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 Veterans Affairs Lowering Readmission in Heart Failure (NCT01144182), a non-randomized na study. The primary outcome is General Quality of Life From the Standardized Physical Component Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01144182 |
| Phase | NA |
| Condition | Heart Failure |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 136 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people hospitalized with heart failure. Its background describes heart failure as a major contributor to mortality and reduced quality of life, and as a common reason for readmission among older adults. The primary outcome analysis included participants with a follow-up visit and a completed VR-36 measure: 50 in the current best practice group and 46 in the quality improvement program group. These analyzed groups are not the full enrollment.
Intervention
The intervention was a comprehensive quality improvement program intended to act at patient, provider, and system levels. The registry describes three monthly phone calls intended to promote diet and medication adherence, using the transtheoretical model as a behavioral framework, as well as checklists to support patient self-monitoring. The program is categorized as behavioral. The registry record does not fully describe every program component.
Comparator
The comparator was current best practice for inpatient heart failure care, with no intervention. The study used a pretest-posttest design: current best practice was evaluated in the pretest phase, while the program was evaluated in the posttest or intervention phase. Allocation was non-randomized, so the groups should not be treated as a like-for-like randomized comparison.
Primary question
The primary question was whether general quality of life, assessed by the standardized physical component score from the VR-36, differed between current best practice and the quality improvement program at 3 months after discharge. The registered outcome is a score on a 0-to-100 scale, with higher values indicating better quality of life. The registry record does not report the group medians, inter-quartile ranges, or a comparison estimate, so the outcome difference cannot be quantified from the record.
3. Trial Design
The Veterans Affairs Lowering Readmissions in Heart Failure Study, also called VALOR, was a completed parallel-group study with non-randomized allocation and no masking. It enrolled 136 participants and was sponsored by the VA Office of Research and Development. The registry lists the study start as 2010-10 and primary completion as 2013-07. The phase is listed as NA.
The design is described as pretest-posttest. Current best practice was assessed in the pretest or pre-intervention phase, while the quality improvement program was assessed in the posttest or intervention phase. The program targeted patients, providers, and systems. The current best practice group received no intervention and continued current best practices for inpatient heart failure care. The quality improvement program description includes three monthly phone calls focused on diet and medication adherence and checklists intended to support patient self-monitoring.
Because allocation was non-randomized and the comparison was between phases, differences between groups may reflect more than the program itself. Changes over time, differences in the people contributing data, or other differences between phases could influence outcomes. The registry explicitly cautions that the arms are not a like-for-like control comparison. The record does not report details that would establish how such factors were addressed analytically.
The primary outcome was general quality of life from the standardized physical component score, assessed 3 months after discharge. It was summarized using the median and inter-quartile range. The record also lists secondary quality-of-life outcomes, including mental component score and several physical, pain, health, vitality, social, and emotional domains. It lists 13 outcome measures and 13 analyses, but does not report a single comparison that captures the entire study. The registry record does not report a statistical analysis plan, the method used to compare the phases, or whether analyses adjusted for baseline characteristics.
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 | Current Best Practice (CBP) | Comprehensive Quality Improvement Program (QIP) |
|---|---|---|
| STARTED | 68 | 68 |
| COMPLETED | 51 | 47 |
| NOT COMPLETED | 17 | 21 |
Reasons for not completing this period:
| Reason | Current Best Practice (CBP) | Comprehensive Quality Improvement Program (QIP) |
|---|---|---|
| Death | 5 | 6 |
| Withdrawal by Subject | 3 | 6 |
| Lost to Follow-up | 9 | 9 |
Analysis population for the primary outcome, as defined in the registry: 51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.
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 | Current Best Practice (CBP) | Comprehensive Quality Improvement Program (QIP) | Total |
|---|---|---|---|---|
| Participants analysed | 68 | 68 | 136 | |
| Age, Continuous | years | 75.3 (61.4 to 83.5) | 74.8 (64.7 to 84.6) | 74.8 (63.8 to 84.0) |
| Sex: Female, Male: Female | Participants | 2 | 0 | 2 |
| Sex: Female, Male: Male | Participants | 66 | 68 | 134 |
| Race/Ethnicity, Customized: White (non-Hispanic) | participants | 37 | 30 | 67 |
| Race/Ethnicity, Customized: Black (non-Hispanic) | participants | 14 | 16 | 30 |
| Race/Ethnicity, Customized: Hispanic | participants | 13 | 19 | 32 |
| Race/Ethnicity, Customized: Other | participants | 4 | 3 | 7 |
| Marital Status: Married | participants | 15 | 18 | 33 |
| Marital Status: Not Married | participants | 53 | 50 | 103 |
| Education: High school graduate or below | participants | 34 | 32 | 66 |
| Education: Some college or higher | participants | 34 | 36 | 70 |
| Employment status: Employed | participants | 6 | 4 | 10 |
| Employment status: Not employed | participants | 62 | 64 | 126 |
| Campus: Manhattan | participants | 50 | 45 | 95 |
| Campus: Brooklyn | participants | 18 | 23 | 41 |
| BNP | pg/mL | 645.0 (433.0 to 1512.5) | 739.0 (383.0 to 1702.0) | 696.0 (413.0 to 1580.0) |
| Number of heart failure medications | number of heart failure medications | 3 (2 to 3) | 3 (2 to 3) | 3 (2 to 3) |
| Length of hospital stay | days | 6 (3 to 9) | 6 (4 to 9) | 6 (3 to 9) |
6. Primary Endpoint
The registry lists the primary outcome as General Quality of Life From the Standardized Physical Component Score, measured over 3 months after discharge.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was general quality of life measured from the VR-36 standardized physical component score at 3 months after discharge. The registry describes the score as ranging from 0 to 100, with higher scores indicating better quality of life. This endpoint summarizes a participant-reported aspect of health rather than a clinical event such as readmission. It is relevant to the study’s stated aim of improving heart failure care in ways that may affect daily functioning and well-being.
The endpoint was summarized by the median and inter-quartile range. A median describes the middle of the observed score distribution, while the inter-quartile range describes the spread of the central portion of that distribution. These summaries can be useful when a score distribution is not well represented by a mean and standard deviation. They do not, by themselves, establish whether groups differ beyond what might arise from sampling variation.
The registry reports that 51 participants in current best practice and 47 in the quality improvement program had a follow-up visit. One participant in each arm did not complete the VR-36, leaving 50 and 46 analyzed for this outcome, respectively. The group medians, inter-quartile ranges, and inferential comparison are not reported in the registry record. The outcome’s direction and precision therefore cannot be assessed from the registry entry.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study’s intended comparison and primary outcome, but it does not report the numerical primary outcome results. In particular, the record does not give the median VR-36 physical component score or inter-quartile range for either group, nor an estimated between-group contrast or its uncertainty. It also does not report a p-value for this endpoint. As a result, the posted record cannot show the magnitude, direction, or precision of the primary outcome difference.
The comparison needs to be interpreted in light of the design. Participants were not randomly allocated, and the study compared a pretest phase using current best practice with a posttest phase using the quality improvement program. This makes the comparison vulnerable to differences between the phases that are unrelated to the program. Even if numerical results were available, a difference between groups would not by itself establish that the program caused the difference. The registry itself notes that the arms are not a like-for-like control comparison.
The record reports outcome-specific analyzed groups of 50 in current best practice and 46 in the quality improvement program. These counts differ from the follow-up visit counts because one participant in each arm did not complete the VR-36. They also should not be mistaken for a full account of missing outcomes across the study: the registry record does not describe missingness for every outcome, the reasons for missing data, or how missing data were handled in analyses.
Although the record lists 13 outcome measures and 13 analyses, it does not report how results across outcomes were interpreted together. The number of listed outcomes alone does not establish that a multiplicity adjustment was or was not used. The statistical analysis plan and any adjustment method are not reported in the registry record.
Accordingly, the registered hypothesis that the program might improve quality of life and lower heart failure recurrence should be distinguished from a reported finding. The registry record gives the rationale and design, but not the primary outcome result needed to evaluate that hypothesis. The record also does not report a primary outcome estimate for recurrence. Conclusions about the effects of the program are therefore not supported by the primary outcome information available in the registry entry.
9. Statistical Methods Explained
The registry describes a non-randomized, parallel, pretest-posttest study with no masking. Those design labels matter because they define what a group comparison can establish. In a randomized study, chance allocation is used to make groups comparable on average at the start. Here, participants were not randomly assigned, and the study compared a pre-intervention phase with an intervention phase. The groups may therefore differ for reasons other than the quality improvement program.
What does the pretest-posttest design compare?
In this design, current best practice was evaluated in the pretest phase and the quality improvement program in the posttest phase. This makes the intervention and calendar phase closely linked. Any change across phases could reflect the program, but it could also reflect other changes occurring over time or differences in the people observed during each phase. This is a general limitation of non-randomized before-and-after comparisons. The registry record does not report whether there was a concurrent control, how phase differences were handled, or whether baseline characteristics were adjusted for in the outcome analysis.
The parallel label indicates that the groups represent separate study arms rather than a crossover sequence. It does not make the groups comparable by itself. The registry explicitly says the arms are not a like-for-like control comparison. This cautions against reading a simple contrast as a randomized treatment effect.
Why report a median and inter-quartile range?
The primary score is summarized by its median and inter-quartile range. In general, the median describes the central location of observations and is less affected by extreme scores than the mean. The inter-quartile range describes the spread of the middle portion of the observations. These summaries can be informative for bounded questionnaire scores or distributions that are skewed. The registry record does not report the observed summaries, so their numerical interpretation is not possible.
A group summary is not the same as an estimated difference between groups. A between-group estimate would quantify the contrast, and an uncertainty interval would indicate how precisely that contrast is estimated. A p-value, when used, addresses a statistical testing question but does not convey the size or practical importance of an effect. The registry record does not report the primary outcome contrast, an uncertainty interval, or a p-value.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the data under the method used to calculate it. A narrow interval indicates greater precision than a wide interval, while neither an interval nor a p-value resolves design limitations such as non-random allocation. The registry record does not report a confidence interval for the primary outcome. Thus, precision cannot be evaluated from the registered primary outcome information.
Statistical methods should also reflect the structure of the data. In general, repeated measurements from the same participant are correlated rather than independent. If observations are clustered within providers, clinics, or periods, that dependence can also affect uncertainty estimates. The intervention description includes patient, provider, and system targets, but the registry record does not describe whether data were clustered, repeatedly measured, or analyzed with methods accounting for such dependence. It does not report a statistical model or analysis details sufficient to assess these issues.
What does the sample-size planning description mean?
The registry describes planning illustrations based on the observed effect, with 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 stated fraction of the observed effect. For time-to-event outcomes, the illustrations use the total number of events; other illustrations use participants per arm. The actual illustration values and the fraction-specific results are not reported in the registry record.
Such calculations are planning illustrations, not evidence that a study had a particular probability of finding a result. They are not observed power. In general, a planning calculation depends on assumptions about the target effect, variability, allocation, and analysis method. If the assumed effect is not a reliable guide to a future effect, the resulting planning figure may not be a reliable guide either. The registry does not report the trial’s own sample-size justification or design calculation.
What can be inferred from the posted analysis information?
The registry lists 13 outcome measures and 13 analyses, and describes the study as not reduced to one comparison. This means the record encompasses multiple outcome domains rather than a single contrast that summarizes all findings. The registry record does not specify whether the analyses were prespecified, whether any were exploratory, or how potential multiplicity was handled. It also does not report the exact analysis population or statistical methods for each outcome.
In general, multiplicity arises when several hypotheses are examined: the chance of at least one apparently unusual result can increase if results are interpreted without accounting for the number of comparisons. Appropriate interpretation depends on the analysis plan and inferential goal. The number of outcomes listed does not, on its own, reveal whether statistical adjustment was necessary or used.
Overall, the available design and endpoint descriptions identify the study question and important constraints, but do not permit reconstruction of the statistical analysis. The registry record does not report the model, covariate adjustments, missing-data method, or primary outcome estimate. Those absences limit both the numerical interpretation and assessment of the analysis choices.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 13 analyses, including the primary quality-of-life outcome and several secondary quality-of-life domains. It characterizes the study as not reduced to one comparison. Multiple outcomes can be useful when a study aims to assess several dimensions of health, but they make interpretation more complex. In general, when many comparisons are examined, the chance of seeing at least one result that appears unusual may increase. Whether and how to address this depends on the intended inferential goal and prespecified analysis plan.
The statistical analysis plan, the status of each analysis as confirmatory or exploratory, and any multiplicity adjustment are not reported in the registry record. It is therefore not possible to determine how the listed outcomes were prioritized or how results were interpreted jointly. The count of outcomes alone does not establish whether an adjustment was applied.
For the primary outcome, the registry reports 51 participants with a follow-up visit in current best practice and 47 in the quality improvement program. One participant in each arm did not complete the VR-36, leaving 50 and 46 analyzed for that measure. This makes clear that the outcome-specific analysis population was smaller than the follow-up population.
The registry record does not report whether these participants were analyzed according to another defined population, how missing VR-36 data were handled, or the reasons for non-completion. It also does not describe missingness for the secondary outcomes. In general, missing data can affect an estimate if the availability of an outcome is related to a participant’s health or other characteristics. Without information on the missing-data approach and assumptions, the possible effect of missingness cannot be evaluated from the record.
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 |
|---|---|---|---|
| Current Best Practice (CBP) | 7 | 68 | 10.3% |
| Quality Improvement Program (QIP) | 8 | 68 | 11.8% |
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 |
|---|---|
| Current Best Practice (CBP) | 6 of 68 |
| Quality Improvement Program (QIP) | 5 of 68 |
Most frequent serious adverse event terms
| Event term | Organ system | Current Best Practice (CBP) | Quality Improvement Program (QIP) |
|---|---|---|---|
| Death | General disorders | 5 of 68 | 6 of 68 |
| myocardial infarction | Cardiac disorders | 2 of 68 | 2 of 68 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Current Best Practice (CBP) | Quality Improvement Program (QIP) |
|---|---|---|---|
| hypertensive emergency | Cardiac disorders | 3 of 68 | 3 of 68 |
| angina | Cardiac disorders | 2 of 68 | 1 of 68 |
| Coronary artery bypass graft | Surgical and medical procedures | 1 of 68 | 0 of 68 |
| broken bone | Injury, poisoning and procedural complications | 0 of 68 | 1 of 68 |
Serious events with the highest arm-level rate: death (8.8%), myocardial infarction (2.9%).
The registry reports serious adverse event figures for current best practice and the quality improvement program. Each group has 68 participants listed as at risk; 7 in current best practice and 8 in the program are listed as affected by serious adverse events. For other adverse events, the record lists 6 affected in current best practice and 5 in the program, with 68 at risk in each group. These are descriptive counts in the registry record and do not establish that the groups had equivalent safety experience or that any difference was caused by the program.
The registry also lists Death at 8.8% and myocardial infarction at 2.9% among the top serious adverse event terms. It does not provide group-specific figures for these terms in the information recorded here, and the deaths field for each group is null. The listed term percentages should therefore not be interpreted as group-specific rates or as a direct comparison between arms. The registry record does not explain the relationship between those term percentages and the group-level affected counts.
In general, serious adverse event counts require context, including how events were defined, how long participants were monitored, whether participants could experience more than one event, and how events were attributed. Those details are not reported in the registry record. The figures describe what was recorded, but do not by themselves establish comparative safety or causation.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to evaluate a comprehensive quality improvement program for heart failure care, compared with current best practice. The program targeted patient, provider, and system factors, with the stated aim of supporting treatment and adherence. The primary endpoint was a VR-36 physical component score intended to measure general quality of life 3 months after discharge.
The record does not report the primary outcome values or a between-group estimate. It therefore does not show whether the quality-of-life scores were higher or lower in either group, how large any difference was, or how precisely it was estimated. The study’s stated hypothesis is not itself evidence of an observed outcome. The record also does not give a primary outcome result for heart failure recurrence.
Even with numerical outcome results, the design would require cautious interpretation. Non-randomized allocation and comparison of a pretest phase with a posttest phase leave open the possibility that group differences or changes over time reflect factors other than the intervention. The registry record specifically warns that the arms are not a like-for-like control comparison. A contrast between these phases would not, on its own, establish that the quality improvement program caused an outcome difference.
The serious adverse event counts and listed event terms are descriptive. They do not establish a treatment-related safety effect, and the record lacks the group-specific term data and monitoring details needed for a more complete comparison. Similarly, the outcome-specific analyzed groups indicate that not all participants with follow-up contributed a VR-36 result, while the record does not describe a missing-data analysis.
The most defensible reading is therefore limited: the registry documents the study’s design, intervention intent, and primary outcome definition, but not the numerical primary outcome results or enough analysis detail to judge the effect. It should not be read as demonstrating that the program did or did not improve quality of life or reduce recurrence.
13. Why This Trial Matters Statistically
This study is statistically noteworthy because it evaluates a multilevel quality improvement program in a setting where outcomes may depend on patients, providers, and care systems. The intervention was not limited to a single medication or isolated clinical procedure: the registry describes phone calls intended to promote diet and medication adherence, together with checklists and system-oriented changes. Such programs raise questions about how to evaluate interventions that operate across several parts of care delivery.
The pretest-posttest design illustrates an important trade-off. It can compare care before and after implementation, but non-randomized phases may differ for reasons unrelated to the program. The timing of the intervention and the timing of observation are intertwined. Recognizing that limitation is essential when interpreting any observed contrast, particularly when the registry itself says the arms are not a like-for-like control comparison.
The study also emphasizes the distinction between defining an outcome and reporting its result. The registry specifies a patient-reported quality-of-life measure, its scale direction, its assessment time, and the summary statistics intended for it. Yet it does not report the medians, inter-quartile ranges, or an inferential comparison. Without those values, a reader cannot evaluate the magnitude or precision of the primary result. A clear endpoint definition is important, but it cannot substitute for a reported estimate.
Finally, the record lists a range of secondary quality-of-life domains and 13 analyses. Multiple outcomes can describe different facets of health, while also making it important to distinguish primary from secondary questions and to understand the analysis plan. The registry record does not report how multiplicity was handled. These features make the study a useful example of why design, outcome reporting, uncertainty, and analysis transparency all matter when reading clinical research.
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.
The primary limitation for interpreting the registry entry is that it does not report the numerical primary outcome results. Group medians, inter-quartile ranges, an estimated contrast, and its uncertainty are not reported in the registry record. The entry therefore does not support a quantitative conclusion about the primary quality-of-life comparison.
The non-randomized pretest-posttest design also limits causal interpretation. The quality improvement program was assessed in a posttest phase, while current best practice was assessed in a pretest phase. Differences between phases could reflect changes over time or differences in the participants, as well as the intervention. The record explicitly notes that the arms are not a like-for-like control comparison. Adjustment methods for such differences are not reported in the registry record.
For the primary outcome, the follow-up visit counts were 51 and 47, while the VR-36 analysis included 50 and 46 after one participant in each arm did not complete the measure. The record does not explain the reasons for non-completion, report a missing-data method, or describe whether any sensitivity analyses were conducted. Details on the analyzed populations for other outcomes are also not reported.
The intervention description is incomplete: it identifies several components and targets, but the registry record does not fully describe every component or implementation detail. The statistical analysis plan, model, covariate adjustments, and approach to the multiple listed outcomes are not reported. The serious adverse event information is also limited: group-level counts are listed, but the record does not report monitoring details or group-specific results for the serious event terms named. These gaps constrain assessment of both outcome and safety evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Veterans Affairs Lowering Readmission in Heart Failure — NCT01144182.
- Registry record last updated 2015-10-16; status last verified 2015-08.
- Results first posted 2015-10-16.
- 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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18. Record Summary
VALOR was a completed, non-randomized, parallel pretest-posttest study sponsored by the VA Office of Research and Development. It enrolled 136 participants with heart failure. Current best practice was compared across phases with a comprehensive quality improvement program targeting patients, providers, and systems. The registry lists no masking and a phase of NA.
The primary outcome was general quality of life from the VR-36 standardized physical component score at 3 months after discharge, summarized by median and inter-quartile range. The record reports outcome-specific analysis counts of 50 in current best practice and 46 in the program, but does not report the primary outcome values or comparison estimate. It lists 13 outcome measures and 13 analyses. Serious adverse event counts and selected terms are recorded, but the information is insufficient for a complete group-specific safety comparison. The registry record cautions that the arms are not a like-for-like control comparison.