The methodological requirements for clinical examination and patient-reported outcomes, and how to test them.

This article presents the methodological requirements for clinical examination and patient-reported outcomes measurements. The assessment of any measurement for clinical research in hand surgery is difficult. A method of measuring a criterion could be 100% reliable but 100% invalid. Bias may be present in our assessment if we do not take into account the methodological requirements related to reliability, validity, and responsiveness of our measures. Reliability refers to intra-observer agreement, inter-observer agreement, or agreement between two methods of assessment, and, for patient-reported measures, internal consistency and test-retest reliability. Validity is the capability of a clinical method to measure what it proposes to measure. Assessing validity involves comparing a measure with one or more other measures, and, if possible, with a reference standard criterion. Responsiveness is the ability to detect important clinical change. The Consensus-based Standards for the Selection of Health Measurement Instruments provides the standards required for design and recommended statistical analyses of patient-reported outcome measures.