Group Medical Visits in Heart Failure: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Group Medical Visits in Heart Failure (NCT02481921), a randomized na study. The primary outcome is EQ Visual Analog Scale (EQVAS).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial comparing MEDIC-HF with usual care. The registry identifies masking as none, so the study is recorded as unmasked. Its phase is listed as NA. The posted enrollment is 242, and the record marks the study completed. The sponsor is the VA Office of Research and Development.

The intended participants had heart failure and were within 12 weeks of either a heart failure hospitalization discharge or an outpatient encounter requiring IV diuretic therapy. The summary names Providence, Cleveland, and Phoenix VA Hospitals as recruitment sites. The registry describes the intervention as group medical visits, with the MEDIC-HF arm characterized as group clinic or shared medical appointments for education and intervention. The comparator is described only as usual care in heart failure.

The registry lists the study start as 2015-05-01 and primary completion as 2021-10-01. It lists two outcome measures, but the information available for the primary endpoint is the EQ Visual Analog Scale at 180 days. The record does not report a primary endpoint estimate or a statistical analysis entry. It also does not report the allocation sequence method, allocation concealment, details of how participants were assigned, or the intervention and usual-care schedules. Those design details should not be inferred from the randomized, parallel-group labels alone.

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

Analysis population for the primary outcome, as defined in the registry: 8 patients in the MEDIC-HF arm and 9 patients in the Usual Care arm died prior to the final survey. Additionally, 11 patients in the MEDC-HF arm and 10 patients in the Usual Care arm were lost to follow-up or did not complete the final survey. 1 usual care patient did not complete the 6 month survey.

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 EQ Visual Analog Scale (EQVAS), measured over 180 days.

The primary endpoint is the EQ Visual Analog Scale (EQVAS), a self-reported rating of how good or bad a participant considers their health to be that day. The registry describes a score from 0, “worst health you can imagine,” to 100, “Best health you can imagine,” with higher scores representing a better health state. The recorded time frame is 180 days.

This type of measure captures a participant’s own overall assessment rather than relying only on a clinician’s judgment or a count of clinical events. In general, a continuous score can describe differences in health status across a range of values, while a mean summarizes the group’s average score and a standard deviation describes spread among individual scores. Those summaries are the measure type specified in the registry record; the actual group means and standard deviations are not reported there.

The primary outcome description also notes participants who died before the final survey and participants who were lost to follow-up or did not complete it. These matters affect how the endpoint can be interpreted because the score is not available from every person described in the record. The registry does not report the approach used to handle missing EQVAS observations, nor does it provide an endpoint estimate or confidence interval. Consequently, the measure and its intended meaning can be described, but the comparative result at 180 days cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean describe?

The registry specifies a mean as the summary parameter for the continuous EQVAS outcome and a standard deviation as its measure of dispersion. In general, a mean is the arithmetic average of observed scores in a group. It offers a compact description of the group’s central level, but it does not show the full distribution: participants can have very different scores while sharing the same mean. The standard deviation describes how spread out individual scores are around that average. It is not the uncertainty in the estimated mean; a confidence interval is commonly used to describe uncertainty in an estimate.

The endpoint is bounded by 0 and 100 according to its description. A reader should interpret a mean in relation to that scale and its direction, with higher scores denoting better self-reported health. The record does not provide the actual means, standard deviations, or an analysis of the score distribution, so no statement about the observed center or spread is possible.

What would a group comparison estimate?

In general, a randomized parallel-group comparison can estimate how the outcome differs between the groups assigned to the intervention and comparator, subject to the analysis population, missing data, and statistical assumptions. For a continuous outcome summarized by means, a common summary is the difference between the group means. A confidence interval around that contrast conveys its precision. The registry record does not report a contrast, confidence interval, or inferential test for EQVAS, and it does not identify which analysis method was used. No particular model or adjustment should therefore be attributed to the trial.

Randomization supports a planned between-group comparison by assigning participants to groups by chance, but it does not remove the need to report how assignment was implemented, how outcomes were analyzed, and how missing observations were handled. The record states that the trial was randomized and parallel-group; further implementation and analysis details are not reported in the registry record.

Why does variability matter?

General explanation: individual outcomes often vary within each treatment group. When variability is large relative to a group contrast, an estimate may be less precise; when variability is smaller, the estimate may be more precise, all else being equal. The standard deviation helps describe individual variation, while the confidence interval describes uncertainty around an estimated quantity. Neither can be interpreted for this endpoint without its posted results. The registry says the outcome is summarized using a mean and standard deviation, but the corresponding values are not reported.

General explanation: statistical tests and confidence intervals rely on assumptions about the data and analysis. For continuous measures, analysts may assess whether an approach to estimating a mean contrast is suitable for the observed distribution and design. The registry does not report diagnostic checks, model assumptions, transformations, covariate adjustments, or a test for the EQVAS comparison. These should not be guessed from the endpoint’s continuous classification.

What is the role of planning illustrations?

General explanation: a sample-size calculation is a planning exercise. It describes the amount of information a future study might need under stated assumptions about the target effect, variability, allocation, significance level, and desired power. It is not an observed result and does not show that a completed trial had a particular probability of detecting an effect. The registry’s sample-size assumptions describe planning illustrations based on an observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. The record does not report the trial’s own sample-size justification or its design assumptions. Any planning illustration should therefore be read as conditional on its stated assumptions, not as evidence about the observed EQVAS comparison or as observed power.

General explanation: over-dispersion is a concern for count outcomes when variability exceeds what a simple count model expects. It can make standard errors too small if the model does not account for that extra variability. This concept is not a basis for interpreting the EQVAS endpoint, which is recorded as continuous, and the registry does not report a count-outcome model. No over-dispersion assessment or correction is described in the record.

What can be concluded from the registered methods?

The registry identifies the design labels, the primary endpoint, its time frame, and the requested descriptive summaries. It also lists zero analysis entries. It does not report the statistical analysis plan, missing-data procedure, adjusted or unadjusted estimate, or endpoint results. Thus, general statistical concepts can explain how a mean, standard deviation, and confidence interval would be read, but they cannot fill in absent trial estimates or establish which methods were actually used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies EQVAS at 180 days as the primary outcome. It does not describe the other outcome measure in the information, nor does it specify whether multiple outcomes were tested together, whether a hierarchy was used, or whether any adjustment for multiple comparisons was planned. The statistical plan is not reported in the registry record, so the handling of multiplicity cannot be determined. This matters because examining multiple outcomes or time points can increase the chance of an apparently unusual result if the testing strategy is not accounted for. No such result or adjustment is reported for the primary endpoint.

The record lists zero analysis entries and gives no EQVAS result, standard error, confidence interval, or p-value. It therefore does not establish the analysis population or whether the primary comparison was based on all randomized participants, participants with observed survey data, or another group. The record also does not state whether the analysis followed assignment regardless of intervention participation.

For missing primary outcome information, the registry notes that 8 MEDIC-HF patients and 9 Usual Care patients died before the final survey. It separately reports 11 MEDIC-HF patients and 10 Usual Care patients lost to follow-up or not completing the final survey, and notes 1 usual care patient who did not complete the 6 month survey. It is not clear whether the final note overlaps with another category, so these entries should not be added together. The record does not explain how death was treated in the endpoint analysis, whether missingness was assumed to depend on observed information, or whether sensitivity analyses were performed. Those details are not reported in the registry record.

11. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: any hospitalizations (48.8%).

The registry’s adverse-event entries list, for MEDIC-HF, 117 at risk for serious adverse events and 57 affected; for Usual Care, 125 at risk and 61 affected. For other adverse events, it lists 117 at risk and 42 affected in MEDIC-HF, and 125 at risk and 55 affected in Usual Care. Deaths are listed as 10 in each arm. These are descriptive registry figures; they do not by themselves establish whether a difference between groups is statistically reliable or attributable to the intervention.

“At risk” indicates the denominator recorded for each category, while “affected” is the corresponding recorded count. The registry lists “Any Hospitalizations” as the top serious-event term, with 48.8%. The context and denominator for that percentage are not explained in the registry record. The term should not be read as a separate treatment-effect estimate, and the posted information does not specify whether hospitalization events were counted as people, event episodes, or both.

The registry does not provide event timing, severity detail beyond the serious-event grouping, relatedness assessments, or an adjusted comparison. These figures can describe what the record lists, but they do not establish a safety advantage or disadvantage. Counts and denominators should be read in their recorded categories rather than converted into new comparisons.

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

The record establishes that a randomized, parallel-group study compared group medical visits for heart failure with usual care, and that its primary endpoint was self-reported health on EQVAS at 180 days. It also describes the score’s direction and scale and gives adverse-event counts. Those details clarify the question the trial was designed to address and the kinds of information recorded.

However, the record does not report the primary outcome results. There is no posted EQVAS mean for either arm, no estimated difference, and no confidence interval or p-value. As a result, the direction, magnitude, and precision of the primary comparison cannot be evaluated from this record. It is not possible to state whether the groups differed on the endpoint, how large any difference was, or how uncertain an estimate might be.

The registry’s safety counts are also descriptive rather than a complete comparative analysis. They do not establish that the intervention caused or prevented any event. The record does not give a detailed event-analysis method, adjusted comparisons, or the context needed to interpret every listed percentage.

More generally, a randomized study can inform a comparison between assigned groups, but interpretation depends on the reported outcomes, the analysis population, missing data, implementation, and statistical methods. The record identifies some design features but does not report many of those details. The absence of a posted result is not evidence that the intervention had no effect; it means the comparative result cannot be judged from the registry information.

Any sample-size planning illustration should likewise be kept separate from the clinical result. Planning calculations describe what could be needed under assumptions; they are not observed effects or evidence that a study did or did not detect a difference. The most defensible reading is therefore limited to the study question, design, endpoint definition, and recorded safety counts, without drawing a treatment-effect conclusion.

13. Why This Trial Matters Statistically

This trial’s statistical question concerns a patient-reported health-status outcome after a heart failure-related hospitalization or qualifying outpatient encounter. That focus matters because a self-reported rating captures a dimension of health that is not identical to hospitalization counts or mortality. The registry defines the scale and identifies the assessment time frame, allowing readers to understand what the planned primary endpoint represents.

The randomized parallel-group design is also important to the intended comparison: the study assigns participants to group medical visits or usual care and aims to compare outcomes between those groups. But a design label alone cannot answer whether the intervention groups differed. Statistical interpretation requires the outcome estimates and their uncertainty, along with information about missing observations and the analysis approach. Those primary results and methods are not reported in the registry record.

The endpoint description explicitly records deaths before the final survey and non-completion or loss to follow-up. This highlights a practical statistical issue in post-hospitalization research: the people whose health can be measured at follow-up may differ from those whose scores are unavailable. How an analysis treats those missing scores can influence both the estimate and its interpretation. The registry does not report that approach, making the limitation visible rather than resolvable from the record.

The record also distinguishes the EQVAS outcome from adverse-event summaries. A patient-reported score, serious adverse events, other adverse events, and deaths answer different questions and should not be collapsed into a single judgment. Their interpretation depends on appropriate estimates and context. For this trial, the registry records the design and selected counts but leaves the primary comparative result unavailable, so the statistical importance lies as much in identifying that evidence gap as in describing the planned comparison.

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.

Several limitations specific to this record restrict interpretation. The primary outcome is named and defined, but its group results are not reported. Without mean scores, standard deviations, an estimated contrast, or uncertainty measures, the primary comparison cannot be quantified or judged for precision. The registry lists two outcome measures, but details for the other measure are not included in the record.

The registry does not report the analysis plan, method of randomization, allocation concealment, adherence to the assigned intervention, or the statistical approach for EQVAS. It also does not state the analysis population or how missing endpoint data were handled. These omissions prevent assessment of whether the reported design was implemented and analyzed in a way that supports a particular interpretation.

Missing outcome information is a particular concern because the primary outcome description reports deaths before the final survey, loss to follow-up or non-completion, and an additional note about a usual care patient who did not complete the 6 month survey. The record does not clarify overlap between the non-completion descriptions or explain how death was addressed analytically. No totals should be inferred from these separate entries.

The safety information is limited to recorded counts and a listed serious-event term with a percentage whose context is not described. It does not report event timing, detailed definitions, or comparative statistical analyses. The study population and recruitment setting are described in relation to three VA hospitals and a specific post-encounter period; applicability beyond that setting cannot be determined from the registry record alone. Finally, the record marks the trial completed but does not provide the primary outcome findings needed to draw a comparative conclusion.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Group Medical Visits in Heart Failure — NCT02481921.
• Registry record last updated 2024-07-24; status last verified 2024-07.
• Results first posted 2023-12-08.
• 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.

18. Record Summary

NCT02481921, titled “Group Medical Visits in Heart Failure,” is a completed randomized, unmasked, parallel-group study sponsored by the VA Office of Research and Development. The registry lists enrollment of 242, a start date of 2015-05-01, and primary completion on 2021-10-01. The study compared MEDIC-HF group medical visits with usual care for people with heart failure after a qualifying hospital or outpatient encounter.

The primary endpoint was EQVAS at 180 days, a self-reported health rating from 0 to 100 in which higher scores indicate a better health state. The registry specifies mean and standard deviation summaries but does not report the group results or a statistical analysis. It lists two outcome measures and zero analysis entries. Safety counts and missing-survey details are recorded, but the registry does not provide enough analysis context to support a treatment-effect conclusion.