Abstract
A criticism of some orthopaedic surgical trials has been that the screening, choice, and application of eligibility criteria to select patients for a study means that many are excluded from the target population. This has been interpreted as limiting the applicability of the findings which may impact on implementation to clinical practice. For orthopaedic surgical trials, the focus has been on how to improve their internal validity. When RCTs are judged for their quality, this does not adequately address external validity. It is orthopaedic research that are published in high impact medical journals that may have the highest visibility and the largest potential for influencing key stake-holders and consequently clinical practice. To address these concerns, and in the context of the wider agenda to improve the under-representation of patients in research, we will conduct a review of orthopaedic surgical RCTs published in high impact journals to examine the selection of patients for recruitment into the trial.
Aim
The aim is to discuss the impact of patient selection for inclusion into orthopaedic surgical RCTs on the applicability of evidence to clinical practice and the implications for the design, conduct and reporting of future RCTs.
Intended Impact of the Study
To improve the quality of design, conduct and reporting of RCTs about the selection of patients into the trial.
Project Lead
Contact Project Author
Keywords
Research Area(s)
Other Areas: Orthopaedic surgical randomised controlled trials
Study Design(s)
Other Designs: Literature review
Data Collection Method(s)
Participant(s)
Other Participants: Individually randomised trials that include an orthopaedic patient population that we define as being about bones or joints will be eligible for inclusion.
Status
Expected completion date: February 8, 2023
Stage
Study Funding/Support
Dissemination Activity/Activities
Other(s): Publish in appropriate journal and at conferences