Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage (NCT03911752), a registered phase not stated study. The primary outcome is Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant.

2. Clinical Question

The question is about perceived relevance, not a comparative estimate of treatment benefit. The study’s brief summary says it sought views from people with acquired brain injury in a subacute situation and from their relatives and/or partners. The record describes interviews and a qualitative, phenomenological approach. This framing is important: participants’ accounts and the themes derived from them are central to the stated objective, while the primary outcome title expresses the question as a count.

The registry does not report the wording or response categories used to determine whether someone felt the approach was relevant. It also does not report a count of participants endorsing relevance. Consequently, the question can be identified, but its observed answer cannot be recovered from the posted results. The three participant groups supply different perspectives, but the registry does not establish them as comparative arms for an effect estimate.

3. Trial Design

The registry record identifies NCT03911752 as a completed study sponsored by Universidade da Coruña. The recorded start date is 2017-09-25 and the primary completion date is 2018-04-10. Enrollment is listed as 12. The brief summary describes a qualitative design with a phenomenological approach, using interviews to explore whether addressing sexuality during occupational therapy is considered relevant.

The 12 interview participants comprised eight people with acquired brain injury, two relatives and two partners. The arm descriptions identify these same participant categories, with people with acquired brain injury in a subacute stage attending occupational therapy. These groups reflect who contributed perspectives; they are not described as randomized treatment arms. Allocation is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison.

Semi-structured interviews and the Canadian Occupational Performance Measure are listed as interventions, each classified as other. The primary outcome description refers to 12 semi-structured interviews and to qualitative data analysis using theoretical concept saturation and thematic analyses. It describes transcription, listening and categorizing participant speech in response to interview questions. The primary outcome timeframe is 2 months.

The record lists four outcome measures and zero analyses. It does not report a detailed protocol, interview guide, recruitment process, eligibility criteria, participant flow, or how the listed measure was used in relation to the primary question. Those details are not reported in the registry record. The completed status indicates the record’s study status, but it does not supply the missing endpoint findings or analytic detail.

This design is suited to eliciting accounts and organizing them into themes. It does not, as described in the registry, create a randomized comparison for estimating a treatment effect. The group counts describe the composition of the interview sample, not evidence of outcomes within each group.

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

Analysis population for the primary outcome, as defined in the registry: Transcription, listening and categorizing the speaking of participants from their answers to the interviews.

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 Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant, measured over 2 months.

The primary endpoint is titled “Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant.” Its unit is participants, and its parameter is a count. In practical terms, it is intended to capture how many interview participants regarded addressing sexuality in occupational therapy as relevant. The stated timeframe is 2 months.

A participant count can give a direct indication of how many people expressed a view, provided the response rule and the number assessed are clear. In this study, the endpoint sits alongside a qualitative approach: the registry describes transcription, listening, categorizing speech, theoretical concept saturation and thematic analyses. The count therefore does not, on its own, convey what participants meant by relevance, why they held that view, or how perspectives differed across people with acquired brain injury, relatives and partners.

The registry does not report the observed count, the exact question or coding rule used to classify a response, or whether all interview participants contributed to this endpoint. It also does not explain how the endpoint count was derived from thematic analysis. These omissions limit interpretation of the measure as a reproducible quantitative outcome. The endpoint name makes the intended construct clear at a broad level, but the posted results do not give its value or enough detail to assess the classification process.

For a qualitative study, participant narratives and themes can provide context that a single count cannot. The count and the thematic findings would answer related but distinct questions: one concerns how many participants were classified as considering the approach relevant, while the other concerns the content and meaning of their accounts. The registry record does not report the thematic findings.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a qualitative, phenomenological approach contribute?

General: Qualitative research is designed to examine accounts, meanings and experiences rather than to estimate a treatment effect from a randomized comparison. A phenomenological approach generally focuses on how people describe and make sense of an experience. The registry characterizes this study as qualitative and phenomenological, and it describes interviews as the means of collecting information. The record does not report a fuller methodological account of how the phenomenological approach guided the interview or analysis.

The primary outcome description refers to transcription, listening and categorizing participants’ speech, along with theoretical concept saturation and thematic analyses. In general, thematic analysis organizes qualitative material into patterns of meaning. Researchers interpret interview responses, develop categories or themes, and consider how those patterns address the research question. The registry does not report the resulting themes, the coding framework, who performed the coding, or how disagreements or alternative interpretations were handled.

What does theoretical concept saturation mean?

General: Saturation is a qualitative sampling and analysis concept. It refers to a point at which additional material is judged not to add meaningfully to the concepts or themes being developed for the study question. It is not equivalent to statistical power, and it is not a numerical guarantee that all possible views have been captured. Judging saturation depends on the research question, the diversity of participants, the quality of the material and the analytic process.

The registry says that theoretical concept saturation was part of the stated qualitative analysis, but does not report how it was assessed or whether it was reached. The enrollment of 12 and the participant-group counts describe the sample; by themselves, they do not establish saturation. The record also does not state whether saturation was assessed separately for people with acquired brain injury, relatives and partners or across the interview set as a whole.

How should the participant count be understood?

The primary endpoint is expressed as a count of participants who felt that addressing sexuality during occupational therapy was relevant. General: A count is a descriptive summary of classified responses. To interpret it, readers need to know the classification rule, the number of people whose responses were assessed, and how missing or ambiguous answers were handled. In a qualitative study, a count can accompany narrative analysis, but it does not capture the richness, context or reasoning in an interview response.

The registry does not report the endpoint value, the coding rule for relevance, or the number with an evaluable response. It therefore does not permit a calculation of the proportion endorsing relevance or an uncertainty interval, and no such calculation should be inferred. The endpoint’s title states the construct broadly, while the methods detail needed to reproduce a classification is not reported in the registry record.

Why is this not a randomized comparison?

General: Randomized comparative trials use an assigned comparison structure to reduce systematic differences between groups. A comparison between groups that differ in their roles or characteristics does not provide the same basis for attributing an outcome difference to an intervention. Here, the record lists people with acquired brain injury, partners and relatives as groups and explicitly warns that they are not like-for-like control arms. Allocation is not stated. Accordingly, these group labels should be understood as participant categories, not as randomized treatment conditions.

No comparative effect estimate or inferential analysis is listed. The record lists zero analyses. It does not report a statistical analysis plan, hypothesis test, model, confidence interval or approach to adjustment. These elements are not reported in the registry record and should not be presumed to have been used.

What can a sample-size planning illustration say?

General: Sample-size planning asks how many participants might be required to detect a specified effect under stated assumptions. Such an illustration is conditional on the assumed effect, significance level, allocation and statistical model. It is a planning exercise, not an observed study finding and not a measure of the probability that the study detected an effect after completion.

The registry’s stated planning assumptions describe a hypothetical two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect framed as a fraction of an observed effect. It also distinguishes event totals for time-to-event planning from participants per arm for other outcomes. Those are general planning assumptions, not evidence that this study used a randomized two-arm design. The record does not report a sample-size justification for the qualitative study, and no planning result or observed effect is reported. The sample of 12 should not be interpreted as a quantitatively justified sample size based on information absent from the record.

How should precision be considered?

General: Precision describes how tightly an estimate is determined by the available data and the analysis. For a quantitative estimate, a confidence interval can communicate uncertainty under its statistical assumptions. For qualitative findings, credibility and depth depend on the data and analytic process rather than on a confidence interval. Here, the endpoint count and thematic findings are both absent from the posted results, so neither quantitative precision nor the content of the qualitative interpretation can be evaluated.

The registry does not report whether participant responses were independently reviewed, whether data collection stopped when saturation was reached, or whether researchers checked interpretations with participants. These are examples of methodological details that can help readers assess qualitative rigor; they are not claims about procedures used in this study.

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("People With Acquired Brain Injury", "Partners of People With Acquired Brain Injury", "Relatives of People With Acquired Brain Injury")
n      <- c(8, 2, 2)
events <- c(8, 2, 2)
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  People With Acquired Brain Injury  8  8  100.0  63.1  100.0  67.6  100.0  66.4  99.7
ARM  Partners of People With Acquired Brain Injury  2  2  100.0  15.8  100.0  34.2  100.0  29.2  99.2
ARM  Relatives of People With Acquired Brain Injury  2  2  100.0  15.8  100.0  34.2  100.0  29.2  99.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and zero analyses. It identifies the participant count about perceived relevance as the primary outcome, but does not report the results for that endpoint or the other outcome measures. The names, definitions, measurement schedules and analysis roles of the other measures are not reported in the registry record.

Multiplicity concerns arise when several outcomes, time points or analyses are examined. In general, testing many hypotheses can increase the chance of obtaining a nominally notable result by chance, so a statistical analysis plan may specify a primary outcome and methods for interpreting additional tests. The record does not report a multiplicity adjustment, a hierarchy of secondary outcomes, or a detailed analysis plan. Because no analyses are listed, there are no reported test results from which to assess multiplicity handling.

Missing-data methods are also not reported in the registry record. The record does not say whether all 12 participants completed interviews, whether every interview contributed to the primary endpoint, or how incomplete, unclear or unavailable responses were handled. Enrollment and the interview-participant count are both listed as 12, but those details alone do not establish that every endpoint was evaluable or that no data were missing.

The analysis population is not defined. The registry does not state whether the outcome count was intended to include all enrolled participants, only those interviewed, or another group. It also does not describe exclusions from analysis. These omissions matter because the denominator and response classification are needed to interpret a participant count. Without the endpoint result, denominator rules and missing-data approach, readers cannot assess the effect of incomplete observations on the reported outcome.

For qualitative analysis, missingness can include absent interviews, incomplete answers or accounts that cannot be coded for a theme. General: Researchers may describe how such material was treated and how it affected the range of perspectives represented. The registry record does not report these procedures. No particular missing-data pattern or correction should be assumed.

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

The registry record establishes that a completed qualitative study enrolled 12 participants and sought views on whether addressing sexuality during occupational therapy was relevant for people with acquired brain injury in a subacute stage and for their relatives or partners. It describes semi-structured interviews and a phenomenological approach, with thematic analyses and theoretical concept saturation named in the primary outcome description.

The record does not report the number of participants who felt the approach was relevant. It also does not report the interview themes, illustrative accounts, or results by participant group. Thus, the posted information cannot show the distribution of views, explain why participants held them, or establish whether the perspectives of people with acquired brain injury differed from those of relatives or partners.

This is not a randomized comparison. The three participant categories are not like-for-like control groups, and allocation is not stated. The study record therefore does not support a comparative treatment-effect claim. Nor does the completed status provide evidence about the direction or size of an effect. The stated question concerns perceived relevance, not a clinical outcome or a comparison of alternative therapies.

General: Qualitative findings can help describe how participants understand a topic and what issues they regard as important. They are interpreted in the context of who was interviewed, how information was collected and how accounts were analyzed. A participant count, if available, would offer a limited descriptive summary and would not by itself convey the meaning of interview responses. In this record, neither the count nor the thematic results are posted.

The adverse-event entries list zero participants at risk and zero affected for the listed categories in the three groups. With no recorded participants at risk, those entries do not establish an event rate or demonstrate the absence of adverse events in a defined exposed population. The record also does not report a detailed safety-monitoring method.

The most defensible reading is therefore narrow: the registry describes the question, qualitative design and sample composition, but does not provide the findings needed to answer its primary question. Any broader conclusion about the relevance of the approach, the views of a wider population, or effects on health outcomes would go beyond the results reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically instructive because its primary question is expressed as a participant count while the stated design is qualitative and phenomenological. Those approaches can complement one another, but they do not answer identical questions. A count can describe how many responses meet a defined category; interview analysis can explain the meanings and reasoning behind those responses. Clear reporting of both the coding rule and the themes would help readers understand how the endpoint relates to participants’ accounts.

The record also illustrates why group labels should not automatically be treated as comparative arms. People with acquired brain injury, partners and relatives contribute distinct perspectives, but they are not equivalent groups assigned to different conditions. The registry explicitly cautions against treating them as like-for-like controls. A comparison between their counts, even if those counts were posted, would require care and would not by itself establish a treatment effect.

For interpretation, a completed study and an enrollment count are not substitutes for outcome results. The record identifies 12 participants and a primary question, yet does not report the endpoint count or thematic findings. Without those results, readers cannot assess the observed response pattern or its precision. Without analysis details, they also cannot judge how speech was categorized or how missing and ambiguous responses were addressed.

More generally, the record highlights the value of matching statistical summaries to study aims. Statistical tests and confidence intervals are useful for specified quantitative estimands, while qualitative analysis is directed at patterns of meaning in accounts. Neither can stand in for the other. Reporting the sample composition, outcome definition, qualitative procedures and findings would allow readers to distinguish a descriptive count from an interpretation of experience.

The registry’s cautions and omissions are therefore central to statistical reading, not technical footnotes. They set the limits on what can be inferred: the study’s question and approach are identifiable, but the posted record does not provide the empirical answer.

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 principal limitation for interpreting this record is that the primary endpoint result is not reported in the registry record. The title and definition identify a count of participants who considered addressing sexuality during occupational therapy relevant, but no observed count or denominator is posted. This prevents a direct description of the primary finding.

The qualitative findings are also absent. Although the record describes a phenomenological approach, thematic analysis and theoretical concept saturation, it does not report themes, participant quotations, coding procedures or how saturation was judged. Readers cannot assess how interview material was interpreted or whether the analysis captures variation among participants.

The sample comprises 12 interview participants: eight people with acquired brain injury, two relatives and two partners. The record does not describe how participants were recruited or whether their perspectives represent a wider population. The small number of participants in the relative and partner groups means those groups are described by limited sample counts; the record does not provide outcome findings that would permit group-specific interpretation.

The registry describes the groups as non-comparative and does not state allocation. As a result, they cannot be treated as randomized intervention and control arms. The record does not provide a detailed account of the occupational therapy exposure, the interview questions, the timing of interviews relative to therapy, or how the Canadian Occupational Performance Measure related to the primary question. Such details are not reported in the registry record.

Finally, the record lists four outcome measures and zero analyses, without a reported statistical plan, analysis population or missing-data procedures. Adverse-event entries give zero participants at risk as well as zero affected, so they do not yield interpretable incidence information. These limitations concern what can be concluded from the registry record; they do not establish that unreported procedures or findings were absent from the study itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage — NCT03911752.
• Registry record last updated 2019-11-06; status last verified 2019-10.
• Results first posted 2019-11-06.
• 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

NCT03911752 is a completed study sponsored by Universidade da Coruña. The recorded start date is 2017-09-25, and the primary completion date is 2018-04-10. Enrollment is 12.

The brief summary describes a qualitative study with a phenomenological approach. Participants included eight people with acquired brain injury in a subacute stage, two relatives and two partners. Semi-structured interviews and the Canadian Occupational Performance Measure are listed. The primary outcome concerns the number of participants who felt that addressing sexuality during occupational therapy was relevant, with a timeframe of 2 months.

The primary outcome count and qualitative themes are not reported in the registry record. Allocation is not stated, and the participant groups are not a like-for-like control comparison. The record lists four outcome measures and zero analyses.