The Tobacco, Alcohol, Prescription Medication and Other Substances Tool: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Tobacco, Alcohol, Prescription Medication and Other Substances Tool (NCT02110693), a na na study. The primary outcome is Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview.

2. Clinical Question

3. Trial Design

This completed study was registered as a single-group validation study, not as a randomized trial. Allocation is listed as NA, and masking is listed as NONE. The registry describes one study intervention: interviewer and tablet administration of the TAPS Tool. All participants were administered the tool via interviewer and tablet computer self-administration in the same session. The record does not describe a separate control group or a treatment comparison.

The listed enrollment is 2057. The study began in 2014-03, had primary completion in 2015-04, and is marked COMPLETED. Its phase is listed as NA. Friends Research Institute, Inc. is the sponsor. These registry entries describe the study structure and conduct dates; they do not establish how many participants contributed data to each outcome analysis.

The stated purpose was to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and related problems. The primary outcome concerns sensitivity for DSM-5 alcohol use disorder diagnosis, measured with the Modified World Mental Health Composite International Diagnostic Interview. Listed secondary outcomes cover high-risk tobacco use measured by ASSIST, unhealthy cannabis use, risky alcohol use, cigarette smoking risk, smokeless tobacco, and a cannabis-positive oral fluid test.

The record lists 11 outcome measures and 14 analyses. It does not describe the allocation process, a masking procedure, or a statistical analysis plan. Because this is a single-group validation design, its central statistical question is measurement performance, not whether assignment to one intervention changes an outcome relative to assignment to a control.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Adult primary care patients

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 Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview, measured over Baseline.

The primary endpoint is labeled sensitivity for a DSM-5 alcohol use disorder diagnosis. The registry names the Modified World Mental Health Composite International Diagnostic Interview as the measure used to determine whether a participant meets DSM-5 diagnostic criteria. The outcome timeframe is Baseline, and the population is adult primary care patients.

In general, sensitivity is the proportion of people who meet a specified reference definition and are identified as positive by the screening approach being evaluated. It is useful in validation research because it describes the extent to which a screening tool detects the condition as defined by the reference assessment. It does not, by itself, describe how often positive screens are correct, which is a different aspect of diagnostic performance.

The registry record does not report the primary sensitivity estimate or its 95% confidence interval. It also does not state the threshold or classification rule used to determine a positive TAPS result for this endpoint. Without those details and the estimate, readers cannot judge the observed sensitivity, its precision, or how performance may vary with a different screening threshold. The endpoint definition identifies the intended statistical quantity, but it is not itself a numerical finding.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is expressed as sensitivity, a diagnostic-performance measure rather than a continuous change score or a comparison of event rates between randomized arms. The listed reference assessment is the Modified World Mental Health Composite International Diagnostic Interview, which is described as a structured interview assessing whether participants meet DSM-5 diagnostic criteria. The outcome is measured at Baseline in adult primary care patients.

What does sensitivity represent?

In general, sensitivity is the fraction of people who meet a reference definition and are classified as positive by the screening method. It focuses on detection among those who have the condition according to that definition. It is not the same as specificity, which concerns classification among people who do not meet the reference definition, and it is not the same as the probability that a positive result is correct. The registry’s primary outcome identifies sensitivity but does not report the numerical estimate or the decision threshold used to classify a TAPS result as positive.

What does the confidence interval add?

The primary outcome lists a 95% confidence interval. In general, a confidence interval gives a range of values compatible with the estimate under the statistical procedure used and reflects sampling uncertainty. Its width helps readers assess precision, while its position indicates the range of plausible values under that procedure. A confidence interval does not correct bias in the reference assessment, selection of participants, or classification rules. The interval limits and the method used to calculate them are not reported in the registry record.

A sensitivity estimate depends on how the screening tool and reference assessment are defined and applied. In validation work, interpretation can be affected by the threshold chosen for a positive screen, the timing and consistency of assessments, and whether the people administering or interpreting assessments know other results. The record states that interviewer and tablet administrations occurred in the same session, but it does not report the classification threshold, the order of administration, assessor independence, or blinding. These procedural details should not be assumed.

How should the single-group structure be understood?

The study model is single group, allocation is NA, and masking is NONE. The arm description says all participants received interviewer and tablet self-administration during the same session. This arrangement can support evaluating a screening instrument, but it is not a randomized treatment comparison. The registry record does not specify whether the principal analysis compared administration modes, evaluated agreement, or focused only on the diagnostic outcome. The listed primary endpoint remains sensitivity for DSM-5 alcohol use disorder diagnosis.

For a diagnostic measure, the relevant observations are classifications relative to the reference definition. Statistical interpretation depends on the number of people meeting the reference criteria and how the tool classified them. Those cross-classified counts are not reported in the registry record. The record also does not describe whether estimates were adjusted for participant characteristics, clustering, or other features of the data. No adjustment or model should be inferred from the outcome label alone.

What do the planning assumptions mean?

The registry includes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It defines the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s design: the registered study is single group and does not have a randomized two-arm comparison. The assumptions therefore should not be read as evidence that the study used equal allocation or as a report of its planned sample size.

Such planning illustrations are generally used to show how a hypothetical future comparison might be sized under selected assumptions. Their outputs depend on the effect chosen and the statistical model. The registry record does not report the numerical planning results or the fraction scenarios in the registry record recorded for this study. They cannot establish the study’s observed power, and they do not replace a confidence interval for the primary outcome. The protocol’s sample-size justification is not reported in the registry record.

What is not specified about the analysis?

The registry reports 11 outcome measures and 14 analyses, but it does not provide a complete statistical plan in the record. The analysis population, exclusions, handling of missing values, treatment of indeterminate assessments, and method for calculating the primary confidence interval are not reported in the registry record. The record also does not state whether any analyses were adjusted for multiple testing. These omissions limit reproducibility and make it difficult to evaluate how the reported outcomes, if available, relate to the original study question.

General statistical interpretation should separate the measurement definition, the estimate, its uncertainty, and the assumptions used to obtain it. In this record, the definition and interval label are present, but the estimate, interval limits, and several analytic details are not reported. Accordingly, the statistical method can be explained conceptually, but the study’s numerical diagnostic performance cannot be reconstructed from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures and 14 analyses. Multiple listed outcomes and analyses can raise questions about which findings were primary, which were secondary, and whether the statistical plan accounted for repeated testing. The primary endpoint is identified as sensitivity for DSM-5 alcohol use disorder diagnosis, and several secondary outcomes address tobacco, alcohol, and cannabis measures. However, the registry record does not report a multiplicity strategy, such as adjustment of significance thresholds or a hierarchy for interpreting outcomes.

That omission does not show that no adjustment was used; it means the approach is not reported in the registry record. Nor do the counts of outcome measures and analyses establish that all were tested in the same way or that each analysis was confirmatory. The record does not describe which analyses were prespecified, exploratory, or added later.

Missing-data methods and analysis populations are also not reported in the registry record. Although enrollment is listed as 2057, the record does not state how many participants contributed to the primary analysis, whether participants with incomplete assessments were excluded, or how missing or indeterminate results were handled. It does not describe whether the analysis used all enrolled participants or a defined subset. These details matter because exclusions and missingness can affect the population represented by a diagnostic-performance estimate.

The registry record also does not report a complete statistical analysis plan, the method for calculating the primary confidence interval, or the handling of incomplete reference interviews. The absence of these details limits assessment of reproducibility and robustness. It should be treated as a reporting limitation rather than evidence about what the investigators did.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The registry reports serious adverse event figures for the group labeled All Participants. It lists 2000 at risk and 0 affected for serious adverse events. The reported count of deaths is 0. For other adverse events, the record lists 2000 at risk and 16 affected. These are the recorded figures; the enrollment value is 2057, and the record does not explain the difference between enrollment and the adverse-event risk denominator.

These counts are descriptive safety information, not a comparison between randomized groups. The study is registered as single group, and no control arm is described. The figures therefore do not estimate a relative safety difference between treatments. They also do not establish that no unrecorded or unreported events occurred; they describe what the registry entry reports.

The registry record does not provide the event terms in the serious-event list, as no top serious terms are listed. It does not give details about event severity, timing, attribution, or the surveillance procedures used. The 16 other adverse events should not be interpreted as a rate or compared with another population without additional information about definitions, follow-up, and ascertainment. The safety figures should be read alongside those reporting limitations, not as evidence of treatment benefit or harm.

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

The study’s stated aim was to develop and validate a questionnaire for screening and assessing adult primary care patients for tobacco, alcohol, prescription drug, and other drug use and related problems. The primary endpoint is a diagnostic-performance quantity: sensitivity for DSM-5 alcohol use disorder diagnosis, measured using a structured interview. That description identifies what the investigators intended to assess.

However, the numerical primary result is not reported in the registry record. Neither the sensitivity estimate nor the limits of its 95% confidence interval are present. As a result, the registry information does not show how often the TAPS Tool identified participants meeting the reference definition, how precise that estimate was, or whether performance differed across groups or administration modes. The record also does not report a threshold or a detailed analysis of the interviewer and tablet administrations.

The study’s completed status and enrollment of 2057 do not fill that evidential gap. Enrollment is not the same as the number analyzed for the primary outcome, and the record does not provide the analysis population or missing-data methods. Likewise, the stated purpose of validation is not itself proof of a particular level of diagnostic performance.

The record does support describing the design as single group, with interviewer and tablet self-administration in the same session, and noting the listed secondary outcomes and safety counts. It does not support a randomized comparison or a causal claim about treatment. The appropriate interpretation is therefore bounded: the registry defines a validation question and some study characteristics, but the posted information is insufficient to quantify the primary result or its uncertainty.

13. Why This Trial Matters Statistically

This study is statistically relevant because screening validation asks a different question from whether a treatment changes an outcome. The primary measure, sensitivity for a DSM-5 alcohol use disorder diagnosis, concerns how a screening result corresponds to a structured diagnostic assessment. Clear definition of the screening classification and the reference assessment is central to interpreting such a measure.

The study also illustrates why a study’s design and its statistical question must be read together. The registry describes a single-group study in which interviewer and tablet self-administration occurred in the same session. It does not describe random allocation to treatment groups. The results, if reported, would therefore need to be interpreted as validation or measurement findings rather than as a randomized estimate of treatment effect.

The record’s multiple outcome measures and analyses raise a separate statistical reporting issue. Without information on prespecification and multiplicity handling, readers cannot tell how the analysis set was organized or how to interpret a collection of outcome findings. Likewise, without the analysis population and missing-data approach, enrollment alone cannot establish the amount of information behind an endpoint estimate.

Most importantly, the primary endpoint’s definition is present but its numerical value is not reported in the registry record. This distinction is a useful lesson in evidence appraisal: a well-described question and a completed study do not substitute for an estimate and its uncertainty. Statistical interpretation depends on both transparent methods and accessible results.

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 central limitation for interpreting this study from the registry record is that the primary sensitivity estimate and its 95% confidence interval are not reported. The endpoint is named and its diagnostic instrument is described, but the numerical result needed to judge magnitude and precision is absent. The record also does not state the TAPS classification threshold used for the primary outcome.

The design is listed as single group, with interviewer and tablet administration in the same session. Allocation is NA and masking is NONE. No separate control arm is described, so the registry does not support a randomized comparison. The record does not explain whether the administration modes were compared, whether the order was fixed or varied, or whether assessors were independent of one another.

Although enrollment is 2057, the registry record does not report the primary analysis population, exclusions, missing-data handling, or the count of participants meeting the reference definition. It also does not report the method used to construct the confidence interval. These omissions prevent a detailed assessment of precision and potential selection or classification effects.

The record lists 11 outcome measures and 14 analyses but does not report a multiplicity plan or identify the status of each analysis as prespecified or exploratory. The sample-size planning assumptions describe an illustration based on an observed effect and a hypothetical equal-allocation comparison; they are not a description of this single-group study’s design or a report of observed power.

Finally, the serious and other adverse-event counts are presented without detail about event terms, timing, attribution, or ascertainment. These limitations concern registry reporting; they should not be taken as evidence that unreported procedures or results did not exist.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Tobacco, Alcohol, Prescription Medication and Other Substances Tool — NCT02110693.
• Registry record last updated 2018-07-26; status last verified 2018-06.
• Results first posted 2018-04-17.
• 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.

18. Record Summary

NCT02110693 is a completed, single-group validation study sponsored by Friends Research Institute, Inc. The listed enrollment is 2057, with a start date of 2014-03 and primary completion in 2015-04. The study concerns adult primary care patients and the TAPS Tool, administered by interviewer and tablet computer self-administration in the same session.

The primary outcome is sensitivity for DSM-5 alcohol use disorder diagnosis measured using the Modified World Mental Health Composite International Diagnostic Interview. The registry record does not report the numerical sensitivity estimate or its 95% confidence interval. It lists 11 outcome measures and 14 analyses. Serious adverse events affected 0 of 2000 at risk; other adverse events affected 16 of 2000 at risk, and deaths are listed as 0. The analysis population, missing-data methods, and multiplicity approach are not reported in the registry record.