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A scale used to assess device benefit through participant experience should fit the concept of interest. Satisfaction, ease of use and health-related function are different concepts. Define the change the investigation seeks to demonstrate before selecting the instrument.
Define the assessment
Examine comprehensibility in the target population, language version, recall period and administration method. Previous use elsewhere does not automatically establish suitability for the device claim. The approach to interpreting meaningful change should not be chosen arbitrarily after results are available.
Worked example
For example, a mobility-support device is assessed with a general satisfaction question. Users like the product, but the intended change in daily functioning is not measured. The team does not present satisfaction as functional clinical benefit. It explains the need for a claim-matched measure and the narrower contribution of existing feedback.
Practical checks
- Match the measured concept to the specific clinical-benefit claim.
- Examine how language, administration and assistance may influence responses.
- Prespecify interpretation of missing answers and differing assessment times.
Decision and limitations
The report should identify the experience or function measured and the instrument’s limitations. Do not extend a favourable response to every health outcome. Additional measurement work may be needed; an unsuitable instrument does not make participant accounts worthless, but limits their evidential scope.
Frequently asked questions
- Is satisfaction the same as improved function?
- Not necessarily. Explicitly match the measured concept with the clinical claim.
- Is a familiar scale appropriate for every device?
- No. Justify suitability for the purpose, population, language and administration conditions.