Adult Normative Performance of the Quotient ADHD System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adult Normative Performance of the Quotient ADHD System (NCT01308450), a registered phase not stated study. The primary outcome is Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test..

2. Clinical Question

3. Trial Design

The registry describes a single-arm, single-site study with a single visit. Its one group is titled “Single Arm, Non ADHD Control Group.” The record lists enrollment of 300 and status as completed. The study start is recorded as 2011-03, and primary completion as 2011-06. BioBehavioral Diagnostics Company is listed as sponsor.

The study was intended to add well-screened controls to the existing Quotient ADHD System database for adolescents and adults. Participants were to complete self-assessment questionnaires, including the ADHD Self Rating Scale, Zung Self-Rated Anxiety Scale, Zung Self-Rated Depression Scale, and Mood Disorder Questionnaire, as well as the Quotient ADHD System Test, Adolescent and Adult Version. A physician evaluated each participant’s assessment scores. Those assessed as normal without ADHD were eligible for inclusion in the normative database.

This design is not a randomized comparison. The registry record does not state an allocation method, and the single-arm structure does not provide a like-for-like control comparison within the study. The study’s stated purpose is to extend reference data, rather than to evaluate a treatment against a comparator.

The primary outcome timeframe is recorded as 12 to 18 weeks, while the arm description calls the study a single-visit study. The registry record does not explain the relationship between these descriptions. Further protocol details, including the recruitment process and any eligibility criteria beyond the screening description, 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.

Before assignment: This one visit, one site study was conducted to enhance and extend the current "normative" database of the adolescent and adult version of the Quotient ADHD System, an FDA cleared medical device. The study enrolled both male and females, between the ages of 15 and 55 (to match the current database)who were considered "normal", non-ADHD subjects.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test., measured over 12 to 18 weeks.

The primary outcome is framed as the number of well-screened non-ADHD controls added to the existing adolescent and adult database, with the aim of expanding the normative reference range of performance on the Quotient test. The outcome is expressed as a number of participants. This is a database-augmentation measure, not a measure of treatment benefit or a direct estimate of diagnostic accuracy.

To determine who could contribute normative data, participants were to complete rating scales intended to screen for ADHD, anxiety disorder, depressive disorder and bipolar disorder. The registry also describes physician review of each participant’s assessment scores. Those evaluated as normal without ADHD could have their Quotient test results added to the existing non-ADHD normative database.

The outcome timeframe is recorded as 12 to 18 weeks. The registry record does not report the number who met the screening criteria, the number whose test results were added, or a numerical summary of test performance. It also does not provide a reference range or describe how the range was calculated. Thus, the stated endpoint identifies what the study was intended to contribute, while the posted results do not quantify that contribution.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study’s purpose determines what statistical methods would be relevant. A normative database is intended to describe test performance among a specified reference population. Its central statistical product would ordinarily be a distributional description, such as a reference range, together with information about the population and the precision of that description. The registry states the goal of expanding the normative reference range, but does not report the distribution or the method used to define that range.

What does a single-arm design allow?

In a single-arm study, data are collected from one group rather than from groups assigned to different interventions. Here, the recorded group is a non-ADHD control group, and the stated purpose is database augmentation. This design can describe the enrolled group’s measurements if those measurements and summaries are reported. On its own, it does not estimate a between-group treatment effect or provide a randomized comparison. The registry does not list a comparator arm or an allocation method.

What would an estimate and its confidence interval mean?

In general, an estimate is a numerical summary calculated from observed data. A confidence interval describes the uncertainty around an estimate under the assumptions of the statistical method. For a normative study, intervals may help communicate uncertainty in estimates of the reference population’s performance. The registry record does not report a numerical test-performance estimate or a confidence interval, so neither the size nor the precision of such an estimate can be evaluated from the posted results.

Why does screening matter?

The record describes screening for ADHD, anxiety disorder, depressive disorder and bipolar disorder using named self-assessment scales, followed by physician evaluation. In general, screening rules define who is included in the reference group and therefore affect which population the resulting reference data describe. The registry does not report the scale scores, thresholds, screening outcomes, or details of how physician evaluations were applied. That limits assessment of how consistently the intended reference group was identified.

How should the planning assumptions be read?

The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe detecting a stated fraction of an observed effect. These assumptions are not evidence that this single-arm study used a two-arm design. Any sample-size figures based on such assumptions are planning illustrations, not observed power and not a report of the study’s own design. The registry record does not list the numerical planning rows or the observed effect used to generate them.

In general, a normal approximation uses a mathematical distribution to approximate the sampling behavior of an estimate. Whether that approximation is suitable depends on the outcome and data structure. The registry describes the primary outcome as a participant count, but does not provide an analysis method, test-performance results, or an effect estimate. The stated planning assumptions cannot fill in those missing analyses.

What does over-dispersion mean in general?

For count outcomes, over-dispersion means that observed variability is greater than expected under a model’s assumptions. If present and ignored, it can make uncertainty appear smaller than it is. This is a general statistical consideration, not a reported feature of this study. The registry record provides no outcome distribution or analysis from which over-dispersion could be assessed. The count data posted for adverse events are not a substitute for the primary test-performance data.

The registry lists no analyses. It therefore does not report a statistical model, adjustment strategy, confidence interval, hypothesis test, or method for constructing normative limits. These absences mean the planned scientific aim can be described, but the statistical result and its uncertainty cannot be reconstructed from the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Adolescent and Adult Normative Group")
n      <- c(300)
events <- c(300)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Adolescent and Adult Normative Group  300  300  100.0  98.8  100.0  98.7  100.0  98.8  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and no analyses. It does not report a multiplicity plan, such as how results would be interpreted if several endpoints, subgroups, or statistical tests were examined. In general, testing multiple hypotheses can increase the chance of obtaining an apparently notable result by chance; prespecified methods can help control that risk. No such methods are reported in the registry record. Because no analyses are listed, there are no posted hypothesis tests to interpret for multiplicity.

The registry does not report a missing-data plan, the amount of missing primary outcome data, or how missing questionnaire or test results were handled. In general, missingness can affect estimates when the observations available for analysis differ systematically from those that are missing. Without counts and analysis details, the extent or direction of any such effect cannot be assessed.

The described screening process identifies participants assessed as normal without ADHD as eligible for addition to the database. The registry does not report a defined analysis population, the number meeting the screening criteria, or whether all enrolled participants completed the test and were evaluated. The record therefore does not establish which participants contributed to the final normative data, beyond describing the intended screening and physician review process.

No adjustment for multiple comparisons, missing-data handling, or analysis-population definition is reported in the registry record. These are reporting gaps, not evidence that a particular method was or was not used outside the registry entry.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists the Adolescent and Adult Normative Group with 300 participants at risk for serious adverse events and 0 affected. It also lists 300 at risk for other adverse events and 0 affected. No serious adverse-event terms are listed among the top terms. These are the posted counts for the registry’s event categories.

A count of 0 affected means that no affected participants are recorded in that category in this entry. It does not establish that the risk of an event is zero, nor does it provide a precise estimate of event risk. In general, uncertainty remains when no events are observed, and interpretation also depends on how events were defined, collected and followed.

The deaths field is not populated with a numerical count, so deaths are not reported in the registry record. The record does not describe event definitions, surveillance procedures, severity grading, or the duration of safety follow-up. The group is a normative control group rather than a treatment arm, and the study description includes a test and questionnaires. The posted event counts should be read as registry reporting, not as a comparative safety assessment.

13. What the Result Does, and Does Not, Mean

The study addresses a specific statistical task: adding screened non-ADHD participants to an existing database intended to characterize performance on the Quotient ADHD System Adolescent and Adult Version. If the resulting observations are appropriately collected and summarized, they could contribute to a description of performance in a selected reference group. The record’s screening description indicates that participant assessment was intended to consider ADHD as well as anxiety disorder, depressive disorder and bipolar disorder, with physician evaluation of individual scores.

The registry entry does not show the numerical test results or the size of the resulting reference range. It also does not report how many participants were assessed as normal, how many were eligible for database inclusion, or how many test results were added. Thus, it is not possible to determine from the posted results how much the database was expanded or how precisely the reference performance was estimated.

The design does not evaluate a treatment. It has a single non-ADHD control group and no recorded comparator arm, so its results cannot be interpreted as evidence for or against a treatment effect. The record also does not present a comparison of diagnostic performance in ADHD and non-ADHD groups. A stated intention to expand normative information is not itself a finding about diagnostic accuracy.

The record reports zero affected participants in the serious and other adverse-event categories. Those counts describe what was entered in the registry; they do not prove the absence of risk. More generally, conclusions about a reference group depend on its selection and the completeness of its data. Details needed to assess representativeness, missingness and the statistical construction of the reference range are not reported in the registry record.

14. Why This Trial Matters Statistically

Normative data give meaning to an individual measurement by placing it in the context of performance in a reference population. A reference range is only as informative as the population and measurement process behind it. This study is statistically relevant because it was designed to add screened adolescent and adult non-ADHD observations to an existing Quotient System database, rather than to test a treatment.

The screening approach matters because the intended database population was not simply described as a group without ADHD. The registry also names scales for anxiety, depression and mood disorder screening, followed by physician evaluation. These procedures define the intended selection process, although the entry does not report screening outcomes or the detailed rules used to make inclusion decisions.

The study’s value as a source of normative evidence cannot be judged from the enrollment figure alone. Interpretation also depends on the observed test results, their distribution, the method used to derive reference limits, and the precision of those estimates. Those results and methods are not reported in the registry record. The record therefore documents an important data-collection aim without enabling an independent statistical assessment of the resulting reference information.

For researchers, this distinction separates a registry’s description of a study objective from an analyzable result. The study may have been completed, but completion status does not supply estimates, uncertainty intervals, or evidence about how well a test performs. The posted entry is most informative about the intended design and screening pathway; it is not a numerical report of the normative performance findings.

15. 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 that the registry record does not report the primary outcome results. It gives the objective and describes the screening process, but does not state the number of participants who qualified for database inclusion, the number of test results added, or any numerical summary of test performance. The contribution to the normative reference range therefore cannot be quantified.

The record describes one group and no comparator. This limits the questions the study can answer within its recorded design: it does not provide a randomized comparison, and it does not report a comparison between participants with and without ADHD. The stated database-building objective should not be mistaken for an evaluation of diagnostic accuracy or treatment effect.

Further details needed to evaluate the normative sample are not reported in the registry record. These include recruitment and selection procedures, participant characteristics, screening thresholds and outcomes, and the handling of incomplete assessments. The record also does not state how the reference range would be calculated or provide estimates of its precision. The relationship between the 12 to 18 weeks outcome timeframe and the single-visit description is not explained.

The registry lists no analyses. It does not report a statistical plan, methods for missing data or multiplicity, or a defined analysis population. The adverse-event record reports zero affected participants for the listed categories, but event definitions and safety follow-up details are absent. These limitations prevent a detailed assessment of the quality, generalizability, uncertainty, and safety-reporting context of the study’s intended contribution.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Adult Normative Performance of the Quotient ADHD System — NCT01308450.
• Registry record last updated 2013-11-27; status last verified 2013-11.
• Results first posted 2013-10-30.
• 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.

19. Record Summary

NCT01308450, titled “Adult Normative Performance of the Quotient ADHD System,” is a completed, single-arm, single-site study sponsored by BioBehavioral Diagnostics Company. The registry records enrollment of 300, a study start of 2011-03, and primary completion of 2011-06.

The stated aim was to expand the normative database for the Quotient ADHD System Adolescent and Adult Version by adding well-screened non-ADHD controls. Participants were to complete rating scales and the Quotient test, with physician evaluation of individual assessment scores. The primary outcome is described as a participant count, with a timeframe of 12 to 18 weeks.

The registry does not report primary outcome results or analyses. It lists 0 affected participants in both the serious and other adverse-event categories. No separate comparator group or randomized allocation is recorded.