PMID- 22093207
OWN - NLM
STAT- MEDLINE
DCOM- 20120109
LR  - 20220409
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 162
IP  - 5
DP  - 2011 Nov
TI  - Days alive and out of hospital and the patient journey in patients with heart 
      failure: Insights from the candesartan in heart failure: assessment of reduction 
      in mortality and morbidity (CHARM) program.
PG  - 900-6
LID - 10.1016/j.ahj.2011.08.003 [doi]
AB  - BACKGROUND: Conventional composite outcomes in heart failure (HF) trials, for 
      example, time to cardiovascular death or first HF hospitalization, have 
      recognized limitations. We propose an alternative outcome, days alive and out of 
      hospital (DAOH), which incorporates mortality and all hospitalizations into a 
      single measure. A refinement, the patient journey, also uses functional status 
      (New York Heart Association [NYHA] class) measured during follow-up. The CHARM 
      program is used to illustrate the methodology. METHODS: CHARM randomized 7,599 
      patients with symptomatic HF to placebo or candesartan, with median follow-up of 
      38 months. We related DAOH and percent DAOH (ie, percentage of time spent alive 
      and out of hospital) to treatment using linear regression adjusting for follow-up 
      time. RESULTS: Mean increase in DAOH for patients on candesartan versus placebo 
      was 24.1 days (95% CI 9.8-38.3 days, P < .001). The corresponding mean increase 
      in percent DAOH was 2.0% (95% CI 0.8%-3.1%, P < .001). These findings were 
      dominated by reduced mortality (23 days) but enhanced by reduced time in hospital 
      (1 day). Percent time spent in hospital because of HF was reduced by 0.10% (95% 
      CI 0.04%-0.14%, P < .001). The patient journey analysis showed that patients in 
      the candesartan group spent more follow-up time in NYHA classes I and II and less 
      in NYHA class IV. CONCLUSIONS: Days alive and out of hospital, especially percent 
      DAOH, provide a valuable tool for summarizing the overall absolute treatment 
      effect on mortality and morbidity. In future HF trials, percent DAOH can provide 
      a useful alternative perspective on the effects of treatment.
CI  - Copyright (c) 2011 Mosby, Inc. All rights reserved.
FAU - Ariti, Cono A
AU  - Ariti CA
AD  - Department of Medical Statistics, London School of Hygiene and Tropical Medicine, 
      United Kingdom. cono.ariti@lshtm.ac.uk
FAU - Cleland, John G F
AU  - Cleland JG
FAU - Pocock, Stuart J
AU  - Pocock SJ
FAU - Pfeffer, Marc A
AU  - Pfeffer MA
FAU - Swedberg, Karl
AU  - Swedberg K
FAU - Granger, Christopher B
AU  - Granger CB
FAU - McMurray, John J V
AU  - McMurray JJ
FAU - Michelson, Eric L
AU  - Michelson EL
FAU - Ostergren, Jan
AU  - Ostergren J
FAU - Yusuf, Salim
AU  - Yusuf S
LA  - eng
SI  - ClinicalTrials.gov/NCT00634400
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20111007
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Benzimidazoles)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Tetrazoles)
RN  - S8Q36MD2XX (candesartan)
SB  - IM
MH  - Aged
MH  - Angiotensin II Type 1 Receptor Blockers/*administration & dosage
MH  - Benzimidazoles/*administration & dosage
MH  - Biphenyl Compounds
MH  - Female
MH  - Heart Failure/drug therapy/*mortality/pathology
MH  - Hospitalization/*statistics & numerical data
MH  - Humans
MH  - Linear Models
MH  - Male
MH  - *Models, Statistical
MH  - Mortality
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
MH  - Tetrazoles/*administration & dosage
MH  - Treatment Outcome
MH  - United States
EDAT- 2011/11/19 06:00
MHDA- 2012/01/10 06:00
CRDT- 2011/11/19 06:00
PHST- 2011/05/24 00:00 [received]
PHST- 2011/08/04 00:00 [accepted]
PHST- 2011/11/19 06:00 [entrez]
PHST- 2011/11/19 06:00 [pubmed]
PHST- 2012/01/10 06:00 [medline]
AID - S0002-8703(11)00574-6 [pii]
AID - 10.1016/j.ahj.2011.08.003 [doi]
PST - ppublish
SO  - Am Heart J. 2011 Nov;162(5):900-6. doi: 10.1016/j.ahj.2011.08.003. Epub 2011 Oct 
      7.