A comprehensive step-by-step approach for the implementation of target trial emulation: Evaluating fluid resuscitation strategies in post-laparoscopic septic shock as an example
Jie Yang, Lihui Wang, Lin Chen, Pengmin Zhou, Suibi Yang, Hongjie Shen, Lifeng Xing, Pengpeng Chen, Yuetian Yu, Hongying Ni, Zhongheng Zhang
Abstract
To develop and demonstrate a comprehensive methodological framework for target trial emulation (TTE) implementation via post-laparoscopic septic shock fluid management as a clinical case study. We designed a simulated study of 10,000 patients in which colloid resuscitation was compared with crystalloid resuscitation. The framework incorporated precise eligibility criteria, standardized intervention protocols, and balanced treatment allocation with temporal anchoring. The primary analyses focused on 28-day mortality and were evaluated through survival analysis and comparative statistics. The methodological framework successfully demonstrated the systematic implementation of TTE principles, providing reproducible protocols for eligibility determination, intervention standardization, and outcome assessment in observational studies. This work bridges the gap between TTE theory and practice by providing a detailed technical roadmap that enhances methodological transparency and reproducibility in comparative effectiveness research.