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Should participants be randomized to “lumbar fusion surgery” or to “referral for surgery?”

PCORI is interested in a study of patients followed in primary care settings for whom a definitive decision about surgery or alternatives has not yet been made. These patients may benefit from lumbar fusion surgery but may also benefit from an optimal non-surgical approach to their care. Some patients who are randomized to the surgical strategy may eventually be deemed unsuitable for surgery after further evaluation, so it is expected that not every patient randomized to surgery will actually undergo lumbar fusion surgery. However, given the study criteria, it is expected that all randomized patients will be “probable candidates” for surgery, given the study parameters as outlined in the PFA. Applicants should specify the patient characteristics and other inclusion criteria that define participants’ eligibility for the proposed study.

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