Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The present study will explore the patients satisfaction to COPD medical treatment (i.e. pharmacological and not pharmacological treatment) in a clinical real-world setting and how the satisfaction for medical treatment is related to clinical parameters, quality of life, illness perception and treatment adherence evolution. Moreover health care resource consumption will be observed during the observation period.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged equal or more than 40 years 2. Patients must have a documented diagnosis of chronic obstructive pulmonary disease (COPD) 3. Patients with no exacerbations in the last 3 months 4. Patients requiring regular treatment according to GOLD guidelines, i.e.: undergoing stable pharmacological treatment for COPD since at least 3 months 5. Written informed consent to both participation in the study and privacy form 6. Patients capable of discernment and able to read or write in Italian language.
Exclusion criteria
1. Patients who are currently participating in a clinical trial on experimental drugs. 2. Patients naïve to pharmacological treatment for COPD 3. Diagnosis of Asthma COPD Overlap Syndrome (ACOS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | At enrollment visit, 6-month follow-up visit and 12-month follow-up visit. | Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9). The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = \[(item1 + item2 + item3) - 3\]/18\*100, (ii) Convenience = \[(item4 + item5 + item6) - 3\]/18\*100 and (iii) Global satisfaction = \[(item7 + item8 + item9) - 3\]/14\*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Up to 12 months | A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. |
| The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Up to 12 months | A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. |
| Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | At enrollment visit, 6-month follow-up visit and 12-month follow-up visit | Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD. Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade. Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities. Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea. |
| The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Up to 12 months | Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations. Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period. |
| Correlation Between Patients' Satisfaction and Resource Utilization | 12-month follow-up visit | Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit. Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months |
| The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Up to 12 months | A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months. |
Countries
Italy
Participant flow
Recruitment details
This was a multi-center, non-interventional (observational), prospective cohort study based mainly on newly-collected data for Chronic obstructive pulmonary disease (COPD) patients. No treatments were administered to the patients on the protocol basis, since this was a non-interventional study. The total number of enrolled patients was 401.
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria were not met.
Participants by arm
| Arm | Count |
|---|---|
| Total COPD Patients Patients were enrolled (enrollment phase was 10 months) in the SAT (SATisfaction and adherence to COPD treatment) study and they were evaluable for the analyses and follow-up visits were scheduled at 6 and 12 months. All patients had a baseline Treatment Satisfaction Questionnaire- 9 items (TSQM-9) usable for the baseline data analysis and were included in the Full Analysis Set (FAS). | 401 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 61 |
| Overall Study | Other than listed | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 11 |
| Overall Study | Withdrawal/Loss To Follow-Up | 1 |
| Overall Study | Withdrawal/ Physician's Decision | 1 |
Baseline characteristics
| Characteristic | Total COPD Patients |
|---|---|
| Age, Continuous | 71.7 Years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 400 Participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 401 |
| other Total, other adverse events | 0 / 401 |
| serious Total, serious adverse events | 12 / 401 |
Outcome results
Primary
The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period
Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9). The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = \[(item1 + item2 + item3) - 3\]/18\*100, (ii) Convenience = \[(item4 + item5 + item6) - 3\]/18\*100 and (iii) Global satisfaction = \[(item7 + item8 + item9) - 3\]/14\*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain.
Time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.
Population: Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Convenience (0-100) | 75.8 Unit on Scale | Standard Deviation 15.9 |
| Enrollment Visit | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Effectiveness (0-100) | 64.2 Unit on Scale | Standard Deviation 17.2 |
| Enrollment Visit | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Global satisfaction (0-100) | 65.7 Unit on Scale | Standard Deviation 17.1 |
| 6-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Convenience (0-100) | 75.7 Unit on Scale | Standard Deviation 15.8 |
| 6-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Effectiveness (0-100) | 66.2 Unit on Scale | Standard Deviation 16.3 |
| 6-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Global satisfaction (0-100) | 67.5 Unit on Scale | Standard Deviation 16.9 |
| 12-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Effectiveness (0-100) | 67.1 Unit on Scale | Standard Deviation 15.1 |
| 12-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Global satisfaction (0-100) | 67.3 Unit on Scale | Standard Deviation 15.4 |
| 12-month Follow-up | The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period | Convenience (0-100) | 76.1 Unit on Scale | Standard Deviation 14 |
Secondary
Correlation Between Patients' Satisfaction and Resource Utilization
Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit. Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months
Time frame: 12-month follow-up visit
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrollment Visit | Correlation Between Patients' Satisfaction and Resource Utilization | Specialist Outpatient_E | -0.14945 Spearman's correlation coefficients |
| Enrollment Visit | Correlation Between Patients' Satisfaction and Resource Utilization | Hospitalization_C | -0.13233 Spearman's correlation coefficients |
Secondary
Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.
Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD. Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade. Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities. Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea.
Time frame: At enrollment visit, 6-month follow-up visit and 12-month follow-up visit
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | B-IPQ (8-80) | 41.8 Unit on Scale | Standard Deviation 11.3 |
| Enrollment Visit | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | MMAS-4 (0-4) | 3.4 Unit on Scale | Standard Deviation 0.9 |
| Enrollment Visit | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | CAT score (0-40) | 15.7 Unit on Scale | Standard Deviation 7.8 |
| Enrollment Visit | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | Patients' dyspnea (MMRC) | 1.6 Unit on Scale | Standard Deviation 1.1 |
| 6-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | Patients' dyspnea (MMRC) | 1.8 Unit on Scale | Standard Deviation 1.1 |
| 6-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | B-IPQ (8-80) | 42.0 Unit on Scale | Standard Deviation 10 |
| 6-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | CAT score (0-40) | 15.9 Unit on Scale | Standard Deviation 7.6 |
| 6-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | MMAS-4 (0-4) | 3.5 Unit on Scale | Standard Deviation 0.9 |
| 12-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | Patients' dyspnea (MMRC) | 1.7 Unit on Scale | Standard Deviation 1.1 |
| 12-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | MMAS-4 (0-4) | 3.5 Unit on Scale | Standard Deviation 0.9 |
| 12-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | CAT score (0-40) | 15.1 Unit on Scale | Standard Deviation 7.5 |
| 12-month Follow-up | Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period. | B-IPQ (8-80) | 42.6 Unit on Scale | Standard Deviation 10.5 |
Secondary
The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period
Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations. Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period.
Time frame: Up to 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Hospitalization | 0.1 Number of events | Standard Deviation 0.4 |
| Enrollment Visit | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Emergency room accesses | 0.1 Number of events | Standard Deviation 0.2 |
| Enrollment Visit | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Specialist Outpatient Visits | 0.2 Number of events | Standard Deviation 0.7 |
| Enrollment Visit | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | GP Visits | 0.4 Number of events | Standard Deviation 0.9 |
| Enrollment Visit | The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period | Laboratory Tests | 0.7 Number of events | Standard Deviation 3.1 |
Secondary
The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Time frame: Up to 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 2 vs Visit 1 | -0.1907 Beta coefficient estimate | Standard Error 1.0026 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 3 vs Visit 1 | 0.1130 Beta coefficient estimate | Standard Error 0.9902 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Age | -0.2438 Beta coefficient estimate | Standard Error 0.0858 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Gender (Female vs Male) | 0.1682 Beta coefficient estimate | Standard Error 1.5588 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Number of exacerbations in the year before Visit 1 | -1.0434 Beta coefficient estimate | Standard Error 0.907 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | FEV1 predicted (%) at enrollment | 0.0348 Beta coefficient estimate | Standard Error 0.0329 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -5.4461 Beta coefficient estimate | Standard Error 1.8328 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -4.2513 Beta coefficient estimate | Standard Error 1.6786 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | CAT score at Visit 1 | -0.0782 Beta coefficient estimate | Standard Error 0.0949 |
Secondary
The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Time frame: Up to 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 2 vs Visit 1 | 0.9639 Beta coefficient estimate | Standard Error 1.145 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 3 vs Visit 1 | 1.8419 Beta coefficient estimate | Standard Error 1.297 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Age | -0.0566 Beta coefficient estimate | Standard Error 0.1015 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Gender (Female vs Male) | 0.6152 Beta coefficient estimate | Standard Error 1.8658 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Number of exacerbations in the year before Visit 1 | 0.1913 Beta coefficient estimate | Standard Error 1.0683 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | FEV1 predicted (%) at enrollment | 0.0924 Beta coefficient estimate | Standard Error 0.0387 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -1.7866 Beta coefficient estimate | Standard Error 2.1787 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -1.3991 Beta coefficient estimate | Standard Error 2.0051 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | CAT score at Visit 1 | -0.2645 Beta coefficient estimate | Standard Error 0.1137 |
Secondary
The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.
A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables. Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months.
Time frame: Up to 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 2 vs Visit 1 | 2.2165 Beta coefficient estimate | Standard Error 1.0757 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Visit 3 vs Visit 1 | 2.4258 Beta coefficient estimate | Standard Error 1.1032 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Age | -0.1139 Beta coefficient estimate | Standard Error 0.1005 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Gender (Female vs Male) | 1.6246 Beta coefficient estimate | Standard Error 1.8334 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | Number of exacerbations in the year before Visit 1 | -0.8055 Beta coefficient estimate | Standard Error 1.0599 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | FEV1 predicted (%) at enrollment | 0.0748 Beta coefficient estimate | Standard Error 0.0385 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 2 vs 4) | -2.2278 Beta coefficient estimate | Standard Error 2.1607 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | MMAS-4 score class at Visit 1 (Score = 3 vs 4) | -5.4749 Beta coefficient estimate | Standard Error 1.9726 |
| Enrollment Visit | The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period. | CAT score at Visit 1 | -0.2445 Beta coefficient estimate | Standard Error 0.1117 |