PMID- 36897529
OWN - NLM
STAT- MEDLINE
DCOM- 20230607
LR  - 20230921
IS  - 1573-2649 (Electronic)
IS  - 0962-9343 (Print)
IS  - 0962-9343 (Linking)
VI  - 32
IP  - 7
DP  - 2023 Jul
TI  - Reliability and validity of PRO-CTCAE(R) daily reporting with a 24-hour recall 
      period.
PG  - 2047-2058
LID - 10.1007/s11136-023-03374-5 [doi]
AB  - PURPOSE: The standard recall period for the patient-reported outcomes version of 
      the common terminology criteria for adverse events (PRO-CTCAE(R)) 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.
CI  - (c) 2023. The Author(s).
FAU - Lee, M K
AU  - Lee MK
AUID- ORCID: 0000-0002-1301-4319
AD  - Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA. 
      lee.minji@mayo.edu.
FAU - Basch, E
AU  - Basch E
AD  - UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
FAU - Mitchell, S A
AU  - Mitchell SA
AD  - National Cancer Institute, Rockville, MD, USA.
FAU - Minasian, L M
AU  - Minasian LM
AD  - National Cancer Institute, Rockville, MD, USA.
FAU - Langlais, B T
AU  - Langlais BT
AD  - Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
FAU - Thanarajasingam, G
AU  - Thanarajasingam G
AD  - Division of Hematology, Mayo Clinic, Rochester, MN, USA.
FAU - Ginos, B F
AU  - Ginos BF
AD  - Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
FAU - Rogak, L J
AU  - Rogak LJ
AD  - Memorial Sloan Kettering Cancer Center, New York, NY, USA.
FAU - Mendoza, T R
AU  - Mendoza TR
AD  - MD Anderson Cancer Center, Houston, TX, USA.
FAU - Bennett, A V
AU  - Bennett AV
AD  - UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
FAU - Schrag, D
AU  - Schrag D
AD  - Memorial Sloan Kettering Cancer Center, New York, NY, USA.
FAU - Mazza, G L
AU  - Mazza GL
AD  - Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
FAU - Dueck, A C
AU  - Dueck AC
AD  - Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
LA  - eng
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - HHSN261200800043C/CA/NCI NIH HHS/United States
GR  - U01 CA233046/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20230310
PL  - Netherlands
TA  - Qual Life Res
JT  - Quality of life research : an international journal of quality of life aspects of 
      treatment, care and rehabilitation
JID - 9210257
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Humans
MH  - *Antineoplastic Agents/therapeutic use
MH  - Reproducibility of Results
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Quality of Life/psychology
MH  - *Neoplasms/therapy
MH  - Patient Reported Outcome Measures
MH  - Surveys and Questionnaires
PMC - PMC10241696
OTO - NOTNLM
OT  - 24-hour recall
OT  - Daily diary
OT  - PRO-CTCAE
OT  - Reliability
OT  - Validity
COIS- EB reports research funding to the University of North Carolina from the National 
      Cancer Institute and Patient-Centered Outcomes Research Institute, and direct 
      funding as a scientific advisor to Sivan, Carevive, Resilience, N-Power, 
      Navigating Cancer, and AstraZeneca. DS reports research funding to the Dana 
      Farber Cancer Institute from the National Cancer Institute, Patient-Centered 
      Outcomes Research Institute, and American Association of Cancer Research, and 
      Grail. She reports serving as an uncompensated advisor to Grail and as a 
      compensated advisor to the Centers for Medicare and Medicaid Services, and to 
      several states and International Governments. She reports compensation from JAMA 
      for editorial services. Other authors declare they have no competing interests.
EDAT- 2023/03/11 06:00
MHDA- 2023/06/07 06:42
PMCR- 2023/03/10
CRDT- 2023/03/10 11:23
PHST- 2023/02/10 00:00 [accepted]
PHST- 2023/06/07 06:42 [medline]
PHST- 2023/03/11 06:00 [pubmed]
PHST- 2023/03/10 11:23 [entrez]
PHST- 2023/03/10 00:00 [pmc-release]
AID - 10.1007/s11136-023-03374-5 [pii]
AID - 3374 [pii]
AID - 10.1007/s11136-023-03374-5 [doi]
PST - ppublish
SO  - Qual Life Res. 2023 Jul;32(7):2047-2058. doi: 10.1007/s11136-023-03374-5. Epub 
      2023 Mar 10.