A framework for the development and implementation of open trauma guidelines: A Delphi consensus validation

Introduction: Lower limb open fractures are severe injuries that can lead to long-term sequelae. Clinical guidelines for managing these patients are associated with expedited treatment and better outcomes. However, few countries have implemented guidelines for open lower limb fractures. The aim of this study was to develop and validate a framework for the introduction of clinical guidelines in settings that do not have one at present. Methods: Using the qualitative analysis for the Limitations to the Implementation of Open Trauma Guidelines (LINEAGE) study, a framework proposal was designed. This included 4 clusters of inter-related concepts, including clinician, team, health and cultural factors. To validate this framework a modified Delphi study was devised. The elements of the framework were translated into 12 statements that were compiled in a Delphi questionnaire. A panel of orthopaedic and plastic surgeons was assembled to obtain structured feedback and assess the degree of consensus regarding the framework proposal. Results: Using purposive sampling, 43 clinicians enrolled in an international expert panel, including 20 orthopaedic and 23 plastic surgeons based in countries with no guidelines at present. Following three Delphi rounds, 11 out of the 12 assessed statements achieved the threshold for validation. The single statement that did not reach consensus status was then removed from the framework. Discussion: Frameworks are a well-described aid in implementation science, being able to describe complexity and propose strategies for improvement. We present the first validated framework for the development and implementation of open fracture guidelines.