This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education (NCT02971735), a randomized na study. The primary outcome is Percentage Change in Multiple-choice Question (MCQ) Scores.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02971735 |
| Phase | NA |
| Condition | Medical Education |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Chang Gung Memorial Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Undergraduate medical education students without previous training in otolaryngology-head and neck surgery (ORL-HNS). The registry describes a planned enrollment of 60 students.
Intervention
A mobile e-learning interactive multimedia module incorporating text, images, and small game tests. The arm description specifies a 100-minute intervention.
Comparator
A mobile e-learning Power Point show module incorporating text, images, and audio. Its arm description also specifies a 100-minute intervention and characterizes learning as linear without interaction.
Primary question
How did the median percentage change in multiple-choice question (MCQ) scores compare between the two modules, using tests administered before and immediately after the intervention?
The trial addresses a focused educational comparison: whether the format of mobile e-learning is associated with different immediate MCQ score changes in an ORL-HNS teaching context. It also identifies cognitive style and other learning outcomes as interests of the study, but the posted primary endpoint is the change in MCQ scores. The registry record does not report a primary analysis that tests the between-module difference or estimates its uncertainty.
3. Trial Design
The registry identifies this study as a randomized, parallel-group trial, marked completed. It lists an enrollment of 60 and two instructional arms: Interactive Multimedia Module and Power Point Show Module. The posted outcome summaries list 30 participants in each arm. The record describes the participants as undergraduate medical students without previous ORL-HNS training. The sponsor is Chang Gung Memorial Hospital.
Each group received a mobile technology of e-learning intervention. The interactive multimedia module is described as combining text, images, and small game tests; the Power Point show module combines text, images, and audio. The latter is described as linear and without interaction. Both arm descriptions specify 100 minutes of instruction. The available arm descriptions are truncated, so details beyond their readable portions are not reported in the registry record.
The record lists no masking. Its study summary uses the phrase “blinded randomization,” but does not explain what that phrase means in practice or identify anyone who was blinded. Allocation concealment procedures, the random sequence method, and the timing of allocation are not reported in the registry record. These details matter because random assignment and masking address different potential sources of bias.
The registered study dates are 2016-11-23 for study start and 2017-07-05 for primary completion. The study is categorized as phase NA, which is consistent with its educational focus rather than a drug-development phase. The registry describes the primary assessment as duplicated 15-minute MCQ tests before and immediately after the intervention. It does not report further detail about the test form, scoring range, or administration procedures.
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: All of the volunteers had at least a basic level of computer literacy, and they were shown the practical aspects of using tablets and applications. The inclusion criteria were as follows: 1) age \>20 years; and 2) undergraduate medical students (clerkship). The exclusion criteria were: 1) previous ORL-HNS training; and 2) declining to participate.
Overall Study
| Stage | Interactive Multimedia Module | Power Point Show Module |
|---|---|---|
| STARTED | 30 | 30 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 0 | 0 |
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: Pretests including a 15-minute 10-question standard MCQ to evaluate the students' existing knowledge (range, 0-100) and a 15-minute 5-question MST to assess their existing competence (range, 0-100) with regards to "emergent ORL-HNS disorders" were given to the students.
| Characteristic | Unit | Interactive Multimedia Module | Power Point Show Module | Total |
|---|---|---|---|---|
| Participants analysed | 30 | 30 | 60 | |
| Age, Continuous | years | 23 (23 to 24) | 23 (23 to 24) | 23 (23 to 24) |
| Sex: Female, Male: Female | Participants | 10 | 14 | 24 |
| Sex: Female, Male: Male | Participants | 20 | 16 | 36 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| The cognitive style was assessed using the 25-item group embedded figures test after enrollment. | units on a scale | 18 (15 to 18) | 17 (16 to 18) | 17 (15 to 18) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage Change in Multiple-choice Question (MCQ) Scores, measured over before and immediately after the M-TEL intervention.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | percentage of MCQ change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage change in MCQ scores from before to immediately after the mobile e-learning intervention. The registry describes duplicated 15-minute tests administered before and after instruction and specifies the median as the summary measure, with an inter-quartile range (IQR) for spread. The assessment concerns emergent ORL-HNS disorders.
An immediate pre/post score change is intended to capture learning performance over the brief instructional period. Comparing the change between the randomized groups can describe whether observed score changes differed across the two teaching formats. The median gives the middle of the observed change distribution and is less influenced by unusually high or low values than the arithmetic mean. The IQR describes the middle portion of that distribution; it helps convey variability but does not, by itself, establish whether a between-group difference is statistically persuasive.
The registry record does not specify the calculation used to express percentage change, the maximum possible score, or whether the duplicated tests used the same questions or equivalent forms. Separate baseline and post-intervention score summaries are not reported in the registry record. These omissions limit interpretation of how the change metric relates to initial performance and to the underlying MCQ scale. The endpoint is an immediate assessment result; longer-term retention or performance in clinical practice is not reported as part of this primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary summaries are medians of percentage change in MCQ scores. For the Interactive Multimedia Module, the median is 40.0, with an IQR from 13.0 to 76.0. For the Power Point Show Module, the median is 45.0, with an IQR from 30.0 to 50.0. These are descriptive summaries of the observed outcome in each arm. They do not establish whether the formats differ beyond the observed participants.
The IQRs describe the spread of individual change values around each arm’s median. The interactive multimedia arm has a wider reported IQR than the Power Point show arm. That describes the distribution of the posted scores; it does not show why participants’ outcomes varied, nor does it establish a treatment-by-cognitive-style relationship. Cognitive-style subgroup results are not reported in the registry record.
A formal comparison would ordinarily report an estimate of the between-arm contrast and a measure of uncertainty, such as a confidence interval, with an appropriate statistical test if planned. Those results are not reported in the registry record. No p-value, confidence interval, adjusted estimate, or analysis details are posted for the primary outcome. The medians alone cannot indicate how compatible the observed summaries are with a range of underlying between-group effects.
The values are percentage changes, rather than separate baseline or post-instruction scores. Since the computation of percentage change and the score scale are not described, interpretation of the numerical magnitude is limited. A change summary can also be influenced by starting score distributions, but baseline summaries are not reported in the registry record. The posted results therefore do not support a conclusion about which format produces a larger underlying learning effect or whether any observed difference is meaningful.
The secondary outcomes listed include percentage change in Multimedia Situation Test scores, global satisfaction, and four AttrakDiff2 questionnaire measures. Their numerical results are not reported in the registry record. Accordingly, the primary summaries should not be treated as a complete account of learning, satisfaction, usability, or longer-term educational outcomes.
In statistical terms, these data provide arm-level descriptive evidence for an immediate MCQ outcome, not a complete inferential analysis. The record does not report an analysis population, missing-data handling, or an adjustment for multiple outcomes. The sample-size illustrations are planning calculations based on the observed effect and stated assumptions; they are not evidence of observed power and do not replace an uncertainty interval for the primary comparison.
9. Statistical Methods Explained
Random allocation is intended to make the groups comparable, on average, with respect to both measured and unmeasured characteristics. It does not guarantee that groups will be identical in a particular trial, especially when participant numbers are limited. A parallel-group design assigns participants to one instructional format and compares their outcomes across groups. In this study, the posted summaries correspond to an interactive multimedia arm and a Power Point show arm. The registry does not report the sequence-generation procedure or allocation concealment details, so those aspects cannot be assessed from the record.
What does a median describe?
The median is the middle value after observations are ordered. It is a useful summary when a distribution may be asymmetric or may include unusually large or small values. Here, the registry specifies a median for the percentage change in MCQ scores. A median is not the same as an average calculated by adding all values and dividing by the number of observations. It also does not show the full shape of the distribution, and two groups can have the same median while differing in other features.
How should the IQR be read?
The inter-quartile range describes the central spread of a distribution, from its lower quartile to its upper quartile. It gives information about variability among observed changes without relying on the most extreme values. For the interactive multimedia group, the reported IQR is 13.0 to 76.0; for the Power Point show group, it is 30.0 to 50.0. The ranges describe within-arm variation. They are not confidence intervals for the medians and do not directly quantify uncertainty about the difference between groups.
What does a confidence interval add?
In general, a confidence interval combines an estimated effect with information about its precision under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while the interval’s position relative to a relevant null value can help readers judge compatibility with different possible effects. No confidence interval for the primary between-arm comparison is reported in the registry record. The arm medians and IQRs cannot be used as substitutes for that interval without additional data and analysis.
Why does the outcome scale matter?
The primary outcome is described as percentage change in MCQ scores. A change measure is intended to capture movement from an earlier score to a later one, but its interpretation depends on how the percentage was calculated and on the scale’s properties. The registry record does not report the calculation formula, scoring range, separate baseline values, or separate post-intervention values. Without these details, the reported medians cannot be translated into a number of questions answered correctly or assessed against baseline performance.
Because the endpoint is measured before and after instruction, a comparison of changes can account for initial performance if the analysis is designed and reported appropriately. Another general approach is to compare post-intervention scores while adjusting for baseline scores. The registry record does not report which inferential approach, if any, was used. It is therefore not possible to assess the role of baseline adjustment or other covariates in the posted summaries.
What is over-dispersion, in general?
Over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variation, standard errors may be too small and confidence intervals may be too narrow. This concept can matter for outcomes with count-like or clustered data, but the registry record does not report a model for this MCQ endpoint or a dispersion assessment. The posted median and IQR summaries do not require readers to assume a particular normal model for the outcome distribution.
The registry’s sample-size planning illustrations are described as calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. They consider detecting a stated fraction of the observed effect. These are planning illustrations, not observed power, and should not be read as evidence that the trial had a particular probability of finding an effect. The registry record does not report the trial’s original sample-size justification or whether the planning assumptions were used when the study was designed.
Finally, statistical significance and practical importance are different questions. A formal test, if reported, would quantify evidence relative to a statistical model and null hypothesis. Practical interpretation would also depend on the score’s meaning, the educational context, and the precision of the estimate. The record does not report a formal primary comparison or define a threshold for an educationally important difference.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and six secondary outcomes. The secondary outcomes cover Multimedia Situation Test score change, global satisfaction, and AttrakDiff2 measures of pragmatic quality, hedonic stimulation, hedonic identification, and attractiveness. Their numerical results are not reported in the registry record. The record lists zero analysis entries, and does not report a plan for controlling the chance of false-positive findings across multiple outcomes or comparisons.
Multiplicity arises when several outcomes, subgroups, or analyses are examined. In general, testing many hypotheses can increase the chance that at least one result appears statistically notable by chance. Approaches to address this include prespecifying a primary comparison, adjusting significance thresholds, or treating secondary analyses as exploratory. The registry record does not report whether any such approach was used. No subgroup analysis results for cognitive style are posted, despite the study summary’s interest in that topic.
Missing-data methods and analysis populations are not reported in the registry record. The posted outcome summaries include 30 participants in each arm, but the record does not state whether all randomized participants contributed to the endpoint, whether any measurements were missing, or how missing measurements were handled. It also does not identify an intention-to-treat, per-protocol, or other analysis population. These details affect how readers assess the possibility of bias from incomplete follow-up or exclusions.
The registry record does not report a statistical analysis plan, interim analyses, or adjustments for baseline characteristics. These omissions do not demonstrate that the procedures were absent; they mean the corresponding methods cannot be evaluated from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Interactive Multimedia Module | 0 | 30 | 0.0% |
| Power Point Show Module | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Interactive Multimedia Module | 0 of 30 |
| Power Point Show Module | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Interactive Multimedia Module | 0 of 30 |
| Power Point Show Module | 0 of 30 |
The registry’s adverse-event figures list zero serious adverse events, zero other adverse events, and zero deaths for each instructional group. Each group has 30 participants listed as at risk for both the serious and other adverse-event summaries. No serious adverse-event terms are listed.
These figures describe what was recorded in the registry. A zero count means no event was entered in that category for the reported group; it does not by itself establish that no event occurred or that the study systematically assessed every possible event. The registry record does not describe how adverse events were solicited, how long participants were monitored for them, or how events were defined and verified.
Safety reporting is also distinct from the educational outcome. The trial compares instructional formats, and the adverse-event counts do not measure MCQ performance, student satisfaction, or learning retention. With no further reporting detail, the counts should be read as a brief registry summary rather than a comprehensive assessment of harms.
12. What the Result Does, and Does Not, Mean
The posted results describe immediate MCQ percentage changes for students assigned to two mobile e-learning formats. The median is 40.0 in the Interactive Multimedia Module group and 45.0 in the Power Point Show Module group. The corresponding IQRs are 13.0 to 76.0 and 30.0 to 50.0. The summaries show the observed arm-level distributions as reported, but do not establish a statistically reliable difference between formats.
The registry record does not report an inferential estimate for the primary comparison, its confidence interval, or a p-value. Without those quantities, the precision of the between-arm contrast cannot be judged. The medians also do not reveal the individual scores, the baseline score distributions, or how the percentage-change calculation was defined. As a result, the magnitude and educational importance of any underlying difference cannot be determined from these summaries alone.
The study’s stated interest in cognitive style does not mean that a cognitive-style effect was demonstrated. No corresponding subgroup estimates or interaction analysis are reported in the registry record. Likewise, the listed satisfaction and questionnaire outcomes cannot be interpreted without their numerical results.
These findings do not establish effects on long-term retention, clinical competence, or education beyond the immediate assessment. They also do not establish that either module is superior or that either is ineffective. The record supports a limited descriptive reading of one primary outcome following a brief instructional intervention. Further interpretation depends on analysis details and results that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it puts two distinct instructional formats into a randomized comparison while measuring an immediate pre/post learning outcome. The active contrast is between interactive multimedia and a linear Power Point show module, rather than instruction versus no instruction. That design focuses the question on the format of mobile e-learning within the ORL-HNS teaching context.
The endpoint also raises useful measurement questions. Percentage change can summarize movement from baseline, but its meaning depends on the underlying score scale and the calculation formula. The registry identifies the median and IQR, which provide distribution-aware descriptive summaries, but does not report the baseline and post-intervention scores or a formal contrast. This illustrates why summaries alone do not answer an inferential question about differences between randomized groups.
The study summary connects the comparison to cognitive style, but the posted results do not report that analysis. This distinction between a study’s motivation and its reported evidence is important: a research question can be described without a corresponding estimate being available to readers. Similarly, secondary outcomes are identified, but their numerical results are not reported in the registry record.
The record also demonstrates the value of complete methods reporting. Details about allocation, masking, the score calculation, missing data, and multiplicity would help readers assess bias and precision. Without them, the strongest statistical interpretation remains descriptive. The trial’s educational setting and immediate assessment make the outcome relevant to learning research, while the missing inferential and measurement details limit what can be concluded from the posted results.
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 leaves several trial-specific uncertainties. Although it identifies random allocation and a parallel design, it does not describe the random sequence generation, allocation concealment, or implementation of assignment. The summary’s reference to blinded randomization is not accompanied by details of who was blinded or how. The masking entry is none, so the record does not support an assumption that participants, instructors, or outcome assessors were masked.
The primary endpoint is not fully defined. The record does not state the formula for percentage change, the possible MCQ score range, or whether the pre- and post-intervention tests used identical or equivalent questions. Separate baseline and post-intervention scores are not reported. These omissions make it difficult to judge scale interpretation, baseline comparability, or the possibility that test repetition influenced the observed changes.
The posted results are descriptive arm summaries. A between-arm effect estimate, confidence interval, p-value, and analysis method are not reported in the registry record. The approach to missing observations, the analysis population, baseline adjustment, and any subgroup analysis are also not reported. Numerical results for the listed secondary outcomes are not reported.
The intervention descriptions available in the registry are truncated, limiting assessment of the complete instructional content and delivery. The record also does not report whether participants used the assigned modules in a supervised setting or how adherence was assessed. The primary endpoint is immediate; longer-term retention is not reported. These limitations restrict interpretation to the posted summaries rather than a broader assessment of instructional effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education — NCT02971735.
- Registry record last updated 2021-02-16; status last verified 2016-11.
- Results first posted 2021-02-16.
- 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.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02971735 is a completed randomized parallel-group trial titled “Cognitive Style and Mobile Technology in E-learning in Undergraduate Medical Education.” It compared an interactive multimedia mobile e-learning module with a Power Point show module for undergraduate medical students without previous ORL-HNS training. The registry lists enrollment of 60 and reports 30 participants in each arm.
The primary outcome is median percentage change in MCQ scores before and immediately after the intervention. The posted medians are 40.0 for interactive multimedia and 45.0 for the Power Point show module; the respective IQRs are 13.0 to 76.0 and 30.0 to 50.0. No formal between-arm analysis is reported in the registry record.
The study sponsor is Chang Gung Memorial Hospital. Study start is listed as 2016-11-23 and primary completion as 2017-07-05. The record lists six secondary outcomes, but does not report their numerical results. It records zero serious adverse events, zero other adverse events, and zero deaths in each group.