Proposing six criteria to improve reproducibility of "usual care" interventions in back pain trials: a systematic review.

OBJECTIVES

The aim of this study is to determine how usual care is defined in clinical trials for low back pain and the components of care that inform its definition. Six components were proposed and assessed for inclusion: type of practitioner providing care, type of self-management education, addressing physical activity, type of medication, dose of the intervention, and reporting whether care was consistent with current guidelines.

STUDY DESIGN AND SETTING

Systematic review of clinical trials published between January 1993 and June 2020.

RESULTS

One hundred eighty-four studies with 37,989 pooled participants from 11 various settings were included. Only one study provided all six components; 86 (47%) studies provided at least three of six components, the most common being practitioner type, use of self-management education, and addressing physical activity.

CONCLUSION

Most studies had fewer than 50% of the components, limiting reproducibility. There was wide variability in the characterization and number of definition components. Usual care interventions are poorly defined in back pain trials and limit understanding of comparator treatment effect sizes and reproducibility of interventions.