MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making (NCT05299983), a randomized na study. The primary outcome is Perceived Quality of Information.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial, with MyMenoPlan and control as the two assigned groups. The record lists enrollment of 410 and shows 200 participants in the MyMenoPlan group and 210 in the control group for the primary outcome. The study is marked completed. The recorded start date is 2022-01-15, and the primary completion date is 2022-03-31.

The intervention was use of an assigned digital resource, rather than a medication or procedure. Participants assigned to MyMenoPlan were asked to spend at least 20 minutes on its website. Control participants were asked to spend at least 20 minutes on at least one of the listed websites or another website of their choice. The outcome timeframe is after spending at least 20 minutes on the assigned website or websites.

The record identifies the work as MsFLASH: Living a Healthy Menopause, Aim 2 Randomized Controlled Trial of MyMenoPlan. The sponsor is the University of California, San Diego. The trial phase is listed as NA. The record does not describe the masking procedures, how adherence to website-use instructions was assessed, or whether participants could access other menopause information during the study. Those details are not reported in the registry record.

The registered primary outcome is perceived quality of information, measured as a mean score on a seven-item scale. The comparison is between randomized groups, but the registry record does not state which analysis population was used, how missing outcome data were handled, or whether the analysis adjusted for baseline characteristics. Those omissions limit how fully the reported group comparison can be reconstructed.

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: Eligibility screening and quality control checks resulted in exclusion of 503. Internet recruited studies requires careful quality control checks for fraudulent participants.

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 Perceived Quality of Information, measured over Each survey question is answered after spending at least 20 minutes on the assigned website(s).

The primary endpoint is perceived quality of information about perimenopause and menopause. It is based on seven questions adapted from the Post-Study System Usability Questionnaire. Each question uses a five-point response scale, from strongly disagree to strongly agree. The item responses were averaged, and the resulting score ranges from 1 to 5. Higher scores indicate higher perceived quality of information.

The questions cover whether the information helped participants feel more in control, was helpful, could be found, answered their questions, and was liked; whether they wanted more in-depth information; and whether the website or websites were comprehensive. The desire for more in-depth information is reverse-coded so that the items contribute in a consistent direction to the average.

This kind of endpoint is used to capture users’ evaluation of the information they encountered. It can describe perceived helpfulness and quality, but it does not itself establish how much factual knowledge participants gained, whether they made more informed decisions, or whether their health changed. Those are distinct outcomes. The registered timeframe places the questionnaire after participants spent at least 20 minutes on their assigned website or websites. Further details about questionnaire administration and scoring beyond the description above are not reported in the registry record.

7. Results Posted in the Registry

• MyMenoPlan: mean 4.10 versus 3.70 on control; difference 0.40 (95% CI 0.27 to 0.53), standardized effect d = 0.60; z-test p = <0.001.

8. Statistical Interpretation

9. Statistical Methods Explained

The endpoint is continuous: each participant’s score is an average of questionnaire item responses, and the reported group summary is a mean. A mean difference compares the average score in one group with the average score in the other. Here the unadjusted recalculation is expressed as MyMenoPlan minus control, so a positive difference corresponds to a higher average perceived-quality score in the MyMenoPlan group. This is a summary of group averages; it does not mean every participant in one group scored higher than every participant in the other.

What does the confidence interval describe?

A confidence interval gives a range of values compatible with the data and the assumptions of the method used to calculate it. For this unadjusted comparison, the interval is approximately 0.272 to 0.528 points for the mean difference. It expresses uncertainty about the estimated group contrast, rather than the range of individual participants’ scores. It also does not capture every possible source of uncertainty, such as limitations in outcome collection or missing data that are not described in the registry record.

What does the p-value tell us?

A p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the analysis. A small p-value is not the probability that the null hypothesis is true, and it is not a measure of the size or practical importance of the difference. The unadjusted recalculation reports p < 0.001. The sponsor’s own analysis reports p < .001. The methods and the precision of those two analyses should be kept distinct: the sponsor’s method is labeled Chi-squared, while the recalculation uses the posted continuous-outcome summaries.

Why consider variability?

The standard deviation describes the spread of individual scores around a group mean. The posted standard deviations are 0.59 for MyMenoPlan and 0.73 for control. Comparing means without considering spread would leave out information about how much participants’ ratings vary. The recalculated interval incorporates the group sizes and variability under its unadjusted method. The standard deviation is not the same as the standard error: the former describes participant-level variation, while the latter describes uncertainty in an estimated quantity.

In some settings, outcomes have more variability than a simple statistical model allows; this is called over-dispersion. As a general statistical point, ignoring over-dispersion can make uncertainty appear smaller than it is. The registry does not report an over-dispersion assessment, and the continuous mean outcome is described with group means and standard deviations. No claim about a separate over-dispersion adjustment can be made from the record.

How should randomization enter the interpretation?

Random assignment is intended to create comparable groups on average, supporting a comparison of outcomes by assigned group. It does not guarantee that the groups are identical in every characteristic, nor does it resolve issues such as missing outcomes or deviations from assigned website use. The record describes randomization and a parallel-group design but does not state the sequence-generation method, allocation concealment process, analysis population, or handling of protocol deviations. These details are not reported in the registry record.

The outcome is measured after at least 20 minutes of website use, rather than as a change from a baseline score. No baseline value for this primary outcome is included in the posted results. The analysis therefore concerns the recorded post-use group scores and their difference, not a before-and-after change. Whether any adjusted or alternative analysis was conducted is not reported in the registry record.

What does the reported sponsor method mean?

The sponsor’s posted analysis is labeled Chi-squared and superiority, with p < .001. The record does not provide an estimate, confidence interval, further test details, or a fuller explanation of how this method was applied to the primary outcome. Those details cannot be inferred. The unadjusted recalculation gives an interpretable difference in average scale points from the posted means and standard deviations, but it does not replace the sponsor’s own analysis.

These methods answer related but not identical reporting needs. The p-value addresses evidence against a null comparison under a test’s assumptions. The mean difference gives the contrast in the original scale’s units, and its confidence interval describes uncertainty around that contrast. Reading the estimate, interval, and p-value together is more informative than treating statistical significance alone as the complete result.

10. Confidence Intervals and Precision

The unadjusted mean difference is 0.4 points, with a confidence interval approximately from 0.272 to 0.528 points. The interval is entirely above zero, indicating that the range of values compatible with this calculation is on the side of a higher average score for MyMenoPlan relative to control. The interval is an estimate of uncertainty around the group mean contrast, not a prediction interval for individual ratings.

The width of an interval depends on the amount of information in the data and the variability of the outcome, as well as the statistical method. The primary-outcome groups contain 200 participants for MyMenoPlan and 210 for control. Their posted standard deviations are 0.59 and 0.73. These figures give context for the calculated precision, but do not remove uncertainty about how completely the outcome data represent all randomized participants.

The registry record does not post a confidence interval for the sponsor’s own analysis. The interval comes from an unadjusted recalculation using the posted group summaries. It should not be read as an adjusted estimate or as evidence that all potential biases have been accounted for. Details about missing outcome data, the analysis population, and the sponsor method’s effect estimate are not reported in the registry record.

Precision is also distinct from importance. The interval describes plausible values for the average score difference under the calculation’s assumptions; it does not establish what size of difference participants would regard as meaningful. A threshold for meaningful change or a justification for the endpoint’s interpretability is 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 sample-size figures are planning illustrations based on the observed effect, not a record of the trial’s original design calculation. All entries are participants per arm, not total participants or total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect.

The column for 80% power gives the illustrative number of participants per arm for a design that would have an 80% chance of detecting the selected effect under the stated assumptions, if that effect and the assumptions were correct. The 90% power column gives the corresponding number per arm for a higher chance of detection. These are planning quantities, not descriptions of what happened in the completed trial.

The rows consider planning for the full observed effect, 75% of the observed effect, and 50% of the observed effect. In general, smaller effects are harder to distinguish from random variation, so they require more participants to achieve the same target power under otherwise similar assumptions. A planning illustration based on an effect estimated from trial results is not observed power; it does not tell whether the completed study was adequately designed before enrollment.

The registry record does not report the trial’s original sample-size justification or its own design assumptions. The illustrations should therefore be read as conditional scenarios, rather than as evidence about the investigators’ original planning or as a recommendation for a future study.

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 = 0.400; pooled standard deviation σ = 0.665.
2. n = 2 × (1.96 + 0.842)² × 0.665² / 0.400² = 43.4, rounded up to 44 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 <- 0.399999999999999                      # observed difference in means
sigma <- 0.665405670160957                     # 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(5299983)
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 = 44 (80% power), 59 (90% power)
 75% of observed effect: n per arm = 78 (80% power), 104 (90% power)
 50% of observed effect: n per arm = 174 (80% power), 233 (90% power)
power.t.test: 44.4 
Simulated power at n = 44 per arm: 0.797 (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. Analyses Reported by the Sponsor

The sponsor’s own analysis is recorded as a Chi-squared superiority analysis, with p < .001 for the two groups. No sponsor-reported effect estimate or confidence interval is included in the registry record. Its result therefore supplies a p-value and test label, but not a numerical difference in scale points or an interval for that difference.

The unadjusted recalculation uses the posted means, standard deviations, and group sizes. It estimates a mean difference of 0.4 points, with a confidence interval approximately from 0.272 to 0.528 and p < 0.001. This calculation makes the group contrast interpretable in the outcome’s original scale units. It is not a substitute for the sponsor’s analysis, and it does not establish what additional procedures the sponsor may have used beyond what the registry record states.

The record does not identify a discrepancy between the sponsor analysis and the recalculation. Still, their reported methods and outputs differ in form, so the recalculated estimate should be understood as a simple, unadjusted summary-statistic analysis. Further details of the sponsor’s test, including how it was applied, are not reported in the registry record.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and four analyses. It identifies perceived quality of information as the primary outcome, but does not explain the status of the other outcomes in relation to that primary endpoint. No secondary outcomes are posted in the results information described in the record. The names, results, and analysis plans for any additional outcomes are not reported in the registry record.

Multiplicity arises when several outcomes, comparisons, or analyses are considered: the more opportunities there are to find a statistically notable result, the more important it becomes to understand whether and how the analysis accounted for that. The registry record does not state whether a multiplicity adjustment was planned or used, nor does it describe a hierarchy among outcomes or any prespecified testing sequence. It is therefore not possible to determine from the record whether the reported p-values were adjusted for multiple testing.

Missing-data handling is also not reported in the registry record. The outcome results include 200 participants in MyMenoPlan and 210 in control, matching the recorded enrollment total, but the record does not describe whether every randomized participant completed the questionnaire, how incomplete item responses were scored, or whether any participants were excluded from the outcome analysis. The posted group counts alone do not establish the analysis population or explain the handling of missing responses.

The record does not state whether analyses followed intention-to-treat principles, whether participants were analyzed according to assigned group, or how non-adherence and other deviations were handled. It also does not report sensitivity analyses for missing data. These omissions do not negate the reported comparison, but they limit assessment of its robustness and the extent to which it represents all randomized participants under their assigned groups.

15. 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 figures record zero affected participants in each group: 0 of 200 in MyMenoPlan and 0 of 210 in control. The registry also records zero deaths in both groups. These figures describe the events captured in the registry record; they do not show that no event of any kind occurred.

The record distinguishes serious adverse events from other adverse events, and shows zero affected participants in both categories for each group. It lists no serious adverse event terms. The figures are counts of participants affected, not a detailed account of event types, timing, severity grading, or whether an event was considered related to website use.

Interpretation depends on how safety information was collected and defined. The methods for surveillance, the duration of safety monitoring, and rules for attributing events are not reported in the registry record. Zero recorded serious events should therefore be read as a registry finding for this study, not as proof that risk is absent or that every possible event was assessed.

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

The posted results show higher average perceived-quality scores after website use among participants assigned to MyMenoPlan than among those assigned to control websites. The group means are 4.1 and 3.7 on the 1-to-5 scale. The unadjusted mean difference is 0.4 points, and its confidence interval is approximately 0.272 to 0.528. The sponsor’s own analysis reports p < .001.

This finding concerns how participants rated the information they encountered, including its helpfulness, accessibility, comprehensiveness, and related qualities. It does not directly measure factual knowledge about menopause, confidence in treatment decisions, actual treatment choices, symptom change, or health outcomes. No conclusion about those outcomes follows from this endpoint alone.

The comparison is specific to the study’s assigned digital resources and its post-use survey timeframe. The control group could use one or more listed websites or websites of their choice, so the comparator was not a single uniform digital resource as described in the registry. Details of actual website use and adherence are not reported in the registry record. The result cannot by itself establish how the groups would compare under other settings, user populations, or patterns of use.

Randomization supports interpreting the comparison by assigned group, but the extent of that interpretation depends on trial conduct and analysis details. The registry does not report the analysis population, missing-data procedures, or multiplicity approach. The recalculated estimate is unadjusted, and the sponsor’s result is reported without an effect estimate or confidence interval. These limits should accompany any reading of the statistical evidence.

In short, the reported data show a difference in average perceived information-quality ratings for this trial’s groups. They do not establish that every user would prefer the same resource, that the rating difference is meaningful to all participants, or that using a particular website leads to better clinical decisions or health.

17. Why This Trial Matters Statistically

This trial illustrates an important distinction in clinical research: a digital resource can be evaluated using a user-reported outcome, but that outcome answers a narrower question than whether the resource changes health or clinical decisions. Perceived quality of information captures participants’ assessment of what they read. It is relevant to usability and acceptability, yet it is not interchangeable with knowledge, informed decision-making, or clinical outcomes.

Reporting the mean difference in the original scale units helps readers understand the size of the observed group contrast. The confidence interval adds information about the precision of that estimate, while the p-value addresses evidence against a null comparison under a statistical model. Considering these together avoids reducing the result to a binary significant-or-not-significant label.

The study also highlights the importance of clearly describing the comparator. Control participants could use at least one listed website or another website of their choice. That flexibility may be useful for a pragmatic comparison of resources, but it means that the control experience is not necessarily identical for every participant. The registry record does not provide details of the websites actually used or the consistency of exposure.

Finally, the gap between a sponsor-reported test result and a complete statistical account matters for interpretation. The record posts a Chi-squared superiority result, while the unadjusted recalculation supplies a mean difference and confidence interval from group summaries. A transparent estimate, interval, analysis population, missing-data plan, and multiplicity approach would enable more complete assessment. The posted findings are informative about the specific rating outcome, while reporting limitations constrain broader conclusions.

18. 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 leaves several trial-specific details unclear. It does not report participant demographic or clinical characteristics, eligibility criteria, recruitment procedures, or how representative the enrolled group was of the intended audience. The result therefore cannot be generalized to populations whose characteristics are not described.

The intervention required at least 20 minutes of website use, but adherence, actual time spent, and the specific content viewed are not reported in the registry record. The control condition allowed use of a listed website or another website of the participant’s choice, creating variation in the comparison experience. The record’s control description is incomplete, and does not identify which alternative websites participants actually accessed.

The primary endpoint is self-reported perceived information quality, measured after website use. The registry does not report a baseline score, follow-up beyond this survey, or measures of factual knowledge, decision quality, treatment behavior, or health outcomes in the results described. The endpoint therefore supports conclusions about participant ratings, not those other domains.

The analysis population, missing-data handling, protocol deviations, multiplicity approach, and any covariate adjustment are not reported in the registry record. The sponsor’s result is given as a Chi-squared test with a p-value but without an estimate or confidence interval. The unadjusted recalculation adds an estimate and interval but cannot fill gaps about the sponsor’s full analysis or trial conduct. These limitations should be considered when interpreting the precision and reach of the reported comparison.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making — NCT05299983.
• Registry record last updated 2025-03-27; status last verified 2025-03.
• Results first posted 2025-03-27.
• 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.

22. Record Summary

NCT05299983 is a completed randomized, double-masked, parallel-group trial of MyMenoPlan compared with control websites. The record lists enrollment of 410 and a primary endpoint of perceived quality of information, assessed after at least 20 minutes of website use. The outcome is a seven-item average score ranging from 1 to 5, with higher scores indicating higher perceived quality.

Posted group means were 4.1 for MyMenoPlan and 3.7 for control. An unadjusted recalculation gives a mean difference of 0.4 points, with a confidence interval approximately from 0.272 to 0.528 and p < 0.001. The sponsor’s own analysis is labeled Chi-squared superiority and reports p < .001, without a posted effect estimate or confidence interval.

The registry does not report important analysis details, including missing-data handling, the analysis population, and multiplicity procedures. The findings describe perceived information quality in this trial; they do not directly establish effects on knowledge, decision-making, or health.