Developing and Testing a Comparative Effectiveness Methodology for Alternative Treatments of Low Back Pain

Abstract

This paper describes and tests a largely ignored but important preliminary step for comparative effectiveness research: retrospective evidence syntheses to first establish a knowledge base of condition-based medical conditions. By aggregating and organizing what is already known about a treatment or system, gaps in knowledge can be identified and future research designed to meet those gaps.An information synthesis process may also discover that few knowledge gaps in the knowledge base yet exist, the gaps are negligible, and / or treatment effectiveness and study quality is stable across many years, but is simply not clinically important. A consistent finding of low effectiveness is evidence against more research, including exclusion of a treatment from future comparative effectiveness studies. Though proponents of weak treatments or systems may choose to proceed with further research, use of public funds or resources that eventually increase costs to the public are unwarranted.By first establishing a treatment or system knowledge base, at least three comparative effectiveness research decisions are conceivable: (1) treatment or system should be included in future comparative effectiveness trials to establish relative effectiveness for a given condition, (2) has promise but requires more research in a prospective CER trial, or (3) the treatment is less effective than others for a given condition, making future research unnecessary. Thus, a "retroactive comparative effectiveness research method," rCER, is proposed here to identify which treatments are worth including in future prospective trials and which are known to have small to modest effect sizes and are not worth the time and expense of a closer look.The rCER method herein showed that for non-surgical low back pain any treatments did not improve greatly upon the normal and natural pain trajectory for acute low back pain. Therefore, any advantage in pain reduction by any treatment of acute low back pain over back pain's normal course of resolution without care, is quite small, and as such, the incremental cost for the marginal improvement over no treatment becomes quite large. While the quality of non-surgical low back pain studies over the past 34 years has steadily increased, the effect size has not, leading to the conclusion that future research on non-surgical low back pain treatment is unwarranted.