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 Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (NCT00699660), a randomized na study. The primary outcome is Completeness and Quality of PTSD Interview.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00699660 |
| Phase | NA |
| Condition | Post-Traumatic Stress Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 406 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes an evaluation of PTSD disability assessment during an initial PTSD C&P examination. Post-Traumatic Stress Disorder is the listed condition. It does not report further eligibility details or a more specific description of the participant population.
Intervention
The CAPS/WHODAS approach used a structured, evidence-based interview incorporating the Clinical Assessment of PTSD Symptoms and WHODAS functional impairment assessment. The project evaluated whether semi-structured, standardized interviews affected the assessment process.
Comparator
The comparator was a usual clinical interview to assess PTSD, without CAPS or WHODAS. The registry describes this as a nonstructured interview. It does not report additional details about interviewer training or how interviews were conducted across the trial.
Primary question
The primary outcome concerned completeness and quality of the PTSD interview, including completeness of diagnostic assessment and functional assessment. The recorded timing was post-exam, same day. The registry record does not give a single numerical comparison between the interview approaches, so it does not establish the size or direction of any difference.
3. Trial Design
The registry record identifies this as a randomized, parallel-group trial with no masking. The two behavioral interventions were CAPS/WHODAS and a nonstructured interview. The trial evaluated semi-structured, standardized interviews during the initial PTSD C&P examination. The record lists an enrollment of 406 and a completed status.
The CAPS/WHODAS arm is described as using the Clinical Assessment of PTSD Symptoms together with WHODAS functional impairment assessment. The comparator is described as a usual clinical interview without those instruments. This contrast concerns the structure and content of assessment; it is not a comparison of a medication or other clinical treatment.
The registry records a start date of 2009-05 and primary completion of 2010-09. Phase is listed as NA. It names the VA Office of Research and Development as sponsor. The record does not report further information about allocation procedures, concealment, interviewer assignment, or whether the same clinicians conducted both approaches. Randomization is recorded, but its implementation cannot be assessed from the information reported.
Although the record lists four outcome measures and four analyses, the primary outcome is not reduced to one comparison. The registry notes that the primary outcome has several categories or time points. The arm-level primary results, the analysis population, and a complete statistical analysis plan are not reported in the registry record. The trial design therefore identifies the intended comparison, but the available record does not provide enough outcome detail to quantify its result.
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 | Arm 1 | Arm 2 |
|---|---|---|
| STARTED | 190 | 216 |
| COMPLETED | 176 | 208 |
| NOT COMPLETED | 14 | 8 |
Reasons for not completing this period:
| Reason | Arm 1 | Arm 2 |
|---|---|---|
| Lost to Follow-up | 4 | 2 |
| missing reports and recording failures | 10 | 6 |
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.
Population: Veterans undergoing compensation and pension examination for PTSD
| Characteristic | Unit | Arm 1 | Arm 2 | Total |
|---|---|---|---|---|
| Participants analysed | 176 | 208 | 384 | |
| Age, Continuous | years | 60 (41 to 63) | 59 (41 to 62) | 59 (41 to 62) |
| Sex: Female, Male: Female | Participants | 6 | 13 | 19 |
| Sex: Female, Male: Male | Participants | 170 | 195 | 365 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 44 | 56 | 100 |
| Race (NIH/OMB): White | Participants | 103 | 124 | 227 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 29 | 28 | 57 |
| Marital Status: Married | participants | 108 | 130 | 238 |
| Marital Status: Single | participants | 28 | 35 | 63 |
| Marital Status: Separated | participants | 32 | 37 | 69 |
| Marital Status: Other/Missing | participants | 8 | 6 | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Completeness and Quality of PTSD Interview, measured over Post-exam, same day.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of criteria PTSD assessment |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Completeness and Quality of PTSD Interview. It is a continuous measure described as a percentage of criteria PTSD assessment. The registry describes a total completeness of diagnostic assessment score ranging from 0 to 100% and also refers to completeness of functional assessment. The recorded assessment time is post-exam, same day.
This endpoint is relevant to the stated study question because the intervention changes how the assessment interview is structured. A completeness measure can describe whether the interview captured the intended diagnostic and functional information. In general, measuring interview completeness can help distinguish the quality of information gathering from later decisions made using that information. It does not, by itself, establish diagnostic accuracy, fairness, patient benefit, or the consequences of an assessment.
The record specifies a mean parameter and standard deviation as the dispersion measure. However, it does not provide the arm-specific means, standard deviations, sample sizes contributing to the primary outcome, or a single between-arm estimate. It also does not clarify how the diagnostic and functional components relate to the several categories or time points noted in the registry. Without those results and definitions, the endpoint can be described but not quantitatively interpreted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes that the trial randomized participants to a CAPS/WHODAS interview approach or a nonstructured interview approach and assessed completeness and quality after the examination. It does not report the primary outcome results as one comparison. Consequently, the record does not support a conclusion about which approach had a higher mean score, how large any difference was, or how precise an estimate might be.
The primary measure is described as a mean of a continuous outcome, with a standard deviation. In general, a mean describes the average score in a group, while a standard deviation describes variation among scores. To interpret the randomized comparison, readers would ordinarily need the arm-level estimates and a between-arm effect estimate with its uncertainty. Those results are not reported in the registry record. The stated scale range of 0 to 100% provides context for the measure but does not reveal where either arm scored.
The registry also lists secondary outcomes of PTSD diagnosis, patient satisfaction, and resource utilization. It does not report their results in the available record. Their presence indicates additional areas of interest, but their names alone do not show whether they were measured in a way that permits comparison or what the findings were.
The trial is marked completed, and the record reports enrollment of 406. Completion status and enrollment do not substitute for outcome reporting. They cannot establish whether all enrolled participants contributed to each endpoint, whether data were missing, or how the trial's results were analyzed. Those details are not reported in the registry record.
The posted serious and other adverse-event fields report zero affected participants in each listed arm, with the reported at-risk counts of 176 and 208. Death counts are not reported in the registry record. These fields should be read as registry entries, not as proof that no unrecorded events occurred or that all safety information was captured. They do not answer the primary question about completeness of assessment.
Overall, the record describes the comparison and the intended outcome but does not provide a result that can be interpreted as evidence for or against either interview approach. No efficacy or effectiveness claim follows from the design description alone. A quantitative conclusion would require the outcome data and analysis details, which are not reported in the registry record.
9. Statistical Methods Explained
What does a randomized parallel-group design mean?
In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the outset, so a later comparison can be more informative about the intervention contrast. It does not guarantee that groups will be identical, and it cannot correct problems such as missing outcome data or biased measurement. The registry records randomized allocation and a parallel model, but it does not describe the assignment procedure or allocation concealment.
A parallel design means each participant is assigned to an interview approach rather than being described as receiving both approaches in sequence. This design can avoid some complications that arise when the same person experiences multiple conditions, such as effects of order or carryover. That is a general feature of parallel-group studies, not a claim about procedures beyond those recorded for this trial.
What does no masking imply?
The registry lists masking as none. In general, masking means keeping participants, assessors, or other study personnel unaware of group assignment. When the intervention is an interview format, the approach may be apparent to the interviewer, but the record does not specify which roles, if any, could have been masked. Lack of masking can matter when an outcome involves judgment or when knowledge of assignment may influence conduct or scoring. Whether that happened in this trial cannot be determined from the registry record.
How should a mean and standard deviation be understood?
The primary outcome is identified as a continuous measure analyzed using a mean, with standard deviation as the dispersion measure. In general, the mean represents the average score, while the standard deviation indicates how spread out individual scores are around that average. Neither statistic alone gives the uncertainty in a comparison between randomized groups. A confidence interval for a group difference would show a range of estimates compatible with the data under the model used; a narrow interval generally indicates greater precision than a wide one. The registry record does not report a mean difference or confidence interval for one primary comparison.
The outcome is described as a percentage of criteria PTSD assessment, with a range from 0 to 100%. A bounded scale can have characteristics that affect how well a statistical model represents its data, particularly if scores cluster near a boundary. The record does not provide score distributions or model diagnostics, so it is not possible to assess whether the analysis addressed such features.
Why does the outcome structure matter?
The registry states that the primary outcome has several categories or time points and was not reduced to one comparison. This matters because an outcome label may cover multiple related measures, components, or assessment times. Readers need to know which comparison was prespecified, how components were scored, and how repeated or multiple measurements were handled before interpreting a result. Those details are not reported in the registry record. The general statistical concern is that selecting among many possible comparisons after seeing results can make nominal uncertainty measures misleading unless the analysis accounts for that selection.
What do the planning illustrations represent?
Planning illustrations based on an observed effect are not observed power. In general, sample-size planning asks how much information a future study would need to detect a chosen effect under stated assumptions. The registry's planning description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation; it says the effect to detect is a stated fraction of the observed effect. For time-to-event tables, it describes total events; for other outcomes, it describes participants per arm. These are planning conventions, not results from the randomized comparison and not evidence that the original trial had a particular power.
The planning description says the illustrations are based on the observed effect, but the registry record does not report a single primary-outcome effect to use for interpretation. Any planning values should therefore be understood only alongside their stated assumptions and the outcome definition to which they apply. The record does not report the trial's own sample-size justification or enough information to assess whether the planning assumptions match the original design.
What can be concluded from the listed analysis information?
The record lists four outcome measures and four analyses, but does not give a full statistical analysis plan, model specifications, covariate adjustments, handling of missing observations, or the population used for each analysis. In general, these choices determine what an estimate represents and how robust its uncertainty assessment is. They are especially important when a primary endpoint has multiple categories or time points. Without those details and the actual outcome estimates, the randomized design and measurement description alone cannot yield an estimate of the intervention contrast.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and four analyses, including the primary outcome and secondary outcomes of PTSD diagnosis, patient satisfaction, and resource utilization. It does not describe a hierarchy among outcomes, identify which comparisons were primary within the several categories or time points, or report a method for controlling the risk of false-positive findings across multiple comparisons. In general, when many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase unless the analysis plan accounts for multiplicity. The record does not permit assessment of how that issue was handled.
Missing-data methods and the number of participants contributing to each outcome are not reported in the registry record. The enrollment figure does not establish how many observations were available for any particular analysis. The record also does not describe reasons for missingness, imputation, or sensitivity analyses. In general, missing data can affect both the estimated group contrast and its precision, and the impact depends on why outcomes are absent and how the analysis handles them.
The analysis population is not reported in the registry record. It is therefore unclear whether analyses included participants according to randomized assignment, required complete outcome data, or used another definition. These approaches answer different questions and can produce different estimates. Without the analysis population, missing-data procedures, and outcome-specific results, the registry record does not support a complete appraisal of multiplicity or attrition-related bias.
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 | 176 | 0.0% |
| Arm 2 | 0 | 208 | 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 176 |
| Arm 2 | 0 of 208 |
The serious adverse-event entries report 0 affected participants in Arm 1, with 176 at risk, and 0 affected participants in Arm 2, with 208 at risk. The other adverse-event entries also report 0 affected participants in each arm, with the same arm-specific at-risk counts. These are the registry's recorded figures and should not be interpreted as a comprehensive account beyond those entries.
The deaths field is not reported in the registry record. The record also lists no top serious adverse-event terms. That does not establish that no deaths or other events occurred; it means the corresponding information is not reported in the registry record. The entries do not describe event definitions, observation duration for safety, or methods for collecting adverse events.
These safety fields are separate from the primary interview-completeness outcome. They do not provide evidence about the quality of the diagnostic or functional assessment, and zero recorded affected participants does not resolve the trial's primary question. The randomized groups and their recorded at-risk counts provide context for reading the entries, but the registry record does not describe safety ascertainment in enough detail to assess completeness.
12. What the Result Does, and Does Not, Mean
The trial asks a focused assessment question: whether using CAPS and WHODAS in a structured, evidence-based interview changes the completeness and quality of PTSD assessment compared with a usual nonstructured interview. The randomized, parallel-group design is appropriate in principle for comparing assigned approaches. The registry also identifies the timing and broad character of the primary outcome.
However, the record does not report a single primary-outcome comparison or the arm-level results needed to interpret one. It therefore does not show whether average completeness differed, the direction of any difference, or the precision of an estimate. The measure's stated range does not replace observed scores, and the completed status does not fill the gap in outcome reporting. The same caution applies to the listed secondary outcomes: their inclusion does not reveal their findings.
Even if an outcome comparison were available, completeness of an interview would be a measure of assessment process, not by itself proof of diagnostic accuracy, equitable treatment, patient satisfaction, or improved decisions. Those are distinct questions that require appropriate definitions and results. The registry record does not provide enough information to infer those broader consequences.
The reported adverse-event entries are also limited to the fields recorded. They should not be converted into a conclusion about the absence of all possible safety events, particularly because deaths are not reported and ascertainment details are unavailable.
The defensible interpretation is therefore narrow: the registry describes a randomized comparison of two interview approaches and identifies completeness and quality as the primary assessment focus, but it does not report the primary comparison in a form that supports a quantitative conclusion. No claim that either approach is superior, equivalent, or ineffective follows from the information in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its intervention changes the way information is collected rather than introducing a conventional drug or device treatment. The comparison focuses on whether a more standardized interview format affects completeness of diagnostic and functional assessment. That makes the definition and scoring of the endpoint central: a reader needs to understand what counts as complete, how components are combined, and whether scoring is reproducible.
Random assignment can make a comparison of interview approaches more interpretable than an observational comparison, because assignment is intended to reduce systematic baseline differences. But randomization alone does not ensure an unbiased outcome assessment. The registry records no masking, while the outcome concerns interview completeness and quality. The record does not state who scored the interviews or whether scoring was independent of assignment, so potential measurement influences cannot be evaluated.
The registry's note that the primary outcome has several categories or time points also highlights a general reporting issue. A broad outcome title is not enough to identify the estimand, meaning the precise quantity the analysis seeks to estimate. A clear primary comparison, its uncertainty, and a transparent approach to multiple measures are important for interpreting findings without selectively emphasizing particular results.
Finally, this record illustrates why design details and outcome results must be read separately. Randomization and a completed status describe the study, but do not provide the effect estimate. Without the outcome comparison, readers cannot judge magnitude or precision. The statistical importance of the question is clear from the contrast between standardized and usual interviews; the empirical answer is not reported in the registry record.
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 trial-specific limitation for interpretation is that the registry record does not report a single primary-outcome comparison. It describes the measure and timing but does not provide arm-level means, standard deviations, a between-arm estimate, or uncertainty for that estimate. As a result, the magnitude and direction of the primary finding cannot be assessed.
The primary outcome is described as having several categories or time points, but the registry does not specify how those components relate to one another or which comparison should be treated as primary. The scoring details, including how diagnostic completeness and functional assessment completeness are represented, are not reported in the registry record. This limits assessment of what the endpoint captures and how readily it can be interpreted.
The registry records no masking, but does not specify which study roles were unmasked or how outcome scoring was performed. It also does not report interviewer training, assignment procedures, allocation concealment, or whether interviewers and assessors were kept distinct. These omissions prevent appraisal of possible influences on administration and scoring.
Analysis populations, outcome-specific participant counts, missing-data handling, model details, and multiplicity procedures are not reported in the registry record. Nor does the record supply results for the listed secondary outcomes. The safety fields contain limited event entries, and deaths are not reported in the registry record. These limitations concern the information available for interpretation; they do not establish that the study procedures themselves were inadequate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment — NCT00699660.
- Registry record last updated 2018-08-16; status last verified 2018-07.
- Results first posted 2014-10-16.
- 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 identifies NCT00699660 as Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment. The sponsor is the VA Office of Research and Development. The record lists randomized allocation, a parallel model, no masking, and an enrollment of 406. Status is completed; the recorded start is 2009-05 and primary completion is 2010-09.
The comparison is between CAPS/WHODAS and a nonstructured interview. The primary outcome concerns completeness and quality of PTSD interview, measured after the exam on the same day. The record describes a continuous mean outcome with standard deviation, but notes that the primary outcome has several categories or time points and is not reduced to one comparison. The primary results and several key analysis details are not reported in the registry record.