PMID- 32685579
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231111
IS  - 2327-2236 (Electronic)
IS  - 2326-697X (Print)
IS  - 2326-697X (Linking)
VI  - 6
IP  - 2
DP  - 2019
TI  - Disutility Study for Adult Patients with Moderate to Severe Crohn's Disease.
PG  - 47-60
LID - 10.36469/9685 [doi]
AB  - BACKGROUND: Crohn's disease (CD) treatments and associated adverse events (AEs) 
      can be burdensome for patients. However, specific values which quantify the 
      impact on health-related quality of life (HRQL) for economic evaluation are 
      lacking. OBJECTIVES: This study aimed to elicit health utility values for AEs 
      related to biologic treatment and surgical complications for CD in the UK. 
      METHODS: Health states were developed by literature review and interviews with CD 
      patients (n=6) and gastroenterologists (n=3). Draft health states were validated 
      in cognitive debrief interviews with patients (n=4) and gastroenterologists 
      (n=2). Treatment AEs were described with moderate-severe CD (reference state) and 
      included hypersensitivity, injection site reactions, serious infection, lymphoma, 
      and tuberculosis. Surgical complications were described following bowel surgery 
      (reference state) and included anastomotic leak, wound infection, prolonged 
      ileus/bowel obstruction, and intra-abdominal abscess. Health states were valued 
      by 100 members of the general public who completed background questions, 
      EQ-5D-3L, visual analogue scale rating task and time trade-off (TTO) interviews. 
      RESULTS: The mean TTO value for reference states 'moderate to severe CD' and 
      'bowel surgery' were 0.70 (SD=0.28) and 0.69 (SD=0.28). Participants rated 
      lymphoma as the worst AE/surgical complication state (0.44, SD=0.37), followed by 
      tuberculosis (0.47, SD=0.85) and anastomotic leak (0.48, SD=0.38). Values of 
      other AE/surgical complication states ranged from 0.76 (hypersensitivity) to 0.56 
      (intra-abdominal abscess). CONCLUSIONS: This study provides utility estimates for 
      AE and surgical complication health states not previously assessed in the context 
      of CD. As new treatments are emerging, it is important to include these 
      influences on quality of life in any economic evaluation of treatments.
FAU - Worbes-Cerezo, Melany
AU  - Worbes-Cerezo M
AD  - Janssen-Cilag Ltd, UK.
FAU - Nafees, Beenish
AU  - Nafees B
AD  - Nafees Consulting Limited, London, UK.
FAU - Lloyd, Andrew
AU  - Lloyd A
AD  - Acaster Lloyd Consulting, London UK.
FAU - Gallop, Katy
AU  - Gallop K
AD  - Acaster Lloyd Consulting, London UK.
FAU - Ladha, Imran
AU  - Ladha I
AD  - The author was employed by Janssen-Cilag Ltd at the time of the study.
FAU - Kerr, Cicely
AU  - Kerr C
AD  - Janssen-Cilag Ltd, UK.
LA  - eng
PT  - Journal Article
DEP - 20190326
PL  - United States
TA  - J Health Econ Outcomes Res
JT  - Journal of health economics and outcomes research
JID - 101648581
PMC - PMC7299447
OTO - NOTNLM
OT  - Crohn's disease
OT  - adverse events
OT  - health-related quality of life
OT  - surgical complications
OT  - time trade-off
OT  - utility
COIS- Conflict of interest BN, AL and KG were paid consultants of Nafees Consulting Ltd 
      and Acaster Lloyd Consulting at the time. Nafees Consulting was paid a fixed 
      price by Janssen-Cilag Ltd to design and conduct this study. MWC, CK are current 
      employees of Janssen-Cilag Ltd and IL was an employee at the time. There are no 
      other conflicts of interests.
EDAT- 2019/03/26 00:00
MHDA- 2019/03/26 00:01
PMCR- 2019/03/26
CRDT- 2020/07/21 06:00
PHST- 2020/07/21 06:00 [entrez]
PHST- 2019/03/26 00:00 [pubmed]
PHST- 2019/03/26 00:01 [medline]
PHST- 2019/03/26 00:00 [pmc-release]
AID - jheor-6-2-9685 [pii]
AID - 10.36469/9685 [doi]
PST - epublish
SO  - J Health Econ Outcomes Res. 2019 Mar 26;6(2):47-60. doi: 10.36469/9685. 
      eCollection 2019.