Outcome Domain and Measurement Instrument Reporting in Randomized Controlled Trials of Interventions for Lumbar Spinal Stenosis: A Systematic Review

OBJECTIVE: To describe outcome measurement instruments and outcome domains in randomized controlled trials of any interventions for lumbar spinal stenosis (LSS). U DESIGN: Systematic review. LITERATURE SEARCH: The Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed were searched from inception to May 2020. STUDY SELECTION CRITERIA: Trials were eligible if patients were diagnosed with LSS, with or without neurogenic claudication. Trials were eligible if they used at least 1 outcome measurement instrument. DATA SYNTHESIS: Measurement instruments used in trials were extracted and then classified into outcome domains. We described the frequency of measurement instruments and outcome domains. RESULTS: After study screening, 29 trials were included. In total, 54 different individual outcome measurement instruments were used. The Visual Analogue Scale (59%; n = 17) and the Oswestry Disability Index (52%; n = 15) were the most frequently used outcome measurement instruments in trials; function (90%; n = 26) and pain (62%; n = 18) were the most common outcome domains. CONCLUSION: In total, 54 different measurement instruments were used in trials of interventions for LSS. This diverse range of observations contributes to outcome instrument heterogeneity between trials and impedes the analysis of data due to lack of comparability. The most common outcome domains assessed were pain and function, which will help inform a core outcome measure set for symptomatic LSS.

Automated summary

This systematic review examined outcome measurement instruments and domains in randomized controlled trials of interventions for lumbar spinal stenosis (LSS). In total, 29 trials using 54 different measurement instruments were included. The Visual Analogue Scale and the Oswestry Disability Index were the most frequently used instruments, while function and pain were the most common outcome domains. The diverse range of measurement instruments used in these trials contributes to heterogeneity in outcome assessment and poses challenges for data analysis. However, the identification of common outcome domains can inform the development of a core outcome measure set for symptomatic LSS.