PMID- 26031708
OWN - NLM
STAT- MEDLINE
DCOM- 20161114
LR  - 20240324
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Print)
IS  - 0885-3924 (Linking)
VI  - 50
IP  - 4
DP  - 2015 Oct
TI  - The Complementary Nature of Patient-Reported Outcomes and Adverse Event Reporting 
      in Cooperative Group Oncology Clinical Trials: A Pooled Analysis (NCCTG N0591).
PG  - 470-9.e9
LID - S0885-3924(15)00238-9 [pii]
LID - 10.1016/j.jpainsymman.2015.04.016 [doi]
AB  - CONTEXT: Clinical trials use clinician-graded adverse events (AEs) and 
      patient-reported outcomes (PROs) to describe symptoms. OBJECTIVES: The aim of the 
      study was to examine the agreement between PROs and AEs in the clinical trial 
      setting. METHODS: Patient-level data were pooled from seven North Central Cancer 
      Treatment Group, two Southwest Oncology Group, and three Radiation Therapy 
      Oncology Group lung studies that included both PROs and AE data. Ten-point 
      changes (on a 0-100 scale) in PRO scores were considered clinically significant 
      differences (CSDs). PRO score changes were compared to AE grade (Gr) categories 
      (2+ yes vs. no and 3+ yes vs. no) using Wilcoxon rank-sum or two-sample t-tests 
      between Gr categories. Incidence rates and concordance of CSD in PRO scores and 
      AE Gr categories were compiled. Spearman correlations were computed between PRO 
      scores and AE severity. RESULTS: PROs completed by patients (n = 1013) were the 
      Uniscale, Lung Cancer Symptom Scale (LCSS), Functional Assessment of Cancer 
      Therapy-Lung (FACT-L), Symptom Distress Scale, and/or Functional Living 
      Index-Cancer. Significantly worse PRO score changes were found for the FACT-L in 
      patients with Gr 2+ AEs. Worse scores were seen for the Uniscale for patients 
      with Gr 2+ AEs (P = 0.07) and LCSS for patients with Gr 3+ AEs (P = 0.09). 
      Agreement between incidence of any Gr 2+ (Gr 3+) AE and a CSD in PROs ranged from 
      27% to 67% (36%-61%). Correlations between PRO scores and AE severity were low: 
      -0.06 Uniscale, -0.03 LCSS, 0.10 FACT-L, -0.11 Symptom Distress Scale, and -0.51 
      Functional Living Index-Cancer. CONCLUSION: These results support previous work 
      and an a priori hypothesis that AEs and PROs measure differing aspects of the 
      disease experience and are complementary.
CI  - Copyright (c) 2015 American Academy of Hospice and Palliative Medicine. Published 
      by Elsevier Inc. All rights reserved.
FAU - Atherton, Pamela J
AU  - Atherton PJ
AD  - Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA. 
      Electronic address: atherton@mayo.edu.
FAU - Watkins-Bruner, Deborah W
AU  - Watkins-Bruner DW
AD  - Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.
FAU - Gotay, Carolyn
AU  - Gotay C
AD  - School of Population and Public Health, University of British Columbia, 
      Vancouver, British Columbia, Canada.
FAU - Moinpour, Carol M
AU  - Moinpour CM
AD  - Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, 
      Washington, USA.
FAU - Satele, Daniel V
AU  - Satele DV
AD  - Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.
FAU - Winter, Kathryn A
AU  - Winter KA
AD  - Statistical Department, Radiation Therapy Oncology Group, Philadelphia, 
      Pennsylvania, USA.
FAU - Schaefer, Paul L
AU  - Schaefer PL
AD  - Toledo Community Hospital Oncology Program, Toledo, Ohio, USA.
FAU - Movsas, Benjamin
AU  - Movsas B
AD  - Department of Radiation Oncology, Henry Ford Medical Center, Detroit, Michigan, 
      USA.
FAU - Sloan, Jeff A
AU  - Sloan JA
AD  - Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.
LA  - eng
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - UG1 CA189867/CA/NCI NIH HHS/United States
GR  - UG1 CA189974/CA/NCI NIH HHS/United States
GR  - U10 CA21661/CA/NCI NIH HHS/United States
GR  - P30 CA138292/CA/NCI NIH HHS/United States
GR  - U10 CA37422/CA/NCI NIH HHS/United States
GR  - UG1 CA189823/CA/NCI NIH HHS/United States
GR  - P30 CA015083/CA/NCI NIH HHS/United States
GR  - U10 CA037422/CA/NCI NIH HHS/United States
GR  - U10 CA021661/CA/NCI NIH HHS/United States
GR  - K05 CA142885/CA/NCI NIH HHS/United States
GR  - U10 CA180822/CA/NCI NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
DEP - 20150530
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
SB  - IM
MH  - Aged
MH  - Clinical Trials as Topic/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/epidemiology/*therapy
MH  - *Patient Outcome Assessment
MH  - Physicians
MH  - Self Report
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC4657556
MID - NIHMS734271
OTO - NOTNLM
OT  - Patient-reported outcomes
OT  - adverse events
OT  - clinical trials
COIS- Disclosures The authors declare no conflicts of interest.
EDAT- 2015/06/03 06:00
MHDA- 2016/11/15 06:00
PMCR- 2016/10/01
CRDT- 2015/06/03 06:00
PHST- 2014/05/06 00:00 [received]
PHST- 2015/04/21 00:00 [revised]
PHST- 2015/04/29 00:00 [accepted]
PHST- 2015/06/03 06:00 [entrez]
PHST- 2015/06/03 06:00 [pubmed]
PHST- 2016/11/15 06:00 [medline]
PHST- 2016/10/01 00:00 [pmc-release]
AID - S0885-3924(15)00238-9 [pii]
AID - 10.1016/j.jpainsymman.2015.04.016 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2015 Oct;50(4):470-9.e9. doi: 
      10.1016/j.jpainsymman.2015.04.016. Epub 2015 May 30.