Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients (NCT03977051), a registered phase not stated study. The primary outcome is Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant.

2. Clinical Question

The study’s stated aim was to describe beliefs, understanding, and experience of immunosuppressant medication adherence through a series of patient focus groups. Its emphasis is therefore on what patients understand and report, rather than on comparing a treatment against a control or estimating a treatment effect.

The primary outcome title focuses on the number of participants who expressed understanding of the term and the importance of adherence after transplant. The broader description says the discussions were intended to explore understanding of adherence and nonadherence, the importance attached to adherence, and whether patients understood that nonadherence may affect transplant outcomes. It also describes exploring practical and perceptual barriers, strategies patients have used, and the support they have received or would find helpful.

The registry record does not report a comparator, a randomized allocation, or a numerical result for the primary question. It also does not report participant characteristics or the criteria used to decide whether a participant had expressed understanding. The question can therefore be described as a registered descriptive focus-group question, but the posted record does not establish how many participants met the endpoint or how their views were distributed.

3. Trial Design

The registry identifies NCT03977051 as a completed study titled “Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients.” Imperial College London is listed as the sponsor. The recorded start date is 2017-02-08, and the primary completion date is 2017-06-20. Enrollment is listed as 26.

The intervention is classified as behavioral and named “Focus group.” The arm description says the focus group was intended to explore immunosuppressant medication adherence in kidney transplant patients. The brief summary describes a series of patient focus groups designed to describe beliefs, understanding, and experience in the current transplant patient population. This is a descriptive, patient-focused purpose; the record does not describe a randomized treatment comparison.

The registry record lists a focus-group group and does not state allocation. It explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. No control condition, alternative intervention, or allocation procedure is reported. The number or structure of focus-group sessions, recruitment process, eligibility criteria, and setting are not reported in the registry record.

There are 3 outcome measures listed and 0 analyses listed. The primary measure is a participant count about expressed understanding and the importance of adherence after transplant. Its timeframe is recorded as 4 months. The record describes additional intended topics, including barriers, interventions, and support, but does not give numerical results for the primary endpoint. It also does not report a statistical analysis plan, a sample-size justification for the study, or a detailed method for turning focus-group responses into the registered count. The completed status indicates the registry’s recorded status, but it does not by itself show whether every planned activity or outcome was reported.

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

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 Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant, measured over 4 months.

The primary endpoint is titled as the number of kidney transplant patients who expressed understanding of the term immunosuppression medication adherence and the importance of adherence after transplant. The unit is participants, and the registry classifies the outcome as a count of participants with an event. Its timeframe is recorded as 4 months.

A participant count is intended to represent how many people met a specified condition—in this case, expressing understanding. Counts can give a direct description of how frequently a defined response occurred in the group being assessed. In a focus-group study, however, the meaning of such a count depends on how responses are elicited, what qualifies as expressing understanding, and how statements are coded. Those operational details are not reported in the registry record.

The endpoint is used alongside the broader qualitative aim: understanding how patients think about adherence, what barriers they identify, and what support they describe as useful. A count may summarize one aspect of those discussions, but it cannot convey the full content, context, or range of participants’ accounts. The registry does not report a numerical primary outcome value, the responses underlying any count, or a denominator for interpreting the count as a proportion. Consequently, the posted record identifies what the endpoint was intended to measure but does not show its observed value.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a focus-group study and a participant-count endpoint, rather than a randomized comparison with a reported treatment effect. The distinction between descriptive and inferential statistics is important. Descriptive statistics organize and summarize observations, such as the number of participants whose responses meet a defined criterion. Inferential methods use observed data and assumptions to estimate uncertainty or compare groups. The registry record lists 0 analyses and reports no numerical primary endpoint result, so neither an observed estimate nor its uncertainty can be interpreted.

What does a participant count represent?

In general, a count records how many observations satisfy a specified definition. For this endpoint, the relevant condition is that a kidney transplant patient expressed understanding of the term and importance of immunosuppressant medication adherence. A count is interpretable only when the rule for classifying responses is clear. For a focus-group outcome, that could involve deciding what statements count as evidence of understanding and how incomplete, mixed, or unclear responses are treated. These procedures are not reported in the registry record.

A count is not the same as a proportion. To interpret a count as a share of a group, the denominator must be known and its relationship to the count must be clear. The registry lists enrollment as 26, but it does not report the number assessed for this endpoint or whether all enrolled participants contributed usable responses. No proportion can be inferred from the enrollment entry alone, and no count should be treated as zero simply because a result is absent.

What would uncertainty measures add?

In general, a confidence interval describes a range of values compatible with the data and a specified statistical procedure. It can communicate the precision of an estimate; it does not guarantee that the true value lies in the interval or correct weaknesses in measurement. For a count or a proportion, the appropriate interval depends on the outcome definition, the denominator, the sampling structure, and the method used. Because the registry does not report the primary count, a denominator, or an analysis method, no interval can be interpreted for this endpoint.

A p-value, in general, measures how incompatible data are with a specified null model under the assumptions of a statistical test. It does not measure the probability that a hypothesis is true, and it is not a measure of practical importance. No p-value or hypothesis test for the primary endpoint is reported. In a descriptive focus-group study without a stated comparator, a p-value would not by itself answer the broader questions about the content or meaning of participants’ accounts.

How should planning calculations be read?

The stated planning assumptions describe illustrations based on an observed effect, not the study’s own design. They use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are planning illustrations, not observed power. They do not show that the study had a particular probability of detecting an effect, and they do not establish that a comparison was conducted.

The two-arm assumptions should be distinguished from the registered study description. The registry identifies a focus group and says the study is not a randomized comparison; it does not describe the equal-allocation design used in the planning assumptions as the study’s actual design. The observed effect on which an illustration is said to be based is not reported in the registry record. Therefore, no particular planning estimate can be connected to a reported result from this study.

In general, a normal approximation is a mathematical simplification used to estimate a sampling distribution. Its suitability depends on the data and design. Equal allocation is a planning choice for a two-arm comparison, not a feature that can be assumed for this focus-group study. The stated convention for time-to-event outcomes uses a total number of events under the Schoenfeld approach; that convention does not turn this participant-count endpoint into a time-to-event outcome. The primary measure is recorded as a count of participants, and no time-to-event analysis is reported.

Why can focus-group coding affect a count?

General qualitative methods recognize that spoken responses contain context, nuance, and sometimes mixed views. Reducing them to a count requires a transparent coding rule. Researchers may need to specify whether coding is performed by one or more reviewers, how disagreements are handled, and how participants who do not express a clear answer are classified. These are examples of methodological details that can affect reproducibility; they are not procedures attributed to this study. The registry record does not report its coding framework or reliability procedures.

Over-dispersion is a general concern when count data vary more than a simple model assumes. It is not possible to assess or attribute over-dispersion to this study from the registry information: the endpoint is a participant count, no result distribution is reported, and no count model is described. More fundamentally, a model cannot restore information about what participants meant if the endpoint’s coding definition is unclear.

In short, the registry provides a useful description of the intended question and the type of outcome, but it does not provide the data or analysis needed to quantify the result. General statistical methods explain what could be learned from a clearly defined count and its uncertainty; they do not fill in the missing endpoint value or establish that an unreported analysis took place.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and 0 analyses. It does not report a statistical analysis plan, identify a hierarchy for interpreting multiple outcomes, or describe a multiplicity adjustment. Multiplicity refers, in general, to the increased chance of obtaining at least one apparently unusual finding when many outcomes or tests are examined. Whether that issue affected this study cannot be determined from the registry record because no analysis results or testing strategy are reported.

The record identifies a primary outcome, but the description also covers several topics: understanding adherence and nonadherence, perceived importance, barriers, interventions, and support. It does not explain whether these topics were prespecified as separate outcomes, how they were assessed, or how any findings were selected for reporting. The number of listed outcome measures should not be treated as the number of statistical tests performed.

Missing-data handling is not reported in the registry record. There is no account of whether participants missed focus groups, declined to answer questions, had responses judged unusable, or were excluded from coding. The enrollment entry does not establish how many participants contributed to each outcome. No imputation procedure, missingness assessment, or sensitivity analysis is described.

Analysis populations are also not reported. The record does not define an included set for the primary endpoint or state how partial participation would be handled. These gaps prevent assessment of whether the endpoint reflects all enrolled participants or a subset. They also prevent a judgment about the effect of incomplete responses on any result. No missingness rate or adjusted estimate should be inferred from the available record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry lists a focus-group group with 26 participants at risk for serious adverse events and 0 affected. It also lists 26 at risk for other adverse events and 0 affected. Deaths are recorded as 0. No serious adverse-event terms are listed.

These entries describe the counts recorded in the registry, not proof that no adverse experiences occurred outside the scope of the reported collection or that every possible event was assessed. The adverse-event timeframe, ascertainment procedure, event definitions, and completeness of reporting are not reported in the registry record. The focus-group intervention is behavioral, but that classification alone does not establish what safety monitoring took place.

The at-risk entries are counts associated with the registry’s focus-group group. They should not be used to infer a rate without a defined observation period and relevant follow-up information. The record does not provide event narratives or explain how events were attributed. The reported zeros mean that the registry records no affected participants for these categories; they do not establish a general safety conclusion or a comparison with another group.

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

The record establishes that this completed study was designed to explore kidney transplant patients’ beliefs, understanding, and experience concerning immunosuppressant medication adherence through focus groups. It identifies a primary participant-count outcome concerning expressed understanding and its importance after transplant. It also describes interest in barriers, strategies, and support. These details clarify the questions the investigators intended to explore.

The posted record does not report the numerical primary outcome result or any analyses. It therefore does not show how many participants expressed the specified understanding, how common particular barriers were, or which forms of support participants identified. The absence of a result is not evidence that no participant understood the concept, nor does it demonstrate that all participants did. The endpoint cannot be quantified from the enrollment figure alone.

The study description does not support a causal claim. No comparator is described, allocation is not stated, and the registry cautions that the study is not a randomized comparison. Even if patient views or strategies were described in a full study report, those descriptions would not, on their own, establish that an intervention changed adherence or transplant outcomes.

In general, qualitative focus groups can help characterize how people describe experiences and what questions may warrant further investigation. Their interpretive value depends on recruitment, discussion procedures, analysis, and transparent reporting. Those methodological details and the underlying findings are not reported in the registry record. The appropriate interpretation is therefore limited: the registry documents a completed exploratory study and its intended outcome, while leaving the primary result and the substance of participants’ accounts unreported.

13. Why This Trial Matters Statistically

This study matters statistically because it illustrates the difference between registering an outcome and reporting an outcome. A well-described question helps readers understand what investigators intended to measure, but interpretation also requires the observed data, an operational definition, and an account of how responses were analyzed. The registry identifies the endpoint as a participant count, yet does not report the value or the coding rule that would make that count reproducible.

It also highlights the importance of matching statistical language to study design. The record describes focus groups and explicitly cautions against treating the study as a randomized comparison. A two-arm planning illustration is not evidence that the actual study had two comparable groups. Keeping planning calculations separate from observed analyses prevents hypothetical assumptions from being mistaken for trial results.

For a patient-perspective study, a numerical count and a qualitative account answer different questions. A count can indicate how many responses met a defined criterion; detailed accounts can explain the meanings, context, or variation behind those responses. Neither can substitute for the other. Reporting the coding framework, participant flow, and outcome findings would allow readers to understand both the summary and its limits.

The record also makes clear why missing results should not be interpreted as negative results. Without the endpoint value, denominator, and analysis details, readers cannot assess magnitude or precision. This is a reporting limitation rather than a basis for a conclusion about adherence knowledge. The statistical lesson is to distinguish what a study set out to learn from what its registry record makes available for evaluation.

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 registry record gives limited detail about the study procedures. It does not report eligibility criteria, participant characteristics, recruitment methods, the number or format of focus-group sessions, or the setting. These omissions restrict assessment of whom the findings might represent and how the discussions were conducted. Enrollment is listed as 26, but the record does not state how many participants contributed to the primary endpoint or each other outcome.

The primary endpoint depends on interpreting what counts as expressing understanding. The registry does not report a formal definition, question wording, coding process, reviewer procedures, or rules for ambiguous and missing responses. Without those details, readers cannot assess consistency or reproduce the classification. The listed timeframe is 4 months, but the timing relative to study activities is not explained.

The study has no comparator described, and allocation is not stated. The registry cautions that it is not a randomized comparison and that arms are not like-for-like controls. This limits the questions that can be answered from its design: the posted information does not support a comparative causal estimate. The record also lists 0 analyses and does not report numerical primary results, so neither the magnitude nor precision of the endpoint can be evaluated.

Finally, the registry does not report missing-data procedures, analysis populations, a statistical analysis plan, or multiplicity handling. It does not describe how focus-group material was analyzed beyond the broad intended exploration. These are limitations of the available registry record; they do not establish that the procedures were absent from the conduct of the study or that no additional findings exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients — NCT03977051.
• Registry record last updated 2024-04-12; status last verified 2023-10.
• Results first posted 2024-04-12.
• 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

NCT03977051 is listed as a completed study sponsored by Imperial College London, with enrollment of 26. The recorded start date is 2017-02-08, and the primary completion date is 2017-06-20. The study used a behavioral focus-group intervention to explore immunosuppressant medication adherence in kidney transplant patients.

The primary endpoint concerns the number of participants expressing understanding of adherence and its importance after transplant; the timeframe is recorded as 4 months. The registry lists 3 outcome measures and 0 analyses. It does not report the primary outcome value, participant characteristics, endpoint coding rules, or analysis populations. Serious adverse events, other adverse events, and deaths are each recorded as 0 in the listed focus-group group, with 26 participants at risk for each adverse-event category.

The record supports describing the study’s exploratory purpose and registered measures. It does not provide enough outcome or analysis information to quantify the primary finding or assess its precision.