This study has established expert consensus on minimum reporting requirements for clinical studies evaluating Mesenchymal Stem Cells (MSCs) in orthopaedics using Delphi consensus methods.
Interpretation of clinical studies evaluating the use of mesenchymal stem cells (MSCs) for orthopaedic applications is limited by inadequate reporting of scientific details critical to outcome. The need for international consensus on minimum reporting requirements for studies evaluating biologic therapies to treat musculoskeletal injuries was agreed at the American Academy of Orthopaedic Surgeons (AAOS) Biologic Treatments for Orthopaedic Injuries Symposium 2015 and the American Orthopaedic Society for Sports Medicine (AOSSM) Biologics II Think-Tank 2015. This study developed a checklist of minimum reporting requirements for clinical studies evaluating MSCs using Delphi consensus methods.
A working group of four experts, convened at the AAOS Biologic Treatments for Orthopaedic Injuries Symposium 2015 and the AOSSM Biologics II Think-Tank 2015, was made responsible for facilitating the development of a consensus through a modified Delphi process. The working group generated an exhaustive list of items that could be reported by studies evaluating MSCs in orthopaedics through a search of published literature and MSC-related protocols. Twenty-four experts who were invited faculty at these symposia were surveyed three-times using a modified Delphi process to establish a consensus on the inclusion of each item within minimum reporting guidelines. Fifteen (62.5%) experts were from the Americas, seven (29.2%) were from Europe, and two were from (8.3%) Asia. In addition to rating agreement, experts were provided the opportunity to suggest modifications or propose further items. Items not meeting pre-defined criteria were discarded after each survey. For consensus, defined a priori, items were included in the final information set if over 75% of respondents were in agreement, and fewer than 5% disagreed. The final shortlist was compiled into a checklist of statements and checked for feasibility in routine practice. Institutional review board approval was not required because the study did not involve patient or registry data.
Review of all data sources generated 103 items for rating within the round one survey. Items were categorised into 12 groups: study design, recipient details, injury details, intervention, donor, tissue harvest, processing, cell culture, MSC characteristics, delivery, post-operative care and outcomes. In the third round survey 62 individual items achieved consensus with over 75% agreement, with less than 5% of experts in disagreement. A checklist of 25 statements incorporating those items reaching consensus was compiled by the working group.
Discussion And Conclusion
This study has established a consensus on the minimum information that must be reported in clinical studies evaluating MSCs in orthopaedics. This checklist can be used to assist authors in writing reports of clinical studies evaluating MSCs, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. This checklist includes critical scientific variables specific to the study of MSCs and should be used in conjunction with checklists that guide the reporting of universal study design features including CONSORT (Consolidated Standards of Reporting Trials).