Compared to what? An analysis of comparators in trials informing the National Institute of Clinical Excellence (NICE) low back pain guideline

Abstract

BACKGROUND: Low back pain (LBP) is the leading cause of disability globally. Clinical practice guidelines (CPGs) have been developed in hopes of encouraging evidence-based care for LBP. However, poor quality of trials that underpin CPGs can lead to misleading recommendations for LBP. OBJECTIVES: To categorize the comparator used in trials included in the National Institute of Clinical Excellence (NICE) LBP CPG and describe the proportion and association of suboptimal comparators with NICE recommendation. METHODS: We conducted a cross-sectional analysis to describe the proportion of trials included in the NICE LBP CPG that used a suboptimal comparator. If comparators used an ineffective treatment, a treatment of unknown effectiveness, or no or minimal treatment then they were considered suboptimal. RESULTS: We included 408 trials and analyzed 580 comparators used in the trials. 30.9% of the comparators used in the trials were suboptimal. Trials testing invasive treatments (32.4%) had the highest proportion of suboptimal comparators followed by non-surgical (32.3%) and pharmacological (19.0%) treatments. Trials using suboptimal treatments were less likely to have their treatment recommended (odds ratio: 0.68; 95% CI: 0.47, 0.98) for use by NICE. CONCLUSION: There is a concerning proportion of suboptimal comparators used in LBP trials that may be misleading CPG recommendations, funding allocation decisions, and ultimately clinical practice. Efforts to increase the use of optimal comparators in LBP trials are urgently needed to better understand what treatments should be recommended.