Living Well Project for Persons With AIDS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Living Well Project for Persons With AIDS (NCT01848483), a randomized na study. The primary outcome is Change in Quality of Life.

2. Clinical Question

3. Trial Design

The registry identifies a randomized, parallel-group trial with no masking. It enrolled 121 participants and is listed as completed. The sponsor was Emory University. The registry record gives a start date of 2014-06 and a primary completion date of 2017-06. The study is described as not having a phase designation.

Participants were assigned to either the AIDS early palliative care package plus motivational interviewing or standard care. The intervention description specifies at least one early palliative-care visit and four weekly motivational-interviewing sessions within a 3 month period. Standard care is described as a routine infectious-disease program HIV-care clinic appointment. The record does not report further information about the randomization method, allocation concealment, or whether the groups were similar at baseline.

The primary outcome was change in quality of life measured at baseline and 3, 6, and 12 months post-baseline. The stated measurement was the McGill Quality of Life Questionnaire, for participants able to complete it at each visit. Secondary outcomes included mortality at 12 months post-baseline, self-reported hospitalizations, and self-reported completion of advance-care-planning activities concerning a health-care decision maker and a living will. The registry lists five outcome measures, but reports no analyses. It does not report numerical outcome results, participant flow by group, or the number contributing data at each visit.

Randomization is intended to support a comparison between groups, but the registry record alone does not show whether the planned comparison was carried out or what it found. The lack of masking and the self-reported nature of some listed outcomes are relevant to interpretation, without indicating that any particular bias occurred.

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: Only included participants that were able to complete the McGill Quality of Life Questionnaire at each visit.

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 Change in Quality of Life, measured over Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline.

The primary outcome is change in quality of life, measured with the McGill Quality of Life Questionnaire at baseline and 3, 6, and 12 months post-baseline. The questionnaire covers physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing, and support during the past 2 days. The record states that a total score was computed. Scores range from 0 to 10, with higher scores indicating better perceived quality of life.

Quality of life is a patient-reported outcome, so it reflects participants’ own assessment rather than only a clinical indicator. That makes it relevant to a study whose stated aim was to test early palliative care and motivational interviewing in relation to quality of life and psychosocial outcomes. The registry record does not report the numerical scores or changes at any visit, however, so the direction and size of observed change cannot be described.

The primary-outcome population was restricted to participants able to complete the questionnaire at each visit. The number meeting that condition, and how their characteristics compared with those who did not, are not reported in the registry record. This restriction matters because a complete-visit group may not represent everyone randomized if completion is related to health, engagement, or other factors. The record does not explain how missing questionnaire data were handled in the analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized as a mean with standard deviation. A continuous measure can take values along a scale rather than belonging only to separate categories. For such data, a mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. Neither statistic is reported for the primary outcome in the registry record.

What would a change estimate describe?

The study planned to measure quality of life at baseline and at 3, 6, and 12 months post-baseline. A change estimate describes how a score differs across assessment times. A comparison of change between randomized groups would address whether the observed trajectory differed between the intervention and standard-care groups. That is distinct from reporting the average change within either group alone. The record does not provide change estimates or explain which formulation was used in an analysis.

Repeated measurements from the same participant are related: a person’s scores over time are not generally independent observations. Statistical methods for repeated measures account for that dependence when estimating changes and uncertainty. The particular model or method used in this trial is not reported in the registry record, so no specific repeated-measures analysis should be attributed to it.

How should uncertainty be read?

A confidence interval is a general statistical way to express uncertainty around an estimate. A narrower interval indicates greater precision under the assumptions of the method; a wider interval indicates less precision. An interval also helps readers judge which effect sizes remain compatible with the observed data. The registry record does not report a confidence interval for the primary outcome, so the precision of a treatment-group comparison cannot be assessed from this record.

A p-value, when reported, measures how incompatible data are with a specified null hypothesis under the assumptions of the statistical test. It does not describe the size or importance of an effect. A small p-value would not by itself show that a difference is large or meaningful, and a larger p-value would not establish that groups are equivalent. No primary-outcome p-value is reported in the registry record.

Why does over-dispersion matter?

As a general concept, over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors can be too small and confidence intervals too narrow, which can make evidence appear more precise than it is. Appropriate methods can account for extra variability. The registry record does not identify a model for the primary outcome or report a dispersion assessment; this general issue should not be mistaken for a finding about this trial.

The primary score is bounded from 0 to 10, and higher scores indicate better perceived quality of life. A bounded scale may affect how analysts assess the distribution of scores and the suitability of a statistical model. The registry record does not report distributional checks, model assumptions, transformations, or any alternative analysis. It is therefore not possible to determine whether these considerations informed the analysis.

What is the role of the planning illustration?

Any sample-size illustration based on an observed effect is a planning exercise: it asks what sample size could be needed under stated assumptions to detect an effect of a specified size. It is not a report of the trial’s observed power and cannot substitute for an effect estimate or confidence interval. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. The registry record does not report the observed primary effect or the numerical sample-size illustrations, so no particular planning requirement can be interpreted.

When the true effect is uncertain, planning for a smaller effect than an initial estimate is a general way to examine how sample-size needs change under different assumptions. Such scenarios remain conditional on their assumptions; they do not show that the trial achieved a particular probability of detecting an effect. No sample-size justification for the trial itself is reported in the registry record.

What can be inferred from the registered design?

Random assignment is intended to make the groups comparable on average, supporting a between-group comparison. It does not guarantee that all outcomes are observed, that the assigned intervention is delivered as planned, or that an analysis is free of bias. The registry record identifies a parallel randomized design and no masking, but does not report the randomization procedure, allocation concealment, adherence, or the analysis population. Those omissions limit appraisal of how the design was implemented.

The record lists five outcome measures and zero analyses. It does not report how outcomes were coded, which contrasts were prespecified, how missing data were addressed, or whether multiple comparisons were considered. These details are important for interpreting estimates, but they cannot be reconstructed from the outcome descriptions alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, including the primary quality-of-life outcome and secondary outcomes concerning mortality, self-reported hospitalizations, and advance-care-planning activities. It reports zero analyses. No multiplicity strategy, hierarchy of secondary outcomes, adjustment method, or distinction between confirmatory and exploratory analyses is reported in the registry record.

As a general statistical concern, examining several outcomes or several assessment times can create multiple opportunities to observe apparently notable results by chance. How that concern should be addressed depends on the planned questions and analysis strategy. The registry record does not state whether or how the trial addressed it, and the absence of registered analyses prevents assessment of which comparisons were conducted.

For the primary outcome, the registry specifies inclusion of participants able to complete the questionnaire at each visit. It does not report the number of participants with complete questionnaires, the number missing at any visit, reasons for missingness, or how missing observations were handled. It also does not identify whether analyses followed assignment regardless of intervention receipt, were restricted to participants completing the intervention, or used another analysis population.

These omissions matter because the available participants may differ from those without outcome data. Statistical methods can make assumptions about missingness, but those assumptions and any sensitivity analyses are not reported in the registry record. No judgment about the extent or direction of missing-data bias can be made from the record alone.

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.

The registry reports zero serious adverse events among 61 participants at risk in the AIDS EPC package plus motivational interviewing group, and zero among 60 participants at risk in the standard-care group. It also reports zero other adverse events among 61 participants at risk in the intervention group and zero among 60 at risk in the standard-care group. Deaths are listed separately: 2 in the intervention group and 1 in the standard-care group.

These are the event counts recorded in the registry, not evidence by themselves that the groups had the same safety experience. The registry record does not report event definitions, event types, timing, duration of follow-up for these counts, or a statistical comparison. It also does not explain how deaths relate to the adverse-event categories. With no event detail or comparative analysis, the counts should be read descriptively rather than as establishing a difference or equivalence in safety.

The absence of reported serious and other adverse events in these entries does not establish that no adverse events occurred outside the registry’s reporting or observation procedures. The posted figures describe what the record reports, and do not support broader conclusions about safety.

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

The registry record makes clear what the trial set out to compare: an early palliative-care package plus motivational interviewing against standard care, with quality of life as the primary outcome. It identifies the questionnaire, its score direction, and the planned assessment times. Those details define the intended question, but they are not outcome findings.

Most importantly, no numerical primary-outcome results are reported. There is no posted estimate of the difference between groups, no uncertainty interval, and no reported test result. Therefore, the registry record does not show whether quality-of-life scores changed, whether changes differed between groups, or how precisely any such difference was estimated. It also does not report results for the listed secondary outcomes.

This absence must not be interpreted as a null result. A missing estimate is not the same as an estimate near zero, and it does not show that groups were equivalent. Equivalence requires a defined margin and an analysis designed to assess whether a difference falls within it; these are not reported in the registry record.

The trial’s enrollment of 121 participants does not tell readers how many contributed primary-outcome data at each assessment. Because the primary outcome included only participants able to complete the questionnaire at each visit, the number in that subset and the missing-data approach are important for evaluating the results. Neither is reported.

The posted design and adverse-event counts can be described, but they do not establish a treatment effect or a safety comparison. Conclusions about benefit, harm, clinical importance, or generalizability would require more complete outcome reporting and methodological details than are present in the registry record. No medical decision should be drawn from this record alone.

13. Why This Trial Matters Statistically

This trial is statistically notable as a randomized comparison of a multidisciplinary early palliative-care package that included motivational interviewing against routine HIV-care clinic appointments. The primary outcome was patient-reported quality of life, an outcome that can capture participants’ perceptions across physical, psychological, existential, and support domains rather than relying only on clinical indicators.

The repeated assessment schedule also makes the distinction between change over time and a difference between randomized groups especially important. A group’s score can change without demonstrating that its change differs from the other group. Clear reporting of the estimated between-group contrast, its uncertainty, and the participants contributing data at each visit would be needed to interpret that question.

The registry record does not provide those outcome analyses. That limitation itself matters statistically: a described design and outcome plan cannot be treated as evidence of a particular result. The absence of registered analyses, numerical estimates, and missing-data details leaves readers unable to assess effect size, precision, or the robustness of findings.

The record also illustrates why adverse-event counts should be read in context. Serious and other adverse-event entries are reported as zero in both groups, while deaths are listed separately. Without event definitions, follow-up details, and comparative analyses, these counts remain descriptive and cannot support a conclusion about relative safety.

For biostatisticians and clinical researchers, the central lesson is the difference between a trial’s stated question and the evidence needed to answer it. Registration details explain the intended comparison; transparent outcome reporting and analysis methods are needed to evaluate what the trial found.

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 main limitation of the available record is that it does not report numerical results for the primary outcome or the listed secondary outcomes. There are no group-specific quality-of-life means or changes, no between-group estimate, and no interval or p-value. The registry reports zero analyses, so readers cannot determine which comparisons were actually performed.

The primary outcome was restricted to participants able to complete the questionnaire at each visit. The size and characteristics of that complete-visit group are not reported. Nor are the number of missing questionnaires, reasons for missingness, or the method used to handle incomplete follow-up. This prevents assessment of whether the analyzed participants represented everyone randomized.

The record does not describe the randomization procedure or allocation concealment. Although masking is recorded as none, it does not explain whether outcome assessors were masked or how the lack of masking was considered in analysis. Intervention adherence and variation in actual care received are not reported, so the fidelity of the comparison cannot be assessed.

The registry gives a score range and assessment schedule but does not report the statistical model, assumptions, covariate adjustment, or planned contrasts. It does not state how multiple outcomes or assessment times were handled, whether interim analyses occurred, or what sample-size justification informed the trial’s own design. These details are not reported in the registry record.

Finally, the adverse-event entries lack definitions, event descriptions, and comparative analyses. The record supports only a descriptive reading of those counts. These limitations do not establish that the conduct or analysis was inadequate; they mark what cannot be evaluated from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Living Well Project for Persons With AIDS — NCT01848483.
• Registry record last updated 2019-12-30; status last verified 2019-12.
• Results first posted 2019-12-30.
• 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

NCT01848483, titled Living Well Project for Persons With AIDS, is listed as a completed randomized, parallel-group trial with no masking and enrollment of 121. The sponsor was Emory University. Its intervention combined an early palliative-care package with motivational interviewing; the comparator was standard care, described as a routine infectious-disease program HIV-care clinic appointment.

The primary outcome was change in quality of life measured with the McGill Quality of Life Questionnaire at baseline and 3, 6, and 12 months post-baseline. The record also lists secondary outcomes concerning mortality, self-reported hospitalizations, and advance-care-planning activities. It reports no analyses and no numerical outcome results. Adverse-event entries list zero serious and zero other adverse events in both groups, with deaths listed as 2 and 1, respectively.

The registry record describes the trial question and design but does not provide the results needed to assess comparative effects or their precision.