Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies (NCT02410252), a na na study. The primary outcome is Percent of Participants That Successfully Used the iThermonitor.

2. Clinical Question

The study was framed as a pilot evaluation of device use as a clinical support and patient self-management tool. Its primary question concerns practical use and successful data display, not a comparison of health outcomes between treatments. Caregiver anxiety, usability, acceptability, and satisfaction are listed as secondary outcomes, but their results are not reported in the registry record.

3. Trial Design

This was a completed, single-group pilot study sponsored by Massachusetts General Hospital. The registry record lists an enrollment of 25 and a phase of NA. Allocation is listed as NA, and masking is NONE. These descriptors are consistent with a feasibility evaluation without a randomized control group; they do not establish how every aspect of study conduct was managed.

Participants were asked to use the iThermonitor for two weeks. The device was intended to monitor body temperature continuously, and participants were asked to wear it for as many hours as they could, with a minimum request to wear it while sleeping. The primary outcome description says that the device needed to capture, transmit, and display temperature data on a study iPad mini. To limit recall bias, subjects were required to log daily whether they could view the data.

The listed conditions are acute lymphocytic leukemia, acute myeloid leukemia, and non-Hodgkin lymphoma. The brief study description also refers to pediatric patients receiving myelosuppressive therapies for acute leukemia and other childhood cancers. The registry record does not report further eligibility criteria, the age range, the treatment regimens, or how participants were recruited.

The record lists a start in 2015-05, primary completion in 2017-07, and status as COMPLETED. Completion status indicates that the study is recorded as completed; it does not supply the missing outcome estimates. The record does not report whether all enrolled participants completed the monitoring period, how many contributed to each analysis, or what statistical analysis plan was used. With no control group, the study can describe device-use feasibility in the enrolled group but cannot estimate a comparative effect against usual care or another device.

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: Caregivers of participants using the device

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 Percent of Participants That Successfully Used the iThermonitor, measured over Two Weeks.

The primary endpoint is the percent of participants who successfully used the iThermonitor during the two-week monitoring period. Success was defined at the individual participant level: the participant had to be able to view temperature data on the provided iPad mini at least 80% of the time in the study. The feasibility assessment also depended on the device successfully capturing and transmitting temperature data so that the information could be displayed.

This endpoint addresses whether the monitoring setup can function in practice, rather than whether temperature monitoring changes a clinical outcome. Daily logging was required to record the ability to view the data and was intended to limit recall bias. The endpoint therefore combines technical operation with whether data could be accessed during the monitoring period. It does not, by itself, establish the accuracy of temperature readings, the effect of monitoring on care decisions, or patient health outcomes; those questions are not described as the primary endpoint.

The registry record states that the device would be considered feasible if at least 80% of study subjects were able to use it successfully. That is a prespecified decision threshold described in the endpoint definition, not an observed result. The actual percentage meeting the participant-level success criterion is not reported in the registry record. Nor does the record report the number of participants with evaluable daily logs or how missing logs were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation starts with what the endpoint counts. This is a binary outcome at the participant level: each participant either met the stated success criterion or did not. The criterion requires being able to view the temperature data on the iPad mini at least 80% of the time in the study. The study-level endpoint is the percent of participants classified as successful. For a binary percentage, the numerator is the number classified as successful and the denominator is the number included in the analysis. Neither quantity is reported for the primary endpoint in the registry record, so the observed percentage cannot be reconstructed.

What does the feasibility threshold mean?

The registry record says the device would be deemed feasible if at least 80% of study subjects were able to use it successfully. This is a decision threshold, not a statistical test result. It sets the criterion the investigators intended to use when judging feasibility. The participant-level rule and the study-level threshold are distinct: first, each participant is classified using the data-viewing criterion; then the proportion classified as successful can be compared with the study-level threshold. The record does not report the resulting proportion or whether it met the threshold.

How should a percentage be read?

A percentage estimates the frequency of an outcome in the group being studied. Its precision depends in part on how many participants contribute usable outcome data and how many meet the definition. A confidence interval expresses uncertainty around an estimated percentage: a narrower interval indicates greater precision, while a wider interval indicates less precision. No primary endpoint estimate or confidence interval is reported in the registry record. The enrollment figure alone cannot substitute for the endpoint denominator because the record does not say how many participants had evaluable data.

What can a single-group design establish?

In a single-group study, the observed endpoint is descriptive of the participants assessed under the study procedures. Without a control group, there is no concurrent comparison for separating device-related feasibility from other influences, such as participant circumstances or study support. This design can still be useful for examining whether a device can be used and whether data can be made viewable in the study setting. It cannot provide a randomized estimate of a difference between interventions. Allocation is listed as NA, and masking is listed as NONE.

What does the daily log contribute?

Participants were required to log whether they could view temperature data once a day throughout the study. Repeated recording can reduce reliance on later recall by documenting access during the monitoring period. It does not, by itself, resolve missing or inaccurate entries. The registry record does not report how logs were checked, whether device records were used to verify them, how missing daily entries were treated, or how conflicting records were resolved.

What are the planning assumptions?

The registry record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is expressed as a fraction of the observed effect. These are planning assumptions for an illustration, not evidence that the completed study had two arms: the trial itself is listed as single-group. Sample-size illustrations are not observed power and do not show the probability that this completed study detected an effect. The registry record does not report a trial-specific sample-size justification, and no planning estimate should be treated as an outcome of this study.

What analysis details are absent?

The registry record lists 3 outcome measures and 4 analyses, but does not explain how the analyses map to outcomes, what statistical tests were used, or whether estimates were adjusted. It does not report a confidence interval, p-value, analysis population, or missing-data method for the primary endpoint. These omissions mean that readers cannot assess the precision or robustness of a primary endpoint estimate from the registry record. Because the observed primary result itself is not reported, a recalculation from posted summary statistics is also not available.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 3 outcome measures and 4 analyses. It identifies caregiver anxiety and usability, acceptability, and satisfaction as secondary outcomes, alongside the primary feasibility endpoint. However, it does not describe how the analyses correspond to the outcomes, which comparisons were planned, or whether any outcomes were designated as confirmatory beyond the stated primary endpoint.

Adjustment for multiple statistical tests is not reported in the registry record. When several outcomes or analyses are examined, the chance of at least one apparently notable result can increase if each is assessed separately. A multiplicity plan can clarify which findings are primary and how interpretation should account for multiple testing. Since the plan and results are not reported, it is not possible to assess whether multiplicity was addressed or how it would affect interpretation.

The primary outcome relies on daily logs of whether participants could view temperature data. The registry record does not report the number of missing logs, whether any participants lacked an evaluable endpoint, or how incomplete records were handled. It also does not report imputation, sensitivity analyses, or rules for classifying incomplete monitoring. These details matter because the percentage depends on who is included and how incomplete information is treated.

The analysis populations are not described in the registry record. It is therefore unclear whether the primary analysis was intended to include all enrolled participants, only participants who began device use, or another defined group. The enrollment of 25 should not be assumed to be the primary endpoint denominator. No reported participant flow or endpoint denominator is available to assess exclusions or attrition.

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.

For the temperature monitoring group, the registry record lists 25 participants at risk for serious adverse events and 0 affected. It also lists 25 at risk for other adverse events and 0 affected, and records 0 deaths. No serious adverse event terms are listed.

These figures are counts recorded for this group; they do not describe a comparison with a control group. The registry record does not provide event definitions, the method of event collection, or detail on the duration and completeness of safety observation. It also does not report confidence intervals or other measures of uncertainty for the zero counts. A zero recorded count means no such events were reported in the listed group during the recorded observation; it does not establish that the risk is absent.

The safety counts should be kept distinct from the primary feasibility endpoint. They do not show how many participants successfully viewed temperature data, and they do not determine whether the prespecified feasibility threshold was reached. The primary endpoint result is not reported in the registry record.

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

The study addresses whether pediatric patients receiving myelosuppressive therapies could use the iThermonitor to monitor temperature and view data on a study iPad mini. The registry record gives a concrete operational definition of successful use: a participant had to be able to view temperature data at least 80% of the time in the study. It also states that feasibility would be judged against a study-level threshold of at least 80% successful participants. These definitions make the intended question clear.

What the record does not establish is whether the observed group met that threshold. The primary percentage, the number of participants who succeeded, the endpoint denominator, and an uncertainty estimate are not reported in the registry record. Accordingly, no observed feasibility rate can be described, and neither success nor failure against the threshold can be inferred.

Even if an observed feasibility rate were reported, it would describe use under the conditions of this pilot study. The single-group design has no randomized control comparison, so it cannot show how device use compares with another monitoring method. The endpoint also focuses on successful capture, transmission, display, and viewing of temperature data. It does not establish temperature-measurement accuracy, a change in clinical management, or improvement in health outcomes.

The registry record lists caregiver anxiety and usability, acceptability, and satisfaction among the secondary outcomes, but does not report their findings. The posted safety counts show zero serious adverse events, zero other adverse events, and zero deaths in the listed monitoring group. These counts are descriptive and do not establish the absence of risk. The most defensible reading is therefore limited: the record documents a pilot design and a prespecified feasibility rule, while leaving the primary result and the reported secondary-outcome results unavailable.

13. Why This Trial Matters Statistically

Feasibility studies ask whether an intervention or measurement process can be carried out as intended before broader conclusions are drawn. For a continuous temperature-monitoring device, practical success involves more than assigning a device: data must be captured, transmitted, displayed, and accessible to the user. The endpoint definition in this study makes those operational steps central to the question.

The study also illustrates why the outcome definition and outcome result must be distinguished. A rule that says at least 80% of participants must meet an individual success criterion establishes how feasibility was meant to be judged. It does not reveal the observed success proportion. Without the numerator, denominator, and uncertainty, the criterion alone cannot show whether the study met its aim.

Daily logging is another statistically relevant feature. Recording data-viewing ability each day can reduce dependence on retrospective recall, while also creating questions about incomplete entries and how they are handled. The registry record does not report those details. Clear reporting of participant flow, outcome denominators, missingness, and uncertainty would help readers assess whether the observed percentage represents the enrolled group reliably.

Finally, a single-group pilot has a defined but limited role. It can describe use under the study procedures, but it cannot answer comparative questions without a control group. Separating feasibility from effectiveness and safety claims prevents an operational endpoint from being overinterpreted as evidence of clinical benefit. In this record, the design and endpoint are described, but the absent primary result prevents a statistical judgment about the stated feasibility threshold.

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 main limitation for interpretation is that the primary endpoint result is not reported in the registry record. The record provides the definition of success and the feasibility threshold, but not the observed percentage, its numerator or denominator, or an uncertainty estimate. Consequently, the principal study question cannot be answered from the posted information.

The enrollment is listed as 25, but the record does not report participant flow or the number contributing evaluable data. It is not possible to determine whether all enrolled participants used the device for the intended period, whether logs were complete, or whether participants were excluded from the primary analysis. The handling of missing daily logs is not reported.

The study has a single-group design, with allocation listed as NA and masking as NONE. Without a comparator, the findings cannot provide a randomized comparison or distinguish device-related factors from the effects of study support and context. The record also does not report details such as eligibility criteria, age range, device adherence summaries, or accuracy validation that would help define the scope of any feasibility conclusion.

Secondary outcomes are named, but their results and measurement details are not reported. Statistical methods for the primary outcome, multiplicity handling, and analysis populations are also not reported in the registry record. Finally, the adverse-event counts are not accompanied by event definitions or details about safety observation. These reporting gaps limit assessment of both the completeness and precision of the study findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies — NCT02410252.
• Registry record last updated 2020-10-22; status last verified 2020-09.
• Results first posted 2018-07-31.
• 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

This completed pilot study evaluated use of the iThermonitor for temperature monitoring in pediatric patients receiving myelosuppressive therapies for acute leukemia and other childhood cancers. The registry record lists Massachusetts General Hospital as the sponsor, enrollment of 25, a single-group model, allocation as NA, and masking as NONE. Participants were asked to use the device for two weeks and to log daily whether temperature data could be viewed on a study iPad mini.

The primary endpoint was the percent of participants successfully using the device. Success required viewing temperature data at least 80% of the time in the study, and the study-level feasibility rule was at least 80% successful participants. The observed primary endpoint result is not reported in the registry record. Caregiver anxiety and usability, acceptability, and satisfaction are listed as secondary outcomes, with results not reported. The temperature monitoring group records zero serious adverse events, zero other adverse events, and zero deaths.