Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG) (NCT02523196), a na phase 3 study. The primary outcome is Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1).

2. Clinical Question

In practical statistical terms, the planned assessment concerns how a measurement from HQ-Shunt relates to a pressure measurement and to categories defined by that pressure. The record also mentions comparing DSI in identifying patients with cirrhosis and patients with varices. It does not state the analysis method intended for those comparisons, how the categories were to be defined beyond the portal-hypertension threshold, or what level of agreement or discrimination would count as useful.

The registry describes a single-group study in which both procedures were performed, with HVPG required before HQ-Shunt. That arrangement permits within-person measurements to be collected, but it does not establish that the tests are interchangeable or that one can replace the other. No observed DSI values, HVPG values, association estimates, classification results, uncertainty intervals, or analysis results are reported in the registry record. The clinical question can therefore be described from the study plan, but the posted record cannot answer it with results.

3. Trial Design

The registry identifies this as a Phase 3 study with a single-group model, no allocation, and no masking. Its status is completed. The planned enrollment was 20, and the recorded study dates run from 2016-03 to primary completion on 2017-02-23. The sponsor is University of Colorado, Denver. These administrative details describe the registered study; they do not establish how many participants completed each procedure or contributed data to a particular analysis.

The study paired Hepatic Venous Pressure Gradient testing with the HepQuant-SHUNT test. The arm description states that successful HVPG testing was required before administration of HQ-Shunt. This sequence matters when interpreting the comparison: both measurements were intended to be available for a participant, but the registry does not describe random assignment to alternative procedures or a separate untreated control group. The allocation entry is NA, and the record explicitly does not characterize the arms as a like-for-like control comparison.

The study objective was to compare the HQ-Shunt Disease Severity Index with HVPG in identifying patients with cirrhosis and patients with varices, as well as in distinguishing patients categorized with and without portal hypertension. Two secondary outcomes are listed: a survey of patients’ experience of having both procedures and the hours for test. The registry lists 10 outcome measures, but it does not report their results in the posted record.

The record labels the primary outcome as the HepQuant SHUNT test elimination rate, measured during the IV Phase 1 only and expressed in min-1, with a timeframe of up to 90 minutes. Its accompanying description instead emphasizes DSI comparisons by HVPG category. Because the endpoint label and description point to different statistical questions, the record does not make clear how the elimination-rate measure was intended to support the stated DSI comparison. Further protocol detail, including eligibility criteria, visit procedures, and the planned analysis, is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Subjects can be excluded if they do not complete the study visit within 60 days of the HVPG testing or if they test positive in a urine pregnancy test the day of the HQ-SHUNT test.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1), measured over Up to 90 minutes.

The primary outcome is titled “Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1).” It is specified as a mean with standard deviation and has a timeframe of up to 90 minutes. In general, an elimination rate describes how quickly a measured substance is removed during a test. A mean summarizes the average measured value, while a standard deviation describes how spread out values are around that average.

The outcome description introduces a different emphasis: comparing HQ-Shunt DSI for defining patients with portal hypertension, using HVPG of at least 6 mmHg, and those without it, using HVPG below 6 mmHg. It also refers to identifying patients with cirrhosis and varices. This makes the registered endpoint information internally difficult to interpret: the title names an elimination-rate measure, while the description frames a DSI-based classification comparison. The registry does not explain how the two descriptions connect, whether one is a proxy or component of the other, or which summary was designated for the primary analysis.

In general, a reference measurement can be used to define categories when assessing whether another test separates people into those categories. That approach requires reporting the test values and the performance or association measure used to compare them. None of those results or analysis details are reported in the registry record. The endpoint’s intended role can therefore be described, but its observed value and its relation to the stated clinical question cannot be assessed from the posted record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods described in the registry are limited. The study is identified as a single-group study, with allocation recorded as NA and masking recorded as none. The arm description says participants were to have successful HVPG testing before receiving HQ-Shunt. No detailed statistical analysis plan is reported in the registry record. The following concepts explain how this kind of comparison is generally interpreted; they are not claims about methods actually used in this study.

What does a single-group comparison tell us?

In general, a single-group study can collect two measurements in the same study context and examine their relationship. It does not, by itself, compare randomly assigned groups or control for differences created by treatment assignment. If measurements are paired within people, a statistical analysis can account for that pairing, but the registry does not say whether the planned analyses used paired methods. The required sequence of successful HVPG before HQ-Shunt also means the record does not describe a randomized order of procedures.

A comparison with a reference measurement can ask several distinct questions. Correlation asks whether higher values on one measure tend to occur with higher values on another. Agreement asks whether the measures give sufficiently similar values for the intended use. Classification asks whether a test separates people into categories defined by a reference. These are not equivalent questions. A strong correlation does not necessarily imply close agreement, and a category-based comparison needs an explicit measure of classification performance. The registry does not report which statistical approach was selected for these questions.

How does the HVPG threshold fit into the question?

The record describes categories using HVPG of at least 6 mmHg and HVPG below 6 mmHg. In general, a threshold converts a continuous measurement into categories. That can make a clinical comparison easier to state, but it also discards information about how far values lie above or below the cut point. A statistical report would ordinarily clarify how the threshold was applied and show the resulting category-specific test values or classification estimates. The posted record gives the threshold but not the category counts, DSI summaries, or comparison results.

The record also mentions cirrhosis and varices as targets for identification. It does not give their definitions, the reference standard used for those conditions, or the analysis method. Those details are important because different definitions or reference standards can yield different classifications. They are not reported in the registry record.

What do the endpoint summaries mean?

The primary endpoint is labeled as an elimination rate and specifies a mean with standard deviation. In general, the mean describes a central value and the standard deviation describes variability among observations. Neither summary alone shows whether two tests agree or whether a test classifies participants correctly. The endpoint description also frames the analysis as a DSI comparison across HVPG-defined categories. Because the title and description do not align clearly, a reader cannot determine from the registry whether the mean and standard deviation refer to the elimination rate, DSI values, or another analysis population. No endpoint results are posted to resolve that ambiguity.

For a continuous measure, an analysis might report an estimate with a confidence interval. In general, a confidence interval conveys uncertainty around the estimate and helps readers assess its precision. A p-value, if used, addresses compatibility with a specified statistical null model; it is not a measure of clinical importance or precision by itself. The record reports no estimates, intervals, p-values, or null hypotheses, so none can be interpreted for this study.

What does over-dispersion mean in general?

For count outcomes, over-dispersion means that observed variability exceeds what a simple model assumes. If present, a model that does not account for it can understate uncertainty. This concept is not directly established as relevant to the registered continuous primary endpoint, and the record does not describe a count-data analysis or any model. It is therefore a general statistical consideration rather than a reported feature of this study.

How should planning illustrations be read?

The record describes sample-size illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The planning effect is described as a stated fraction of the observed effect. The illustration assumptions also distinguish participant-per-arm outputs from total event counts for time-to-event settings. These are planning conventions, not evidence that the study used those assumptions in its original design or that the study had a particular probability of detecting an effect.

In general, a sample-size illustration shows what a hypothetical future study might require under specified assumptions. It is not observed power, and it cannot replace a confidence interval for the effect actually estimated. The registry does not report the sample-size justification used when this trial was designed. No illustration values are reported in the record, so no specific planning requirement can be interpreted.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("HVPG <6 mmHg", "HVPG ≥6 mmHg")
n   <- c(11, 9)
m   <- c(0.104, 0.092)
sp  <- c(0.017, 0.023)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  HVPG <6 mmHg  11  0.104  0.017  0.093  0.115
CARM  HVPG ≥6 mmHg  9  0.092  0.023  0.074  0.110

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and identifies one primary outcome, while also describing comparisons involving portal hypertension, cirrhosis, and varices. The posted record reports no analyses. It does not describe a strategy for handling multiple outcomes, multiple comparisons, or the risk of false-positive findings when several statistical questions are tested. Whether any multiplicity adjustment was planned or used is not reported in the registry record.

In general, multiplicity arises when several hypotheses or endpoints are examined. The more comparisons made, the greater the chance that at least one result may appear noteworthy by chance under a set of null assumptions. A prespecified hierarchy or adjustment can address that issue, but the registry does not state that one was used. It also does not report which of the listed outcomes were analyzed or how they were prioritized beyond the primary-outcome designation.

Missing-data handling is not reported in the registry record. The posted information does not give the number of participants with available primary endpoint data, the reasons for any missing measurements, or whether incomplete measurements were included in any analysis. It does not describe imputation, complete-case analysis, sensitivity analysis, or other missing-data procedures. The planned enrollment therefore should not be interpreted as the number contributing to every outcome.

The analysis population is also not defined in the posted record. The record does not say whether analyses were based on all enrolled participants, participants who completed both procedures, or another subset. This matters because successful HVPG testing was required before HQ-Shunt administration, and the registry does not explain how failed or incomplete procedures were handled statistically. These omissions limit assessment of both potential bias and the population to which any eventual results might apply.

12. 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.

The adverse-event record lists two groups: Hepatic Venous Pressure Gradient and HepQuant-SHUNT. For each listed group, the number at risk for serious adverse events is 20 and the number with a serious adverse event is 0. For other adverse events, the number at risk is 20 and the number affected is 0. The death count is 0 in each listed group.

These are the figures recorded for the listed groups; they should not be added together to infer a total number of distinct participants. The study description indicates that the procedures were part of a single-group evaluation and that HVPG was required before HQ-Shunt. The registry does not explain whether the group entries represent the same participants across procedures or provide additional detail about event collection and attribution.

In general, a zero count means that no event was recorded in that category in the posted data. It does not establish that an event is impossible or that a procedure has no safety risk. Interpretation also depends on the duration and completeness of follow-up, event definitions, and ascertainment procedures. Those details are not reported in the registry record. No serious adverse-event terms are listed. The counts should therefore be read as the posted safety record, not as a complete characterization of comparative safety.

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

The registry record establishes that a completed Phase 3 study was registered to compare HQ-Shunt DSI with HVPG in people with liver disease. It describes a single-group design in which successful HVPG testing was required before HQ-Shunt. It also gives a planned enrollment of 20, a stated portal-hypertension threshold of 6 mmHg, and a primary endpoint title referring to an elimination rate. These details define the study context and intended questions.

The posted record does not establish how well HQ-Shunt DSI correlated with HVPG, whether the measurements agreed, or whether DSI identified participants in the HVPG-defined categories. It contains no reported outcome estimates, uncertainty intervals, p-values, or analysis results. The listed trial status of completed does not supply those missing results. In addition, the primary endpoint title and its description do not clearly identify a single statistical target.

The design also does not constitute a randomized comparison between alternative tests or a test versus no-test group. It can support an assessment of measurements collected in the study, subject to the analysis and data quality, but the posted registry information does not provide that assessment. No conclusion about the clinical performance of either procedure follows from the design description alone.

The safety entries report zero serious adverse events, zero other adverse events, and zero deaths in each of the two listed groups, with 20 at risk for each event category in each group. Those entries describe what is recorded, but the record does not give follow-up and event-ascertainment details needed to interpret the completeness of safety reporting.

Overall, the record supports a description of the planned comparison and limited safety counts. It does not support a conclusion about whether one test can replace, reproduce, or outperform the other. Those conclusions would require posted results, a clear analysis description, and estimates with enough information to judge their precision and relevance.

14. Why This Trial Matters Statistically

This study is statistically interesting because it places a new test measure alongside an established pressure measurement and frames the comparison in more than one way. The registry mentions correlation and comparison, DSI-based identification, and categories defined by HVPG. These are related but distinct statistical aims. Separating them is essential: association, agreement, and classification answer different questions and require different summaries.

The single-group design and required order of procedures are also important context. A within-study comparison may be informative when both measurements are available, but the record does not describe randomization, masking, or an independent control group. The analysis must therefore be understood as a comparison of measurements in the registered study, not as evidence from a randomized trial of competing strategies.

The primary-outcome entry illustrates why precise endpoint definitions matter. The title identifies an elimination rate, while the description emphasizes DSI comparisons across HVPG-defined categories. Without a clear connection between these statements, readers cannot confidently identify which quantity was intended to answer the primary question. A transparent report would clarify the endpoint, analysis population, method, and uncertainty around the result.

Finally, the registry lists a completed study but no analyses. That distinction is useful for statistical literacy: trial completion and outcome reporting are separate details. A design can motivate an important question without supplying evidence that answers it. The record’s limits should be kept visible rather than filled in with assumptions about the protocol or results.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation of the posted record is that it contains no outcome results or analyses. It therefore cannot show the observed relation between HQ-Shunt DSI and HVPG, the spread of the endpoint, or the performance of DSI in the categories described. Estimates and measures of uncertainty are not reported in the registry record.

The primary endpoint information is not fully coherent. The title names an elimination rate measured during IV Phase 1, with a mean and standard deviation over up to 90 minutes. The description instead emphasizes DSI comparisons based on HVPG-defined portal hypertension and mentions cirrhosis and varices. The registry does not clarify whether these are components of one endpoint, separate outcomes, or a mismatch in the record.

The study is described as a single-group comparison, with successful HVPG required before HQ-Shunt. Allocation is NA and masking is none. The record does not describe randomization or an independent control group, and it does not report whether procedure order, measurement interpretation, or other sources of potential bias were addressed. Further procedural detail is not reported in the registry record.

The record gives planned enrollment but does not report the number contributing data to each outcome, the analysis populations, or how missing or unsuccessful measurements were handled. It also does not provide participant characteristics, eligibility criteria, endpoint definitions for cirrhosis and varices, or the statistical analysis plan. These omissions constrain assessment of generalizability, missing-data bias, and the validity of the intended comparisons.

Safety counts are posted, but follow-up duration and event-collection procedures are not. The record also lists several outcomes without explaining how multiplicity was handled. These limitations concern the available registry information; they do not establish that the study itself lacked further methods or results outside the posted record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG) — NCT02523196.
• Registry record last updated 2021-08-09; status last verified 2021-08.
• Results first posted 2021-02-05.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02523196 is a completed Phase 3, single-group study sponsored by University of Colorado, Denver. The registry records planned enrollment of 20, a study start of 2016-03, and primary completion on 2017-02-23. The study evaluated HepQuant-SHUNT alongside Hepatic Venous Pressure Gradient testing, with successful HVPG testing required before HQ-Shunt.

The stated aim was to compare HQ-Shunt DSI with HVPG, including identification of patients with cirrhosis and varices and classification by portal-hypertension status using an HVPG threshold of 6 mmHg. The primary endpoint title specifies an elimination rate, while its description focuses on DSI comparisons. The registry lists 10 outcome measures and no analyses. Outcome estimates and detailed analysis methods are not reported in the registry record.

The adverse-event entries list zero serious events, zero other events, and zero deaths in each of the two procedure groups. These entries do not provide a comparative effectiveness result or a complete account of safety follow-up.