The smallest worthwhile effect on pain and function for rotator cuff repair surgery: a benefit-harm trade-off study

Area of Science:

• Orthopedics
• Patient-Reported Outcomes
• Clinical Trial Design

Background:

• The smallest worthwhile effect (SWE) defines the minimum patient-perceived benefit for an intervention to be considered worthwhile.
• Estimating the SWE for rotator cuff repair is crucial for understanding patient expectations and optimizing treatment decisions.

Purpose of the Study:

• To estimate the smallest worthwhile effect (SWE) for rotator cuff repair surgery.
• To compare the SWE of rotator cuff repair against decompression/debridement alone and non-surgical treatment for shoulder pain.

Main Methods:

• A benefit-harm trade-off study involving adults aged 45-75 with chronic shoulder pain (intensity ≥ 4/10).
• Participants completed an online survey to determine the SWE for rotator cuff repair compared to alternative treatments.
• Univariable linear regression analyzed associations between baseline characteristics and SWE.

Main Results:

• The SWE for rotator cuff repair was a median 40% improvement in pain and function compared to both decompression/debridement alone and non-surgical treatment.
• On the WORC Index, this equates to a 28/100 point improvement, higher than established minimum clinically important differences.
• Female sex was associated with larger SWEs.

Conclusions:

• The SWE for rotator cuff repair is substantial, indicating patients require greater benefit than previously defined minimum clinically important differences.
• These findings can inform the design and interpretation of clinical trials for shoulder pain interventions.