Abstract
Graphical abstract
Abstract
Endometriosis is a common yet under-recognised chronic inflammatory disease, affecting 176 million women, trans and gender diverse people globally. The National Endometriosis Clinical and Scientific Trials (NECST) Registry is a new clinical registry collecting and tracking diagnostic and treatment data and patient-reported outcomes on people with endometriosis. The registry is a research priority action item from the 2018 National Action Plan for Endometriosis and aims to provide large-scale, national and longitudinal population-based data on endometriosis. Working groups (consisting of patients with endometriosis, clinicians and researchers) developing the NECST Registry data dictionary and data collection platform started in 2019. Our data dictionary was developed based on existing and validated questionnaires, tools, meta-data and data cubes – World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project, endometriosis CORE outcomes set, patient-reported outcome measures, the International Statistical Classification of Diseases-10th Revision Australian Modification diagnosis codes and Australian Government datasets: Australian Institute for Health and Welfare (for sociodemographic data), Medicare Benefits Schedule (for medical procedures) and the Pharmaceutical Benefits Scheme (for medical therapies). The resulting NECST Registry is an online, secure cloud-based database, prospectively collecting minimum core clinical and health data across eight patient and clinician modules and longitudinal data tracking disease life course. The NECST Registry has ethics approval (HREC/62508/MonH-2020) and is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000987763).
Lay summary
The National Endometriosis Clinical and Scientific Trials (NECST) Registry is part of a national collaborative project by Australian clinicians, researchers and patient advocates – the NECST Network, an Australian Government initiative. The NECST Registry will be a national resource of participant data, facilitating high-quality research aiming to understand the causes of endometriosis and to improve diagnosis and treatment outcomes and may eventually reduce the burden of disease. Currently, there is limited long-term clinical data about endometriosis and a delay of 7–12 years before a diagnosis of endometriosis is made for some people. In addition, clear care management plans, that are based on high-quality and strong clinical trial studies, are not yet available (despite the available guidelines) due to the lack of understanding of how endometriosis develops or changes during a woman’s lifetime. The NECST Registry will collect and securely store demographic and health-related information from consenting participants, who experience and/or seek management for endometriosis and/or endometriosis-related symptoms or conditions (e.g. adenomyosis).
Introduction
The Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry is a new, cloud-based, modular clinical registry. Recording and tracking diagnostic and treatment data for patients with endometriosis and/or associated conditions (e.g. adenomyosis). This clinical and health information from the registry is capturing patient-reported outcomes for endometriosis and how endometriosis affects people’s lives and is identifying trends in clinical management and potential gaps in health service provision.
The NECST Registry was developed by a collaborative group of clinicians, allied healthcare professionals, researchers and endometriosis patient advocates. It was established as part of the Australian research framework, clinical trials network and data collection infrastructure action items outlined in the National Action Plan for Endometriosis (NAPE) (Commonwealth of Australia (Department of Health), 2018).
National Action Plan for Endometriosis
In 2018, the NAPE was published by the Australian Government following consultation with consumers, clinicians, researchers and policymakers (Commonwealth of Australia (Department of Health) 2018). The NAPE is Australia’s roadmap and blueprint to tackle endometriosis and was the first of its kind under the Commonwealth Health Portfolio (https://www.health.gov.au/resources/publications?search_api_views_fulltext=national+action+plan; accessed 29 August 2022).
Three key priority areas were identified – Awareness and education, Clinical management and care and Research (Commonwealth of Australia (Department of Health) 2018), with a number of action items, supported by objectives and knowledge gaps, were outlined and defined. Alongside this, implementation of any action were to be prioritised and coordinated to ensure any increase in demand for services are able to be met. The establishment of the NECST Network falls under the Research priority.
Endometriosis prevalence
Endometriosis is a common yet under-recognised chronic inflammatory disease (Giudice 2010, As-Sanie et al. 2019). It is estimated that by the age of 44, one in nine Australian women, trans and gender diverse (TGD) people, equating to 830,000, are diagnosed with endometriosis (Rowlands et al. 2021). Globally, it is estimated that endometriosis affects 176 million women and TGD people (Adamson et al. 2010a ). The delay in diagnosis of endometriosis is 6–8 years from symptom onset (Armour et al. 2020, O’Hara et al. 2020) and has decreased from 7 to 12 years approximately 3–5 years ago (Nnoaham et al. 2011, Agarwal et al. 2019). This decrease may be attributed to the rise in education and awareness of this condition and global recognition by governments including Australia, All Party Parliamentary Group on Endometriosis in the UK and European Parliament in France (All Party Parliamentary Group (APPG) on Endometriosis Inquiry Report 2020, Armour et al. 2020, Committee on Women’s Rights and Gender Equality 2021). The diagnosis may involve an invasive laparoscopy to determine disease presence. A clinical diagnosis may also be made based on symptoms and/or imaging scans (via ultrasound or magnetic resonance imaging (MRI)) (Abrão et al. 2007, Agarwal et al. 2019, Armour et al. 2022). Pain and infertility significantly impacting the quality of life are the most common symptoms of endometriosis. Endometriosis has a high individual and societal burden costing an estimated $6.5 billion USD annually (Armour et al. 2019), with poorer quality of life, long-term employment, mental and emotional health and social and sexual relationships (Nnoaham et al. 2011, De Graaff et al. 2013, Armour et al. 2020, Rowlands et al. 2022a). It is documented that those diagnosed with endometriosis experience a physical reduction in quality of life similar to that of cancer patients (Nnoaham et al. 2011).
Debilitating chronic pelvic pain and associated symptoms are the most frequent presentations (approximately 71–87% of patients) (ACOG Committee on Practice Bulletins - Gynecology 2000). Endometriosis is as common as asthma or diabetes but is much less well understood (As-Sanie et al. 2019). Multiple theories of pathogenesis have been described including genetic and environmental factors, retrograde menstruation, coelomic metaplasia, embryonic rests and immune dysregulation (Montgomery et al. 2008, Upson 2020, Lamceva et al. 2023). There is no cure for endometriosis and treatment largely relies on medicines, surgery and/or complementary and allied health practices to manage women’s symptoms. Medical management options are often limited due to their hormonal basis and the impact this has on the menstrual cycle and fertility. Symptomatic treatments for pain include hormonal medications or surgical removal of disease deposits and are currently the primary choices for women with endometriosis. Despite treatments, recurrence of symptoms and disease, which may require additional surgery, is common, occurring in 20–44% of patients up to 10 years (Abbott et al. 2003, Guo, 2009, Bougie et al. 2021).
Clinical guidelines and practice standards provide a baseline for endometriosis care. Current endometriosis guidelines include:
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The Royal Australia and New Zealand College of Obstetrician and Gynaecologists (RANZCOG) Clinical Practice Guideline for the Diagnosis and Management of Endometriosis (2021).
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The Society of Obstetricians and Gynaecologists of Canada Practice Guidelines on Endometriosis: Diagnosis and Management (Leyland et al. 2010).
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The American College of Obstetricians and Gynecologists Practice Bulletin and Committee Opinion on Management of Endometriosis (2010) and Dysmenorrhea and Endometriosis in the Adolescent (2018), respectively.
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The National Institute for Health and Care Excellence (NICE) in the UK, updated (2017) and
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The European Society of Human Reproduction and Embryology (ESHRE) (updated 2022) (Becker et al. 2022).
A common theme observed across all guidelines is that there still remains a paucity of supportive evidence for many of the recommendations made. Inconsistent reporting practices and limited prospective data collection framework for endometriosis may be contributing factors to the limited data. The RANZCOG Clinical Practice Guidelines make a clear recommendation and mandate for detailed surgical documentation and data collection on the appearance and site of endometriosis, in line with the NECST Registry Surgical Module data dictionary (RANZCOG 2021).
Clinical registries
Clinical registries are a collection of organised health data, including outcomes, using observational study methods to collect a defined minimum dataset (Hoque et al. 2017). Registries (condition-, disease- or procedure-specific) can play an important role in monitoring or describing the natural history of disease and determine clinical effectiveness or cost-effectiveness of healthcare products or services and delivery patterns. The objective of registries is to measure or monitor safety and harm, to measure the quality of care and to generate population-level evidence of the impact of treatment and models of service delivery (Hoque et al. 2017, Tan et al. 2019, Gliklich et al. 2020, Parums 2021) (https://www.safetyandquality.gov.au/publications-and-resources/australian-register-clinical-registries; accessed 22 September 2022). They facilitate public health reporting and transparency (e.g. cardiac surgery or assisted reproductive technology treatments) (Bridgewater et al. 2013, Ahern et al. 2017) (https://npesu.unsw.edu.au/data-collection/australian-new-zealand-assisted-reproduction-database-anzard; accessed 14 October 2022). They may provide evidence to improve the healthcare system, for example, the UK National Joint Registry identified specific devices (some metal-on-metal articulations) had higher-than-expected revisions rates, leading to their removal from the UK market (Porter et al. 2022). The Nordic arthroplasty registries collect longitudinal data, ascertaining survival and causes of revisions, with the addition of patient-reported outcomes data. Results are reported back to healthcare professionals providing an overall assessment of the care provided (Porter et al. 2022). Additionally, registries may facilitate clinical trials. For example, The Australian Cystic Fibrosis Data Registry publishes clinical, health-economic, health service utilisation and medication use from trials (Ahern et al. 2018). A well-designed clinical registry may support both retrospective and prospective research – generating research hypotheses and answering important research questions and do this alongside randomised clinical trials (Hoque et al. 2017, Bak et al. 2021).
The NECST Registry
The NAPE has increased research and awareness of endometriosis nationally and worldwide, with the UK (All Party Parliamentary Group (APPG) on Endometriosis Inquiry Report 2020, Scottish Government, 2021, Endometriosis UK 2022), Canada (Wahl et al. 2021, EndoAct Canada 2022) and France (Committee on Women’s Rights and Gender Equality 2021) following in Australia’s example of developing their own national action plans. While the diagnostic delay in Australia has reduced (Armour et al. 2020), the impact on long-term health outcomes for patients (e.g. fertility, maternal, reproductive life, symptom-control and recurrence beyond 5 years) remains largely unknown globally and is a substantial evidence gap that must be addressed (Rowlands et al. 2021, Rowlands et al. 2022b ).
Since 2008, the endometriosis research community has met to define research priorities (Rogers et al. 2009, Rogers et al. 2013, Horne et al. 2017, Rogers et al. 2017); tools to standardise research design in areas of clinical and symptom presentation, phenotype recording and specimen collection (Becker et al. 2014, Fassbender et al. 2014, Rahmioglu et al. 2014, Vitonis et al. 2014). A recent core outcome set to facilitate and enhance comparable data between trials has been published (Hirsch et al. 2016, Duffy et al. 2020).
Internationally, a small number of endometriosis registries exist (search performed on ClinicalTrials.gov for ‘endometriosis’ (condition or disease) and ‘observational – patient registries’ (study type) – the Canadian Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry (EPPIC; https://clinicaltrials.gov/ct2/show/NCT02911090; accessed 25 October 2022) (Yosef et al. 2016, Yong et al. 2018, Arion et al. 2020), the French North-West Inter Regional Female Cohort for Patients with Endometriosis (CIRENDO; https://www.clinicaltrials.gov/ct2/show/NCT02294825; accessed 25 October 2022) (Auber et al. 2011, Rozsnyai et al. 2011, Roman et al. 2013, 2016, 2017, Saavalainen et al. 2016, Darwish et al. 2017, Badescu et al. 2018) and French Quality of Life and Fertility Patients with Deep Surgical Endometriosis: A Prospective Cohort (ENDORAA; https://www.clinicaltrials.gov/ct2/show/NCT03555903; accessed 25 October 2022). The strengths of these registries include substantive numbers, expected long-term follow-up of the cohort and alignment of data instruments to allow pooling of results. Weaknesses of existing registries include the inclusion of only surgical and histopathology-confirmed endometriosis and data from only one clinical site that may limit the external validity due to a high rate of tertiary referrals being assessed and treated.
The aim of the Australian NECST Registry is to provide large-scale population-based data at a national level on endometriosis. Registry data will be systematically and prospectively collected over time with support and funding from the Australian Government.
Objective
To develop a national clinical registry that prospectively collects core, standardised health data from patients with endometriosis-related symptoms, have been diagnosed with endometriosis or a related condition to investigate the long-term patient outcomes, impact, prognosis, causes and treatment of endometriosis and its related symptoms and conditions.
Outcomes
The primary outcome of the NECST Registry is to assess the overall quality of life of endometriosis patients using validated patient-reported outcomes measures (PROMs) tools. Our secondary outcomes are (i) to detect the incidence of other conditions, including adenomyosis, fibroids and symptoms related to endometriosis; (ii) incidence of diagnosis of endometriosis via imaging methods (including ultrasound and/or MRI); (iii) proportion of participants being managed expectantly vs medically vs surgically vs allied health and/or complementary therapies and iv) incidence of adverse events.
Materials and methods
Governance structure
The NECST Registry is driven by patients, clinicians and researchers. A not-for-profit women’s health organisation oversaw the daily activities and registry’s development, with the NECST Advisory and Strategic Governance Committees, providing clinical, scientific research and registry oversight. The next phase of management and development will be managed and overseen by a university organisation.
Data dictionary and minimum dataset
The NECST Registry was developed sequentially: (i) drafting of the data dictionary, (ii) formation of seven working groups (one for each module), with subject matter experts to revise and refine the data dictionary, (iii) a nationwide workshop presenting the data to the wider endometriosis community and key external stakeholders, (iv) commissioning IT developers to build the cloud-based NECST Registry platform, (v) content experts and IT developers defining the technical and functional requirements of each registry module and (vi) extensive user acceptance testing of the registry platform prior to live launch of the registry (Fig. 1).
The chronological set of events in the design and development of the NECST Registry data dictionary and hosting platform.
Citation: Reproduction and Fertility 4, 2; 10.1530/RAF-23-0014
To enable sustainability and compatibility, essential data items (minimum core dataset) were defined (Table 1) and aligned with national and international datasets, such as the World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonisation Project (EPHect) (Becker et al. 2014, Fassbender et al. 2014, Rahmioglu et al. 2014, Vitonis et al. 2014) and endometriosis CORE outcomes set for research (Hirsch et al. 2016, Duffy et al. 2020). Data monitoring and quality assurance plans are in place with regular review between the data custodian and NECST Governance Committees, in accordance with the Australia’s Framework for Clinical Quality Registries (Australian Commission on Safety and Quality in Health Care 2014).
NECST Registry data modules and variables.
| Module | General variables |
|---|---|
| Patient | |
| Demographics | Name, DOB, Medicare number, gender, residency location, country of birth, language(s) spoken, indigenous status, education level, employment status, marital status, BMI, smoking and alcohol status |
| Clinical presentation and medical history | Presenting symptom(s) (primary and secondary), menstrual symptoms, pain history and symptoms, endometriosis history, reproductive and obstetric history, medication history, general medical history |
| PROMs – EQ-5D-5L | Mobility, self-care, usual activities, pain/discomfort, anxiety/depression, self-rated health |
| PROMs – EHP-30 | Pain, control and powerlessness, social support, emotional well-being, self-image Optional modules: Work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, feelings about infertility |
| Clinician | |
| Diagnosis | Clinical diagnosis (primary and secondary), LMP, hormonal treatment |
| Imaging (US/MRI) | Date of imaging assessment, Specialist imaging service, referrer type, reason for imaging assessment, imaging finding(s) (primary and secondary), ultrasound assessment (bowel prep, uterus position, myometrium and junctional zone, fibroids, adenomyosis, endometrium, ovaries and adnexa, bladder and anterior compartment, posterior compartment, sliding sign, others) |
| Medical management (including list of medications) | Date of consultation, LMP, presenting symptom(s) (primary and secondary), principal diagnosis (primary and secondary), medications (hormonal, pain, other), allied and complementary therapies, adverse/side effects, reason for using, reason for ceasing/stopping |
| Surgical management | Date of surgery, LMP, surgeon category, assisting surgeon, other specialist, presenting symptom(s) (primary and secondary), principal diagnosis (primary and secondary), surgical summary (primary and secondary surgical diagnoses, primary and secondary surgical procedure(s), complication(s)), endometriosis summary (location, excised/removed, residual disease, photo, sample collected, reason for residual, method of removal, EFI scoring), date of discharge |
| Histopathology | Date of surgery, primary and secondary finding(s) |
| Environmental and lifestyle risk factors | Demographics, residential information, occupation, family history, ancestry, medical history, medication history, family medical history, menstruation and pregnancy, lifestyle, physical activity, diet, hazard exposure |
BMI, body mass index; DOB, date of birth; EFI, Endometriosis Fertility Index; EHP-30, Endometriosis Health Profile-30; EQ-5D-5L, Euroqol-5D-5L; LMP, last menstrual period; MRI, magnetic resonance imaging; PROMs, patient-reported outcome measures; US, ultrasound.
The data dictionary outlines the ‘data spine’ to which additional items may be added for time-limited collection or permanent collection depending on outcome measures and approvals by the NECST Governance Committees. Existing patient questionnaires, validated PROMs tools, meta-data and data cubes were used to develop the first draft of the data dictionary. The reasons for using existing data items were to avoid duplication of data collection, aligning with existing data collections with a future view to undertake data linkage studies and national or international research collaborations, to ensure data comparisons/analyses were utilising an identical set of ‘epidemiologically sound’ data.
The WERF EPHect is a collection of standardised phenotypic data compilation and biological sample collection and storage tools (Becker et al. 2014, Fassbender et al. 2014, Rahmioglu et al. 2014, Vitonis et al. 2014). The objective of these collection tools is to facilitate large-scale international, multicentre trials with robust data and advance endometriosis research (Casper 2014). We used these tools to inform the development of our Clinical Presentation and Medical History, Medical Management and Surgical Management modules. Additionally, the Endometriosis Fertility Index, which incorporates the revised American Fertility Society/American Society for Reproductive Medicine endometriosis classification, is used to capture endometriosis staging and predict pregnancy rates (Adamson et al. 2010b) and is part of our Surgical Management module.
The World Health Organization International Statistical Classification of Diseases (ICD)-10th Revision Australian Modification was used to define diagnostic health information (including symptoms) captured in the Clinical Presentation and Medical History module and all the clinician modules. ICD codes are used globally and provide knowledge on the extent, cause and consequence of human disease. It forms the main basis for health recording and statistics of disease across all levels of the healthcare system; with the data supporting payment systems, service planning, quality and safety assessments and health services research, offering standardisation of diagnostic data collection, enabling large-scale research (Harrison et al. 2021).
Existing Australian Government datasets, meta-data and data cubes were also used to inform NECST Registry modules. The Australian Institute for Health and Welfare Metadata Online Registry (METEOR) is a collection of metadata standards for statistics and information in a variety of areas including health, Indigenous, housing and homelessness, etc. METEOR was used to define our Demographics and Consent module for sociodemographic data. The Medicare Benefits Schedule (MBS) is a listing of all the services subsidised by the Australian Government. MBS item numbers are used to inform the coding of surgical procedures in the Surgical Management module. Both the Australian Register of Therapeutic Goods, a public database of all the legal therapeutic goods supplied in Australia, and the Pharmaceutical Benefits Scheme (PBS), details of Australian subsidised medicines, are used to inform the coding of medicines or therapies in the Medical Management module.
Incorporated are two validated PROMs as part of the NECST Registry patient modules. These questionnaires allow patients to report on outcomes relating to their health and focus on varying aspects of health (such as symptoms), daily functioning and quality of life (Hutchings & Alrubaiy 2017, Haugstvedt et al. 2019). Use of PROMs on more than two occasions allows comparisons over a period of time (van der Willik et al. 2021). For the NECST Registry, a generic PROM, which measures aspects of health common to most patients and suitable for use across several patient populations, was selected. This was the Euroqol-5D-5L (EQ-5D-5L), which assesses the quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The generated health-state profile from respondents can be converted to an index value (reflecting how good or bad a health state is for the general population of a country/region), and this index value facilitates health economic analyses, informed by the calculation of quality-adjusted life years (EuroQol Research Foundation 2019). It also consists of the addition of a visual analogue scale which records the patient’s self-rated health on a vertical scale (Janssen et al. 2013, Stolk et al. 2019).
A validated, condition-specific PROMs, the Endometriosis Health Profile (EHP)-30, was also selected and is the only PROMs currently available that assesses the impact on quality of life for those living with endometriosis (Jones et al. 2004, Jones et al. 2006). The EHP-30 is a 30-item instrument (a short form, EHP-5, also exists), which covers the areas of pain (11 items), control and powerlessness (6 items), social support (4 items), emotional well-being (6 items) and self-image (3 items). In addition to the 30 core items, we also use the six instrument supplementary modules, and these cover the areas of work (5 items), relationship with child/children (2 items), sexual relationship (5 items), feelings about medical profession (4 items), feelings about treatment (3 items) and feelings about infertility (4 items).
The resulting eight modules make up the NECST Registry and are split into patient and clinician modules (Fig. 2). One of the objectives of the NECST Registry is to understand the life course and impact of endometriosis. For this reason, a shortened version of the Clinical Presentation and Medical History questionnaire was developed. This in addition to both PROMs – the EQ-5D-5L and EHP-30 are automatically sent to consenting participants to complete at 6 months, 12 months and annually as follow-up. The NECST Registry data dictionary is provided in the Supplementary materials (see section on supplementary materials given at the end of this article). Currently, the NECST Registry is only available in English.
Patient and clinician modules of the NECST Registry. EHP-30, Endometriosis Health Profile-30; EQ-5D-5L, Euroqol-5D-5L; MRI, magnetic resonance imaging; NECST, National Endometriosis Clinical and Scientific Trials; PROMs, patient-reported outcome measures; US, ultrasound.
Citation: Reproduction and Fertility 4, 2; 10.1530/RAF-23-0014
Patient and public involvement
Integral to the registry are the experiences and outcomes of individuals with endometriosis and their families, partners and carers. To achieve these formalised partnerships with major endometriosis consumer and advocacy organisations in Australia were entered. The result is the NECST Registry has been endorsed by Australia’s leading endometriosis consumer and advocacy organisations, these include Endometriosis Australia, EndoActive Australia and New Zealand, EndoHelp, EndoSupport SA, Endometriosis Western Australia, Epworth Endometriosis Support Group, Pelvic Pain Foundation of Australia and QENDO. Representatives from these key organisations were involved in the review, evaluation and testing of the data dictionary and data capture platform.
NECST Registry data capture platforms
Our patient modules questionnaire data are collected using the Research Electronic Data Capture (REDCap) electronic data capture tool (Harris et al. 2009, Harris et al. 2019). REDCap is a secure, web-based software platform designed to support data capture for research studies. Participant responses are then automatically uploaded onto the NECST Registry, built on the digital health management system, canSCREEN™.
The clinician modules of the NECST Registry are built on canSCREEN™, a secure, cloud-based online web platform and take approximately 10 min to complete. Best practice security measures are embedded in the architecture. Features of the system include role-based user privileges with only authorised users able to access participant records, multilevel authentication of users, encryption of all data at rest and in flight, and a full audit trail of all registry activity. All system users are required to sign an agreement acknowledging the confidential nature of the data held on the registry.
All aspects of the design and development of the data capture platforms of the NECST Registry were in consultation with all relevant end-users – clinicians, allied health professionals, researchers and patients. Multiple workshops with online presentations of the platforms, end-user testing and re-testing were conducted prior to the NECST Registry going live in December 2020.
Participant recruitment and eligibility criteria
Participants are recruited by several complementary methods: invitation by researchers and clinicians at sites (including hospital and private clinics) involved in the NECST Registry, patient advocates and not-for-profit organisations (i.e. EndoActive Australia and New Zealand, Endometriosis Australia, EndoHelp, Endo Support SA, Jean Hailes for Women’s Health, QENDO) and through social media (LinkedIn, Facebook, Instagram, Twitter, etc.).
Site representatives, clinicians and/or research team members have the responsibility to assess the eligibility of patients for the registry. The NECST Registry uses an opt-in recruitment method, with participants invited to register and complete the patient questionnaires (approximately 30–40 min to complete). Participants can withdraw from the registry at any time either by requesting to be fully removed from the NECST Registry or requesting no further contact. Figure 3 illustrates the NECST Registry recruitment and data capture pathways.
Participant recruitment and NECST Registry data entry process. NECST, National Endometriosis Clinical and Scientific Trials.
Citation: Reproduction and Fertility 4, 2; 10.1530/RAF-23-0014
Eligible participants are women, TGD people and people assigned female at birth, aged 18 years and over, experiencing endometriosis-related symptoms (such as persistent pelvic pain, problems with fertility, excessive menstrual bleeding or bleeding between periods, heavy periods, dysuria, dyschezia, dyspareunia, etc.) or have been diagnosed with endometriosis or a related condition (e.g. adenomyosis).
The NECST Registry went live in December 2020 and has been piloted at sites in New South Wales to test the registry infrastructure. This has been expanded to new sites across five Australian states and recruitment via social media. The next phase of development of the NECST Registry will involve analysing and assessing data collection trends (e.g. completion rates, missing data, etc.) to further refine and amend our recruitment strategies, participant questionnaires and modules.
Ethical approval
The NECST Registry has received National Mutual Acceptance (NMA) ethics approval from Monash Health Human Research Ethics Committee (HREC), NMA HREC Reference Number: HREC/62508/MonH-2020. The NECST Registry has received Services Australia approval (to extract data on government-subsided health services and medicines) from consenting participants, approval reference number: RMS1246.
Study registration
The NECST Registry has been registered with i) the Australian New Zealand Clinical Trials Registry, registration number: ACTRN12622000987763 (https://www.anzctr.org.au/), ii) the Australian Register of Clinical Registries (Australian Commission on Safety and Quality in Health Care, ACSQHC), registry ID: ACSQHC-ACRC-149 (https://www.safetyandquality.gov.au/publications-and-resources/australian-register-clinical-registries) and iii) WERF EPHect (https://endometriosisfoundation.org/centres-using-ephect-tools/).
Reporting and dissemination of results
The investigators will submit an Annual Progress Report to ethics and funding organisations in accordance with local policies. Findings utilising NECST Registry data will be published in peer-reviewed journals and disseminated at national and international conferences.
The purpose of the NECST Registry is to quantify and determine variations and improve on the outcomes for those with endometriosis across the Australian healthcare system. As the NECST Network and Registry moves towards the next phase of development, initial data captured of the first 1000 participants will be analysed to assess the quality of the data captured, missing data and review of the data dictionary, amending data elements collected as necessary. Requests to access NECST Registry data by external research groups are reviewed and assessed by the Governance Committees on a case-by-case basis.
In time, it is expected that the potential of the NECST Registry will be increased, as comparisons may be drawn to identify variations across high vs low volume sites, urban vs regional vs rural sites, clinical vs imaging vs surgical diagnosis, impact of endometriosis during the fertile vs menopause period and other comparisons. High-volume, public tertiary hospitals and clinicians have been recruited first to provide solid evidence of ‘best practice’ and what may be realistically achievable. It is the hope that the registry will provide evidence to improve care locally, nationally and globally.
Discussion
Establishment of the NECST Registry responds to the action item under the Research priority area of Australia’s National Action Plan for Endometriosis. With development driven by collaboration between clinicians, allied healthcare professionals, research and endometriosis patient advocates, ensuring that the data dictionary was defined based on existing and validated questionnaires, tools, meta-data and data cubes aligning with national and international guidelines and standards. Data analyses from data collected at pilot sites will provide valuable insights into the ability of the NECST Registry to capture supportive population-level data on patterns of care and impact on quality of life from patients diagnosed with endometriosis. Gynaecologists and other clinical specialities are integral to the management of endometriosis and its associated conditions. Their engagement and expertise are vital to the future and success of the NECST Registry. The NECST Registry is a valuable resource and research infrastructure, collecting prospective longitudinal data to assess the current standard of care, identifying any variation that may exist and how this is impacting on patient outcomes.
Supplementary materials
This is linked to the online version of the paper at https://doi.org/10.1530/RAF-23-0014.
Declaration of interest
CN reports grant funding from Medical Research Future Fund (MRFF) and other financial or non-financial interests with CSL Vifor as a previous employee (formerly Vifor Pharma Pty. Ltd.; past employee). GDM reports grant funding from NHMRC. PR reports grant funding from MRFF; Participation on a Data Safety Monitoring Board or Advisory Board with Bayer; Leadership or fiduciary role in other board, society, committee or advocacy group with Jean Hailes for Women’s Health (Board Member); and other financial or non-financial interests with University of Melbourne and Royal Women’s Hospital (employee). JA reports grant funding from MRFF; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Hologic Australia; Participation on a Data Safety Monitoring Board or Advisory Board with Hologic Australia and CSL Vifor (formerly Vifor Pharma Pty. Ltd.); Leadership roles with the Australasian Gynaecological Endoscopy & Surgery Society (AGES; Past president), Heavy Menstrual Bleeding Clinical Care Standards 2017 and 2023 (Australian Government; Co-Chair), Expert Endometriosis Working Group and Endometriosis Clinical Guidelines Group (RANZCOG, Chair); Endometriosis Australia (Former Chair, 2021–2022 (Associate Editor). The other authors have no conflicts of interest to declare.
Funding
This work is supported by the Australian Commonwealth Department of Health’s Medical Research Future Fund (MRFF), under the Accelerated Research Program grant number EPDCD000020.
Data availability
Deidentified data from the NECST Registry for research projects may be available upon request and approval of the responsible authorities at the NECST Network.
Author contribution statement
CN prepared the initial drafts of the protocol and data dictionary for this project with input from the authored clinicians and researchers. JA supervised all aspects of the development and implementation of the NECST Registry. CN prepared the draft of this paper and was critically revised with input from all the listed authors AM, GDM, GM, PR and JA. All authors have read and approved the manuscript.
Acknowledgements
The authors would like to acknowledge the NECST Registry Working Group Members, Mrs Janet Michelmore AO from Jean Hailes for Women’s Health, Ms Donna Ciccia from Endometriosis Australia, Ms Meg Thomson endometriosis patient representative, Dr Rebecca O’Hara from the Robinson Research Institute, Ms Rowena Gibson from Sydney Ultrasound Care, and Mr David Lloyd and Dr Rachel Mudge for their contribution to establishing the NECST Registry.
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