Guidelines of the International Headache Society for Real-World Evidence studies in migraine and cluster headache

Real-world evidence studies are an important tool for investigating the effectiveness, safety and tolerability of treatments for headache disorders in clinical practice. These studies use data generated from routine clinical practice from a variety of sources and can help to identify unmet needs in headache care and guide new therapies, including populations not always included in randomized clinical trials of different ages, comorbidities, and concomitant stable treatments. Real-world evidence pertains to the clinical evidence surrounding the utilization, as well as the potential advantages or drawbacks of treatment, which is extracted through an analysis of real-world data. Real-world evidence studies can present unique challenges, including timing of data collection (prospective vs retrospective), data selection, data quality issues and potential biases (selection, confounding factors, etc.). The International Headache Society has developed these guidelines for optimizing the design and conduct of real-world evidence studies, and therefore the strength and reliability of their output.