BACKGROUND

Randomized controlled trials of surgical and minimally invasive interventions of the skin are common, with at least 326 such trials identified during the period 1995-2012 in just one key journal. Many of these trial reports assess advances in skin cancer surgery and aesthetic procedures. Given the recruitment challenges of randomized procedural trials, many are small, and must be considered in the context of similar trials.  However, an obstacle to systematic reviews and meta-analyses is the lack of uniformity among the outcome measures used.  Non-validated, subjective, outcomes predominate.

IMPROVED was formed to provide investigators in skin surgery with a standard set of outcomes for relevant diseases and conditions.  IMPROVED brings together trialists, methodologists, content experts, patients,clinicians, and other stakeholders to develop core outcome sets and measures that can be incorporated in future clinical trials.