PMID- 30240543
OWN - NLM
STAT- MEDLINE
DCOM- 20191107
LR  - 20230829
IS  - 1538-7836 (Electronic)
IS  - 1538-7836 (Linking)
VI  - 16
IP  - 12
DP  - 2018 Dec
TI  - Determining the minimal clinically important difference for the PEmbQoL 
      questionnaire, a measure of pulmonary embolism-specific quality of life.
PG  - 2454-2461
LID - 10.1111/jth.14302 [doi]
AB  - Essentials The minimal clinically important difference (MCID) for PEmbQoL has not 
      yet been determined. We estimated the MCID for PEmbQoL and its subscales via 
      anchor- and distribution-based approaches. Our results indicate that MCID for 
      PEmbQoL appears to be 15 points. Our work enables interpretation of changes or 
      differences in PEmbQoL. SUMMARY: Background Pulmonary embolism (PE) reduces 
      quality of life (QOL). The PEmbQoL questionnaire, a PE-related QOL measure, was 
      recently developed and validated and has been used to quantify disease-specific 
      QOL in clinical studies of patients with PE. However, to date, interpretation of 
      PEmbQoL scores has been limited by a lack of information on the minimal 
      clinically important difference (MCID) of this measure. Objective To determine 
      the MCID for PEmbQoL and its subscales using anchor-based and distribution-based 
      approaches. Methods We analyzed data from the ELOPE Study, a prospective, 
      multicenter cohort study of long-term outcomes after a first episode of acute PE. 
      At baseline and 1, 3, 6 and 12 months after PE, we measured generic QOL (SF-36), 
      PE-specific QOL (PEmbQoL) and dyspnea severity (UCSD Shortness of Breath 
      Questionnaire). We used time-varying repeated-measures mixed-effect models to 
      estimate anchor-based MCID and effect sizes to estimate distribution-based MCID. 
      Results Eighty-two patients participated in this sub-study. Their mean age was 
      49.4 years, 60% were male and 84% had PE diagnosed in an outpatient setting. 
      Using both anchor- and distribution-based approaches, the MCID for PEmbQoL 
      appears to be 15 points. Based on this MCID, 42%, 59%, 66% and 75% of patients 
      experienced at least one MCID unit of improvement in PEmbQoL from baseline to 1, 
      3, 6 and 12 months, respectively. Conclusion Our results provide new information 
      on the MCID of PEmbQoL, a PE-specific QOL questionnaire that can be used by 
      researchers and clinicians to measure and interpret changes in PE-specific QOL 
      over time, or as an outcome in clinical trials.
CI  - (c) 2018 International Society on Thrombosis and Haemostasis.
FAU - Akaberi, A
AU  - Akaberi A
AD  - Center for Clinical Epidemiology, Lady Davis Institute, Montreal, QC, Canada.
FAU - Klok, F A
AU  - Klok FA
AUID- ORCID: 0000-0001-9961-0754
AD  - Department of Thrombosis and Hemostasis, Leiden University Medical Center, 
      Leiden, the Netherlands.
FAU - Cohn, D M
AU  - Cohn DM
AD  - Department of Vascular Medicine, Academic Medical Center, University of 
      Amsterdam, Amsterdam, the Netherlands.
FAU - Hirsch, A
AU  - Hirsch A
AD  - Department of Medicine, Jewish General Hospital, Montreal, QC, Canada.
FAU - Granton, J
AU  - Granton J
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Kahn, S R
AU  - Kahn SR
AD  - Center for Clinical Epidemiology, Lady Davis Institute, Montreal, QC, Canada.
AD  - Department of Medicine, Jewish General Hospital, Montreal, QC, Canada.
LA  - eng
GR  - CDT-142654/CIHR/Canada
GR  - MOP-93627/CIHR/Canada
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20181102
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
SB  - IM
MH  - Adult
MH  - Canada
MH  - Cost of Illness
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Minimal Clinically Important Difference
MH  - Predictive Value of Tests
MH  - Prognosis
MH  - Prospective Studies
MH  - Pulmonary Embolism/*diagnosis/physiopathology/psychology
MH  - *Quality of Life
MH  - *Surveys and Questionnaires
MH  - Time Factors
OTO - NOTNLM
OT  - minimal clinically important difference
OT  - patient-reported outcome measures
OT  - prognosis
OT  - pulmonary embolism
OT  - quality of life
EDAT- 2018/09/22 06:00
MHDA- 2019/11/08 06:00
CRDT- 2018/09/22 06:00
PHST- 2018/04/19 00:00 [received]
PHST- 2018/09/22 06:00 [pubmed]
PHST- 2019/11/08 06:00 [medline]
PHST- 2018/09/22 06:00 [entrez]
AID - S1538-7836(22)02947-6 [pii]
AID - 10.1111/jth.14302 [doi]
PST - ppublish
SO  - J Thromb Haemost. 2018 Dec;16(12):2454-2461. doi: 10.1111/jth.14302. Epub 2018 
      Nov 2.