For priority populations, such as Indigenous children, school-based screening programmes can increase equitable access to care. However, current traditional economic measures evaluating the effectiveness of many screening programmes in Australia do not capture the value perceived by those at the intersection of the benefits, including children and families, communities, health workers and teachers or the differences between Western-Anglo and Indigenous conceptualisations of health. This mixed-methods study aims to develop and validate a Community Reported Outcome Measure (CROM) of school health screening programmes based on concepts of value of health and healthcare and school screening programmes from the perspective of Indigenous peoples. The purpose of the tool is to provide a robustly developed and validated tool to assess the experiences of school health screening programmes from the perspective of Indigenous stakeholders including families, communities, health workers and teachers.

This mixed-methods study will be conducted in three stages in accordance with regulatory and international consensus guidance: (1) concept elicitation to construct a conceptual framework of value in school screening; (2) item generation and mapping to the conceptual framework and (3) a psychometric evaluation of the CROM. Phase 1 concept elicitation: this involves an umbrella review (phase 1.1); yarning circles with communities in New South Wales (phase 1.2); concept integration of the umbrella review and yarning circles data (phase 1.3) and an online e-Delphi study to ensure the framework of value is nationally representative (phase 1.4). Phase 2 item generation and mapping: this involves item generation (phase 2.1) and cognitive testing of the item pool (phase 2.2). Phase 3 psychometric evaluation: this involves field testing (phase 3.1) and assessing the structural validity of the CROM via Rasch analysis (phase 3.2).

This study was reviewed and approved by the Australian Institute of Aboriginal and Torres Strait Islander Studies (Ref: REC-0397) and State Education Research and Partnerships (Ref: SERAP 6500). The results of this study will be presented at relevant academic and non-scientific conferences and meetings and published in high-impact peer-reviewed journals.

The burden of rheumatoid arthritis (RA) is profound, although treated with the treat-to-target strategy for RA patients according to the two most influential organisations for rheumatology worldwide. The need to timely achieve the control of disease activity for RA patients, especially for those difficult-to-treat individuals, is still unmet. Besides, the data on the diagnosis and prognosis of RA-related complications or comorbidities such as sarcopenia, cardiovascular diseases (CVD), malignancies and infections in large real-world cohorts are still limited. Therefore, the aim of this large-scale cohort study is to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications/comorbidities and to evaluate their impact on the prognosis of RA.

In this real-world multicentre prospective cohort, consecutive RA patients are planned to be recruited during 2024 and 2033 and with at least 5-year follow-up. Sociodemographic characteristics collection, clinical assessment, muscle assessment, histopathological assessment, imaging examination and biological samples collection will be performed at baseline, 1st, 3rd, 6th and 12th month during the first year and subsequently every 6 months until 5 years to repeat the assessments and collect the information of interested outcomes. The outcomes of interest include RA disease outcomes (including disease activity, functional and radiographic indicators) and RA-related complications/comorbidities (eg, sarcopenia, CVD, malignancies and specific infection).

Ethical approval has been approved by the Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University (ID: SYSKY-2023-1235-01); the Affiliated Panyu Central Hospital of Guangzhou Medical University (ID: PYRC-2024-214-01); and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (ID: 2024-SSKY-118-01). All study participants sign an informed consent form. Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media.

NCT06233929.