Magnus P Ekström1, Hans Bornefalk2, C Magnus Sköld3, Christer Janson4, Anders Blomberg5, Anna Bornefalk-Hermansson6, Helena Igelström7, Jacob Sandberg8, Josefin Sundh9. 1. Faculty of Medicine, Department of Clinical Sciences, Respiratory Medicine and Allergology, Lund University, Lund, Sweden. Electronic address: pmekstrom@gmail.com. 2. Hans Bornefalk AB, Vallentuna, Sweden. 3. Respiratory Medicine Unit, Department of Medicine Solna and Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Respiratory Medicine and Allergy, Karolinska University Hospital Solna, Stockholm, Sweden. 4. Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden. 5. Department of Public Health and Clinical Medicine, Section of Medicine, Umeå University, Umeå, Sweden. 6. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 7. Department of Neuroscience, Uppsala University, Uppsala, Sweden. 8. Faculty of Medicine, Department of Clinical Sciences, Respiratory Medicine and Allergology, Lund University, Lund, Sweden. 9. Faculty of Medicine and Health, Department of Respiratory Medicine, Örebro University, Örebro, Sweden.
Abstract
CONTEXT: Breathlessness is a cardinal symptom in cardiorespiratory disease and consists of multiple dimensions that can be measured using the instruments Dyspnea-12 (D12) and the Multidimensional Dyspnea Profile (MDP). OBJECTIVES: The objective of the study is to determine the minimal clinically important differences (MCIDs) of all D12 and MDP summary and subdomain scores as well as the instruments' feasibility in patients with cardiorespiratory disease. METHODS: Prospective multicenter cohort study of outpatients with diagnosed cardiorespiratory disease and breathlessness in daily life. D12 and MDP were assessed at baseline, after 30-90 minutes and two weeks. MCIDs were calculated using anchor-based and distributional methods for summary and subdomain scores. Feasibility was assessed as rate of missing data, help required, self-reported difficulty, and completion time. RESULTS: A total 182 outpatients (53.3% women) were included; main diagnoses were chronic obstructive pulmonary disease (COPD; 25%), asthma (21%), heart failure (19%), and idiopathic pulmonary fibrosis (19%). Anchor-based MCIDs were for D12 total score 2.83 (95% CI 1.99-3.66); D12 physical 1.81 (1.29-2.34); D12 affective 1.07 (0.64-1.49); MDP A1 unpleasantness 0.82 (0.56-1.08); MDP perception 4.63 (3.21-6.05), and MDP emotional score 2.37 (1.10-3.64). The estimates were consistent with small-to-moderate effect sizes using distributional analysis, and MCIDs were similar between COPD and non-COPD patients. The instruments were generally feasible and quick to use. CONCLUSION: D12 and MDP are responsive to change and feasible for use for assessing multidimensional breathlessness in outpatients with cardiorespiratory disease. MCIDs were determined for use as endpoints in clinical trials.
CONTEXT: Breathlessness is a cardinal symptom in cardiorespiratory disease and consists of multiple dimensions that can be measured using the instruments Dyspnea-12 (D12) and the Multidimensional Dyspnea Profile (MDP). OBJECTIVES: The objective of the study is to determine the minimal clinically important differences (MCIDs) of all D12 and MDP summary and subdomain scores as well as the instruments' feasibility in patients with cardiorespiratory disease. METHODS: Prospective multicenter cohort study of outpatients with diagnosed cardiorespiratory disease and breathlessness in daily life. D12 and MDP were assessed at baseline, after 30-90 minutes and two weeks. MCIDs were calculated using anchor-based and distributional methods for summary and subdomain scores. Feasibility was assessed as rate of missing data, help required, self-reported difficulty, and completion time. RESULTS: A total 182 outpatients (53.3% women) were included; main diagnoses were chronic obstructive pulmonary disease (COPD; 25%), asthma (21%), heart failure (19%), and idiopathic pulmonary fibrosis (19%). Anchor-based MCIDs were for D12 total score 2.83 (95% CI 1.99-3.66); D12 physical 1.81 (1.29-2.34); D12 affective 1.07 (0.64-1.49); MDP A1 unpleasantness 0.82 (0.56-1.08); MDP perception 4.63 (3.21-6.05), and MDP emotional score 2.37 (1.10-3.64). The estimates were consistent with small-to-moderate effect sizes using distributional analysis, and MCIDs were similar between COPD and non-COPDpatients. The instruments were generally feasible and quick to use. CONCLUSION: D12 and MDP are responsive to change and feasible for use for assessing multidimensional breathlessness in outpatients with cardiorespiratory disease. MCIDs were determined for use as endpoints in clinical trials.
Authors: Zainab Ahmadi; Helena Igelström; Jacob Sandberg; Josefin Sundh; Magnus Sköld; Christer Janson; Anders Blomberg; Hans Bornefalk; Anna Bornefalk-Hermansson; Magnus Ekström Journal: ERJ Open Res Date: 2022-01-24