Comparison of Surgical and Nonsurgical Options for Management of Chronic Nonspecific Low Back Pain - Cycle 1 2017

Reopened PCORI Funding Announcement

Research Initiative Highlights

The Patient-Centered Outcomes Research Institute (PCORI) seeks to fund one or more randomized clinical trials (RCTs) that will compare the effectiveness of surgical and nonsurgical interventions for the management of chronic nonspecific low back pain in adults. In particular, the goal of this announcement is to support patient-centered CER that addresses questions about the effectiveness of lumbar fusion versus optimized, multidisciplinary nonsurgical approaches. RCTs proposed under this funding announcement should carefully account for the risk of selection bias that may occur in such trials and have sufficient sample sizes to address the priority research question adequately, including in subgroups of interest (i.e., heterogeneity of treatment effects). The trials should generate information that is readily generalizable to the broader population. PCORI is interested in studies with no greater than a five-year study period, which should include a two-year post-intervention follow-up.

Background

PCORI’s mission is to improve the quality and relevance of evidence available for decision making. Better evidence aids patients, caregivers, clinicians, employers, insurers, and policy makers to make informed health decisions. Specifically, we fund CER and work that will improve the methods used to conduct such studies.

PCORI relies on input from multiple stakeholders to set its research priorities. Members of its advisory panels include patients, clinicians, researchers, purchasers, payers, industry, and other healthcare stakeholders. Stakeholders identified the management of chronic nonspecific low back pain as an important topic, which PCORI’s Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options then ranked as a high priority. PCORI then convened two large multi-stakeholder workshops (June 2015 and January 2016) to help identify and refine the specific CER questions related to low back pain that should be answered by PCORI-funded research. Through these stakeholder engagement efforts and discussions with PCORI’s Science Oversight Committee as part of our topic prioritization pathway, the topic was narrowed to focus on the particular CER research question described above. PCORI’s Board of Governors approved this topic on March 22, 2016, for a targeted funding initiative.

A preannouncement of this PCORI Funding Announcement (PFA) was provided to encourage research institutions or consortiums of institutions with expertise in clinical comparative effectiveness research (CER)/patient-centered outcomes research (PCOR) and in clinical research related to chronic nonspecific low back pain to consider applying for this PFA. A similar PFA on this topic was released in 2016, and this PFA was reopened in January 2017. The reopening of this targeted funding announcement reflects the significant policy importance and the crucial need for evidence regarding the comparative effectiveness of different treatment strategies for patients with chronic low back pain.