Defining substantial clinical benefit for patient-rated outcome tools for shoulder impingement syndrome.

The authors conducted this study in order to define for 2 shoulder outcomes scales the substantial clinical benefit (SCB)-a metric that defines the change amount associated with patient perception of a large meaningful improvement and that can be used to interpret change over time in the outcome score.  74 patients with shoulder impingement syndrome were used for the study.  The interventions used by the researchers consisted of standardised exercise and manual therapy for 6 weeks, and outcome measures completed at first evaluation, discharge, and 6 to 8 weeks after discharge.  The outcome measures used included the Disabilities of the Arm, Shoulder and Hand (DASH), Pennsylvania Shoulder Score (Penn), and a 13-point Global Rating of Change (GROC). Patients were classified as “substantially improved” when they reported “quite a bit better” (11) or greater on the GROC at discharge and again 6 to 8 weeks after discharge. Patients with GROC <11 at discharge or follow-up were classified as “nonsubstantially improved.” The percentage and raw points change in the Penn and DASH that corresponded with patient-rated substantial improvement was determined with receiver operator characteristic (ROC) analyses.

The closing assertions of the authors were that the SCB of 40% for the DASH, and 20% and 21 points for the Penn is representative of significant improvement over 6 weeks of care, which was sustained at 12 weeks. The SCB of 11 points for the DASH is not recommended for use because of poor discrimination. The SCB can be used to enable clinical decision-making and in future clinical trials. Alternative approaches such as the within- and between-group change values can produce different SCB values.

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