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| Name | Class |
|---|---|
| University College, London | OTHER |
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What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA). FHA is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (PCOS). This could cause delays in starting the correct treatment.
What is the justification for doing this study? Undiagnosed women with FHA are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. The failure to accurately identify women with FHA and mislabel those women with FHA as having PCOS, may delay appropriate treatment. Treatment delay causes harm for affected women, including bone fractures and infertility.
What do the investigators propose? Improve the diagnosis of women with FHA by composing an assessment score, which could be used by women to improve the accuracy of diagnosing FHA. The investigators designed a questionnaire based on literature search, which can be used to identify women with FHA. A questionnaire-based study (on-line or in person) will be performed to identify risk of FHA, in women referred to hospital with period loss.
A questionnaire was developed to be used by women with period loss to facilitate the diagnosis of women with FHA. The development of the questionnaire was based on systematic literature review and comments from a small patient involvement group, as per National Institute for Health and Care Research (NIHR) INVOLVE guidelines.
Participants will be recruited via distributing a patient information sheet, consent form and a questionnaire to all women referred with amenorrhea to the Endocrinology or Reproductive Medicine clinics at Imperial College Healthcare NHS Trust and/or participating NHS organisations. Completion of the consent form and questionnaire is entirely dependent on each potential participant's choice.
Every woman taking part can complete the questionnaire before or after her appointment. All questionnaires will be anonymised with a unique study code, and handed back to the NHS clinician.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | A questionnaire including up to 20 questions will be distributed to study participants. This questionnaire will be used to identify women with FHA. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of clinical features in women with Functional hypothalamic amenorrhea | Descriptive statistics will be applied to questionnaire responses looking at frequency of different clinical features in women with FHA and women with other diagnoses. | 3 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of biochemical features in women with Functional hypothalamic amenorrhea | Descriptive statistics will be applied to standard medical investigation results looking at frequency of different biochemical features in women with FHA and women with other diagnoses. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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All women referred by their GP with amenorrhea to the Endocrinology or Reproductive Medicine clinics at Imperial College Healthcare NHS Trust hospitals and participating NHS organisations.
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| Name | Affiliation | Role |
|---|---|---|
| Channa Jayasean, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital NHS Trust | London | NW1 2BU | United Kingdom | |||
| Imperial College Healthcare NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33354766 | Background | Phylactou M, Clarke SA, Patel B, Baggaley C, Jayasena CN, Kelsey TW, Comninos AN, Dhillo WS, Abbara A. Clinical and biochemical discriminants between functional hypothalamic amenorrhoea (FHA) and polycystic ovary syndrome (PCOS). Clin Endocrinol (Oxf). 2021 Aug;95(2):239-252. doi: 10.1111/cen.14402. Epub 2021 Jan 19. | |
| 34323305 |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| London |
| W12 0HS |
| United Kingdom |
| Abou Sherif S, Newman R, Haboosh S, Al-Sharefi A, Papanikolaou N, Dimakopoulou A, Webber LJ, Abbara A, Franks S, Dhillo WS, Jayasena CN. Investigating the potential of clinical and biochemical markers to differentiate between functional hypothalamic amenorrhoea and polycystic ovarian syndrome: A retrospective observational study. Clin Endocrinol (Oxf). 2021 Oct;95(4):618-627. doi: 10.1111/cen.14571. Epub 2021 Aug 9. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |