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Behavioral Shift (Researcher Willingness to Repo NA Continuous Endpoint NCT06046872

Impacts of a Report-back Training Program: Complete Statistical Analysis

This analysis examines a single-group training program for researchers who report personal environmental exposure results. The registry describes pre- and post-training belief surveys but does not report their results.

Trial start: 2023-06-22  ·  Enrollment: 56  ·  Sponsor: Silent Spring Institute
Scope of this record

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 Impacts of a Report-back Training Program (NCT06046872), a na na study. The primary outcome is Beliefs About Report-back, Before and After Training Program.

56
Enrollment
NA
n/a
Arms
In the primary outcome
n/a
Effect
No re-analysis shown
n/a
95% CI
See limitations
FeatureRegistry value
ClinicalTrials.gov identifierNCT06046872
PhaseNA
ConditionBehavioral Shift (Researcher Willingness to Report-back)
AllocationNot applicable (single group)
Design modelSingle Group
MaskingNone (open label)
Enrollment56
Arms in the primary outcomen/a
Lead sponsorSilent Spring Institute
Results postedYes

2. Clinical Question

The registry record concerns a behavioral training program for researchers and asks whether beliefs about reporting personal environmental exposure results differ before and after training. The primary outcome is described as a score based on participants’ agreement with statements about report-back. The record says surveys were completed before and after the program, and that only participants completing both tests were included in the primary analyses.

Population

Researchers participating in a hands-on report-back training program. The registry lists enrollment as 56, but the number completing both surveys and included in the primary analysis is not reported in the registry record.

Intervention

A behavioral report-back training program focused on sharing personal exposure results. The record describes a training program, but does not report further details about its content, duration, or delivery.

Comparator

Each participant’s survey before training is compared descriptively with their survey after training. There is no control group, so the comparison is not between separately assigned intervention and control groups.

Primary question

How do participants’ reported beliefs about report-back compare before and after training? The registry names the outcome and measurement scale but does not report the scores or an estimated pre–post change.

3. Trial Design

This is a completed, single-group behavioral study of a report-back training program. The registry lists enrollment as 56 and identifies researchers participating in training on sharing personal exposure results. Its description says surveys were administered before and after the program to assess perspectives and willingness to report results. There is no control group, and the allocation field is recorded as not applicable. The masking entry is none. The record labels the study phase as not applicable.

The design therefore centers on change over time within the training group, rather than a randomized comparison of training against an alternative. Pre-training responses can describe participants’ views before training, and post-training responses can describe their views afterward. A paired analysis could use each participant’s two measurements, but the registry record does not report which statistical analysis was conducted. It also does not report an analysis plan, an allocation procedure, or a sample-size justification.

The study start date is 2023-06-22, and the primary completion date is 2024-12-15. The status is completed. The registry identifies three outcome measures and zero analyses. It does not report the numerical results for the primary outcome, the number included in its analysis, or the estimated change between surveys. Thus, the design and intended measurement are described, but the evidence needed to quantify the pre–post pattern is not present 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.

Before assignment: Participants were not assigned to an arm or group. Rather, for all individuals who participated in a report-back training program, we evaluated any shifts in participants perspectives on environmental health report-back and wiliness to report-back with pre- and post-tests.

Overall Study

StageReport-back Training Program
STARTED56
COMPLETED34
NOT COMPLETED22

Analysis population for the primary outcome, as defined in the registry: Only participants who completed both pre-and post-tests are included in the analyses.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: The baseline analysis population (N=56) includes everyone who completed both a pre- and post-test (n=34), those who only completed a pre-test and no post-test (n=21), and those who only completed a post-test (n=1).The number of baseline participants is the same as the number of participants in the flow table because this number incorporates everyone enrolled who completed a survey at any time point. In outcome measures, we report only on those who completed both pre-and post-tests (n=34).

CharacteristicUnitReport-back Training Program
Participants analysed56
Age, ContinuousYears—
Sex/Gender, Customized: FemaleParticipants29
Sex/Gender, Customized: MaleParticipants4
Sex/Gender, Customized: Sex/gender unknownParticipants23
Race (NIH/OMB): American Indian or Alaska NativeParticipants1
Race (NIH/OMB): AsianParticipants2
Race (NIH/OMB): Native Hawaiian or Other Pacific IslanderParticipants0
Race (NIH/OMB): Black or African AmericanParticipants0
Race (NIH/OMB): WhiteParticipants26
Race (NIH/OMB): More than one raceParticipants2
Race (NIH/OMB): Unknown or Not ReportedParticipants25
Ethnicity (NIH/OMB): Hispanic or LatinoParticipants7
Ethnicity (NIH/OMB): Not Hispanic or LatinoParticipants26
Ethnicity (NIH/OMB): Unknown or Not ReportedParticipants23
Region of Enrollment: United StatesParticipants56

6. Primary Endpoint

The registry lists the primary outcome as Beliefs About Report-back, Before and After Training Program, measured over Participants completed surveys before and after the training program..

ElementRegistry entry
Result typeMean
Measure of spreadStandard Deviation
UnitScore on a scale
Endpoint classificationContinuous Endpoint

The primary outcome is titled “Beliefs About Report-back, Before and After Training Program.” It is described as a score on a scale, with the mean and standard deviation as the stated summary measures. Participants ranked how strongly they agreed with each statement using a Likert scale from 1 (strongly disagree) to 5 (strongly agree). The surveys were completed before and after training, and the primary analysis population is described as participants who completed both pre- and post-tests.

This measure is intended to capture participants’ stated beliefs about report-back at two time points. Comparing the two measurements can describe whether responses shifted among people with both surveys. The registry record does not report the statements included, how responses were combined into a score, whether any items were reverse-scored, or whether a higher aggregate score has a defined interpretation. It also does not report the score values or a pre–post estimate.

As a general statistical point, a mean can summarize the average score, while a standard deviation describes the spread of individual scores around that average. These summaries do not by themselves show how precisely an average or a change has been estimated. A confidence interval or other uncertainty measure would help convey precision, but such results are not reported in the registry record.

7. Why No Re-analysis Is Shown

Reported as posted, not recalculated. Not a randomized comparison (allocation: NA); arms are not a like-for-like control comparison. A result is recalculated only when the posted data support a clean two-arm comparison, so no result is shown beyond what the sponsor posted.

8. Statistical Interpretation

Clinical Biostats interpretation

The registry describes a within-group measurement plan: participants completed surveys before and after a report-back training program, and the primary outcome concerns beliefs about report-back. It does not report the actual means, standard deviations, estimated pre–post change, confidence interval, or test result. Consequently, the direction, size, and precision of any change cannot be determined from the registry record. The record’s description of what was measured should not be mistaken for evidence that beliefs shifted.

The enrollment is listed as 56, but that is not necessarily the number contributing to the primary analysis. The record explicitly limits that analysis to participants who completed both surveys, while not reporting how many met that requirement. Without the analysis count and outcome values, it is not possible to assess how much information the primary comparison contains or how representative the analyzed participants may be of all enrolled participants.

Because there is no control group, a pre–post difference, if one were reported, would describe change over time in the training group. It would not isolate the effect of training from other possible explanations for change. General examples include becoming more familiar with survey questions, events occurring during the study period, or changes in who completed the second survey. These are design considerations, not claims that any particular explanation occurred in this study.

The stated outcome is based on agreement ratings from 1 (strongly disagree) to 5 (strongly agree), but the registry does not explain how individual statements form the reported score. That missing detail limits interpretation of what a change in the score would represent. The record also does not report a statistical analysis, uncertainty interval, or multiplicity procedure. The three listed outcome measures therefore cannot be interpreted as a set of reported statistical findings.

In short, the available registry information establishes the study question, broad design, measurement scale, and complete-case criterion for the primary analysis. It does not establish whether scores increased, decreased, or remained similar, nor how precisely any estimated change was measured. Any numerical outcome conclusion would require results not reported in the registry record.

9. Statistical Methods Explained

The record describes a continuous outcome summarized by a mean and standard deviation. It also says participants rated agreement on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). The record does not give the score values, the method used to combine responses, or the statistical analysis. The explanations below are general statistical context and should not be read as a description of analyses confirmed to have been performed.

What does a mean and standard deviation describe?

In general, a mean summarizes the average of observed scores. A standard deviation describes how dispersed those scores are around the mean. The mean describes the center of a distribution, while the standard deviation describes variability among individual observations. Neither one alone gives the uncertainty around an estimated pre–post change. That uncertainty is often conveyed with a confidence interval or a test result, neither of which is reported in the registry record.

Agreement ratings are ordered categories: a higher response indicates stronger agreement. A mean treats steps between response categories as if they can be represented by equal numerical intervals. This is a common descriptive summary, but its interpretation depends on how the scale is constructed and scored. Because the registry does not report the statements or scoring procedure, it is not possible to assess the composition or range of the aggregate score beyond the stated response scale.

Why does the paired structure matter?

When the same person is measured before and after an intervention, the two observations are related. In general, a paired analysis uses that relationship by evaluating each person’s within-person change. This differs from treating the pre-training and post-training observations as if they came from unrelated groups. A paired analysis can account for stable differences between participants, but it does not by itself address changes over time unrelated to the intervention.

The registry identifies a before-and-after survey design but does not name the analysis method. It is therefore not possible to say whether the results were analyzed as paired observations, whether the score was treated as continuous, or whether another approach was used. The analysis population is described as participants who completed both tests; the number in that population is not reported in the registry record.

What does uncertainty add?

In general, a confidence interval gives a range of values compatible with the data and the method used to calculate it. Its width conveys precision: a narrower interval indicates greater precision under that method, while a wider interval indicates more uncertainty. A p-value, when used, addresses how compatible the data are with a specified null hypothesis under the test’s assumptions. Neither measure substitutes for the estimated change itself, and neither establishes that a change is important in practical terms.

No confidence interval, p-value, or other uncertainty measure for the primary outcome is reported in the registry record. There is also no reported analysis estimate to interpret. A sample-size illustration based on an observed effect is a planning exercise, not an observed power calculation or evidence that a particular effect occurred. The registry’s general planning assumptions mention a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. However, this study is described as single-group with no control group, and the record does not provide a trial-specific statistical plan or sample-size justification. Those planning assumptions do not establish the method used for this study.

How should multiple outcomes be considered?

The registry lists three outcome measures and zero analyses. In general, examining multiple outcomes can raise the chance of finding at least one apparently notable result by chance, depending on the testing strategy. Statistical plans may address this through a prespecified primary outcome, adjusted thresholds, or a hierarchy of tests. The record does not report a multiplicity strategy or the analyses for the additional outcomes, so it is not possible to determine how those issues were handled.

General statistical interpretation also depends on assumptions appropriate to the chosen model. For example, if a model treats observations as independent when they are paired, its uncertainty estimates may be inappropriate. If a measure is highly skewed or has unusual variability, a method based on a simple distributional assumption may fit poorly. These are general considerations only: the registry does not report a model, diagnostics, or data distributions that would allow assessment of assumptions for this study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and zero analyses. It identifies one primary outcome concerning beliefs about report-back, measured before and after training. The registry record does not report results for that outcome or describe analyses of the other measures. It also does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a prespecified approach to interpreting multiple comparisons.

As a general statistical issue, testing or interpreting several outcomes can make chance findings more likely if each result is treated as independent evidence without regard to the overall set. A multiplicity strategy can help control that concern, but the appropriate approach depends on the study questions and analysis plan. Because no such plan is reported, the handling of multiplicity cannot be assessed.

For the primary outcome, the record says that only participants who completed both pre- and post-tests are included in the analyses. This identifies a complete-case criterion, but does not report how many participants completed both tests or how many did not. It does not say whether missing responses were imputed, whether other missing-data methods were used, or whether reasons for missing tests were collected. The handling of missing data for the other outcomes is not reported in the registry record.

In general, restricting analysis to people with complete measurements can affect interpretation if completion is related to participants’ characteristics or their outcomes. That is a possible methodological concern, not evidence that missingness was related to outcomes in this study. Without the analysis count, missingness information, and outcome results, the degree to which incomplete follow-up could affect the findings cannot be evaluated.

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

The registry record describes a training program and a plan to assess participants’ beliefs before and after it. It does not report the primary outcome values or a statistical estimate of change. Therefore, the posted information does not show whether participants’ beliefs shifted, how large any shift was, or how precisely it was estimated. A conclusion about the direction or magnitude of change would go beyond the reported results.

Even if a pre–post difference were available, the single-group design would support a description of change over time in the measured participants, not a controlled estimate separating training from other influences. Without a control group, general alternative explanations can include repeated exposure to the survey, events during the study period, or selection associated with completing both tests. These are limitations inherent to interpretation of an uncontrolled before-and-after comparison; they are not findings about what happened in this study.

The outcome reflects agreement ratings, not direct evidence of researchers’ later behavior or the consequences of report-back in research settings. The record’s summary mentions willingness to implement report-back as a topic assessed, but the primary outcome named in the registry is beliefs about report-back. It does not report a measure of actual implementation or its effects.

The listed enrollment is 56, while the number included in the primary analysis is not reported. The registry also does not report score construction details, uncertainty estimates, or analyses of the other listed outcomes. These omissions limit assessment of precision, measurement meaning, and the completeness of the evidence. The appropriate reading is therefore narrow: the record documents a completed single-group training study with pre- and post-surveys, but numerical results and their statistical interpretation are not reported in the registry record.

12. Why This Trial Matters Statistically

This study raises statistical questions that are common in behavioral research: how to describe change when the same participants are measured at two times, how to interpret a scored agreement scale, and how to distinguish change over time from an effect attributable to an intervention. The registry specifies the broad measurement approach and the complete-case criterion for the primary outcome, making those features central to interpreting any eventual results.

The single-group design is especially important. In general, paired measurements can show how participants’ responses differ across time, but a pre–post comparison without a control group cannot establish what would have happened over the same period without training. This distinction matters when a study question concerns change following an educational program. It separates a descriptive within-group finding from a causal comparison.

The record also illustrates why reporting the analysis population, scoring rules, estimates, and uncertainty matters. The registry lists enrollment as 56 but does not report how many completed both surveys. It identifies a mean and standard deviation as summary measures, yet does not provide values or the construction of the score. Without those details, readers cannot evaluate the size, precision, or interpretation of any outcome.

Finally, three outcome measures are listed, but the record reports zero analyses. In general, transparent reporting of which outcomes were analyzed and how multiple results were handled helps readers understand the strength and scope of evidence. Here, the documented design and measurement question can be understood, while the statistical findings themselves are not reported in the registry record.

13. Limitations

The principal limitation for statistical interpretation is that the registry record does not report numerical results for the primary outcome. No pre- or post-training means, standard deviations, estimate of change, confidence interval, or test result is stated. The direction, magnitude, and precision of the outcome therefore cannot be assessed from the record.

The study has a single-group, before-and-after design with no control group. In general, this design cannot separate changes associated with training from other changes over time or from effects of taking the same survey twice. That concern limits causal interpretation even if a pre–post estimate is reported elsewhere; it is not evidence that any particular alternative explanation occurred.

The primary analysis is described as including only participants with both pre- and post-tests, but the number meeting that criterion is not reported. The record does not describe missingness, reasons for incomplete surveys, or whether any method beyond complete-case inclusion was used. The aggregate score’s construction and the statements used are also not reported, limiting assessment of exactly what the score represents.

Further, the registry lists three outcome measures but zero analyses. It does not report a statistical analysis plan, a multiplicity approach, or a sample-size justification. The listed enrollment of 56 does not resolve these gaps and should not be treated as the primary analysis count. These limitations concern what is documented in the registry record; they do not establish that the study lacked other analyses or documentation outside that record.

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17. Record Summary

NCT06046872, titled “Impacts of a Report-back Training Program,” is listed as completed. The sponsor is Silent Spring Institute. The study is described as a single-group behavioral training program for researchers on sharing personal exposure results, with no control group and no masking. Enrollment is listed as 56. The study start date is 2023-06-22, and the primary completion date is 2024-12-15.

The primary outcome concerns beliefs about report-back, assessed with surveys before and after training. Participants rated agreement on a Likert scale from 1 (strongly disagree) to 5 (strongly agree); the outcome is described using a mean and standard deviation. Only participants who completed both tests are included in the stated primary analysis population. The number in that population and the primary outcome results are not reported in the registry record. Three outcome measures and zero analyses are listed.

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