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 Prehospital Telemedicine Feasibility/Acceptability Pilot (NCT05967624), a na na study. The primary outcome is Agreement in Assessment of Respiratory Distress.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05967624 |
| Phase | NA |
| Condition | Respiratory Distress Syndrome |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boston Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Children eligible for care from urban paramedic teams responding to 911 calls in the prehospital setting. The condition listed in the registry is Respiratory Distress Syndrome. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Teleconsultation during ambulance transport. A Medical Control Physician remotely assesses each subject through the HIPAA-compliant Zoom Pro web application on a tablet, while a transport team member is at the patient bedside.
Comparator
There is no separate control group. The primary assessment compares the remote physician's respiratory-distress scoring with the bedside transport team member's scoring. This is an agreement assessment within the teleconsultation setting, not a randomized treatment comparison.
Primary question
How closely do remote and bedside assessors agree when scoring respiratory distress during ambulance transport? The registry defines agreement on a scale from 0 to 1.0 and specifies a mean proportion of agreement with a 95% confidence interval. The observed estimate and interval are not reported in the registry record.
The study addresses a practical feasibility question: whether remote physician assessment can be conducted with real children in moving ambulances, building on prior simulation work described in the registry. Its primary endpoint is narrower than a test of clinical benefit. It evaluates agreement between two assessments, rather than whether teleconsultation changes care, improves outcomes, or performs better than usual practice. The registry also lists measures related to usability, connection quality, tablet mounting, and transport workflow. Those measures reflect the pilot's feasibility and acceptability focus, but their results are not reported in the registry record.
3. Trial Design
This is a completed, single-group pilot study of teleconsultation for children assessed by urban paramedic teams responding to 911 calls. The registry lists an enrollment of 20 and identifies Boston Medical Center as the sponsor. The recorded start date is 2024-06-21, and the primary completion date is 2025-02-14. The phase and allocation are listed as NA, and masking is listed as NONE.
The intervention is remote physician assessment during ambulance transport. A Medical Control Physician uses a tablet with the HIPAA-compliant Zoom Pro web application to assess the child. At the same time, the transport team member at the bedside completes the Respiratory Observation Checklist. The primary outcome is agreement between those assessments. The registry describes the assessment period as transport to the hospital by ambulance, up to 4 hours.
The registry frames the enrolled group as eligible children managed by urban paramedic teams in the prehospital setting, with the aim of supporting a future clinical efficacy trial. There is no like-for-like control arm, and the record explicitly identifies the study as not being a randomized comparison. Consequently, the design can describe the feasibility of conducting assessments and the degree of agreement between assessors, but it cannot isolate a comparative treatment effect.
The registry states that two calls did not connect and that the overall number analyzed was 18. It does not report further details about participant flow, the eligibility criteria, recruitment procedures, or the reasons for any other differences between enrollment and analysis. A more detailed statistical analysis plan, including the intended handling of incomplete observations, is not reported in the registry record.
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
| Stage | Teleconsultation Group |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Two calls did not connect so the overall number analyzed is 18.
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.
| Characteristic | Unit | Teleconsultation Group |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 0.9 (0.1 to 4) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 15 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: White | Participants | 15 |
| Race/Ethnicity, Customized: Black or African American | Participants | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 1 |
| Race/Ethnicity, Customized: Unknown or Not Reported | Participants | 3 |
| Region of Enrollment: United States | Participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Agreement in Assessment of Respiratory Distress, measured over During transport to the hospital via ambulance, up to 4 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | proportion agreement |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is agreement in assessment of respiratory distress. The remote Medical Control Physician and the bedside transport team member score the Respiratory Observation Checklist simultaneously during ambulance transport. The registry defines the measure as a proportion of agreement, with values from 0 to 1.0: 0 means no agreement and 1 is perfect agreement. The planned summary is a mean with a 95% confidence interval.
This endpoint is useful for the study's feasibility question because it assesses whether remote and in-person clinicians give similar respiratory-distress assessments while a child is being transported. Simultaneous scoring makes the comparison about agreement between assessors at the same assessment occasion, rather than a comparison across separate visits. It is not, by itself, a measure of diagnostic accuracy: the registry does not designate either assessor as a reference standard.
The registry gives interpretive bands for the agreement scale: 0.01–0.20 is none to slight, 0.21–0.40 is fair, 0.41–0.60 is moderate, 0.61–0.80 is substantial, and 0.81–1.0 is almost perfect agreement. These labels describe the scale, not the study's observed performance. The endpoint estimate and its confidence interval are not reported in the registry record, so the observed level and precision of agreement cannot be characterized from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record defines a primary agreement outcome and reports that 18 participants were analyzed after two calls did not connect. It does not report the mean agreement estimate or its 95% confidence interval. Without those values, the primary outcome cannot be described as indicating any particular degree of agreement, and its precision cannot be assessed. The agreement bands in the endpoint definition are interpretive thresholds only; they do not establish where the study result falls.
A confidence interval communicates uncertainty around an estimated quantity. In general, a narrower interval indicates greater precision, while a wider interval indicates greater uncertainty about the underlying value. The interval's endpoints and the estimate are not reported in the registry record, so neither the magnitude nor the precision of agreement can be evaluated. The record also does not report a hypothesis test or a p-value for the primary endpoint.
The study has a single group and no separate control arm. Its primary comparison is between simultaneous scores from a remote physician and a bedside team member. Agreement does not establish that either score is correct, nor does it show that teleconsultation changes care or patient outcomes. No conclusions about comparative efficacy can be drawn from this design. The registry describes the pilot as intended to support a future efficacy trial, which is consistent with treating it as an assessment of feasibility and agreement rather than a test of clinical benefit.
The registry reports enrollment of 20 and an overall analyzed number of 18, noting that two calls did not connect. This is relevant to implementation: a remote assessment could not be completed in those calls. The record does not state whether those calls were excluded from every outcome, how other missing observations were handled, or whether the analyzed participants differed from those without a connection. The reason for the unsuccessful connections and any consequences for the agreement estimate are not reported.
The registry lists several secondary outcomes, including usability, video and audio quality, successful video-call connections, tablet mounts, and transport times. Their observed results are not reported in the registry record. In the absence of results for these operational measures, the posted information cannot establish how acceptable or workable the platform was in routine ambulance conditions. The listed outcomes do show that the pilot considered technical performance and workflow, not only agreement between assessors.
Overall, the record establishes the study's question, design, endpoint definition, and analyzed count, but leaves the primary result and secondary findings unavailable. Statistical interpretation therefore has to remain focused on what was measured and what information is missing, rather than assigning a level of agreement or making claims about performance.
9. Statistical Methods Explained
The primary measure is a mean of a continuous quantity: a proportion agreement on a scale from 0 to 1.0. A mean describes the average of the observed values under the analysis used. The registry specifies that the result should be accompanied by a 95% confidence interval. It does not report the estimate, the interval, or the detailed calculation method.
What does agreement measure?
Agreement describes how often or how closely two assessors give matching scores, according to the measure being used. Here, the assessors are the remote Medical Control Physician and the transport team member at the bedside, and both score the Respiratory Observation Checklist simultaneously. Agreement is distinct from accuracy. Accuracy requires judging assessments against a suitable reference, and the registry does not identify one. Agreement also does not show whether a teleconsultation changes treatment or improves an outcome.
The scale's endpoints have direct interpretations: 0 means no agreement and 1 is perfect agreement. The record also assigns descriptive bands to ranges of the scale, from none to slight through almost perfect agreement. These are labels for interpreting an eventual estimate. They are not study results, and the registry record does not report which band, if any, contains the observed mean.
What does the confidence interval add?
In general, a confidence interval expresses sampling uncertainty around an estimate. It helps readers judge how compatible the observed data are with a range of possible underlying values under the method used. It is not a guarantee that the true value lies within the interval, and it does not correct for design limitations, measurement problems, or selection into the analysis. The interval's width is informative about precision; an interval that spans a broad range would leave more uncertainty than one concentrated over a narrower range. Here, neither the estimate nor its interval is reported, so these features cannot be assessed.
The registry does not report a test statistic, a p-value, or a null hypothesis for the primary endpoint. A significance test would answer a different question from describing the estimated agreement and its uncertainty. Without an explicit test and its result, no claim about statistical significance is supported by the posted results.
How should a single-group pilot be read?
In general, a single-group design can describe observed measurements under the study conditions, but it does not provide a concurrent control group for estimating a comparative effect. In this study, the paired scoring setup is relevant to agreement, but it is not a randomized comparison of teleconsultation against another care strategy. The registry lists allocation as NA and masking as NONE. It does not report a statistical analysis plan explaining adjustment, clustering, or any other modeling choices.
Because the outcome involves two assessors evaluating the same child during transport, analyses of agreement can depend on the exact scoring structure and on how repeated or clustered assessments are handled. In general, clustering matters when observations are related rather than independent; treating related observations as independent can make uncertainty estimates misleading. The registry record does not report whether the analysis accounted for transport teams, physicians, calls, or other sources of dependence. It is therefore not possible to assess that aspect of the analysis.
The registry describes a separate sample-size 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 states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not the design of the single-group pilot itself. Planning illustrations do not represent observed power, and they do not substitute for a reported primary estimate or confidence interval. The specific illustration values and the study's own sample-size justification are not reported in the registry record.
Overall, the methods information supports identifying the endpoint as mean agreement with a confidence interval and understanding the scale. It does not support reconstructing an analysis, because the estimate, interval, detailed model, and analysis plan are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes, covering usability, video quality, audio quality, adequacy of video-call connections, tablet mounts, adequacy of video for assessment, time to arrival at the referring facility, and scene time. It reports 11 outcome measures in total. The record does not report how many outcomes were designated as confirmatory, whether outcomes were tested statistically, or whether any adjustment for multiple testing was planned or used. A multiplicity strategy is not reported in the registry record.
Multiplicity matters when many outcomes are examined: in general, the chance of at least one apparently notable result can increase when many statistical tests are conducted. The extent of that concern depends on which outcomes were tested, how the tests were related, and whether results were treated as exploratory or confirmatory. Those details are not reported, so the degree of multiplicity concern cannot be quantified from the record. The registry reports zero analyses, and the observed results for the listed secondary outcomes are not reported.
For missing data, the registry states that two calls did not connect and that the overall number analyzed was 18, compared with enrollment of 20. It does not describe the analysis population in further detail, provide participant-level flow, or explain whether the unsuccessful connections were the only reason for not being analyzed. The handling of missing checklist items or other incomplete outcome data is not reported in the registry record.
The connection failures are operationally relevant, but the record does not explain their cause or establish whether missingness was related to participant or assessment characteristics. No imputation method, sensitivity analysis, or other missing-data approach is reported. Consequently, the possible influence of unavailable observations on the agreement estimate cannot be assessed.
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 |
|---|---|---|---|
| Teleconsultation Group | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Teleconsultation Group | 0 of 20 |
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 |
|---|---|
| Teleconsultation Group | 0 of 20 |
The registry reports zero serious adverse events, zero other adverse events, and zero deaths in the Teleconsultation Group. Each of these event summaries lists 20 as the number at risk. These are the recorded safety figures for this study group; they do not establish that the intervention is free of risk.
In general, an event count describes what was recorded during the study under its monitoring and reporting procedures. Interpreting a zero count also requires information about the observation period, event definitions, completeness of follow-up, and how events were collected. The registry record does not give further detail on those procedures, and it does not list serious adverse event terms.
The safety figures are not a comparison with another group, because the study is single-group. They do not permit a relative safety estimate or a controlled comparison. The registry also does not report whether an event, had one occurred, would have been judged related to teleconsultation. These counts should therefore be read as descriptive registry entries, not as evidence that no safety concerns are possible or that the intervention has a particular safety profile.
12. What the Result Does, and Does Not, Mean
The registry record identifies a pilot evaluating teleconsultation for children assessed by urban paramedic teams in the prehospital setting. Its primary question is whether the remote physician's respiratory-distress assessment agrees with the bedside team member's assessment during ambulance transport. The endpoint is clearly defined as a mean proportion agreement, with a 95% confidence interval and interpretive bands for the scale.
The posted results do not include the primary agreement estimate or its confidence interval. They therefore do not show how much agreement was observed or how precisely it was estimated. The secondary outcomes are named, but their results are also not reported in the registry record. A reader cannot use the posted information to judge observed usability, connection quality, or transport workflow performance.
The study's single-group design matters for interpretation. Agreement between two assessors is not a controlled comparison of teleconsultation with usual care, and it does not establish that either assessment is accurate. It also does not determine whether teleconsultation affects clinical decisions or patient outcomes. The registry describes this pilot as supporting a future clinical efficacy trial, rather than reporting a comparative efficacy result.
The registry reports that two calls did not connect and gives an overall analyzed number of 18. That information indicates that connection failure occurred in the study setting, but the record does not report why it occurred or its implications for the primary estimate. The absence of a reported estimate and analysis details means the record supports a description of the study's purpose and measurement approach, not a conclusion about the degree of agreement, the feasibility outcome overall, or the clinical value of the intervention.
The reported zero adverse event counts are descriptive and do not demonstrate absence of risk. Further details about safety monitoring and event collection are not reported. Taken together, the record offers useful context about the planned assessment and study conduct, while leaving the key outcome findings and their statistical uncertainty unreported.
13. Why This Trial Matters Statistically
This trial is statistically interesting because its primary question concerns agreement between two assessors operating in different locations during ambulance transport. Such a question is not the same as asking whether a treatment group has better outcomes than a control group. It focuses on the consistency of assessments made at the bedside and remotely, which is a relevant measurement issue for teleconsultation research.
The endpoint definition is explicit: mean proportion agreement on a scale from 0 to 1.0, with a 95% confidence interval and named interpretive bands. Clear operational definitions help readers understand what a future estimate would represent. At the same time, the estimate and interval are not reported in the registry record. This makes the distinction between a well-described endpoint and an interpretable result especially important.
The study is also a reminder that technical and workflow outcomes can matter alongside clinical measurements. The registry names outcomes concerning usability, audio and video quality, connections, tablet mounts, and transport times. Those factors could inform whether remote assessment is practical in the intended setting, but their results are not reported. The record notes that two calls did not connect, making connectivity a concrete feature of study conduct rather than only a planned outcome.
Finally, the single-group pilot design is suited to describing feasibility and agreement but cannot provide a randomized estimate of comparative clinical effect. The registry's stated aim of supporting a future efficacy trial places the pilot in an evidence-building role. Statistical interpretation should distinguish that role from a definitive test of benefit and should avoid inferring performance when the primary estimate, its uncertainty, and the secondary results are absent.
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 the posted findings is that the primary estimate and its 95% confidence interval are not reported in the registry record. The secondary outcome results are also absent. This prevents assessment of the observed agreement, its precision, and the stated feasibility-related measures.
The design is single-group, with no separate control arm and no randomized comparison. The primary endpoint compares simultaneous assessments by a remote physician and a bedside team member; it does not identify either assessment as a reference standard. Agreement therefore cannot be treated as diagnostic accuracy or as evidence of comparative clinical effect.
The registry reports enrollment of 20, an overall analyzed number of 18, and two calls that did not connect. Further participant-flow details, eligibility criteria, and reasons for any other exclusions or unavailable observations are not reported. The record does not state how missing checklist data were handled or whether the failed connections affected only the primary endpoint or other measures.
Important analytic details are not reported, including the statistical analysis plan and whether the analysis accounted for potentially related assessments within teams, physicians, or calls. The registry does not report how multiplicity across the listed outcomes was addressed, whether outcomes were tested, or which results were considered exploratory. These omissions limit evaluation of the analysis and of uncertainty beyond the endpoint definition.
Safety information is limited to the recorded event counts. Further details about event definitions, monitoring, follow-up, or attribution are not reported. As a pilot, the study also has a stated role in supporting a future efficacy trial; the registry record does not provide a comparative clinical outcome that would resolve efficacy questions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prehospital Telemedicine Feasibility/Acceptability Pilot — NCT05967624.
- Registry record last updated 2026-02-19; status last verified 2026-02.
- Results first posted 2026-02-19.
- 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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18. Record Summary
This completed, single-group pilot examines teleconsultation for children assessed by urban paramedic teams responding to 911 calls. Boston Medical Center is listed as sponsor. The registry reports enrollment of 20, with a start date of 2024-06-21 and primary completion date of 2025-02-14.
The primary outcome is mean agreement between a remote Medical Control Physician and a bedside transport team member scoring the Respiratory Observation Checklist during ambulance transport, up to 4 hours. The record says that two calls did not connect and that the overall number analyzed was 18. It reports zero serious adverse events, zero other adverse events, and zero deaths in the teleconsultation group.
The primary estimate and confidence interval, secondary outcome findings, and detailed statistical analysis plan are not reported in the registry record. The design supports an assessment of agreement and feasibility, not a randomized comparison of clinical efficacy.