Response to Comments on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016;39:392-399.

摘要: We welcome this opportunity to respond the comments (1–3) regarding our study (4). There are a few common themes that we would like clarify. The first theme is around criticism of using “meeting criteria for amputation” instead “amputation event.” It ideal use more final patient outcomes in all research; however, sample size and time needed recruit follow patients sufficient duration observe events often prohibitive. This reason why intermediate markers used many disease areas, including diabetes. In addition, amputations may be an inappropriate outcome small, randomized controlled trials (RCTs) where other factors confound true treatment effect. For example, cultural preferences, psychological trauma, procedure-booking logistics (among factors) frequently override medical advice about whether when limb should amputated. (extrinsic disease) variability precludes actual amputation event as consistent measure unless very large long follow-up times used. impractical prohibitively costly placebo-controlled hyperbaric trials. However, Margolis et al. (5) have done it elegantly different design. multicenter observational cohort with propensity score matching methodology showed no amputation-sparing effect or improved wound healing over 700 treated oxygen therapy (HBOT) matched …