This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for SATisfaction and Adherence to COPD Treatment (NCT02689492), a registered phase not stated study. The primary outcome is The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02689492 |
| Phase | Phase not stated |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 401 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic obstructive pulmonary disease (COPD) enrolled in a real-world study. The registry reports enrollment of 401 patients and defines the primary analysis population as the Full Analysis Set, comprising enrolled patients evaluable for baseline data analysis.
Intervention
No assigned intervention is described. The study concerns patients' satisfaction with their COPD medical treatment, including pharmacological treatment for the primary outcome and pharmacological and non-pharmacological treatment in the broader study question.
Comparator
No like-for-like control group is described. Allocation is not stated, and the registry record does not present this as a randomized comparison.
Primary question
How do patients report satisfaction with COPD pharmacological treatment at enrollment, 6-month follow-up, and 12-month follow-up, as measured by the TSQM Version 1.4?
The broader study aims to explore how satisfaction relates to clinical parameters, quality of life, illness perception, treatment adherence, and health care resource use during the observation period. Its secondary outcomes also describe disease perception, adherence, health status, dyspnea, and relationships between satisfaction domains and patient characteristics or reported outcomes. These are observational questions about patterns and relationships, not treatment-effect questions based on an assigned comparison.
The registry record does not report numerical primary satisfaction scores, so it cannot establish from the posted results whether satisfaction changed over time or how large any change was. The primary question is therefore identifiable from the registered outcome definition, while its empirical answer is not reported in the registry record.
3. Trial Design
The registry describes a real-world study of patients with COPD and their satisfaction with medical treatment. It lists enrollment of 401 and a completed study status. The recorded start date is 2015-12-11, and the primary completion date is 2017-09-15. Boehringer Ingelheim is listed as sponsor.
The primary outcome is planned at enrollment, 6-month follow-up, and 12-month follow-up. It uses patient-reported satisfaction with pharmacological treatment. The broader study description also includes non-pharmacological treatment and proposes observing relationships between satisfaction and clinical measures, quality of life, illness perception, adherence, and health care resource consumption. The registered secondary outcomes include changes or measurements in disease perception, adherence, health status, and dyspnea over the 12-month observation period, as well as associations involving satisfaction domains and resource utilization.
Allocation is not stated. The registry record does not describe a randomized treatment assignment or identify a control arm, so the study should not be read as a randomized comparison. The registry does not report additional details about recruitment procedures, eligibility criteria, treatment regimens, visit windows, or the handling of treatment changes. Those features are not reported in the registry record.
The primary analysis population is the Full Analysis Set (FAS), defined as enrolled patients evaluable for baseline data analysis. The number of patients in that analysis population and the number with outcome data at each follow-up are not reported in the registry record. The enrolled count alone therefore does not establish how many contributed to each satisfaction estimate.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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.
Overall Study
| Stage | Total COPD Patients |
|---|---|
| STARTED | 401 |
| COMPLETED | 315 |
| NOT COMPLETED | 86 |
Reasons for not completing this period:
| Reason | Total COPD Patients |
|---|---|
| Lost to Follow-up | 61 |
| Withdrawal by Subject | 11 |
| Death | 9 |
| Physician Decision | 2 |
| Withdrawal/Loss To Follow-Up | 1 |
| Withdrawal/ Physician's Decision | 1 |
| Other than listed | 1 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.
| Characteristic | Unit | Total COPD Patients |
|---|---|---|
| Participants analysed | 401 | |
| Age, Continuous | Years | 71.7 (SD 7.6) |
| Sex: Female, Male: Female | Participants | 102 |
| Sex: Female, Male: Male | Participants | 299 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 400 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period, measured over At enrollment visit, 6-month follow-up visit and 12-month follow-up visit..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Unit on Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint measures patients' reported satisfaction or dissatisfaction with pharmacological COPD treatment using the Treatment Satisfaction Questionnaire for Medication, TSQM Version 1.4. The registry describes a nine-item instrument, TSQM-9, with responses to nearly all items rated on a 5-point or 7-point rating scale. The items contribute to three domains: effectiveness, convenience, and global satisfaction.
Each domain score ranges from 0 to 100, with higher scores representing higher satisfaction on that domain. The registry states that domain scores were calculated according to the instrument authors' recommendations. A domain score can be calculated only when all three items used for that domain are nonmissing. The registered summary measure is the mean, with standard deviation as the dispersion measure, at enrollment and follow-up visits.
This patient-reported endpoint is used because treatment satisfaction captures patients' assessments of treatment effectiveness, convenience, and overall satisfaction, which are not interchangeable with clinical measurements. The registry also proposes examining how these domains relate to clinical parameters and patient-reported outcomes. Such relationships can describe co-occurring experiences, but they do not by themselves establish that one factor caused another.
Numerical means and standard deviations for the registered visits are not reported in the registry record. The description defines what the endpoint measures, but does not provide the observed satisfaction levels or their precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a longitudinal satisfaction outcome and its measurement schedule, but it does not report the numerical results needed to describe the primary endpoint's observed level or pattern. In particular, the mean and standard deviation for the TSQM domains at enrollment, 6-month follow-up, and 12-month follow-up are not reported in the registry record. No direction or magnitude of change can therefore be attributed to the posted results.
The outcome description distinguishes effectiveness, convenience, and global satisfaction. These domains represent different aspects of treatment experience; a score in one domain should not be treated as a substitute for the others. Each score is on a scale from 0 to 100, and higher values indicate higher satisfaction within that domain. The scale's stated interpretation does not reveal where the study participants scored, because those values are not reported.
The primary outcome is a mean of a continuous measure, with standard deviation specified to describe dispersion among observed scores. A mean describes the central level of scores, while the standard deviation describes how spread out scores are around that mean. General statistical interpretation: a mean alone cannot show whether participant experiences were tightly clustered or widely varied. The numerical estimates and standard deviations are absent, so neither feature can be assessed from the registry record.
The registered question also concerns relationships between satisfaction and clinical parameters, quality of life, illness perception, adherence, and resource use. Such associations, if reported, would describe how measures vary together in the observed population. They would not establish that satisfaction caused changes in adherence or that resource use caused satisfaction to change. The registry record lists several planned secondary questions but does not report their numerical findings.
The registry identifies a Full Analysis Set based on baseline evaluability. It does not report the number included in that set, the number contributing to each follow-up mean, or the amount and handling of missing data. Consequently, the observed population behind each potential estimate cannot be assessed. This is relevant because missing follow-up responses could affect both the representativeness and precision of a mean, depending on why those responses are absent.
There is no described randomized comparison and no assigned control group. The study's observational associations should therefore not be interpreted as randomized treatment effects. The sample-size assumptions described for planning illustrations are not the study's observed results, do not substitute for precision estimates, and are not observed power. As the numerical primary results and their uncertainty are not reported in the registry record, the principal conclusion is limited to what was measured and when; the extent of satisfaction and its change remain unknown from this record.
9. Statistical Methods Explained
The primary outcome is continuous: the registry specifies a mean and standard deviation for the TSQM domain scores. A continuous outcome can take values across a scale rather than representing only membership in a category. Here, each domain score ranges from 0 to 100. The score construction combines responses to the items assigned to that domain, and the registry states that calculations follow the instrument authors' recommendations.
What does the mean describe?
General statistical explanation: the mean is a measure of the center of a set of observations. It gives a concise description of the average score, but it does not show how scores are distributed or whether some participants' experiences differ substantially from others. The standard deviation complements the mean by describing the spread of observed scores around it. A mean and standard deviation are most informative when read together, while recognizing that neither fully describes every feature of a distribution.
The record names the effectiveness, convenience, and global satisfaction domains. Because they represent distinct constructs, each should be interpreted on its own terms. Higher scores are defined as higher satisfaction for that particular domain. The description does not provide a threshold for classifying a score as clinically important or for defining a satisfactory level, so such cutoffs should not be inferred.
Why do the visit times matter?
The outcome is planned for measurement at enrollment, 6-month follow-up, and 12-month follow-up. Repeated measurements can describe scores at different stages of observation, and can support an analysis of change if the relevant estimates and methods are reported. A comparison of group means at visits is not automatically the same as an analysis of within-person change. The registry record does not state which model or contrast was used to analyze repeated measurements, whether the analysis accounted for correlation between measurements from the same patient, or how visit timing was handled beyond the listed visits.
General statistical explanation: observations from the same person are often related, so an analysis of repeated measurements may need to account for that dependence. Treating related measurements as independent can make uncertainty estimates inappropriate. The specific statistical approach used for this trial is not reported in the registry record.
How should uncertainty be read?
General statistical explanation: an estimate such as a mean is subject to sampling uncertainty. A confidence interval, when reported, gives a range of values compatible with the data and analysis under its stated assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. The registry record does not report confidence intervals for the primary outcome, so the precision of any visit-specific satisfaction estimate cannot be evaluated from this record.
The standard deviation is not a measure of uncertainty in the mean. It describes variability among individual scores. A confidence interval or another suitable uncertainty measure would address precision of an estimate; neither should be confused with the spread of individual responses. No numerical uncertainty measure for the primary outcome is reported in the registry record.
What do the planning assumptions mean?
The study materials describe sample-size planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is framed as a stated fraction of the observed effect. These are planning assumptions for hypothetical calculations, not a description of randomized arms in this study. Allocation is not stated, and the registry record does not describe a like-for-like control comparison.
General statistical explanation: a sample-size illustration estimates how many participants might be needed under particular assumptions about an effect, variability, allocation, and statistical procedure. Changing those assumptions can change the planning estimate. A calculation based on an observed effect does not demonstrate the power achieved by the completed study. The planning output is not observed power, and it cannot supply missing outcome estimates or uncertainty. No numerical planning outputs are reported in the registry record.
What can associations establish?
The secondary questions concern relationships between satisfaction domains and demographics, clinical parameters, patient-reported outcomes, adherence, and resource use. General statistical explanation: an association indicates that measurements vary together in the observed data. It does not by itself distinguish cause from consequence or rule out other factors that may influence both. Because treatment allocation is not stated and no randomized comparator is described, any reported relationship would need to be interpreted as observational unless further design information establishes otherwise. The numerical association estimates and their analysis methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary satisfaction outcome and multiple secondary questions. These cover disease perception, adherence, health status, dyspnea, satisfaction domains, patient characteristics, clinical parameters, patient-reported outcomes, and resource utilization. Considering multiple outcomes or relationships raises a multiplicity issue: the more statistical questions assessed, the greater the chance that some results may appear noteworthy by chance if each is interpreted without regard to the full set of analyses.
The registry record does not report whether a multiplicity adjustment was planned or applied, how the secondary analyses were prioritized, or whether any outcomes were designated exploratory. It also does not report a statistical analysis plan that would clarify those choices. The listed questions should therefore be read as registered areas of assessment, not as evidence that a particular multiplicity strategy was used.
The primary analysis population is the Full Analysis Set, defined as all enrolled patients evaluable for baseline data analysis. The record does not give the number meeting that definition or explain how evaluability was determined. It also does not report the number with valid TSQM domain scores at each visit. Since every score requires all three relevant items to be present, missing items prevent calculation of that domain score under the stated rule.
Beyond this item-level requirement, the approach to missing follow-up measurements is not reported in the registry record. There is no reported description of imputation, exclusion, or sensitivity analyses. General statistical explanation: missing data can affect estimates if the likelihood of missingness is related to participant characteristics or outcome values. Without the counts and handling method, the possible effect on the reported population and estimates cannot be assessed. The registry record also does not report whether analyses used all available visits or required complete follow-up data.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Total COPD Patients | 12 | 401 | 3.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Total COPD Patients | 9 of 401 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Total COPD Patients | 0 of 401 |
Most frequent serious adverse event terms
| Event term | Organ system | Total COPD Patients |
|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 2 of 401 |
| Death | General disorders | 2 of 401 |
| Cardiac failure | Cardiac disorders | 2 of 401 |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 401 |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | 1 of 401 |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 401 |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 401 |
| Sudden cardiac death | General disorders | 1 of 401 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 401 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 401 |
Serious events with the highest arm-level rate: chronic obstructive pulmonary disease (0.5%), death (0.5%), cardiac failure (0.5%), gallbladder cancer (0.2%), respiratory arrest (0.2%).
The registry lists safety information for the group titled Total COPD Patients. Serious adverse events affected 12 patients among the 401 listed as at risk. The count for other adverse events is 0, and the death count is 9. These are separate registry fields; the record does not explain the overlap, if any, between deaths and serious adverse events. They should not be added together or treated as mutually exclusive categories.
The listed serious terms and percentages are chronic obstructive pulmonary disease, 0.5%; death, 0.5%; cardiac failure, 0.5%; gallbladder cancer, 0.2%; respiratory arrest, 0.2%; and lung neoplasm, 0.2%. These entries identify reported terms, but the registry record does not provide further case narratives, timing, severity details beyond the serious classification, or an assessment of whether events were related to treatment.
These safety figures are descriptive counts in the listed group, not a comparison between randomized arms. Since allocation is not stated and no control comparison is described, the counts cannot establish comparative risk or causation. The registry record does not report additional detail needed to interpret event exposure time or the circumstances of individual events.
12. What the Result Does, and Does Not, Mean
The record identifies a clear measurement question: patient-reported satisfaction with pharmacological COPD treatment across the enrollment and follow-up visits, assessed through the TSQM Version 1.4. It defines three distinct domains and specifies that higher scores indicate higher satisfaction. The broader study also sets out questions about treatment experience, adherence, clinical measures, patient-reported outcomes, and resource use.
What the record does not establish is the observed level of satisfaction, whether scores changed during follow-up, or how precise any estimate was. The primary means and standard deviations are not reported in the registry record. Numerical results for the registered secondary relationships are also not reported. It is therefore not possible to describe the size, direction, or statistical uncertainty of those findings from this record.
The observational setting matters for interpretation. Satisfaction may be associated with adherence, health status, clinical parameters, or resource use, but an association does not prove that one measure caused another. The registry does not describe randomized allocation or a like-for-like comparator. The data should not be read as a randomized estimate of a treatment effect.
The outcome definition also does not supply a clinical threshold for meaningful change. A difference in a score, if one were reported, would need to be interpreted with its uncertainty, the scale's context, and an appropriate threshold for importance. No such numerical change or threshold is reported in the registry record.
Accordingly, the record supports understanding of the intended questions, outcome construction, follow-up schedule, analysis population definition, and descriptive safety fields. It does not support a conclusion about the actual trajectory of satisfaction or the strength of its relationships with other measures. Those results are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of measuring a patient-reported construct over time rather than reducing treatment experience to a clinical measure alone. Its primary outcome separates effectiveness, convenience, and global satisfaction, allowing the study question to distinguish different aspects of treatment experience. That distinction matters because an overall view may not capture how a patient assesses each domain.
The score definition also makes the completeness requirement explicit: each domain needs all three of its component items. This illustrates how missing responses can affect which scores are calculable, even before decisions about missing follow-up visits are considered. Knowing the eligible analysis population is not enough to understand the precision of repeated outcome estimates; the number of valid observations at each visit and their handling are also relevant, and those details are not reported in the registry record.
The planned links between satisfaction, adherence, health status, clinical parameters, and resource use raise a second statistical lesson. Observational associations can help describe patterns in care and patient experience, but do not by themselves establish direction or cause. The absence of a stated allocation and a like-for-like control comparison constrains treatment-effect interpretations.
Finally, an outcome definition and a completed status are not substitutes for posted numerical results. Without means, dispersion, or uncertainty estimates, readers cannot evaluate the observed level, change, or precision of satisfaction. The registry record is useful for understanding what was intended to be measured, while leaving the primary empirical findings not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting the primary outcome is that numerical TSQM results are not reported in the registry record. The record gives the score construction and scheduled visits but not the domain means, standard deviations, or uncertainty estimates. Consequently, the observed satisfaction level and its trajectory cannot be assessed.
The registry defines the Full Analysis Set as enrolled patients evaluable for baseline data analysis, but does not report the size of that set or the number contributing valid scores at each visit. Because each domain requires all three component items, the number of usable scores may differ by domain or visit; actual counts are not reported. The approach to missing follow-up data and any sensitivity analyses are also not reported in the registry record.
Allocation is not stated, and there is no described like-for-like control comparison. Thus, relationships between satisfaction and adherence, clinical measures, patient-reported outcomes, or resource utilization cannot be interpreted as causal effects from the registry description. The specific statistical methods for repeated measures and secondary relationships are not reported.
The record does not report a multiplicity strategy for the numerous secondary questions, nor does it state thresholds for meaningful differences in satisfaction scores. Safety information is presented as descriptive group counts and selected terms, without further detail on timing, treatment relationship, or overlap between the serious-event and death counts. These omissions limit what can be concluded from the posted registry information, independent of the study's stated aims.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SATisfaction and Adherence to COPD Treatment — NCT02689492.
- Registry record last updated 2019-08-28; status last verified 2019-07.
- Results first posted 2019-08-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02689492, SATisfaction and Adherence to COPD Treatment, is listed as completed, with enrollment of 401. The registry lists Boehringer Ingelheim as sponsor, a start date of 2015-12-11, and a primary completion date of 2017-09-15.
The primary outcome is mean satisfaction with pharmacological COPD treatment measured using TSQM Version 1.4 at enrollment, 6-month follow-up, and 12-month follow-up. The three domains are effectiveness, convenience, and global satisfaction, each scored from 0 to 100. The analysis population is defined as the Full Analysis Set of enrolled patients evaluable for baseline data analysis.
Numerical primary and secondary outcome results, visit-specific analysis counts, missing-data methods, and the statistical analysis plan are not reported in the registry record. Allocation is not stated, and no randomized comparator is described.