Cervical Dysplasia, Cervix Cancer, HPV Infection
Conditions
Keywords
Visual Inspection cervix, Artificial Intelligence, Screening Cervical Cancer, decision support system
Brief summary
The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.
Detailed description
This research project aims to validate an image processing algorithm in order to study if the AI can function as decision support system (DSS) for healthcare workers, who perform VIA. The AI-DSS has been designed by the Manipal Academy of Higher Education in India and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions. The first step of the validation process is a dry run using a database of VIA pictures with pathology confirmation. The accuracy, sensitivity and specificity of healthcare workers, an expert team and the AI will be analysed, based on the ground truth of database pictures. Thereafter, the AI-DSS will be validated under field conditions. Women who are hrHPV-positive in Uganda, India and Bangladesh will undergo a VIA. The AI is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). The user experience of the device will be evaluated. The AI-DSS will be validated by comparing the VIA assessment by health workers, the AI with assessment by the expert panel. Accuracy, sensitivity and specificity of the AI algorithm will be assessed.
Interventions
DIAGNOSTIC_TESTValidation of AI-DSS in Bangladesh
VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
DIAGNOSTIC_TESTValidation of AI-DSS in Uganda
VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
DIAGNOSTIC_TESTValidation of AI-DSS in India
VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.
Sponsors
Uganda Cancer Institute
Female Cancer Foundation
International Centre for Diarrhoeal Disease Research, Bangladesh
Manipal Academy for Higher Education
Friendship Bangladesh
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
In Uganda, India and Bangladesh eligible women in geographic areas are invited to perform self-test for hrHPV. hrHPV-positive women are invited for further examination of the cervix using VIA. In all VIAs pictures are taken with the device and the AI decision support system is activated. Health workers will give an independent VIA assessment before the AI assessment can be accessed. An expert panel gives an independent assessment without knowing the health worker or AI assessment.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Female in eligible age group * Women who tested HPV positive and are eligible for VIA * Ability to give informed consent and participate in study
Exclusion criteria
* Clinical signs of cervical carcinoma * Menstruation or other vaginal blood loss * HPV negative women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy, sensitivity, specificity of AI-DSS | through study completion, estimated 2 years | Measurement of true and false positive and true and false negative results of the AI DSS in relation to assessment by expert panel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of quality pictures | through study completion, estimated 2 years | Percentage of pictures taken during the VIA procedures, which meet according to the expert panel the quality standards suitable for AI-DSS assessment, based on visibility of cervix and Squamo-Columnar Junction (SCJ), light, reflection of speculum, mucus-free surface |
Other
| Measure | Time frame | Description |
|---|---|---|
| User-friendliness of AI-DSS device among healthcare providers | through study completion, estimated 2 years | Scoring on Likert scale by healthcare providers using AI-DSS device based on their assessment of device software human machine interface, weight, size, flashlight, |
Countries
Uganda
Outcome results
None listed