Establishing the Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry: a protocol paper

GRAPHICAL ABSTRACT: [Image: see text] 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).