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Do You Recall?: Results From a Within-Person Recall Study of the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 – Physical Function 8c

Published:October 03, 2021DOI:https://doi.org/10.1016/j.jval.2021.08.011

      Highlights

      • The Patient-Reported Outcomes Measurement Information System Physical Function Short Form v2.0 – Physical Function 8c (PROMIS PF8c) instrument is a useful clinical outcome assessment to capture patient-reported physical functioning among patients with advanced cancer currently being considered for qualification as a drug development tool with the US Food and Drug Administration. There are currently 2 versions of the PROMIS PF8c: one with a 7-day recall and one with no recall. This article determined whether these versions yielded similar responses using a within-person design.
      • Responses to the no recall and 7-day recall versions of the PROMIS PF8c were very similar. Both in terms of T scores and raw scores, average differences between these versions approached 0.
      • Given that it is more similar to other PROMIS Physical Function measures, the no recall version is a preferable choice for administering the PF8c.

      Abstract

      Objectives

      This study aimed to determine whether responses to Patient-Reported Outcomes Measurement Information System Short Form v2.0 – Physical Function 8c (PROMIS PF8c) items differed when the use of a 7-day recall period was compared with no specified recall period.

      Methods

      Using a within-subject design, we surveyed 1810 individuals from the US general population, administering PROMIS PF8c at survey beginning and end. The order of measure presentation was randomly assigned. We calculated recall difference scores (RDSs) as no recall score minus 7-day recall score using both item response theory-based T scores and raw summed scores. We examined the distribution and created Bland-Altman plots for both RDSTscore and RDSRaw. We also calculated correlations between no recall versus 7-day recall T score and raw scores. Finally, we determined whether differences in no recall versus 7-day recall scores were associated with patient-reported PF.

      Results

      RDSTscore and RDSRaw had means (root mean square differences) of 0.00 (5.43) and −0.04 (3.79), respectively. The vast majority (%) of RDSTscore and RDSRaw values fell between the Bland-Altman limits of agreement (−10.65 to 10.66 and −7.46 to 7.38, respectively). Pearson’s correlations between no recall and 7-day recall for T scores and raw scores were 0.88 and 0.87, respectively. Effect sizes for mean RDSTscore and RDSRaw compared across level of Eastern Oncology Cooperative Group performance status, patient global impression of PF severity, and single PF items were near 0.

      Conclusions

      We did not find any significant recall period effect on PF8c responses. Therefore, we recommend the use of the PROMIS physical function standard, with no specified recall time period.

      Keywords

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