LIDEA Registry
Information for physicians
Select one of the options below
What is the study about?
Discover more about the LIDEA Registry by clicking the button below.
Who can be included in the study?
Find out more about the inclusion/exclusion criteria.
What are my responsibilities?
Your responsibilities summarized in a nutshell.
FAQs
Have a look at our Frequently Asked Questions (FAQs).
– A 5-year non-interventional, dual-source, decentralized registry
– Inclusion of diagnosed patients or patients with unclear symptom profile of endometriosis and/or adenomyosis experiencing chronic gynecologic pain and/or bleeding irregularities
– Overseen by a Scientific Governance Board
KEY GOALS
Study participants
Recruiting physicians
Countries (Germany, Spain, Italy, France, UK, USA)
Years of follow-up directly with the patient
Our objectives
Our primary objectives are:
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Epidemiological assessment of the course of pelvic pain, and the development of endometriosis and/or adenomyosis
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Examine treatment pathways and outcomes of pelvic pain with or without specific diagnoses (e.g., endometriosis, adenomyosis), including health economic outcomes
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Examine the relationship between changes in patient-reported outcome measures and healthcare resources utilization in patients treated for pelvic pain
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Evaluate the disease burden and unmet need in patients with pelvic pain, despite available treatment
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Secondary objectives include:
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Effect of therapies on pain
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Effect of therapies on bleeding
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Identification of therapeutic gaps / niches
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Situational analysis of treatment across geographies / countries
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Operative versus medical treatment
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National preferences regarding diagnostic and therapeutic pathways, physician perception of successful disease management
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Impact of disease and different treatments on work, partnership, sexuality, family planning, life course impact, and satisfaction
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Who can be included in this study?
Individuals of reproductive age, aged 14 years to 50
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Have a confirmed diagnosis of endometriosis and/or adenomyosis based on laparoscopy, laparotomy, biopsy, or histological confirmation.
OR
– Have a presumed diagnosis of endometriosis and/or adenomyosis based on another diagnostic test such as ultrasound, magnetic resonance imaging, other imaging tests or laboratory tests;
OR
– Based on presentation of clinical symptoms that could indicate endometriosis or adenomyosis including persistent pelvic pain, excessive menstrual bleeding or bleeding between periods, heavy periods, dysuria, dyschezia or dyspareunia and treatment with a first-line endometriosis treatment (e.g. combined oral contraceptive or progestin-only pill).
Who cannot be included in this study?
- Patients unwilling to sign the Informed Consent Form (ICF)
- Patients who are unable to understand study instructions
- Patients who do not have the possibility to complete online questionnaires on a phone, computer or tablet with internet connection
What are your responsibilities?
Sign a study participation form, complete a short feasibility questionnaire and register for a 15-20 minute study training.
Step 2
Identify eligible patients for participation, explain the study and hand over the pre-prepared study materials for patient enrollment into the study. Guide the participant through the consenting process and be available in case of any questions by the patient
Step 3
Provide information at baseline for each participant by entering data directly into ClinicalOne, an electronic data capture system. You will be provided with an account.
We will inform you via email on a regular basis which questionnaires are due for completion.
Data entry should take approximately 10 to 15 minutes per questionnaire.
If available, provide information at 12 and 36 months for each participant by entering data directly into ClinicalOne. Your data collection is independent from the patient’s clinical visit.
We will inform you via email on a regular basis which questionnaires are due for completion.
Data entry should take approximately 10 to 15 minutes per questionnaire.
FAQs
Read our Frequently Asked Questions (FAQs) by clicking on the boxes below. In case your question is not included, please reach out to the LIDEA Registry study team.
Is this an interventional study?
No, this is a patient-centric observational registry study. This study should not influence your management and prescriptions decisions, or the decisions made by individual patients. The option of participating in this study should only be discussed after you and your patient have decided on the appropriate management strategy.
Is an ethics/IRB approval in place?
Ethical approval for the study has been acquired following the rules for observational studies in the respective countries. Global approval from the Ethics Commission overseeing the Principal Investigator has been acquired in Germany. If desired, we can send you a copy of this document.
What data will be collected?
You will be asked to provide information on the patient’s diagnosis, disease status, (surgical) treatments, and medical information via a web-based electronic data capture platform Clinical One. The physician questionnaires will ask specific clinical questions that cannot be easily answered by the study participant.
What is expected from my patients?
- Your eligible patients should voluntarily consent to participate in the LIDEA Registry.
- After signing the consent form, a baseline questionnaire should be completed online using a web-based platform Greenlight Guru Clinical.
- Two weeks after study enrollment, participants will receive a web-based baseline daily pain questionnaire, which needs to be completed for 30 consecutive days.
- Web-based follow-up questionnaires will be sent directly to participants at 6, 12, 24, and 36 months.
- The follow-up daily pain diary will be activated again approximately at 6 and 12 months after study enrollment which will need to be completed for 30 consecutive days.
Participant questionnaires will be provided directly to the participants via the Greenlight Guru Clinical website and no action from you is required. Participants will receive a small remuneration after successful completion of each questionnaire.
Do I receive a remuneration?
Yes, you will receive a remuneration for 1) enrollment and completion of the baseline questionnaire of each participant and 2) completion of each follow-up questionnaire at 12 and 36 months.
For more details on the payment plan, please reach out to the LIDEA Registry research team.
How many patients do I need to recruit?
You can recruit as many patients as you’d like as long as they match the inclusion and exclusion criteria