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| Name | Class |
|---|---|
| The Hospital of Vestfold | OTHER |
| University Hospital, Akershus | OTHER |
| St. Olavs Hospital | OTHER |
| Turku University Hospital |
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Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.
In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the prediction model for adenomyosis | Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intraclass correlation coefficient (ICC) between readers | ICC values are categorized as follows: 0-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement; and 0.81-1, almost perfect agreement | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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A consecutive sample of women that are scheduled for a hysterectomy at one of the study sites and fulfill eligibility criteria are invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Marit Lieng, Phd | Oslo University Hospital, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20521 | Finland | |||
| Akershus University Hospital, Dept. of gynecology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30316443 | Background | Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009. |
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We will share the values of all evaluated predictors in the model so that they can be used for re-calculation.
The data is planned to be made available within a year after the publication of all results.
Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into adenomyosis and a detailed protocol has to be submitted.
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER_GOV |
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| Lørenskog |
| Akershus |
| 1478 |
| Norway |
| St. Olavs Hospital, Dept. of Gynecology | Trondheim | Trøndelag | NO-7006 | Norway |
| Sykehuset i Vestfold | Tønsberg | Vestfold | 3103 | Norway |
| Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital | Oslo | 0382 | Norway |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |