Objective The objective of this study is to assess which risk scoring model is most cost-effective for the discrimination between benign and malignant ovarian tumors that guides referral decisions for women with ovarian tumors in the…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Health condition
Ovarian tumors
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
Quality of Life (measured by the EuroQol-5D (EQ-5D)
Secondary outcome
Physical and mental health status (Short Form 12), Healthcare resource use costs (iMCQ instrument), Productivity losses (iPCQ instrument), Extend of cancer worries and anxiety (Cancer Worry Scale (CWS), Hospital Anxiety And Depression Scale (HADS), Intolerance of Uncertainty Scale (IUS 12) .
Background summary
Correct referral of women with an ovarian tumor is still a major challenge. Annually, 6500 women undergo surgery for an ovarian tumor in the Netherlands of which a minority is malignant. It is important to accurately differentiate between benign and malignant ovarian tumors in order to reduce morbidity and mortality and make optimal use of scarce resources. There are several risk scoring models to guide referral decisions. Current cost-effectiveness analysis (CEAs) of the available risk scoring models do not deal with the impact of pre- operative misdiagnosis on women’s quality of life (QoL) and disutility due to incorrect referral as these data are not available yet. In the ACCEPT study this knowledge gap will be closed.
Hypothesis
The use of IOTA risk scoring models or subjective assessment by an expert (SA) to guide referral decisions for women with ovarian tumors is more cost-effective than the use of the Risk of Malignancy Index (RMI) (usual care) as it will enhance correct referral which will improve QoL of women which will result in reduced costs and better use of healthcare budget in the Netherlands.
Study objective
The objective of this study is to assess which risk scoring model is most cost-effective for the discrimination between benign and malignant ovarian tumors that guides referral decisions for women with ovarian tumors in the Netherlands.
Study design
The study design is two-fold. First a prospective observational cohort study will be conducted to collect data on quality of life and resource use of women with an ovarian tumor at diagnosis, at hospital admission as well as 6 weeks and 3 months post hospital admission. Data will be collected by means of questionnaires and case report forms (CRF). Secondly a cost-effectiveness analysis will be performed in which different risk assessment models (the RMI, simple ultrasound-based rules (SR), Assessment of Different NEoplasias in the adneXa (ADNEX) and logistic regression model 2 (LR2) and subjective assessment (SA) will be compared. In total 584 women will be included.
Study population
Women (age >18 years) presenting in outpatient clinics of general hospitals with an ovarian tumor and indication for surgery will be included.
Data collection
No treatment or intervention will be performed. Data on quality of life and costs will be collected through questionnaires and CRFs. Data on the performance of the different risk assessment models will be retrieved from literature. With these data a decision analytic- model will be developed to compare the different risk assessment models.
Main study parameters/endpoints
Generic Quality of Life (QoL) measured by the EuroQol-5D (EQ-5D) to assess the impact of (in)correct referral on health-related QoL for women presenting with an ovarian tumor.
Secondary analysis
Secondary outcomes include physical and mental health status (Short Form 12), healthcare resource use costs (iMCQ instrument), productivity losses (iPCQ instrument), extend of cancer worries and anxiety (Cancer Worry Scale (CWS), hospital Anxiety And Depression Scale (HADS) and intolerance of Uncertainty Scale (IUS 12).
Intervention
Age
Inclusion criteria
1. Age ≥ 18 years 2. Presentation in outpatient clinic of general hospital 3. Ovarian tumor with indication for surgery 4. Understanding of Dutch language
Exclusion criteria
1. Obvious benign ovarian tumor: a. Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma b. Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma) c. Unilocular tumor with regular walls and maximal diameter < 10cm (suggestive of simple cyst or cystadenoma) d. Remaining unilocular tumors with regular walls 2. Obvious malignant ovarian tumor: tumor with ascites and at least moderate color Doppler blood flow in postmenopausal women 3. Ovarian cancer or ovarian borderline tumor in medical history 4. Concurrent other malignancy
Design
Recruitment
IPD sharing statement
Plan description
Postbus 7777
5500 MB Veldhoven
040 888 9528
metc@mmc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9572 |
| Other | METC Maxima Medisch Centrum : N21.056 |