Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia (NCT02959450), a randomized na study. The primary outcome is Adequacy of Oral Intake of Energy.

2. Clinical Question

The trial’s stated purpose was to design, implement and evaluate a nutritional intervention, focusing on body composition and oral intake of energy and protein. The primary endpoint reported in the registry record is energy intake per kilogram per day. It therefore addresses one part of that broader purpose; it does not, by itself, describe every aspect of nutritional status or the experience of swallowing.

The comparison is randomized and parallel: participants were assigned to one of two treatment groups. The record describes the study as single blind, but does not identify who was masked. The primary result is a comparison of group means at the stated 12-month timeframe. It should be read as an estimate with uncertainty, rather than as a precise measure of what every participant experienced.

3. Trial Design

This was a randomized, parallel-group clinical trial comparing the modified consistency and volume diet with a control group receiving standard treatment. The registry record describes masking as single blind; which people were blinded is not reported in the registry record. The trial is listed as completed, with enrollment of 127. Its start is recorded as 2015-05 and its primary completion as 2021-07. Phase is listed as NA.

The intervention combined modification of food consistency with control of volume. The description specifies nectar consistency at a viscosity of 51 to 350 centiPoises (cP) and pudding consistency menus at 1,750 cP. The control was not described as no treatment: it consisted of a modified-consistency diet intended to provide adequate energy and protein, together with general dietary recommendations prescribed by the treating physician. Thus, the clinical contrast is between two dietary approaches, not between a dietary intervention and absence of dietary care.

The primary outcome was adequacy of oral energy intake, measured as a mean in kcal/kg/d at 12 months. The posted primary result includes 54 participants in the intervention arm and 51 in the control arm. The record also lists body weight, mortality, swallowing ability and BMI as secondary outcomes. Numerical results are posted for body weight, mortality and swallowing ability; a numerical BMI result is not reported in the registry record.

The registry record does not report the original sample-size justification, the intended analysis population, how allocation was generated or concealed, or the exact masking arrangements. It also does not describe participant flow or explain why the outcome group counts differ from total enrollment. These omissions limit assessment of how the trial was planned and how complete the outcome data were. Although the record lists six outcome measures, it does not give a full account of the analysis plan or explain how multiple outcomes were handled.

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.

Before assignment: Patients who not agreed to participate or with severe oropharyngeal dysphagia (enteral feeding) was excluded

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 Adequacy of Oral Intake of Energy, measured over 12 months.

The primary endpoint is adequacy of oral energy intake, expressed as energy intake in kcal/kg/d and summarized as a group mean at 12 months. Reporting intake relative to body weight gives a measure of energy consumed in relation to the participant’s weight, rather than an unscaled daily energy total. The trial’s stated purpose included evaluating oral energy and protein intake, and this endpoint addresses the energy-intake part of that objective.

A mean is useful for comparing the overall level of a continuous measure between randomized groups. It does not show how values are distributed among individuals, whether all participants had similar intake, or whether the result was driven by a small number of particularly high or low observations. The posted standard deviations describe spread around each group mean, but the record does not provide individual-level results or further distributional summaries.

The intervention group’s posted mean was 41.0 kcal/kg/d, with a standard deviation of 15.0 and 54 participants. The control group’s mean was 36.0 kcal/kg/d, with a standard deviation of 12.0 and 51 participants. The unadjusted mean difference was 5.0. The confidence interval crosses zero, so the estimate is compatible with a range that includes no mean difference as well as positive differences. The endpoint is one measure at one stated timeframe; it is not a complete measure of nutritional status, swallowing function, or overall health.

7. Results Posted in the Registry

• Modified Consistency and Volume Diet: mean 41.00 versus 36.00 on control; difference 5.00 (95% CI -0.18 to 10.18), standardized effect d = 0.37; z-test p = 0.059.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Body Weight

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Modified Consistency and Volume Diet: mean 62.00 versus 57.00 on control; difference 5.00 (95% CI -0.21 to 10.21), standardized effect d = 0.37; z-test p = 0.060.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Modified Consistency and Volume Diet and the control. The interval gives the range of effects that remain compatible with the data.

Mortality

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Modified Consistency and Volume Diet: 14.8% (8/54) versus 35.3% (18/51) on control; risk difference -20.5 percentage points (95% CI -36.7 to -4.3), risk ratio 0.42 (0.20–0.88); unadjusted two-proportion z-test p = 0.015.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Modified Consistency and Volume Diet than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Swallowing Ability

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Modified Consistency and Volume Diet: 48.1% (26/54) versus 43.1% (22/51) on control; risk difference 5.0 percentage points (95% CI -14.0 to 24.0), risk ratio 1.12 (0.73–1.70); unadjusted two-proportion z-test p = 0.606.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Modified Consistency and Volume Diet and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the focus beyond oral energy intake to body weight, mortality and swallowing ability. The record also names BMI as a secondary outcome, but a numerical BMI result is not reported in the registry record. The reported secondary results do not all point with the same degree of statistical clarity: one comparison has an interval that excludes no difference, while the other posted continuous and binary comparisons have intervals crossing their respective no-difference values.

This pattern is not a substitute for the primary result. Body weight is another continuous measure, mortality is a count-based endpoint, and swallowing ability is also reported as a count. These outcomes capture different aspects of the trial’s stated aims, use different scales, and cannot be combined into a single conclusion simply because they were measured in the same study. The primary energy-intake estimate remains the direct answer to the designated primary question; secondary results can add context but do not remove its uncertainty.

Unadjusted secondary comparisons carry less weight because examining multiple outcomes creates more opportunities for chance findings. The registry record lists multiple outcome measures but does not report a multiplicity strategy, a hierarchy among secondary endpoints, or adjusted analyses. It also does not identify whether each secondary comparison was prespecified or exploratory. The mortality finding should therefore be considered in light of this incomplete statistical context, rather than interpreted as definitive on its own.

There is also limited information about completeness and analysis populations. The record does not explain why the posted endpoint group counts differ from total enrollment, nor does it describe missing-data handling. Without those details, it is difficult to know how the secondary estimates relate to all randomized participants. Taken together, the secondary results offer useful descriptive context, but their unadjusted status and reporting gaps argue for caution and for avoiding claims that go beyond the endpoint-specific estimates.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Body Weight
• Mortality
• Swallowing Ability
• BMI

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference represent?

The primary endpoint is continuous, so its group summaries are means and standard deviations. A mean difference compares the average outcome in the intervention group with the average in the control group. The reported difference of 5.0 kcal/kg/d is positive because the intervention-group mean is higher. It is a difference between group averages, not a statement that each participant’s intake increased by that amount. Participants can have values well above or below their group mean, and the standard deviations of 15.0 and 12.0 describe substantial spread around the respective averages.

What does the confidence interval add?

A confidence interval expresses uncertainty around an estimated effect. In general, a narrower interval indicates greater precision, while a wider interval leaves more possible values compatible with the data and the statistical method. For the primary mean difference, the interval crosses zero. Zero represents no difference between group means, so the interval does not rule out no difference at the conventional boundary represented by zero. It also includes positive values, consistent with the observed direction. This is why the point estimate alone should not be read as a precise or conclusive result.

How should the p-value be read?

The unadjusted p-value for the primary comparison is 0.059. In general, a p-value describes how unusual results at least as incompatible with a no-difference model would be under that model and its assumptions. It is not the probability that the no-difference model is true, and it does not measure the size or clinical importance of the observed difference. The registry record does not report an adjusted primary analysis or a broader analysis plan, so the p-value should be understood as an unadjusted comparison rather than as a complete account of the study’s inferential strategy.

Why do the secondary endpoints use different measures?

Body weight is continuous and is reported with group means and standard deviations. Mortality and swallowing ability are reported as counts, so their comparisons use risk differences rather than mean differences. A risk difference compares the event proportions between groups. Its confidence interval indicates uncertainty in that contrast; an interval that crosses zero includes no difference in the underlying event proportions. The interpretations of these measures are not identical: a mean difference is in the units of the continuous outcome, while a risk difference is on the proportion scale.

The mortality comparison has an unadjusted risk difference of -0.205, with a confidence interval that does not cross zero and an unadjusted p-value of 0.015. The swallowing-ability risk difference is 0.050, with an interval that crosses zero and an unadjusted p-value of 0.606. These comparisons are not adjusted for other variables in the posted results. No adjusted analysis is reported in the registry record.

What does randomization contribute?

In general, random assignment is intended to make comparison groups similar, on average, with respect to characteristics known and unknown at the start of a study. It supports interpretation of a between-group contrast, but does not remove uncertainty from a finite sample, fix missing outcome data, or guarantee that all later comparisons are unbiased. The registry record confirms randomized allocation but does not describe the sequence-generation or allocation-concealment procedures. It also does not state the analysis population or whether participants were analyzed according to their assigned group.

Why can over-dispersion matter?

General statistical context: over-dispersion occurs when the observed variability is greater than a statistical model assumes. If it is ignored, uncertainty can be understated and confidence intervals may be too narrow. The posted continuous outcomes include standard deviations, but the registry record does not report a diagnostic assessment of distributional assumptions, an over-dispersion analysis, or a model-based analysis. This is not evidence that over-dispersion occurred; it is a reminder that assumptions matter when interpreting estimates and their precision.

What analysis details are absent?

The record does not report the original sample-size justification, analysis model, handling of missing observations, covariate adjustment, sensitivity analyses, or interim analyses. It lists six outcome measures and identifies several secondary outcomes, but does not report how multiplicity was addressed. The number of reported analyses is listed as zero, and no reported secondary analyses are listed. These absences mean that the posted summary comparisons cannot be placed within a fully documented statistical analysis plan. General statistical practice would distinguish planned analyses from exploratory ones, but the record does not identify which category applies to each comparison.

The posted comparisons are unadjusted recalculations from summary statistics. They are useful for describing the contrasts and their uncertainty, but do not replace details of the sponsor’s own prespecified analysis. In this record, no discrepancy is flagged, and no sponsor analysis is reported that would take precedence. For that reason, conclusions should stay close to the posted group summaries, confidence intervals and unadjusted p-values.

11. Confidence Intervals and Precision

The primary mean difference is estimated as 5.0 kcal/kg/d, but its confidence interval crosses zero. That interval conveys an important limitation: the posted result is compatible with no mean difference and with a range of positive differences. The p-value of 0.059 similarly indicates that the unadjusted result is near, but does not cross, a conventional 0.05 threshold. Neither feature should be treated as a pass-or-fail verdict. The estimate’s direction and magnitude, its uncertainty, the endpoint’s relevance, and limitations in the record all matter to interpretation.

The standard deviations are 15.0 in the intervention group and 12.0 in the control group. In general, standard deviation describes how spread out individual observations are around their group mean. It is not the uncertainty interval for the mean difference. The confidence interval for the comparison accounts for group sizes and observed variability; the spread within groups and precision of the between-group estimate answer related but distinct questions.

Precision also varies across the secondary outcomes. The body-weight mean-difference interval crosses zero. The swallowing-ability risk-difference interval also crosses zero. In contrast, the mortality risk-difference interval does not cross zero. These differences in interval position do not, on their own, establish that one endpoint is more reliable or more important than another. The record does not report adjustment for multiple comparisons or detailed information about missing data and analysis populations, both of which affect how confidently the estimates can be interpreted.

Confidence intervals describe statistical uncertainty under the analysis used; they do not account for every source of uncertainty. They cannot resolve questions about outcome completeness, adherence, selection of analyses, or whether a measured difference matters to patients. Since those details are not reported in the registry record, the numerical precision should be read alongside the reporting limitations rather than in isolation.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations for future-study planning, not a description of the trial’s original design. For these continuous and binary outcomes, the figures are participants per arm; they are not total event counts. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario uses the stated fraction of the observed effect as the effect to detect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed to detect the assumed effect with 80% power under those assumptions. The 90% power column uses a higher target probability of detecting that same assumed effect if it is truly present, and therefore generally calls for more participants per arm. For the primary outcome, the illustration based on 100% of the observed effect lists 117 participants per arm for 80% power and 157 for 90% power. Planning for 75% of the observed effect lists 208 and 278 participants per arm, respectively. Smaller effects need more participants because they are harder to distinguish from random variation.

These calculations are based on the observed effect, which is uncertain and may not be a stable estimate of what a future study would find. The scenarios are planning illustrations under the stated assumptions; this is not observed power. They do not establish whether the completed trial was adequately designed or whether its result is true or false. A future study would need its own justified target effect and design assumptions, which are not reported for the original trial.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 5.000; pooled standard deviation σ = 13.626.
2. n = 2 × (1.96 + 0.842)² × 13.626² / 5.000² = 116.6, rounded up to 117 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 5                      # observed difference in means
sigma <- 13.626430627662                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2959450)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 117 (80% power), 157 (90% power)
 75% of observed effect: n per arm = 208 (80% power), 278 (90% power)
 50% of observed effect: n per arm = 467 (80% power), 625 (90% power)
power.t.test: 117.6 
Simulated power at n = 117 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes or comparisons are examined: even if each analysis is considered separately, the chance of observing an apparently notable result by chance can increase across the collection of analyses. The registry record lists six outcome measures and names body weight, mortality, swallowing ability and BMI as secondary outcomes. It does not report a strategy for controlling or interpreting multiplicity, such as a prespecified hierarchy or adjustment procedure. The posted secondary comparisons are unadjusted, so their p-values should not be read as if they were the only analyses undertaken.

The record’s analysis reporting is limited. It lists zero analyses and no reported secondary analyses, while numerical outcome summaries and unadjusted comparisons are available. A full statistical analysis plan, including which outcomes were primary or secondary for inferential purposes, whether analyses were prespecified, or whether additional analyses were conducted, is not reported in the registry record. The original sample-size rationale and any interim analyses are also not reported. These gaps prevent a complete assessment of how the statistical findings were selected and interpreted.

Missing-data details are likewise not reported. The primary outcome results include 54 participants in one arm and 51 in the other, compared with total enrollment of 127. The reason for this difference, the number of missing observations for each outcome, and any methods used to handle missingness are not reported in the registry record. It is therefore not possible to determine whether the outcome analyses included all randomized participants or to assess the potential effect of missing data.

The record does not state the analysis population, such as whether participants were analyzed according to randomized assignment, nor does it provide sensitivity analyses for missing outcomes. It also does not report whether estimates were adjusted for baseline values or other covariates. These omissions do not establish that a particular bias occurred, but they constrain interpretation: the posted estimates are unadjusted comparisons from the available summaries, and the record does not show how robust they are to alternative analytic choices.

15. 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 record reports zero serious adverse events affecting participants in each group and zero other adverse events affecting participants in each group. The listed numbers at risk were 54 for the modified-diet group and 51 for the control group. No serious adverse-event terms are listed. These are the adverse-event figures posted in the record, and they should be read as reported counts rather than as a complete description of every possible safety outcome.

Deaths are reported separately: 8 in the modified-diet group and 18 in the control group. Mortality is also listed as a secondary outcome, with the same group counts. The record does not explain how deaths were classified in relation to adverse-event reporting, nor does it provide detail about cause, timing, ascertainment procedures, or missing safety information. The posted counts alone cannot establish why the groups differed or whether the difference was related to the dietary intervention.

Zero reported adverse events does not prove that no adverse events occurred outside the registry’s reporting definitions or observation process. Interpretation is limited by the information available about surveillance and follow-up. The figures describe the record’s reported counts; they should not be taken as a complete safety assessment or as medical advice.

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

The primary result describes a higher posted mean energy intake in the modified-diet group than in the control group at 12 months. The estimated mean difference was 5.0 kcal/kg/d. Its confidence interval crosses zero, and the unadjusted p-value is 0.059. Taken together, these results do not provide a precise estimate that rules out no difference. They also do not show that the groups were identical: the interval includes positive differences, and the point estimate is positive. The appropriate reading is uncertainty around the size and direction of the group contrast, not a categorical verdict.

The result does not show that every participant in the intervention group had higher energy intake, or that each participant’s intake changed by the group mean difference. Group averages conceal individual variation. Nor does this endpoint directly establish effects on body composition, protein intake, swallowing, or other aspects of health. The broader trial purpose mentions body composition and energy and protein intake, but the primary posted measure is energy intake per kilogram per day.

Randomization supports comparison between assigned groups in general, but the registry record does not provide enough detail to assess the allocation procedure, analysis population, missing data, or the relation between total enrollment and endpoint counts. Those omissions limit certainty about how broadly the posted comparison represents the randomized participants. The record also does not report a complete analysis plan or adjustment for multiple outcomes.

The secondary results should be considered separately and cautiously. They concern distinct outcomes and include unadjusted comparisons; one interval excludes no difference, while others include it. A secondary finding does not resolve uncertainty in the primary endpoint, and a result for one outcome should not be generalized to all outcomes. The registry record gives no numerical BMI result.

In general, statistical evidence describes uncertainty under specified data and analysis assumptions. It does not determine clinical importance by itself. The registry record does not report a threshold for a clinically important difference in energy intake, so the posted estimate cannot be classified against such a threshold using this record. These results describe the reported trial data; they do not establish a treatment recommendation or provide individual medical advice.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison should be read through both its estimate and its uncertainty. The primary group means differ, and the estimated mean difference is positive, but the confidence interval crosses zero. Focusing only on the point estimate would hide that uncertainty; focusing only on a threshold for the p-value would also discard information about direction and plausible effect sizes. The estimate, interval and study context all contribute to a balanced statistical reading.

The record also contrasts continuous and count-based outcomes. Energy intake and body weight are summarized as means and standard deviations, while mortality and swallowing ability are represented by counts and risk differences. Different outcome scales answer different questions and yield different kinds of uncertainty. This is a useful reminder that evidence across endpoints is not automatically comparable or combinable.

Multiplicity matters in this setting because several outcome measures are listed and more than one secondary comparison is posted. Without a reported strategy for handling multiple comparisons, an isolated unadjusted result should be interpreted with care. That is particularly important when a secondary comparison appears more statistically distinct from no difference than the primary comparison.

Finally, the record’s reporting gaps are part of the statistical interpretation, not merely administrative details. Total enrollment and endpoint group counts are not reconciled, and missing-data handling, analysis populations, the original sample-size rationale and a complete analysis plan are not reported. Those details would help readers judge precision, potential selection effects and the status of the analyses. The case demonstrates that numerical results are most informative when paired with transparent methods and participant-flow reporting.

18. 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.

Several trial-specific reporting limitations constrain interpretation. The registry record gives total enrollment of 127, whereas the primary endpoint summaries list 54 participants in the modified-diet arm and 51 in the control arm. It does not explain why these counts differ, describe participant flow, or report the number and reasons for missing outcome values. As a result, the completeness and representativeness of the posted endpoint summaries cannot be assessed from the record.

The record does not report the trial’s original sample-size justification, the allocation-generation or concealment procedures, or who was masked under the single-blind design. It does not identify the analysis population or explain whether analyses followed randomized assignment. These omissions make it harder to assess the design and the relationship between randomization and the reported comparisons.

The statistical reporting is also incomplete. No full analysis plan, adjusted analyses, sensitivity analyses, interim analyses, or multiplicity strategy is reported. The posted comparisons are unadjusted recalculations from summary statistics. The record lists BMI as a secondary outcome but does not give its numerical result; the available secondary results therefore do not cover every listed outcome. The reasons for the mortality counts and their relationship to adverse-event reporting are not described.

These limitations do not show that bias or errors occurred. They identify what cannot be assessed from the registry record. In particular, they restrict evaluation of missingness, robustness to analytic choices, and the interpretation of multiple unadjusted results. The findings should therefore be kept close to the reported outcome summaries and treated as estimates with the stated uncertainty.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia — NCT02959450.
• Registry record last updated 2023-06-09; status last verified 2023-06.
• Results first posted 2023-06-09.
• 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.

22. Record Summary

NCT02959450 is a completed, randomized, parallel-group, single-blind trial in patients with oropharyngeal dysphagia, with total enrollment of 127. It compared a modified-consistency and controlled-volume diet with standard treatment. The primary endpoint was mean oral energy intake in kcal/kg/d at 12 months.

The posted primary means were 41.0 in the intervention group and 36.0 in the control group; the unadjusted mean difference was 5.0, with a confidence interval crossing zero and an unadjusted p-value of 0.059. Secondary results were posted for body weight, mortality and swallowing ability. BMI is listed as a secondary outcome, but a numerical result is not reported in the registry record. The record does not report a full analysis plan, missing-data handling, or the original sample-size justification.