PMID- 32239794
OWN - NLM
STAT- MEDLINE
DCOM- 20210426
LR  - 20210426
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 22
IP  - 6
DP  - 2020 Jun
TI  - Minimal clinically important difference in quality of life scores for patients 
      with heart failure and reduced ejection fraction.
PG  - 999-1005
LID - 10.1002/ejhf.1810 [doi]
AB  - AIMS: While the associations of health-related quality of life scores in heart 
      failure (HF) [e.g. the Kansas City Cardiomyopathy Questionnaire (KCCQ)] with 
      clinical outcomes are well established, their interpretation in the context of 
      what magnitudes of change are clinically important to patients is less clear. The 
      main objective of this study was to correlate the changes in the KCCQ and Patient 
      Global Assessment (PGA) in patients with HF with reduced ejection fraction 
      (HFrEF) to determine minimal clinically important difference (MCID). METHODS AND 
      RESULTS: We analysed data from 459 patients of the FAIR-HF trial. Both KCCQ and 
      PGA were assessed at 4 and 24 weeks after enrolment. An anchor-based approach was 
      used to calculate MCID at week 4 and 24. PGA was chosen as the clinical anchor 
      against which changes in the KCCQ scores were calibrated. For each category of 
      change in PGA, the corresponding differences were calculated by the mean scores 
      of various domains of KCCQ along with 95% confidence intervals (CIs). There was 
      fair correlation between PGA and changes in overall summary scores (OSS) 
      (r = 0.31; P < 0.001), clinical summary scores (CSS) (r = 0.36; P < 0.001) and 
      physical limitation scores (PLS) (r = 0.31; P < 0.001) from baseline to week 4. 
      KCCQ OSS, CSS and PLS MCID for 'little improvement' at week 4 were 3.6 (1.0-6.2), 
      4.5 (1.8-7.2) and 4.7 (1.4-8.0) points, respectively. OSS, CSS and PLS MCID for 
      'little improvement' at week 24 were 4.3 (0.2-8.4), 4.5 (0.5-8.5) and 4.0 
      (-0.9-9.0) points, respectively. CONCLUSION: The MCID threshold for KCCQ score 
      was generally consistent and numerically lower than the threshold of 5-point 
      change considered for clinical outcome prognosis and were stable between 4 and 
      24 weeks. This suggests that even changes smaller than the traditional 5-point 
      improvements in KCCQ may be clinically meaningful. Also, these results can aid in 
      the clinical interpretation of patient-reported outcomes, and better endpoint 
      selection in future studies.
CI  - (c) 2020 European Society of Cardiology.
FAU - Butler, Javed
AU  - Butler J
AD  - Department of Medicine, University of Mississippi, Jackson, MO, USA.
FAU - Khan, Muhammad Shahzeb
AU  - Khan MS
AD  - Department of Medicine, Cook County Hospital, Chicago, IL, USA.
FAU - Mori, Claudio
AU  - Mori C
AD  - Vifor Pharma Ltd., Glattbrugg, Switzerland.
FAU - Filippatos, Gerasimos S
AU  - Filippatos GS
AD  - Medical School, University of Cyprus, Nicosia, Cyprus.
AD  - National and Kapodistrian University of Athens, Athens University Hospital 
      Attikon, Athens, Greece.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - Wroclaw Medical University, Wroclaw, Poland.
FAU - Comin-Colet, Josep
AU  - Comin-Colet J
AD  - Department of Cardiology, Bellvitge University Hospital and IDIBELL, University 
      of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.
FAU - Roubert, Bernard
AU  - Roubert B
AD  - Vifor Pharma Ltd., Glattbrugg, Switzerland.
FAU - Spertus, John A
AU  - Spertus JA
AD  - Department of Cardiology, University of Missouri-Kansas City, Saint Luke's Mid 
      America Heart Institute, Kansas City, MO, USA.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Cardiology (CVK); and Berlin Institute of Health Center for 
      Regenerative Therapies (BCRT), German Center for Cardiovascular Research (DZHK) 
      partner site Berlin; Charite Universitatsmedizin Berlin, Berlin, Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200402
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
CIN - Eur J Heart Fail. 2020 Jun;22(6):1006-1008. PMID: 32297433
MH  - Aged
MH  - Female
MH  - Health Status
MH  - *Heart Failure/physiopathology/therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Minimal Clinically Important Difference
MH  - *Patient Reported Outcome Measures
MH  - *Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Stroke Volume/*physiology
OTO - NOTNLM
OT  - Heart failure
OT  - Kansas City Cardiomyopathy Questionnaire
OT  - Minimal clinically important difference
OT  - Patient Global Assessment
OT  - Patient-reported outcomes
OT  - Quality of life
EDAT- 2020/04/03 06:00
MHDA- 2021/04/27 06:00
CRDT- 2020/04/03 06:00
PHST- 2019/11/22 00:00 [received]
PHST- 2020/02/25 00:00 [revised]
PHST- 2020/06/07 00:00 [accepted]
PHST- 2020/04/03 06:00 [pubmed]
PHST- 2021/04/27 06:00 [medline]
PHST- 2020/04/03 06:00 [entrez]
AID - 10.1002/ejhf.1810 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2020 Jun;22(6):999-1005. doi: 10.1002/ejhf.1810. Epub 2020 Apr 
      2.