PMID- 27045992
OWN - NLM
STAT- MEDLINE
DCOM- 20170207
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 38
IP  - 4
DP  - 2016 Apr
TI  - Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of 
      Symptomatic Adverse Events in Cancer Clinical Trials.
PG  - 821-30
LID - S0149-2918(16)30148-5 [pii]
LID - 10.1016/j.clinthera.2016.03.011 [doi]
AB  - PURPOSE: There is increasing interest to use patient-reported outcome (PRO) 
      measures to evaluate symptomatic adverse events (AEs) in cancer treatment trials. 
      However, there are currently no standard recommended approaches for integrating 
      patient-reported AE measures into trials. METHODS: Approaches are identified from 
      previous trials for selecting AEs for solicited patient reporting, administering 
      patient-reported AE measures, and analyzing and reporting results. FINDINGS: 
      Approaches for integrating patient-reported AE measures into cancer trials 
      generally combine current standard methods for clinician-reported AEs and 
      established best practices for using PRO measures. Specific AEs can be selected 
      for a PRO questionnaire based on common and expected reactions in a given trial 
      context, derived from literature review and qualitative/mixed-methods evaluations 
      and should be the same set administered across all arms of a trial. A mechanism 
      for collecting unsolicited patient-reported AEs will also ideally be included. 
      Patients will preferably report at baseline and at the end of active treatment as 
      well as on a frequent standardized schedule during active treatment, such as 
      weekly from home, with a recall period corresponding to the frequency of 
      reporting (eg, past 7 days). Less frequent reporting may be considered after an 
      initial intensive monitoring period for trials of prolonged treatments and during 
      long-term follow-up. Electronic PRO data collection is preferred. Backup data 
      collection for missed PRO reports is advisable to boost response rates. Analysis 
      can use a combination of approaches to AE and PRO data. If a high proportion of 
      patients is experiencing baseline symptoms, systematic subtraction of these from 
      on-study AEs should be considered to improve reporting of symptoms related to 
      treatment. More granular longitudinal analyses of individual symptoms can also be 
      useful. IMPLICATIONS: Methods are evolving for integrating patient-reported 
      symptomatic AEs into cancer trials. These methods are expected to further evolve 
      as more data from trials become available.
CI  - Copyright (c) 2016 Elsevier HS Journals, Inc. All rights reserved.
FAU - Basch, Ethan
AU  - Basch E
AD  - Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, 
      University of North Carolina, Chapel Hill, North Carolina; Health Outcomes 
      Research Group, Department of Epidemiology and Biostatistics, Memorial Sloan 
      Kettering Cancer Center, New York, New York.
FAU - Rogak, Lauren J
AU  - Rogak LJ
AD  - Health Outcomes Research Group, Department of Epidemiology and Biostatistics, 
      Memorial Sloan Kettering Cancer Center, New York, New York.
FAU - Dueck, Amylou C
AU  - Dueck AC
AD  - Section of Biostatistics, Mayo Clinic, Scottsdale, Arizona. Electronic address: 
      dueck@mayo.edu.
LA  - eng
GR  - UG1 CA189823/CA/NCI NIH HHS/United States
GR  - P30 CA016086/CA/NCI NIH HHS/United States
GR  - P30 CA015083/CA/NCI NIH HHS/United States
GR  - U10 CA180882/CA/NCI NIH HHS/United States
GR  - U10 CA180838/CA/NCI NIH HHS/United States
GR  - U10 CA180821/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20160402
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Neoplasms/*drug therapy
MH  - *Patient Reported Outcome Measures
MH  - Surveys and Questionnaires
PMC - PMC4851916
MID - NIHMS767196
OTO - NOTNLM
OT  - Adverse event
OT  - Cancer
OT  - Common Terminology Criteria for Adverse Events
OT  - Patient-reported outcome
OT  - Symptom
OT  - Toxicity
COIS- Conflict of Interest statement The authors have no commercial interests in any 
      questionnaire system and report no financial conflicts of interest.
EDAT- 2016/04/06 06:00
MHDA- 2017/02/09 06:00
PMCR- 2017/04/02
CRDT- 2016/04/06 06:00
PHST- 2016/01/25 00:00 [received]
PHST- 2016/03/02 00:00 [revised]
PHST- 2016/03/07 00:00 [accepted]
PHST- 2016/04/06 06:00 [entrez]
PHST- 2016/04/06 06:00 [pubmed]
PHST- 2017/02/09 06:00 [medline]
PHST- 2017/04/02 00:00 [pmc-release]
AID - S0149-2918(16)30148-5 [pii]
AID - 10.1016/j.clinthera.2016.03.011 [doi]
PST - ppublish
SO  - Clin Ther. 2016 Apr;38(4):821-30. doi: 10.1016/j.clinthera.2016.03.011. Epub 2016 
      Apr 2.