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 Supervised Asthma Medication in Schools (SAMS) (NCT01997463), a randomized phase 4 study. The primary outcome is The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01997463 |
| Phase | Phase 4 |
| Condition | Childhood Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 442 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Arizona |
| Results posted | Yes |
2. Clinical Question
Population
The registry identifies the condition as childhood asthma and describes school-based treatment. It does not report detailed eligibility criteria, participant ages, or other demographic characteristics, so the population cannot be characterized more specifically from the registry record.
Intervention
The intervention is supervised asthma therapy in schools: direct supervision of daily controller therapy. The registry’s hypothesis is that this approach will improve asthma control, assessed by the Asthma Control Questionnaire (ACQ), compared with usual care.
Comparator
The comparator is regular asthma therapy, also described as usual care. The registry does not further specify the therapies received under regular care or describe how those treatments were managed.
Primary question
The primary question concerns participants’ ACQ scores at 1 year and whether school-based supervision is associated with better asthma control than regular therapy. The registry also states a cost-effectiveness hypothesis involving cost per quality-adjusted life year (QALY) gained. It does not report the primary-outcome comparison or a cost-effectiveness result.
3. Trial Design
Supervised Asthma Medication in Schools (SAMS) is listed as a Phase 4, randomized, parallel-group trial. The registry reports enrollment of 442 and a completed status. The study start is listed as 2014-08, with primary completion in 2016-06. These dates describe the registry record; they do not establish when each participant entered or completed follow-up.
The two named groups are Regular Therapy and Supervised Therapy. The former is described as regular asthma therapy; the latter as supervised asthma therapy in schools. The intervention description refers to direct supervision of daily controller therapy at school. The registry lists masking as none, so the trial was not masked according to this record. Further details about who knew the assigned treatment, how randomization was implemented, and whether allocation was concealed are not reported in the registry record.
The primary outcome is the ACQ score, with a timeframe of 1 year. The registry describes score thresholds for well-controlled and not well-controlled asthma, and identifies the outcome unit as participants. It also describes a missing ACQ score as a participant who was not administered an ACQ. The registry lists 0 analyses, and no primary-outcome result or comparison is reported. Eligibility requirements, recruitment procedures, the exact visit schedule, adherence measures, and the handling of participants who changed or stopped treatment are not reported in the registry record.
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.
Overall Study
| Stage | Regular Therapy | Supervised Therapy |
|---|---|---|
| STARTED | 192 | 250 |
| COMPLETED | 107 | 147 |
| NOT COMPLETED | 85 | 103 |
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.
| Characteristic | Unit | Regular Therapy | Supervised Therapy | Total |
|---|---|---|---|---|
| Participants analysed | 192 | 250 | 442 | |
| Age, Categorical: <=18 years | Participants | 192 | 250 | 442 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 72 | 88 | 160 |
| Sex: Female, Male: Male | Participants | 120 | 162 | 282 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 128 | 168 | 296 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 | 57 | 105 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 16 | 25 | 41 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 12 | 32 | 44 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 4 | 1 | 5 |
| Race (NIH/OMB): Black or African American | Participants | 17 | 24 | 41 |
| Race (NIH/OMB): White | Participants | 78 | 92 | 170 |
| Race (NIH/OMB): More than one race | Participants | 62 | 66 | 128 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 19 | 34 | 53 |
6. Primary Endpoint
The registry lists the primary outcome as The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ), measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is based on the Juniper Asthma Control Questionnaire (ACQ), a measure used to assess asthma control. The registry defines an ACQ score > 1.5 as asthma that is not well controlled and a score <= 1.5 as asthma that is well controlled. It identifies the timeframe as 1 year and describes the outcome in terms of participants.
In general, a patient-reported or questionnaire-based measure can capture aspects of a condition that may not be represented by a single clinical event. Turning a score into categories can make the result easier to interpret as a count of participants in each control category, but it also groups together participants with different scores within the same category. The registry record does not report the score distribution, the numbers in each category, or a between-group estimate. It therefore does not show whether participants’ ACQ results differed between the treatment groups.
The registry defines a missing ACQ score as a participant who was not administered an ACQ. That definition identifies one reason a score may be absent, but does not report how many scores were missing or how missing results were treated in an analysis. The registry also states a cost-effectiveness hypothesis, but does not report a cost or QALY endpoint result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of supervised school-based asthma therapy with regular asthma therapy, with the ACQ score at 1 year identified as the primary outcome. It records the investigators’ hypothesis that supervised daily controller therapy would result in more effective asthma control. A hypothesis is a question to be tested, not a finding. The registry does not report the ACQ category counts, an effect estimate, a confidence interval, or a test of the primary comparison. It lists 0 analyses. Consequently, the record does not establish the direction, size, or precision of a difference in asthma control.
The ACQ thresholds give a clinical interpretation to individual scores: a score > 1.5 means asthma is not well controlled, while a score <= 1.5 means it is well controlled. Those definitions do not, by themselves, indicate how participants were distributed across categories in either group. Nor do they say how large a between-group difference would be important. Such information is not reported in the registry record.
Statistical precision concerns how much uncertainty surrounds an estimated result. In general, a confidence interval communicates a range of values compatible with the data and the analysis assumptions; a wide interval indicates less precision than a narrow one. No confidence interval for the primary outcome is reported, so its precision cannot be assessed from this registry record. A p-value, even if reported, would not by itself describe the size or clinical importance of an effect. No primary-outcome p-value is reported.
The registry also gives a cost-effectiveness hypothesis: improved control and reduced health care utilization might lead to lower cost per QALY gained than usual care. This is not a reported economic finding. Costs, QALYs, health care utilization results, and an incremental cost-effectiveness estimate are not reported in the registry record. The stated hypothesis cannot be treated as evidence that costs or utilization changed.
The record lists enrollment of 442, but enrollment alone does not reveal how many participants contributed an ACQ result, whether the groups remained comparable during follow-up, or how precisely a treatment contrast could be estimated. Nor does randomized allocation guarantee that every later analysis preserves the benefit of randomization; that depends in part on follow-up and analysis methods, which are not reported. The appropriate interpretation is therefore limited: the registry establishes the design, intervention, comparator, outcome definition, and stated hypotheses, but does not provide the result needed to judge the primary comparison.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design with no masking. It does not report the detailed statistical methods used to analyze the primary outcome. In particular, the analysis population, model, covariate adjustment, handling of missing outcomes, and inferential procedures are not reported in the registry record. The statistical concepts below are general explanations, not claims about methods used in this trial.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable, on average, with respect to factors present before treatment. This helps support a causal interpretation of a well-conducted comparison. Randomization does not ensure that observed group characteristics will be identical, and it cannot prevent bias from missing follow-up data, departures from assigned treatment, or selective reporting. To assess how the assignment was carried out and how participants were analyzed, details beyond the registry’s designation of the trial as randomized would be needed.
How should a categorized questionnaire outcome be analyzed?
The registry presents ACQ thresholds that distinguish well-controlled from not well-controlled asthma and describes the primary outcome as a count of participants. A general analysis of a binary outcome compares the proportion of participants meeting one category in each group, while an analysis of the underlying score could preserve more of the score’s information. These approaches answer related but not identical questions. The registry record does not say which approach was used, how the outcome categories were represented in the analysis, or whether the score itself was also analyzed. No result should be inferred from the threshold definitions alone.
For a binary comparison, an effect estimate needs to state what is being compared, such as a difference or ratio between groups, and should be accompanied by an uncertainty measure where available. A confidence interval helps communicate the range of effects consistent with the observations under the analysis assumptions. General statistical interpretation should consider the estimate’s magnitude and precision, rather than treating a significance test as a complete summary. The registry reports no such estimate or interval for the ACQ comparison.
What do the planning assumptions mean?
The registry record describes planning illustrations based on the observed effect. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s own design justification. The record does not report the original sample-size justification, and a planning illustration is not observed power. In general, planning calculations explore how a future study might perform under specified assumptions; they do not establish that the completed study had a particular probability of detecting an effect.
The record’s general convention distinguishes participants per arm for non-time-to-event planning from total events for time-to-event planning. The primary outcome is an ACQ outcome, not a time-to-event endpoint. No additional numeric planning result is stated in the registry entries, so no planning total or target can be inferred.
Why do dispersion and model choice matter?
In general, model choice should match the type and distribution of the outcome. A binary endpoint has two categories, whereas the underlying ACQ score may contain more detail. If a count outcome varies more than a simple model assumes, over-dispersion can make standard errors too small and confidence intervals too narrow unless the analysis accounts for it. That general issue cannot be assessed for this outcome without the observed data and model details. The registry does not report a model, dispersion estimate, or diagnostics.
What does the absence of a reported analysis mean?
The registry lists 0 analyses and does not provide an ACQ comparison estimate. That means the registry record cannot support an interpretation of statistical significance, effect magnitude, or precision for the primary endpoint. It does not establish what analyses may have been conducted outside the registry; those details are not reported in the registry record. The statistical plan, including any interim analyses, is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. In general, the more comparisons considered, the greater the chance that at least one result will appear unusual by chance if no adjustment or prespecified testing strategy is used. An analysis plan can define which result is primary and how additional tests will be interpreted. The registry identifies an ACQ primary outcome with a 1 year timeframe, but the multiplicity strategy and any adjustment for multiple comparisons are not reported in the registry record.
The registry describes the primary outcome as having several categories or time points and indicates that it was not reduced to one comparison in the posted outcome information. That means a single primary comparison cannot be reconstructed from the record. The registry lists 0 analyses; it does not report category-specific or time-specific estimates, tests, or uncertainty intervals. The statistical plan and any interim analyses are not reported in the registry record.
For missingness, the registry defines a missing ACQ score as a participant who was not administered an ACQ. It does not report the number of missing scores, reasons for non-administration, or whether missingness differed between groups. It also does not report an imputation method, a complete-case analysis, sensitivity analyses, or another missing-data procedure. In general, missing outcomes can affect both the precision and interpretation of a comparison, particularly if the probability of missingness is related to a participant’s health or treatment experience.
The analysis population is not reported in the registry record. It is therefore unclear whether the intended analysis included all randomized participants, participants with observed ACQ scores, or another defined population. Details about treatment adherence, withdrawals, and participants’ analysis assignments are also not reported. These gaps limit evaluation of whether the analysis preserved the advantages of randomization and how representative the reported outcome, if available elsewhere, would be.
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 |
|---|---|---|---|
| Regular Therapy | 0 | 192 | 0.0% |
| Supervised Therapy | 0 | 250 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Regular Therapy | 0 of 192 |
| Supervised Therapy | 0 of 250 |
The registry’s serious adverse event entries report 0 serious events among 192 participants at risk in Regular Therapy and 0 among 250 participants at risk in Supervised Therapy. The other adverse event entries likewise report 0 among 192 at risk in Regular Therapy and 0 among 250 at risk in Supervised Therapy. These are the posted counts for the listed at-risk groups; they do not substitute for a complete account of safety monitoring or establish that no adverse experiences occurred outside the recorded categories.
In general, a zero event count means no events of that specified type were recorded in the stated group. It does not prove that the underlying event risk is zero. The amount of uncertainty around a rate depends on the event definition, ascertainment, follow-up, and analysis. The registry does not provide a safety analysis or confidence intervals for these counts.
No serious adverse event terms are listed. Death counts are not reported in the registry record. A missing death count should not be read as a reported count of zero. The record does not provide additional detail on adverse event definitions, collection methods, timing, severity beyond the serious-event classification, or attribution to treatment.
12. What the Result Does, and Does Not, Mean
The registry record establishes that SAMS was a completed, randomized, parallel-group Phase 4 trial comparing regular asthma therapy with supervised asthma therapy in schools. It identifies an ACQ outcome at 1 year and defines score thresholds for well-controlled and not well-controlled asthma. It also records the investigators’ hypotheses about asthma control and cost effectiveness. These are useful descriptions of the questions the trial was designed to address.
The record does not report the primary-outcome comparison. It gives no category counts, effect estimate, confidence interval, or statistical test for the ACQ endpoint, and it lists 0 analyses. As a result, the posted information does not establish whether asthma control differed between groups, the direction or magnitude of any difference, or the precision of an estimate. The endpoint definitions cannot replace those results.
The cost-effectiveness hypothesis is also not a result. The registry does not report health care utilization, costs, QALYs, or a comparative cost-effectiveness estimate. It is not possible to determine from the registry record whether supervised therapy changed any of these outcomes.
The adverse event entries show 0 serious adverse events and 0 other adverse events in each listed group, with the respective at-risk counts reported in the safety record. These entries are limited to the recorded categories and do not show that all possible adverse experiences were absent. Death counts are not reported in the registry record.
In general, a trial’s design and stated hypotheses describe its aims, while conclusions about an intervention require interpretable outcome estimates and their uncertainty. Those estimates are not reported for the primary outcome in this registry record. Accordingly, the record supports a description of the trial and its intended comparison, but not a conclusion about the comparative outcome or economic value.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how a school-based intervention is evaluated against regular care. The randomized, parallel-group design identifies a direct comparative framework, and the ACQ endpoint gives the question a defined measure of asthma control. The registry’s threshold definitions also illustrate how a continuous questionnaire score can be expressed in clinically interpretable categories.
That categorization makes the result dependent on the selected threshold and on how participants are classified around it. In general, a category-based summary may be easier to communicate but can conceal variation among participants within a category. The underlying scores, category counts, and between-group estimate would all help readers understand the information retained and the uncertainty in the comparison. These outcome details are not reported in the registry record.
The record also distinguishes a clinical outcome question from an economic one. The stated hypothesis links asthma control and health care utilization to cost per QALY gained. In general, an economic comparison requires information on both costs and health outcomes, along with a clearly defined comparison and uncertainty assessment. The registry record reports the hypothesis but not the economic data or analysis results.
Finally, the record is a reminder that a randomized label and an enrollment figure do not alone provide an interpretable result. Follow-up completeness, analysis population, and analytic methods affect how confidently a treatment comparison can be read. The registry reports enrollment of 442, but does not report these methodological details or the primary comparison. The statistical importance of SAMS lies in the clearly stated comparative question; the registry’s missing outcome analysis prevents that question from being answered using this record alone.
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 this trial from the registry record is that the primary ACQ comparison is not reported. Although the outcome, threshold definitions, and 1 year timeframe are identified, the record gives no category counts, score summaries, effect estimate, confidence interval, or statistical test. It lists 0 analyses. The primary result’s direction, magnitude, and precision therefore cannot be evaluated from the registry record.
The outcome description notes several categories or time points and does not reduce these to one comparison in the posted information. The record does not clarify which categories or time points would be used for the primary analysis, or how repeated measurements, if any, would be handled. It also does not report the statistical plan, model, adjustment strategy, or interim analyses.
Important population and implementation details are not reported in the registry record, including detailed eligibility criteria, participant characteristics, randomization procedures, allocation concealment, and the content of regular therapy. The registry says masking was none, but does not provide further information about which study personnel or outcome assessors knew treatment assignments. The extent of adherence to supervised therapy is not reported.
Missing-data information is limited to the definition of a missing ACQ score as a participant who was not administered an ACQ. The number and pattern of missing scores, reasons for missingness, and analysis methods for incomplete outcomes are not reported. The analysis population is also not reported, limiting assessment of how the randomized comparison was maintained.
The economic hypothesis has no reported costs, QALYs, utilization results, or comparative estimate. Safety entries list zero events in the recorded categories, but do not include a detailed safety analysis; death counts are not reported. Together, these omissions mean that the registry record supports a description of the trial’s aims and design, but not a substantive estimate of its clinical or economic outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Supervised Asthma Medication in Schools (SAMS) — NCT01997463.
- Registry record last updated 2022-03-23; status last verified 2022-02.
- Results first posted 2022-03-23.
- 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
SAMS is listed as a completed Phase 4 randomized, parallel-group trial with no masking and enrollment of 442. The study start is recorded as 2014-08 and primary completion as 2016-06. It compares regular asthma therapy with school-based supervised asthma therapy for childhood asthma.
The primary outcome is the Juniper Asthma Control Questionnaire score at 1 year. The registry defines scores > 1.5 as not well controlled and scores <= 1.5 as well controlled. It also states hypotheses concerning asthma control and cost per QALY gained. The primary-outcome comparison, economic results, and analysis methods are not reported in the registry record; the record lists 0 analyses.
The safety entries report 0 serious and 0 other adverse events in each listed group. Death counts are not reported in the registry record.