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 Palliative Care in Heart Failure (NCT01589601), a randomized na study. The primary outcome is Change in Kansas City Cardiomyopathy Questionnaire (KCCQ).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01589601 |
| Phase | NA |
| Condition | Heart Failure, Heart Diseases, Cardiovascular Diseases |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 150 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced heart failure are the population of interest in the registry description. The primary endpoint population is narrower: participants who completed the baseline and 6-month KCCQ. The registry record does not report further eligibility details in the registry record for this analysis.
Intervention
Interdisciplinary palliative care combined with usual heart failure management. The description characterizes the intervention as multicomponent and intended to address multiple domains of quality of life, including physical symptoms. More detailed delivery procedures are not reported in the registry record.
Comparator
Usual heart failure care, described as management by a cardiologist-directed team with heart failure expertise. The registry description mentions symptom relief and initiation of evidence-based therapies during inpatient care, as well as management of comorbidities. The available description is incomplete.
Primary question
How does change in KCCQ health-related quality of life from baseline to 6 months compare between participants assigned to interdisciplinary palliative care plus usual heart failure management and participants assigned to usual heart failure care? The registry record identifies this endpoint but does not report a single numerical between-group result.
The question is comparative: it concerns the difference in change between randomized groups, rather than whether either group changed on its own. A group’s change from baseline can describe its observed course, but does not by itself isolate the effect of the assigned care strategy. The relevant evidence would include the estimated between-group contrast and its uncertainty. Those numerical results are not reported in the registry record as a single comparison.
3. Trial Design
PAL-HF is listed as a randomized, parallel-group trial with no masking. The registry record lists enrollment as 150 and the study status as completed. The recorded start is 2012-08, and primary completion is recorded as 2016-02. The phase is listed as NA. These registry fields describe the trial’s recorded design and chronology; they do not, by themselves, establish how many participants contributed data to each endpoint analysis.
The comparison is between usual heart failure care and usual heart failure care combined with interdisciplinary palliative care. The registry describes usual care as cardiologist-directed management by a team with heart failure expertise. It describes the added intervention as interdisciplinary and multicomponent, intended to assess and manage multiple quality-of-life domains. The arm descriptions in the record are incomplete, so detailed staffing, treatment frequency, adherence, and variation in delivery are not reported in the registry record.
The primary endpoint is change in the Kansas City Cardiomyopathy Questionnaire (KCCQ), with baseline and 6 months listed as the assessment times. The endpoint population is participants who completed both assessments. The registry also identifies secondary outcomes involving anxiety and depression, bereaved-family interviews, FACIT-Sp, aggregate cost of care, and hospital readmissions. Seven outcome measures and 17 analyses are recorded, but a complete mapping of those analyses to outcomes and time points is not reported in the registry record.
Randomization supports a comparison of assigned groups, but the record does not report the allocation sequence method, concealment procedures, or details of how departures from assignment were handled. Because masking is listed as none, the trial is recorded as unmasked. The record does not provide enough detail to establish whether outcome assessment or analysis was masked.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Usual Care + Palliative Care | Usual Heart Failure Care |
|---|---|---|
| STARTED | 75 | 75 |
| COMPLETED | 28 | 26 |
| NOT COMPLETED | 47 | 49 |
Analysis population for the primary outcome, as defined in the registry: Participants that completed the baseline and 6 month KCCQ
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Usual Care + Palliative Care | Usual Heart Failure Care | Total |
|---|---|---|---|---|
| Participants analysed | 75 | 75 | 150 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 | 25 | 46 |
| Age, Categorical: >=65 years | Participants | 54 | 50 | 104 |
| Age, Continuous | years | 71.9 (SD 12.41) | 69.8 (SD 13.43) | 70.8 (SD 12.93) |
| Sex: Female, Male: Female | Participants | 33 | 38 | 71 |
| Sex: Female, Male: Male | Participants | 42 | 37 | 79 |
| Region of Enrollment: United States | participants | 75 | 75 | 150 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Kansas City Cardiomyopathy Questionnaire (KCCQ), measured over Baseline, 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Kansas City Cardiomyopathy Questionnaire, or KCCQ, from baseline to 6 months. The registry identifies the endpoint as a mean on a scale and describes the KCCQ as a 23-item, disease-specific questionnaire scored from 0-100, with higher scores representing better health status. It is intended to measure health-related quality of life in the context of heart failure.
A change score expresses how a participant’s measured score differs between the listed assessments. Comparing mean change between randomized groups can address whether their observed changes differ, while retaining the scale’s clinical interpretation. A change within one group alone is not the same as a randomized comparison, because it does not account for the other group’s observed course.
The endpoint is relevant to the trial’s stated aim because the intervention is described as addressing multiple quality-of-life domains alongside heart failure management. The brief summary also mentions the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale, but the registry identifies change in KCCQ as the primary endpoint. The registry record does not report a single numerical estimate of the primary between-group difference, its confidence interval, or its statistical test result. The analysis population is specified as participants who completed both baseline and 6-month KCCQ assessments; the handling of participants without both assessments is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the clinical question, comparison groups, and primary outcome, but the primary endpoint is not reduced to one numerical comparison. It states that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the record does not provide a single effect estimate that can be interpreted as the average difference in KCCQ change between the randomized groups. A direction, magnitude, or precision for that primary contrast is not reported in the registry record.
This distinction matters because an endpoint label is not a result. Knowing that the measure is KCCQ, that it is recorded as a mean, and that the relevant assessments are baseline and 6 months does not reveal what values were observed in either group. Nor does it indicate whether the groups differed, how large any difference was, or how compatible the data were with a range of possible effects. The registry record does not report group means, standard deviations, a confidence interval, or a p-value for a single primary comparison.
The record lists seven outcome measures and 17 analyses, and identifies several secondary outcomes. That breadth can describe the range of questions examined, but the number of analyses alone does not indicate which findings are most reliable or whether any adjustment was made for multiple comparisons. The statistical analysis plan and multiplicity procedures are not reported in the registry record. Individual results should therefore be interpreted in the context of the exact outcome, time point, analysis population, and any uncertainty interval reported with them; those details are not available as one primary contrast in the record.
The safety fields report no serious adverse events in either recorded group, with 75 at risk in each group, and list deaths as 40 in the palliative-care group and 38 in the usual-care group. These are separate registry fields and do not substitute for a complete safety analysis. The record does not report event timing, cause of death, follow-up duration for these counts, or a comparative statistical analysis. The counts alone cannot establish whether groups differed in risk.
In short, the registry record supports a description of the trial’s design and measurement plan, but not a numerical conclusion about the primary KCCQ comparison. The absence of that comparison should not be treated as evidence that the groups were the same or that the intervention had no effect. It means the posted registry information does not establish the direction, size, or precision of the primary result.
9. Statistical Methods Explained
The registry record describes a continuous primary endpoint summarized as a mean, with standard deviation as its stated measure of dispersion. The primary measure is change in KCCQ between baseline and 6 months, among participants who completed both assessments. The record does not report a single reduced comparison for this endpoint, so the interpretation below explains the statistical concepts relevant to such a comparison without assigning a result to this trial.
What does a mean change represent?
For a continuous measure, a mean summarizes the central value of observations in a group. A mean change summarizes the average difference between a participant’s follow-up and baseline scores, subject to the analysis definition used. A randomized comparison typically focuses on the contrast between the groups’ mean changes. That contrast is distinct from each group’s change considered separately: improvement or worsening within a group can reflect many influences over time and does not alone quantify the between-group difference.
The KCCQ is scored from 0-100, with higher scores indicating better health status. The direction of a change can therefore be understood against that scale, but the size and uncertainty of the trial’s change estimates are not reported in the registry record as a single comparison. A numerical scale does not remove the need to examine how the estimate was calculated or which participants contributed data.
What does the standard deviation describe?
A standard deviation describes how spread out individual observations are around a group mean. It is a measure of participant-level variability, not a direct measure of uncertainty in the estimated mean or in the between-group contrast. A confidence interval is used for the latter purpose: it gives a range of values compatible with the data and the stated method, while reflecting sampling uncertainty. The registry record does not report a confidence interval for a single primary KCCQ contrast.
A narrow interval would indicate greater precision than a wide interval, but precision is not the same as importance. Interpretation depends on the interval’s location, the scale, and the clinical question. Without an estimate and interval, neither the magnitude nor precision of the primary result can be judged from the registry record.
What can a p-value tell the reader?
A p-value is a measure of how compatible data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A small p-value, considered alone, would not explain whether a difference is meaningful; a larger p-value would not prove equivalence. The registry record does not report a p-value for a single reduced primary comparison.
Statistical significance also depends on the analysis definition and assumptions. The endpoint is a mean change, but the statistical test or model used for the primary analysis is not reported in the registry record. It is therefore not appropriate to infer whether the analysis used a simple comparison of changes, a model adjusting for baseline, or another approach.
What do the planning assumptions mean?
The record describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. The actual illustration values are not reported in the registry record available for this analysis, and the primary result has not been reduced to one comparison. These planning assumptions should not be mistaken for the trial’s observed findings or for evidence that the trial had a particular probability of detecting an effect.
Sample-size calculations are conditional on their assumptions, including the effect size selected, variability, allocation, significance level, and analysis method. A planning illustration describes a hypothetical design under those assumptions; it is not observed power. The registry record does not report the original sample-size justification or the assumptions used in the trial’s own design.
Why does the analysis population matter?
The primary endpoint population is explicitly defined as participants who completed baseline and 6-month KCCQ. This identifies who is included in that endpoint description, but the record does not report how many completed both assessments or how missing measurements were handled. A complete-case analysis can differ from an analysis that uses other methods for incomplete follow-up, particularly if missingness is related to health status or group assignment. No such relationship or method should be assumed.
These concepts clarify what would be needed to interpret a continuous randomized endpoint: a defined contrast, an estimate, a measure of uncertainty, and a clear account of participants and analysis procedures. The registry record identifies the measure and endpoint population but does not report those elements as a single primary comparison.
10. Multiplicity, Missing Data and Analysis Populations
The record lists seven outcome measures and 17 analyses. It identifies the KCCQ change as the primary endpoint and lists secondary outcomes involving HADS depression and anxiety, a bereaved-family interview, FACIT-Sp, aggregate cost of care, and hospital readmissions. The primary endpoint description also specifies baseline and 6-month assessments. The registry record does not provide a complete account of how the analyses correspond to all outcomes, categories, or time points.
When a study conducts multiple statistical tests, the chance of observing at least one apparently unusual result can increase if each test is interpreted separately. Multiplicity procedures can address this issue, but the choice depends on the study’s aims and analysis plan. Whether the trial used an adjustment, a testing hierarchy, or another approach is not reported in the registry record. The 17 analyses should not be read as 17 independent confirmations of a finding.
For the primary endpoint, the record defines the analysis population as participants who completed baseline and 6-month KCCQ assessments. It does not report how many participants met that definition, the number missing either assessment, reasons for missingness, or how incomplete measurements were handled. It also does not report whether the analysis followed randomized assignment for all participants or used another analysis population. The record therefore does not support assumptions about intention-to-treat analysis, imputation, or sensitivity analyses.
These omissions affect interpretation because missing outcome data can change the population represented by an estimate, and the handling method can influence both the estimate and its uncertainty. Without the analysis plan and details of missingness, the robustness of a primary comparison cannot be assessed. The registry record also does not report whether interim analyses were conducted or how the final analysis was selected.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Usual Care + Palliative Care | 0 | 75 | 0.0% |
| Usual Heart Failure Care | 0 | 75 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Usual Care + Palliative Care | 40 of 75 |
| Usual Heart Failure Care | 38 of 75 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Usual Care + Palliative Care | 0 of 75 |
| Usual Heart Failure Care | 0 of 75 |
The adverse-event fields list 75 participants at risk in the Usual Care + Palliative Care group and 75 in the Usual Heart Failure Care group. Serious adverse events affected 0 participants in each recorded group. The registry also lists deaths as 40 in the Usual Care + Palliative Care group and 38 in the Usual Heart Failure Care group.
These entries should be read as separate reported counts, not as a complete comparison of safety. The record does not provide event-level descriptions, timing, duration of observation, causes of death, or a statistical comparison. It also does not report whether the death counts refer to a particular follow-up window or how deaths were classified for other outcome analyses. The serious-event fields do not establish that no other adverse events occurred; they report zero participants affected in the serious-event fields shown in the record.
Counts alone do not account for exposure time, participant characteristics, or uncertainty in the difference between groups. The registry record does not provide the information needed for a rate-based or adjusted safety interpretation. The serious adverse event and death entries should therefore be treated as descriptive registry data, not as proof that either care strategy is safer or riskier.
12. What the Result Does, and Does Not, Mean
The record establishes that PAL-HF was a randomized, parallel-group comparison of usual heart failure care with usual care plus interdisciplinary palliative care, with no masking listed. It identifies change in KCCQ from baseline to 6 months as the primary endpoint and defines the endpoint population as participants completing both assessments. These details clarify what the trial was designed to compare and how its primary outcome was framed.
They do not establish the result of that comparison. The registry record does not report a single numerical estimate of the between-group difference in KCCQ change, its confidence interval, or a p-value for such a comparison. It is therefore not possible to determine from this record whether the groups differed, the direction of any difference, or how precisely an effect was estimated. An absent numerical result is not evidence of no effect, equivalence, or benefit.
The listed secondary outcomes and analysis count indicate that the trial considered a broader set of questions, but a list of outcomes does not show their findings. Likewise, the safety entries are descriptive counts without the follow-up and comparative details needed to establish relative safety. No treatment recommendation follows from these registry fields.
The strongest interpretation is consequently limited: the record describes a clinical trial and its primary measurement framework, while leaving the principal comparative estimate unreported as a single result. To assess the result itself, readers would need the group-level outcome data or the sponsor’s reported analysis, together with its uncertainty, analysis population, missing-data handling, and multiplicity approach. Those details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable in its use of a patient-reported quality-of-life measure as the primary endpoint. The KCCQ is described as disease-specific, scored from 0-100, and oriented so that higher scores represent better health status. The endpoint therefore concerns a dimension of health status that complements the trial’s clinical context, rather than relying only on event counts or utilization measures.
The design is randomized and parallel-group, which frames the central statistical question as a comparison between assigned care strategies. The primary outcome is change from baseline to 6 months, and the record defines a completion-based analysis population. That definition makes follow-up completeness important to interpretation: without information on missing assessments and their handling, readers cannot determine how closely the reported analysis population would represent the randomized groups.
The record also lists several secondary outcomes and 17 analyses. This highlights a common statistical challenge: multiple outcomes and analyses can make it harder to distinguish a prespecified primary conclusion from exploratory findings. The registry record does not report the multiplicity strategy or a complete analysis plan, so the interpretation of any individual result would need that context.
Finally, the primary endpoint is not reduced to a single numerical comparison in the registry record. This is a useful reminder that a well-defined clinical question and measurement plan are not substitutes for an estimate and its uncertainty. Statistical interpretation requires both a clear estimand and reported results that show magnitude and precision. Here the design and endpoint are described, but the central numerical contrast is not.
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.
A key limitation for interpreting the trial from the registry record is that the primary endpoint is not reported as a single between-group comparison. Group-specific means, standard deviations, an effect estimate, confidence interval, and p-value for that contrast are not reported in the registry record. The direction and precision of the primary result therefore cannot be assessed from the available outcome description.
The endpoint population is limited to participants who completed both baseline and 6-month KCCQ. The record does not report how many participants contributed to this analysis, the extent or pattern of missing data, or how missingness was handled. It also does not describe the primary statistical model, whether baseline values were incorporated in a particular way, or the analysis population used for other outcomes.
The intervention and usual-care arm descriptions are incomplete. Detailed information about intervention delivery, adherence, treatment exposure, and changes in care is not reported in the registry record. Masking is listed as none, but the record does not clarify whether outcome assessment or analysis was masked.
The record lists multiple outcomes and analyses but does not report a complete analysis plan or multiplicity procedure. It also does not report the original sample-size justification, interim analyses, or the assumptions used for the trial’s own design. The safety entries lack event timing, causes of death, and follow-up details. These limits constrain interpretation of efficacy and safety; they do not, on their own, establish that the trial was poorly conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Palliative Care in Heart Failure — NCT01589601.
- Registry record last updated 2019-08-28; status last verified 2019-08.
- Results first posted 2017-07-24.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
PAL-HF is recorded as a completed, randomized, unmasked, parallel-group trial sponsored by Duke University. The registry lists enrollment as 150, a start of 2012-08, and primary completion in 2016-02. The comparison is usual heart failure care versus usual heart failure care combined with interdisciplinary palliative care.
The primary endpoint is change in KCCQ from baseline to 6 months among participants who completed both assessments. The registry describes the KCCQ as a 23-item questionnaire scored from 0-100, with higher scores indicating better health status. Seven outcome measures and 17 analyses are listed, along with secondary measures concerning mood, bereaved-family experience, spiritual well-being, cost, and readmissions.
The record does not report a single numerical primary comparison or the accompanying uncertainty. It also does not report the missing-data approach or multiplicity procedure. Serious adverse events are recorded for 0 participants in each group; deaths are listed as 40 and 38 in the respective groups. These safety counts lack comparative and follow-up details.