Patient-Reported Outcome (PRO) Instrument

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A Patient-Reported Outcome (PRO) Instrument is a clinical outcome assessment instrument that is based on self-reported perception-based information (from a patient or clinical study participant).



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  • (Arthurs et al., 2012) ⇒ Erin Arthurs, Russell J. Steele, Marie Hudson, Murray Baron, Brett D. Thombs, and (CSRG) Canadian Scleroderma Research Group. (2012). “Are Scores on English and French Versions of the PHQ-9 Comparable? An Assessment of Differential Item Functioning.” In: PloS One, 7(12).
    • QUOTE: Health-related patient-reported outcomes (HR-PROs) assess patient health based on patient perspectives. HR-PROs may reflect complex constructs, such as health-related quality of life (HRQL), or narrower constructs, such as pain, fatigue or depressive symptoms [1]–[3]. Assessment of HR-PROs has been emphasized in recent years, especially among patients with chronic diseases [4], and this has been reflected in initiatives aimed at improving measurement quality and operationalization in research and clinical practice, such as the PROMIS initiative [5] and OMERACT in rheumatology [6]. Recently, the COSMIN checklist (Consensus based Standards for the selection of health status Measurement INstruments) was developed to establish general criteria for assessing the methodological quality of studies that evaluate measurement properties of HR-PROs [7].

      In recent years, international collaboration, and, thus, interest in HR-PRO research in the context of multinational studies, has grown [8]. HR-PROs are increasingly translated and used in diverse linguistic and cultural settings [9]. As described in the COSMIN checklist [7], the cross-linguistic or cross-cultural equivalence of HR-PRO measures is an important consideration for instruments that will be administered in more than one language or for comparisons of results across linguistic or cultural settings.

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