Pictograms to Facilitate Comprehension of Medical Indications: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pictograms to Facilitate Comprehension of Medical Indications (NCT05609760), a randomized na study. The primary outcome is Disease Control at 60 Days.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial of SIMAP pictograms versus usual care. The registry lists quadruple masking, while the brief summary describes the study as triple-masked. It does not identify which trial participants or staff were masked, or explain the difference between those descriptions. The record lists the trial phase as not applicable and enrollment as 22. The sponsor was Universidad de Concepcion.

The trial concerned adult patients with a recent diagnosis of asthma. According to the brief summary, participants were to receive either a pictographic depiction of treatments and recommended interventions or standard communication without assistance from their attending physician. The arm descriptions add that the usual-care group received a bronchial asthma information leaflet and no pictograms. These descriptions do not specify further details about how the intervention was implemented or how closely it was followed.

The planned follow-up was 60 days. The primary outcome was asthma control measured by the ACT, and the registry lists inhaler technique and adherence to inhaler-technique steps at 60 days as secondary outcomes. The brief summary also describes hospitalisations, emergency care unit visits, and need to increase bronchodilator therapy as secondary outcomes. Numerical results for these outcomes are not reported in the registry record.

The record gives a start date of 2022-08-01 and a primary completion date of 2023-02-20, and lists the trial status as terminated. It does not report why the trial was terminated. The endpoint summaries include 9 participants in the Pictogram Group and 11 in the Usual Care Group. The record’s narrative participant accounting is incomplete, so the relationship between the listed enrollment, follow-up descriptions, and endpoint group counts is not fully clear.

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: We recruited 10 patients, who voluntarily signed the informed consent. One patient withdrew from the study after signing the informed consent, and we lost contact with another patient during the 30-day follow-up. Consequently, we were able to analyze 21 patients in the first control (7 days of follow-up) and 20 patients in the second and third follow-ups (30 days).

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: The pictogram group initially consisted of 10 patients who signed the informed consent. However, after signing, one of the patients withdrew from the study and did not answer to the instruments. Despite being initially assigned to the pictogram group, we lack details about the baseline characteristics of this patient. As a result, this individual was not included in the total count of patients in the pictogram group for the baseline analysis.

6. Primary Endpoint

The registry lists the primary outcome as Disease Control at 60 Days, measured over 60 days.

The primary endpoint was disease control 60 days after randomization, measured using the Asthma Control Test (ACT). The registry describes the reported summary as the median ACT score with an inter-quartile range. The ACT scale runs from a minimum score of 5, indicating poor asthma control, to a maximum score of 25, indicating complete control; the record says a score above 19 suggests well-controlled asthma.

The ACT provides a structured measure of asthma control that can be summarized across participants. A median describes the middle of the observed scores, while the inter-quartile range describes the span covering the middle half of those scores. These summaries help convey both the typical score and the distribution’s spread without assuming that scores follow a particular symmetric pattern. They do not, by themselves, establish whether groups differ beyond the observed sample.

The posted median was 22 for the Pictogram Group, with an inter-quartile range of 18 to 22, and 21 for the Usual Care Group, with an inter-quartile range of 18 to 23. The endpoint is relevant to the trial’s stated question because its aim was to assess comprehension and adherence to medical indications in relation to asthma control. The registry record does not report a formal inferential analysis of the group contrast or provide an estimate of its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Random allocation is intended to make the treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. A parallel-group design assigns each participant to a group and compares outcomes between groups. These are general features of randomized trials; the registry record does not describe the allocation sequence, concealment procedures, or the specific randomization method used for this trial.

What do the group summaries describe?

The primary endpoint is reported as a median and inter-quartile range rather than as a mean and standard deviation. In general, the median is the middle of an ordered set of observations. The inter-quartile range gives the lower and upper quartiles, marking the middle half of the observations. These summaries can be useful when scores are not well represented by a symmetric distribution or when a small number of extreme values could strongly influence the mean. The registry record does not report a distributional assessment or explain why this summary was selected.

The posted values are medians of 22 and 21, with inter-quartile ranges of 18 to 22 and 18 to 23, respectively. A median does not identify each participant’s score, and an inter-quartile range does not provide the full range of observations. The summaries also do not directly estimate the uncertainty in the contrast between groups. A statistical comparison would ordinarily require an analysis method suited to the endpoint and design, together with a clearly defined analysis population. The registry record does not report that method or a formal comparison result.

What would inferential results add?

In general, an effect estimate describes the magnitude and direction of a group contrast, while a confidence interval describes its uncertainty. A p-value, when used, summarizes how compatible the observed data are with a specified null model and its assumptions. These measures answer different questions: neither replaces the need to assess the study design, the outcome definition, or the relevance of the observed values. For this trial, an effect estimate, confidence interval, and p-value for the primary comparison are not reported in the registry record. No inferential result should be reconstructed from the medians and inter-quartile ranges alone.

The brief summary says outcomes would be analyzed under the intention-to-treat principle by a statistician unaware of treatment allocation. In general, intention-to-treat analysis aims to retain participants in their randomized groups, regardless of whether they fully followed the assigned intervention. The record does not report whether the planned approach was carried out for the posted endpoint, how missing outcomes were handled, or whether the statistician remained unaware of allocation during analysis. The record’s masking descriptions also differ: the trial-design listing says quadruple-masked, whereas the brief summary says triple-masked.

How should planning illustrations be read?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect; for time-to-event outcomes, the illustration uses total events, and for other outcomes it uses participants per arm. These are planning assumptions, not evidence about the trial’s design or an observed measure of power. The actual trial sample-size justification is not reported in the registry record. The record does not report numerical planning results for this endpoint, and any sample-size illustration should not be interpreted as observed power.

In general, small samples tend to yield uncertain estimates, and the observed distribution can be sensitive to individual participants. The endpoint summaries use 9 and 11 participants, and the record does not provide a confidence interval that would show the precision of an estimated contrast. This does not permit calculation of a reliable inferential result from the posted summaries. The trial’s status is terminated, but no reason for termination or account of its effect on the planned analysis is reported.

The record lists five outcome measures and two secondary outcomes by name, but reports no secondary outcome analyses. The brief summary mentions additional clinical events, yet numerical findings for them are not reported in the registry record. Without those results, the primary endpoint summaries should not be treated as a complete account of all planned or described outcomes.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study assesses multiple outcomes, time points, or analysis choices: the more comparisons considered, the greater the chance that at least one result may appear unusual by chance. This is a general statistical concern. The registry record lists five outcome measures and names inhaler technique and adherence to inhaler-technique steps at 60 days as secondary outcomes. The brief summary also describes hospitalisations, emergency care unit visits, and need to increase bronchodilator therapy as secondary outcomes. No numerical results for these secondary outcomes are reported, and the record does not describe a multiplicity adjustment or testing hierarchy.

The primary endpoint is reported with medians and inter-quartile ranges, but there is no reported formal test or confidence interval. The record lists 0 analyses. It does not say whether other statistical analyses were conducted but not entered in the registry, or whether the posted summaries represent all analyses performed. A prespecified statistical analysis plan is not reported in the registry record.

Missing data are also difficult to assess. The primary endpoint population description says one participant withdrew after signing informed consent and another was lost to contact during 30-day follow-up, then refers to 21 patients analyzed at a first control. That narrative is incomplete and does not explain how missing ACT measurements were handled. It is difficult to reconcile with the listed enrollment of 22 and the endpoint groups of 9 and 11. The record does not report imputation, a complete-case approach, sensitivity analyses, or a participant flow accounting that resolves these details.

The brief summary states an intention-to-treat analysis was planned. Whether that analysis was performed, and how participants without observed outcomes were treated, is not reported in the registry record. As a result, the representativeness of the reported endpoint summaries and the potential influence of missing data cannot be evaluated from the posted information.

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.

The serious adverse event record lists 0 serious events among 9 participants at risk in the Pictogram Group and 0 among 12 participants at risk in the Usual Care Group. It lists 0 deaths in each group. The record also lists 0 other adverse events among 9 participants at risk in the Pictogram Group and 0 among 12 in the Usual Care Group. No serious adverse event terms are listed.

These are event counts and denominators as entered in the registry record. A zero count means that no events of the listed category were recorded for the stated group in this record; it does not establish that no event occurred outside the information captured or submitted. With limited participant counts, event counts alone also provide little information about how precisely an underlying event rate is known. The record does not describe the adverse-event collection procedures or give further detail about ascertainment and follow-up.

The safety denominators differ from the primary endpoint denominators, which are 9 and 11. The record does not explain why the Usual Care Group denominator is 12 for safety and 11 for the endpoint. These denominators apply to different posted results and should not be combined or substituted for one another. The safety figures describe recorded events; they do not establish a comparative safety effect.

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

The registry record supports a narrow descriptive statement: among the participants included in the 60-day endpoint summaries, the reported median ACT score was 22 in the Pictogram Group and 21 in the Usual Care Group. The corresponding inter-quartile ranges were 18 to 22 and 18 to 23. These summaries describe the observed scores; they do not establish why those scores occurred or whether a group contrast reflects a reproducible effect.

The posted data do not establish that SIMAP improved asthma control, nor do they establish that it did not. The record does not report an inferential comparison, confidence interval, or p-value for the primary endpoint. Without an estimate of the contrast and its uncertainty, the observed medians cannot determine how compatible the results are with a range of possible underlying group differences. The overlapping inter-quartile ranges are also not a formal test of equality.

The trial’s stated rationale connects pictograms with comprehension and adherence, but the available primary result is an ACT score summary. The record lists inhaler technique and adherence to inhaler-technique steps as secondary outcomes, but their numerical results are not reported. The brief summary mentions hospitalisations, emergency care visits, and increased bronchodilator therapy, but results for those outcomes are also not reported. Thus the available endpoint summaries do not answer every question described in the trial summary.

The record lists enrollment of 22, while the primary endpoint summaries include 9 and 11 participants. Its participant-accounting narrative is truncated and difficult to reconcile with those counts. The safety denominators differ as well. These limitations make it important not to treat the group summaries as a complete account of all randomized participants or all trial outcomes.

The record’s terminated status is relevant context, but the reason for termination is not reported. The results should be interpreted as limited posted descriptive data from a small trial record, not as a definitive estimate of the effect of pictogram-assisted communication. No medical conclusion follows from these summaries alone.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is important in clinical communication research: how to evaluate an intervention whose intended pathway involves comprehension and adherence, while using a clinical outcome such as asthma control as the primary endpoint. The distinction matters because an outcome can be relevant to a trial’s aim without directly measuring every step in the proposed pathway. In this record, ACT scores are the primary endpoint, while inhaler technique and adherence to technique are listed as secondary outcomes.

The registry record also illustrates why estimates need to be read alongside their uncertainty and analysis population. The medians and inter-quartile ranges describe observed ACT scores, but no formal comparison estimate or confidence interval is reported. The endpoint group counts are 9 and 11, while enrollment is listed as 22, and the participant-accounting narrative is incomplete. These details limit conclusions about precision and about how the analyzed participants relate to the enrolled group.

There is a further distinction between a registry’s planned analysis description and posted results. The brief summary refers to intention-to-treat analysis and a statistician unaware of allocation, but the record lists 0 analyses and does not report how missing outcomes were handled. A stated plan is useful context, but it is not itself evidence that the analysis was completed as planned.

Finally, the record’s different masking descriptions and its terminated status emphasize the value of clear reporting. The record does not explain the masking discrepancy or the reason for termination. For biostatisticians and clinical researchers, these omissions demonstrate why interpretation requires attention not only to outcome values but also to denominator accounting, analysis details, and completeness of reporting.

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 does not provide a formal statistical comparison for the primary endpoint. It reports medians and inter-quartile ranges but no effect estimate, confidence interval, or p-value. As a result, the precision and inferential strength of the observed group summaries cannot be assessed from the posted results.

Participant accounting is unclear. The record lists enrollment of 22, while the endpoint summaries include 9 participants in the Pictogram Group and 11 in the Usual Care Group. The primary endpoint population description is truncated and refers to 10 patients recruited, one withdrawal, another participant lost to contact, and 21 patients analyzed at a first control. The registry record does not explain these statements or reconcile them with the group summaries. Safety denominators also differ from the endpoint denominators.

The record lists the trial status as terminated but does not report the reason. It describes different masking counts in different places: quadruple in the design listing and triple in the brief summary. The roles masked and the reason for the discrepancy are not reported. The record also does not provide the allocation method, an analysis plan, or details of missing-data handling.

Numerical results for the secondary outcomes are not reported. The record’s summary describes additional outcomes, but their results and analyses are not available in the registry record. The record does not report whether the intention-to-treat analysis described in the brief summary was carried out. These limitations constrain both the assessment of outcome completeness and interpretation of the primary endpoint summaries.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pictograms to Facilitate Comprehension of Medical Indications — NCT05609760.
• Registry record last updated 2025-04-17; status last verified 2025-04.
• Results first posted 2025-04-17.
• 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

NCT05609760 is a randomized, parallel-group trial of SIMAP pictograms versus usual care for adults with a recent diagnosis of asthma. The registry lists Universidad de Concepcion as sponsor, enrollment of 22, and trial status as terminated. It gives a start date of 2022-08-01 and a primary completion date of 2023-02-20.

The primary endpoint was ACT disease-control score at 60 days. The posted median was 22 (inter-quartile range 18 to 22) for the Pictogram Group and 21 (18 to 23) for the Usual Care Group. The registry does not report a formal comparison, confidence interval, or p-value. It lists inhaler technique and adherence to inhaler-technique steps as secondary outcomes, but numerical results for them are not reported.

The record lists 0 serious adverse events and 0 deaths in both groups, with safety denominators of 9 and 12. The reason for trial termination, complete participant accounting, and details of missing-data handling are not reported in the registry record.