Virtual Visits for Postoperative Care Following Urogynecologic Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Virtual Visits for Postoperative Care Following Urogynecologic Surgery (NCT05641077), a randomized na study. The primary outcome is Patient Satisfaction.

2. Clinical Question

The posted outcome means were 75.18 for virtual visits and 75.14 for office visits. The comparison estimate was a mean difference of -0.04, with a confidence interval from -3.344 to 3.264. These figures describe the observed scores and the uncertainty around the comparison; they do not by themselves establish that the trial met a prespecified non-inferiority criterion. The registry record identifies the study as completed and reports enrollment of 100 participants. It does not post secondary outcome results, despite describing safety, healthcare resource use, and patient and provider preferences as additional areas of interest.

3. Trial Design

The VIDEO trial is registered as a randomized, parallel-group study with no masking. The registry identifies The Cleveland Clinic as the sponsor and gives the status as completed. Enrollment is 100. The recorded start date is 2023-01-20, and the primary completion date is 2024-01-31. The registry lists the phase as not applicable.

Participants were assigned to one of two postoperative follow-up formats. In the Virtual Visit arm, the follow-up was planned as a videoconference with a surgeon or advanced practice provider at six weeks after the anticipated surgery date. In the Office Visit arm, follow-up was planned as an in-office visit with a surgeon or advanced practice provider at six weeks after the planned surgery date. The registry describes the visits in relation to surgery and notes that a rescheduled surgery would affect the timing of the postoperative visit. Further operational details about scheduling and conduct are not reported in the registry record.

The primary outcome is continuous: a mean PSQ-18 score at six weeks. The registry describes one outcome measure and posts results for 50 participants in each arm. The two group summaries are means with standard deviations. The trial’s randomization method, concealment procedures, detailed eligibility criteria, and original sample-size justification are not reported in the registry record. The posted results include a comparison estimate and confidence interval, but the registry lists zero analysis records. It is therefore important to distinguish the posted group summaries and comparison from a detailed account of the trial’s full analysis plan.

The registry summary also describes intended evaluation of postoperative healthcare use and adverse events, with healthcare resource use considered within six and twelve weeks and adverse events within twelve weeks. It mentions preferences and attitudes among patients and providers. However, no secondary results are posted in the registry record, so those aims cannot be assessed from the recorded outcome data.

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

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 Satisfaction, measured over 6 weeks.

The primary endpoint is patient satisfaction measured at the six-week postoperative visit with the Patient Satisfaction Questionnaire-18, or PSQ-18. The registry describes this as a validated 18-item questionnaire. Each response uses a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 18, described as dissatisfaction with medical care, to 90, described as the highest satisfaction with medical care. The outcome is summarized as a mean and standard deviation in each arm.

Satisfaction is relevant to the trial’s central comparison because the intervention changes how the postoperative visit is delivered. The questionnaire provides a standardized way to represent patients’ reported experience as a numeric score, allowing the average scores in the two randomized groups to be compared. It measures satisfaction rather than a clinical event, healthcare utilization, or the safety of the surgery itself. The registry summary describes safety and healthcare use as additional areas of interest, but results for secondary outcomes are not posted in the registry record.

The registry states that the investigators hypothesized virtual-visit satisfaction would be non-inferior to office-visit satisfaction. A non-inferiority conclusion ordinarily depends on a prespecified margin defining how much lower an outcome could be while still meeting that criterion. The margin, and a formal registry-posted non-inferiority analysis, are not reported in the registry record. The observed means and confidence interval can therefore be described, but the recorded information does not permit verification of a prespecified non-inferiority decision.

7. Results Posted in the Registry

• Office Visit: mean 75.14 versus 75.18 on control; difference -0.04 (95% CI -3.34 to 3.26), standardized effect d = -0.00; z-test p = 0.981.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous score, so the registry reports an average for each arm and a mean difference between arms. The Virtual Visit mean was 75.18, with a standard deviation of 8.15. The Office Visit mean was 75.14, with a standard deviation of 8.7. The comparison is defined as Office Visit relative to Virtual Visit, giving an estimated difference of -0.04. The sign indicates the direction of that subtraction; the magnitude is close to zero on the PSQ-18 score scale.

What does a mean difference represent?

In general, a mean difference compares the average outcome in one group with the average in another. It retains the original scale of the measure, which makes it possible to relate the estimate to the PSQ-18 score range. A mean difference is not a comparison of every individual participant: individual scores can vary around each group average. The standard deviations describe that variation within the arms, while the confidence interval around the difference describes uncertainty about the group contrast.

The reported pooled standard deviation is 8.429, and the standardized effect estimate is -0.005. In general, a standardized effect expresses a group difference in units of a standard deviation rather than PSQ-18 score points. It can help put effects from differently scaled measures on a common kind of scale, but it does not replace the original-score estimate when interpreting this outcome. The registry does not report an adjusted model for the primary outcome, and the analysis records count is zero.

How should the p-value be understood?

The unadjusted p-value is 0.981. In general, a p-value is calculated under a specified null hypothesis and statistical model. It describes how unusual data at least as discrepant as those observed would be if that null hypothesis and model were correct. It is not the probability that the null hypothesis is true, and it does not quantify the probability that one visit format is better or worse. It also does not show whether a difference is clinically meaningful. The estimate and confidence interval are needed to understand the range of differences compatible with the data.

“Unadjusted” indicates that the listed p-value is not adjusted for multiple comparisons. The registry posts one primary outcome and no secondary outcome results, but a complete multiplicity plan is not reported in the registry record. The intended comparisons and any adjustment strategy for analyses beyond the primary endpoint are therefore not known from the record.

What does a confidence interval add?

In general, a confidence interval gives a range of values that are reasonably compatible with the observed data under the method used. The interval for the mean difference runs from -3.344 to 3.264. It includes zero, which corresponds to no difference in group means, and also includes values in either direction. The interval’s interpretation depends on the analysis assumptions and the way the estimate was calculated. It is not a range that contains a fixed proportion of individual participants’ scores.

The registry reports standard deviations for the two arms and a pooled standard deviation for the comparison. Standard deviations describe participant-level spread; they are not the same as standard errors or confidence limits. The listed standard errors are 1.153 for the Virtual Visit mean and 1.23 for the Office Visit mean. In general, a standard error describes the sampling variability of an estimated quantity, while a standard deviation describes variability among observations. Neither should be interpreted as an additional treatment effect.

Why does the non-inferiority framework need special care?

In general, a non-inferiority test asks whether a new approach is not worse than a comparator by more than a prespecified margin. The margin gives meaning to the acceptable difference; a point estimate near zero is not enough on its own. The registry states a non-inferiority hypothesis, but the margin, the formal testing procedure, and the analysis populations used for that test are not reported in the registry record. The posted mean difference and interval can be examined descriptively, but they cannot confirm whether a defined non-inferiority criterion was met.

Randomization is intended, in general, to make comparison groups similar on average with respect to factors that could affect outcomes. The registry identifies the study as randomized and parallel, but does not report the randomization sequence method or concealment details. No masking was used. Satisfaction is a self-reported outcome, and participants know whether their visit was virtual or in-office; the registry does not report further procedures intended to address that awareness.

These methods explain how the posted statistics are commonly interpreted. They do not fill gaps in the registry record: the original sample-size justification, missing-data procedures, analysis-population definitions, covariate-adjustment plan, and detailed non-inferiority analysis are not reported there.

10. Confidence Intervals and Precision

The estimated mean difference was -0.04, with a confidence interval from -3.344 to 3.264. The interval includes zero and spans values below and above zero. Thus, the result is not an exact estimate of the difference; the interval conveys uncertainty around the observed contrast. In general, a confidence interval is most informative when read together with the scale of the outcome and a threshold that defines a meaningful or acceptable difference.

The PSQ-18 total score ranges from 18 to 90. The confidence limits are expressed in score points, so they describe uncertainty in the average difference on that scale. They do not describe the range of individual scores, and they do not mean that every possible value inside the interval is equally likely. The standard deviations, 8.15 for Virtual Visit and 8.7 for Office Visit, describe spread among the scores in each arm; they answer a different question from the confidence interval for the mean difference.

The registry describes a non-inferiority hypothesis but does not report the margin needed to judge the interval against a prespecified acceptable loss. Consequently, the interval cannot be used to verify that a non-inferiority boundary was excluded. It also should not be read as proof that the visit formats are identical. The point estimate is close to zero, but precision is about the range of differences compatible with the data, not just how close the point estimate is to zero.

The comparison is based on the posted summaries and the registry does not give detailed information about missing outcomes, adjustments, or analysis populations. Such information can affect how an interval should be interpreted. The reported interval is the available measure of precision for the mean difference, while the broader methodological details needed to assess the analysis are not reported in the registry record.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total event counts. They are an illustration based on the observed effect, not the trial’s original design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column means the illustrative number of participants per arm under those assumptions for a design intended to have an 80% chance of detecting the selected effect, if that effect and the assumptions were correct. The 90% power column uses the same interpretation with a 90% chance. These are planning concepts, not guarantees about what a future study will find. This is not observed power.

The planning rows consider 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The corresponding participants-per-arm figures are 697,140 and 933,273 for 100% of the observed effect; 1,239,360 and 1,659,152 for 75%; and 2,788,560 and 3,733,091 for 50%, for the 80% and 90% power columns respectively. Because the observed mean difference is very close to zero, the calculation based on that estimate implies extremely large illustrative sample sizes. Smaller effects require more participants to detect under a fixed set of assumptions. These figures should not be mistaken for actual enrollment targets or evidence about the trial’s design intent.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.040; pooled standard deviation σ = 8.429.
2. n = 2 × (1.96 + 0.842)² × 8.429² / -0.040² = 697,140.0, rounded up to 697,140 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.0400000000000063                      # observed difference in means
sigma <- 8.42948693575119                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5641077)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 697,140 (80% power), 933,273 (90% power)
 75% of observed effect: n per arm = 1,239,360 (80% power), 1,659,152 (90% power)
 50% of observed effect: n per arm = 2,788,560 (80% power), 3,733,091 (90% power)
power.t.test: 697140.9 
Simulated power at n = 697,140 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The primary outcome is patient satisfaction at six weeks, measured by the PSQ-18. The registry lists one outcome measure and no posted secondary outcome results. Its summary describes additional interests, including healthcare resource utilization, adverse events, and patient and provider preferences, but those aims do not appear as posted secondary results in the registry record. A complete plan for how multiple outcomes, time points, or comparisons would be handled is not reported in the registry record.

Multiplicity matters in general when several statistical tests are performed: the chance of at least one apparently notable result can increase as the number of tests grows. Adjustments or a prespecified hierarchy can address this concern, but the registry does not describe such procedures. The listed p-value is unadjusted. There is no basis in the posted information to infer whether an adjustment was planned elsewhere or how unposted outcomes would have been analyzed.

Missing-data methods are also not reported in the registry record. The primary outcome results include 50 participants in each arm, but the record does not state whether every randomized participant completed the questionnaire, how incomplete questionnaires were scored, or how missing responses were handled. The reported arm counts should therefore not be treated as a full description of outcome availability or participant flow.

The analysis population is not defined in the registry record. It is not stated whether the comparison uses all randomized participants, participants who received their assigned visit, or another population. This matters particularly for a non-inferiority question, for which different analysis populations can provide different perspectives on the comparison. The registry also does not give a detailed model specification, adjustment plan, or protocol for deviations from the planned visit format. These omissions limit assessment of the inferential framework beyond the posted summaries and comparison statistics.

14. 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 serious adverse-event counts are zero in the Virtual Visit arm and zero in the Office Visit arm. Each arm lists 50 participants at risk. Other adverse-event counts are also zero in both arms, with 50 participants at risk in each, and the recorded death count is zero in both arms. These figures are counts reported in the registry, not estimates that the true chance of an event is zero.

In general, an observed zero count means no events of that recorded category were reported among the participants counted as at risk. It does not rule out events that were not captured or reported, and the counts alone do not establish that two groups have identical safety profiles. Interpretation depends on event definitions, follow-up completeness, and how events were collected. Those details are not reported in the registry record.

The study summary describes safety and healthcare resource use as secondary areas of interest, including monitoring after surgery. However, no secondary results are posted in the registry record. The adverse-event counts should therefore be read narrowly as the posted figures; they do not provide results for the separately described measures of phone calls, unscheduled visits, emergency or urgent care visits, or readmissions.

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

The primary outcome results show closely similar observed average PSQ-18 scores: 75.18 in the Virtual Visit arm and 75.14 in the Office Visit arm. The estimated mean difference was -0.04, and its confidence interval ranged from -3.344 to 3.264. The unadjusted p-value was 0.981. Together, these statistics describe little separation between the observed averages, alongside uncertainty about the underlying difference.

They do not establish that the two visit formats are identical. They also do not, by themselves, establish non-inferiority. The registry describes a non-inferiority hypothesis, but a margin and a formal test against that margin are not reported in the registry record. Without those details, the result cannot be judged against a stated threshold for acceptable difference. A non-significant result is not proof of equality, and a point estimate near zero does not settle the question of precision.

The outcome concerns patient satisfaction, not every aspect of postoperative care. The registry summary also describes safety, healthcare use, and patient and provider preferences, but no secondary results are posted. The recorded zero adverse-event counts are limited to the categories and participants reported and should not be interpreted as proof of no risk. The data also do not answer whether virtual and office visits differ in resource use or clinical outcomes.

Finally, the registry provides limited detail about missing data, analysis populations, and the statistical plan. The trial is recorded as randomized and completed, but those design labels do not substitute for details needed to assess how the reported comparison was conducted. The posted results are useful for describing the observed satisfaction scores and their uncertainty, while the limits of the registry record constrain stronger inferential claims.

16. Why This Trial Matters Statistically

This trial makes a delivery-format question amenable to a direct randomized comparison. Both arms involve postoperative follow-up with a surgeon or advanced practice provider, while the visit format differs: videoconference versus an office appointment. That structure focuses the primary comparison on patient satisfaction with how the follow-up is delivered. Reporting a continuous score in each arm and a mean difference gives readers an estimate on the questionnaire’s own scale, rather than only a statement about statistical significance.

The example also illustrates why a non-inferiority question requires more than observing similar sample means. A prespecified margin defines what difference would be acceptable for the purpose of that question. The registry describes a non-inferiority hypothesis, but does not report the margin or a corresponding formal test. Statistical interpretation must remain tied to what can be evaluated from the posted estimate and interval, not what might have been specified elsewhere.

Precision is particularly important when an observed difference is very small. The confidence interval shows a range of values compatible with the posted comparison, and its meaning depends on the outcome scale and decision threshold. A high p-value alone cannot demonstrate that a difference is absent. The posted interval and the missing non-inferiority details together show why a result can look close to zero yet still require cautious interpretation.

The registry also distinguishes intended broader evaluation from results actually posted. It describes safety, healthcare resource use, and preferences as secondary interests, but does not include secondary results. This is a useful reminder that a trial’s clinical question can be broader than the outcomes available for statistical review. Transparent outcome and analysis reporting is necessary to understand both the scope and limits of the evidence.

17. 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 registry record does not report the non-inferiority margin, so the primary comparison cannot be assessed against a defined threshold for acceptable loss in satisfaction. It also lists zero analysis records and does not provide a detailed statistical analysis plan. The randomization sequence method, allocation concealment, original sample-size justification, and analysis population are not reported in the registry record.

Although the registry reports 50 participants in each arm for the primary outcome, it does not describe participant flow, questionnaire completion, missing responses, or the handling of missing data. The number of outcome summaries therefore does not establish how complete the data were or how the analyzed population was defined. The registry also does not state whether the reported comparison was adjusted for other variables.

The study is listed as having no masking, and satisfaction is a self-reported outcome. Participants know whether they received a videoconference or in-office visit; the registry record does not describe additional methods to address the possible influence of that awareness on questionnaire responses. Generalizability also cannot be assessed fully because detailed eligibility criteria and participant characteristics are not reported in the registry record.

The registry summary describes secondary questions about safety, healthcare resource use, and preferences, but no secondary outcome results are posted. The adverse-event counts are reported as zero in both arms, but event definitions and collection procedures are not described. These reporting limits mean the posted record supports a focused description of the primary satisfaction scores and reported adverse-event counts, not a complete appraisal of all intended outcomes.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Virtual Visits for Postoperative Care Following Urogynecologic Surgery — NCT05641077.
• Registry record last updated 2024-09-26; status last verified 2024-06.
• Results first posted 2024-09-26.
• 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.

21. Record Summary

NCT05641077 is a completed randomized, parallel-group trial sponsored by The Cleveland Clinic, with no masking and enrollment of 100. It compared virtual and office postoperative visits following urogynecologic surgery. The primary outcome was PSQ-18 satisfaction score at six weeks.

The recorded mean scores were 75.18 for Virtual Visit and 75.14 for Office Visit. The mean difference was -0.04, with a confidence interval from -3.344 to 3.264 and an unadjusted p-value of 0.981. Serious adverse events, other adverse events, and deaths were recorded as zero in both arms. Secondary results, the non-inferiority margin, missing-data procedures, analysis populations, and detailed statistical plan are not reported in the registry record.