Protocol for the development of Polish clinical guidelines for the management of patients with systemic lupus erythematosus.

Abstract

Introduction: Systemic lupus erythematosus (SLE) is a complex, chronic autoimmune disease that causes multi-organ inflammation and damage. Left untreated or inadequately managed, SLE can lead to severe organ dysfunction, disability, and reduced quality of life. In Poland, the absence of standardized, evidence-based clinical guidelines tailored to local resources and practices has created inconsistencies in SLE management. The purpose of these guidelines is to provide clear, evidence-based recommendations for the treatment and management of adult patients with SLE in the Polish healthcare system. These recommendations aim to align clinical practices with international standards, optimize treatment strategies, standardize patient care, and improve health outcomes while guiding healthcare policy.

Material and methods: The adaptation process follows the ADAPTE Collaboration guidelines, the GRADE methodology, and the Evidence to Decision (ETD) framework. An interdisciplinary Working Group (WG), comprising experienced rheumatologists, organ-specific specialists, young rheumatologists, and a patient representative, will develop the guidelines. Key steps will include: 1) creation of clinical questions using the PICO format; 2) systematic search of relevant international guidelines (EULAR, ACR) and national sources; 3) evaluation of identified guidelines using the AGREE II instrument to ensure methodological quality; 4) formulation of recommendations through consensus-based discussions, addressing clinical treatment, monitoring, and care organization.

Scope and implementation: The guidelines cover pharmacological interventions for SLE, including hydroxychloroquine, glucocorticosteroids, immunosuppressive drugs biologics. Specific focus areas include treatment of organ-specific manifestations, management during pregnancy, treatment of disease flares, maintenance therapy, monitoring, and comorbidity management. The finalized document will undergo external review and be published in both Polish (on the Polish Society for Rheumatology website) and English (in the journal Reumatologia) as open access. Implementation strategies will include dissemination through scientific journals, presentations at conferences.

Conclusions: These guidelines aim to provide a standardized framework for SLE management in Poland. By implementing evidence-based recommendations, they will support healthcare providers in improving patient outcomes, optimizing resource allocation, and addressing the unique challenges of SLE within the Polish healthcare system.