Evaluating the content validity of the Single Assessment Numeric Evaluation (SANE) in shoulder pathologies

Area of Science:

• Orthopedics
• Patient-Reported Outcomes
• Measurement Science

Background:

• The Single Assessment Numeric Evaluation (SANE) is a patient-reported outcome measure (PROM) for function, but lacks validation for shoulder pathologies.
• Content validity of the SANE for shoulder conditions has not been previously explored.

Purpose of the Study:

• To understand how patients with shoulder conditions interpret the SANE.
• To explore how patients define 'normal' in the context of the SANE.
• To assess the calibration of SANE responses by patients and clinicians.

Main Methods:

• Cognitive interviewing with a talk-aloud protocol.
• Inclusion of patients with rotator cuff disorders (n=10), clinicians (n=6), and measurement researchers (n=10).
• Verbatim transcription and open coding analysis using a framework for interpretation variances.

Main Results:

• The SANE was well-received, perceived as cognitively simple with low response burden.
• Key interpretation variances included Comprehension (20%), Reference Point (20%), Relevance (10%), and Perspective Modifiers (50%).
• Patients defined 'normal' based on current pain, recovery expectations, and pre-injury activity levels.

Conclusions:

• While favored by patients and clinicians, the SANE's interpretation and response calibration are highly variable.
• The construct measured by the SANE may differ across patients with shoulder conditions.
• Further validation is recommended for the SANE in shoulder pathologies.