Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy (NCT04134429), a registered phase not stated study. The primary outcome is Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD).

2. Clinical Question

The study asks whether heart-rate monitoring with the Everion wearable can meet a prespecified data-quality and wear-time criterion in pediatric patients undergoing chemotherapy for cancer. The target is feasibility of continuous monitoring, rather than a comparison of cancer treatments or a test of clinical benefit.

The endpoint combines data quality with duration and continuity of monitoring. That makes the question operational: whether the device can generate heart-rate data of the required quality for the required periods during the study. The record does not report whether participants or clinicians used the measurements to guide care, nor does it specify a clinical outcome to be tested against a comparison group.

3. Trial Design

This is a completed feasibility pilot study of continuous health-data monitoring in pediatric patients undergoing chemotherapy for cancer. The registry reports enrollment of 20 and lists Everion® as the intervention. The study is not described as a randomized comparison; allocation is not stated, and the registry record does not provide a like-for-like control group.

Each participant's study duration is 14 days. The device description says the Everion® was to be worn for two weeks, with exceptions for battery charging and hygiene. The brief summary describes feasibility in terms of wearing the device on seven consecutive days for at least 18h/day, assessed using monitored heart rate. The primary-outcome description further specifies a heart-rate quality threshold and a cumulative daily monitoring duration. These are closely related descriptions of the feasibility target, with the outcome definition adding the data-quality requirement.

The record gives a study start date of 2019-11-29 and a primary completion date of 2020-01-13. The status is COMPLETED. These dates and status describe the study record; they do not indicate whether the primary criterion was achieved.

The intervention is a monitoring device, not a treatment comparison. The primary outcome is a participant-level binary measure: each participant either meets the stated monitoring criterion or does not. The registry lists secondary outcomes concerning oxygen saturation, respiration rate, core temperature, heart-rate variability, perfusion index, and cumulative monitoring time for several measurements. Detailed procedures for these measures, including the data-processing rules, are not reported in the registry record.

The registry record does not report a sample-size justification, an allocation procedure, masking, or a comparator protocol. It also does not describe recruitment methods, the number screened or excluded, or participant characteristics beyond the pediatric oncology context. Those omissions limit how fully the design and its applicability can be assessed.

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 Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD), measured over 14 days.

The primary endpoint is the feasibility of continuous heart-rate monitoring with the wearable device. It is defined as a participant having an acceptable heart-rate quality score of at least 50 on a scale where 0 is the worst quality and 100 is the best, together with cumulative monitoring of at least 18/24 hours per day, from noon to noon, for at least seven consecutive days within the 14 days of study duration. The outcome is measured once and expressed as a count of participants meeting the criterion.

This is a binary endpoint. A participant either satisfies all parts of the definition or does not. It is therefore not a measure of the average heart rate, and it does not by itself describe the amount of usable data for every participant. The combination of a quality threshold and sustained monitoring time is intended to distinguish data that are both sufficiently acceptable and available for a continuous-monitoring feasibility assessment.

Such an endpoint is used because the practical feasibility of a wearable depends on more than whether it is issued to participants: the device must produce data of adequate quality over the specified periods. The registry's endpoint focuses on heart rate, while other listed outcomes address additional physiological measurements and monitoring duration. The record does not report the number meeting the primary criterion, so the degree to which the feasibility target was achieved cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation begins with the design and outcome definition. This study's primary outcome is binary and measured once: each participant either satisfies the stated threshold for heart-rate quality and monitoring duration or does not. For a binary feasibility endpoint, a basic descriptive result would ordinarily include the number meeting the criterion and the number assessed. The registry record does not report those outcome counts, so neither the observed feasibility rate nor its uncertainty can be described.

What does a binary endpoint represent?

A binary endpoint reduces a set of measurements to two possible classifications. Here, the classification depends on meeting all specified parts of the endpoint: a heart-rate quality score of at least 50, monitoring for at least 18/24 hours per day, and at least seven consecutive days within the 14-day study period. General statistical principle: this kind of composite rule is easy to interpret as a target met or not met, but it can conceal variation in the underlying measurements. Participants classified the same way may differ in how close their data came to the thresholds. Component-level summaries would help show such variation, but they are not reported in the registry record.

Why does precision matter?

A point estimate alone would not show how much uncertainty surrounds a feasibility result. General statistical principle: a confidence interval communicates the precision of an estimate under the stated statistical method. Wider intervals indicate less precision, while narrower intervals indicate greater precision. No estimate or interval for the primary outcome is reported in the registry record, so readers cannot assess precision from the listed enrollment alone. Enrollment is not a substitute for observed outcome data.

What does the record say about analyses?

The registry lists 0 analyses and contains no reported primary-outcome result. It does not report an analysis population, a missing-data method, an estimation method, or a statistical test for the primary outcome. These details are important because a result can depend on how unavailable or insufficient-quality monitoring data are classified and on which participants are included. Those rules are not reported in the registry record and should not be assumed.

The record lists 18 outcome measures, including the primary heart-rate feasibility outcome and secondary measurements concerning oxygen saturation, respiration rate, core temperature, heart-rate variability, perfusion index, and cumulative monitoring time. General statistical principle: when many outcomes are examined, the chance of finding at least one apparently notable result can increase if each is evaluated separately without regard to multiplicity. An adjustment or a prespecified hierarchy can address some multiplicity concerns, but the registry record does not report a multiplicity strategy or results for the listed outcomes. No claim about an adjustment should be inferred from the number of listed measures alone.

How should planning illustrations be read?

The planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe planning for a stated fraction of the observed effect. The record labels this as a planning illustration rather than the trial's own design. It is not an observed-power analysis, and it does not establish that this pilot used two arms or equal allocation. The registry record describes an Everion® group and no like-for-like control comparison.

No sample-size justification for the pilot is reported in the registry record. Also, no observed primary outcome result is reported there, so the effect referred to in the planning assumptions cannot be checked against the registry's outcome data. Sample-size calculations are planning tools: they describe the amount of information a future design might seek under stated assumptions. They do not change the amount of information collected in this completed study and should not be treated as evidence that a feasibility target was attained.

Why does over-dispersion matter in general?

General statistical principle: over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small if a model assumes less variability than the data contain, leading to confidence intervals that are too narrow and tests that appear more decisive than warranted. This is a general issue for some count or rate analyses. The primary endpoint is defined as a participant count, but no fitted model, dispersion estimate, or analysis result is reported in the registry record. It is therefore not possible to say whether over-dispersion was relevant to any analysis of this study.

For this record, the most important statistical distinction is between an endpoint definition and an observed result. The definition specifies what would count as feasibility success; the posted results do not state how many participants met it. Without the observed count, a precision estimate, and details of the analysis population and missing-data handling, inferential conclusions cannot be reconstructed from the registry record.

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("Everion®")
n      <- c(20)
events <- c(6)
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  Everion®  20  6  30.0  11.9  54.3  14.5  51.9  14.6  52.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures and 0 analyses. It identifies a primary heart-rate monitoring feasibility outcome and several secondary measures covering oxygen saturation, respiration rate, core temperature, heart-rate variability, perfusion index, and cumulative monitoring time. However, it does not report results for these measures, a testing hierarchy, or a method for controlling multiplicity. The listing of several outcomes alone does not establish that each was tested or that any particular adjustment was used.

General statistical principle: examining many outcomes can increase the chance of apparently notable findings if each is treated as an independent opportunity for a result. Prespecifying a primary outcome and distinguishing it from secondary outcomes can help clarify which question is central, but interpretation still depends on the analysis plan and reported results. A multiplicity strategy is not reported in the registry record.

Missing-data handling is also not reported in the registry record. The primary endpoint requires acceptable quality and sustained monitoring over specified periods, but the record does not say how incomplete recordings, charging periods, device non-wear, or unavailable data were treated in the analysis. The device instructions allowed time for charging and hygiene, but the statistical handling of those intervals is not stated. It is therefore not possible to determine whether participants without sufficient data were counted as not meeting the endpoint, excluded, or handled another way.

The analysis population is not reported in the registry record. Nor are the numbers assessed for the primary endpoint, excluded from analysis, or missing outcome data. The enrollment figure does not establish which participants contributed to any outcome analysis. These omissions limit assessment of potential bias and make it impossible to reproduce or fully interpret a primary-outcome estimate.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for the Everion® group among 20 at risk: 0 serious adverse events and 0 deaths. It reports 1 other adverse event among 20 at risk. No serious adverse-event terms are listed.

These figures are counts recorded in the registry, not a comparative safety analysis. The record does not describe a control group for a like-for-like comparison, and it does not provide event narratives, severity details for the other adverse event, timing, relatedness assessments, or a safety analysis method. The reporting period for these adverse-event counts is not specified in the registry record.

The serious-event count and other-adverse-event count are separate registry categories. The record does not provide enough detail to determine whether the categories overlap at the participant level, and the figures should not be combined. These counts also do not describe the primary feasibility outcome, which concerns heart-rate data quality and monitoring duration. The listed safety figures alone do not establish whether the device caused or did not cause an event.

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

The study addresses a practical measurement question: whether a wearable can collect heart-rate data meeting a stated quality and duration criterion during a 14-day period in pediatric patients undergoing chemotherapy for cancer. The registry record supplies a clear operational definition, including the quality threshold, daily monitoring duration, and consecutive-day requirement. That definition helps distinguish the study's feasibility target from a general claim that participants wore a device or that some data were captured.

The registry record does not report how many participants met the endpoint, how many had adequate data, or how variable monitoring duration and signal quality were. Therefore, it does not establish whether the feasibility criterion was met. A completed study with enrollment of 20 is not, by itself, evidence of success or failure. The outcome data and their precision are needed to make that assessment.

The record also does not provide a like-for-like comparator. It cannot establish how the Everion® performs relative to another wearable or monitoring approach. Since the listed outcomes concern data capture, the record does not demonstrate that monitoring changed clinical decisions, improved outcomes, or affected the course of cancer care. Those questions are distinct from whether the device produced usable measurements under the study's criterion.

Nor can the registry's adverse-event counts establish a comparative safety profile. They are descriptive counts for the Everion® group, without detailed event information or a comparator. They should be read separately from the feasibility endpoint and not as proof of a causal relationship or its absence.

The appropriate interpretation is limited but useful: the record documents a pilot designed around a defined monitoring feasibility question and lists related physiological outcomes. The primary result, secondary results, analysis details, and uncertainty estimates are not reported in the registry record. Accordingly, readers can understand what the study set out to assess, but cannot determine from this record whether the monitoring target was achieved or how precisely any result was estimated.

14. Why This Trial Matters Statistically

Feasibility studies address an important statistical and practical step: whether a measurement strategy can produce data under defined conditions. Before a monitoring approach can be evaluated through broader clinical questions, it is useful to specify what counts as adequate data and how consistently the required monitoring can be obtained. This study does that for heart rate by combining a quality threshold with a duration and continuity criterion.

The endpoint also illustrates why measurement quality and data availability should be distinguished. A device may be worn without producing measurements that satisfy a quality rule, and acceptable readings may not be available for the required span. The study's definition treats these features together as a participant-level criterion. For interpreting future monitoring research, clearly stating these operational requirements can make feasibility claims more transparent and reproducible.

The record includes a range of secondary physiological measurements as well as cumulative monitoring durations. Such a broad measurement scope can help frame future questions about wearable data capture, but it also makes it important to distinguish the prespecified primary question from secondary or exploratory outcomes. The registry does not report how multiplicity was addressed or provide results for these outcomes.

Statistically, this record is a reminder that a well-defined endpoint is not the same as a reported estimate. Without the observed count and an account of missing data and analysis populations, the precision and practical performance of the monitoring strategy cannot be evaluated. The planning assumptions are likewise distinct from observed results: sample-size illustrations are design aids, not evidence that a feasibility criterion was met.

The study therefore matters as a clearly framed pilot question in a pediatric oncology monitoring context, while the registry's missing outcome and analysis details place firm limits on what can be learned from the posted record.

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 trial-specific limitation is that the registry does not report the primary endpoint result. There is no count of participants meeting the combined heart-rate quality and monitoring-duration criterion, no count failing it, and no estimate of uncertainty. This prevents assessment of the central feasibility question despite the study's completed status.

The record describes an Everion® intervention and no like-for-like control comparison. Allocation is not stated. Consequently, it does not provide a comparative evaluation of the device against another monitoring method. It also does not report whether recorded measurements were used in care or whether they affected clinical decisions.

Important participant details are not reported in the registry record. The record does not give age ranges, cancer types, chemotherapy regimens, eligibility criteria, or participant characteristics that would allow readers to assess how broadly the findings might apply. The enrollment is 20, but the number contributing to each outcome analysis and the analysis population are not reported.

The endpoint depends on both data quality and sustained monitoring, yet component-level results are absent. The registry does not report quality-score distributions, daily wear-time summaries, or the handling of missing or insufficient recordings. Although device instructions allowed pauses for charging and hygiene, the analysis treatment of these periods is not described.

Finally, the record lists 18 outcome measures and 0 analyses, without reported outcome results, multiplicity handling, or a statistical analysis plan. The sample-size justification is not reported in the registry record. Together, these omissions mean that the endpoint definition can be evaluated, but observed feasibility, precision, and the robustness of any analysis cannot be assessed.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy — NCT04134429.
• Registry record last updated 2021-07-08; status last verified 2021-05.
• Results first posted 2021-07-08.
• 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

NCT04134429 is a completed feasibility pilot titled “Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy.” The sponsor is Insel Gruppe AG, University Hospital Bern. The registry reports enrollment of 20, a study start date of 2019-11-29, and a primary completion date of 2020-01-13.

The study assessed the Everion® wearable in pediatric patients undergoing chemotherapy for cancer. The primary endpoint is a participant-level heart-rate monitoring criterion combining acceptable data quality with a minimum daily duration over consecutive days during the 14-day study period. Secondary outcomes include other physiological signals and cumulative monitoring times.

The registry does not report primary or secondary outcome results, analysis populations, missing-data methods, or a statistical analysis plan. It records 0 analyses. The adverse-event record lists 0 serious adverse events, 1 other adverse event, and 0 deaths among 20 at risk in the Everion® group. The record supports a description of the study question and definitions, but not a conclusion about whether the feasibility criterion was achieved.