Interpreting change from patient reported outcome (PRO) endpoints: patient global ratings of concept versus patient global ratings of change, a case study among osteoporosis patients

Health and Quality of Life Outcomes
Annabel NixonApril N Naegeli

Abstract

Regulatory guidance recommends anchor-based methods for interpretation of treatment effects measured by PRO endpoints. Methodological pros and cons of patient global ratings of change vs. patient global ratings of concept have been discussed but empirical evidence in support of either approach is lacking. This study evaluated the performance of patient global ratings of change and patient global ratings of concept for interpreting patient stability and patient improvement. Patient global ratings of change and patient global ratings of concept were included in a psychometric validation study of an osteoporosis-targeted PRO instrument (the OPAQ-PF) to assess its ability to detect change and to derive responder definitions. 144 female osteoporosis patients with (n = 37) or without (n = 107) a recent (within 6 weeks) fragility fracture completed the OPAQ-PF and global items at baseline, 2 weeks (no recent fracture), and 12 weeks (recent fracture) post-baseline. Results differed between the two methods. Recent fracture patients reported more improvement while patients without recent fracture reported more stability on ratings of change than ratings of concept. However, correlations with OPAQ-PF score change were stronger for ratings...Continue Reading

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Citations

Mar 30, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Yih-Lin Chung, Newman N M Pui
Jul 25, 2020·Health and Quality of Life Outcomes·Frank BehrendtCorina Schuster-Amft
Jun 18, 2017·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Cheryl D Coon, Karon F Cook
Jul 29, 2021·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Andrew Trigg, Philip Griffiths

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