| Popis: |
Randomized control trials (RCTs) are the gold standard for clinical trials to evaluate effectiveness and safety of interventions. Conducting RCTs, however, is not always feasible, particularly for rare conditions. Real-world data (RWD), including clinical information from Electronic Health Records (EHR), are utilized for similar analyses in retrospective data. The United States Food and Drug Administration are increasingly receptive of accepting such analyses as evidence as long as the studies are designed and conducted robustly. EHR work suffers from a reproducibility crisis due to such factors such as hospital-specific biases, among others. Akin to preregistration of RCTs, devising, detailing, and publishing protocols of RWD before conducting analyses can enhance reproducibility and fidelity of results. In the current work, we release a detailed protocol to assess effectiveness and safety of a cryoablation intervention compared to epidural for pain control in adolescent patients undergoing the Nuss procedure in the retrospective EHRs of a major hospital system. |
