R21 India Pal-Care Evaluation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for R21 India Pal-Care Evaluation (NCT04972630), a randomized na study. The primary outcome is Palliative Care Outcomes (POS Total Scores).

2. Clinical Question

3. Trial Design

The registry record describes R21 India Pal-Care Evaluation, a randomized, double-masked, parallel-group clinical trial. It lists the condition as Cancer Palliative Care, the sponsor as Medical University of South Carolina, and the status as completed. The record lists the start date as 2021-11-01, the primary completion date as 2023-07-31, and enrollment as 112. The phase is listed as NA.

Participants were recruited from cancer patients in need of palliative care at Tata Medical Center in Kolkata, India. The intervention group received Pal-Care, described as a home-based program delivered over a 6-month period. Community health workers facilitate delivery, drawing on the Palliative Care Toolkit for limited-resource settings. The control group received usual care. The record says allocation to control or Pal-Care was random. Details of the randomization procedure, including sequence generation and allocation concealment, are not reported in the registry record.

The registry describes double masking, but does not identify which participants, clinicians, outcome assessors, or analysts were masked, or how masking was maintained. These details matter when interpreting a trial, especially for outcomes collected through patient-reported scales, but cannot be assumed from the masking label alone.

The study has two stated aims: evaluate implementation within the RE-AIM Framework and assess outcomes relative to a standard control group. Outcomes named in the summary include palliative care needs, symptom burden, quality of life, and experience with care. The record also describes stakeholder interviews to evaluate the intervention. The interview component is distinct from the outcome survey population: outcome surveys and data collection were not conducted on post-intervention interview participants. Further operational details for the intervention and control descriptions are not fully reported in the registry record.

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.

Before assignment: Post-intervention interviews: The participants were people who had in some way engaged in the Pal-Care intervention as a provider, community health worker or patient. Hence for the research purpose, we only needed to know if they had engaged in the intervention and NO additional demographics/OUTCOME DATA were counted twice for research. All participants were informed through a statement of research (waiver of signed consent in place) and verbally consented prior to conducting interviews.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Outcome surveys/data collection were not conducted on Post-intervention interview participants.

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.

Population: Baseline data was only meant to be collected for control and intervention participants. For the post-intervention interviews, the participants were people who had in some way engaged in the Pal-Care intervention as a provider, community health worker or patient. Hence for the research purpose, we are not double counting as the outcome data is only reflective of control and intervention groups and not impacted by the qualitative interviews.

6. Primary Endpoint

The registry lists the primary outcome as Palliative Care Outcomes (POS Total Scores), measured over 6-month.

The primary endpoint is Palliative Care Outcomes (POS) Total Scores at 6-month, reported as a mean score with a 95% confidence interval. The POS Scale is described as a multidimensional measure of palliative care outcomes. Its 10 items cover physical and psychological symptoms, spiritual, practical and emotional concerns, and psychosocial needs of the patient and family. Each item uses a 5-point Likert scale scored from 0 to 4, and the summed total ranges from 0-40. The registry states that a score of 0 means an issue is not a problem, while a score of 4 represents an overwhelming burden or concern. Higher total scores indicate worse palliative care outcomes.

A multidimensional score can capture aspects of care and burden that are not represented by a single symptom measure. Using a total score makes it possible to describe the overall measured burden, while the confidence interval communicates the precision of the estimated mean. The interpretation depends on the registered scoring direction: a higher score is less favorable on this scale. The endpoint description does not give a minimally important difference or a threshold for a clinically meaningful change; these are not reported in the registry record. The actual group means, confidence intervals, and between-group result are also not reported in the registry record, so the endpoint’s observed direction and precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group trial. Random allocation is intended to create groups that are comparable on average at the time of assignment, including with respect to factors that may not have been measured. It does not guarantee that the groups will be identical, and the method used to generate or conceal the allocation is not reported in the registry record. The parallel-group description means that the record identifies separate intervention and control groups; details about participant-level follow-up and analysis are not reported.

What does the mean describe?

The primary endpoint is a continuous summed score, and the registry specifies the mean as its summary measure. In general, a mean describes the average score in a group. It can be useful for comparing group-level outcomes, but it does not show the full spread of individual responses or whether some participants experienced very different outcomes from others. The POS Scale combines multiple palliative care concerns into a total, so the mean summarizes that composite measure rather than the separate experience captured by each item.

The score direction is essential for interpretation. The record says higher total POS scores indicate worse palliative care outcomes. Any comparison of means must therefore be read with that direction in mind. The registry does not provide the group means or a comparison estimate, so there is no basis in the record for saying which group had a higher mean or how large a difference was.

How should a confidence interval be read?

The endpoint is described with a 95% confidence interval. In general, a confidence interval expresses statistical uncertainty around an estimate under the method used to construct it. It is not a guarantee that the true value lies within a particular interval, and it does not by itself determine whether an observed difference is important to patients. Its width is informative about precision, while its location is informative about the range of effects compatible with the data. Neither can be evaluated for the primary endpoint because the results are not reported in the registry record.

The registry lists the endpoint as a mean with a confidence interval, but does not state whether the reported analysis would be adjusted for baseline score or other characteristics. The statistical model, standard error calculation, and handling of repeated measurements are not reported in the registry record. No adjusted or unadjusted primary estimate can be described.

What can be inferred from the planning assumptions?

The record includes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustration considers an effect that is a stated fraction of the observed effect. Such calculations can help show how sample-size requirements depend on the size of an effect one wishes to detect, but they are not a report of the trial’s original sample-size justification. The registry’s own sample-size justification is not reported.

A sample size calculated from an observed effect is a planning illustration, not observed power. Observed power is not a substitute for the outcome estimate and its uncertainty. The illustration also does not establish that the assumptions were used when the trial was designed. For non-time-to-event outcomes, the stated planning convention is participants per arm; time-to-event calculations use total events. The primary endpoint is a continuous measure, but no specific calculated planning value is reported in the registry record for this account.

Why can over-dispersion matter in general?

Over-dispersion is a general concern for count outcomes when their variability is greater than a model assumes. If it is ignored, uncertainty estimates can be too small, making results appear more precise than they are. The registered primary endpoint is a continuous POS score, not a count endpoint, and the registry record does not say that an over-dispersion model was used. This concept should not be taken as a description of the trial’s analysis.

More broadly, statistical interpretation depends on the analysis model matching the endpoint and the data structure. The record does not report the primary model, assumptions checks, missing-data procedures, or prespecified analysis details. Consequently, the available description can explain what the endpoint means and how common statistical summaries work, but cannot establish how those methods were applied to the trial results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures and 24 analyses. Multiple outcomes and analyses can create a multiplicity issue: when many comparisons are examined, the chance of finding at least one apparently notable result may increase, even when all comparisons address the same underlying question. In general, statistical plans may address multiplicity by specifying a primary outcome, a hierarchy of tests, or an adjustment procedure. The methods used to address multiplicity are not reported in the registry record. The primary outcome description indicates several categories or time points and is not reduced to one comparison, so a single primary contrast cannot be reconstructed from the record.

The registry describes outcome surveys and data collection as not conducted on post-intervention interview participants. That clarifies that the interview participants were not part of the outcome-survey data collection, but does not explain how missing outcomes among randomized participants were handled. The amount and reasons for missing primary outcome data, any imputation, and the assumptions used for missingness are not reported in the registry record.

The analysis populations are also not reported in the registry record. It is therefore not possible to tell from this account whether the primary analysis included all randomized participants, only participants with available outcome data, or another defined group. The record does not specify whether analyses followed an intention-to-treat approach, whether participants were analyzed according to assigned group, or how protocol deviations were handled. Those details can affect interpretation and should not be inferred from the randomized design label.

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 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: patient expired at home (37.2%), patient expired at local hospital (9.3%), progression of disease (4.7%), consumption of a liquid mosquito repellent (2.3%), pleural effusion (2.3%).

The registry lists 43 participants at risk for serious adverse events in each of the Control and Pal-Care groups. It reports 19 participants with serious adverse events in Control and 24 in Pal-Care. Other adverse events are listed as 0 in each group. The record separately lists deaths as 17 for Control and 18 for Pal-Care. These are posted counts, not a complete comparative safety analysis.

The most frequently listed serious event terms are Patient Expired at Home at 37.2%, Patient Expired at Local Hospital at 9.3%, and Progression of Disease at 4.7%. Other listed terms include Consumption of a liquid mosquito repellent, Pleural effusion, and Dyselectrolytemia and Sepsis, each at 2.3%. The record does not give enough detail to establish how these terms relate to the group-level counts, whether terms can overlap, or the basis for the percentages. The event terms should therefore be read as registry descriptions, not as evidence that an event was caused by either intervention.

Serious adverse event counts and death counts are distinct reported quantities and should not be combined or converted into rates. The registry record does not report event timing, severity details beyond the serious classification, attribution, or a formal between-group safety comparison.

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

The record identifies a randomized evaluation of home-based Pal-Care against usual care and defines a clinically relevant outcome: the POS total score at 6-month. It also gives the scale’s content and scoring direction, describes the intervention’s community health worker approach, and lists group-level serious adverse event and death counts. These details help readers understand the question the trial was designed to address and the type of information registered.

However, the primary outcome results are not reported in the registry record. There are no reported group means, confidence intervals, or between-group estimate from which to judge direction, magnitude, or precision. Accordingly, the record cannot establish whether the observed POS scores differed between groups, nor whether any difference was substantial enough to matter. The endpoint description says higher scores indicate worse outcomes, but that scoring rule alone says nothing about the scores participants actually recorded.

The record’s enrollment and safety counts do not fill this gap. Enrollment is not an outcome estimate, and adverse event counts do not measure the primary endpoint. Likewise, planning illustrations based on an observed effect are not trial results and are not observed power. Any interpretation of those calculations must remain separate from evidence about what happened to participants.

The study’s implementation aim and stakeholder interviews may provide a different kind of information about delivery and experience, but detailed findings are not reported in the registry record. Without the primary outcome estimates, missing-data account, and analysis methods, the posted information supports a description of the trial and its registered measurement approach, not a conclusion about comparative effectiveness. This distinction is particularly important when a registry record contains design details but not the results needed to answer its primary comparative question.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its main outcome is multidimensional rather than a single symptom or event. The POS Scale combines physical and psychological symptoms with spiritual, practical, emotional, and psychosocial concerns. A total score offers a broad summary, but its meaning depends on the stated scoring direction and on how the underlying dimensions contribute to the total. Interpretation also benefits from access to group estimates and uncertainty, neither of which is reported in the registry record.

The design places an implementation question alongside a patient-outcome question. Evaluating delivery in a limited-resource setting may involve information that differs from a randomized comparison of patient scores. The registry describes both aims, but does not report detailed implementation findings or the primary endpoint results. Keeping these questions distinct prevents implementation descriptions from being mistaken for an estimate of the outcome contrast.

The record also illustrates why a randomized label and an enrollment figure are not enough to assess evidence. Readers need the outcome estimates, uncertainty intervals, analysis population, missing-data approach, and statistical plan to understand how the comparison was conducted and how robustly it answers the question. The registry lists multiple outcomes and analyses, while multiplicity procedures are not reported. That makes a clearly specified primary comparison and transparent reporting especially important.

Finally, the registered safety counts are useful descriptive information but do not replace an outcome analysis or a formal safety comparison. The record permits a careful account of what was planned and which counts were posted, while leaving important questions about results and analysis unanswered. That separation between design, observed outcomes, and uncertainty is central to sound clinical biostatistics.

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 trial is that the registry record does not report the POS outcome values or a between-group estimate. Without the means and confidence intervals, the direction, size, and precision of the primary comparison cannot be assessed. The endpoint description gives the scale range and scoring direction, but no threshold for a clinically meaningful difference is reported in the registry record.

The registry states that the trial was double-masked but does not identify who was masked or describe the masking procedures. It also does not report the randomization method, allocation concealment, primary statistical model, or whether the comparison was adjusted for baseline score. These omissions limit assessment of potential bias and analytical choices.

Outcome surveys and data collection were not conducted on post-intervention interview participants. The record does not provide the number of missing outcome observations among other participants, reasons for missingness, or methods used to address it. Analysis populations and adherence to assigned allocation are not reported in the registry record. With 15 outcome measures and 24 analyses listed, the absence of a reported multiplicity approach also leaves uncertainty about how findings across outcomes were interpreted.

The descriptions of the intervention and control arms are incomplete in the registry record, so the precise content of usual care and all intervention procedures cannot be assessed. The safety figures lack event timing, attribution, and a formal comparative analysis. These limitations concern the information available in the registry record; they do not establish that the trial itself lacked procedures or analyses that were not reported there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: R21 India Pal-Care Evaluation — NCT04972630.
• Registry record last updated 2024-11-27; status last verified 2024-11.
• Results first posted 2024-11-27.
• 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

R21 India Pal-Care Evaluation is listed as a completed, randomized, double-masked, parallel-group trial of home-based palliative care for cancer patients in need of palliative care. The registry lists enrollment as 112 and identifies Tata Medical Center in Kolkata, India, as the recruitment setting. Pal-Care was delivered over a 6-month period, with community health workers facilitating care; the comparator was usual care.

The registered primary endpoint is the mean Palliative Care Outcomes Scale total score at 6-month, with a 95% confidence interval. Higher scores indicate worse palliative care outcomes. The registry record does not report the primary outcome estimates or a between-group result. It lists 15 outcome measures, 24 analyses, serious adverse event counts of 19 in Control and 24 in Pal-Care among 43 at risk in each group, and deaths of 17 and 18, respectively. Statistical plan details, analysis populations, and missing-data methods are not reported in the registry record.