Pharmacist Provision of Medication Abortion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pharmacist Provision of Medication Abortion (NCT04956731), a na na study. The primary outcome is Completion of Medication Abortion.

2. Clinical Question

3. Trial Design

NCT04956731, titled Pharmacist Provision of Medication Abortion, is a completed pilot study sponsored by the University of California, San Diego. The registry record lists the condition as abortion in the first trimester and the intervention as pharmacist provision of medication abortion. It describes a single group of participants receiving start-to-finish care from a pharmacist, with a previously created toolkit. The brief summary describes two pharmacists providing care to 10 patients.

The record lists the study start as 2022-01-12 and primary completion as 2022-08-05. Phase and allocation are listed as NA, and masking is listed as none. These entries do not describe a randomized, masked comparison. There is no concurrent control group in the design, so the study is not set up to estimate a between-group treatment effect.

The pilot also planned in-depth semi-structured interviews with participating patients and pharmacists after the pilot, to understand their experiences and obtain feedback on refining the toolkit for possible future scale-up. The record lists patient satisfaction, pharmacist experience, and toolkit changes as secondary outcomes. It does not report the interview findings or whether the planned interviews were completed.

The registry lists four outcome measures and no analyses. The primary outcome is completion of medication abortion, assessed by negative pregnancy test at 6 weeks. The outcome result itself is not reported in the registry record. Thus, the design and goals can be described, but the registry information does not support a numerical estimate of the primary endpoint.

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 Completion of Medication Abortion, measured over 6 weeks.

The primary endpoint is completion of medication abortion, defined as a negative pregnancy test at 6 weeks. The unit is participants, and the registry describes the measure as a count of participants. In general, a binary endpoint classifies each participant according to whether a specified event or condition is present. Here, the specified condition is a negative pregnancy test at the stated follow-up time.

A defined endpoint makes the intended outcome explicit: the result is not simply an account of care being provided, but an assessment tied to a particular measure and time frame. A test-based endpoint can be reported as a count of participants meeting the definition. Interpretation depends on the recorded result, the number assessed, and how missing assessments are handled. The registry record does not report the primary endpoint result, the number assessed at 6 weeks, or how missing test results were handled.

The endpoint is a measure of the outcome at 6 weeks; it does not, by itself, describe the care experience or explain why a participant did or did not meet the definition. Patient satisfaction, pharmacist experience, and toolkit changes are listed separately as secondary outcomes. Their results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study with a binary primary outcome. In general, a binary outcome records whether each participant meets a prespecified condition. The condition in this study is a negative pregnancy test at 6 weeks. A count of participants meeting that definition can be useful for describing the observed result, but interpretation also depends on the number with an evaluable test and the handling of participants without a recorded test.

What does a single-group design estimate?

In general, a single-group study can describe outcomes observed among participants receiving the study intervention. Without a concurrent comparison group, it cannot directly estimate a contrast between that group and another group under the same study conditions. Differences from outcomes in another setting or study may reflect differences in participants, procedures, follow-up, or measurement, rather than the intervention alone. This pilot is listed as single-group; allocation is NA and masking is none.

A pilot may also be intended to learn about procedures, experiences, or implementation. The registry summary states that patient and pharmacist interviews were planned to understand experiences and obtain feedback on toolkit refinement. Those qualitative aims are distinct from estimating a comparative treatment effect. The record does not report the interview results, so no interpretation of those experiences can be made from the posted information.

What does the endpoint definition contribute?

A prespecified endpoint definition helps make clear which observation counts as meeting the outcome. Here, the definition links completion to a negative pregnancy test at a specified follow-up. In general, changing an endpoint definition or follow-up time can change what the result represents. The definition should therefore be considered together with the timing and completeness of outcome assessment. The registry record supplies the definition and timeframe, but not the observed primary outcome result or follow-up completeness.

For a binary outcome, an analysis often reports the number meeting the criterion and the number assessed. A proportion may also be reported, with uncertainty quantified by an interval. These are general statistical approaches, not reported analyses for this study. The registry record lists no analyses, and it does not report a primary outcome estimate or confidence interval. No such result should be inferred from the trial enrollment or status.

How should precision be understood?

In general, a confidence interval describes a range of estimates compatible with the data and the assumptions of the method. Wider intervals indicate less precision, while narrower intervals indicate more precision. The interval is not a guarantee about the true value, and its interpretation depends on the analysis and design. Since no primary estimate or interval is reported in the registry record, its precision cannot be assessed.

Small pilot studies can yield imprecise estimates, particularly when the outcome is a count or proportion. This is a general consideration, not a computed finding about the primary endpoint in this record. The reported enrollment is 10, but the primary outcome result and number assessed are not reported, so an outcome estimate or its uncertainty cannot be reconstructed from the information recorded.

How should planning illustrations be read?

The record’s sample-size assumptions describe a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. The assumptions also distinguish total events for time-to-event calculations from participants per arm for other calculations. These are planning assumptions, not evidence that this single-group pilot used a two-arm design.

Any sample-size figures associated with such assumptions are planning illustrations, not the number enrolled in this pilot and not observed power. They do not show that the study had a particular probability of detecting an effect. The registry record does not report the observed primary effect needed to interpret the illustration, nor does it report a trial-specific sample-size justification. The assumptions should not be mistaken for the protocol’s design or analysis plan.

Over-dispersion is a general issue when variability exceeds what a simple model assumes. It can make standard errors too small if a model fails to account for the extra variability. The registry record does not describe an over-dispersion model, and a count-based endpoint alone does not establish that such a model was needed. In this study, the primary outcome is described as a count of participants with a binary event, not as a repeated count process.

Finally, the record’s listing of four outcome measures and no analyses tells readers what is and is not documented in the registry. It does not provide enough detail to identify a statistical model, estimation method, interval method, or adjustment strategy. Those methods are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Pharmacist Provision of Medication Abortion")
n      <- c(10)
events <- c(9)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Pharmacist Provision of Medication Abortion  10  9  90.0  55.5  99.7  59.6  98.2  58.7  97.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary outcome and secondary outcomes concerning patient satisfaction, pharmacist experience, and toolkit changes. When a study evaluates several outcomes, multiplicity can matter: in general, assessing many outcomes can increase the chance that at least one appears notable by chance if each is tested separately. A prespecified testing hierarchy or adjustment can address some multiplicity concerns, but the appropriate approach depends on the study’s aims and analysis plan.

The registry record lists no analyses and does not report a multiplicity strategy, testing hierarchy, or adjustment. It is therefore not possible to tell whether formal statistical tests were planned or how any multiple outcome assessments were intended to be interpreted. The record does not report results for the secondary outcomes, either.

Missing-data handling is also not reported in the registry record. For the primary endpoint, this leaves unanswered how participants without a recorded negative pregnancy test at 6 weeks would be treated in an analysis, whether such tests were missing, and how many participants had an evaluable result. These details matter because a result based only on observed assessments may not describe the full enrolled group if follow-up is incomplete.

The record does not report analysis populations, such as a defined group of participants included in a primary analysis, or whether any participants were excluded from analyses. No assumptions about missing outcomes, exclusions, or analysis populations can be made from the design description alone. These omissions limit assessment of how a reported estimate would have been produced; in this case, the primary outcome estimate itself is also not reported in the registry record.

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 safety entries list 10 participants at risk for serious adverse events, with 0 affected; 10 at risk for other adverse events, with 0 affected; and 0 deaths. These figures describe the counts recorded in the registry for the pharmacist provision group. The registry lists no serious adverse event terms.

In general, an adverse-event count is interpreted in relation to who was monitored, what events were collected, and over what observation period. A count of 0 affected in the posted record means no events are recorded in that category; it does not establish that the underlying risk is absent. The record does not provide event definitions, detailed ascertainment procedures, or a safety observation timeframe beyond the entries shown. It also does not describe whether any unrecorded or unreported events occurred.

The safety counts should be kept separate from the primary endpoint. Serious adverse events, other adverse events, deaths, and a negative pregnancy test at 6 weeks are different measures. The safety entries do not answer how many participants met the primary endpoint, which is not reported in the registry record. Nor do the counts form a comparison with another care group, because the study is single-group.

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

The record documents a completed pilot of pharmacist-provided medication abortion, a single-group design, an enrollment of 10, and a primary endpoint defined as a negative pregnancy test at 6 weeks. It also records safety counts for the intervention group. These registry entries describe the study’s scope and what was entered into the registry.

The record does not report the primary outcome result. It therefore does not establish how many participants met the endpoint, the proportion meeting it, or the precision of such an estimate. The study status of completed indicates its recorded status, not that a particular outcome was achieved or that outcome data are available in the registry.

Because there is no control group, the record does not provide a like-for-like comparison with another provider, care setting, or intervention. It cannot establish from this design alone whether any observed outcome was caused by pharmacist provision or by use of the toolkit. This limitation applies even if descriptive outcomes are later available; a single-group outcome is not a comparative treatment effect.

The stated pilot aims included learning about patient and pharmacist experiences and identifying toolkit refinements. The record lists related secondary outcomes but does not report their findings. Thus, it does not establish participant satisfaction, pharmacists’ views, or which toolkit changes were made. Those questions remain unanswered by the posted registry information.

The safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths among the participants listed at risk. These counts are limited to what the registry records and should not be treated as proof that risk is absent. They also do not replace a full account of event definitions, observation, or outcome ascertainment, which is not reported in the registry record.

In short, the record supports a description of a small pilot and its intended outcome measures, but not a conclusion about the frequency of primary endpoint completion, the comparative effect of the care model, or the results of the planned experience-focused work.

14. Why This Trial Matters Statistically

This trial is statistically notable as a pilot of a care model in which pharmacists provided start-to-finish medication abortion using a previously created toolkit. Its single-group design and focus on participants’ and pharmacists’ experiences make the distinction between descriptive, implementation-oriented questions and comparative treatment-effect questions important. The registry identifies several outcomes, but the primary and secondary results are not reported.

The endpoint is clearly tied to a measurement and follow-up time: a negative pregnancy test at 6 weeks. That definition illustrates why endpoint specifications matter. A result is interpretable only in relation to what was measured, when it was measured, and how missing assessments were addressed. Those supporting details are not reported, and the endpoint result itself is absent from the registry record.

The record also illustrates why a completed study and a reported analysis are not the same thing. Its status is completed, but it lists no analyses. Readers therefore cannot assess an effect estimate, its uncertainty, or how the listed outcome measures were handled analytically. This is especially relevant when several outcomes are of interest: the record does not describe a prespecified testing strategy or multiplicity approach.

Finally, a single-group pilot should not be interpreted as a controlled comparison. The reported safety counts are descriptive, and the planned interviews address experience and toolkit refinement rather than a between-group effect. Keeping these distinctions clear helps readers understand what the registry documents, what it leaves unreported, and which questions would require further information or a comparative design.

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 registry record has important limits for outcome interpretation. Although it defines the primary endpoint as a negative pregnancy test at 6 weeks, the primary outcome result is not reported. The number of participants with an evaluable test and the handling of missing assessments are also not reported. Consequently, no primary endpoint estimate or assessment of its precision can be drawn from the record.

The study is described as single-group, with allocation listed as NA and masking as none. There is no concurrent control group for a like-for-like comparison. The design therefore does not provide a comparative estimate of pharmacist provision against another care approach.

The record lists secondary outcomes concerning patient satisfaction, pharmacist experience, and toolkit changes, but does not report their results. It describes plans for interviews after the pilot, but does not report whether they were conducted or what participants said. The registry also lists no analyses, so the statistical methods, analysis populations, multiplicity strategy, and missing-data approach are not reported.

Safety reporting is limited to the counts of participants at risk and affected, plus deaths. Event definitions, detailed ascertainment procedures, and a specific safety observation period are not reported in the registry record. Zero recorded events should therefore be read as a registry count, not as evidence that adverse events are impossible.

The enrollment of 10 reflects the pilot’s recorded size, but the registry does not report a trial-specific sample-size justification. Planning assumptions described in the record are not a substitute for an analysis plan and do not establish observed power. Taken together, the missing outcome results and methodological details constrain what can be concluded from the public record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pharmacist Provision of Medication Abortion — NCT04956731.
• Registry record last updated 2024-09-23; status last verified 2024-05.
• Results first posted 2024-09-23.
• 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

NCT04956731 is a completed, single-group pilot sponsored by the University of California, San Diego, titled Pharmacist Provision of Medication Abortion. The registry lists a start date of 2022-01-12, primary completion date of 2022-08-05, and enrollment of 10. The intervention involved pharmacist provision of medication abortion using a previously created toolkit.

The primary outcome was completion of medication abortion, defined as a negative pregnancy test at 6 weeks. The primary outcome result is not reported in the registry record. Patient satisfaction, pharmacist experience, and toolkit changes are listed as secondary outcomes, but their results are also not reported. The record lists no analyses.

Safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths. The design has no control group, so the registry record does not provide a comparative effect estimate.