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 Telephone-based Care for OEF/OIF Veterans With PTSD (NCT00680524), a non-randomized na study. The primary outcome is Acceptability to Providers and Patients.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00680524 |
| Phase | NA |
| Condition | Post-Traumatic Stress Disorder |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | US Department of Veterans Affairs |
| Results posted | Yes |
2. Clinical Question
Population
OEF/OIF veterans with post-traumatic stress disorder were the intended population. The record describes veterans receiving care for PTSD; it does not report further eligibility details or participant characteristics.
Intervention
The intervention was phone-based outreach, described in the research plan as TIDES telephone-based nurse care management added to standard PTSD treatment. The registry labels the trial an open pilot.
Comparator
There was no separate comparison group. The study is listed as non-randomized and single-group, so it does not compare the intervention with a control arm or another assigned treatment.
Primary question
The primary outcome concerned acceptability to providers and patients. Both groups rated intervention components on a 5 point scale, where 1 = poor and 5 = excellent; the timeframe was six months. The registry does not report the average ratings.
The research plan describes feasibility as the purpose of the open trial, specifically assessing whether standard PTSD treatment could be augmented with telephone-based nurse care management. The listed primary measure captures acceptability ratings, rather than a reported comparison of PTSD symptoms or another clinical outcome. The registry record therefore identifies what the study set out to assess, but its missing outcome values prevent readers from judging the ratings themselves. With no comparator group, the study also cannot estimate how ratings or other outcomes would have differed under a different care approach.
3. Trial Design
This was a completed, open pilot trial with a single group and non-randomized allocation. The intervention was phone-based outreach, described as TIDES telephone-based nurse care management augmenting standard PTSD treatment. The listed condition was post-traumatic stress disorder. The sponsor was the US Department of Veterans Affairs. Enrollment was 20. The registry lists the study start as 2008-09 and primary completion as 2009-09.
The design is suited to describing experience within the enrolled group, but it does not provide a randomized contrast. No separate control arm is listed, and there is no basis in this record for a like-for-like comparison between participants receiving different assigned care. Because the trial was open, masking was none. The registry describes the arm as an open pilot trial.
The distinction between the study objective and its listed endpoint matters. The research plan says the trial assessed feasibility of adding telephone-based care management to standard treatment. The primary measure is acceptability to providers and patients, assessed using ratings of intervention components. The record does not specify additional feasibility criteria or report how feasibility was judged.
The record lists one outcome measure and no analyses. It does not report the number of providers or patients who posted ratings, how many participants completed follow-up, or whether all enrolled participants contributed outcome data. Completion status means the trial is listed as completed; it does not by itself establish that every planned measurement is available in the registry record. The phase is listed as NA.
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 |
|---|---|
| STARTED | 20 |
| COMPLETED | 17 |
| NOT COMPLETED | 3 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Arm 1 |
|---|---|---|
| Participants analysed | 20 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 20 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability to Providers and Patients, measured over Six months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Acceptability to Providers and Patients. It is a continuous measure reported as a mean, with standard deviation as the stated measure of dispersion. Patients and providers rated intervention components on a 5 point scale, with 1 = poor and 5 = excellent. The listed timeframe is six months, and the record says average ratings for each group are reported; however, the rating values are not reported in the registry record.
Acceptability is relevant to a feasibility-focused pilot because it describes how patients and providers evaluated components of the telephone-based intervention. It is not, by itself, a measure of PTSD symptom change or evidence that the intervention altered clinical outcomes. Ratings from providers and patients represent different perspectives, so their averages would need to be read separately rather than treated as interchangeable.
As general statistical context, a mean summarizes the central level of responses, while a standard deviation describes variation among those responses. A mean alone would not show whether ratings were closely clustered or widely spread. The record does not give either the averages or their standard deviations, nor does it report respondent counts for the outcome. Consequently, the actual acceptability estimates and their precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies an acceptability outcome but does not report its numerical results. It is therefore not possible to describe whether patients’ or providers’ ratings were favorable, unfavorable, or mixed, or how much variation there was in either group. The record also gives no confidence interval or other measure of uncertainty for these ratings. The stated scale anchors establish how responses were interpreted, but they do not reveal the responses collected.
The design places an important boundary on interpretation. This was a single-group, non-randomized, open pilot, not a comparison of telephone-based care with a control condition. Even if acceptability ratings had been reported, they would describe participants’ and providers’ assessments in this study; they would not establish that the intervention caused a change in clinical outcomes. No comparison of outcomes with usual care alone is available in this record.
The enrollment was 20, but the record does not state how many patients or providers contributed ratings. Enrollment should not be assumed to equal the number analyzed. The record lists no analyses, and it does not provide outcome estimates from which statistical significance, precision, or patterns across respondents could be assessed. No conclusion about the magnitude of acceptability is supported by the reported information.
The safety entries list 0 serious adverse events among 20 at risk and 0 other adverse events among 20 at risk. These counts describe the posted safety entries; they do not supply evidence about the primary acceptability outcome. The death count is not reported in the registry record. Zero events in the listed categories should not be read as proof that risks are absent, particularly when the available record does not describe event ascertainment or follow-up in detail.
As general statistical context, results from a small pilot are usually most informative for describing implementation and identifying questions for further study, rather than establishing a definitive treatment effect. That general point does not fill the missing results in this record. The most accurate interpretation is that the study design and intended acceptability measure are documented, while the outcome values needed to assess acceptability are not reported in the registry record.
9. Statistical Methods Explained
The design and available outcome information determine which statistical conclusions are possible. This record describes a single-group, non-randomized, open pilot with enrollment of 20. Its primary endpoint is a continuous measure summarized by a mean and standard deviation. The registry lists no analyses and does not report the endpoint values. The explanations below are general statistical context; they do not imply that any particular analysis was conducted in this trial.
What a mean and standard deviation describe
For a continuous measure, the mean is a summary of the average observed response. The standard deviation describes how dispersed individual responses are around that mean. Together they give more information than a mean alone: two groups can have the same mean but different response variability. In this study, patients and providers rated intervention components on a 5 point scale, anchored at 1 = poor and 5 = excellent. The registry says average ratings for each group are reported, but those averages and their standard deviations are not reported in the registry record.
A rating scale uses ordered response categories. Treating an average of such ratings as a continuous summary is common in descriptive reporting, but the mean does not retain every detail of the response distribution. For example, it cannot by itself show whether responses gathered around one category or were split across categories. As general context, response counts or distributions can complement a mean when the number and pattern of responses are available. Those details are not reported in the registry record.
What uncertainty would mean
A confidence interval is a range of values compatible with the data under a stated statistical procedure. Its width reflects statistical precision: a narrower interval generally indicates more precision than a wider one, given the same method and assumptions. A confidence interval is not reported for the primary endpoint. Since neither the means, standard deviations, nor respondent counts are available, the precision of the acceptability estimates cannot be evaluated from this record.
A p-value addresses how compatible observed data are with a specified null hypothesis under a statistical model. It does not measure the probability that a hypothesis is true, nor does it show the size or practical importance of an effect. No p-value or analysis result is reported in the registry record. There is also no comparator group in this single-group design against which an intervention effect could be estimated.
Why the design affects inference
Random allocation, when used, helps create groups that are comparable on average with respect to factors known and unknown at assignment. This study is listed as non-randomized and single-group, with no separate control arm. Accordingly, it cannot use a randomized between-group contrast to distinguish intervention effects from other explanations for an outcome. This is a general design principle, not a claim that a particular source of bias occurred in this trial.
Open-label conduct means masking was none. As general context, awareness of the intervention can influence reported experiences or ratings, especially when the endpoint is based on judgments by patients or providers. The registry does not describe procedures intended to reduce such influence. Without a comparator and reported ratings, the extent or direction of any influence cannot be assessed.
What planning calculations can and cannot say
Sample-size calculations are planning tools that estimate the amount of information a proposed study might need under specified assumptions. They are not observed outcomes and do not establish that a study had a particular probability of detecting an effect. The planning assumptions associated with the posted illustrations specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. Those are planning assumptions, not a description of this trial’s single-group design. The registry record does not report a sample-size justification for this pilot, and no observed endpoint effect is reported from which to assess the illustrations.
Over-dispersion is a general statistical concern when observed variability is greater than a model assumes. If a model understates variability, its standard errors may be too small and its intervals too narrow. That issue is not specifically reported as a feature of this trial. The outcome is described using means and standard deviations, and no model-based analysis is listed.
In sum, the endpoint definition supports a descriptive interpretation in principle, but the registry record lacks the numerical estimates, respondent counts, and analysis details required to evaluate that description. General methods explain what those statistics would mean; they should not be mistaken for results from this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, titled Acceptability to Providers and Patients, and no analyses. It describes ratings from patients and providers and says average ratings for each group are reported. The separate perspectives could yield separate summaries, but the record does not report those summaries or describe a multiplicity adjustment. A multiplicity plan, including how any multiple outcomes or comparisons were to be handled, is not reported in the registry record.
As general statistical context, evaluating multiple outcomes or testing multiple hypotheses can increase the chance of at least one apparently unusual result when each is judged separately. Methods for addressing that issue depend on the intended questions and analysis plan. The available record does not establish that multiple hypothesis tests were performed, so no claim about multiplicity-adjusted or unadjusted testing is possible.
Missing-data handling is also not reported in the registry record. The record does not give the number of patients or providers who completed the ratings, the number of missing responses, reasons for missingness, or any method for handling incomplete data. It does not state whether analyses used all enrolled participants, only respondents, or another analysis population. Enrollment of 20 cannot be treated as the endpoint denominator without that information.
These omissions affect interpretation because response availability and analysis choices can influence descriptive estimates. Without respondent counts and missingness details, it is not possible to assess how representative the reported ratings would have been even if the averages were available. The record also does not report a protocol-level analysis plan or interim analyses.
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 | 20 | 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 20 |
The registry lists 0 serious adverse events among 20 participants at risk and 0 other adverse events among 20 at risk. These are event counts and denominators in the posted safety record. The death count is not reported in the registry record. No serious adverse-event terms are listed.
As general context, an adverse-event count is a description of events recorded under the relevant category; it is not a measure of the acceptability endpoint. A zero count means no events are entered in that category in the posted results. It does not establish that an event could not occur, or that all possible events were captured. The registry record does not describe event definitions, ascertainment procedures, or the completeness of safety follow-up.
The at-risk count should not be confused with the number of participants who posted acceptability ratings. The record gives no outcome respondent count, and it does not explain whether the safety and outcome populations were identical. These safety entries therefore provide limited descriptive information and do not resolve the missing primary outcome results.
12. What the Result Does, and Does Not, Mean
The record documents a pilot study of telephone-based nurse care management added to standard PTSD treatment, along with a planned acceptability measure for patients and providers. It does not report the mean ratings or their standard deviations. As a result, the posted information does not show how participants or providers evaluated the intervention components, or how consistent their ratings were.
The study’s single-group, non-randomized, open design also limits what any observed ratings could establish. Without a separate comparison group, the study cannot estimate a contrast with another care approach. And acceptability ratings, even if available, would describe judgments about the intervention rather than demonstrate an effect on PTSD or another clinical outcome. The record does not report such a clinical outcome result.
The registry lists enrollment of 20 and a completed status, but it does not report how many people contributed the primary outcome data. The absence of analyses and endpoint values means that neither a statistical comparison nor the precision of the acceptability estimates can be assessed. It is not possible to conclude from this record that the intervention was acceptable or unacceptable, or that it did or did not affect health outcomes.
The safety entries list no serious or other adverse events among the stated at-risk group, while the death count is not reported in the registry record. These limited counts should be interpreted as registry entries, not as proof that no safety concerns could arise. Overall, the record describes the study question and design, but does not contain the numerical primary results needed to answer that question.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a feasibility-oriented pilot objective and the results needed to evaluate that objective. The record describes an open pilot intended to assess adding telephone-based nurse care management to standard PTSD treatment. It identifies acceptability ratings as the primary outcome, with ratings from patients and providers on a 5 point scale. But the outcome values are not reported in the registry record, so readers cannot assess the actual acceptability findings.
The design also illustrates why a single-group study answers a different question from a controlled comparison. A single group can be described, but it does not provide a concurrent contrast that isolates differences associated with the intervention from other influences. This matters especially when the main endpoint is a judgment about intervention components and masking is none. These are general statistical considerations; the record does not establish that any particular bias occurred.
The small enrolled group and missing respondent counts make clarity about denominators especially important. The record lists enrollment of 20, but does not say how many patients or providers contributed ratings. Without outcome counts, averages, and variability, neither the central response nor its precision can be characterized.
Planning calculations have a separate role: they express what a hypothetical design might require under specified assumptions, not the probability that this completed pilot detected an effect. The stated planning assumptions involve two arms, whereas this trial is single-group. The record does not report an outcome effect or trial-specific sample-size justification. The statistical significance of the study therefore lies in the design and reporting questions it raises, not in an unreported treatment effect.
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 direct limitation of the registry record is that it does not report the primary outcome values. Although the outcome is described as mean acceptability ratings with standard deviations, neither the means nor standard deviations appear in the record. No confidence interval or analysis result is reported. Consequently, the principal question about how patients and providers rated the intervention cannot be answered from the posted results.
The study was open, non-randomized, and single-group, with no separate control arm. It therefore cannot support a controlled estimate of the intervention’s effect. These features also mean the record cannot separate changes associated with the intervention from other influences. This is a limit of what the design can establish, not evidence that a specific source of bias occurred.
Enrollment was 20, but the number of patients and providers who completed ratings is not reported. The registry does not provide participant characteristics, response distributions, missing-data handling, or the analysis populations. It is therefore not possible to judge who contributed to the primary endpoint or how representative the ratings may be.
The registry lists one outcome measure and no analyses, but does not report a statistical analysis plan, multiplicity approach, or interim analyses. It also does not give detailed feasibility criteria beyond the stated study objective and acceptability measure. Safety reporting is limited to zero serious and zero other adverse events among 20 at risk; the death count is not reported, and event ascertainment details are absent. These limitations restrict interpretation of both the planned acceptability assessment and the safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Telephone-based Care for OEF/OIF Veterans With PTSD — NCT00680524.
- Registry record last updated 2015-04-28; status last verified 2014-06.
- Results first posted 2014-09-26.
- 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
NCT00680524 is a completed, open, non-randomized, single-group pilot sponsored by the US Department of Veterans Affairs. It enrolled 20 participants and studied phone-based outreach, described as TIDES telephone-based nurse care management added to standard PTSD treatment for OEF/OIF veterans with PTSD. The registry lists the study start as 2008-09 and primary completion as 2009-09.
The primary outcome was acceptability to patients and providers, using ratings of intervention components on a 5 point scale from 1 = poor to 5 = excellent, with a six-month timeframe. The registry record does not report the rating results or any analyses. Safety entries list 0 serious and 0 other adverse events among 20 at risk; deaths are not reported in the registry record. The design does not include a separate comparison group.