TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to Healthcare: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to Healthcare (NCT03808883), a non-randomized na study. The primary outcome is Change in Knowledge of TGNC Individuals of Total Number of Locations to Receive Medical Care in Cleveland Known.

2. Clinical Question

3. Trial Design

TRANSLATE is a completed, nonrandomized, parallel study sponsored by Case Western Reserve University. The registry lists an enrollment of 49 and identifies Gender Identity as the condition. The study began on 2019-02-01, with primary completion on 2019-12-10. Its phase is listed as NA, and masking is listed as none.

The study used two participant groups with different roles: a TGNC cohort and healthcare participants. The TGNC cohort took part in advocacy activities and discussions with healthcare providers and staff. Healthcare participants included physicians, nurse practitioners, registered nurses, students, physician assistants, and non-provider staff. The registry describes facilitated dialogues between the groups, and the arm description reports three sessions.

Because allocation was nonrandomized, the groups are not a like-for-like control comparison. Their differing roles also mean that a simple contrast between group outcomes would not isolate an intervention effect. The registry describes the project as participatory and focused on TGNC-directed advocacy, rather than as a conventional randomized efficacy trial.

The primary measure concerned TGNC participants’ knowledge of medical-care locations in Cleveland, assessed at baseline and 11 months. The measure included only TGNC participants who completed both surveys. The record lists 7 outcome measures but lists no analyses. It does not report a statistical analysis plan, an allocation procedure beyond nonrandomized allocation, or a rationale for the enrollment target. Those details are not reported in 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:

Analysis population for the primary outcome, as defined in the registry: Only TGNC participants who completed pre and post intervention surveys were included.

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.

Population: Study conducted with transgender and gender non-conforming individuals so gender categories reflect the ways that participants identify.

6. Primary Endpoint

The registry lists the primary outcome as Change in Knowledge of TGNC Individuals of Total Number of Locations to Receive Medical Care in Cleveland Known, measured over Baseline and 11 months.

The primary endpoint concerns the number of Cleveland locations where TGNC participants knew they could receive medical care. Participants were asked before and after the intervention to name hospitals where they knew medical care was available. The registry reports that the measure was summarized using a mean and a full range, with assessments at baseline and 11 months. Only participants who completed both surveys were included.

This kind of measure can be used as an indicator of reported awareness of local care options. Awareness is relevant to a project focused on navigating healthcare access, but it is not the same as obtaining care, receiving appropriate care, or experiencing a health benefit. It captures what participants named in response to a survey question.

The registry itself cautions that the measure was unreliable. On the post-intervention survey, participants were not shown the locations they had named at baseline, so some could name fewer locations on the later survey. The record also says that the reported growth is the change in the group mean, not the mean of each participant’s individual change. These features affect how the measure can be interpreted and make it especially important not to treat a change in the group summary as a straightforward measure of each participant’s learning.

The registry record does not report the endpoint’s numerical mean or range values. It therefore does not establish the size or direction of the observed change in this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a nonrandomized, parallel project with a TGNC cohort and healthcare participants. It does not report a statistical analysis plan or list analyses. The statistical methods that would be appropriate for this kind of question can still be explained in general terms, but the record does not establish that any particular method was used.

What does the primary measure represent?

The endpoint is a count of locations that participants could name, summarized by a group mean and a full range. A mean describes the average response in the group, while the range describes the span from the lowest to the highest observed response. These summaries can convey different aspects of the data: a mean gives a central summary, while a range is sensitive to the most extreme observations. The registry does not report the actual mean or range values.

The question is about the change in reported knowledge between baseline and 11 months. In a paired analysis, each participant’s later response would be linked to that same participant’s baseline response. Summarizing individual changes can distinguish within-person change from differences between the group averages at two time points. The registry specifically warns that its reported growth is a change in the group mean, not the mean of individual changes. It does not report a paired analysis or the individual-level data needed to assess one.

Why does the survey procedure matter?

For a recall-based count, the conditions under which the question is asked can influence responses. The registry says that participants were not shown the locations they had identified on the pre-intervention survey when completing the post-intervention survey. This could affect whether a previously named location was recalled. The registry identifies this as a source of unreliability and notes that some participants named fewer locations later. That warning should be considered when interpreting any apparent change, especially a decline.

What can a confidence interval tell a reader?

In general, a confidence interval describes the precision of an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates greater uncertainty. An interval also helps readers consider which effect sizes are compatible with the data. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be assessed from the posted information.

What would a significance test establish?

In general, a significance test evaluates how compatible the observed data are with a specified null model, under assumptions such as the chosen outcome distribution and analysis design. A p-value does not measure the size or practical importance of an effect, and it does not establish causation. The registry lists no analyses and reports no p-value for the primary endpoint. A statistical test therefore cannot be reconstructed from the record.

How does the design affect analysis?

Because allocation was nonrandomized and the groups had different roles, a between-group comparison would not automatically estimate an intervention effect. Randomization can help balance measured and unmeasured characteristics on average, but that protection is not part of this design. The registry explicitly warns that the arms are not a like-for-like control comparison. The primary endpoint is described for TGNC participants who completed both surveys, rather than as a comparison of the two groups.

General planning illustrations based on an observed effect are not the same as observed power, nor do they establish the study’s original design assumptions. The registry describes planning assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. Such assumptions describe an illustration, not evidence that the study was designed or analyzed that way. The registry record does not report a sample-size justification or a statistical plan for the completed study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures, but it does not report how those outcomes were prioritized or how the risk of multiple statistical comparisons was handled. When researchers test several outcomes, the chance of finding at least one apparently notable result can increase if each test is interpreted independently. In general, an analysis plan may identify a primary outcome in advance and specify whether any multiplicity adjustment is intended. Whether such procedures were used is not reported in the registry record.

The record lists no analyses. It therefore reports no inferential results for the primary endpoint or the other outcomes, and it does not describe an interim-analysis plan. The statistical analysis plan, including any prespecified model, test, or adjustment procedure, is not reported in the registry record.

The primary endpoint population included only TGNC participants who completed both pre-intervention and post-intervention surveys. The record does not state how many participants lacked either survey, why surveys were incomplete, or whether any missing responses were imputed or otherwise addressed. It also does not report whether the endpoint was analyzed for any broader population.

Restricting a change analysis to participants with both observations can be useful for comparing paired responses, but it may limit interpretation if completion is related to participants’ experiences or responses. That is a general consideration, not a finding about this study: the registry does not report enough information to assess whether incomplete data could have affected the results. The stated concerns about the survey procedure and the group-mean summary also apply independently of missingness.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports serious adverse event counts and deaths separately for the TGNC cohort and healthcare participants. For the TGNC cohort, 0 serious adverse events were recorded among 20 at risk, and 0 deaths were recorded. For healthcare participants, 0 serious adverse events were recorded among 29 at risk, and 0 deaths were recorded. The registry also records 0 other adverse events in each group.

These are the event counts reported in the registry; they should not be interpreted as proof that no adverse events occurred outside the events captured and reported. The record does not provide further detail about how adverse events were solicited, monitored, or attributed to study activities. It also does not identify any serious adverse event terms.

The groups had different roles in the project, so these figures are descriptive group-specific safety entries, not a comparison of equivalent treatment arms. The registry’s figures do not establish that any activity caused or prevented an event. They describe what was recorded in the safety fields.

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

The registry record describes a participatory project involving TGNC-directed advocacy and facilitated discussion with healthcare participants. Its primary question was whether TGNC participants’ reported knowledge of local medical-care locations changed between baseline and 11 months. This question is relevant to awareness of care options, but the endpoint is not a direct measure of access, healthcare use, stigma, quality of care, or health outcomes.

The posted registry information does not include the primary endpoint’s numerical results. It therefore does not show whether the group mean increased or decreased, how large any change was, or how uncertain an estimate might be. The record also lists no analyses, so there is no reported inferential result to interpret.

Even if a change in the endpoint were reported, the survey procedure would matter: the post-intervention survey did not display participants’ baseline lists, and the registry says some participants named fewer locations on the later survey. The reported growth was a change in the group mean, not an average of individual changes. These features limit what a difference between group summaries could say about participants’ individual learning.

The nonrandomized design and the distinct roles of the two groups also limit causal claims. The healthcare participants do not serve as a like-for-like control group for the TGNC cohort. A change over time in the cohort could not, on this record alone, be attributed specifically to the advocacy activities or dialogues.

The record supports an account of the project’s goals, design, and stated measurement concerns. It does not support a conclusion about whether the intervention changed knowledge, whether any change was statistically significant, or whether access to care improved.

13. Why This Trial Matters Statistically

This study raises a statistical issue that is important for participatory healthcare research: the outcome chosen to represent a broad goal may capture only one part of that goal. Naming locations where care is available measures reported awareness, but does not establish whether someone can obtain care, feels comfortable seeking it, or receives appropriate services. Clear separation between a proxy measure and the broader concept helps keep conclusions proportional to the data.

The registry’s description of the survey procedure illustrates how measurement conditions can influence a change score. Participants were not shown their baseline answers during the post-intervention survey, and the registry notes that some later responses contained fewer locations. This makes it important to consider recall and survey design when interpreting repeated measures, rather than assuming every observed difference reflects a change in underlying knowledge.

The record also distinguishes a change in group means from an average of individual changes. These summaries can differ, and they answer different questions. A well-described analysis should make clear whether the focus is on changes within participants or on a comparison of group-level summaries.

Finally, the nonrandomized design is relevant to interpretation. The two groups had different roles and were not like-for-like controls. This design can describe a project and its participants, but it cannot by itself separate the effect of the intervention from other explanations for change. The registry’s missing numerical outcome results and analyses further limit conclusions. Together, these issues underscore why transparent measurement, analysis reporting, and careful qualification of causal claims matter when evaluating projects aimed at reducing healthcare disparities.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary outcome has limitations identified in the registry itself. Participants were asked to recall medical-care locations without being shown the locations they had named at baseline. The registry notes that some participants named fewer locations in the post-intervention survey and describes the measure as unreliable. This makes it difficult to interpret changes as a clean measure of increased or decreased knowledge.

The registry also clarifies that reported growth is the change in the group mean, not the mean of each participant’s individual growth. The record does not provide individual responses or enough analysis detail to assess within-person changes. The primary endpoint includes only TGNC participants who completed both surveys, but the number and characteristics of participants without paired surveys are not reported in the registry record.

The study was nonrandomized, and the TGNC cohort and healthcare participants had distinct roles. The registry states that the arms are not a like-for-like control comparison. Consequently, comparisons between them should not be interpreted as if they came from equivalent groups assigned to alternative treatments.

The registry lists 7 outcome measures but no analyses. Numerical primary endpoint results, uncertainty estimates, and a statistical analysis plan are not reported in the registry record. The record also does not report a sample-size justification or how multiple outcomes were handled. These omissions prevent assessment of the precision and inferential strength of any outcome claim based on the registry information alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to Healthcare — NCT03808883.
• Registry record last updated 2024-08-14; status last verified 2024-08.
• Results first posted 2024-08-14.
• 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.

18. Record Summary

TRANSLATE is a completed, nonrandomized, parallel study sponsored by Case Western Reserve University. The registry lists an enrollment of 49, no masking, and a study period beginning 2019-02-01, with primary completion on 2019-12-10. The project involved a TGNC cohort and healthcare participants, with advocacy activities and facilitated dialogues between the groups.

The primary measure assessed TGNC participants’ knowledge of Cleveland locations where medical care was available at baseline and 11 months. The registry describes a group mean and full range, and includes only participants who completed both surveys. It also warns that the measure was unreliable because baseline locations were not shown in the post-intervention survey.

The record lists 7 outcome measures and no analyses. Numerical primary outcome results and inferential statistics are not reported in the registry record. Safety entries record 0 serious adverse events and 0 deaths in each group.