Women's Experience of Premature Ovarian Insufficiency (POI) Diagnosis: Update on Actual Practices and Patient's Follow up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ovarian Insufficiency
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- women's satisfaction
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Premature ovarian insufficiency (POI) affects 2,8 to 3,5% of women before the age of 40. Previous foreign studies revealed that only half of POI disclosures occurred during a medical consultation and that the diagnosis was often discussed in less than 5 minutes. As a result, most of patients felt a lack of information, and consequently sought data on the internet. None of these studies were conducted in France. The aim of this study is to analyze current practices related to POI diagnosis and to assess women's satisfaction
Detailed Description
POI is defined by the association of 1 clinical and 1 biological criterion: amenorrhea or spaniomenorrhea of \> 4 months with onset before 40 year of age, and elevated follicle-stimulating hormone (FSH) \> 25 IU/L on 2 assays at \> 4 weeks' interval, associated with low estradiol level. This condition affects approximately 2% of young women. POI can first lead to infertility and various symptoms caused by a lack of estrogens. Thus, patients may experience vaso-motor flushes, genitourinary syndrome, sleep disturbance, humor disorder, decrease libido and dyspareunia. After several years, POI can lead to osteoporosis, increased cardiovascular risk, and dementia. The administration of hormone replacement therapy (HRT) can help prevent these complications. Otherwise, POI may result in psychological repercussions such as anxiety, anger, loss of self-esteem, even depression. Few studies analyzed POI diagnosis and the way it was perceived by patients. Alzubaidi et al. and subsequently Groff et al. reported that only half of POI notifications occurred during a medical consultation. Moreover, 35% of the consultations lasted less than 5 minutes. Thereby, Singer et al. founds that 68% of women felt inadequately informed. The majority of patients sought additional information on the internet. No recent study focused on the disclosure of POI diagnosis, and none of the existing studies were conducted in France. The purpose of this study is to analyze the circumstances surrounding POI diagnosis and to evaluate women's experience. In other ways, in 2016, Bachelot et al. emphasized that after more than 5 years after POI diagnosis, only 61,7% of women were undergoing HRT whereas only 6% had no regular follow-up. Moreover, among the treated patients, 42,6% had already stopped HRT for more than 1 year without any medical recommendation. Therefore, this study aims to examine the association between women satisfaction regarding POI disclosure and their compliance to HRT and medical follow-up
Investigators
Eligibility Criteria
Inclusion Criteria
- •woman aged 18 years and older,
- •diagnosed with POI following ESHRE 2016 criteria,
- •speaking and reading French language,
- •woman's oral consent,
- •affiliated or beneficiary of health insurance.
Exclusion Criteria
- •iatrogenic POI (surgery, radiotherapy, chemotherapy linked),
- •chromosomic POI (Turner Syndrome),
- •inability for the woman to understand the nature or risks or significance and implications of the study,
- •woman under legal protection
Outcomes
Primary Outcomes
women's satisfaction
Time Frame: Baseline
Women's satisfaction regarding POI disclosure will be evaluated using a standardized questionnaire specifically made for this study. Findings will be presented as a score based on 5 questions assessing patient's experience of POI diagnosis (Healthcare provider adjustments to patient's emotional state, speech clarity, information provided, opportunity to ask questions, relevance of the topics discussed based on the patient's concerns). For each question a score from 1 to 4 will be assigned (Very unsatisfied = 1 ; Unsatisfied = 2 ; Satisfied = 3 ; Very satisfied = 4), resulting in a total score ranging from 5 to 20. Patients scoring from 5 to 8 will be categorized as overall very unsatisfied, 9 to 12 as unsatisfied, 13 to 16 as satisfied, and 17 to 20 as very satisfied
Secondary Outcomes
- Patient's expectations(Baseline)
- interrupted HRT(Baseline)
- hormone replacement therapy(Baseline)
- osteoporosis(Baseline)
- residual symptoms of POI(Baseline)
- side effects when taking HRT(Baseline)
- bone mineral density evaluation(Baseline)
- cardiovascular risk factor(Baseline)
- gynecological follow-up(Baseline)
- cervical cancer(Baseline)