Process for Consensus Statements on Lumbar Total Disc Replacement
Consensus statements regarding the evidence-base for lumbar total disc replacement, as it pertains to payer decision-making, were developed through a modified-Delphi technique involving 17 spine surgeons and a former payer medical director. The Delphi process involved one round of anonymous survey and one round with a face-to-face meeting. The survey was a 51-item, electronically administered questionnaire to determine level of agreement with proposed statements on the evidence for lumbar total disc replacement and to provide additional diagnosis and management practice information for further deliberations. A subset of the proposed statements was discussed at the face-to-face meeting to identify reasons for disagreement, revise wording, and obtain consensus. The meeting involved presentation of the current evidence base for lumbar total disc replacement, as well as three themed sessions that were moderated by surgeons on the panel. The voting processes during meeting deliberations remained anonymous. Consensus was defined as ≥ 90% agreement. Consensus was reached on 11 statements, divided into themes that focused on patient eligibility and diagnosis, evidence criteria for coverage decisions, clinical evidence, and budgetary implications.