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 Littlears Auditory Questionnaire: Validation Study in CI Children (NCT00785707), a registered phase not stated study. The primary outcome is To Validate the LittleEARS Auditory Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00785707 |
| Phase | Phase not stated |
| Condition | Hearing Loss |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Med-El Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns children with hearing loss who received a cochlear implant before 24 months of age. The registry lists an enrollment of 31. The named questionnaire version is North American English. Further details about the children included in the outcome analyses, such as their characteristics or the number with complete follow-up, are not reported in the registry record.
Intervention
The cohort is described as children with cochlear implants. The registry does not describe a treatment comparison or specify an allocation method. The stated purpose is to evaluate the LittlEARS Auditory Questionnaire in this population, rather than to estimate the effect of an assigned treatment against a control condition.
Comparator
A comparator group is not described in the available record. The record explicitly indicates that the arms are not a like-for-like control comparison and that allocation is not stated. Although the planning assumptions refer to equal allocation between two arms, details of a second arm and its role in the study are not reported in the registry record.
Primary question
The primary objective is to validate the LittleEARS Auditory Questionnaire in children with cochlear implants. Parents respond to questions about auditory behavior, and the questionnaire produces a score from 0 to 35; lower scores indicate poorer performance and higher scores indicate better performance. The primary measure is described as the mean score at 24 months, with the full range as the dispersion measure. Numerical outcome results are not reported in the registry record.
3. Trial Design
This is a validation study of the LittleEARS Auditory Questionnaire, not a reported randomized treatment comparison. The registry describes a cochlear-implant group comprising children who were less than 24 months old at the time of implantation. Enrollment is listed as 31. The allocation method is not stated, and the registry cautions that the arms are not a like-for-like control comparison. Details about any other arm are not reported in the registry record.
The study record is marked completed. The listed start is 2008-05 and the listed primary completion is 2016-02. The sponsor is Med-El Corporation. The condition listed is hearing loss. These record details describe the study’s registration, but do not establish which participants completed follow-up or how many contributed to each outcome analysis.
The primary objective is to validate the questionnaire in children with cochlear implants. The primary outcome is described as a mean LittleEARS Auditory Questionnaire score over a 24-month timeframe, with full range as the dispersion measure. A secondary outcome concerns change in the scale score over 24 months after first cochlear-implant fitting. The registry lists two outcome measures but no analyses. It does not report a statistical analysis plan, a sample-size justification for the trial, or numerical outcome results. The planning assumptions listed in the record are explicitly described as an illustration rather than the trial’s own design.
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 | Cochlear Implant |
|---|---|
| STARTED | 31 |
| COMPLETED | 24 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Cochlear Implant |
|---|---|
| Lost to Follow-up | 7 |
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 | Cochlear Implant |
|---|---|---|
| Participants analysed | 31 | |
| Age, Continuous | months | 16.2 (11.1 to 24.7) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 12 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 31 |
6. Primary Endpoint
The registry lists the primary outcome as To Validate the LittleEARS Auditory Questionnaire, measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the LittleEARS Auditory Questionnaire, abbreviated as LEAQ in the registry description. Parents answer questions intended to assess auditory behavior in children up to 24 months of age. The scale runs from 0 to 35, with 0 indicating poorer performance and 35 indicating better performance. The questionnaire has no subscales. The primary measure is identified as the mean score, and the stated timeframe is 24 months. Full range is named as the dispersion measure, but the registry does not give the observed mean, minimum, maximum, or other numerical outcome results.
For a validation study, a questionnaire’s score is relevant because it is the instrument being evaluated in the population of interest. Describing scores can show how the measure behaves in that population, while change over time can describe how scores vary during follow-up. These are general statistical interpretations, not findings from this record. The registry does not report validation criteria, a reference measure, or numerical evidence about the questionnaire’s performance. It therefore does not allow readers to determine how closely the instrument’s scores corresponded to any external standard or how precisely the mean was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study’s stated aim: to validate the LittleEARS Auditory Questionnaire in children with cochlear implants. It identifies a 31-participant enrollment, a primary measure based on the mean LEAQ score, and a 24-month timeframe. It also describes the score’s range and direction. However, the registry record does not report numerical primary or secondary outcome results. In particular, no observed mean, full range, change estimate, confidence interval, or test result is reported in the registry record.
The distinction between a study objective and a study result is important. Naming validation as the objective does not itself demonstrate that validation criteria were met. The record does not specify those criteria or present analyses against a reference measure. It lists two outcome measures but zero analyses. This means the posted record does not give an analysis result to interpret; it does not establish whether analyses were performed elsewhere or whether results were unavailable for other reasons.
General statistical interpretation: an estimate describes the value calculated from observed data, while a confidence interval conveys uncertainty around an estimate under the assumptions of the method used. Neither can be evaluated without reported outcome estimates and analysis details. A mean score alone would also need context about the distribution and completeness of observations. The full range can describe the spread between observed extremes, but it does not show how scores are distributed between those extremes. No such numerical summaries appear in the registry record.
The record also does not support a treatment-effect interpretation. It does not describe a randomized comparison, states that allocation is not stated, and cautions that the arms are not a like-for-like control comparison. The registry’s planning assumptions refer to two arms, but the comparator details are not reported. Any contrast between groups would therefore need clear arm definitions and an appropriate analysis before it could be interpreted. Those details are not available in the registry record.
The listed completion status and dates do not resolve these evidentiary gaps. They describe the administrative status and recorded timing, not whether the questionnaire was successfully validated or what scores participants achieved. The cautious reading is that the registry documents a validation objective and outcome definitions, while numerical findings and analysis methods are not reported in the registry record.
9. Statistical Methods Explained
What does the primary measure summarize?
The primary outcome is described as the mean LEAQ score at a 24-month timeframe. A mean is a measure of central tendency: it summarizes a set of observed values with a single average. General statistical explanation: a mean is most informative when read alongside measures of spread and information about who contributed data. Here, the registry names full range as the dispersion measure, but does not report the mean or range values. It also does not describe how missing questionnaire items or incomplete follow-up were handled.
The scale is described as ranging from 0 to 35, with higher values indicating better performance. The registry says there are no subscales. That defines the intended score direction and broad scoring structure, but does not report whether score distributions were assessed, whether any assumptions were checked, or what validation analyses were performed.
What does full range tell a reader?
General statistical explanation: a range describes the distance between the lowest and highest observed values. It can reveal whether observations span a broad portion of a scale, but it is sensitive to extreme observations and does not describe the frequency of values between the endpoints. A range does not, by itself, show uncertainty in the estimated mean. In this record, full range is named as the dispersion measure, but its observed limits are not reported in the registry record.
What is known about the analysis plan?
The registry lists two outcome measures and zero analyses. It does not report the statistical analysis plan, the methods used to assess validity, the treatment of repeated observations, or the method for estimating uncertainty. General statistical explanation: methods for repeated measurements need to account for the fact that observations from the same participant are related. The appropriate approach depends on the design, timing, completeness, and structure of the data. Those details are not reported in the registry record, so no particular repeated-measures method can be attributed to this study.
Likewise, an analysis of a mean may rely on assumptions about the data and the sampling process. General statistical explanation: checking assumptions helps determine whether a chosen method gives suitable estimates and uncertainty measures. The record does not state which assumptions were considered or whether diagnostic checks were performed. It would not be appropriate to infer these details from the stated endpoint alone.
How should the planning assumptions be read?
The record describes a planning illustration based on the observed effect, rather than the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence about the design or observed analysis. The registry does not report numerical planning outputs or the observed effect needed to assess such an illustration.
General statistical explanation: sample-size planning estimates how many participants may be needed to detect a specified effect under stated assumptions. Such estimates are prospective illustrations and do not show the probability that a completed study actually detected an effect. They are not observed power. A planning result also depends on the assumed effect, variability, allocation, significance level, and method. The record explicitly distinguishes its illustration from the trial’s design; it does not report the trial’s own sample-size justification.
What can be concluded about precision?
General statistical explanation: precision is commonly assessed using uncertainty intervals around estimates. A narrow interval indicates less sampling uncertainty under the specified model, while a wide interval indicates greater uncertainty. Intervals also depend on the data and analysis assumptions. No confidence interval or other uncertainty measure for the LEAQ results is reported in the registry record, so the precision of the mean or change over time cannot be assessed.
The registry provides no numerical outcome results, no analysis details, and no numerical sample-size illustration. The endpoint definition is therefore interpretable, but the statistical evidence needed to evaluate the questionnaire’s observed performance is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary objective to validate the LittleEARS Auditory Questionnaire and a secondary measure concerning change in LEAQ score over 24 months after first cochlear-implant fitting. It lists zero analyses. No numerical results or analysis outputs are reported in the registry record.
When a study examines multiple outcomes or conducts multiple statistical tests, the chance of finding at least one apparently notable result can increase. General statistical explanation: multiplicity methods can address this issue, but the appropriate approach depends on which outcomes and tests were planned and how they relate to the study questions. The registry does not report whether multiplicity was considered, whether any adjustment was planned, or which outcome was intended to be confirmatory. It is not possible to infer an adjustment strategy from the outcome list alone.
Missing-data handling is also not reported in the registry record. The enrollment of 31 does not establish how many participants had usable scores at each assessment or whether missing observations occurred. The record does not state how incomplete questionnaires, missed assessments, withdrawals, or other unavailable observations were handled. It also does not identify analysis populations, such as which participants were included in each outcome analysis.
These omissions limit interpretation of both the primary score and the stated change outcome. Without analysis populations and missing-data methods, readers cannot assess how representative the analyzed observations were of the enrolled cohort. Without multiplicity details, readers cannot determine how the study handled the presence of more than one outcome. No assumptions about these choices should be attributed to the study.
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 |
|---|---|---|---|
| Cochlear Implant | 0 | 31 | 0.0% |
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 |
|---|---|
| Cochlear Implant | 0 of 31 |
The registry lists 31 participants at risk for serious adverse events and 0 affected. It also lists 31 at risk for other adverse events and 0 affected. These are the recorded figures for the cochlear-implant group. No serious adverse-event terms are listed. Deaths are not reported in the registry record.
These counts should be read as registry reporting, not as proof that no adverse events occurred under every definition or during every period of observation. General statistical explanation: an observed count of zero does not establish that the underlying risk is zero, particularly when the number observed is limited or follow-up and event-collection methods are unclear. The registry record does not describe the duration or completeness of safety follow-up, event definitions, or how events were assessed for relationship to the intervention.
The record also does not provide detail about events that may not meet the serious-event category beyond the count for other adverse events. The absence of listed serious-event terms means no terms are shown in the record, not that an unreported term can be ruled out. These safety figures should therefore be interpreted narrowly as the adverse-event counts entered in the registry.
12. What the Result Does, and Does Not, Mean
The record documents a study intended to validate the LittlEARS Auditory Questionnaire in children with cochlear implants. It defines the primary score, its direction, and the 24-month timeframe, and it identifies a secondary outcome concerning score change after first fitting. It also records enrollment of 31 and lists the study as completed. These details clarify what the study set out to assess.
They do not establish the observed questionnaire scores or whether the instrument met any validation standard. Numerical outcome results and analyses are not reported in the registry record. The record does not state validation criteria or identify an external reference measure. As a result, it cannot support a conclusion about the measured association, performance, change, or precision of the questionnaire in this cohort.
The record also does not establish a comparative treatment effect. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. A validation objective is different from a randomized comparison of treatments: the former concerns how a measurement instrument performs, while the latter estimates a contrast between assigned groups. The available information is insufficient to interpret a group contrast.
General statistical explanation: study results are most useful when the outcome estimates, uncertainty, analysis population, and methods are reported together. Those details allow readers to distinguish a numerical pattern from uncertainty around that pattern and to assess whether conclusions depend on modeling or missing-data assumptions. The registry record does not include that information for the LEAQ outcomes.
The appropriate conclusion is limited: the registry describes the intended validation study and its outcome definitions, but its posted results do not report the numerical evidence needed to judge the questionnaire’s performance in the enrolled children. The absence of reported results should not be converted into a claim of benefit, lack of benefit, or validation success or failure.
13. Why This Trial Matters Statistically
Questionnaire validation has statistical importance because clinical and developmental research often depends on measurements that represent a construct consistently in the population being studied. A score can be clearly defined and still require evidence about how it behaves in a particular language and population. This study’s stated purpose is to assess the LittleEARS Auditory Questionnaire in children with cochlear implants, extending its stated use beyond the normal-hearing children described in the background summary.
The record identifies a North American English version and describes the questionnaire as a parent-response measure of auditory behavior. It gives the score direction and range, and identifies a 24-month primary timeframe. These details make the measurement question concrete: the study is concerned with the score’s use in a specified clinical population, not simply with a treatment comparison.
Statistically, validation needs more than an instrument description. Readers ordinarily need reported analyses tied to clearly stated validation questions, along with estimates and uncertainty. The record lists two outcomes but zero analyses, and it does not report the numerical findings or validation criteria. Thus, it illustrates a distinction that matters in evidence appraisal: a registered objective identifies what a study intends to examine, whereas reported analyses and results are needed to evaluate what the study found.
The record also highlights why design context matters. It describes a cochlear-implant group but does not provide a like-for-like control comparison. That cautions against treating the record as a randomized efficacy comparison. The statistical relevance of the study lies in its measurement objective, but the posted record does not include the results needed to assess that objective.
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 most consequential limitation for interpretation is that numerical outcome results are not reported in the registry record. The primary mean, full range, secondary change estimate, and measures of uncertainty are absent. Although the record specifies a scale from 0 to 35 and a 24-month timeframe, it does not show the observed score distribution or the degree of precision of any estimate.
The registry also does not state the validation criteria, identify a reference measure, or describe the analysis methods. It is therefore not possible to determine from the record how validation was assessed. Enrollment is listed as 31, but the number contributing data to each outcome and the handling of missing observations are not reported. Participant characteristics beyond the stated cochlear-implant age condition are not reported in the registry record.
Design information is limited. Allocation is not stated, the registry says the arms are not a like-for-like control comparison, and details of a comparator are not reported. The planning assumptions mention two arms, but those assumptions are explicitly an illustration rather than the trial’s own design. The registry does not report the trial’s sample-size justification or a statistical analysis plan.
Safety interpretation is also limited by the absence of information about follow-up duration, event definitions, and ascertainment. The listed adverse-event counts should be read as registry entries, without assuming that they characterize every possible event or observation period. Together, these gaps restrict conclusions to the study’s stated objective and registered outcome definitions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Littlears Auditory Questionnaire: Validation Study in CI Children — NCT00785707.
- Registry record last updated 2017-06-26; status last verified 2017-04.
- Results first posted 2017-06-26.
- 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
NCT00785707 is a completed study titled “Littlears Auditory Questionnaire: Validation Study in CI Children.” The official title identifies the North American English version with LittlEARS My Diary. The listed condition is hearing loss, the sponsor is Med-El Corporation, enrollment is 31, the start is 2008-05, and primary completion is 2016-02.
The stated purpose is to validate the LittleEARS Auditory Questionnaire in children with cochlear implants. The primary measure is the mean questionnaire score over 24 months, with full range named as the dispersion measure. The questionnaire assesses auditory behavior through parent responses and is scored from 0 to 35, with higher scores indicating better performance. A secondary outcome concerns score change over 24 months after first fitting.
The registry lists two outcome measures and zero analyses. Numerical outcome results, analysis methods, and validation criteria are not reported in the registry record. The record lists 0 serious adverse events and 0 other adverse events among 31 at risk; deaths are not reported.