A Methodological Framework for Quality-of-life Assessment in Tracheostomy Patients: Evidence-Based Guidance for Research Design

A BSTRACT Background: Tracheostomy significantly impacts patient quality of life (QOL), yet methodological heterogeneity in assessment approaches limits evidence synthesis and clinical application. This methodological framework paper presents evidence-based guidance for QOL assessment in tracheostomy patients. Objectives: To develop a comprehensive methodological framework for QOL assessment, including instrument selection, study design guidance, and implementation protocols for diverse clinical settings. Methods: Three-phase framework development: (1) Systematic literature review of PubMed, Embase, Cochrane Library, and CINAHL (2010–2024); (2) Psychometric appraisal of identified QOL instruments; (3) Expert consensus and synthesis. From 847 identified articles, 156 met inclusion criteria. Results: The framework recommends SF-36 or WHO-QOL BREF as primary instruments, supplemented by disease-specific tools (SGRQ, TQOL) when available. Assessment should begin ≥3 months post-tracheostomy with 3–6-month follow-up intervals. Study design selection should match research questions, with specific guidance for cross-sectional, longitudinal, and interventional designs. Conclusions: This framework provides the first comprehensive, evidence-based guidance for QOL research in tracheostomy patients, addressing methodological gaps and offering practical implementation strategies for diverse healthcare settings including resource-limited environments.