UHMS 20 Randomized Controlled Trials

Описание: #RandomizedControlledTrials #RCTs #HyperbaricOxygenTherapy #HBO #EvidenceBasedMedicine #EBM #ClinicalTrials #Bias #Equipoise #ShamControl #Cochrane #CriticalAppraisal

Despite perceptions of limited evidence, many randomized controlled trials (RCTs) exist for hyperbaric oxygen therapy, though quality varies. RCTs are the gold standard in evidence-based medicine (EBM) for determining causal relationships due to their low potential for bias, specifically selection bias via randomization and confounding. EBM integrates best research evidence, clinical expertise, and patient values, not solely relying on RCTs for all decisions, especially rare conditions.

Evidence hierarchies place systematic reviews of RCTs and well-conducted individual RCTs highest. Distinctions exist between explanatory trials testing efficacy in ideal settings and pragmatic trials assessing effectiveness in real-world practice, crucial for applicability. Ethical challenges like traditional clinical equipoise can hinder research, potentially addressed by concepts like behavioral equipoise.

Appraising RCTs involves assessing internal validity (was the study done right) and external validity (do results apply to my patients). Key elements of good trial conduct include adequate sample size calculation, allocation concealment to protect randomization, and blinding of patients/assessors using sham controls. Hyperbaric shams pose methodological challenges, like minimal pressure or altered gas mixtures. Intention-to-treat analysis is standard for evaluating real-world effectiveness. The Cochrane Collaboration systematically reviews scattered evidence, aiding synthesis. Understanding these principles is vital for evaluating hyperbaric literature.