Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV (NCT04682301), a registered phase not stated study. The primary outcome is Focus Group Analysis (Aim I).

2. Clinical Question

3. Trial Design

The registry record describes a completed study titled Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV. Fred Hutchinson Cancer Center is listed as the sponsor. The study began on 2021-02-05, had a primary completion date of 2023-03-14, and lists enrollment of 102. These record details describe study administration; enrollment should not be mistaken for the number completing the primary measure.

The work is organized around two aims. Aim I uses focus groups to obtain feedback on potential methods for shared decision making. The stated focus group participation lasts an average of 1-1.5 hours. Aim II gives participants the intervention developed in Aim I and obtains their feedback. Participants may also take part in a telephone interview lasting 45 minutes 1 month later. The record lists a behavioral intervention, focus group discussion, discussion giving feedback on shared decision making, interview, and survey administration.

The record describes focus groups as recorded and transcribed, with analysis intended to identify themes and refine the focus group guide iteratively. It also states that pre- and post-shared-decision-making survey data are collected by tablet, with a paper option if desired. The record does not state a randomized allocation, and the design is not a like-for-like control comparison. The actual allocation method is not reported in the registry record.

There are five outcome measures listed, but the record reports zero statistical analyses. The primary outcome is a participant count for completion of focus group participation for analysis. The protocol details, sample-size justification, and full statistical analysis plan are not reported in the registry record. The planning assumptions used in statistical illustrations do not establish what design or analysis was prespecified for the study.

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:

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 Focus Group Analysis (Aim I), measured over During focus participation, an average of 1-1.5 hours.

The primary endpoint is the number of participants who complete focus group participation for analysis. It is a count, with participants as the unit. The endpoint description links the count to focus group work intended to refine potential methods of shared decision making for lung cancer screening in persons living with HIV.

This measure is useful for describing participation in the focus group activity. In a study focused on refining an intervention, completion of the activity identifies how many participants contributed material for the planned analysis. The record says that focus groups are recorded and transcribed and that the analysis is intended to map generated themes onto an implementation framework, then compare coded material to identify key themes. The measure therefore reflects participation in the qualitative work; it is not itself a measure of whether screening decisions changed or whether the intervention improved a health outcome.

The registry record does not report the observed count for this endpoint. It also does not report a result describing the themes, the number of focus groups, or how many participants contributed usable data. Enrollment of 102 is a separate record detail and does not establish how many completed focus group participation. The endpoint's result and the extent of missing participation data are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General explanation: statistical methods must match the question and the type of outcome. The primary measure in this record is a count of participants completing focus group participation. A count answers how many participants met the stated completion criterion; it does not, by itself, describe the content of the focus group discussions or establish a difference between interventions.

What does a count measure?

A count records the number of units meeting a defined condition. Here, the unit is a participant and the condition is completion of focus group participation for analysis. To interpret such a measure, readers need a clear definition of completion, the number of participants eligible or invited to take part, and the number with an observed status. The registry record gives the endpoint definition but does not report the observed count, the invitation denominator, or further completion rules. Without these details, the count cannot be reconstructed or its completeness assessed.

Enrollment and endpoint completion are not interchangeable. Enrollment describes the number entered in the study record, whereas the primary measure concerns participation in a specific activity. Some enrolled participants might not complete that activity, and the record does not say whether all enrolled participants were expected to attend. Consequently, the enrollment figure should not be treated as an endpoint value or denominator unless an analysis explicitly defines it that way.

How do the qualitative and survey activities differ?

The record describes recording and transcribing focus groups, mapping themes to an implementation framework, and using a constant comparison method to identify key themes. These are qualitative analytic activities. They organize and interpret text rather than estimate a numerical treatment contrast. The stated iterative approach also means that feedback can inform changes to the focus group guide while data collection is in progress. The registry record does not report the resulting themes or describe the final qualitative findings.

Pre- and post-intervention survey data are also described. General explanation: paired survey measurements can describe change within participants when the same measure is collected at both times, while a comparison between groups requires a clearly defined group structure and analysis. The registry record does not report survey results, the survey instruments, the analysis used, or a comparison of change. Therefore no direction or size of survey change can be inferred.

What would an inferential analysis require?

General explanation: an inferential analysis combines observed data with an analysis plan to estimate a quantity and its uncertainty. For a participant count, a descriptive result could state the observed count and its relevant denominator. If the aim were to compare groups, the groups, allocation, outcome definition, and comparison method would need to be specified. The registry record does not report a statistical analysis for the primary endpoint, and it lists zero analyses. It therefore supplies no interval estimate or test result to interpret.

A confidence interval is a range of values generated by a statistical procedure to express uncertainty around an estimate. Its width depends on features such as the amount of information in the data and the variability represented by the model. It is not a guarantee that the true value lies in the interval, and it does not correct bias from missing data, measurement problems, or an unsuitable design. Since no primary estimate or interval is reported, precision cannot be evaluated in this record.

Over-dispersion is a general issue for count data when observed variability exceeds what a chosen model assumes. If present, it can make uncertainty estimates from an overly restrictive model too small. No count model, dispersion estimate, or variance information is reported for this endpoint, so there is no basis to say whether over-dispersion applies. For the primary outcome, which is a count of participants rather than a reported rate or repeated count process, a model choice would need to be justified by the actual data and analysis question.

How should planning calculations be read?

General explanation: sample-size calculations illustrate how much information may be needed under stated assumptions. The record’s planning assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. For time-to-event calculations, the assumptions refer to a total event count, while other calculations refer to participants per arm.

Those assumptions are not proof that the study enrolled two randomized arms, and they do not describe the actual allocation method. The study is explicitly not a randomized comparison in the record. The record does not report its own sample-size justification, and the observed effect needed to make a planning illustration specific to this study is not reported. A planning calculation is not an observed result and is not observed power. It cannot establish whether the trial was adequately powered after completion.

General explanation: power is a design-stage probability defined under a particular statistical model, effect size, sample size, and decision threshold. Once a study is complete, the observed estimate and its uncertainty are more informative for interpreting the data than a retrospective claim about power. Since no result or inferential analysis is reported, neither an observed effect nor its precision can be evaluated.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Aims I-II")
n      <- c(102)
events <- c(43)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Aims I-II  102  43  42.2  32.4  52.3  33.0  51.9  33.0  51.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures and zero statistical analyses. It does not report which outcomes were designated primary beyond the focus group analysis measure, whether other outcomes were secondary or exploratory, or how multiple outcomes were handled. A multiplicity adjustment or a prespecified hierarchy of tests is not reported in the registry record. With no inferential results posted, there are no reported p-values to interpret in light of multiple testing.

Missing-data handling is also not reported in the registry record. For the primary count, the number completing the focus group activity is not given, and no information is posted about participants who did not attend, incomplete records, or whether all focus group material was usable for analysis. For the pre- and post-surveys, the record does not report the number of completed forms at either time, reasons for missing data, or any method used to handle missing responses.

Analysis populations are not described beyond the endpoint’s definition of participants who complete focus group participation for analysis. The record does not report an intention-to-treat population, a per-protocol population, or criteria for including participants in survey or qualitative analyses. These details matter because different inclusion rules can produce results that describe different participant sets. Without a posted analysis plan and participant-level accounting, the extent and potential influence of missingness cannot be assessed.

General explanation: missingness can affect interpretation when the people with observed data differ in relevant ways from those without observed data. Reporting a denominator, completion flow, reasons for missingness, and the planned analysis population helps readers judge that risk. Those items are not reported in the registry record.

12. 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 safety record lists the Aims I-II group with 102 participants at risk in both the serious and other adverse-event categories. It records zero participants affected in each of those categories and lists three deaths. These are the posted counts; the record does not provide event descriptions or additional context for the deaths.

These figures should be read as separate registry entries, not as a causal assessment. The record does not report whether deaths were related to study participation, when they occurred, or their causes. It also does not report the definitions used for serious or other adverse events, the observation period for these entries, or whether events were actively collected in a particular way. Without those details, the counts cannot establish that an event was caused by the intervention, nor can the zero affected entries establish the absence of all possible harms.

General explanation: safety counts describe events recorded under the study’s definitions and follow-up procedures. Interpretation depends on who was monitored, how long they were observed, and how events were classified. The registry record does not report those details. The safety entries should therefore be treated as a limited description of recorded categories, not a complete clinical safety profile or a comparison against a control group.

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

The record establishes that a completed study examined tailoring shared decision making for lung cancer screening in persons living with HIV. Its focus group and feedback activities were intended to help refine an intervention. The primary measure was defined as a count of participants completing focus group participation for analysis. That is a participation measure, not a direct estimate of the intervention’s effect on screening choices, patient understanding, or health outcomes.

The primary result itself is not reported in the registry record. Enrollment of 102 does not tell readers how many participants completed the focus group activity, and the record lists zero statistical analyses. The posted information therefore does not quantify the primary endpoint or show a numerical change in survey responses. It also does not estimate an intervention effect against a control group, because an allocation method and like-for-like comparator are not reported.

These absences do not establish that the intervention was ineffective, that participants did not contribute useful feedback, or that no change occurred. They mean that such conclusions cannot be drawn from the registry record. Similarly, the safety entries do not establish whether deaths were related to study activities, and they do not constitute a comparative safety analysis.

General explanation: statistical interpretation depends on the match between the design, the outcome, and the analysis. A count can describe participation; qualitative analysis can describe themes; and a controlled comparison can estimate a difference under its assumptions. These are distinct forms of evidence. The record describes planned qualitative and survey activities but does not post their results or a quantitative analysis. Readers should distinguish the study’s stated aims from findings that are actually reported.

The planning assumptions do not fill this evidence gap. A sample-size illustration based on a stated effect and calculation assumptions describes a hypothetical planning scenario. It does not supply an observed endpoint, demonstrate power, or provide evidence of an intervention effect. The trial’s own sample-size justification is not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable because its primary measure is participation in qualitative work rather than a clinical event or a conventional treatment contrast. The endpoint asks how many participants complete focus group participation for analysis. This aligns with an intervention-refinement purpose: participant feedback can inform how shared decision making is shaped for persons living with HIV who are considering lung cancer screening.

The record also illustrates why the outcome definition and the posted result must be read separately. The endpoint is defined, but the observed count is not reported. A total enrollment figure cannot answer a question about completion of a particular study activity. That distinction is important in studies involving focus groups, interviews, and surveys, where participation in each activity can differ and the useful analytic population may not equal the enrolled population.

The combination of qualitative feedback and surveys also makes clear that different methods answer different questions. The planned framework and constant-comparison approaches are intended to organize textual themes. Survey data can quantify responses if measures and analyses are reported. Neither method, on its own, creates a randomized comparison. The record does not describe a like-for-like control comparison or report statistical analyses.

General statistical context: intervention-development studies can generate useful evidence about feasibility, acceptability, and how an intervention should be refined, but those claims require results suited to those questions. A transparent account of participant flow, qualitative findings, survey completion, and analysis methods would help readers assess the evidence. Such results are not reported in the registry record. The study’s stated focus is therefore informative about its purpose, while the available numerical record remains insufficient to evaluate what the study found.

15. 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 for statistical interpretation is that the primary endpoint has no posted observed value. The registry record defines the measure but does not report how many participants completed focus group participation for analysis. Enrollment of 102 cannot be used as a substitute, because the record does not establish that every enrolled participant completed the activity.

The record lists five outcome measures but zero analyses. It does not report survey findings, qualitative themes, an estimated intervention effect, or uncertainty around an estimate. This prevents assessment of both the direction and precision of any reported outcome. The record also does not provide the participant flow or missing-data information needed to determine who contributed to each type of analysis.

The study is not described as a randomized comparison, and the allocation method is not reported. A comparator suitable for estimating an intervention contrast is not identified. Consequently, the available record does not support a causal comparison between the intervention and an alternative. Further design details, eligibility criteria, and the protocol’s statistical analysis plan are not reported in the registry record.

The listed serious and other adverse-event counts have limited context. Event definitions, collection procedures, observation periods, and the relationship of the three deaths to study participation are not reported. The counts should not be treated as a complete safety assessment.

Finally, planning assumptions are not a substitute for a trial-specific design rationale or completed analysis. The record does not report a sample-size justification, and the calculation assumptions do not establish the actual study allocation. These limitations reflect what is and is not available in the registry record, rather than demonstrating that the study activities were not conducted.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV — NCT04682301.
• Registry record last updated 2024-05-06; status last verified 2024-05.
• Results first posted 2024-05-06.
• 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.

19. Record Summary

The registry record describes a completed study of tailoring shared decision making for lung cancer screening in persons living with HIV. Fred Hutchinson Cancer Center is listed as the sponsor. The study began on 2021-02-05, reached primary completion on 2023-03-14, and lists enrollment of 102.

Aim I involved focus group feedback on potential methods of shared decision making. Aim II involved the intervention developed in Aim I and participant feedback, with a possible telephone interview 1 month later. The primary measure is the count of participants completing focus group participation for analysis. Five outcome measures are listed, and zero statistical analyses are reported.

The record does not report the observed primary endpoint, survey findings, qualitative results, or a comparative intervention effect. Its safety entries list zero affected participants in the serious and other adverse-event categories among 102 at risk, and three deaths; further details are not reported in the registry record.