Identification of serious adverse events in a large acupuncture trial: Linkage and agreement of primary and secondary data

Background: Large randomized and non-randomized trials in routine care are an important tool to evaluate effectiveness and safety of medical interventions in clinical practice. Complete assessment of serious adverse events (SAEs) is crucial to characterize the safety profile of the drug or intervention under study. We linked data from a large acupuncture trial with hospital claims data to evaluate the agreement of physician-reported SAEs and SAEs identified by using hospital discharge diagnoses. Methods: Patients treated with acupuncture for chronic pain, asthma, allergic rhinitis, or dysmenorrhea within the Acu…