Organisational impact and patient management models for biomarker integration in multiple sclerosis care in Italy: the 0Tolerance project

Background Despite advances in multiple sclerosis (MS) management, the need for more accurate biomarkers remains critical. Conventional MRI, while essential for diagnosis, prognosis and disease monitoring, has limitations in capturing the full complexity of disease progression. This paper aims to identify biomarkers likely to be available in clinical practice by 2028, define a prospective organisational follow-up model for patients with MS, explore organisational requirements and propose solutions to facilitate their implementation. These insights aim to inform and anticipate future discussions among policymakers regarding the adoption of prospective biomarkers into clinical practice. Methods A multimethod qualitative design was employed, including a systematic literature review of 82 studies, two modified Delphi consensus processes and semistructured interviews with nine neurologists and three healthcare programming experts, applying the Structural, Technological, Organisational and Professional (STOP) framework. The STOP framework was used to assess structural, technological, organisational and professional requirements and to explore solutions. Results The research identified a prospective organisational follow-up model that integrates the most probable prospective biomarkers into clinical practice. The prospective organisational follow-up model defined an optimal testing frequency of Serum Neurofilament Light Chain and Glial Fibrillar Acidic Protein every 6 months, as well as Cognitive Tests and Optical Coherence Tomography every 12 months. Combining biomarkers and aligning them with MRI was seen as beneficial. Despite the validation of the model through a modified Delphi consensus process based on organisational feasibility and economic sustainability, structural and organisational challenges need to be addressed to ensure smoother integration into clinical practice. Conclusions This article aims to define an organisational model for the integration of prospective biomarkers into clinical follow-up in MS. It also explores potential strategies to facilitate their transition from research settings to routine clinical practice. The proposed approach provides a framework with potential for replication across various care pathways.