AsseSSing Impact in pSoriatic Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for AsseSSing Impact in pSoriatic Treatment (NCT05171270), a registered phase not stated study. The primary outcome is Number of Patients Undergoing Treatment Escalation.

2. Clinical Question

In practical terms, the study addresses whether routine use of a structured patient-impact questionnaire is related to treatment decisions in clinic. The registry summary also describes an interest in communication between patients and physicians, patient satisfaction, disease activity, and characteristics of patients and physicians that might influence decisions. These aims describe the topics under investigation, not findings. Without a reported escalation count, a comparator, and an analysis, the record cannot show whether questionnaire use was associated with more or fewer treatment changes, or whether any observed difference would be attributable to questionnaire use.

3. Trial Design

The registry record describes a study of routine PsAID-12 use in a clinic consultation for psoriatic arthritis. The listed intervention is a questionnaire, and the arm description says PsAID questionnaires were used within routine clinic consultation. Enrollment was 503. The record gives the study status as completed, with a start date of 2021-07-12 and a primary completion date of 2022-03-22.

The record does not state an allocation method. It does not describe a randomized comparison, and it does not provide a control group description suitable for a like-for-like comparison. One group is described as Psoriatic Arthritis; whether there were other study groups or how participants were assigned is not reported in the registry record. Those omissions matter when considering whether observed outcomes could be attributed to the questionnaire rather than to other differences in care or participants.

The primary outcome is the number of participants undergoing treatment escalation during the consultation visit, with a timeframe described as around 30-60 mins. Escalation includes increase in dose, frequency, change of route, or a new medication. The full population is named for this outcome. The registry also lists five secondary outcomes: reduction of therapy, mean PsAID-12 scores, median CollaboRATE score, median PEPPI score, and physicians' opinions of how PsAID-12 influenced treatment decisions. Numerical results for these outcomes are not reported in the registry record.

The record does not report a sample-size justification, eligibility criteria, recruitment setting details, protocol deviations, or a detailed statistical analysis plan. The registry’s completion status and enrollment figure describe the study record, but do not themselves establish how many participants contributed data to each outcome. The analyzed population and outcome-specific denominators 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

Analysis population for the primary outcome, as defined in the registry: Full population

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Full population

6. Primary Endpoint

The registry lists the primary outcome as Number of Patients Undergoing Treatment Escalation, measured over During the consultation visit (around 30-60 mins).

The primary endpoint is a count: the number of participants who underwent treatment escalation during the consultation visit. The registry defines escalation to include an increase in dose, an increase in frequency, a change of route, or starting a new medication. The stated timeframe is around 30-60 mins. The outcome is intended to capture a treatment decision made during the clinic encounter, rather than a later clinical response to that decision.

Counts of participants with an event can describe how often an outcome occurred in the study population. For interpretation, the count is most informative when its denominator is also clear and when the record explains how participants with missing outcome data were handled. The registry identifies the full population as the primary outcome population and reports enrollment of 503, but it does not report the number who underwent escalation or the number with evaluable primary-outcome data. Consequently, the frequency of escalation cannot be determined from the registry record.

This endpoint is relevant to the stated study aim because the investigators were interested in whether routine use of PsAID-12 was related to treatment decisions. However, an outcome count alone does not establish that questionnaire use caused a treatment change. A comparison group, a specified analysis, and information about other influences on treatment decisions would be needed to interpret an association more fully. The registry record does not report those analyses or a comparator. It also does not report whether escalation was assessed by a prespecified process beyond the listed definition.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods determine how a study turns observations into estimates and how much uncertainty to attach to those estimates. For this record, the endpoint definition and enrollment are available, but a detailed analysis plan and numerical outcome results are not reported in the registry record. The explanations below are general and should not be read as descriptions of methods that the investigators necessarily used.

What does a participant count represent?

The primary endpoint counts participants who meet the stated definition of treatment escalation during a consultation. A count is a direct description of the number of observed events. To compare groups or estimate a rate, an analysis also needs the relevant denominator and a clearly specified comparison. The registry record gives enrollment of 503 and identifies the full population for the primary outcome, but it does not give the number with escalation or the number with evaluable outcome data. It is therefore not possible to derive an outcome frequency from the record. No additional percentage or rate can be inferred without the missing numerator and denominator information.

In general, a binary outcome can be recorded for each participant as an event or no event, and the study can report the number of participants with the event. A count is not itself an effect estimate comparing treatment strategies. If a study has a suitable comparator, an analysis may quantify differences between groups, with uncertainty reflecting the amount and variability of the data. Here, a comparator and a between-group analysis are not reported in the registry record.

Why does the comparison structure matter?

General statistical interpretation depends on how participants enter each group. Random allocation, when used and properly implemented, can help balance measured and unmeasured characteristics on average. A nonrandomized or single-group description does not provide the same protection against confounding. The registry record does not state allocation and does not present a like-for-like control comparison. Consequently, any unreported association between questionnaire use and treatment escalation could not be interpreted as a causal effect based on this record alone.

Confounding occurs when other factors influence both the exposure or group assignment and the outcome. The registry summary identifies patient characteristics, physician characteristics, disease activity, and the quality of patient-physician interactions as factors of interest. The record does not report which factors were measured, how they were analyzed, or whether any adjusted estimates were produced. It would be speculative to describe a particular adjustment method.

How should uncertainty be understood?

General explanation: an estimate describes the data observed in a study, while a confidence interval describes uncertainty around that estimate under the assumptions of the statistical method. A narrow interval generally indicates greater precision than a wide interval, but the interval does not remove bias from study design, measurement, or missing data. No primary-outcome estimate or confidence interval is reported in the registry record, so precision cannot be judged. The record also does not report a p-value or a hypothesis-testing result.

For a count outcome, an analysis may use methods appropriate to the data structure and the comparison being made. The choice depends on matters such as whether observations are independent, whether participants are grouped or measured repeatedly, and whether a comparator exists. The registry record does not specify an analysis model, and no particular model should be attributed to the investigators. In general, model assumptions matter because an apparently precise estimate can be misleading if the method does not fit the data or design.

What do the planning illustrations mean?

General explanation: a sample-size calculation is a planning exercise about how much information a future study might need to detect a chosen effect under stated assumptions. The registry’s planning-illustration description says the calculation uses the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set as a stated fraction of the observed effect. For time-to-event outcomes, that description says the illustration gives total events; for other outcomes, it gives participants per arm.

Those assumptions describe a planning illustration, not the study’s own design justification. A planning result is not observed power and does not establish that the study was adequately designed. The registry record does not report the study’s sample-size justification. Because a like-for-like two-arm comparison and an observed primary effect are not reported, the illustration assumptions should not be mistaken for evidence about the actual study design or its findings.

General explanation: over-dispersion occurs when the variation in count data exceeds what a chosen model expects. If ignored, standard errors can be too small and uncertainty intervals too narrow. Whether over-dispersion is relevant depends on the data and analysis model; no count-model diagnostics or model details are reported in the registry record. There is no basis to say that over-dispersion occurred in this study.

What can be said about recalculation?

No sponsor estimate, analysis result, or recalculated estimate for the primary outcome is reported in the registry record. A simple recalculation from summary statistics could describe an unadjusted result, but it would not replace an analysis that accounts for the actual design or participant-level information. Where a discrepancy exists, the sponsor’s own analysis takes precedence; a discrepancy is not reported in the registry record. In this case, the absence of the outcome summary means no recalculation can be described.

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("Psoriatic Arthritis")
n      <- c(503)
events <- c(160)
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  Psoriatic Arthritis  503  160  31.8  27.8  36.1  27.9  36.0  27.9  36.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and five secondary outcomes, covering therapy reduction, PsAID-12 scores, patient-physician interaction scores, and physician opinion of questionnaire influence. When a study examines multiple outcomes or multiple analyses, the chance of at least one apparently notable result can increase. General approaches to multiplicity include prespecifying a primary outcome, adjusting inference across a defined family of tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity plan or an adjustment procedure.

The presence of a listed primary endpoint helps identify the principal outcome of interest, but does not reveal how tests were conducted or interpreted. The record reports no analyses, and no numerical results for the primary or secondary outcomes. It is therefore not possible to determine whether the analyses followed a prespecified hierarchy, whether any adjustment was used, or how secondary outcomes should be weighted relative to the primary outcome. These details are not reported in the registry record.

Missing data can affect both the estimate and its precision. General explanation: if outcome data are absent for some participants, an analysis needs to state how those observations were handled and whether assumptions were made about why they were missing. The registry reports enrollment of 503 and identifies the full population for the primary outcome, but it does not report the number with observed outcome data, missingness by outcome, exclusions, or a missing-data method. A complete-case analysis, imputation, or any other approach should not be assumed.

The record does not report interim analyses, stopping rules, or a detailed analysis population beyond the full population named for the primary outcome. It is also unclear whether all enrolled participants contributed to each secondary measure. Those omissions limit assessment of selective reporting, missing-data bias, and the consistency of the analysis population across outcomes.

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 reports 503 participants at risk for serious adverse events and 0 participants affected. It also reports 503 at risk for other adverse events and 0 affected, with 0 deaths. The serious adverse event terms list is empty. These are the safety figures recorded for the Psoriatic Arthritis group.

Zero recorded events means that no events in those categories are reported in the registry record. It does not by itself establish that no adverse events occurred, that every participant was monitored in the same way, or that all relevant events were captured. The record does not describe the safety surveillance method, event definitions, reporting period beyond the study record, or whether participants had complete safety follow-up. The at-risk count is the listed denominator; it should not be assumed to mean that every participant had complete safety data.

These figures are descriptive and do not compare risks between treatment groups. A comparator is not described, and the registry does not report a comparative safety analysis. They also do not address risks outside the categories and reporting in the record. The appropriate reading is limited: the registry lists zero serious adverse events, zero other adverse events, and zero deaths among the stated at-risk counts, while details needed to assess ascertainment and completeness are not reported in the registry record.

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

The registry record establishes that a study of routine PsAID-12 questionnaire use in psoriatic arthritis clinic consultations was completed, with enrollment of 503. It specifies a primary process outcome: the number of participants undergoing treatment escalation during a consultation described as around 30-60 mins. It also defines which treatment changes count as escalation. These details clarify what the investigators intended to measure.

The record does not report the primary outcome count, secondary outcome values, or analyses. It therefore does not show how often escalation occurred, whether the questionnaire was associated with a change in treatment decisions, or how patient satisfaction and interaction measures were distributed. No estimate of effect or precision can be read from the reported enrollment and endpoint definition alone.

Even if an outcome count were available, an uncontrolled description would not by itself establish that questionnaire use caused the result. The registry does not state allocation and does not provide a like-for-like control comparison. Other patient, physician, disease, and interaction characteristics are identified as potential influences, but their measurements and analyses are not reported. An association, if one were reported elsewhere, would need to be interpreted in light of those design and analysis limitations.

The stated purpose of using PsAID-12 was to understand individual patient impact, support communication, and relate questionnaire use to treatment decisions and satisfaction. Those aims are not findings. The registry record neither demonstrates improvement nor demonstrates lack of improvement in communication or satisfaction. It also does not report evidence about longer-term clinical outcomes or the consequences of treatment changes.

The safety record lists zero serious adverse events, zero other adverse events, and zero deaths among 503 participants at risk in each category. This is a description of recorded events, not proof that risk was absent. Taken together, the record conveys the study question, its primary outcome definition, and the scale of enrollment, but does not provide enough outcome or analysis information to draw a statistical conclusion about the study’s central question.

14. Why This Trial Matters Statistically

This study is statistically interesting because it focuses on a decision made during routine care rather than only on a biological or symptom measurement. A questionnaire intended to capture patient-reported impact may contribute information that is not conveyed by clinical measures alone. The registry summary frames treatment decisions as potentially influenced by patient and physician characteristics, disease activity, and the quality of their interaction. This makes the question relevant to how clinical decisions are studied, not just to how a questionnaire score is summarized.

At the same time, process outcomes need careful interpretation. A treatment escalation count can describe what clinicians did during consultations, but it does not alone explain why a change occurred or whether it was appropriate. For a statistical comparison, the design needs to support a meaningful contrast, and the analysis needs to account for the outcome data and the way participants entered groups. The registry does not state allocation or report a control comparison, so causal interpretation is not available from this record.

The record also illustrates why endpoint definitions and reporting completeness matter. It clearly defines treatment escalation to include several kinds of treatment change and identifies the consultation timeframe. Yet without the event count, denominator, uncertainty estimate, and analysis, a reader cannot judge the magnitude or precision of the primary result. Reporting the numerical outcomes and analysis population would be essential for evaluating what the study found.

The listed secondary measures span patient impact, patient-physician interaction, and physician opinion. Such measures can broaden understanding of a care process, but multiple outcomes raise questions about prespecification and multiplicity. The registry does not report how these outcomes were analyzed or whether any multiplicity approach was used. The study therefore raises a useful statistical question about linking patient-reported information to clinical decisions, while the registry record leaves the results and inferential framework unresolved.

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 central limitation for interpreting this registry record is that no numerical result is reported for the primary endpoint. The number of participants who underwent treatment escalation is not reported in the registry record, nor are an estimate of frequency, a confidence interval, or a p-value. Enrollment of 503 does not indicate how many participants had complete primary-outcome data.

The comparison structure is also unclear. Allocation is not stated, and a like-for-like control comparison is not described. The record lists Psoriatic Arthritis as a group and describes routine questionnaire use, but does not establish how participants were selected or assigned. Without that information, attribution of any treatment decision to questionnaire use would be limited even if an outcome estimate were available.

Further detail needed to assess the result is not reported in the registry record. This includes eligibility criteria, baseline characteristics, outcome-specific denominators, missing-data handling, analysis populations, a detailed statistical analysis plan, and the methods used to assess treatment escalation. The record does not report interim analyses or a multiplicity plan. It also does not give numerical results for the five secondary outcomes.

The summary identifies several possible influences on treatment decisions, including patient and physician characteristics, disease activity, and interactions. Their measurement and role in analysis are not reported. The record therefore does not show whether these factors were balanced, accounted for, or related to escalation. Finally, safety counts are presented without details of event collection or completeness. These limitations concern what can be inferred from the registry record; they do not establish that the study itself lacked additional methods or results outside the record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: AsseSSing Impact in pSoriatic Treatment — NCT05171270.
• Registry record last updated 2024-09-25; status last verified 2023-12.
• Results first posted 2024-09-25.
• 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 for NCT05171270 describes routine use of the PsAID-12 questionnaire in clinic consultations for psoriatic arthritis. Enrollment was 503, and the record lists the study as completed, with a start date of 2021-07-12 and a primary completion date of 2022-03-22.

The primary outcome is the number of participants undergoing treatment escalation during a consultation described as around 30-60 mins. Escalation includes an increase in dose or frequency, a change of route, or a new medication. Five secondary outcomes are listed, addressing therapy reduction, questionnaire scores, patient-physician interaction, and physician opinion.

The primary and secondary numerical results and analyses are not reported in the registry record. Allocation is not stated, and a like-for-like control comparison is not described. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths among 503 participants at risk for each category. The record defines the study question and endpoint, but does not provide the outcome information needed to estimate an effect or its precision.