Abstract
BackgroundThis study aimed to address the current limitations of the use of composite endpoints in orthopaedic trauma research by quantifying the relative importance of clinical outcomes common to orthopaedic trauma patients and use those values to develop a patient-centered composite endpoint weighting technique.MethodsA Best-Worst Scaling choice experiment was administered to 396 adult surgically-treated fracture patients. Respondents were presented with ten choice sets, each consisting of three out of ten plausible clinical outcomes. Hierarchical Bayesian modeling was used to determine the utilities associated with the outcomes.ResultsDeath was the outcome of greatest importance (mean utility = − 8.91), followed by above knee amputation (− 7.66), below knee amputation (− 6.97), severe pain (− 5.90), deep surgical site infection (SSI) (− 5.69), bone healing complications (− 5.20), and moderate pain (− 4.59). Mild pain (− 3.30) and superficial SSI (− 3.29), on the other hand, were the outcomes of least importance to respondents.ConclusionThis study revealed that patients’ relative importance towards clinical outcomes followed a logical gradient, with distinct and quantifiable preferences for each possible component outcome. These findings were incorporated into a novel composite endpoint weighting technique.
Highlights
IntroductionA commonly used definition of a composite endpoint in clinical research is the occurrence of any one of several study events of interest [1]
This study aimed to address the current limitations of the use of composite endpoints in orthopaedic trauma research by quantifying the relative importance of clinical outcomes common to orthopaedic trauma patients and use those values to develop a patient-centered composite endpoint weighting technique
Study design A Best-Worst Scaling experiment was used to determine the relative importance of common clinical outcomes to orthopaedic trauma patients
Summary
A commonly used definition of a composite endpoint in clinical research is the occurrence of any one of several study events of interest [1]. Composite endpoints enable the inclusion of rare, but clinically important, outcomes; providing a broader interpretation of the net clinical benefit of a treatment [1]. Composite endpoints have several limitations [4,5,6,7]. The treatment effect of an outcome of high importance but low frequency, such as death, may be muted by the Composite endpoints are becoming increasingly common in orthopaedic trauma research. The objective of this study was to address the limitations related to the use of composite endpoints in orthopaedic trauma
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