Team Science (The Liver Health Study): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Team Science (The Liver Health Study) (NCT06924281), a randomized na study. The primary outcome is Satisfaction With Fibroscan® Liver Imaging.

2. Clinical Question

3. Trial Design

Team Science (The Liver Health Study), registered as NCT06924281, is described as a randomized, double-masked, parallel trial. Its registry status is completed, and the listed enrollment is 14. The registry gives a start date of 2025-04-25 and a primary completion date of 2025-08-29. The phase is listed as NA. Brown University is the sponsor.

The trial compares two behavioral interventions. Participants assigned to the standard intervention received psychotherapy using manualized motivational interviewing principles with standard health information. Those assigned to the enhanced intervention received manualized motivational interviewing with personalized feedback on self-reported alcohol intake and two Fibroscan® scores indicating liver fat and fibrosis. The enhanced-arm description in the registry record is incomplete; additional intervention details are not reported in the registry record.

The stated study aim is to compare standard and enhanced approaches to screening, brief intervention, and referral to treatment or prevention for MetALD. The study summary describes noninvasive liver screening with Fibroscan® as a potential source of information for tailoring a brief intervention. That aim should be distinguished from the primary outcome actually posted: satisfaction with liver imaging at baseline. A baseline satisfaction measure describes participants’ reported experience of the screening, not a post-intervention change or a between-group intervention effect.

The registry identifies random allocation and double masking but does not report how the allocation sequence was generated or concealed, who was masked, or whether masking was maintained. The planned allocation ratio and the reasons for the enrollment target are not reported in the registry record. The outcome counts are 6 for standard intervention and 8 for enhanced intervention; those are the group sizes reported for this primary measure.

4. Participant Flow and Accounting

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

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This is the number of participants who were identified by electronic health record reviews who responded to pre-screening questions.

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 Satisfaction With Fibroscan® Liver Imaging, measured over Baseline.

The primary endpoint is satisfaction with Fibroscan® liver imaging at baseline. The registry describes a single-item visual analog scale, with 0 indicating low satisfaction and 100 indicating high satisfaction. The outcome is measured in units on a scale and summarized as a mean with a standard deviation for each intervention group.

Satisfaction is a participant-reported measure of how the screening experience is received. In this study context, it can describe acceptability of the liver imaging among participants who completed the measure. It is distinct from a clinical measure of liver fat or stiffness, a measure of alcohol intake, and a measure of whether the intervention changes behavior or health. The Fibroscan® scores are described as part of personalized feedback in the enhanced intervention; they are not the primary endpoint.

The endpoint is specified at baseline. Therefore, the posted means characterize baseline satisfaction and do not represent change after motivational interviewing. The registry record does not report a prespecified clinically meaningful difference for this scale, a threshold for interpreting scores, or a comparative estimate with uncertainty. The scale’s endpoints give a direction for interpreting individual responses, but the posted group summaries alone do not explain how participants understood the scale or how they used it.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry reports group means and standard deviations for a continuous outcome. These summaries describe the center of the observed responses and their spread. A mean gives the arithmetic average of the values recorded for a group. A standard deviation describes how dispersed those values are around the mean. Neither summary alone provides the uncertainty around a comparison between groups.

What a group mean can tell the reader

For this endpoint, each mean is on the satisfaction scale whose endpoints are described as 0 for low satisfaction and 100 for high satisfaction. The reported means give a concise account of the observed group-level responses at baseline. They do not show how every participant responded, whether responses clustered near the mean, or whether there were unusually low or high values. Such details are not reported in the registry record.

Comparing two means for an inferential purpose generally requires an estimated contrast and a measure of its uncertainty, such as a confidence interval, along with any test specified by the analysis plan. A confidence interval is a range of values compatible with the observed data under the model and its assumptions; it communicates estimation uncertainty rather than the spread of individual observations. No contrast, confidence interval, or test for this endpoint is reported in the registry record. A numerical comparison should not be constructed from the two means as a substitute for the sponsor’s analysis.

Why the endpoint timing matters

The outcome’s timeframe is baseline. A baseline measure describes participants’ scores at that assessment point. It is not a follow-up measurement and cannot represent change caused by an intervention delivered later. The trial’s randomized design is relevant to comparing interventions, but randomization alone does not turn a baseline descriptive summary into an estimated treatment effect. A post-intervention outcome and an analysis tied to the intended comparison would be needed to address an intervention effect on satisfaction. Such a primary-outcome analysis is not reported in the registry record.

Why small groups limit precision

General statistical principle: estimates based on fewer observations tend to be less precise than estimates based on more observations, all else equal. The primary outcome is reported for 6 participants in the standard group and 8 in the enhanced group. Those counts make the descriptive summaries useful for characterizing the observed data, but they do not guarantee precision or representativeness. The registry does not provide confidence intervals or individual responses that would help readers assess the range of plausible group values.

General statistical principle: the mean and standard deviation are most informative when the data and analysis assumptions are suitable for those summaries. A single-item scale may produce values concentrated near one end, and a mean can conceal that shape. The registry record does not report a distributional assessment, an alternative summary, or a model for this endpoint. No conclusion about whether a particular model assumption was met can be drawn from the posted summaries alone.

What the analysis record does and does not contain

The registry lists zero analyses. Thus, the posted primary-outcome information consists of descriptive group summaries rather than a reported inferential analysis. Details of the statistical analysis plan, including any adjustment variables, model choice, handling of repeated measures, or hypothesis-testing procedure, are not reported in the registry record. The reported outcome counts also do not establish how many randomized participants were included in every other outcome or analysis.

General statistical principle: an analysis should match the outcome’s timing, scale, and study question. If the question concerns a difference between randomized groups, the chosen estimate and uncertainty should make that contrast explicit. If the question concerns change over time, the analysis should account for measurements at the relevant times. The registry record does not post such an analysis for the primary baseline satisfaction outcome.

Planning calculations are not observed results

General statistical principle: sample-size planning uses assumptions about a target effect, variability, allocation, and an error-rate criterion to illustrate the number of observations that might be needed for a planned analysis. It is not an estimate of the probability that a completed study has detected a true effect. The registry’s stated planning approach refers to two-sided significance level 0.05, equal allocation, a normal approximation, and fractions of an observed effect. Numerical planning outputs are not reported in the registry record. Such illustrations cannot replace an analysis of the posted outcomes, and they should not be described as observed power.

The registry’s sample-size assumptions are described as planning illustrations based on an observed effect, not as the trial’s own design. The registry does not report the original sample-size justification or say whether the assumptions were used to set enrollment. The completed enrollment of 14 should therefore be read as the recorded enrollment, not as evidence that a particular target precision or power was achieved.

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("Standard Intervention", "Enhanced Intervention")
n   <- c(6, 8)
m   <- c(88.5, 93.9)
sp  <- c(11.2, 7.1)
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  Standard Intervention  6  88.500  11.200  76.746  100.254
CARM  Enhanced Intervention  8  93.900  7.100  87.964  99.836

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one secondary outcome: alcohol intake assessed by Timeline Followback Interview before and after intervention. It also reports four outcome measures in total and zero analyses. The registry record does not describe a multiplicity plan, such as a hierarchy of outcomes, an adjustment procedure, or a distinction between confirmatory and exploratory tests. Because no analyses are posted, the record does not show how multiple outcomes or time points were handled statistically.

General statistical principle: when several outcomes or comparisons are tested, the chance of at least one apparently noteworthy result can increase if each is interpreted without regard to the full set of tests. Prespecified priorities or adjustment methods can help clarify how evidence across outcomes should be interpreted. No such approach is reported in the registry record, so readers cannot determine how multiplicity was addressed.

The registry gives primary-outcome counts of 6 for standard intervention and 8 for enhanced intervention. It does not report a participant flow account, the number with missing values for each outcome, reasons for missingness, or an imputation method. It also does not state whether the primary outcome was analyzed for all randomized participants, only participants with observed responses, or another analysis population. These details are not reported in the registry record.

General statistical principle: missing outcome data can affect interpretation when the probability of a value being missing is related to the value itself or to participant characteristics. The impact depends on how much information is missing and the assumptions used to handle it. Without a missing-data description and analysis method, the extent or direction of any impact cannot be assessed from the registry information.

The registry identifies randomization but does not report the analysis population or whether participants were analyzed according to their randomized group. It also does not report protocol deviations, exclusions, or adherence summaries. These omissions limit assessment of how the reported summaries relate to the randomized study population.

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 figures report zero serious adverse events among 6 participants at risk in the standard intervention group and zero among 8 participants at risk in the enhanced intervention group. The registry also reports zero other adverse events among 6 participants at risk in the standard group and zero among 8 participants at risk in the enhanced group. Deaths are reported as zero in each group. No serious-event terms are listed.

These figures describe the events recorded for the participants counted at risk. They do not establish that no event could occur, nor do they provide a precise estimate of event frequency in a larger population. With small group counts, an absence of recorded events is limited evidence about uncommon events. The registry record does not provide event definitions, ascertainment procedures, event timing, exposure duration, or additional detail on how adverse events were collected.

The figures should be read as registry-reported counts, not as a comparative safety analysis. No statistical comparison of adverse events is reported in the registry record. The counts also do not address whether participants experienced unlisted symptoms or other outcomes outside the adverse-event reporting categories.

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

The posted primary results describe baseline satisfaction with Fibroscan® liver imaging among participants in the two randomized groups. The standard intervention group’s reported mean is 88.5 units, with standard deviation 11.2 and 6 participants. The enhanced intervention group’s reported mean is 93.9 units, with standard deviation 7.1 and 8 participants. The scale is described as ranging from 0 for low satisfaction to 100 for high satisfaction.

These summaries can be used to describe the responses recorded for this endpoint and these participants. They do not establish a difference attributable to either intervention. The endpoint is measured at baseline rather than after intervention, and the registry does not report a comparative estimate, confidence interval, or hypothesis test. It therefore does not quantify the uncertainty around a group contrast or show whether satisfaction changed over time.

The primary endpoint is satisfaction with imaging, not a direct measure of liver health, alcohol use, or intervention effectiveness. Although the enhanced intervention incorporates personalized feedback based on alcohol intake and Fibroscan® scores, the baseline satisfaction results do not answer whether that feedback changes behavior, liver measures, or later satisfaction. The registry lists alcohol intake before and after intervention as a secondary outcome, but an analysis of that outcome is not reported in the registry record.

The study summary describes an aim to compare standard and enhanced screening and brief-intervention approaches for MetALD. The posted primary outcome addresses a narrower descriptive question about baseline experience of imaging. The completed status and enrollment count document the trial record’s administrative status and participation count; they do not supply missing treatment-effect analyses or establish the generalizability of the findings.

Accordingly, the posted information supports a limited description of baseline satisfaction and the reported adverse-event counts. It does not support a conclusion about the comparative effects of the interventions. It also does not establish that screening or either intervention improves clinical outcomes. Such questions would require outcomes and analyses that are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial illustrates why a registry’s stated study aim and its posted primary endpoint need to be read separately. The study summary describes integrating noninvasive liver screening with brief intervention, while the primary outcome reported is satisfaction with Fibroscan® imaging at baseline. That endpoint can describe participants’ experience of screening, but it does not measure intervention-related change or a clinical effect.

The record also shows the distinction between descriptive statistics and an inferential comparison. Group means and standard deviations summarize observed responses. Without a reported contrast and uncertainty interval, readers cannot assess the precision of a difference between groups from the registry’s analysis. The reported group sizes of 6 and 8 are particularly important context for interpreting how much information the summaries contain.

Randomization is a design feature intended to support fair comparisons, but a randomized design still requires an analysis aligned with the question and outcome timing. Here, the registry reports zero analyses, and the primary measure is at baseline. The record therefore offers no posted statistical test or adjusted comparison to interpret as an intervention effect.

The registry’s sparse analysis information also makes transparency about outcome selection, missingness, and multiplicity important. Four outcome measures are listed, including a secondary measure of alcohol intake before and after intervention, but analysis populations, missing-data handling, and a multiplicity approach are not reported in the registry record. These are not merely technical details: they determine how the evidence can be understood and how far conclusions can be extended.

For clinical researchers and biostatisticians, the central statistical lesson is to distinguish what an outcome measures, when it was measured, and what analysis is actually posted. A descriptive baseline result can be informative about the enrolled participants while remaining insufficient to answer the broader comparative question.

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.

The main limitation for interpreting the primary result is that it is a baseline satisfaction measure, while the stated study aim concerns screening and intervention approaches. No post-intervention satisfaction result or primary-outcome comparison is reported in the registry record. As a result, the posted endpoint does not show change after treatment or the effect of personalized feedback.

The primary outcome summaries are based on 6 participants in the standard group and 8 in the enhanced group. The registry does not report confidence intervals, participant-level responses, or a statistical test for this endpoint. The precision and distribution of the observed values therefore cannot be assessed fully from the reported summaries.

The description of the enhanced intervention is incomplete in the registry record. Details about the delivery and duration of the interventions, and about the allocation process and masking procedures, are not reported. The characteristics of the enrolled participants and the number contributing to outcomes other than the primary measure are also not reported in the registry record. These gaps limit assessment of intervention fidelity and applicability to other populations.

The registry lists four outcome measures and one secondary outcome concerning alcohol intake before and after intervention, but reports zero analyses. A statistical analysis plan, multiplicity approach, missing-data methods, analysis populations, and reasons for any missing measurements are not reported in the registry record. The available information therefore does not establish how the full set of outcomes was analyzed or whether any departures from planned methods occurred.

The reported absence of adverse events is based on the listed at-risk counts and should be interpreted in light of the limited enrollment and the lack of additional event-collection detail. The registry record does not report follow-up duration for safety monitoring or event ascertainment procedures.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Team Science (The Liver Health Study) — NCT06924281.
• Registry record last updated 2026-02-04; status last verified 2025-09.
• Results first posted 2026-02-04.
• 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

NCT06924281 is the completed randomized, double-masked, parallel Team Science (The Liver Health Study), sponsored by Brown University. The registry lists enrollment of 14, phase NA, a start date of 2025-04-25, and a primary completion date of 2025-08-29. The study concerns steatotic liver disease of mixed origin and compares standard with enhanced motivational interviewing approaches.

The primary outcome is baseline satisfaction with Fibroscan® liver imaging on a visual analog scale from 0 to 100. The standard group has a reported mean of 88.5 and standard deviation of 11.2 among 6 participants; the enhanced group has a mean of 93.9 and standard deviation of 7.1 among 8 participants. No primary-outcome analysis is reported in the registry record.

The record lists one secondary outcome about alcohol intake before and after intervention, four outcome measures, and zero analyses. Serious adverse events, other adverse events, and deaths are reported as zero in both groups. Missing-data methods, analysis populations, and multiplicity procedures are not reported in the registry record.