PMID- 30175317
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2509-8020 (Electronic)
IS  - 2509-8020 (Linking)
VI  - 2
DP  - 2017
TI  - Integrating the patient voice with clinician reports to identify a hepatocellular 
      carcinoma-specific subset of treatment-related symptomatic adverse events.
PG  - 35
LID - 10.1186/s41687-018-0063-4 [doi]
LID - 35
AB  - BACKGROUND: Incorporating patient reporting of symptomatic adverse events (AEs) 
      is important in evaluating safety and tolerability in cancer clinical trials. The 
      Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse 
      Events (PRO-CTCAE) was developed to assess the frequency, severity, and/or 
      interference of patient-reported symptomatic AEs. The objective of this study was 
      to identify, based on oncologist and patient interviews, a relevant subset of 
      symptomatic AEs from the PRO-CTCAE that can be used to optimize patient reporting 
      of symptomatic AEs in hepatocellular carcinoma (HCC) clinical trials. METHODS: 
      Qualitative and quantitative data on HCC diagnosis, treatment, symptoms, and side 
      effects were collected from patients. Using a numerical rating scale, medical 
      oncologists specializing in HCC rated the importance of (1) 34 symptomatic AEs 
      (grade >/= 2) identified in past sponsor HCC clinical trials, (2) each PRO-CTCAE 
      symptomatic AE item to the patient, and (3) each PRO-CTCAE symptomatic AE item 
      with respect to patient safety or tolerability. Patients completed the PRO-CTCAE 
      items and were debriefed on the importance of each PRO-CTCAE symptomatic AE to 
      them. RESULTS: Five medical oncologists from the United States, Spain, Taiwan, 
      Korea, and Hong Kong with 14 to 30 years of experience, and 17 patients with HCC 
      and Child-Pugh class A or B cirrhosis status completed interviews. Medical 
      oncologists rated the following symptomatic AEs from prior trials as being highly 
      important to patients (mean rating of >/=7 on a scale from 0 to 10): hand-foot 
      syndrome, diarrhea, fatigue, decreased appetite, rash, vomiting, and weight loss. 
      PRO-CTCAE symptomatic AEs rated by medical oncologists as being highly important 
      to patients included diarrhea, vomiting, shivering or shaking chills, hand-foot 
      syndrome, rash, fatigue, difficulty swallowing, decreased appetite, and loss of 
      control of bowel movements. Patients rated the following PRO-CTCAE symptomatic 
      AEs as being highly important: loss of appetite/lack of interest in food, 
      pain/tenderness at injection/insertion site, fatigue/lack of energy/tiredness, 
      nausea, and hair loss. CONCLUSIONS: This study identified a preliminary list of 
      clinically relevant symptomatic AEs from interviews with both medical oncologists 
      and patients that can be used to support assessments of treatment safety and 
      tolerability in HCC clinical trials.
FAU - Speck, Rebecca M
AU  - Speck RM
AD  - 1Evidera, Bethesda, MD USA. ISNI: 0000 0004 0510 2209. GRID: grid.423257.5
FAU - Lenderking, William R
AU  - Lenderking WR
AD  - 1Evidera, Bethesda, MD USA. ISNI: 0000 0004 0510 2209. GRID: grid.423257.5
FAU - Shaw, James W
AU  - Shaw JW
AUID- ORCID: 0000-0002-7019-3720
AD  - 2Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ 08648 USA. GRID: 
      grid.419971.3
LA  - eng
PT  - Journal Article
DEP - 20180822
PL  - Germany
TA  - J Patient Rep Outcomes
JT  - Journal of patient-reported outcomes
JID - 101722688
PMC - PMC6104407
OTO - NOTNLM
OT  - Hepatocellular carcinoma
OT  - PRO-CTCAE
OT  - Patient-reported outcomes
OT  - Symptomatic adverse events
COIS- RMS and WRL are employees of Evidera. JWS is an employee and shareholder of 
      BMS.Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/09/04 06:00
MHDA- 2018/09/04 06:01
PMCR- 2018/08/22
CRDT- 2018/09/04 06:00
PHST- 2018/01/04 00:00 [received]
PHST- 2018/07/09 00:00 [accepted]
PHST- 2018/09/04 06:00 [entrez]
PHST- 2018/09/04 06:00 [pubmed]
PHST- 2018/09/04 06:01 [medline]
PHST- 2018/08/22 00:00 [pmc-release]
AID - 63 [pii]
AID - 10.1186/s41687-018-0063-4 [doi]
PST - epublish
SO  - J Patient Rep Outcomes. 2018 Aug 22;2:35. doi: 10.1186/s41687-018-0063-4. 
      eCollection 2017.