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Health Professionals

Aims

The NECST Registry has been developed to be a national resource of standardised patient data that will facilitate high quality research aiming to understand the causes of endometriosis, improve diagnosis and treatment outcomes, and reduce the burden of disease for patients with endometriosis-related symptoms or diagnosed with endometriosis.

The NECST Registry aims to collect and securely store demographic and health related information from consenting participants, who experience and/or seek management for endometriosis and/or endometriosis- and related symptoms (e.g. chronic pelvic pain, fatigue, infertility, etc.) utilising a minimum agreed and standardised core dataset. Such data will be collected at baseline enrolment and prospectively at regular intervals from participants, allowing longitudinal health outcomes data to be collected.

Participants

People are eligible to participate in the registry if they are:

  • Women aged 18 and over
  • Reside in Australia
  • Presenting with symptoms consistent with suspected or confirmed endometriosis.

Recruitment

  • Potential participants are identified through referral to, or attendance at, a gynaecology service provider who is part of the NECST Registry.
  • The registry uses an opt-in approach for recruitment.
  • Potential participants are sent an Invitation Letter and Consent Forms.
  • Participants can withdraw at any time and request for their data be removed from the registry.

Data collection

  • Eligible and consenting participants will be asked to complete questionnaires (online) to collect the following health information:
    • Demographics information
  • Clinical and medical history information
  • Patient-Reported Outcome Measures (PROMs), are assessments of overall health and quality of life as reported by patients at specific time points after diagnosis. The two PROMs tool being used by the NECST Registry are the EQ-5D-5L (general overall health state) and also the Endometriosis Health Profile (EHP)-30 (endometriosis specific).
  • Clinicians will be required to collect data for the NECST Registry. With additional or missing data collected from electronic or paper medical records by NECST Network and Registry staff, where required.
    • The information collected includes data about: diagnostic information, imaging information (ultrasound and/or MRI) and treatment (medical and/or surgical) information.

The NECST Registry modules

To ensure that data collected in the NECST Registry is sustainable, the working groups defined a limited series of essential data items (minimum core dataset). This will form the ‘data spine’ to which additional items may be added for time-limited collection or permanent collection depending on outcome measures.

The NECST Registry will consist of a series of modules (figure below) that all participating sites (public and private) will use to collect an identical set of ‘epidemiologically sound’ data. The modules that are required include:

  • Demographics and consent
  • Clinical presentation and medical history (including follow-up visits)
  • Patient reported outcome measures (PROMs; quality of life)
  • Imaging (ultrasound and/or MRI)
  • Medical management
  • Surgical management
  • Histopathology and biobanking*

* The biobanking module are planned for development and implementation in the future

Necst biobank graphic

Each of these modules will contribute to the overall dataset in the NECST Registry however, not all modules will be completed for each participant, since not all participants will require all interventions.

In defining the essential data items, we have referred to the World Endometriosis Research Foundation (WERF), EPHect Project that has SOPs and standardisation for data collection for endometriosis research.

Comment: Will need a link to a FAQ and also Instructions for NECST Registry Users documents

VCS Foundation and Digital

The NECST Registry will be stored and managed in a for-purpose, customised on-line platform built, and IT managed under contract by VCS Digital, a division of VCS Foundation. VCS Foundation is a Victorian not-for-profit health promotion charity with over 30 years’ experience in delivery and management of population-based health registry services (e.g. National HPV Vaccination Program Register for the Commonwealth Department of Health and the Victorian and South Australian Cervical Screening Registries).

The project/research management and data custodianship of the Registry will occur at Jean Hailes for Women’s Health. Investigators will be able to access, through unique log-ins and secure two-factor authentication, relevant views of the NECST Registry online (as per defined user roles which only allow entering of data or updating of records and viewing of database reports of direct relevance to that clinician/investigator/their service).

For more information on the VCS Foundation, please visit https://www.vcs.org.au/