What we cannot miss in clinical trials on compression therapy

Abstract

BackgroundCompression therapy (CT) is widely prescribed for chronic venous disease (CVD), lymphedema, and lipedema despite robust evidence supporting its effectiveness only in a minority of clinical scenarios.AimProvide an overview of the methodological parameters essential for obtaining a high-quality scientific trial.MethodsThe International Compression Club (ICC) chairman prepared a preliminary list of the main methodological flaws in publications on CT, and a list of parameters to be included in high-quality randomized controlled trials (RCTs). This list was circulated among ICC board members, who provided their comments and suggestions. The document was then presented and discussed at an ICC consensus meeting with various professionals in May 2024 in London. Meeting minutes were distributed to ICC members, and the final document reflecting all additional comments and suggestions was compiled. In summary, the following recommendations represent the consensus of the ICC members.ResultsThe ICC recommends that the following parameters be reported in randomized clinical trials (RCTs): appropriate patient selection, adequate sample size, detailed classification of venous and lymphatic diseases, detailed description of CT modality, adherence to CT, and reasons for non-adherence. Tailored recommendations for specific scenarios and the use of standardized quality-of-life (QoL) tools are emphasized. Despite their value, RCTs face limitations and do not reflect real-world clinical practice. Real-world evidence (RWE) can complement RCTs by providing insights into routine applications, safety, compliance, and cost-effectiveness across diverse patient populations by standardized methodologies, large cohorts, and reliable validated registries to ensure validity.ConclusionsCombining data from RCTs and RWS allows for a comprehensive understanding of CT. RCTs provide evidence of effectiveness in a controlled scenario, while RWE offers real-world perspectives on compliance and economic outcomes in clinical practice. Together, these approaches enable a more holistic evaluation of CT, addressing current gaps in knowledge and guiding its optimal use.

Keywords: compression therapy; methods flaws; randomized control trials; real-world evidence; real-world studies.