2017 ISAKOS Biennial Congress Paper #28

 

Minimum Reporting Requirements for Clinical Studies Evaluating Platelet Rich Plasma in Orthopaedics: A Modified Consensus Delphi Study

Iain R. Murray, MRCS, DipSportsMed, PhD, Edinburgh UNITED KINGDOM
Andrew Geeslin, MD, Vail, CO UNITED STATES
Ewan B Goudie, MD, Edinburgh UNITED KINGDOM
Frank A. Petrigliano, MD, Los Angeles, CA UNITED STATES
Robert F. LaPrade, MD, PhD, Chanhassen, MN UNITED STATES

Steadman Philippon Research Institute, Vail, Colorado, UNITED STATES

FDA Status Not Applicable

Summary

This study has established expert consensus on the minimum reporting requirements for clinical studies evaluating platelet rich plasma (PRP) for orthopaedic applications using Delphi consensus methods.

Abstract

Introduction

Clinical studies evaluating the use of platelet rich plasma (PRP) for orthopaedic applications are 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. To encourage improved reporting standards, this study developed a checklist of minimum reporting requirements for clinical studies evaluating PRP using Delphi consensus methods.

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. An exhaustive list of items that could be reported by clinical studies evaluating PRP for orthopaedic applications was generated through a search of published literature and PRP-related protocols by the working group. Twenty-four experts taking part in 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. Seventeen (70.8%) experts were from the Americas, 5 (20.8%) were from Europe, and 2 were from (8.3%) Asia. In addition to rating their agreement, experts were provided the opportunity to suggest modifications or propose further items. Anonymized feedback was provided after each survey. Pre-defined criteria were used to refine the item list after each survey. 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.

Results

Review of all data sources describing the clinical application of PRP generated 93 items for rating within the first round survey. Items were categorized into 12 groups: study design, recipient details, injury details, intervention, whole blood processing, whole blood characteristics, PRP processing, PRP characteristics, activation, delivery, post-operative care and outcome. Twenty-three experts (96%) completed three rounds of surveys as part of the Delphi consensus process. After three rounds of online surveys 59 individual items achieved consensus with over 75% of experts in agreement and fewer than 5% of experts disagreeing. A practical checklist of 23 statements incorporating those items reaching consensus was compiled by the working group.

Discussion And Conclusion

This study has established minimum reporting requirements for clinical studies evaluating PRP in orthopaedics, through an iterative consensus process using an optimal number of subjects for Delphi studies. The resulting checklist can be used to guide authors in writing reports of clinical studies, assist editors and peer reviewers in reviewing manuscripts for publication, and aid readers in the critical appraisal of published articles. This checklist includes critical scientific variables specific to the study of PRP and should be used in conjunction with checklists that guide the reporting of universal study design features including CONSORT (Consolidated Standards of Reporting Trials).