The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ ): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ ) (NCT04943666), a registered phase not stated study. The primary outcome is Sensitivity of the HDQ for Screening.

2. Clinical Question

The study rationale is that the investigators considered suitable self-evaluation tools for haemorrhoid screening unavailable in Russia. The intended role of the HDQ was to support wider screening, raise awareness, and prompt people to seek professional advice. Those aims describe the motivation for the research, not evidence that the questionnaire achieved a particular level of accuracy or changed behavior.

The registry also lists secondary aims to describe the prevalence of haemorrhoids and the prevalence of haemorrhoid symptoms among study participants. Prevalence is a description of how commonly a condition or symptom occurs in a defined population. The registry record does not give prevalence estimates, symptom counts, or their uncertainty. It also does not specify whether the population studied represents people beyond those seeking help from a coloproctologist.

3. Trial Design

This is a multicenter observational study conducted in Russia. The record identifies the study group as consecutive patients seeking help from a coloproctologist and lists the HDQ as the intervention. It does not describe randomized assignment, and the registry classification notes that this is not a randomized comparison. The study therefore should not be read as a trial comparing outcomes between treatment arms.

The registry lists enrollment of 725 participants. The study start date is 2021-07-12, the primary completion date is 2022-11-01, and the study status is completed. The intervention is categorized as “other,” reflecting evaluation of a questionnaire rather than a drug or procedure. The primary outcome timeframe is 1 month.

The primary outcome title refers to sensitivity of the HDQ for screening, while the outcome description says it is the number of participants with a false-negative screening result. A false negative occurs when screening does not identify a participant who has the condition according to the study’s disease classification. The record does not explain how that classification was established, how the questionnaire was scored, or whether participants completed any additional assessment. Those details are important for understanding how screening results were compared with disease status.

The registry lists two secondary outcomes: the prevalence rate of haemorrhoids among the study population and the prevalence of haemorrhoid symptoms among participants. The record does not provide results for these outcomes. It also does not report the number of participants contributing data to each outcome, how incomplete observations were handled, or whether the listed enrollment corresponds to the analysis population for each measure.

The sponsor is Servier Russia. The registry record lists four outcome measures and no analyses. It does not report a protocol, a statistical analysis plan, a sample-size justification, or whether any analyses were conducted outside the registry entry. The design and stated aims can therefore be described, but the study’s statistical implementation and findings cannot be reconstructed from this 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

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 Sensitivity of the HDQ for Screening, measured over 1 month.

The primary outcome is titled “Sensitivity of the HDQ for Screening.” Its description defines the measure as the number of participants with a false-negative screening result, and its unit is participants. The outcome timeframe is 1 month. This wording matters: a count of false negatives and sensitivity are related but are not interchangeable quantities.

In general, sensitivity describes how often a screening tool identifies people who have the condition, among people who do have it according to a chosen reference classification. False negatives are the people with the condition whom the screen misses. The count of false negatives depends on how many participants had the condition and how many received an evaluable screening result. Sensitivity additionally requires the relevant denominator: all participants classified as having the condition.

A screening study can use these quantities to assess whether a questionnaire tends to miss people with the target condition. However, interpretation also depends on how disease status was determined, how the questionnaire result was defined, and how missing or indeterminate results were handled. Those details are not reported in the registry record.

The registry record does not give the observed false-negative count, sensitivity estimate, specificity estimate, or a confidence interval. It therefore does not allow a numerical assessment of the HDQ’s screening performance. The title alone should not be treated as a reported sensitivity result, and the outcome description alone does not establish how many participants were missed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Diagnostic screening studies ask how well a test separates people who have a target condition from those who do not, according to a reference classification. General statistical interpretation begins by distinguishing the screening result from that reference classification. A questionnaire’s result is not itself proof of disease status; performance is assessed by comparing the questionnaire classification with the classification used to determine whether the condition is present.

What do sensitivity and false negatives mean?

In general, sensitivity is the proportion of people classified as having the condition who also screen positive. A false negative is a person classified as having the condition who screens negative. A false-negative count is an absolute number, while sensitivity is a proportion. The count alone does not show the share missed unless the number of condition-positive participants is also known. The registry record names sensitivity as the primary outcome but describes the outcome as a count of participants with false-negative screening. It reports neither the count nor the denominator.

Specificity is a related but different measure. In general, it is the proportion of people classified as not having the condition who screen negative. It requires information about the condition-negative group and screening classifications. The study’s brief summary identifies sensitivity and specificity as objectives, but the registry record does not provide either estimate or enough results to calculate them.

Why does the reference classification matter?

Any diagnostic accuracy estimate depends on how the target condition is established. If the reference classification is unclear, readers cannot tell exactly what a positive or negative HDQ result was compared against. The record does not describe a reference standard, the assessment process, or the threshold used to call the questionnaire result positive. It also does not explain how uncertainty or disagreement in disease classification was handled. These are not minor reporting details: they define the comparison underlying sensitivity and specificity.

How should uncertainty be read?

General statistical practice is to consider both an estimate and its uncertainty. A confidence interval gives a range of values compatible with the observed data under a specified method and assumptions. A narrow interval indicates greater precision than a wide interval, while an interval that spans materially different performance levels may leave the practical interpretation uncertain. The registry record does not report confidence intervals or other uncertainty measures for the primary or secondary outcomes. No precision judgment can therefore be made from the entry.

Prevalence is also an estimate whose meaning depends on the population assessed and the definition of the condition. The registry lists prevalence of haemorrhoids and prevalence of haemorrhoid symptoms as secondary outcomes. It does not report the estimates, their denominators, or their uncertainty. Generalization beyond the enrolled study population would require attention to how patients were selected and how closely they resemble the population of interest. The record describes consecutive patients seeking help from a coloproctologist, but does not give further information to assess representativeness.

What does the design imply?

The study is observational and does not describe randomized allocation. This fits an evaluation of questionnaire performance in a clinical setting, but it is not a randomized comparison of treatments. The record does not identify a separate control arm. It also does not state whether all participants received the same disease assessment or whether the assessment was performed without knowledge of questionnaire results. Such procedural details can affect diagnostic accuracy and are not reported in the registry record.

The primary outcome timeframe is 1 month. The record does not clarify what events or assessments occurred during that timeframe, nor does it report timing details needed to understand the comparison. The questionnaire is listed as the intervention, but its items, scoring rules, administration method, and positivity threshold are not available in the registry entry.

What can be inferred from the analysis information?

The registry record lists no analyses. It does not provide a statistical analysis plan, specify how missing results were handled, describe analysis populations, or report adjustments for study site or other factors. It is therefore not possible to determine whether the intended diagnostic performance measures were calculated with a prespecified method or whether the reported results, if any, were adjusted. The sample-size justification and any interim analyses are not reported in the registry record.

General planning calculations based on an observed effect are not observed power and should not be confused with evidence that an analysis had adequate precision. The registry record does not report a sample-size justification or diagnostic-accuracy results for evaluating such planning. In general, planning depends on the target accuracy, expected prevalence, desired precision, and study design. Those assumptions cannot be recovered from the registry information available.

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("Consecutive Patients Seeking Help From a Coloproct")
n      <- c(725)
events <- c(627)
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  Consecutive Patients Seeking Help From a Coloproct  725  627  86.5  83.8  88.9  83.8  88.8  83.8  88.8

11. Multiplicity, Missing Data and Analysis Populations

The study lists a primary screening outcome and secondary outcomes concerning haemorrhoid prevalence and symptom prevalence. When a study assesses multiple outcomes, general statistical interpretation should consider whether the outcomes were prespecified and whether the analysis plan addressed the possibility of chance findings across multiple tests. The registry record does not report a multiplicity strategy, a statistical analysis plan, or inferential results. It is therefore not possible to assess how multiple outcomes were handled or whether any reported comparisons were adjusted.

Missing-data handling is also not reported in the registry record. The entry does not state whether participants had incomplete questionnaire responses, missing disease assessments, or other unavailable outcome information. It does not describe exclusions, imputation, or sensitivity analyses. Without this information, readers cannot assess whether the reported enrollment and the number contributing to each outcome would be the same.

The record does not define analysis populations, such as which participants were included in the primary diagnostic analysis or how participants with indeterminate classifications were treated. It also does not report whether the analysis accounted for the multicenter setting. The number of analyses recorded is zero, and no outcome estimates are included. Thus, multiplicity, missingness, and population definitions cannot be evaluated from the registry entry.

These are reporting limitations, not evidence that a particular method was or was not used outside the registry record. The registry record does not report the relevant details.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists one study group, consecutive patients seeking help from a coloproctologist. For serious adverse events, the record lists 725 participants at risk and 0 affected. For other adverse events, it also lists 725 at risk and 0 affected. The death count is 0, and no serious adverse-event terms are listed.

These entries describe what the registry records; they do not by themselves establish that no adverse events occurred in every possible sense. The record does not give further details about how adverse events were defined, collected, monitored, or attributed. It does not describe whether the questionnaire assessment could generate events that were not captured by the listed categories.

The study evaluates a questionnaire rather than a treatment comparison, and no control group is described. The adverse-event figures should therefore be read as registry safety entries for the listed study group, not as a comparative estimate of risk. The record provides no basis for comparing these counts with another group or for estimating a treatment effect.

Because no additional safety methods or event details are reported in the registry record, the figures are best interpreted narrowly: the posted registry values are zero affected in each listed adverse-event category and zero deaths.

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

The study addresses a relevant measurement question: whether a patient-specific questionnaire could help screen for haemorrhoidal disease in Russia. Its stated rationale and intended use are described in the registry record, and the entry identifies the population as consecutive patients seeking help from a coloproctologist. Those features help explain the purpose and setting of the evaluation.

The record does not report the results needed to judge whether the HDQ identified people with haemorrhoids accurately. It gives no false-negative count, sensitivity estimate, specificity estimate, or confidence interval. The title of the primary outcome is not a result, and the stated objective of achieving appropriate sensitivity and specificity does not establish that either was achieved.

The entry also does not report the secondary prevalence results. Without those estimates and their denominators, readers cannot describe how common haemorrhoids or symptoms were in the enrolled participants. Nor can the registry information establish that these participants represent people who might encounter the questionnaire in a broader screening setting.

Even a numerical accuracy estimate would need context: the reference classification, questionnaire scoring, threshold for a positive screen, handling of incomplete assessments, and uncertainty around the estimate. Those details are not reported in the registry record. The study’s observational design and lack of a stated comparator also mean that it should not be interpreted as a randomized comparison of interventions.

In short, the entry documents a completed study with a screening objective and listed outcomes, but does not provide posted outcome findings. It can describe what was intended to be evaluated; it cannot support a conclusion about the questionnaire’s observed diagnostic performance or its effect on screening practice.

14. Why This Trial Matters Statistically

Statistically, this study matters because screening performance is not captured by a questionnaire’s stated purpose or by a single count alone. Sensitivity, specificity, and false-negative counts answer related but distinct questions. Clear reporting of the classification standard, the screening threshold, the relevant denominators, and uncertainty is necessary for readers to understand what an accuracy estimate means.

The registry entry makes the distinction especially important: the primary outcome title refers to sensitivity, while its description specifies a count of participants with false-negative screening. That is a useful reminder that outcome labels and operational definitions should align. A count can help describe missed cases, but a sensitivity estimate requires a denominator of participants classified as having the condition.

The study also highlights the importance of setting. The record describes consecutive patients seeking help from a coloproctologist, while the intended use mentioned in the study rationale includes wider screening. Evidence from a specialist-seeking population and evidence for broader screening are not automatically interchangeable. Generalization depends on the population’s disease prevalence, clinical characteristics, and the way the questionnaire is used; the registry record does not report enough information to assess those factors.

Finally, registry entries are most informative when they include results, precision, analysis populations, missing-data handling, and methods for establishing disease status. Those details are absent from this record. The study’s stated question is clear, but the entry does not provide the findings required to evaluate its answer. That gap is itself important for researchers interpreting diagnostic studies: transparent outcome reporting is necessary before performance estimates can inform scientific discussion.

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 main limitation for interpretation is that outcome results are not reported in the registry record. There is no primary false-negative count or sensitivity estimate, no specificity estimate, no confidence interval, and no secondary prevalence result. Consequently, the study’s diagnostic performance cannot be evaluated from the registry entry.

The primary outcome is not fully clear from its wording. Its title names sensitivity, but its description specifies the number of participants with false-negative screening. The record does not provide the denominator required to interpret that count as sensitivity or explain how the outcome was operationalized.

Important diagnostic methods are also not reported. The registry entry does not describe the disease reference classification, questionnaire scoring, threshold for a positive result, or the procedures used to compare screening with disease status. The timing and conduct of assessments within the 1 month timeframe are not explained. Without those details, the validity and reproducibility of an accuracy estimate could not be assessed even if one were listed.

The study population is described as consecutive patients seeking help from a coloproctologist, but additional eligibility criteria and participant characteristics are not reported. The record therefore does not establish how representative the enrolled group is of people who might be screened in other settings. The entry does not report analysis populations, missing-data methods, or how results were handled across study centers.

Finally, the registry record does not provide a statistical analysis plan, sample-size justification, multiplicity approach, or interim-analysis information. These omissions mean the analysis strategy and precision cannot be evaluated. They should be understood as gaps in the registry record, not as proof that the study team did not perform such work.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ ) — NCT04943666.
• Registry record last updated 2026-03-05; status last verified 2024-04.
• Results first posted 2026-03-05.
• 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.

19. Record Summary

The registry record describes a completed Russian multicenter observational study evaluating the Hemorrhoid Disease Questionnaire for screening for haemorrhoidal disease. It lists enrollment of 725 participants, identified as consecutive patients seeking help from a coloproctologist. The study began on 2021-07-12 and reached primary completion on 2022-11-01.

The primary outcome is titled sensitivity of the HDQ for screening and described as the number of participants with a false-negative screening result, with a timeframe of 1 month. Secondary outcomes concern the prevalence of haemorrhoids and haemorrhoid symptoms among participants.

The registry record does not report the primary or secondary outcome results, diagnostic accuracy estimates, or their precision. It also does not report the reference classification, statistical analysis plan, missing-data handling, or analysis populations. The listed safety figures are 0 affected for serious adverse events, 0 affected for other adverse events, and 0 deaths.