Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance? (NCT02875977), a randomized na study. The primary outcome is Number of Participants With Completed PT Visits.

2. Clinical Question

The registry describes random assignment to the two counseling approaches. Its stated aim is to measure compliance with attending pelvic floor physical therapy in a urogynecology population. The clinical question is therefore about appointment attendance behavior, not a direct comparison of symptom improvement as the primary endpoint. Change in urogenital distress from baseline to 3 months is listed as a secondary outcome.

The record also lists initiation of physical therapy, discharge from physical therapy, and days to initiation as secondary outcomes. These outcomes address other points in the pathway from referral to treatment completion, but their results are not reported in the registry record. The primary outcome focuses on reaching a threshold of recommended visits, rather than documenting the precise number of visits completed by each participant.

3. Trial Design

This is a randomized, parallel-group trial. Participants were assigned to Experimental Counseling or Standard Counseling. The registry lists masking as none, so the record does not describe a masked design. The planned enrollment is 200, and the record status is completed. The study start is 2016-08-03 and the primary completion date is 2017-11-15.

Experimental Counseling combined standard counseling, a 2-page educational handout, and a 4-minute educational video. Standard Counseling included standard counseling and the same handout. The contrast is therefore the addition of the video to the handout-based counseling approach. The registry does not report details such as how the counseling was delivered, whether participants viewed the video as intended, or how adherence to the assigned approach was monitored.

The primary outcome is the number of participants who completed at least half of their recommended pelvic floor physical therapy visits, assessed over 3 months. The primary analysis population is described as randomized participants for whom follow-up physical therapy completion information was available. This description means the primary analysis does not necessarily include every person enrolled or randomized; the counts and reasons for any exclusions are not reported in the registry record.

Five outcome measures and five analyses are listed, including secondary outcomes involving initiation, discharge, time to initiation, and change in urogenital distress. The record does not provide the detailed analysis procedures for these outcomes. It also does not report the sequence-generation method, allocation concealment procedures, eligibility criteria, or the intended handling of participants who did not follow their assigned counseling approach. Such details should not be inferred from the fact that the design is described as randomized.

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: This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available

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 Number of Participants With Completed PT Visits, measured over 3 months.

The primary endpoint counts participants who completed at least half of their recommended pelvic floor physical therapy visits. It is assessed over 3 months and is defined as a threshold-based attendance outcome. Each participant is classified according to whether the threshold was met, rather than the endpoint representing a continuous measure of visit completion.

This endpoint is used to operationalize attendance compliance in a way that can be compared between the counseling arms. A threshold can make the outcome straightforward to interpret, but it also compresses information: participants who complete different numbers of visits can fall into the same category if they are on the same side of the threshold. The exact number of recommended visits, how recommendations were determined, and whether they varied between participants are not reported in the registry record.

The record states that the comparison is between those assigned to enhanced counseling and those assigned to standard counseling. It does not report the number meeting the endpoint in either arm, the denominators used for an arm-level estimate, or an effect estimate with uncertainty. Consequently, the endpoint definition is available, but the magnitude and precision of the observed comparison cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the start of a trial, including differences that may not have been measured. It does not ensure that every characteristic will be balanced in a particular study, and it does not guarantee that the assigned approaches are followed or that outcome data are complete.

For this trial, the registry identifies the allocation as randomized and the model as parallel. The exact randomization method and allocation concealment procedures are not reported in the registry record. Those details matter when assessing whether assignment could have been anticipated or influenced. The record also lists masking as none; it does not describe procedures to mask outcome assessment.

How should a threshold outcome be understood?

In general, a binary outcome records whether an event or condition occurred for each participant. The primary endpoint applies that structure to attendance: the event is completing at least half of recommended visits within the stated timeframe. The endpoint is then expressed as a number of participants meeting that condition. Although the measure is presented as a participant count, comparing it between groups ordinarily requires knowing both the number who met the threshold and the relevant number assessed in each group.

A count by itself is not an estimate of the chance of meeting the threshold unless its denominator is known. A group comparison can be expressed in several ways, such as a difference in proportions or a ratio of proportions, but these are distinct summaries and can convey different perspectives. The registry record does not report arm-level counts, denominators for the primary outcome, or a chosen effect measure. No such estimate can be reconstructed from enrollment alone.

Thresholding also has a general interpretive cost. Participants just below the cutoff and participants with substantially fewer completed visits are treated alike for this endpoint, as are participants who meet the threshold to different degrees. The registry gives the threshold definition but does not report visit distributions or the recommended visit counts. The binary result, if available, would therefore answer the stated threshold question but not every question about attendance patterns.

What does statistical uncertainty mean?

In general, an estimate from a trial is subject to sampling uncertainty because the participants enrolled are one realization of a broader process. A confidence interval represents a range of values compatible with the data under the assumptions of the analysis; it is not a guarantee that the true effect lies in that range. A narrow interval indicates greater precision than a wide interval, while an interval spanning both possible benefit and harm can leave the direction uncertain, depending on the outcome and effect measure.

The primary outcome estimate and its uncertainty interval are not reported in the registry record. The statistical test, significance level used for the primary result, and any adjustment for covariates are also not reported. Accordingly, there is no basis for characterizing the estimate as precise or imprecise, or for interpreting a p-value. Statistical significance, if reported, would not on its own describe the size or practical importance of an effect.

What do the planning assumptions mean?

General sample-size calculations estimate how many participants may be needed under specified assumptions to detect a target effect with a chosen statistical procedure. They are planning illustrations, not results from the trial, and they are not observed power. The record describes planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The intended effect for those illustrations is expressed as a fraction of the observed effect.

These assumptions do not establish what sample-size rationale was used when the trial was designed. The protocol’s original sample-size justification, the target effect chosen before enrollment, and any planned allowance for missing outcomes are not reported in the registry record. Because the outcome estimates underlying the observed effect are also not reported in the registry record, the planning illustration cannot be independently interpreted as evidence that the trial was adequately powered. Planning values are conditional on their assumptions and should not be read as the probability that this completed study detected an effect.

More generally, if an outcome is a count of participants with an event, the analysis may use a model for binary data or a direct comparison of group proportions. The appropriate approach depends on the prespecified estimand, outcome availability, and analysis plan. The registry record does not identify the method used for the primary comparison, so no specific model or test should be attributed to this trial. The methods used for the secondary outcomes are likewise not reported.

10. Multiplicity, Missing Data and Analysis Populations

The record lists five outcome measures and five analyses. The primary outcome concerns reaching the physical therapy attendance threshold; secondary outcomes concern initiation, discharge, days to initiation, and change in urogenital distress from baseline to 3 months. When a study examines multiple outcomes, time points, or analyses, the chance of obtaining at least one apparently unusual result can increase if each is assessed separately. A prespecified hierarchy or multiplicity adjustment can help define how such findings are interpreted.

The registry record does not report whether the outcomes were arranged in a formal testing hierarchy, whether multiplicity adjustments were planned or used, or which results were considered confirmatory. It also does not report details of any interim analyses. These omissions limit assessment of how the collection of outcome analyses should be interpreted; they do not establish that any particular procedure was or was not used outside what the record states.

Missing outcome information is especially relevant because the primary analysis is described as including randomized participants with follow-up physical therapy completion information available. The number missing, the reasons for missingness, and the handling of missing outcomes are not reported in the registry record. The record does not state whether an intention-to-treat analysis, imputation, sensitivity analysis, or another approach was used. The number excluded from the primary analysis and whether missingness differed between arms are also not reported in the registry record.

In general, excluding participants without observed outcomes can affect a comparison if outcome availability is related to attendance or differs between groups. This is a methodological concern to assess, not evidence that bias occurred in this trial. Without the analysis population counts and missing-data procedures, the effect of unavailable follow-up information cannot be evaluated from the registry record.

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 5% reporting threshold.

The serious adverse event entries list 100 participants at risk in Experimental Counseling and 100 at risk in Standard Counseling. Serious adverse events are listed for 0 participants in each arm. Other adverse events are also listed for 0 participants in each arm, and deaths are listed as 0 in each arm. No serious adverse event terms are listed.

These are registry safety entries, separate from the primary attendance outcome. A zero count means that the registry record lists no affected participants in those categories; it does not establish that no event of any kind occurred or that all possible events were captured. The record does not report the safety surveillance procedures, monitoring duration, event definitions, or the completeness of event reporting. It also does not provide detail about events that may not have met the registry’s serious-event or other-event reporting categories.

Safety figures should be interpreted with their stated population and reporting context in mind. The counts are not a comparison of attendance and do not show whether the video changed appointment completion. Nor do they by themselves establish safety: the available record gives the listed counts but not enough information to evaluate ascertainment or completeness.

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

The trial’s question is whether adding a brief educational video to standard counseling and a handout is associated with a difference in physical therapy attendance. The primary endpoint is clearly defined as completing at least half of recommended visits within 3 months. The record also describes a randomized, parallel-group comparison and identifies secondary outcomes related to treatment initiation, discharge, timing, and urogenital distress.

Those design details do not establish the result. The primary event counts, analyzed denominators, effect estimate, confidence interval, and statistical test are not reported in the registry record. It is therefore not possible to say from this record whether attendance was higher in either arm, whether any difference was large or small, or whether the data were precise enough to distinguish an effect from little or no difference.

Even a reported difference in the primary endpoint would answer a focused question about the specified attendance threshold. It would not, by itself, establish why participants attended, whether the video was viewed or understood, or whether treatment led to changes in symptoms. Those are separate questions. The record’s listed secondary measures could address parts of that broader picture, but their results are not reported in the registry record.

The zero adverse-event entries should also be read within their limits. They report no affected participants in the listed categories, but the registry does not describe event monitoring or completeness. Likewise, the planned enrollment does not show how many participants had usable primary outcome information. The record supports an account of the study’s intended comparison and endpoint, but not a conclusion about efficacy, safety, or the certainty of the primary result.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between describing an intervention and evaluating its effect. Both groups received counseling and the same handout; the experimental approach added a 4-minute video. A well-defined contrast helps clarify the intended comparison, while the randomized parallel design identifies the general framework for comparing outcomes between assigned groups.

The primary endpoint also illustrates how an outcome definition shapes interpretation. Counting participants who meet a threshold is relatively direct, but it does not retain the detail of each person’s attendance. The result would describe threshold attainment, not the full pattern of visits completed. Understanding this distinction is important when translating an outcome label into the clinical behavior it represents.

The record highlights why estimates and denominators matter. Enrollment is not interchangeable with the analysis population, particularly when the primary analysis requires follow-up completion information. Without arm-specific outcome counts, denominators, and uncertainty estimates, a reader cannot judge the size or precision of the comparison. A trial design and a stated endpoint are essential context, but they are not substitutes for the reported result.

Finally, the presence of multiple outcomes makes transparent analysis planning important. Initiation, discharge, timing, and urogenital distress capture different aspects of the care pathway. Knowing which analyses were prespecified and how multiplicity was addressed would help distinguish primary evidence from exploratory patterns. Those analysis details are not reported in the registry record, making careful limits on interpretation especially important.

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.

A central limitation of the available record is that it does not report the primary outcome results. No arm-level counts, analysis denominators, effect estimate, confidence interval, or test result are reported in the registry record. The comparative attendance result therefore cannot be evaluated, regardless of the planned enrollment.

The primary analysis includes only randomized participants with follow-up completion information available, but the record does not report how many participants met that definition or how missing information was handled. Reasons for missingness and any sensitivity analyses are not reported in the registry record. This prevents assessment of whether the analyzed population differed from the randomized population in ways relevant to attendance.

The outcome uses a threshold of at least half of recommended visits. The record does not state how recommended visit counts were determined or provide the underlying distribution of visits. It is consequently not possible to assess how the threshold behaved across participants or how much detail was lost by classifying completion as a threshold outcome.

The registry lists secondary outcomes but does not report their results or the analysis procedures used for them. It also does not report a multiplicity plan, interim-analysis details, allocation concealment methods, or the original sample-size justification. The record identifies no masking, but does not explain whether outcome assessment or data handling involved other safeguards. These are limits of what can be assessed from the registry record; they do not establish that procedures were absent.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance? — NCT02875977.
• Registry record last updated 2019-05-24; status last verified 2019-05.
• Results first posted 2018-09-27.
• 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

The registry record describes NCT02875977, a completed randomized, parallel-group trial of counseling approaches for pelvic floor physical therapy attendance. Experimental Counseling included standard counseling, a 2-page educational handout, and a 4-minute educational video; Standard Counseling included standard counseling and the handout. The planned enrollment was 200. The study start was 2016-08-03, and primary completion was 2017-11-15.

The primary outcome was the number of participants who completed at least half of recommended visits within 3 months. Its analysis population was randomized participants with follow-up completion information available. Secondary outcomes included initiation, discharge, days to initiation, and change in urogenital distress from baseline to 3 months. Primary outcome results, analysis details, and missing-data procedures are not reported in the registry record. Serious and other adverse events are listed as 0 in each arm, with 100 at risk in each arm; deaths are listed as 0 in each arm.