Impact of Self Assessment of Foetal Ultrasound Images on Image QualityPhase 3SAVE USNCT02074592
Self Assessment of Fetal Ultrasound Images
A Phase 3 study testing Self assessment of ultrasound fetal biometry images and assessment of ultrasound fetal biometry images by expert in people with Impact of Self Assessment of Foetal Ultrasound Images on Image Quality, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective. To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups. One group assess their own images (self assessment). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impact of Self Assessment of Foetal Ultrasound Images on Image Quality
- What is being tested?
- Self assessment of ultrasound fetal biometry images and assessment of ultrasound fetal biometry images by expert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2012to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteer ultrasonographers
- Single pregnancy
- gestational age at ultrasound: 18-36
Who cannot join
- any fetal structural abnormality identified during ultrasound
- multiple pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Collège Français d'échographie Foetale
Montpellier, 34000
Marc Dommergues, MD, PhD
- Recruiting
Groupe Hospitalier Pitié Salpetrière
Paris, 75013
Marc Dommergues, MD, PhD
About this study
Official title: Self Assessment Vs. Expert for Fetal Ultra Sound Biometry Images
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective.
To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups.
Read more
One group assess their own images (self assessment). The other group has their images assessed by an expert. Images are audited via the internet in a standardized procedure that generates feedback with recommendation for change.
Three to 6 months later, participants are audited again. If the improvement in image quality turns to be the same in both groups, it will be likely that self assessment is indeed as effective as assessment by an expert reviewer - at least for professionals experienced in fetal ultrasound.
Read the detailed description
Background: Audit and feedback based on image scoring by an expert improve ultrasound image quality, but is time consuming. Self assessment of ultrasound still images might be an alternative to assessment by an expert.
Objective. To compare image quality improvement following self assessment of fetal biometry images versus audit and feedback by an expert.
Methods. Study design: prospective blinded randomised controlled trial. Inclusions Doctors or midwifes experienced in the field of fetal ultrasound, are solicited by email to enrol. Volunteers upload a first set of 30 biometry images (10 cephalic, 10 abdominal and 10 femoral) obtained from 10 consecutive screening scans performed in the second or third trimester of pregnancy. Abnormal scans are excluded.
Randomization:
After uploading the first set of images, ultrasonographers are randomised with a 1:1 ratio * Arm 1: Ultrasonographers assess their own images online according to a standardized procedure. They receive an automatically generated report with detailed recommendations for change.
Their images are also audited by an expert, but the result of this audit remains concealed to the ultrasonographer
- Arm 2: Ultrasonographers do not assess their own images. Their images are assessed by an expert according to the same standardized online procedure. They receive an automatically generated report with detailed recommendations for change.
Follow up Three to 6 months later, ultrasonographers are asked to upload a second set of 30 biometry images. Images are audited by an expert reviewer using the same standardized online procedure as for the first set.
Online image scoring procedure:
The procedure is the same whether the reviewer is the ultrasonographer himself or an expert.
Uploaded images are presented to the reviewer after an automatic black contour concealed the identity of the patient and ultrasonographer.
Images are presented on the left hand side of the screen. Buttons on the right hand side are clicked according to the presence or absence of quality criteria. Online help provides specifics on each criterion, together with typical images.
Scoring criteria are derived from L. J. SALOMON, et al Ultrasound Obstetric Gynecology 2006; 27: 34-40).
For each set of images sent by a given ultrasonographer, image quality is evaluated based on:
- the percentage of images meeting all criteria (IMAC)
- the mean of a score based on attributing one point per criterion present on a given image.
Feed back and recommendations for change A feedback adapted to the scoring results is generated automatically. It provides the ultrasonographer with the percentage of IMAC, and a mean score, overall and for each type of image. Whenever a criterion is not met, a pop up window shows the corresponding image and a short document is displayed, with recommendations for change.
Data collected:
- Gestational age
- Demographic characteristics of professionals enrolled: age, gender, experience in fetal ultrasound (years), medical doctor vs. midwife, fetal ultrasound practice (screening only, vs. screening plus referral ultrasound), medical practice other than fetal ultrasound, continuous medical education in the field of fetal biometry, membership of the French College of fetal ultrasonography.
- For each set and type of image:
- percentage of IMAC
- mean score
Main outcome :
Improvement in the mean percentage of IMAC between the first and the second set of images
Secondary outcomes:
Improvement in the mean percentage of IMAC between the first and the second series of cephalic images Improvement in the mean percentage of IMAC between the first and the second series of abdomen images Improvement in the mean percentage of IMAC between the first and the second series of femur images Difference in mean score, overall and for each image type, between the first and the second set of images.
Subgroup analysis may be performed based on ultrasonographers characteristics. The agreement between self assessment and audit by expert reviewers will be analysed Statistical analysis A descriptive analysis of data will be done. An equivalence test for quantitative data will be done to study the main and secondary outcomes.
Subgroups analysis will be made for each image type. Agreement between self assessment and expert audit will be evaluated by intraclass correlation coefficient method.
For all tests, a value of P < 0.05 was considered statistically significant. Number of participants to be included The mean increase in the percentage of IMAC for each ultrasonographer (Δ% IMAC) is the main outcome. The equivalence in Δ% IMAC between the two arms will be tested.
We choose the following equivalence margins: ± 6.67% (i.e. a difference of 2 IMAC for each set of 30 images). The standard deviation of Δ% IMAC observed in a previous study was 20. This study showed a Δ% IMAC of 15% after audit and feedback (i.e. 4 to 5 images improved).
For a two sided alpha of 5% and a power of 80%, 156 ultrasonographers are needed in each group. We thus expect to enrol 320 ultrasonographers in the study.
Expected results. Equivalence in improvement of image quality in the self assessment and the expert audit group.
This would suggest that online self assessment may be as effective as audit by an expert to improve ultrasound image quality.
- Being tested
- Self assessment of ultrasound fetal biometry images, assessment of ultrasound fetal biometry images by expert
- Keywords
- Self assessment, Audit, Feedback, Quality, Ultrasound, Fetal, Biometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self assessment of ultrasound fetal biometry imagesBehavioural
self assessment of ultrasound fetal biometry images followed by automatically generated feedback
assessment of ultrasound fetal biometry images by expertBehavioural
assessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | self assessment of ultrasound fetal biometry images followed by automatically generated feedback Receives: Behavioral: Self assessment of ultrasound fetal biometry images |
| 2 | Active comparator | assessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback Receives: Behavioral: assessment of ultrasound fetal biometry images by expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the percentage of IMAC at 3-6 months after inclusion comparing the group with self-assessment and the group with assessment by expert.
Measured: 3-6 months
Secondary outcomes (1)
Increase in mean images quality score at 3-6 months comparing the group with self-assessment and the group with assessment by expert
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJul 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Self Assessment of Foetal Ultrasound Images on Image QualityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Dommergues, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074592
- Sponsor's protocol ID
- AOR08021
- Acronym
- SAVE US
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Assessment Vs. Expert for Fetal Ultra Sound Biometry Images
- ClinicalTrials.gov ID
- NCT02074592
- Acronym / sponsor ID
- SAVE US / AOR08021
- Keywords
- Self assessment, Audit, Feedback, Quality, Ultrasound, Fetal, Biometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective.
To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups.
One group assess their own images (self assessment). The other group has their images assessed by an expert. Images are audited via the internet in a standardized procedure that generates feedback with recommendation for change.
Three to 6 months later, participants are audited again. If the improvement in image quality turns to be the same in both groups, it will be likely that self assessment is indeed as effective as assessment by an expert reviewer - at least for professionals experienced in fetal ultrasound.
Detailed description
Background: Audit and feedback based on image scoring by an expert improve ultrasound image quality, but is time consuming. Self assessment of ultrasound still images might be an alternative to assessment by an expert.
Objective. To compare image quality improvement following self assessment of fetal biometry images versus audit and feedback by an expert.
Methods. Study design: prospective blinded randomised controlled trial. Inclusions Doctors or midwifes experienced in the field of fetal ultrasound, are solicited by email to enrol. Volunteers upload a first set of 30 biometry images (10 cephalic, 10 abdominal and 10 femoral) obtained from 10 consecutive screening scans performed in the second or third trimester of pregnancy. Abnormal scans are excluded.
Randomization:
After uploading the first set of images, ultrasonographers are randomised with a 1:1 ratio * Arm 1: Ultrasonographers assess their own images online according to a standardized procedure. They receive an automatically generated report with detailed recommendations for change.
Their images are also audited by an expert, but the result of this audit remains concealed to the ultrasonographer
- Arm 2: Ultrasonographers do not assess their own images. Their images are assessed by an expert according to the same standardized online procedure. They receive an automatically generated report with detailed recommendations for change.
Follow up Three to 6 months later, ultrasonographers are asked to upload a second set of 30 biometry images. Images are audited by an expert reviewer using the same standardized online procedure as for the first set.
Online image scoring procedure:
The procedure is the same whether the reviewer is the ultrasonographer himself or an expert.
Uploaded images are presented to the reviewer after an automatic black contour concealed the identity of the patient and ultrasonographer.
Images are presented on the left hand side of the screen. Buttons on the right hand side are clicked according to the presence or absence of quality criteria. Online help provides specifics on each criterion, together with typical images.
Scoring criteria are derived from L. J. SALOMON, et al Ultrasound Obstetric Gynecology 2006; 27: 34-40).
For each set of images sent by a given ultrasonographer, image quality is evaluated based on:
- the percentage of images meeting all criteria (IMAC)
- the mean of a score based on attributing one point per criterion present on a given image.
Feed back and recommendations for change A feedback adapted to the scoring results is generated automatically. It provides the ultrasonographer with the percentage of IMAC, and a mean score, overall and for each type of image. Whenever a criterion is not met, a pop up window shows the corresponding image and a short document is displayed, with recommendations for change.
Data collected:
- Gestational age
- Demographic characteristics of professionals enrolled: age, gender, experience in fetal ultrasound (years), medical doctor vs. midwife, fetal ultrasound practice (screening only, vs. screening plus referral ultrasound), medical practice other than fetal ultrasound, continuous medical education in the field of fetal biometry, membership of the French College of fetal ultrasonography.
- For each set and type of image:
- percentage of IMAC
- mean score
Main outcome :
Improvement in the mean percentage of IMAC between the first and the second set of images
Secondary outcomes:
Improvement in the mean percentage of IMAC between the first and the second series of cephalic images Improvement in the mean percentage of IMAC between the first and the second series of abdomen images Improvement in the mean percentage of IMAC between the first and the second series of femur images Difference in mean score, overall and for each image type, between the first and the second set of images.
Subgroup analysis may be performed based on ultrasonographers characteristics. The agreement between self assessment and audit by expert reviewers will be analysed Statistical analysis A descriptive analysis of data will be done. An equivalence test for quantitative data will be done to study the main and secondary outcomes.
Subgroups analysis will be made for each image type. Agreement between self assessment and expert audit will be evaluated by intraclass correlation coefficient method.
For all tests, a value of P < 0.05 was considered statistically significant. Number of participants to be included The mean increase in the percentage of IMAC for each ultrasonographer (Δ% IMAC) is the main outcome. The equivalence in Δ% IMAC between the two arms will be tested.
We choose the following equivalence margins: ± 6.67% (i.e. a difference of 2 IMAC for each set of 30 images). The standard deviation of Δ% IMAC observed in a previous study was 20. This study showed a Δ% IMAC of 15% after audit and feedback (i.e. 4 to 5 images improved).
For a two sided alpha of 5% and a power of 80%, 156 ultrasonographers are needed in each group. We thus expect to enrol 320 ultrasonographers in the study.
Expected results. Equivalence in improvement of image quality in the self assessment and the expert audit group.
This would suggest that online self assessment may be as effective as audit by an expert to improve ultrasound image quality.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Self assessment of ultrasound fetal biometry imagesself assessment of ultrasound fetal biometry images followed by automatically generated feedback |
| 2 | Active comparator | Behavioral: assessment of ultrasound fetal biometry images by expertassessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer ultrasonographers
- Single pregnancy
- gestational age at ultrasound: 18-36
Key exclusion criteria (2 listed)
- any fetal structural abnormality identified during ultrasound
- multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self assessment of ultrasound fetal biometry imagesself assessment of ultrasound fetal biometry images followed by automatically generated feedback | Behavioural | 1 |
| assessment of ultrasound fetal biometry images by expertassessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback | Behavioural | 2 |
Primary outcome
Increase in the percentage of IMAC at 3-6 months after inclusion comparing the group with self-assessment and the group with assessment by expert.
Time frame: 3-6 months
1 secondary outcome
Increase in mean images quality score at 3-6 months comparing the group with self-assessment and the group with assessment by expert
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Dommergues, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self assessment of ultrasound fetal biometry images and assessment of ultrasound fetal biometry images by expert in people with Impact of Self Assessment of Foetal Ultrasound Images on Image Quality, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Dommergues, MD, PhD (0033608486925, marc.dommergues@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the percentage of IMAC at 3-6 months after inclusion comparing the group with self-assessment and the group with assessment by expert. (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.