Using Artificial Intelligence to Screen for Hip Dysplasia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Artificial intelligence augmented ultrasound.
- Кому может быть актуально
- Состояния в реестре: Developmental Dysplasia of Hip. Базовые параметры: 4 Weeks — 20 Weeks · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Artificial Intelligence Augmented Ultrasound for Developmental Dysplasia of the Hip: a Validity Study
Обзор
The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia. It will also seek to understand how parents feel about their children undergoing this scan. Participants will: * Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia * Complete a short questionnaire about the experience of having the measurement performed on their child
Подробное описание
Initial screening for Developmental Dysplasia of the Hip (DDH) in Australia is performed most often by general practitioners and paediatricians shortly after birth and by maternal child health care nurses (MCHN) throughout the first year of life. These physical examinations consist of the Ortolani and Barlow tests and the examination of the thigh and gluteal creases. A recent meta-analysis reported the sensitivity of these tests as 36%, which indicates there is potential for a large proportion of cases to go undetected when solely relying on these examinations. Moreover, there currently are no formalised processes by which standards of practice are taught, assessed, or maintained. Thus, there is a clear need for a less operator-dependent screening protocol that can be performed within the current models of infant care. While some countries utilise universal ultrasound screening, this too is limited by access to care, as devices are not portable and thus cannot be used in current care models. Furthermore, it requires a specialist operator, substantially increasing cost. The screening program's limited nature, combined with the need for more consensus among international healthcare providers regarding the best method for managing DDH, has produced highly mixed clinical practices.
One part of the solution is optimising screening protocols for DDH in existing care models. Each state in Australia has established MCHN care protocols that provide access care for young children. While physical screening for DDH in these visits is standard practice, there remains considerable scope for improvement in the accuracy and reliability of these screening methods. Selective screening relies on several clinical associations with DDH to identify which patients receive ultrasound screening. Still, it has been shown to detect only 50% of infants with dysplasia. The MCHN screening program relies on clinical examination alone to detect dysplasia, an inferior identification method. Universal screening has a higher rate of detection of dysplasia but is expensive, single point in time (so misses the development of dysplasia) and results in higher levels of treatment.
A possible solution is portable artificial intelligence (AI)-augmented ultrasound. Recently technology has been developed to support a portable ultrasound device to screen DDH that uses AI-enabled technology to screen for DDH rapidly and accurately. Prior data has demonstrated that physicians and nurses could operate the device following training from expert sonographers. With its low-cost and ease of operation (with simple training) by healthcare providers such as MCHNs, it could significantly augment the physical screening. Thus, there is clear potential for an affordable, repeatable, and accessible screening methodology to be translated into clinical care. Initial Canadian data is promising. Pilot data suggests that DDH detection rates with this technology is on par with the detection rates of orthopaedic specialists. However, as this study was performed in a community setting and only those participants referred to orthopaedic clinics had a standard ultrasound measure performed, this pilot was unable to compare this screening technique with current gold standard diagnostic measures across the whole cohort, nor determine device sensitivity or predictive values. To demonstrate that this technology is fit for purpose, it is imperative that the rate of false negatives is also understood, as this is what will lead to late presentation, - which is what screening ultimately endeavours to prevent. Moreover, in an Australian context an important consideration in a wider roll-out is whether this technology would be accepted for uptake by clinicians and parents.
The proposed project will seek to gather pilot data to assess the validity and feasibility of this technology within a population of infants aged 4-20 weeks flagged at risk for DDH and referred to the Royal Children's Hospital. This will enable the recruitment of a sufficient number of cases of DDH to determine the sensitivity of the device. While the sensitivity and specificity of the device in this at-risk population may not be generalizable to the wider community the information gathered will then inform and refine a larger study of this technology in a community setting such as tertiary (birthing hospitals) and primary (MCHN clinics) care. If it can be demonstrated that it is feasible to implement this technology into existing care models, there is clear scope for this technology to revolutionize DDH screening. Thus, this project seeks to determine how well the device performs (sensitivity, specificity and predictive value) and the the clinical acceptability of this measure within the patient population.
Вмешательства
- Устройство Artificial intelligence augmented ultrasound
The hip ultrasound is performed using a handheld device (Exo Iris) that uses a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. . A real-time algorithm detects and records the anatomical landmarks. When there are enough images for analysis the operator is notified that the scan is complete.
Первичные конечные точки
- Artificial Intelligence augmented ultrasound screening test capability: Sensitivity [Срок оценки: 1 day, both ultrasound scans will be performed on the same day]
- Artificial Intelligence augmented ultrasound screening test capability: Specificity [Срок оценки: 1 day, both ultrasound scans will be performed on the same day]
- Artificial Intelligence augmented ultrasound screening test capability: Positive predictive value (PPV) [Срок оценки: 1 day, both ultrasound scans will be performed on the same day]
- Artificial Intelligence augmented ultrasound screening test capability: Negative predictive value (NPV) [Срок оценки: 1 day, both ultrasound scans will be performed on the same day]
Вторичные конечные точки (9)
- Factors associated with differences in device sensitivity [Срок оценки: 1 day, all data will be collected from day of scan]
- Factors associated with differences in device specificity [Срок оценки: 1 day, all data will be collected from day of scan]
- Factors associated with differences in device positive predictive value [Срок оценки: 1 day, all data will be collected from day of scan]
- Factors associated with differences in device negative predictive value [Срок оценки: 1 day, all data will be collected from day of scan]
- Device operator reliability in performing successful scans [Срок оценки: 12 months or entire study duration]
- Acquisition of successful scans [Срок оценки: 12 months or entire study duration]
- Time taken to acquire scan [Срок оценки: 1 day, calculated at time of scan]
- Caregiver perspectives on their infant undergoing the artificial intelligence augmented ultrasound [Срок оценки: 1 day, caregivers will be asked to complete immediately following the scan]
- Operator perspectives on performing the artificial intelligence augmented ultrasound [Срок оценки: At the conclusion of their involvement in the study device (up to 12 months)]
Критерии участия
Критерии включения
- Enrolled in the VicHip study
- Is 4-20 weeks of age at enrolment
- Is attending The Royal Children's Hospital for the purpose of the potential diagnosis of DDH
- Has a diagnostic (standard) hip ultrasound on the day of their out-patient appointment
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Критерии исключения
Participants will be excluded from enrolment if:
- They are currently receiving treatment for DDH
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
Австралия · 1 центр
- Royal Children's Hospital — Parkville
Идентификаторы
NCT: NCT06647225 · 107227