Making Sense of Dyspnea Assessment
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 10/4/2018 |
| Start Date: | October 2014 |
| End Date: | May 2019 |
Interpreting COPD Dyspnea Change: Sensitivity, Responsiveness, and Predictive Validity of the Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT)
Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO).
It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD).
There is a high priority to improve dyspnea PRO assessment and predict exacerbations.
Frequent exacerbations are associated with increased disability, decreased quality of life
(QOL), and accelerated lung function decline.
Goals: To test the relative sensitivity to change, responsiveness and predictive validity of
a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and
activity avoidance domains and is more efficient to administer than existing dyspnea scales.
Expected Outcomes: Investigators expect to:
1. begin to transform how dyspnea is assessed;
2. improve dyspnea symptom management;
3. impact functional status;
4. improve QOL;
5. facilitate the earlier treatment and prevention of exacerbations;
6. improve COPD prognosis and survival; and
7. improve COPD healthcare utilization.
It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD).
There is a high priority to improve dyspnea PRO assessment and predict exacerbations.
Frequent exacerbations are associated with increased disability, decreased quality of life
(QOL), and accelerated lung function decline.
Goals: To test the relative sensitivity to change, responsiveness and predictive validity of
a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and
activity avoidance domains and is more efficient to administer than existing dyspnea scales.
Expected Outcomes: Investigators expect to:
1. begin to transform how dyspnea is assessed;
2. improve dyspnea symptom management;
3. impact functional status;
4. improve QOL;
5. facilitate the earlier treatment and prevention of exacerbations;
6. improve COPD prognosis and survival; and
7. improve COPD healthcare utilization.
Theoretical Background: COPD research and practice has focused predominately on evaluating
and treating the sensory component of dyspnea. However, dyspnea (like pain) is a complex
symptom with sensory and affective components. Current dyspnea scales are limited in scope by
only measuring the sensory component of dyspnea, and have high respondent and data collection
burden and/or high measurement error. Only sensory dyspnea to date has been used to classify
COPD severity. The DMQ-CAT addresses the limitations of other dyspnea scales by using
state-of-the-art item banking method techniques to provide a tailored multidimensional
dyspnea assessment using only a minimal number of items. The 71-item DMQ-CAT captures four
distinct dyspnea constructs: intensity, anxiety, activity avoidance, and self-efficacy to
evaluate outcomes of COPD pharmacologic, pulmonary rehabilitation, and cognitive-behavioral
therapy. The DMQ-CAT showed evidence of minimal ceiling and floor effects, acceptable Rasch
model fit statistics, high internal consistency reliability, good accuracy compared to the
total item pool, and good to excellent concurrent and known-groups validity. The relative
sensitivity to change, responsiveness, and predictive validity of the DMQ-CAT is not
currently known.
Hypotheses: The DMQ-CAT has superior sensitivity to change and responsiveness compared to
other widely used COPD dyspnea scales. The DMQ-CAT has superior predictive validity compared
to other dyspnea measures to predict acute COPD exacerbation incidence and severity.
Study Design: To achieve Aims 1 and 2, the investigators will use a prospective observational
design and a target sample of 110 pulmonary rehabilitation (PR) outpatients with COPD. The
investigators will use distribution-based statistics to compare the sensitivity to change of
dyspnea instruments including: effect sizes, standardized response means (SRM), standardized
error of measurement (SEM), and the percentage of participants exceeding the minimal
detectable change (MDC90) from baseline to discharge from PR. The investigators will estimate
the minimal clinically important difference (MCID) for the DMQ-CAT and compare the percentage
of participants exceeding MCID thresholds using established MCIDs for dyspnea instruments.
For Aim 3, the investigators will use a retrospective observational design to conduct
secondary analyses from existing data of 240 patients with COPD. The investigators will use
odds ratios (OR) and 95% confidence interval (CI) and the area under the receiver operator
curve (ROC) to compare the predictive validity of different dyspnea measures.
and treating the sensory component of dyspnea. However, dyspnea (like pain) is a complex
symptom with sensory and affective components. Current dyspnea scales are limited in scope by
only measuring the sensory component of dyspnea, and have high respondent and data collection
burden and/or high measurement error. Only sensory dyspnea to date has been used to classify
COPD severity. The DMQ-CAT addresses the limitations of other dyspnea scales by using
state-of-the-art item banking method techniques to provide a tailored multidimensional
dyspnea assessment using only a minimal number of items. The 71-item DMQ-CAT captures four
distinct dyspnea constructs: intensity, anxiety, activity avoidance, and self-efficacy to
evaluate outcomes of COPD pharmacologic, pulmonary rehabilitation, and cognitive-behavioral
therapy. The DMQ-CAT showed evidence of minimal ceiling and floor effects, acceptable Rasch
model fit statistics, high internal consistency reliability, good accuracy compared to the
total item pool, and good to excellent concurrent and known-groups validity. The relative
sensitivity to change, responsiveness, and predictive validity of the DMQ-CAT is not
currently known.
Hypotheses: The DMQ-CAT has superior sensitivity to change and responsiveness compared to
other widely used COPD dyspnea scales. The DMQ-CAT has superior predictive validity compared
to other dyspnea measures to predict acute COPD exacerbation incidence and severity.
Study Design: To achieve Aims 1 and 2, the investigators will use a prospective observational
design and a target sample of 110 pulmonary rehabilitation (PR) outpatients with COPD. The
investigators will use distribution-based statistics to compare the sensitivity to change of
dyspnea instruments including: effect sizes, standardized response means (SRM), standardized
error of measurement (SEM), and the percentage of participants exceeding the minimal
detectable change (MDC90) from baseline to discharge from PR. The investigators will estimate
the minimal clinically important difference (MCID) for the DMQ-CAT and compare the percentage
of participants exceeding MCID thresholds using established MCIDs for dyspnea instruments.
For Aim 3, the investigators will use a retrospective observational design to conduct
secondary analyses from existing data of 240 patients with COPD. The investigators will use
odds ratios (OR) and 95% confidence interval (CI) and the area under the receiver operator
curve (ROC) to compare the predictive validity of different dyspnea measures.
Inclusion Criteria:
- English Speaking
- Over 40 years of age
- Physician-diagnosed COPD documented in their clinic notes
- Have at least one pulmonary function test (PFT) with a pre-bronchodilator or
post-bronchodilator ratio of forced expiratory volume in one second divided by the
forced vital capacity (FEV1/ FVC) OF < 0.70 and/or evidence of COPD on chest computed
tomography (CT)
Exclusion Criteria:
- Neurological dysfunction that interferes with their participation in the pulmonary
rehabilitation program
- Are unable to provide informed consent
- PR participants who are hospitalized during their PR program will be excluded from
further evaluation
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