SPARK Symptom Screening and Feedback to Providers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SPARK Symptom Screening and Feedback to Providers (NCT03593525), a randomized na study. The primary outcome is SSPedi (Symptom Screening in Pediatrics) Total Scores.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group controlled trial of SPARK symptom screening and feedback to providers. The registry lists allocation as randomized and masking as none. The trial status is completed, and the recorded enrollment is 345. The phase is listed as NA. The sponsor is The Hospital for Sick Children. The record gives a start date of 2018-09-01 and a primary completion date of 2023-09-16.

SPARK is described as a web-based application built around SSPedi and a supportive care clinical practice guideline component. In the intervention arm, participants completed SSPedi once daily for 5 days on a study iPad. Reports were available to the child at any time. Inpatients received daily reminders on the iPad; for outpatients, clinical research associates provided the iPad in person. The stated intervention also included symptom feedback to healthcare providers.

In the standard-care arm, participants did not complete daily screening. They completed SSPedi on day 1 and day 5 for the primary outcome. Their providers were not notified of SSPedi scores, and the arm description states that symptom reports and alerts were not generated. Thus, the contrast involves both the screening schedule and feedback to providers, not feedback in isolation.

Random allocation is intended, as a general design principle, to make treatment groups comparable on average with respect to measured and unmeasured baseline factors. It does not guarantee identical groups, and interpretation still depends on how participants were assigned, retained, and analyzed. Details of sequence generation, allocation concealment, eligibility criteria, and analysis populations are not reported in the registry record. Although the record identifies the trial as completed, it does not provide the primary comparison results.

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: No participants were enrolled but excluded from assignment to study groups.

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 SSPedi (Symptom Screening in Pediatrics) Total Scores, measured over Measure will be completed by all participants at baseline (day 1) and day 5±1 day..

The primary endpoint was the self-reported total SSPedi score on day 5. The registry describes SSPedi as a validated measure of the total burden of bothersome symptoms. Its total is formed by summing scores across 15 items. Each item ranges from 0, meaning not at all bothered, to 4, meaning extremely bothered; the total score ranges from 0, indicating no bothersome symptoms, to 60, indicating the worst bothersome symptoms. Higher values therefore represent greater reported symptom burden on the scale as described in the record.

The outcome was scheduled for measurement at baseline, identified as day 1, and on day 5±1 day. The primary outcome description focuses on the day 5 total score, while the baseline measurement offers a starting assessment. A common scale and specified follow-up time make a comparison between randomized groups interpretable, provided outcome data are available and the analysis accounts appropriately for the trial design.

As a general measurement principle, a continuous score retains gradations in symptom burden rather than reducing the outcome to a simple yes-or-no category. That can make changes across the scale meaningful for analysis, though the clinical interpretation of a particular difference depends on context and is not established by the scale description alone. The registry record does not report day 5 scores, a group contrast, or an estimate of uncertainty.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation of this trial depends on separating the design, the outcome measure, and the analysis results. The design is randomized and parallel group, with no masking recorded. The primary measure is a continuous SSPedi total score, and the registry identifies mean and standard deviation as the summary. These details describe the intended comparison; they do not reveal which statistical procedure was used or what the results were. The analysis method and primary comparison results are not reported in the registry record.

What does a mean and standard deviation describe?

As a general statistical explanation, the mean is the arithmetic average of observed scores. It gives a central summary that can be compared across groups. The standard deviation describes the spread of scores around the mean. A group mean does not show whether participants had similar scores or a broad range of scores; the standard deviation helps describe that variation. Neither summary, on its own, gives the uncertainty of a between-group estimate. The registry record specifies mean and standard deviation as the summary type but reports no group values.

A treatment contrast for a continuous outcome is often expressed as a difference between group averages. That contrast would describe how far apart the group means are on the SSPedi scale. The sign and size of the contrast require the actual group means or an estimate calculated from participant-level data; neither is reported for this trial. No new contrast can be reconstructed from the design information.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated effect under the chosen statistical model and its assumptions. It helps readers distinguish a comparatively precise estimate from one compatible with a broad range of effects. The interval should be interpreted alongside the estimate and the outcome scale, not as a stand-alone verdict. No confidence interval for the primary comparison is reported in the registry record, so the precision of the estimated contrast cannot be evaluated from this record.

What can a significance test tell readers?

In general, a significance test evaluates how compatible the observed data are with a statistical null hypothesis under specified assumptions. A p-value is not the probability that the null hypothesis is true, and it does not measure the clinical value of an outcome difference. A small p-value can accompany an effect that is modest, while a larger p-value can occur when estimates are imprecise. These are general principles, not findings from this trial. The registry record does not report a p-value or the test used for the primary comparison.

Why do the analysis population and missing outcomes matter?

Randomization defines the assigned groups, but an analysis can include different sets of participants depending on the stated analysis population and outcome availability. As a general principle, retaining participants in their assigned groups can preserve the benefits of randomization, while exclusions or incomplete follow-up can affect comparability. Missing day 5 SSPedi scores may matter if the likelihood of missingness is related to symptoms, group assignment, or other factors. The record does not report the analysis population, the amount or pattern of missing primary-outcome data, or the methods used to address missingness. No assumptions about these choices should be made.

Baseline SSPedi was scheduled on day 1 in both arms, and the primary outcome was specified for day 5. General statistical approaches could compare follow-up scores directly or account for baseline scores, but these approaches are not interchangeable in every setting and require a prespecified rationale. The registry record does not say which approach was used. It also does not report whether any covariates were included, whether assumptions were checked, or whether results were adjusted.

What does the planning information mean?

The registry describes sample-size planning illustrations as based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. These are planning assumptions, not evidence about the outcome. Planning illustrations are not observed power and do not show that the trial achieved a particular probability of detecting an effect. They should not be treated as the trial's original design justification. The registry record does not report the trial's own sample-size justification or the numerical planning outputs in the record details.

As a general principle, power calculations depend on assumptions about the effect of interest, variability, allocation, significance threshold, and analysis. If those assumptions differ from the eventual data or target question, the illustration may not describe the operating characteristics of the completed trial. Over-dispersion is a general concern for count outcomes when variability exceeds what a simple model assumes; it is not a stated feature of this continuous primary endpoint. No model for the primary outcome is reported, so a particular variance structure or distributional assumption should not be attributed to the trial.

How should multiple outcomes be considered?

The registry lists a primary outcome and secondary outcomes. In general, examining multiple outcomes can increase the chance of finding an apparently unusual result by chance if many tests are treated as confirmatory without an appropriate plan. Prespecifying a primary outcome helps distinguish the main question from additional questions, but the registry record does not describe a multiplicity adjustment, a hierarchy among outcomes, or a statistical analysis plan. Results for the secondary outcomes are not reported in the registry record. These omissions prevent a fuller assessment of the analysis strategy.

Overall, the recorded design and endpoint allow the research question to be understood, but they do not establish how the data were analyzed. The analysis procedure, estimates, uncertainty intervals, p-values, missing-data handling, and analysis populations are not reported in the registry record. General statistical concepts can clarify what those quantities would mean, but they cannot replace the absent trial results.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary outcome, SSPedi total score on day 5, and lists three secondary outcomes: the number of participants with a self-reported severely bothersome SSPedi score per symptom, Faces Pain Scale-Revised, and PedsQL 3.0 Acute Cancer Module. The results for these outcomes are not reported in the registry record. The record does not state whether secondary outcomes were considered confirmatory, how they were ordered, or whether any adjustment for multiple comparisons was planned or used.

As a general statistical principle, testing several outcomes can create more opportunities for chance findings. A prespecified primary outcome can help focus interpretation, but it does not by itself explain how secondary findings should be assessed. The multiplicity strategy is not reported in the registry record, so readers cannot determine whether the trial used a correction, a hierarchical procedure, or another approach. No specific procedure should be assumed.

Missing-data information is also absent. The record does not report the number of day 5 scores available for analysis, the reasons for missing measurements, or the methods used to address missingness. It does not describe the primary analysis population or whether participants were analyzed according to randomized assignment. These details matter because missing outcomes and analysis exclusions can affect the interpretation of a randomized comparison. The registry record does not report an interim analysis plan or whether interim analyses occurred. The statistical analysis plan is not reported in the registry record.

These gaps do not demonstrate that the trial had a particular problem; they mean that the posted record does not supply the information needed to assess these aspects of the analysis. The absence of reported methods should not be filled by assuming common practice.

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 registry lists safety counts separately for the SPARK Intervention and Standard of Care Arm. For the SPARK group, 176 participants are listed as at risk for serious adverse events and 0 as affected; 176 are listed as at risk for other adverse events and 0 as affected. For the standard-care group, the corresponding figures are 169 at risk and 0 affected for serious adverse events, and 169 at risk and 0 affected for other adverse events. Deaths are recorded as 0 in both groups. No serious adverse-event terms are listed.

These entries describe what is recorded in the registry; they do not establish that no adverse events of any kind occurred. The registry gives zero affected counts for the serious and other adverse-event categories, but does not report further details about event collection, definitions, observation periods, or completeness of reporting. A count of zero in a posted record should therefore be read as no events entered in that category, not as proof of zero underlying risk.

These safety fields do not provide a statistical comparison or an estimate of uncertainty. The record does not report an analysis of adverse events or explain whether the counts were assessed for between-group differences. The counts should be interpreted as registry-reported safety summaries, not as evidence by themselves about the presence or absence of a treatment-related effect.

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

The record documents a randomized comparison of daily SSPedi screening through SPARK, with symptom feedback to healthcare providers, against standard care. The primary outcome was the self-reported SSPedi total score on day 5. The intervention description specifies daily screening for 5 days, while the control description specifies SSPedi measurement on day 1 and day 5 without daily screening or provider feedback. This identifies the intended contrast and the outcome used to assess symptom burden.

The record does not report the primary outcome results. It therefore does not show whether day 5 scores were higher, lower, or similar between groups, nor how large or precise any difference may have been. Without an estimate and its uncertainty, the posted record cannot establish whether the groups differed statistically or whether a difference would be important in practice. No conclusion that SPARK did or did not affect symptom burden is supported by the registry information recorded.

More generally, a trial result is an estimate from observed data, interpreted in light of its uncertainty, design, measurement, missingness, and analysis choices. The randomized design supports a planned comparison, but it cannot supply missing results. The registry record also does not report results for the secondary outcomes, the analysis population, or the handling of missing outcome data. Those omissions limit the conclusions available from this record.

The safety entries list zero affected participants in the reported serious and other adverse-event categories and zero deaths in each arm. They should be read as registry counts rather than proof that all possible harms were absent. Details about event definitions and ascertainment are not reported in the registry record.

Accordingly, the clearest conclusion is about what was studied, not what the intervention achieved: the trial was designed to compare a screening-and-feedback approach with standard care using SSPedi total score at day 5 as its primary outcome. The outcome comparison and its statistical precision are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically informative as a design example because it distinguishes the intervention strategy from usual care and specifies a patient-reported continuous primary outcome. The intervention combines regular symptom screening with feedback to healthcare providers; the control arm is described as not receiving daily screening or provider feedback. A comparison between these arms evaluates the strategy as described, rather than isolating the separate contribution of screening and feedback.

The choice of a total SSPedi score provides a structured way to represent the burden of bothersome symptoms across the measure's items. As a general principle, continuous outcomes can preserve variation that may be lost when scores are reduced to categories. Interpretation still depends on the scale, the group estimates, and their uncertainty. In this case, the record describes the scale and its range but does not report the estimates needed to understand the observed results.

The trial also illustrates why registration details and outcome reporting serve different purposes. Randomization, allocation, masking, intervention descriptions, and measurement timing help readers understand how a comparison was planned. They cannot answer the outcome question without results and an account of analysis. The record is marked completed, yet the primary comparison and secondary outcome results are not reported in the registry record.

For biostatistical interpretation, the missing details are consequential: group summaries, an effect estimate, uncertainty, analysis population, missing-data handling, and multiplicity strategy are not reported. These are not interchangeable reporting details. Together they determine how readers judge the magnitude, precision, and robustness of a finding. The trial's statistical importance therefore lies in the clear registered question and the distinction between a study design and evidence about its outcomes. The record supports understanding what was compared, but not an empirical conclusion about the primary effect.

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 interpreting this trial from the registry record is the absence of posted outcome comparisons. The record identifies the primary endpoint and its measurement schedule but does not report group means, standard deviations, an estimated contrast, a confidence interval, or a p-value. The record lists zero analysis records. The direction, magnitude, and precision of the primary comparison are therefore not reported in the registry record.

Important analysis details are also absent. The registry does not report the analysis population, the number of available day 5 assessments, the pattern or reasons for missing data, or how missing outcomes were handled. It does not identify the statistical model or whether baseline scores were incorporated into the primary analysis. These are information gaps in the record; they do not establish that the trial did or did not use any particular method.

The registered secondary outcomes have no results reported in the registry record, and the approach to multiplicity is not described. The record also does not describe an interim-analysis plan, the trial's own sample-size justification, or a statistical analysis plan. The planning assumptions recorded for sample-size illustrations should not be mistaken for the original design rationale or for evidence about the completed trial's power.

Finally, masking is listed as none, and the intervention includes participant-reported symptom measurement and provider feedback. In general, knowledge of assignment can be relevant when outcomes are self-reported or when care processes may be influenced by feedback. The record does not provide evidence to quantify any such influence. Eligibility details and participant characteristics are also not reported in the registry record, which limits assessment of how broadly the results might apply even if outcome estimates were available.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: SPARK Symptom Screening and Feedback to Providers — NCT03593525.
• Registry record last updated 2025-08-08; status last verified 2025-07.
• Results first posted 2025-07-02.
• 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

NCT03593525 records a completed randomized, parallel-group trial titled SPARK Symptom Screening and Feedback to Providers. The registry lists enrollment of 345, no masking, and The Hospital for Sick Children as sponsor. The intervention combined daily SSPedi screening through SPARK with symptom feedback to healthcare providers; the comparator was standard care without daily screening or provider feedback.

The primary outcome was self-reported SSPedi total score on day 5, with measurement scheduled at baseline on day 1 and day 5±1 day. The registry also lists three secondary outcomes: severely bothersome SSPedi scores per symptom, Faces Pain Scale-Revised, and PedsQL 3.0 Acute Cancer Module. Primary and secondary outcome results, analysis methods, and missing-data handling are not reported in the registry record. Safety entries record zero affected participants in the serious and other adverse-event categories and zero deaths in both arms.