Real-world evidence in lumbar degenerative disease: from data to decision

Abstract

Degenerative lumbar spine diseases, including disc herniation, spinal stenosis and spondylolisthesis, represent a major cause of disability worldwide. Low back pain (LBP) is the leading cause of years lived with disability (YLD), affecting up to 84% of the population during their lifetime and creating a significant socioeconomic burden. Despite the availability of multiple treatment options, ranging from conservative management to invasive surgical interventions, selecting the optimal treatment pathway for individual patients remains challenging. Traditional randomized controlled trials (RCTs) provide evidence on treatment efficacy but often include highly selected populations that do not reflect the diversity of real-world clinical practice. As a result, their findings have limited external validity when applied to heterogeneous patients commonly seen in neurosurgical clinics. Real-world evidence (RWE) has emerged as a complementary approach, integrating routinely collected clinical and patient-reported data to improve decision-making and optimize personalized care pathways. The primary objective of this doctoral project was to develop and evaluate a comprehensive framework for collecting and analysing real-world evidence in patients with lumbar degenerative disease. We aimed to identify meaningful patient subgroups that could benefit from tailored treatment strategies by prospectively collecting multidimensional patient-reported outcome measures (PROMs). A digital patient-driven platform, the Back-App®, was developed to facilitate data collection, allowing patients to report symptoms, disability, quality of life and psychological characteristics during routine consultations. This platform was successfully implemented in three Belgian spine centers and provided a foundation for longitudinal, multicenter research. This thesis explored patient outcomes following both non-invasive and surgical interventions. A retrospective study of 959 patients who underwent lumbar surgery revealed that nearly one-quarter required a secondary operation within 17 years of follow-up. This study was an illustration of the patient pathway over the years, without measuring outcomes. An increasing number of surgeries were associated with significantly lower quality of life. This highlighted the need for improved patient selection and long-term prospective monitoring as the majority of same-level and adjacent level surgery occurred beyond the one-year follow-up period.