Rutgers Pilot for PREDICT- Patient LAB Test: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Rutgers Pilot for PREDICT- Patient LAB Test (NCT05607043), a na na study. The primary outcome is Patient Willingness to Participate in the Study.

2. Clinical Question

3. Trial Design

This was a completed, non-randomized pilot registered as NCT05607043, titled “Rutgers Pilot for PREDICT- Patient LAB Test.” Rutgers, The State University of New Jersey, is listed as the sponsor. The study condition is SARS-CoV2 Infection, and the intervention is testing for SARS-CoV2 RNA. The registry lists the phase as NA.

The design is a single-group study with one arm, SARS-CoV-2 testing. All subjects in that arm were to receive testing as described in the record. Allocation is listed as NA, and masking is listed as NONE. There is no treatment or control arm against which to compare the participants who were tested. The record therefore describes a feasibility assessment, not a randomized comparative trial.

The study start date is 2021-01-31, and the primary completion date is 2021-02-25. Its status is COMPLETED. Enrollment is listed as 11. Separately, the primary endpoint description says that 36 patients were approached to enroll. These figures describe enrollment and approach counts; the registry does not report the primary endpoint percentage that relates them.

The brief summary frames the pilot around feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine. The registry lists 6 outcome measures and 0 analysis entries. Further details on study procedures, eligibility, sample-size justification, and statistical planning are not reported in the registry record. In particular, the record does not establish a comparative design or explain how the pilot’s size was selected.

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: 36 patients were approached to enroll in the study. The percentage of 36 patients who consented to participate in the study is tabulated

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 Patient Willingness to Participate in the Study, measured over Day 1.

The primary endpoint is “Patient Willingness to Participate in the Study.” It is defined as the percentage of patients approached who consented to participate. The endpoint description states that 36 patients were approached and identifies Day 1 as the timeframe. The record also lists enrollment of 11, but does not give the percentage result. That percentage is therefore not reported in the registry record and should not be inferred from the counts.

Willingness to enroll is useful in a feasibility study because it addresses whether patients invited to take part agree to do so. It can inform whether a study process is acceptable enough to examine further, though this endpoint alone does not establish that recruitment would be similar in another clinic or population. General statistical context: a recruitment percentage describes a proportion within the people approached; its interpretation depends on how those people were selected and whether the approach process was applied consistently. Those details are not reported in the registry record.

This endpoint is not a measure of the RT-PCR test’s diagnostic accuracy, the frequency of SARS-CoV-2 infection, or the effect of an intervention on health. No primary endpoint estimate, uncertainty interval, or analysis is reported in the registry record. The endpoint’s stated purpose is therefore clear, but its observed numerical result and precision cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and endpoint determine what statistical conclusions are possible. This registry record describes a single-group, non-randomized pilot. Its primary question is a proportion: among patients approached, what share consented to participate? A proportion is a descriptive summary of a binary outcome, where each person either consents or does not. The record specifies the endpoint definition and approach count, but does not report the resulting percentage.

What does a proportion estimate?

In general, a proportion is calculated from the number with the outcome of interest relative to the relevant denominator. Here, the endpoint is willingness to participate, and the denominator described is patients approached. The registry also reports enrollment of 11, but it does not provide an explicit numerical primary endpoint result. No percentage should be reconstructed from the enrollment and approach figures: the endpoint result is not reported in the registry record. The information needed to understand the approach process, including how patients were selected and whether all approached patients were assessed in the same way, is also not reported.

For a proportion, uncertainty matters as well as the point estimate. General statistical context: a confidence interval expresses uncertainty about an estimated quantity under the assumptions of a statistical method. It does not guarantee that the true value lies within the interval. The registry record does not report a primary endpoint estimate or confidence interval, so neither the observed willingness percentage nor its precision can be assessed.

What can a single-group design establish?

A single-group study can describe recorded outcomes among participants who received the study procedure. It lacks a concurrent comparator, so it cannot separate the effect of the procedure from other explanations for any observed outcome. In this pilot, allocation is listed as NA, masking is NONE, and the record states there is one arm. There is no randomized treatment contrast to estimate. The study’s primary recruitment endpoint is descriptive and does not require a treatment comparison to have a practical interpretation, but it remains specific to the patients approached and the study setting.

General statistical context: randomization helps make comparison groups similar, on average, with respect to measured and unmeasured factors. Without randomized allocation and a comparator group, a study cannot use that design protection to interpret differences between arms. There are no arms to compare in this record, so comparative methods and adjusted treatment effects are not reported.

How should event counts be read?

The safety information is recorded as counts of events and numbers at risk in the testing group. A count gives the number of events recorded; it is not, on its own, an estimate of comparative risk. The posted safety entries list no serious or other adverse events among the group recorded as at risk. General statistical context: when event counts are low or absent, the data can still be compatible with a range of underlying event rates. A zero count should not be translated into certainty that an event is impossible, and a single-group record cannot establish whether event risk differs from another approach.

Over-dispersion is a general concern for count outcomes when variability exceeds what a simple count model expects. It can affect standard errors and uncertainty estimates if a model assumes less variability than the data have. In this record, the primary endpoint is a percentage and the adverse-event information is descriptive. No count model, dispersion estimate, or inferential event analysis is reported in the registry record, so over-dispersion is not something that can be assessed from the posted results.

What do the analysis and planning details show?

The registry lists 6 outcome measures and 0 analysis entries. This means the posted record does not provide analysis-level estimates for the outcomes. It does not establish that analyses were or were not conducted outside the registry; those details are not reported in the registry record. There is also no reported statistical plan, interim analysis, or sample-size justification.

The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Those are illustration assumptions, not the design of this single-group study. The record does not report a two-arm comparison or an observed effect estimate for the primary endpoint, nor does it provide results from a planning calculation. Any such illustration should be treated as planning context rather than evidence about this pilot’s actual power. It is not observed power.

General statistical context: a prospective sample-size calculation is conditional on assumptions about the effect to detect, variability, and analysis. It does not guarantee that a study will detect an effect, and a post hoc power calculation based on observed results is not a substitute for an estimate and its uncertainty. Since no primary endpoint result or analysis is reported, no recalculated effect estimate or precision assessment is available for this study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 6 outcome measures, but the primary endpoint information available in the record concerns willingness to participate. The record lists 0 analysis entries. It does not describe which outcomes were analyzed, whether additional outcomes were designated as secondary, or how multiple outcome questions were handled. No multiplicity procedure is reported in the registry record.

General statistical context: when several outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if each is assessed separately without accounting for the family of tests. Methods to address multiplicity depend on the goals and analysis plan. Since no analysis plan or outcome-level analyses are reported, it is not possible to determine whether any adjustment was planned or used. The existence of multiple registered outcome measures alone does not establish that multiple statistical tests were performed.

Missing-data handling is also not reported in the registry record. The record does not say whether any approached patients had incomplete consent information, whether outcome data were missing, how missing values were handled, or whether any sensitivity analysis was undertaken. The enrollment count does not reveal the completeness of endpoint data.

Analysis populations are not described. The registry does not specify an intention-to-treat, per-protocol, or other defined analysis population. In a single-group feasibility study, clear reporting of who was approached, who consented, who was tested, and who contributed to each outcome would help readers understand the denominator and the applicability of the findings. Those details beyond the stated approach and enrollment counts are not reported in the registry record. These reporting gaps prevent assessment of whether the primary endpoint analysis included all eligible observations or how exclusions may have affected it.

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’s safety entries for the SARS-CoV-2 Testing group report 0 serious adverse events among 11 participants at risk and 0 other adverse events among 11 participants at risk. Deaths are listed as 0. These are descriptive counts recorded for this study group; there is no comparator arm.

A zero count is not the same as proof that an event cannot occur. General statistical context: observed event counts are subject to uncertainty, especially when the number of participants is limited. Without a reported uncertainty interval or comparative analysis, the safety entries do not quantify a precise underlying event rate or establish how that rate compares with another testing approach.

The record does not provide further detail on event definitions, collection procedures, duration of safety follow-up, or adjudication. Those details are not reported in the registry record. The figures therefore describe what was recorded in the posted results, within the listed group and at-risk counts. They should not be extended to settings or populations beyond the study, and should not be interpreted as a comparison of safety between interventions.

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

The posted record establishes that Rutgers conducted a completed pilot involving SARS-CoV-2 RNA testing in a single group of asymptomatic dental patients presenting to the Oral Medicine Clinic. Its primary endpoint was willingness to participate, expressed as the percentage of patients approached who consented. The description identifies 36 patients approached, and the registry lists enrollment of 11. The actual primary percentage is not reported in the registry record, so the endpoint’s observed value cannot be stated or interpreted.

The study does not answer whether testing changed a health outcome. It has no randomized comparator and no treatment contrast. Its primary endpoint concerns recruitment feasibility, rather than the diagnostic performance of the RT-PCR assay. The registry does not report a positivity count, sensitivity, specificity, or another measure of test performance. No conclusion about those outcomes follows from the stated study purpose alone.

The safety entries record no serious or other adverse events in the testing group, with no deaths listed. These counts are descriptive and do not establish that risk is absent. No comparative safety estimate or uncertainty interval is reported in the registry record.

General statistical context: pilot studies can help describe whether a study process is workable and can identify practical questions for future research. Their findings are not automatically representative of other clinics or patient groups. Recruitment may depend on local context and the way participants are approached. The record does not provide details that would support judging how broadly these findings might generalize.

The registry record supports a narrow description of the study design and intended feasibility question. It does not report the primary endpoint percentage, analysis results, or the information needed to assess its precision. It therefore cannot establish a numerical level of willingness to enroll, test accuracy, infection frequency, or a comparative effect. Those conclusions would require results and analyses that are not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically notable because its primary question is about recruitment feasibility rather than a treatment effect. The endpoint asks whether patients approached consented to take part. That is a proportion-based question, and interpreting it depends on a clearly reported numerator, denominator, and approach process. The registry describes the endpoint and says 36 patients were approached, but does not report the percentage. The absence of that estimate limits the central feasibility interpretation.

The design also illustrates why the estimand must match the study question. A single-group pilot can describe participation and testing within its setting, but it cannot provide a randomized comparison with another strategy. No control arm is present, and allocation is listed as NA. A statistical analysis should not imply a comparative effect where the design does not supply a comparator.

General statistical context: feasibility outcomes are often useful even when they are not clinical efficacy outcomes. Recruitment, consent, and implementation information can help assess whether a larger or differently designed study is practical. However, those measures are most informative when the registry reports the outcome value, the population contributing to it, and relevant uncertainty. Without the result, readers cannot assess whether the observed recruitment experience was precise or how it might inform later work.

The record lists multiple outcome measures but no analysis entries. This emphasizes the importance of transparent reporting of the intended analysis, missing-data handling, and analysis populations. These details help distinguish a planned endpoint from results selected or reported after data collection. Such details are not reported in the registry record.

Finally, the safety counts are best understood as descriptive observations, not comparative evidence. A zero event count may be reassuring as a record of what was reported, but it does not establish that risk is zero. The study’s statistical contribution can therefore be assessed only within the limits of its single-group feasibility aim and the outcome information recorded.

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 most direct limitation for interpreting the primary question is that the registry record does not report the willingness-to-participate percentage. It identifies 36 patients approached and lists enrollment of 11, but those figures do not replace a reported endpoint result. The record also does not give an uncertainty interval, so precision cannot be assessed.

The study is a non-randomized, single-group pilot with no comparator. It can describe the enrolled group but cannot support a like-for-like comparison of testing strategies. Masking is listed as NONE. The record does not describe whether lack of masking affected recruitment or outcome assessment, so the implications cannot be assessed from the registry information.

Generalizability is uncertain because the study concerns asymptomatic dental patients presenting to one named clinic. Further details about eligibility criteria, participant characteristics, and the approach process are not reported in the registry record. Those factors matter when considering whether the recruitment experience might apply to other settings or populations.

The registry lists 6 outcome measures but 0 analysis entries. Statistical methods, analysis populations, missing-data procedures, and multiplicity handling are not reported. The record also does not describe the sample-size justification, interim analyses, or a statistical analysis plan. As a result, the basis for analysis choices and the completeness of outcome reporting cannot be evaluated.

Finally, no test-positive results or diagnostic accuracy estimates are reported in the registry record, despite RNA testing being the intervention. Safety data are limited to the posted counts, without further information on event definitions or follow-up. These omissions restrict interpretation to the study’s design and recorded descriptive information; they do not establish findings beyond what the registry reports.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Rutgers Pilot for PREDICT- Patient LAB Test — NCT05607043.
• Registry record last updated 2023-09-22; status last verified 2023-09.
• Results first posted 2023-09-13.
• 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

NCT05607043 is a completed, single-group, non-randomized pilot sponsored by Rutgers, The State University of New Jersey. Its title is “Rutgers Pilot for PREDICT- Patient LAB Test,” and its condition is SARS-CoV2 Infection. The study tested SARS-CoV-2 RNA in asymptomatic patients presenting to the Rutgers School of Dental Medicine Oral Medicine Clinic, using an FDA-approved RT-PCR assay identified as Accurate Diagnostics.

The registry lists enrollment of 11, a start date of 2021-01-31, and a primary completion date of 2021-02-25. The primary endpoint concerns the percentage of 36 patients approached who consented to participate, but the result is not reported in the registry record. The study has no comparator arm; allocation is NA and masking is NONE. The registry lists 6 outcome measures and 0 analysis entries. Safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths in the testing group.