PMID- 35576502
OWN - NLM
STAT- MEDLINE
DCOM- 20220719
LR  - 20221013
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 40
IP  - 21
DP  - 2022 Jul 20
TI  - Toward Incorporating Health-Related Quality of Life as Coprimary End Points in 
      Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles.
PG  - 2378-2388
LID - 10.1200/JCO.21.02750 [doi]
AB  - PURPOSE: Besides morbidity and mortality, quality of life (QoL) is a key outcome 
      of cancer treatments. Trials on the basis of clinical outcomes have expectations 
      that QoL outcomes can be either tolerated or improved. Simultaneously considering 
      QoL and clinical outcomes is challenging with lack of suitable metrics allowing 
      incorporation of QoL as coprimary end points in clinical trial design and 
      utilization of hierarchical hypothesis testing. METHOD: We propose combining time 
      to achieving a minimal clinically important difference (MCID) and probabilities 
      of a MCID occurring in each QoL domain to provide QoL metrics analogous to those 
      used for clinical end points. For QoL domains of interest, these yield QoL 
      profiles, time to MCID, and number needed to treat. Incorporation of QoL as 
      coprimary end points in clinical trial designs through hierarchical hypothesis 
      testing can easily be achieved. The noninferiority designed Laparoscopic Approach 
      to Carcinoma of the Endometrium trial, evaluating laparoscopic versus open 
      abdominal surgery for endometrial cancer with Functional Assessment of Cancer 
      Therapy-General QoL domains, is used to illustrate the usefulness of these 
      metrics. RESULTS: This analysis revealed that laparoscopic surgery had a 
      significant shorter time to MCID for physical and functional well-being QoL 
      domains (physical mean: 1.5 months, 95% CI, 0.5 to 2.6; P = .002; and functional 
      mean: 1.4 months; 95% CI, 0.4 to 2.4; P = .003) than abdominal surgery, but 
      little difference between the two approaches for psychologic social and emotion 
      well-being. Probability profile plots show a consistent > 2-fold higher chance of 
      attaining a MCID for physical and functional well-being over time for 
      laparoscopic compared with abdominal surgery. CONCLUSION: This analysis 
      reinforces the potential value of novel MCID metrics and their usefulness in 
      raising the profile of QoL outcomes to complement clinical end points. The 
      methods will allow health professionals to counsel patients about QoL outcomes 
      and clinical outcomes simultaneously.
FAU - Gebski, Val
AU  - Gebski V
AUID- ORCID: 0000-0001-8748-1844
AD  - NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, 
      Australia.
FAU - Obermair, Andreas
AU  - Obermair A
AUID- ORCID: 0000-0003-2199-1117
AD  - Queensland Centre for Gynaecological Cancer Research, University of Queensland, 
      Brisbane, Queensland, Australia.
FAU - Janda, Monika
AU  - Janda M
AUID- ORCID: 0000-0002-1728-8085
AD  - Centre for Health Services Research, The University of Queensland, Brisbane, 
      Queensland, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT00096408
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220516
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
MH  - *Endometrial Neoplasms
MH  - Female
MH  - Humans
MH  - *Laparoscopy
MH  - Minimal Clinically Important Difference
MH  - Quality of Life/psychology
EDAT- 2022/05/17 06:00
MHDA- 2022/07/20 06:00
CRDT- 2022/05/16 16:02
PHST- 2022/05/17 06:00 [pubmed]
PHST- 2022/07/20 06:00 [medline]
PHST- 2022/05/16 16:02 [entrez]
AID - 10.1200/JCO.21.02750 [doi]
PST - ppublish
SO  - J Clin Oncol. 2022 Jul 20;40(21):2378-2388. doi: 10.1200/JCO.21.02750. Epub 2022 
      May 16.