Rationale and Methods of a Surveillance System for Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies: A Qualitative Participatory Action Research Approach in Middle-Income Countries-The Experience in Iran.

BACKGROUND AND AIMS: Hematopoietic Stem Cell Transplantation (HSCT) represents a cornerstone in the therapeutic management of hematological malignancies, aimed at achieving durable remission and enhancing survival. Optimal post-transplant care, however, necessitates access to near-real-time, actionable clinical data. Iran currently lacks a dedicated national surveillance framework for HSCT recipients. This study aims to develop and pilot a comprehensive surveillance system tailored to the complexities of HSCT within the Iranian healthcare context. METHODS: This qualitative Participatory Action Research (PAR) study was conducted at a tertiary HSCT center in Iran (2024-2025). Using purposive sampling, 15 stakeholders (hematologists, nurses, informaticians, and registry experts) with 5 years of experience were recruited. Data comprised 46 iterative, semi-structured interviews (face-to-face and telephone) conducted until data saturation was reached. Thematic analysis with independent double coding and triangulation (methodological, data source, and theoretical triangulation against EBMT/CIBMTR standards) ensured credibility. A pilot phase tested feasibility, followed by iterative refinement based on stakeholder feedback prior to institutional integration. RESULTS: Qualitative synthesis identified three pivotal domains for establishing a national HSCT surveillance system: transplant-specific clinical challenges, systemic barriers to development, and essential implementation phases. Primary impediments included regulatory and policy gaps, acute resource constraints, and technological deficits. Key developmental steps involved the standardization of case definitions, the design of robust data acquisition protocols, and the selection of evidence-based performance indicators. The pilot implementation highlighted critical operational hurdles, such as increased clinician workload and data entry burdens, which subsequently informed the development of tailored technical and structural solutions for the hospital-based rollout. CONCLUSIONS: This study provides a replicable methodological roadmap for establishing standardized HSCT monitoring systems in middle-income countries. By identifying longitudinal data gaps and treatment deficiencies, this framework fosters multi-level collaboration with policymakers and advocates for evidence-based clinical practices to ultimately improve patient outcomes.