Bias in neuromodulation studies on chronic pain

While bias is an integral part of human behavior, bias in clinical research studies may lead to erroneous study conclusions and potentially negative consequences affecting medical care. Bias may influence multiple stages of clinical research and is remarkably prevalent in industry-sponsored studies. Particularly challenging are neuromodulation studies involving patients with chronic pain, whereby industry sponsorship, physicians' conflicts of interest, and patient factors collide to create a highly complex medium that renders clinical research design and interpretation very intricate. This narrative review aims to explore the various biases that complicate clinical neuromodulation studies on chronic pain and potential bias mitigation strategies.

Recent studies have highlighted the influence of industry sponsorship of clinical research and the various types of bias that may occur in designing studies. Biases within device-related industry-sponsored studies, including neuromodulation, have come to the forefront, as have recommendations put forward by societal workgroups on best practices in designing and implementing clinical neuromodulation studies.

This review critically examines the various forms of bias in clinical research, and in particular in relation to neuromodulation studies with a focus on spinal cord stimulation, and on potential means to mitigate such bias.