This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial (NCT03470194), a randomized na study. The primary outcome is Patient Satisfaction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03470194 |
| Phase | NA |
| Condition | Pelvic Floor Disorders |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 106 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Massachusetts, Worcester |
| Results posted | Yes |
2. Clinical Question
Population
Limited English-proficient patients attending urogynecological office visits were the population of interest. The registry lists pelvic floor disorders as the condition. It does not report further eligibility criteria or a more detailed description of participants.
Intervention
Participants assigned to the in-person interpretation group used an in-person interpreter for the duration of the urogynecological office visit. The intervention is a service-delivery approach, rather than a medication or procedure.
Comparator
Participants assigned to the telephonic interpretation group used a phone interpreter for the duration of the office visit. The comparison therefore concerns interpretation modality during the visit, with satisfaction assessed immediately afterward.
Primary question
The primary question was whether patient satisfaction differed between visits using in-person interpreters and visits using phone interpretation. Satisfaction was recorded using a questionnaire and summarized as a score. The registry reports a rank-based comparison but does not give an estimated between-group effect or its confidence interval.
The study aim was to compare satisfaction with urogynecological office visits among limited English-proficient patients according to interpreter modality. This is a question about patients’ reported experience of a visit, not a direct comparison of clinical outcomes. The registry describes satisfaction subscales concerning the interpreter, nursing, and physician communication. The primary outcome is named Patient Satisfaction, but the registry does not specify a separate primary score for each of those subscales in the posted results.
3. Trial Design
This was a randomized, parallel-group trial with no masking reported. Participants were assigned to use either an in-person interpreter or a telephonic interpreter for the duration of a urogynecological office visit. The registry lists the study as completed and reports enrollment of 106. The study start date was 2017-12-15, and primary completion was 2019-06-10.
The two intervention groups differed by interpretation modality. The registry does not report additional treatment components, the process used to generate or conceal random assignments, or whether assignment was stratified. Details such as the clinical setting beyond urogynecological office visits, the number of participating sites, and how interpreters were selected are not reported in the registry record. The registry also does not describe adherence, crossover, or whether any participants received a different modality from their assigned group.
The primary outcome was assessed immediately after the office visit. The posted outcome counts are 38 for the in-person group and 40 for the telephonic group. These arm-level counts do not account for all 106 enrolled participants, and the registry does not report a participant flow or explain the difference between enrollment and the counts with outcome results. It is therefore not possible to determine from the record whether the difference reflects outcome availability, analysis eligibility, or another reason.
The registry identifies the study as randomized but does not report a phase, which is listed as not applicable. It describes one primary outcome measure and one reported analysis. Further protocol details, including a sample-size justification, planned interim analyses, and a full statistical analysis plan, 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
| Stage | Interpretation Modality: In Person | Interpretation Modality: Telephonic |
|---|---|---|
| STARTED | 49 | 57 |
| COMPLETED | 38 | 40 |
| NOT COMPLETED | 11 | 17 |
Reasons for not completing this period:
| Reason | Interpretation Modality: In Person | Interpretation Modality: Telephonic |
|---|---|---|
| Lost to Follow-up | 11 | 17 |
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.
| Characteristic | Unit | Interpretation Modality: In Person | Interpretation Modality: Telephonic | Total |
|---|---|---|---|---|
| Participants analysed | 49 | 57 | 106 | |
| Age, Continuous | years | 55.3 (SD 9.9) | 52.4 (SD 13.8) | 54.1 (SD 11.1) |
| Sex: Female, Male: Female | Participants | 49 | 57 | 106 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 25 | 30 | 55 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 24 | 27 | 51 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Language of Translation: Spanish | Participants | 25 | 30 | 55 |
| Language of Translation: Portugese | Participants | 24 | 27 | 51 |
6. Primary Endpoint
The registry lists the primary outcome as Patient Satisfaction, measured over Immediately assessed after office visit.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is patient satisfaction assessed immediately after the office visit. The registry describes a 14-item questionnaire previously created, validated, and used in emergency medicine research. It includes subscales assessing satisfaction with the interpreter, nursing, and physician. The interpreter satisfaction score is described as a summation index of 4 items. The description also refers to a summated index of 5 items for physician and nursing communication, with responses on a Likert scale from 1 to 4.
All items are described as weighted on a 100-point scale to facilitate interpretation. A lower score indicates less satisfaction or greater dissatisfaction, while a higher score indicates more satisfaction or less dissatisfaction. The posted primary outcome is summarized using a median, with inter-quartile range named as the dispersion measure. However, the registry does not provide an inter-quartile range value for either arm. It lists arm-level values and lower and upper bounds, but the bound type and confidence level are not specified in the outcome description.
Patient satisfaction is used to address the study’s stated question about patients’ experience of interpreter services during office visits. Such a self-reported outcome can capture perceptions of communication and care that are not represented by clinical measures alone. In general, questionnaire scores depend on how items are worded, combined, and interpreted. The registry description does not report additional scoring details, such as how incomplete questionnaires were handled or whether a threshold for a meaningful difference was defined.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a median patient-satisfaction score of 100 for the in-person group, with lower and upper bounds of 92.9 and 100. For the telephonic group, it reports a median of 94, with bounds of 94 and 98.8. The outcome description names the inter-quartile range as the dispersion measure, but no inter-quartile range values are posted. The record does not clarify the meaning or confidence level of the reported bounds, so they should not be interpreted as a particular type of confidence interval.
The reported comparison used the Wilcoxon (Mann-Whitney) method and has p = 0.002. This is evidence that the observed scores differ in their rank distributions under the assumptions of that test. The arm-level medians are also numerically different, with the in-person group having the higher median. The p-value does not quantify the size of the between-group difference, and the registry does not report an estimated contrast or its confidence interval. The p-value alone cannot show how large or practically important a difference might be.
In general, a p-value describes how unusual data at least as inconsistent with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the probability that the finding occurred by chance. The registry does not provide enough detail to assess the test’s assumptions or to determine whether the analysis was adjusted for any participant characteristics.
The posted arm counts are 38 and 40, while enrollment is 106. The registry does not explain the disposition of participants who are not represented in those arm-level outcome counts. Without information on missing outcome data or the analysis population, the extent to which the posted scores represent all randomized participants cannot be assessed. The reported comparison should therefore be read as the result for the data included in the registry’s analysis, rather than assumed to represent every enrolled participant.
The finding is specific to reported satisfaction scores after urogynecological visits in this trial. It does not establish that one interpretation modality improves clinical outcomes, nor does it identify which parts of the visit drove the scores. The record does not give separate comparative results for interpreter, nursing, or physician subscales. No threshold for a clinically meaningful score difference is reported, so statistical evidence of a difference does not by itself establish its practical importance.
9. Statistical Methods Explained
The trial is described as randomized and parallel, with participants assigned to one of two interpreter modalities for the duration of the visit. Randomization is intended, in general, to create groups that are comparable on average with respect to measured and unmeasured characteristics. That intention does not guarantee identical groups in a particular trial. The registry does not give the randomization sequence method, allocation concealment procedures, or baseline characteristics, so those features cannot be evaluated from the record.
What does the reported test compare?
The registry reports a Wilcoxon (Mann-Whitney) test. In general, this is a rank-based method: it compares the ordering of observations between two groups rather than directly comparing their arithmetic means. It can be useful when scores are bounded, skewed, or otherwise not well described by a normal distribution. Its interpretation concerns differences in the distributions or ranks. It is not automatically a test of medians alone; a median-focused interpretation requires appropriate distributional assumptions, including similar distribution shapes.
The primary outcome is summarized with medians, which describe the middle of an ordered set of scores. The registry names the inter-quartile range as the dispersion measure. In general, the inter-quartile range describes the central portion of a distribution and is less sensitive to extreme observations than the full range. Although that measure is named, its values are missing from the posted arm results. The registry lists lower and upper bounds for each arm, but does not identify their statistical meaning or confidence level. Those bounds cannot substitute for an unreported inter-quartile range or be confidently described as confidence intervals.
How should the p-value be read?
The reported p-value is p = 0.002. In general, a p-value is calculated under a null hypothesis and model assumptions. It measures how compatible the observed data are with that null model according to the specified test. A small p-value indicates that the observed rank pattern would be relatively unusual if the null model and assumptions were correct. It is not a measure of effect size, clinical importance, or certainty that the alternative hypothesis is true. The registry does not report a test statistic, a confidence interval for the group contrast, or an adjusted analysis.
What information would help interpret the score?
The questionnaire description says that it has 14 items and subscales for interpreter, nursing, and physician satisfaction. It describes an interpreter summation index of 4 items and a summated index of 5 items for physician and nursing communication. Responses are described on a Likert scale from 1 to 4, and items are weighted on a 100-point scale. The record does not give the full scoring algorithm, the handling of incomplete responses, or separate posted results for the subscales. Such information would help readers understand exactly what the overall score represents and whether all participants’ responses were scored consistently.
In general, questionnaire scores may be affected by response patterns, item interpretation, and the way items are combined. Validation in a previous study, as described in the registry, is relevant background, but the record does not specify whether the questionnaire was validated in this population or setting. Nor does it report a threshold that would distinguish a meaningful change from a small score difference. Consequently, the direction and statistical evidence can be described, but the practical meaning of the score difference is less certain.
How should planning assumptions be distinguished from trial results?
General sample-size planning uses assumptions about the effect to detect, variability, significance level, allocation, and the statistical approximation. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. These assumptions describe planning illustrations, not observed evidence and not the trial’s own documented design justification. Participants-per-arm estimates used in planning are not observed power. The registry does not report the trial’s sample-size justification, and no planning illustration should be read as proof that the study had a particular probability of detecting an effect.
Overall, the posted inferential method is identifiable, but important analysis details remain unreported: the test statistic, a contrast estimate, uncertainty around the contrast, the handling of missing scores, and the analysis population. Those omissions limit independent assessment of the size and precision of the observed difference. The available test result still communicates evidence from a rank-based comparison, but it does not provide a complete account of the magnitude or uncertainty of the group contrast.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Wilcoxon (Mann-Whitney) | not reported | =0.002 |
The registry’s reported inferential result is the Wilcoxon (Mann-Whitney) comparison, with p = 0.002. No separate recalculated contrast estimate, confidence interval, or recalculated p-value is reported, so there is no second numerical comparison to set alongside the sponsor’s test result. The posted arm medians and bounds describe the groups but do not themselves provide an estimated between-group effect or its precision.
In general, a recalculation from summary statistics is an unadjusted analysis and may not reproduce an analysis based on individual participant data or a different method. Here, the registry does not provide a recalculated comparison result or the information needed to independently reconstruct the reported rank-based test from participant-level scores. The record does not flag a discrepancy between the sponsor analysis and a recalculation. The sponsor’s reported analysis is therefore the only posted inferential comparison, while its magnitude and uncertainty remain unquantified in the record.
11. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure and reports one analysis. It lists no posted secondary outcomes. This limits the multiplicity questions visible in the record, but does not establish that the study tested only one outcome or made only one analytic choice. Whether there were additional planned comparisons, subgroup analyses, or interim looks is not reported in the registry record. A multiplicity strategy, such as adjustment of significance thresholds across tests, is also not reported.
The record does not state whether the primary analysis included all randomized participants, only participants with observed questionnaire scores, or another analysis population. Enrollment is 106, while the posted primary outcome counts are 38 for the in-person arm and 40 for the telephonic arm. There is no participant flow explaining which participants contributed data, why other enrolled participants are not represented in those arm counts, or whether these counts correspond to all randomized participants.
Missing-data methods are not reported in the registry record. It is not stated whether incomplete questionnaires were excluded, scored when some items were missing, or handled by imputation. The record also does not describe withdrawals, exclusions after randomization, or sensitivity analyses for missing outcomes. These details matter because satisfaction scores that are unavailable may differ systematically from those observed. Without them, the direction or size of any bias from incomplete outcome data cannot be assessed.
The registry does not report baseline balance, covariate adjustment, or the handling of protocol deviations. It also does not specify whether the reported analysis followed an intention-to-treat approach. These omissions do not invalidate the posted result, but they constrain the assessment of how closely it reflects the randomized comparison and how robust it is to analysis choices.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Interpretation Modality: In Person | 0 | 38 | 0.0% |
| Interpretation Modality: Telephonic | 0 | 40 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Interpretation Modality: In Person | 0 of 38 |
| Interpretation Modality: Telephonic | 0 of 40 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Interpretation Modality: In Person | 0 of 38 |
| Interpretation Modality: Telephonic | 0 of 40 |
The registry reports 0 serious adverse events and 0 deaths in the in-person group, with 38 participants at risk for those outcomes. It reports 0 serious adverse events and 0 deaths in the telephonic group, with 40 participants at risk. Other adverse events are also reported as 0 in both groups, using the same arm-specific counts at risk. No serious adverse event terms are listed.
These figures describe the adverse-event entries in the registry. They do not establish that no adverse events occurred beyond those captured and reported, and they do not show that the approaches are equivalent with respect to safety. The record does not provide further detail about the adverse-event collection process, follow-up duration for safety, event definitions, or whether events were actively solicited. Because the study compares interpreter services during office visits, the reported zero counts should be read as the registry’s safety reporting, not as a broad assessment of risks associated with care.
13. What the Result Does, and Does Not, Mean
The posted results show higher reported median satisfaction in the in-person interpreter group than in the telephonic group: 100 compared with 94. The Wilcoxon (Mann-Whitney) analysis reports p = 0.002, indicating a difference in rank distributions according to the reported test. The registry does not report an estimated group contrast or its confidence interval, and it does not provide the named inter-quartile range values. Thus, the direction of the arm-level medians and the statistical comparison can be described, but the magnitude and precision of the between-group difference are not fully quantified.
The result does not establish how patients’ satisfaction scores would differ in other settings, populations, or types of clinical visits. The registry describes limited English-proficient patients attending urogynecological office visits, and does not report enough detail about recruitment or setting to assess broader applicability. The record also does not report separate comparative outcomes for the interpreter, nursing, and physician subscales. It cannot identify which aspect of satisfaction accounts for the overall score pattern.
Statistical evidence of a difference is not the same as evidence that a difference is important to patients or clinicians. No threshold for a meaningful score difference is reported. The posted information also does not establish effects on communication accuracy, care quality, clinical outcomes, or subsequent health. Those were not the primary outcome reported in the registry.
Finally, enrollment is larger than the arm-level counts reported for the primary outcome, and the registry does not explain the participant accounting. Missing-data handling and the analysis population are not described. The results should therefore be interpreted with attention to the available outcome data and the limits of the registry’s reporting. They describe satisfaction scores and a rank-based comparison, not a complete estimate of the size, precision, or broader implications of the difference.
14. Why This Trial Matters Statistically
This trial raises a practical statistical question about how patient experience can be compared when the intervention is a service modality rather than a drug or procedure. Satisfaction is inherently a reported outcome, and the questionnaire approach offers a way to represent patients’ views of interpreter, nursing, and physician communication. The endpoint’s meaning depends on how its items are scored and summarized, which makes clear reporting of the scoring method especially useful.
The registry’s use of a rank-based method alongside medians is a recognizable approach for ordered or non-normally distributed scores. At the same time, the reported p-value is not enough to show the size or precision of the difference. Arm-specific summaries give context, but the absence of inter-quartile range values and a contrast estimate leaves important uncertainty about the score distributions and their separation. The record also does not explain the bounds accompanying the arm summaries.
Participant accounting is another statistical concern. Enrollment is 106, whereas the posted arm counts for the primary outcome are 38 and 40. Without a flow description or missing-data methods, readers cannot judge which participants contribute to the analysis or how incomplete data might affect the comparison. Transparent reporting of allocation, analysis populations, missing outcomes, and uncertainty would make the randomized result easier to evaluate.
The registry therefore offers a useful but partial account: it identifies the randomized comparison, the primary satisfaction outcome, the analysis method, and the reported p-value. The limits of the record are also instructive. A statistically detectable difference can be reported without a sufficiently detailed estimate of its magnitude or practical importance, underscoring why effect estimates and uncertainty measures matter alongside significance tests.
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 posted outcome information does not include the inter-quartile range values named in the primary outcome description. It gives lower and upper bounds for each arm but does not identify what those bounds represent or their confidence level. The record also does not report a between-group effect estimate or confidence interval. As a result, the precision and magnitude of the comparison cannot be fully assessed from the registry results.
There is no explanation of why the arm-level primary outcome counts are 38 and 40 when enrollment is 106. Participant flow, missing questionnaire data, exclusions, and analysis-population definitions are not reported. Missing-data handling is not reported in the registry record, so potential effects of incomplete outcome data cannot be evaluated. Baseline characteristics and adjustment methods are also not described in the posted results.
The registry describes the questionnaire and several subscales but does not provide separate comparative results for them or a complete scoring algorithm. It does not specify a threshold for a meaningful score difference. The type of the reported bounds is unclear, limiting their interpretation as measures of uncertainty or score spread.
Further trial details are also not reported in the registry record, including the randomization procedure, allocation concealment, analysis plan, interim analyses, multiplicity approach, and sample-size justification. The study is described as randomized, parallel, and unmasked, but those details would be needed to assess the full conduct and analysis. The record’s reporting does not establish whether the results extend to other populations or clinical settings.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial — NCT03470194.
- Registry record last updated 2021-04-05; status last verified 2021-03.
- Results first posted 2021-04-05.
- 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.
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19. Record Summary
The registry describes a completed randomized, parallel-group trial comparing in-person and telephonic interpretation during urogynecological office visits for limited English-proficient patients. Enrollment was 106. The primary outcome was patient satisfaction assessed immediately after the visit, using a questionnaire described as having interpreter, nursing, and physician subscales.
Posted median scores were 100 for the in-person group and 94 for the telephonic group. The reported Wilcoxon (Mann-Whitney) comparison had p = 0.002. The registry does not report inter-quartile range values, a between-group effect estimate, or a confidence interval for the comparison. It also does not explain why the primary outcome counts are 38 and 40 or describe missing-data handling and the analysis population.
Serious adverse events, other adverse events, and deaths are reported as 0 in both groups. These registry entries do not provide a complete assessment of event collection or follow-up.