Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO): Platelet-Rich Plasma and Mesenchymal Stem Cells.

BACKGROUND A comprehensive approach to the evaluation of biologic therapies for musculoskeletal conditions is required to guide appropriate future use. Clinical studies evaluating platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) are limited by inadequate reporting of scientific details critical to outcome. We developed minimum reporting requirements for clinical studies evaluating PRP and MSCs using Delphi consensus methods. METHODS The need for consensus on the minimum reporting requirements for studies evaluating biologics was identified at the American Academy of Orthopaedic Surgeons/Orthopaedic Research Society (AAOS/ORS) Biologic Treatments for Orthopaedic Injuries Symposium in 2015 and the American Orthopaedic Society for Sports Medicine (AOSSM) Biologic Treatments for Sports Injuries II Think Tank in 2015. A working group facilitated the development of 2 expert consensus statements for PRP and MSCs using Delphi techniques. Exhaustive lists of items that could be reported on by clinical studies evaluating PRP or MSCs were generated by searching the published literature and protocols. PRP and MSC expert groups, each made up of 24 invited speakers at the AAOS and AOSSM symposia, were surveyed on 3 occasions to establish consensus on the inclusion of each item within minimum reporting guidelines. In addition to rating their agreement, the experts were encouraged to propose further items or modifications. Predefined criteria were used to refine item lists after each survey. Final lists were compiled into checklist statements by the working group. RESULTS For PRP, the working group identified 93 experimental information items from the literature. Twenty-three experts (96%) completed 3 rounds of surveys. After 3 rounds, 58 items generated consensus with >75% agreement and <5% disagreement. These items were compiled into a 23-statement checklist. For MSCs, 103 items were identified from the published literature. Twenty-three experts (96%) completed 3 rounds of surveys. After 3 rounds, the 61 items for which consensus was reached were compiled into a 25-statement checklist. CONCLUSIONS This study has established expert consensus on the minimum reporting requirements for clinical studies evaluating PRP and MSCs. CLINICAL RELEVANCE These checklists provide specifications for the minimum information that should be reported by clinical studies evaluating PRP or MSCs.