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 Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty (NCT01990820), a randomized na study. The primary outcome is Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01990820 |
| Phase | NA |
| Condition | Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Endeavor Health |
| Results posted | Yes |
2. Clinical Question
Population
Children with chronic rhinosinusitis are the population of interest. The registry describes a pediatric condition and says caregivers would complete the symptom and quality-of-life questionnaire. A more detailed eligibility description is not reported in the registry record.
Intervention
The intervention is adenoidectomy with balloon dilation of the maxillary sinus opening, followed by maxillary sinus irrigation. The device named in the record is Acclarent Relieva Balloon Sinuplasty.
Comparator
The comparison is adenoidectomy with maxillary sinus irrigation without balloon dilation. The central contrast is therefore the addition of balloon dilation to the procedure, rather than a comparison with no surgery or no irrigation.
Primary question
The trial asks whether caregiver-reported quality-of-life outcomes differ between the surgical approaches. The registry identifies SN-5 assessments at baseline and at 6 and 12 months postoperatively. It does not report the scores, the between-group comparison, or an analysis of change over time.
The clinical rationale in the record is that chronic rhinosinusitis in children is poorly understood and that adenoidectomy and sinus irrigation may be performed with or without balloon dilation. The stated question concerns quality of life after these procedures. It is not a direct comparison of balloon dilation alone against adenoidectomy, since the comparator includes both adenoidectomy and maxillary sinus irrigation.
The outcome description also refers to a separate visual analog assessment of overall health-related quality of life. That rating is scored separately from the SN-5 overall score. The registry does not specify a single time point or a single category as the sole comparison in the posted results, so the exact primary contrast cannot be reconstructed from the record.
3. Trial Design
The study is identified as a randomized, single-masked, parallel-group trial. Randomized allocation means that assignment to the trial approaches was intended to use a chance-based process, rather than being determined solely by participant or clinician choice. The registry does not describe the sequence-generation method, the allocation-concealment procedure, or which people were masked.
The parallel structure compares participants assigned to one surgical approach with participants assigned to the other approach. One arm is described as adenoidectomy with balloon dilation of the maxillary sinus openings and irrigation. The other is adenoidectomy with maxillary sinus irrigation without balloon dilation. The shared procedures make the incremental role of balloon dilation the main intended contrast.
The registry lists enrollment as 25 and marks the study completed. It records a start date of 2009-03 and a primary completion date of 2016-09-29. These dates describe the registry record; further details about recruitment duration, follow-up completion, or reasons for the study timeline are not reported in the registry record. The phase is listed as NA.
The registry identifies a quality-of-life outcome and describes caregiver completion of the SN-5 at baseline, 6 months postoperatively, and 12 months postoperatively. The stated outcome timeframe is 6 and 12 months after surgery. The record does not provide outcome values, participant flow, or details about the number of participants assessed at each time point.
Although the record lists the trial as randomized and completed, it reports no analyses for the outcome. It also does not give a statistical analysis plan, a sample-size justification, or details about the intended handling of missing observations. Those omissions limit how fully the design and results can be assessed from the registry record alone.
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: 4 participants were enrolled on incorrect consent forms so their data were not collected. The IRB provided approval to enroll additional patients to make up for these 4 patients.
Overall Study
| Stage | Arm 1 | Arm 2 |
|---|---|---|
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
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 | Arm 1 | Arm 2 | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 12 | 25 | |
| Age, Continuous | years | 7.0 (SD 2.9) | 6.5 (SD 2.1) | 6.75 (SD 2.5) |
| Sex: Female, Male: Female | Participants | 7 | 6 | 13 |
| Sex: Female, Male: Male | Participants | 6 | 6 | 12 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia., measured over 6 and 12 months postoperatively.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome concerns quality of life in children with chronic rhinosinusitis. Caregivers are described as completing the SN-5 Pediatric Sinonasal Symptom Survey at baseline and after surgery. The questionnaire covers sinus infection, nasal obstruction, allergy symptoms, emotional distress, and activity limitations. Caregivers rate each item on a 7-point response scale, and the responses are averaged into an overall SN-5 score.
The overall score ranges from 1 to 7 in the registry description. A score of 1 is identified as the best quality of life and 7 as the worst. Thus, the score direction matters when interpreting any reported change: lower scores correspond to better reported quality of life on this instrument. The registry identifies the endpoint parameter as a mean and its dispersion as a standard deviation.
The record also describes a caregiver rating of overall health-related quality of life on a visual analog scale from 0, the worst possible quality of life, to 10, the best possible quality of life. This visual analog rating is scored separately from the SN-5 average. The registry does not report results for either measure.
Patient- and caregiver-reported measures can capture symptoms and day-to-day effects that may not be represented by clinical observations alone. That is a general reason for using quality-of-life instruments in clinical research. The record does not report information about validation procedures, scoring rules beyond the stated averages, or how the separate visual analog rating was incorporated into the primary analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison and names quality of life as the primary outcome. However, it does not report the SN-5 mean scores, standard deviations, changes from baseline, or between-arm estimates at either postoperative assessment. It also does not provide confidence intervals or p-values for the primary outcome. Consequently, the record does not establish the size, direction, or precision of any difference in quality-of-life outcomes between the approaches.
The absence of an outcome analysis is important for interpretation. The record lists one outcome measure and no analyses. It also flags that the primary outcome has several categories or time points and was not reduced to one comparison. The stated schedule includes baseline and postoperative assessments at 6 and 12 months, while the primary timeframe is described as 6 and 12 months postoperatively. Without reported results and a defined primary contrast, it is not possible to tell whether the intended comparison was a difference at a particular follow-up, a change from baseline, or a pattern across follow-up assessments.
In general, an estimate of a between-group difference describes the observed contrast, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. Neither is reported for this outcome. A p-value, if reported, would address compatibility with a specified null hypothesis under a statistical model; it would not by itself establish the importance of an effect. No such test result appears in the registry record.
The enrollment entry is 25, but enrollment alone does not indicate how many participants contributed outcome data at each assessment or how precise an estimate would be. The safety entries list participants at risk in each arm, but those figures should not be treated as an outcome-analysis denominator without an explicit link to the quality-of-life analysis. The registry does not report follow-up completion, missing questionnaire counts, or an analysis population for the primary outcome.
The absence of a reported estimate should not be interpreted as evidence of no difference. It means that the registry record does not contain the outcome information needed to describe a difference or its uncertainty. Similarly, the randomized design is relevant to the intended comparison, but randomization alone cannot replace transparent reporting of outcome estimates, analysis methods, and missing-data handling. The available record supports describing the research question and design, but not drawing a conclusion about comparative quality-of-life outcomes.
9. Statistical Methods Explained
What does the listed outcome measure?
The endpoint is described as a mean of a continuous measure, with standard deviation as the dispersion summary. A continuous measure can take values across a scale rather than being limited to categories such as event or no event. For the SN-5, the caregiver ratings are averaged to form an overall score. The record describes the scale as ranging from 1 to 7, with lower values representing better quality of life and higher values representing worse quality of life. The separate visual analog quality-of-life rating runs from 0 to 10 and has the opposite direction: higher values represent better quality of life.
In general, a mean gives a measure of the center of observed scores, while a standard deviation describes how spread out individual scores are around that mean. These summaries do not show the full distribution. They also do not, by themselves, show whether a difference between groups is statistically precise or important to participants. The registry identifies these summary-statistic types but does not report their values.
What would a group comparison mean?
A comparison of the trial arms would address the difference in outcomes between assignment to the procedure with balloon dilation and assignment to the procedure without balloon dilation. Because both arms include adenoidectomy and maxillary sinus irrigation, the intended contrast is the addition of balloon dilation within those surgical approaches. In general, a randomized comparison can support a causal interpretation when assignment and follow-up are conducted appropriately and the analysis respects the trial design. Details needed to assess those conditions, including the specific allocation procedure and analysis population, are not reported in the registry record.
An estimate should be read together with its uncertainty. In general, a confidence interval communicates the precision of an estimated effect: a narrower interval indicates greater precision under the chosen model and assumptions, while a wider interval indicates less precision. A confidence interval is not reported for the quality-of-life outcome. There is therefore no posted estimate from which to assess either the direction or precision of the comparison.
How should repeated assessments be considered?
The SN-5 is described at baseline and at 6 and 12 months postoperatively. Repeated observations can be analyzed in different ways. A study might compare groups at a specific follow-up, compare changes from baseline, or model the measurements over time. These approaches answer related but not identical questions, and their interpretation depends on the analysis specification. The registry does not identify which approach was used, and the posted results do not provide a single comparison across the several time points and categories described.
In general, repeated measurements from the same participant are related rather than independent. Statistical methods for repeated measurements account for that within-participant relationship. The record does not report whether such a method was planned or used. It also does not describe whether the SN-5 and visual analog rating were analyzed separately, how the outcomes were prioritized, or how a result across follow-up times would be summarized.
What do the design labels establish?
Randomized allocation indicates that the study was designed to assign participants by chance to the approaches under study. A parallel design means that participants are assigned to one approach rather than crossing over between approaches as part of the design. Single masking indicates that one party or group was intended to be masked, but the identity of that party is not reported in the registry record. The label does not establish that masking was maintained throughout follow-up or that outcome ratings were completed without knowledge of treatment assignment.
The record does not describe the randomization sequence, allocation concealment, or the procedures used to maintain masking. These are design details that can help readers assess potential sources of bias. Their absence from the registry record does not prove that a procedure was absent; it means the details are not reported in the registry record.
What can be said about sample size and precision?
The registry lists enrollment as 25. Enrollment is a count of participants recorded for the study; it is not a substitute for the number with an observed outcome at each follow-up. The record does not report outcome-specific denominators or a sample-size justification. In general, sample size affects the precision of estimates, but precision also depends on the variability of the outcome and the amount of missing information. No outcome variability or effect estimate is reported for this comparison.
Planning calculations based on an observed effect are not observed trial results and are not a measure of the trial's realized power. Such calculations are illustrative and depend on their assumptions. The registry record does not report a trial-specific sample-size justification or statistical plan, so the intended design assumptions cannot be established from the record.
Why does over-dispersion matter in general?
Over-dispersion is a general concern for count outcomes when observed variability exceeds what a chosen model expects. A model that understates variability can produce uncertainty estimates that are too small. This trial's primary endpoint is described as a continuous mean score, not a count outcome, and the registry does not report a count-based primary analysis. Over-dispersion therefore is not a reported feature of this endpoint. More generally, choosing a model that matches the outcome and its variability is important, but the record does not provide enough analysis detail to assess the model used.
Overall, the record gives the endpoint description and broad design labels but no outcome estimates or inferential results. Statistical interpretation of comparative effectiveness would require the arm-specific outcome summaries, the specified contrast, an uncertainty estimate, and information about follow-up and analysis populations. Those items are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The outcome description includes more than one assessment time: baseline, 6 months postoperatively, and 12 months postoperatively. It also describes the SN-5 overall score and a separate visual analog rating of overall health-related quality of life. Multiple outcomes or time points can create multiplicity concerns when several comparisons are tested. In general, the more comparisons considered, the greater the chance that at least one result may appear notable by chance if no adjustment or prioritization is used. The registry does not report a multiplicity strategy, a hierarchy of outcomes, or a single prespecified contrast to resolve this issue.
The record notes that the primary outcome has several categories or time points and is not reduced to one comparison. It reports no analyses. Accordingly, it is not possible to determine which time point or measure would be treated as primary in an inferential analysis, whether any adjustment was planned, or how multiple results would be interpreted.
Missing-data methods are also not reported in the registry record. The registry does not state how many caregivers completed questionnaires at each time point, why observations may have been missing, or whether missing scores were handled by exclusion, imputation, or another method. In general, missingness can affect the interpretation of an estimate, especially if the likelihood of missing data is related to symptoms, treatment assignment, or other characteristics.
The analysis population is not reported. The registry does not specify whether the primary outcome was to be analyzed according to randomized assignment, among participants who received the assigned procedure, or using another population. These distinctions can affect what a treatment comparison represents. Without the analysis population, missing-data approach, and multiplicity plan, the intended statistical framework cannot be fully assessed.
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 |
|---|---|---|---|
| Arm 1 | 0 | 13 | 0.0% |
| Arm 2 | 0 | 12 | 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 |
|---|---|
| Arm 1 | 0 of 13 |
| Arm 2 | 0 of 12 |
The registry's adverse-event entries list zero serious adverse events in Arm 1 among 13 participants at risk and zero in Arm 2 among 12 participants at risk. It also lists zero other adverse events among the same at-risk counts for the respective arms. These are the posted counts for the listed event categories. The record does not provide serious adverse-event terms.
These figures should be read as reported counts, not as proof that no adverse events occurred beyond the categories and reporting captured in the registry. The record does not give definitions for the event categories, ascertainment procedures, severity criteria, or details about the period over which events were collected. The number of participants at risk in these entries should not be assumed to be the number with complete quality-of-life data.
Deaths are listed as null for both arms. A null entry is not a reported count of zero; deaths are not reported in the registry record. In general, an absence of a recorded event count can reflect missing reporting rather than an observed absence of events. The adverse-event information therefore provides limited descriptive safety reporting and does not allow broader conclusions about comparative safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, single-masked, parallel-group study was conducted to compare adenoidectomy and maxillary sinus irrigation with versus without balloon dilation for pediatric chronic rhinosinusitis. It identifies caregiver-reported quality of life as the principal outcome and describes the SN-5 assessment schedule and scoring direction. It also lists the enrollment as 25 and the study status as completed.
The record does not establish whether quality-of-life outcomes differed between the approaches. It contains no reported SN-5 scores, visual analog ratings, group-level estimates, confidence intervals, or p-values. It therefore cannot show the direction, magnitude, or precision of a comparative effect. No conclusion about benefit or lack of benefit follows from missing outcome results.
In general, a statistically detectable difference and a clinically meaningful difference are not interchangeable concepts. A numerical comparison would need to be interpreted in relation to the instrument, its scoring, the uncertainty around the estimate, and relevant clinical context. The registry record does not provide an estimated difference or a threshold for interpreting clinical importance. A formal claim about either statistical or clinical importance cannot be drawn from the available outcome reporting.
The zero adverse-event counts are limited to the event categories recorded and do not resolve the missing quality-of-life results. The entries for deaths are null, which means a death count is not reported in the registry record. Safety information should therefore be described narrowly, without treating missing reporting as evidence of absence.
Overall, the record is useful for identifying the question, intervention contrast, design labels, and planned outcome assessment. It is insufficient for evaluating the comparative outcome results or the analysis that would support them. Further outcome and methods reporting would be needed to assess the estimated effect, its precision, and the completeness of follow-up.
13. Why This Trial Matters Statistically
This study addresses a statistical question that is easy to misstate: the comparison is not balloon dilation against no treatment. Both arms include adenoidectomy and maxillary sinus irrigation, and the contrast is whether balloon dilation is added. A clear definition of the comparison is essential for interpreting any estimate as the effect of the added procedure within the stated surgical approaches.
The endpoint also illustrates the importance of interpreting a scale according to its direction. The SN-5 overall score is described so that lower scores correspond to better quality of life, whereas the separate visual analog rating assigns higher values to better quality of life. If estimates for both measures were reported, readers would need to keep these directions distinct. The registry describes the instruments but does not report their results.
Repeated measurements raise a further statistical issue. Baseline and postoperative assessments can support different kinds of comparisons, and the choice of analysis affects what question an estimate answers. Since the record does not identify a single comparison across its time points and categories, readers cannot determine the intended summary contrast or whether multiple testing was addressed.
Finally, a completed randomized study without posted outcome analyses illustrates the difference between knowing a trial's design and being able to evaluate its findings. Randomization is relevant to reducing confounding in the planned comparison, but the interpretation still depends on outcome reporting, uncertainty estimates, missing-data handling, and the analysis population. Those details are not reported in the registry record. The record therefore informs the structure of the research question while leaving the central comparative result unresolved.
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 statistical interpretation is the absence of reported quality-of-life results. The registry identifies the outcome and schedule but gives no SN-5 or visual analog values, group comparisons, confidence intervals, or p-values. It also reports no analyses, so the comparative outcome cannot be assessed.
The outcome description includes multiple assessments and measures, but a single primary contrast is not reported. There is no statistical analysis plan in the registry record specifying whether the principal comparison would use an endpoint score, a change from baseline, or a repeated-measures approach. Multiplicity handling is also not reported.
Enrollment is listed as 25, but outcome-specific denominators and participant flow are not reported. The registry does not state how many caregivers completed each questionnaire or how missing observations were handled. Consequently, the completeness and representativeness of the observed outcome data cannot be assessed.
Important design details are also absent from the registry record. The method of sequence generation, allocation concealment, and the identity of the masked party are not reported. The record does not provide eligibility criteria in detail, a sample-size justification, or information about the analysis population. These omissions do not establish that procedures were not used; they limit what can be evaluated from the registry record.
Safety reporting is similarly limited. Event counts are listed, but definitions, ascertainment methods, and follow-up details are not reported. Deaths are not reported in the registry record. These constraints mean that neither the comparative quality-of-life outcome nor the full safety context can be characterized from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty — NCT01990820.
- Registry record last updated 2020-02-19; status last verified 2020-02.
- Results first posted 2019-10-01.
- 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
The registry record describes a completed randomized, single-masked, parallel-group study of pediatric chronic rhinosinusitis. It compares adenoidectomy with maxillary sinus irrigation and balloon dilation against adenoidectomy with maxillary sinus irrigation without balloon dilation. Enrollment is listed as 25.
The primary outcome concerns caregiver-reported quality of life, including the SN-5 overall score assessed at baseline and postoperatively at 6 and 12 months. The score is described as a mean with standard deviation; lower SN-5 scores indicate better quality of life. A separate visual analog rating is also described.
No outcome analyses or quality-of-life results are reported. The registry does not report the statistical plan, missing-data approach, multiplicity strategy, or analysis population. Adverse-event entries list zero serious and zero other adverse events for each arm; deaths are not reported in the registry record.