Barriers to conducting randomised controlled trials: lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT).
The RCT is considered the gold standard for testing a therapeutic intervention. However, the conduct of an RCT is not without numerous obstacles. As illustrated through the recent Horsechestnut and Venous Leg Ulcer Trial (HAVLUT), these barriers can be attributed to randomisation, recruitment, retention, blinding and sampling procedures, and to gate keeping. These obstacles, together with strategies to prevent and overcome them, are detailed throughout this article, and are aimed at ameliorating the future design and conduct of RCTs.
Leach
Matthew J
MJ
University of South Australia, and Royal District Nursing Service, South Australia.
D031319:Aesculus; D015982:Bias; D003152:Community Health Nursing; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy*; D015337:Multicenter Studies as Topic / Q000451:nursing / Q000592:standards*; D018579:Patient Selection; D008517:Phytotherapy / Q000379:methods; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000451:nursing / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012639:Seeds; D014945:Wound Healing / Q000187:drug effects
D010936:Plant Extracts