Sonya Eremenco1, Wen-Hung Chen2, Steven I Blum3, Elizabeth Nicole Bush4, Donald M Bushnell5, Kendra DeBusk6, Adam Gater7, Linda Nelsen2, Stephen Joel Coons8. 1. Critical Path Institute, 1730 East River Road, Suite 200, Tucson, AZ, USA. seremenco@c-path.org. 2. GlaxoSmithKline, Collegeville, PA, USA. 3. Bristol Myers Squibb, Lawrenceville, NJ, USA. 4. Eli Lilly and Company, Indianapolis, IN, USA. 5. Evidera | PPD, Phoenix, AZ, USA. 6. Seagen Inc, Bothell, WA, USA. 7. Adelphi Values, Bollington, Cheshire, UK. 8. Critical Path Institute, 1730 East River Road, Suite 200, Tucson, AZ, USA.
Abstract
PURPOSE: Score reproducibility is an important measurement property of fit-for-purpose patient-reported outcome (PRO) measures. It is commonly assessed via test-retest reliability, and best evaluated with a stable participant sample, which can be challenging to identify in diseases with highly variable symptoms. To provide empirical evidence comparing the retrospective (patient global impression of change [PGIC]) and current state (patient global impression of severity [PGIS]) approaches to identifying a stable subgroup for test-retest analyses, 3 PRO Consortium working groups collected data using both items as anchor measures. METHODS: The PGIS was completed on Day 1 and Day 8 + 3 for the depression and non-small cell lung cancer (NSCLC) studies, and daily for the asthma study and compared between Day 3 and 10. The PGIC was completed on the final day in each study. Scores were compared using an intraclass correlation coefficient (ICC) for participants who reported "no change" between timepoints for each anchor. RESULTS: ICCs using the PGIS "no change" group were higher for depression (0.84 vs. 0.74), nighttime asthma (0.95 vs. 0.53) and daytime asthma (0.86 vs. 0.68) compared to the PGIC "no change" group. ICCs were similar for NSCLC (PGIS: 0.87; PGIC: 0.85). CONCLUSION: When considering anchor measures to identify a stable subgroup for test-retest reliability analyses, current state anchors perform better than retrospective anchors. Researchers should carefully consider the type of anchor selected, the time period covered, and should ensure anchor content is consistent with the target measure concept, as well as inclusion of both current and retrospective anchor measures.
PURPOSE: Score reproducibility is an important measurement property of fit-for-purpose patient-reported outcome (PRO) measures. It is commonly assessed via test-retest reliability, and best evaluated with a stable participant sample, which can be challenging to identify in diseases with highly variable symptoms. To provide empirical evidence comparing the retrospective (patient global impression of change [PGIC]) and current state (patient global impression of severity [PGIS]) approaches to identifying a stable subgroup for test-retest analyses, 3 PRO Consortium working groups collected data using both items as anchor measures. METHODS: The PGIS was completed on Day 1 and Day 8 + 3 for the depression and non-small cell lung cancer (NSCLC) studies, and daily for the asthma study and compared between Day 3 and 10. The PGIC was completed on the final day in each study. Scores were compared using an intraclass correlation coefficient (ICC) for participants who reported "no change" between timepoints for each anchor. RESULTS: ICCs using the PGIS "no change" group were higher for depression (0.84 vs. 0.74), nighttime asthma (0.95 vs. 0.53) and daytime asthma (0.86 vs. 0.68) compared to the PGIC "no change" group. ICCs were similar for NSCLC (PGIS: 0.87; PGIC: 0.85). CONCLUSION: When considering anchor measures to identify a stable subgroup for test-retest reliability analyses, current state anchors perform better than retrospective anchors. Researchers should carefully consider the type of anchor selected, the time period covered, and should ensure anchor content is consistent with the target measure concept, as well as inclusion of both current and retrospective anchor measures.
Authors: Donald M Bushnell; Kelly P McCarrier; Elizabeth Nicole Bush; Lucy Abraham; Carol Jamieson; Fiona McDougall; Madhukar H Trivedi; Michael E Thase; Linda Carpenter; Stephen Joel Coons Journal: Value Health Date: 2019-05-17 Impact factor: 5.725
Authors: Bryce B Reeve; Kathleen W Wyrwich; Albert W Wu; Galina Velikova; Caroline B Terwee; Claire F Snyder; Carolyn Schwartz; Dennis A Revicki; Carol M Moinpour; Lori D McLeod; Jessica C Lyons; William R Lenderking; Pamela S Hinds; Ron D Hays; Joanne Greenhalgh; Richard Gershon; David Feeny; Peter M Fayers; David Cella; Michael Brundage; Sara Ahmed; Neil K Aaronson; Zeeshan Butt Journal: Qual Life Res Date: 2013-01-04 Impact factor: 4.147
Authors: Adam Gater; Linda Nelsen; Cheryl D Coon; Sonya Eremenco; Sean O'Quinn; Asif H Khan; Laurent Eckert; Hannah Staunton; Nicola Bonner; Rebecca Hall; Jerry A Krishnan; Stuart Stoloff; Michael Schatz; John Haughney; Stephen Joel Coons Journal: J Allergy Clin Immunol Pract Date: 2021-12-08
Authors: Donald M Bushnell; Thomas M Atkinson; Kelly P McCarrier; Astra M Liepa; Kendra P DeBusk; Stephen Joel Coons Journal: Curr Ther Res Clin Exp Date: 2021-08-26