Reliability and validity of PRO-CTCAE® daily reporting with a 24-hour recall period Journal Article
| Authors: | Lee, M. K.; Basch, E.; Mitchell, S. A.; Minasian, L. M.; Langlais, B. T.; Thanarajasingam, G.; Ginos, B. F.; Rogak, L. J.; Mendoza, T. R.; Bennett, A. V.; Schrag, D.; Mazza, G. L.; Dueck, A. C. |
| Article Title: | Reliability and validity of PRO-CTCAE® daily reporting with a 24-hour recall period |
| Abstract: | Purpose: The standard recall period for the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) is the past 7 days, but there are contexts where a 24-hour recall may be desirable. The purpose of this analysis was to investigate the reliability and validity of a subset of PRO-CTCAE items captured using a 24-hour recall. Methods: 27 PRO-CTCAE items representing 14 symptomatic adverse events (AEs) were collected using both a 24-hour recall (24 h) and the standard 7 day recall (7d) in a sample of patients receiving active cancer treatment (n = 113). Using data captured with a PRO-CTCAE-24h on days 6 and 7, and 20 and 21, we computed intra-class correlation coefficients (ICC); an ICC ≥ 0.70 was interpreted as demonstrating high test–retest reliability. Correlations between PRO-CTCAE-24h items on day 7 and conceptually relevant EORTC QLQ-C30 domains were examined. In responsiveness analysis, patients were deemed changed if they had a one-point or greater change in the corresponding PRO-CTCAE-7d item (from week 0 to week 1). Results: PRO-CTCAE-24h captured on two consecutive days demonstrated that 21 of 27 items (78%) had ICCs ≥ 0.70 (day 6/7 median ICC 0.76), (day 20/21 median ICC 0.84). Median correlation between attributes within a common AE was 0.75, and the median correlation between conceptually relevant EORTC QLQ-C30 domains and PRO-CTCAE-24 h items captured on day 7 was 0.44. In the analysis of responsiveness to change, the median standardized response mean (SRM) for patients with improvement was − 0.52 and that for patients with worsening was 0.71. Conclusion: A 24-hour recall period for PRO-CTCAE items has acceptable measurement properties and can inform day-to-day variations in symptomatic AEs when daily PRO-CTCAE administration is implemented in a clinical trial. © 2023, The Author(s). |
| Keywords: | adult; controlled study; human tissue; major clinical study; cancer therapy; correlation coefficient; reliability; test retest reliability; validity; recall; pro-ctcae; human; male; female; article; european organization for research and treatment of cancer quality of life questionnaire core 30; 24-hour recall; daily diary |
| Journal Title: | Quality of Life Research |
| Volume: | 32 |
| Issue: | 7 |
| ISSN: | 0962-9343 |
| Publisher: | Springer |
| Date Published: | 2023-07-01 |
| Start Page: | 2047 |
| End Page: | 2058 |
| Language: | English |
| DOI: | 10.1007/s11136-023-03374-5 |
| PUBMED: | 36897529 |
| PROVIDER: | scopus |
| PMCID: | PMC10241696 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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