![]() Response scale selection is a critical aspect of PRO instrument development and has broad downstream implications for the usability of the measure from the patient perspective, the level of precision with which the construct of interest is measured, and the quantitative properties of the outcome score including range, standard deviation, scoring, and score interpretation guidelines, as well as the responsiveness of the measure to detect change. ![]() Such considerations are central because response scales contribute to the precision as well as the performance of an instrument in the clinical trial setting, such as the ability to detect changes with treatment. When considering a response scale for a PRO instrument, it is important to consider the context of use including population of interest, therapeutic area, and study implementation. horizontal), or the response scale verbal anchors. Despite the importance of response scale selection for PRO instruments, there seems to be little empirical basis for the type of response scale selected, the response options, the visual orientation of the scale (i.e., vertical vs. Part of developing or adapting a PRO instrument includes the selection of a response scale (e.g., verbal rating scale, numeric rating scale, visual analogue scale ). Patient-reported outcome (PRO) instruments are important for assessing the symptoms and/or impact of symptoms on patients’ lives. Conclusionsīoth empirical studies and review articles provide evidence that the 11-point NRS is likely the optimal response scale to evaluate pain among adult patients without cognitive impairment. When reviewing the empirical basis for these recommendations, we found that the NRS had slightly superior measurement properties (e.g., reliability, validity, responsiveness) across a wide variety of contexts of use as compared to other response scales. Across 42 review articles, consensus guidelines, expert opinion pieces, and primary research articles, the NRS response scale was most often recommended in these guidance documents. Based on the extensive and varied literature on pain assessments, the adult pain studies typically use simple response scales with single-item measures of pain-a numeric rating scale, visual analog scale, or verbal rating scale. The review included 42 review articles, consensus guidelines, expert opinion pieces, and primary research articles providing insights into optimal response scale selection for pain assessment in the adult population. The searched yielded 6918 abstracts which were reviewed against study criteria for eligibility across the adult pain objective. The search strategy involved a comprehensive, structured, literature review with multiple search objectives and search terms. The purpose of this literature review was to examine the existing patient-reported outcome measurement literature to understand the empirical evidence supporting response scale selection in pain measurement for the adult population.
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