TY - JOUR
T1 - Determining the minimal clinically important difference for the PEmbQoL questionnaire, a measure of pulmonary embolism-specific quality of life
AU - Akaberi, A.
AU - Klok, F. A.
AU - Cohn, D. M.
AU - Hirsch, A.
AU - Granton, J.
AU - Kahn, S. R.
PY - 2018
Y1 - 2018
N2 - 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.
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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85055951223&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30240543
U2 - https://doi.org/10.1111/jth.14302
DO - https://doi.org/10.1111/jth.14302
M3 - Article
C2 - 30240543
SN - 1538-7933
VL - 16
SP - 2454
EP - 2461
JO - Journal of thrombosis and haemostasis
JF - Journal of thrombosis and haemostasis
IS - 12
ER -