To use the benefit-harm trade-off method to determine a SWE of motor training on strength for people with SCI.
Face to face interviews were conducted with 40 people with recent SCI who had participated in intensive motor training as part of the SCI-MT Trial. The interviews guided participants through an iterative process via a custom-made computer application using the benefit-harm trade-off method to determine their SWE. Participants were asked to consider the implications of participating in the intensive motor training, as per the SCI-MT trial, and then asked to determine a smallest improvement in TMS, over and above usual care, that justifies the costs, inconveniences and potential harms of the intervention. This was deemed their SWE.
The participants needed a median (IQR) improvement in strength (TMS, points) of 3/100 (1 to 5) points to justify the intensive motor training program as delivered in the SCI-MT trial. The participants’ estimated SWE was independent of their baseline TMS. That is, participants with lower baseline TMS did not need to see greater increases in strength from the intensive motor training intervention than those with larger baseline TMS.
The benefit harm trade off method is a valid and useful way to determine a SWE. People with recent SCI are willing to undertake an intensive motor training programme for small gains in strength.
Defining a SWE is important for RCTs to aide in the interpretation of their results and translation into clinical practice. Future RCTs should consider the addition of the benefit-harm trade-off methodology within the study design to define a threshold of clinical importance. This will enable meaningful interpretation of their results and application to practice.
motor training
clinical importance