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 Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention (NCT00122187), a randomized na study. The primary outcome is Percent of Patients Receiving GI Consult for FOBT+ Results.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00122187 |
| Phase | NA |
| Condition | Colorectal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | US Department of Veterans Affairs |
| Results posted | Yes |
2. Clinical Question
Population
Patients with positive fecal occult blood testing (FOBT+) results in sites that completed the intervention and post-intervention data collection. The registry record gives enrollment as 8 but does not specify whether that count refers to patients, sites, or another unit.
Intervention
An electronic consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results.
Comparator
Usual care, in which primary care physicians remained responsible for follow-up of FOBT+ results.
Primary question
What percentage of patients with FOBT+ results received a gastroenterology consult within 30, 90, and 180 days under the intervention and usual-care approaches?
The clinical context is the follow-up of an abnormal colorectal cancer screening result. The registry description emphasizes that screening only leads to the intended diagnostic pathway when a positive result is followed by complete diagnostic evaluation (CDE). The intervention was designed to change physician- and system-level processes by initiating a consult request automatically. The stated primary outcome, however, is receipt of a gastroenterology consult, not completion of diagnostic evaluation. Those are related but distinct steps: a referral request or consult does not by itself establish that CDE occurred.
The registry record does not report percentages for either arm at any of the listed time points. It therefore does not establish whether the approaches differed, the size or precision of any difference, or whether the consult outcome corresponded to completed diagnostic evaluation.
3. Trial Design
The registry describes a randomized, parallel-group study with no masking. The intervention was the Electronic Consult System; the comparator was Usual Care. The intervention was designed to automatically send a gastroenterology consult request after a positive FOBT result. Under usual care, primary care physicians continued to be responsible for follow-up. The sponsor was the US Department of Veterans Affairs.
The registry lists enrollment as 8. It does not state what unit this enrollment count represents, nor does it identify the unit of randomization. Although the outcome population is described in terms of sites that completed the intervention and post-intervention data collection, that wording alone does not establish whether sites or individuals were randomized. The randomization procedure, allocation concealment, and handling of any grouping or clustering are not reported in the registry record.
The study is marked completed. Its listed start was 2005-08, and primary completion was 2008-05. The phase is listed as NA. The intervention is classified as a device in the registry record, but no further implementation details are reported beyond the automatic consult request description.
The primary outcome is the percentage of patients receiving a gastroenterology consult within 30, 90, and 180 days of FOBT+ results, with a listed timeframe of 6 months. The registry describes the analyzed population as sites that completed the intervention and post-intervention data collection. It does not give the number of such sites, the number of eligible patients, or arm-specific denominators. These omissions make it difficult to assess how much information the outcome analysis contained or how broadly it represents the enrolled study units.
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: Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.
Overall Study
| Stage | Electronic Consult System | Usual Care |
|---|---|---|
| STARTED | 4 | 4 |
| Matched by Colonoscopy Volume | 4 | 4 |
| Randomized to Intervention or Usual Care | 4 | 4 |
| Intervention Implemented | 3 | 4 |
| Post-intervention Data Collection | 2 | 2 |
| COMPLETED | 2 | 2 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Electronic Consult System | Usual Care |
|---|---|---|
| Withdrew because of resource limitations | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: Sites that completed the intervention and post-intervention data collection were included in the analysis
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: The population is the number of VAMCs that enrolled in the study.
| Characteristic | Unit | Electronic Consult System | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 4 | 8 | |
| Age, Customized: Not collected | participants | 4 | 4 | 8 |
| Sex/Gender, Customized: Not collected | participants | 4 | 4 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Percent of Patients Receiving GI Consult for FOBT+ Results, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percent patients receiving GI consult |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the percentage of patients with positive FOBT results who received a gastroenterology consult. The registry specifies assessment within 30, 90, and 180 days after the positive result, and gives the outcome timeframe as 6 months. In plain terms, this outcome tracks whether a consult was received during specified follow-up windows.
This measure is relevant to the intervention’s stated purpose: the electronic system was intended to trigger a gastroenterology consult request, while usual-care follow-up rested with primary care physicians. A consult outcome can therefore describe whether a referral-related step occurred. It is not interchangeable with complete diagnostic evaluation. A request, a completed consultation, and the completion of diagnostic procedures are distinct events; the registry’s primary outcome does not state that all stages were completed.
Assessing the outcome at multiple time points can describe how quickly consults occur as well as whether they occur by later follow-up points. General statistical context: repeated time-point measures can be informative, but they also require clarity about the comparison and analysis used at each point. The registry record does not report the percentages, denominators, or analysis results for these time points. It therefore supports describing the intended endpoint, but not estimating the observed frequency or comparing the arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of an automatic electronic consult system with usual care. It also states the intended outcome: the percentage of patients receiving a gastroenterology consult after a positive FOBT result, assessed within 30, 90, and 180 days. These details describe the question and measurement plan, but they are not outcome findings.
No arm-specific percentages, counts, effect estimates, confidence intervals, or p-values are reported in the record. The primary outcome includes several time points and is not reduced to a single comparison. Accordingly, the posted information does not support a quantitative statement about whether consult receipt differed between the intervention and usual-care arms, how large any difference might have been, or how precisely it was estimated. No direction of effect can be inferred from the intervention’s rationale or design.
The study’s focus also matters for interpretation. The system was designed to send a consult request, whereas the clinical context emphasizes complete diagnostic evaluation after an abnormal screening result. The listed endpoint is receipt of a gastroenterology consult. Without reported results for that endpoint, and without an outcome explicitly documenting completed diagnostic evaluation, no conclusion about completion of CDE follows from the registry description.
The record says that sites completing the intervention and post-intervention data collection were included in the analysis. It does not report how many sites met that criterion or how many patients contributed data. Enrollment is listed as 8, but the unit represented by that number is not specified. Thus, neither the analysis population size nor its relationship to the enrollment figure is clear.
General statistical context: an estimate is more informative when accompanied by its uncertainty, commonly expressed with a confidence interval. Such an interval indicates a range of values compatible with the data under the analysis assumptions; it is not a guarantee that the true effect lies within that range. No interval is reported, so precision cannot be evaluated. Likewise, the absence of a reported comparison is not evidence that the two approaches were equivalent or that no difference existed. The registry record leaves the effect and its uncertainty unknown.
The record lists zero counts in the serious and other adverse-event fields for each arm. These entries should be read as registry fields, not as proof that all possible harms were comprehensively assessed or absent. The methods of adverse-event ascertainment and the completeness of reporting are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the design as randomized and parallel, with no masking. Randomization is a design approach intended to make comparison groups comparable on average with respect to both measured and unmeasured characteristics. General statistical context: randomization does not guarantee balance in a particular study, especially when the number of randomized units is small. Here, the registry lists enrollment as 8 but does not identify the unit counted or the unit randomized. The allocation sequence, concealment procedures, and any method for accounting for site-level grouping are not reported in the registry record.
The planned outcome is a percentage of patients receiving a gastroenterology consult within specified follow-up windows. A percentage is a proportion-based measure: interpretation depends on both the number meeting the outcome definition and the denominator eligible for assessment. The registry record does not give arm-specific numerators or denominators, nor does it report how patients with incomplete follow-up were handled. Without those details, the outcome cannot be reconstructed or its precision assessed.
The primary outcome description includes 30, 90, and 180 days. General statistical context: measuring an outcome at multiple time points can show whether events occur earlier or accumulate over follow-up. The points are not automatically independent comparisons, because patients contributing information at an earlier time can also contribute at a later time. An analysis should specify how these repeated observations are handled and what comparison is primary. The registry record does not report a selected time point, a method for repeated measures, or an analysis that combines or prioritizes the listed time points.
Several statistical quantities commonly used to describe a comparative trial are not reported in the registry record: the arm-specific outcome results, an effect estimate, a confidence interval, and a p-value. General statistical context: an effect estimate describes the contrast between groups on a chosen scale, while a confidence interval conveys the estimate’s uncertainty. A p-value, when reported, evaluates how compatible the observed data are with a specified null model; it does not measure the size or clinical importance of an effect. In the absence of those results, no inferential conclusion can be drawn from the registry description.
The record indicates that no analysis is listed and that the outcome has several categories or time points and is not reduced to one comparison. It does not report a statistical model, adjustment variables, an analysis scale, or a strategy for handling site-level variation. General statistical context: if outcomes are clustered within sites, observations from the same site may be more alike than observations from different sites. Treating correlated observations as independent can understate uncertainty. Whether clustering is relevant to the actual analysis cannot be determined because the randomization unit and analytic method are not reported.
The record includes assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. The convention for time-to-event calculations is total events using Schoenfeld; other calculations are expressed as participants per arm. These are planning assumptions, not a report of the trial’s original design justification. The registry record does not report the original sample-size justification, any target effect, or the results of a particular planning calculation. Any planning illustration based on an observed effect must not be interpreted as observed power or as evidence that the study had adequate power.
General statistical context: power is a design-stage probability of detecting a specified effect under specified assumptions. It is not a measure of whether an observed result is true, and calculations made after observing an effect do not establish the study’s prospective power. Planning estimates depend on assumptions about the effect, variability, allocation, significance level, and analysis. If the observed effect is unknown or no single comparison has been selected, a specific planning result cannot be meaningfully interpreted from the registry description alone.
Finally, the registry’s endpoint is consult receipt, not completion of CDE. This distinction is methodological as well as clinical: an outcome definition must match the event being counted. General statistical context: a precisely measured process step can still be an incomplete proxy for a later outcome. The registry record does not report validation of consult receipt as a measure of completed diagnostic evaluation, and it does not provide a separate CDE result.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described at 30, 90, and 180 days. The registry record does not identify one of these time points as the sole primary comparison, and the outcome is explicitly not reduced to one comparison. It also does not report results for the time points or a method for accounting for multiple comparisons.
General statistical context: when several outcomes or time points are examined, the chance of at least one apparently unusual result can increase if each is assessed separately. Multiplicity methods can address that issue, but the appropriate approach depends on which outcomes were prespecified and how the analyses relate to one another. No multiplicity strategy is reported in the registry record, so it is not possible to assess whether or how the several time points were handled.
The record describes the analyzed population as sites that completed the intervention and post-intervention data collection. It does not report the number of eligible sites or patients, or how many were excluded or lacked follow-up. The handling of missing outcome data, incomplete follow-up, protocol deviations, and participants who did not receive the intended intervention is not reported in the registry record.
The analysis population is therefore only partly characterized. The record does not say whether analyses followed original randomized assignment, used only participants with observed outcome data, or used another approach. General statistical context: excluding units with missing data can affect both precision and the comparability created by randomization if missingness is related to treatment assignment or outcome. Without counts and a stated missing-data strategy, the direction and extent of any such effect cannot be assessed. The record also does not report whether any sensitivity analyses were conducted.
11. What the Result Does, and Does Not, Mean
The record describes a system-level intervention intended to initiate gastroenterology consult requests after positive FOBT results, compared with usual care in which primary care physicians were responsible for follow-up. It specifies consult receipt within 30, 90, and 180 days as the primary outcome. These details define the study question; they do not show what happened in either arm.
Because arm-specific results are not reported, the magnitude, direction, and precision of any difference remain unknown. The record does not establish that the electronic system increased or decreased consult receipt, nor that the approaches were similar. A missing result is not a null finding and cannot be interpreted as evidence of equivalence.
The outcome also represents a particular step in follow-up. Receiving a gastroenterology consult is not the same as completing diagnostic evaluation after an abnormal screening result. The record’s stated rationale concerns CDE, but its primary endpoint is consult receipt. No result for completed diagnostic evaluation is reported, so conclusions about CDE cannot be drawn from this endpoint description.
The study is marked completed, but completion status does not supply missing outcome data. Enrollment is listed as 8, while the unit counted is not specified; the number of sites and the number of patients contributing to the analysis are also not reported. The record therefore does not allow a reader to judge the precision or representativeness of an outcome comparison.
The registry lists zero counts in the adverse-event fields for both arms. Those entries do not establish that harms were comprehensively collected or that none occurred beyond what was recorded. Overall, the record is useful for identifying the intervention, comparator, and intended outcome, but it does not support a conclusion about comparative effectiveness, diagnostic completion, or safety.
12. Why This Trial Matters Statistically
This study poses a practical statistical question about translating a follow-up process into routine clinical practice. Its intervention was not a medication or procedure directed at the patient; it was an electronic system designed to generate a gastroenterology consult request after a positive FOBT result. The comparison with usual care therefore concerns how a care process is organized and whether a specified follow-up step is recorded.
Statistically, the registry highlights the importance of matching conclusions to the measured endpoint. The clinical rationale concerns complete diagnostic evaluation, while the named primary outcome is consult receipt. These events are related, but they are not interchangeable. A study can measure a process step without establishing that the full downstream process occurred.
The outcome is listed at multiple time points, yet the registry record does not identify a single comparison or provide the corresponding results. That makes the record a useful example of why readers need the outcome definition, analysis population, denominators, effect estimate, and uncertainty to interpret a randomized comparison. Randomization alone does not supply those missing results or clarify the unit of analysis.
The record also illustrates the limits of interpreting a completed study entry. Completion status and design labels do not establish the size or direction of an effect. Without outcome data, the intended comparison remains a research question rather than an evaluable result. The listed enrollment count is difficult to interpret without knowing what was counted, and the population definition based on sites completing data collection leaves the analysis size unclear.
For clinical researchers and biostatisticians, these distinctions help keep process measures, patient-level outcomes, and implementation steps separate. They also show why transparent reporting of time-point-specific results, denominators, missingness, and analysis methods is necessary before drawing a comparative conclusion.
13. 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 of the registry record is that it does not report the primary outcome results. No arm-specific percentages, counts, effect estimates, confidence intervals, or p-values are available in the record. The outcome includes several time points and is not reduced to one comparison, which further prevents a single quantitative interpretation.
The enrollment count is 8, but the registry record does not specify its unit. It also does not report the number of sites or patients included in the outcome analysis. Because the analysis population is defined as sites that completed the intervention and post-intervention data collection, the number and characteristics of excluded or incomplete sites are unknown.
The randomization unit and procedures are not reported. The record therefore does not establish whether randomization was at the patient or site level, whether any site-level clustering was incorporated into analysis, or how allocation was generated and concealed. No statistical model or adjustment strategy is reported.
The primary endpoint measures consult receipt, while the stated clinical aim concerns complete diagnostic evaluation. The record does not report a separate CDE outcome or establish that consult receipt represents completion of diagnostic work-up. The handling of missing data, follow-up loss, and deviations from assigned care is also not reported.
Finally, the adverse-event fields list zero counts in both arms, but the record does not describe ascertainment or completeness. These limitations restrict interpretation to the study’s stated design and intended measure; they do not allow conclusions about its comparative results.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention — NCT00122187.
- Registry record last updated 2015-04-24; status last verified 2013-09.
- Results first posted 2014-01-27.
- 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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17. Record Summary
NCT00122187 is a completed, randomized, parallel-group study with no masking, sponsored by the US Department of Veterans Affairs. It evaluated an Electronic Consult System designed to automatically send a gastroenterology consult request after a positive FOBT result, compared with usual care in which primary care physicians remained responsible for follow-up. Enrollment is listed as 8, but the unit represented by that count is not stated.
The primary outcome is the percentage of patients receiving a gastroenterology consult within 30, 90, and 180 days of FOBT+ results, with a listed timeframe of 6 months. The analysis population is described as sites that completed the intervention and post-intervention data collection. The registry record does not report the outcome results, arm-specific denominators, or a single comparison. The randomization unit, statistical analysis plan, missing-data handling, and original sample-size justification are not reported. The endpoint concerns consult receipt rather than completion of diagnostic evaluation.