Statistical Design and Reporting of Randomised Controlled Trials for Raynaud’s Phenomenon

Randomised controlled trials (RCTs) represent our most credible method for identifying safe, effective treatments for Raynaud’s phenomenon (RP), provided that they are designed and analysed in an appropriate fashion. We describe some important design and analysis considerations relating to RCTs for RP, including choice of outcome measure, seasonality, and heterogeneity of the conditions. We address some persistent misunderstandings around RCTs including concerns relating to imbalance in participant characteristics, the concept of placebo response, and our capacity to learn who will benefit from a particular treatment.