Comparison of Surgical and Nonsurgical Options for Management of Chronic Nonspecific Low Back Pain - Cycle 1 2017
View questions and answers about the Comparison of Surgical and Nonsurgical Options for Management of Chronic Nonspecific Low Back Pain - Cycle 1 2017 PFA.
- How much variation in the non-surgical care is acceptable? Can different study sites use different approaches to non-surgical care? How should applicants approach the issue of fidelity and intensity of the non-surgical care?
- Does PCORI expect the study to have individual randomization of each participant, or could a cluster randomization design be used?
- Should participants be randomized to “lumbar fusion surgery” or to “referral for surgery?”
- Why doesn't this PFA allow comparison of two different surgical interventions? Why doesn’t this PFA allow comparison of two different nonsurgical interventions? Will other PFAs related to this topic be released?
- Lumbar fusion is not recommended for "nonspecific" low back pain—why is this one of the required treatment arms?
- What is meant by “a defined period of standard protocol-driven rehabilitation care before randomization” as discussed in the PFA? How is this different from the comparator arm of the study featuring a multidisciplinary nonsurgical intervention?
- Would retrospective observational study designs be considered responsive in addition to randomized controlled trials (RCTs)? There are several potential advantages over RCTs in some scenarios; for example, when study recruitment may be difficult.
- Where should the study take place?
- What is the minimum recommended sample size for this PFA?
- What does the exclusion for prior surgery for LBP include?
- How is "nonspecific" low back pain being defined?
- Does this PFA support cost-effectiveness analysis?