Original Research and Clinical Studies
摘要
This chapter provides a structured, practice-oriented framework for the design, conduct, analysis, and reporting of clinical research in maxillofacial surgery. Ethical imperatives, translational pathways, and methodological standards are integrated to align surgical innovation with reliable evidence. The content addresses staged development and evaluation of complex interventions, appropriate selection between randomized trials and observational emulations of a target trial, and practical considerations such as eligibility, consent, outcome standardization, imaging, digital workflows, and comprehensive documentation of harms. The statistical section highlights estimands, sample size and power planning, precision-oriented analyses, strategies for managing missing data, and contemporary approaches to clustering, survival analysis, and adaptive trial designs. Recommendations for writing and reporting follow IMRaD conventions alongside CONSORT/CONSORT-NPT, SPIRIT, and STROBE guidelines to support reproducible manuscripts and cumulative science. The chapter concludes with approaches to translating evidence into practice through pragmatic trial designs, structured implementation strategies, and attention to external validity and service readiness.