Population Health and ADREU St. Georges.  In recent years, there has been an increase in resistance to first-line therapies used to treat STIs such as gonorrhoea. The Aquarius team built a decision tree model to assess the cost-effectiveness of standard care compared to several hypothetical rapid point-of-care tests (POCT) for antibiotic susceptibility. The model simulated a cohort of sexual health clinic attendees. The results showed that while standard care is the cheapest option, AMR POCTs may be cost-effective and maximise the number of effective agents in treatment regimens, providing long-term benefits in some scenarios.

Harding-Esch EM, Huntington SE, Harvey MJ, et al. Cost-effectiveness of antimicrobial resistance point-of-care testing for optimising the treatment of gonorrhoea STI & HIV World Congress. 9-12 July 2017. Rio de Janiero, Brazil.

 

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Evaluating the costs, benefits and cost-effectiveness of multi-pathogen point-of-care tests for sexually transmitted infections

We estimated costs, benefits and cost-effectiveness of three accurate 30-minute NAAT POCT strategies that detect different STI combinations, compared with standard care  (laboratory-based NAAT for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)).  We found the CT-NG-MG-TV POCT strategy was the cheapest using tariff costing. It offered the most benefits, which in turn may have wider public health impacts through rapid and accurate STI diagnosis and management. Different testing strategies may be more cost-effective in different SHCs and patient groups. Further evidence is needed to capture the diversity of STI prevalence and management of patients across clinical services to better inform economic analyses.

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Harding-Esch EM, Huntington SE, Burns RM, et al. Evaluating the costs, benefits and cost-effectiveness of multi-pathogen point-of-care tests for sexually transmitted infections STI & HIV World Congress. 9-12 July 2017. Rio de Janiero, Brazil.

 

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