Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials

Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines

“… 43 While not yet required in the STRICTA guidelines, 46 fidelity reporting was added to the updated CONSORT (Consolidated Standards of Reporting Trials) Statement extension (2017) for ‘Nonpharmacologic Treatments’: ‘whether and how’ fidelity or adherence to interventions is assessed or enhanced. 52 There has been movement to assess and report intervention fidelity in some complex interventions that also use manualizations such as behavioral research, 53 , 54 surgery, 55 quality improvement, 56 manual therapies 57 , 58 and mind-body 59 therapies. We propose that assessment of fidelity be added as a STRICTA extension in acupuncture trial reporting.…”