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. This study assessed the performance and user experience of cytotechnologists (CTs) reviewing liquid-based cytology samples using a new digital cytology platform Digital Diagnostics System (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 artificial intelligence 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. While the results suggest a positive user experience, the sample size was small in this pilot study, and the results are not statistically significant. 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.

Gara-Adams R, Dombrowski C, Adams E. “User experience and workflow performance: pilot evaluation of Genius Digital Diagnostics System for screening cervical cytology samples.” Presented at: 43rd European Congress of Cytology, October 3-6, 2021; Virtual.

Estimating the costs and benefits of HR-HPV assay choice in a theoretical HPV primary cervical screening algorithm in Ontario, Canada

Current cervical screening program guidelines for Ontario recommend cytology testing every 3 years for ages 25-70. Primary HR-HPV screening has been found to be more sensitive than primary cytology in detecting high-grade disease of the cervix. As Canadian provinces and territories move towards implementing primary HR-HPV screening in their cervical screening programs, how cervical screening is organized and implemented will need to be considered, including the choice of HR-HPV assay as the type of test influences costs and resource use.

A published decision tree model based on the Cervical Screening Programme (CSP) in England was adapted to simulate the primary HPV algorithm proposed by the Cervical Screening Guideline Working Group in Ontario. Results showed using mRNA tests instead of DNA tests could save over CAD $4 million annually, and avoid approximately 11,000 unnecessary colposcopies, 15,000 HPV tests and 40,000 cytology tests. Whilst the Ontario algorithm has not yet been agreed upon, this study shows that the choice of HPV assay is an important consideration within an HPV primary cervical screening program.

presentation_icon


Weston G, Steben M, Popadiuk C, Bentley J, Dombrowski C, Adams E. Estimating the costs and benefits of HR-HPV assay choice in a theoretical HPV primary cervical screening algorithm in Ontario, Canada. Poster presented at: EUROGIN International Multidisciplinary HPV Congress; 2021 May 30 – June 1; Virtual

Read Publication

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

How to prevent cervical cancer: HPV – we are coming to get you!

Prevention of cervical cancer in women is the focus of vaccination and screening programmes globally. However, there is no consensus on the best way to approach screening, and screening across Europe varies considerably. Innovations in diagnostic testing and new ways to engage women in screening may improve screening uptake and increase the efficiency of screening pathways. In this talk, we explore opportunities for a rapid or point of care test for HPV as part of the screening pathway, and how self-sampling may be an effective way to engage women in screening.

presentation_icon
Adams EJ. How to prevent cervical cancer: HPV – we are coming to get you! EUROGIN. June 15-18, 2016. Salzburg, Austria.

 

Read Publication

Cervical screening and HPV testing: Opportunities for rapid tests

Problem:  Our client Cepheid has developed a rapid HPV PCR test that can be used as a point-of-care test (POCT). They wanted to understand where in the cervical cancer screening and treatment pathway the test would be most beneficial to patients and the healthcare system. This comes during a time of uncertainty about how best to screen women, and how to organise laboratory services around screening. It is also unclear how screening may differ across Europe and the burden of cervical disease.

 Approach:  We conducted a literature review of the evidence about the current national cervical screening programme in the UK. Then, we conducted 25 semi-structured interviews with key opinion leaders across the UK to gain additional insight about the pathway and the opportunities for using a POCT in the screening pathway. Results also contributed to a European tool to understand cervical cancer diagnosis and burden.

 Impact:  We have presented our findings at international conferences (EUROGIN 2015, IPC 2015), and results have helped our client as they communicate the opportunities and value of a POCT for HPV to their stakeholders and customers. We have engaged with the international community on the requirements for the creation of a standardised international cervical cancer data repository, to inform better evidence-based decision making.

 

Testimonial

“While perfectly responding to the originally given mission, the Aquarius team painted a comprehensive picture of how healthcare is really delivered currently in Europe. This opened up our minds to new ways of improving patient care. The Aquarius team under Elisabeth’s leadership is highly professional, very creative and great fun to work with, without ever taking short cuts. I cannot imagine better results for us.”

  • Dr Anne Postulka, Senior Director Medical & Economic Value, Cepheid

 

Related publications

presentation_iconAdams EJ, Glover R, Vecino A, Postulka A. Exploring the value of a rapid, on-demand test for the detection of human papillomavirus. 30th International Papillomavirus Conference. Lisbon, Portugal. September 17 -21, 2015.

 

presentation_iconAdams EJ, Glover R, Vecino A, Postulka A. How can European countries improve cervical cancer prevention for women? 30th International Papillomavirus Conference. Lisbon, Portugal. September 17 -21, 2015.

How can European countries improve cervical cancer prevention for women?

We conducted a literature review on cervical cancer incidence, screening algorithms and coverage across Europe. Data on the structure and provision of screening programmes are sparse, with large heterogeneity reported by sources. A lack of comparable data across countries makes it challenging for researchers and policy-makers to assess screening effectiveness and what is most beneficial for women. A central data repository could facilitate effectiveness and cost-effectiveness analyses to support the adoption of the best screening algorithm.

presentation_iconAdams EJ, Glover R, Vecino A, Postulka A. How can European countries improve cervical cancer prevention for women? 30th International Papillomavirus Conference. Lisbon, Portugal. September 17 -21, 2015.

 

Read Publication

Exploring the value of a rapid, on-demand test for the detection of human papillomavirus

We explored the use of a rapid, on-demand human papillomavirus (HPV) test as part of a cervical screening programme. Through semi-structured interviews with experts from across the UK, we found that a co-located, laboratory-based, and on-demand HPV test following cytology could reduce the time to results by up to a week, whilst a near-patient test under primary HPV screening followed by cytology triage could radically change the testing paradigm, with most women notified the same day.

presentation_iconAdams EJ, Glover R, Vecino A, Postulka A. Exploring the value of a rapid, on-demand test for the detection of human papillomavirus. 30th International Papillomavirus Conference. Lisbon, Portugal. September 17 -21, 2015.

 

Read Publication