Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities (NCT04651114), a na na study. The primary outcome is Final Decisional Conflict Scale Score - Values Clarity Sub-scale.

2. Clinical Question

The project aimed to develop and pilot test a decision-making tool tailored for women with physical disabilities. Its stated purpose was to support participants considering whether pregnancy was right given their individual situation. The primary endpoint focuses on clarity about the values guiding that decision, rather than on whether a participant chose to pursue a pregnancy.

The record also lists feasibility outcomes for acceptability, demand, and ease of use. These address whether the tool is regarded as acceptable, whether there is interest or demand for it, and how readily it can be used. Their presence indicates that the pilot considered implementation-related questions as well as the primary values-clarity measure. However, the registry does not report numerical results for these outcomes, so the clinical question cannot be answered from the posted record.

The study is described as completed, with enrollment of 38. That enrollment figure alone does not establish how many participants completed the endpoint assessment or contributed data to an analysis; those details are not reported in the registry record.

3. Trial Design

NCT04651114 is a completed pilot study sponsored by the University of Michigan. The registry lists the study start as 2020-12-11 and primary completion as 2021-05-14. It records enrollment of 38 and describes a behavioral intervention called the Decision-making tool. The listed study model is single group, with no masking and no randomized allocation.

Participants were to receive the decision-making tool and use it for a 3 month period. The primary endpoint is a continuous measure: the final Decisional Conflict Scale Score for the Values Clarity sub-scale, assessed at 12 weeks and described as a mean with standard deviation. The registry additionally lists feasibility outcomes for acceptability, demand, and ease of use. It records 7 outcome measures overall.

This design is suited to piloting the tool and collecting information about its use and feasibility. Because there is no concurrent control group, the record cannot support a direct estimate of how outcomes would have differed under another intervention or without the tool. A change from an earlier assessment, if one was collected, would also require reported measurements at the relevant time points and an analysis; those details are not reported in the registry record.

The record does not report the protocol’s sample-size justification, detailed eligibility criteria, recruitment procedures, or whether outcome assessors were involved. Although masking is listed as none, the registry does not describe any further procedures concerning knowledge of treatment assignment. The registry status is completed, but that status does not itself establish the completeness of outcome reporting or analysis.

The registry lists 0 analyses. It does not report a statistical analysis plan, an endpoint estimate, a standard deviation, a confidence interval, or a significance test for the primary outcome. Consequently, the design and endpoint can be described, but the primary statistical result cannot be evaluated from the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

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 Final Decisional Conflict Scale Score - Values Clarity Sub-scale, measured over 12 weeks.

The primary endpoint is the final score on the Values Clarity sub-scale of the Decisional Conflict Scale, assessed at 12 weeks. Decisional conflict is described in the record as uncertainty about a course of action; in this study, the relevant course of action is whether to pursue a future pregnancy. The Values Clarity sub-scale concerns how clearly a respondent identifies the values guiding that decision.

The sub-scale has 3 items. Each is rated on a 5-point Likert scale, from strongly agree [5] to strongly disagree [1], and item ratings are summed. The possible total score ranges from 3 to 15, with higher scores representing greater clarity of values. The registry describes the endpoint as a mean measured in units on a scale, with standard deviation as the dispersion measure.

This endpoint is relevant to the tool’s stated purpose because it assesses clarity about decision-making values. It does not directly measure whether a pregnancy occurred, whether a participant decided to pursue pregnancy, or whether that decision was clinically appropriate. Nor does a score by itself establish that the tool caused a change. Interpretation would depend on the observed score distribution, the assessment process, and the study’s analysis. The numerical endpoint result and its standard deviation are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous and is specified as a mean with standard deviation. These statistics describe different features of a set of scores. A mean gives a measure of the group’s average score, while a standard deviation describes how dispersed individual scores are around that average. Neither statistic is reported for the primary endpoint in the registry record, so there is no numerical summary to interpret.

What does the scale score represent?

The Decisional Conflict Scale concerns uncertainty about a course of action. In this study, the focus is a decision about pursuing a future pregnancy. The Values Clarity sub-scale asks about clarity of the values that guide decision-making. Its 3 items use 5-point Likert ratings, running from strongly agree [5] to strongly disagree [1], and are summed to produce a total from 3 to 15. Higher total scores are defined as indicating greater values clarity. This scoring direction should not be confused with a claim that a particular decision is better or more appropriate: the scale measures the stated construct, not the merits of an individual choice.

For Likert-type items, the response categories are ordered, but the distance between adjacent categories is not necessarily identical in the way that distances on a physical measurement scale might be. The registry specifies a summed sub-scale score and a mean summary. That describes the planned form of reporting; it does not tell the reader how scores were distributed or whether the assumptions of any particular inferential procedure were assessed.

What would uncertainty statistics add?

A standard deviation conveys variation among scores. A confidence interval, if calculated and reported, would convey uncertainty around an estimated quantity, such as the mean. It would not describe the range containing every participant’s score, and it would not alone determine whether a result is meaningful for participants. The registry does not report a confidence interval, standard error, or other uncertainty estimate for the primary outcome. No p-value or inferential test is reported either.

In general, statistical interpretation should consider both the estimate and its uncertainty. An estimate may be relatively precise or imprecise depending on the amount and variability of the information analyzed. The enrollment figure cannot substitute for an analyzed sample size: the record does not say how many participants contributed a 12-week score. It also does not report the number of missing scores, the reasons for missingness, or whether the analysis included all enrolled participants.

Why does the design matter for inference?

A single-group study describes outcomes in the group receiving the intervention. Without a concurrent control group, there is no direct estimate of the outcome that would have occurred under a different condition over the same period. General changes over time, outside influences, and other explanations cannot be ruled out by a post-intervention score alone. This is why a single-group endpoint mean should not be interpreted as a controlled treatment effect.

The registry records no randomized allocation and no masking. These design features do not automatically determine the direction of a result, but they matter to how comparisons and measurement processes are interpreted. Since no control group is listed, the record does not support a between-group comparison regardless of the endpoint’s eventual numerical value.

How should planning calculations be read?

The stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe planning illustrations based on a fraction of an observed effect; they are not the study’s recorded allocation or its actual single-group design. In general, sample-size planning asks how much information might be needed to detect a prespecified effect under stated assumptions. A planning result is not evidence that an effect was observed, and it is not observed power.

Because the registry does not report an endpoint estimate or its variability, it does not provide the empirical quantities needed to assess the observed effect for the primary endpoint. The planning assumptions should therefore not be used to infer the study’s result. The registry does not report the protocol’s own sample-size justification or a detailed statistical analysis plan.

What does over-dispersion mean in general?

Over-dispersion is a concern when the observed variability in data exceeds what a statistical model assumes. If a model understates variability, its uncertainty estimates can be too small and inferential conclusions can appear more certain than warranted. This concept is general; the primary endpoint is described as a continuous scale score, and the registry does not report a model-based analysis or any assessment of over-dispersion. It would not be appropriate to assert that over-dispersion occurred in this study.

Finally, the registry lists 0 analyses. That means the record does not contain a reported statistical analysis for the outcomes in the submitted entry. It does not establish why analyses are absent, whether analyses were conducted outside the registry, or what the results would be. Such details are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Decision-making Tool")
n   <- c(30)
m   <- c(13.1)
sp  <- c(2.3)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Decision-making Tool  30  13.100  2.300  12.241  13.959

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures, including the primary Values Clarity sub-scale endpoint and feasibility outcomes for acceptability, demand, and ease of use. When a study assesses multiple outcomes, multiplicity can arise if several statistical tests are used to support conclusions. In general, the more tests considered, the more important it is to understand which outcomes were prespecified and how inferences across tests were handled. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a detailed statistical analysis plan. It also does not report the results of analyses for these outcomes.

Missing-data interpretation requires knowing which participants were expected to provide each measure, how much information was missing, why it was missing, and how the analysis handled it. The enrollment is 38, but the registry does not report the analyzed sample size for the primary outcome, the number with missing 12-week scores, or a method for handling missing data. Enrollment should not be treated as proof that every participant contributed an endpoint value.

The record does not specify an analysis population, such as whether the primary analysis included all enrolled participants or only those with an observed endpoint. It does not report exclusions, protocol deviations, or sensitivity analyses. These details are not reported in the registry record, so the possibility of bias related to incomplete observations cannot be assessed.

Although the study is marked completed, that status does not resolve these reporting gaps. The registry lists 0 analyses. Without an analysis population, missing-data description, and reported results, readers cannot determine how the outcome data were summarized or whether conclusions might depend on assumptions about missing observations.

12. 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 lists the Decision-making Tool group with 38 participants at risk for the serious adverse-event count and 0 affected. It also records 38 at risk for the other adverse-event count and 0 affected, with 0 deaths. No serious adverse-event terms are listed.

These are the adverse-event figures recorded in the registry entry. They should be read as counts reported for the listed group, not as proof that no adverse experiences occurred outside the categories or reporting procedures represented in the entry. The record does not provide event descriptions, follow-up detail for safety reporting, or an explanation of how adverse events were collected. It also does not report a control group, so there is no comparative safety estimate.

A zero count in a registry does not by itself establish the absence of risk. The enrollment and at-risk figures describe the record’s safety denominator, but the registry does not explain whether all participants had the same duration of safety observation. These figures therefore support only a description of what was recorded, not a broader claim about safety or the intervention’s effects.

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

The record documents a pilot test of a decision-making tool intended for women with physical disabilities who are considering whether a future pregnancy is right for their circumstances. It identifies a relevant primary construct: clarity of values in decision-making. It also lists feasibility outcomes that concern acceptability, demand, and ease of use. This establishes what the study set out to examine, but the registry does not report numerical results for those outcomes.

The primary score is defined as a summed scale, with higher scores indicating greater values clarity. However, its final mean and standard deviation are not reported in the registry record. It is not possible to say whether values clarity was high or low in the assessed group, how variable participants’ scores were, or how precisely the mean was estimated.

The design is single group. Even if a post-use score were available, a result from this design alone would describe the observed group and would not isolate the tool’s effect from other possible explanations. The registry record does not provide a concurrent comparator or a reported analysis of change over time.

The endpoint does not establish which participants chose to pursue pregnancy, whether they changed their plans, or whether their choices were appropriate. It measures the stated construct of values clarity. A score is not a judgment about an individual’s decision, and the record does not report pregnancy outcomes.

The completed status and enrollment of 38 are useful descriptions of the study record, but they do not replace endpoint results, uncertainty estimates, or information about missing observations. The registry also does not report an analysis population or statistical plan. Thus, the record supports a description of the pilot’s aim and design, but not a conclusion that the tool did or did not improve decision-making or feasibility.

14. Why This Trial Matters Statistically

This trial matters statistically because it focuses on a construct that is narrower than a broad clinical outcome. Values clarity concerns how clearly a person identifies the values guiding a decision. Defining the endpoint this way makes the measurement question explicit, while also setting limits on what the score can represent. It is not a direct measure of pregnancy intention, pregnancy occurrence, or the quality of a decision.

The study also illustrates the distinction between piloting an intervention and estimating a comparative effect. A single-group pilot can be used to examine a tool and collect feasibility information, but the absence of a concurrent control means it cannot directly show how outcomes would compare under an alternative. Statistical interpretation must remain aligned with that design rather than treating a post-use measure as a controlled effect.

Feasibility outcomes are important to the stated project because a tool’s potential use depends on more than a scale score. Acceptability, demand, and ease of use address different practical questions. Yet the registry lists these outcomes without their numerical results, so the record does not establish how participants evaluated or used the tool.

The entry also illustrates why complete reporting matters. An endpoint definition, enrollment figure, and completed status are not enough to assess an estimate. Readers also need the observed outcome, its variability or uncertainty, the analysis population, and information about missing data. Those elements are not reported in the registry record. The result is that the statistical question is identifiable, but its answer cannot be evaluated from this entry.

Finally, the planning assumptions described for sample-size illustrations differ from the recorded single-group design. Keeping hypothetical planning calculations separate from the actual study design prevents readers from interpreting planning outputs as observed evidence or as proof that the study was adequately powered.

15. 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 central limitation for interpreting this trial is that the registry record does not report the primary endpoint result. The final mean and standard deviation for the Values Clarity sub-scale are absent, and the entry lists 0 analyses. Without an estimate and its uncertainty, readers cannot assess the observed score or its precision.

The study is described as single group, with no randomized allocation and no concurrent comparator. This limits causal interpretation: the record cannot show how outcomes would have differed under another condition. No analyzed change from baseline is reported, and the registry does not state whether a baseline assessment was conducted.

The record gives enrollment of 38 but does not report endpoint completion, the analysis population, or the amount and handling of missing data. It does not describe exclusions or sensitivity analyses. These omissions prevent assessment of whether the reported group, if analyzed elsewhere, represents all enrolled participants or whether missing observations could influence the result.

Although the registry lists 7 outcome measures and names three feasibility outcomes, numerical results for them are not reported. The registry does not describe multiplicity procedures or a detailed statistical analysis plan. It also does not report its own sample-size justification, so the planning assumptions listed for illustrations should not be mistaken for the trial’s original design rationale.

Further limitations include the lack of detailed eligibility and recruitment information in this entry and the absence of descriptions of safety-event collection and follow-up. These are limits of what is reported in the registry record; they do not establish that such procedures or information do not exist elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities — NCT04651114.
• Registry record last updated 2022-07-14; status last verified 2022-06.
• Results first posted 2022-07-14.
• 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.

19. Record Summary

NCT04651114 is a completed, single-group pilot sponsored by the University of Michigan. The study is titled “Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities.” The registry lists enrollment of 38, a behavioral decision-making tool used for a 3 month period, and a primary Values Clarity sub-scale endpoint at 12 weeks.

The endpoint is a summed Decisional Conflict Scale sub-scale score, with higher scores representing greater clarity of values. Feasibility outcomes include acceptability, demand, and ease of use. The registry lists 7 outcome measures and 0 analyses.

The entry does not report the primary outcome estimate, its standard deviation, an inferential analysis, or details about missing data and analysis populations. It records 0 serious adverse events, 0 other adverse events, and 0 deaths in the listed intervention group. The registry record describes the study’s purpose and design, but does not provide results sufficient to evaluate the primary endpoint or estimate a comparative effect.