The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial (NCT03508661), a na na study. The primary outcome is Participant Feedback on Usability of Program Materials.

2. Clinical Question

Population: People living with systemic sclerosis, also called scleroderma, who lead or are involved in peer-led support groups are the broader population relevant to the program. This feasibility trial enrolled participants in a support group leader education program; further participant characteristics are not reported in the registry record.

Intervention: The SPIN-SSLED Program is described as a 13-session program. Its stated aims include improving support group leader confidence and self-efficacy, reducing burnout, and supporting emotional well-being and health-related quality of life. These are program aims, not findings from this trial.

Comparator: There was no separate comparison group. The registry record identifies a single-group study, with allocation and masking listed as not applicable and none, respectively. Consequently, there is no like-for-like control group for estimating a comparative treatment effect.

Primary question: At the 13 week timeframe, did participants find the program materials useful? The primary endpoint is described as participant feedback gathered through interviews, with the number of participants who found the materials useful recorded. The registry record does not report that number, the denominator used for the endpoint, or interview findings. The trial therefore documents a feasibility question and its intended measurement, but the posted record does not permit a reader to establish how participants answered.

The broader motivation was to address barriers to support groups, including limited access, difficulties sustaining groups, and the demands placed on leaders. The study is not a randomized evaluation of whether the program improves participant outcomes relative to usual practice. Measures of self-efficacy, health, and burnout are listed as secondary outcomes, but their results are not reported in the registry record.

3. Trial Design

This was a completed, single-group feasibility trial of the SPIN-SSLED Program. The registry lists an enrollment of 10 and describes the intervention as a 13-session program. The study concerned scleroderma, also known as systemic sclerosis, and was sponsored by the Lady Davis Institute. The listed study start was 2018-04-18, and the primary completion date was 2018-08-10.

A single-group design does not include a concurrent control arm. The record lists allocation as not applicable and masking as none. The study is therefore not a randomized comparison, and changes measured among participants cannot be separated from other influences by comparison with a control group. It is better understood as a feasibility evaluation than as a controlled estimate of intervention effect.

The primary outcome was participant feedback about whether the program materials were useful, collected through interviews at the 13 week timeframe. Secondary outcomes named in the record include the Scleroderma Support Group Leader Self-efficacy Scale, the Personal Health Questionnaire, the PROMIS-29 Profile Version 2.0, and the Oldenburg Burnout Inventory. The record lists 11 outcome measures, but does not report results for those measures.

The registry record does not report the phase of the trial beyond listing it as not applicable, nor does it describe a comparator, randomization procedure, or masking procedure beyond the entries noted above. It also does not report further details about recruitment, participant eligibility, adherence, or completion of program sessions. Those details should not be inferred from the intervention description or enrollment figure.

The record marks the study as completed. Completion status and dates do not by themselves establish that all planned outcomes were collected or analyzed. The registry record lists no analyses, and the primary usability count is not reported. The available record can therefore be used to describe the trial’s broad design and intended feasibility question, but not to evaluate the program’s observed effects.

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: One of the 10 participants who initially indicated that she would participate was hospitalized and was unable to take part before providing informed consent. This participant was replaced with one of the remaining interested support group leaders that were contacted prior to the start of the program. Thus, 10 participants were enrolled.

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 Participant Feedback on Usability of Program Materials, measured over 13 week.

The primary endpoint is participant feedback on the usability of the program materials. The record describes participant interviews in which participants were asked whether they found the materials useful. The outcome was the number of participants who said they did. The stated timeframe is 13 week.

This kind of endpoint is relevant to a feasibility trial because it addresses whether intended users find the materials useful, an issue that can affect whether a program is practical to deliver and acceptable to participants. It is distinct from an outcome such as a measured change in self-efficacy, emotional well-being, or health-related quality of life. A favorable usability response would not, by itself, establish improvement in those other outcomes.

The primary endpoint is defined as a count of participants, but the registry record does not report the observed count or the denominator for that count. It also does not report interview questions, how responses were categorized, whether all participants were interviewed, or how missing responses were handled. Without those details and the result, the posted record does not support a numerical summary of usability or a judgment about how consistent participant feedback was.

As a general statistical point, a count is easier to interpret when its denominator and the way responses were classified are clear. Here, neither the endpoint count nor its denominator is reported in the registry record. The endpoint definition explains what the investigators intended to measure, but it is not itself evidence of the participants’ responses.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design estimate?

In general, a single-group study describes outcomes among people who take part in an intervention without comparing them with a separate control group. Such a design can be useful for examining feasibility questions, including whether materials are usable or whether a program can be delivered. It does not, on its own, distinguish an intervention effect from changes that might have occurred for other reasons. The registry record identifies this trial as single-group and non-randomized, so it does not support a treatment-versus-control estimate.

In a randomized comparison, allocation is used to create groups that can be compared under the study design. This record lists allocation as not applicable and has no control group. Statistical methods that rely on between-group comparisons are therefore not appropriate descriptions of the primary design. The record does not report an adjusted comparison or another comparative analysis.

How should the primary count be understood?

The primary outcome is defined as a count of participants who found the program materials useful. In general, a participant-level response can be classified into outcome categories and then summarized as a count. The count’s interpretation depends on the response definition, the number asked, and how incomplete responses are treated. The record gives the intended question and count, but does not report the observed result, denominator, response categories in detail, or handling of missing interview data.

A count does not automatically convey precision. General methods for expressing uncertainty around a count or a proportion require relevant outcome data and a clearly defined denominator. Neither is reported for the primary endpoint. No confidence interval or other uncertainty estimate for usability is reported in the registry record, and none can be reconstructed from the endpoint description alone.

What can the secondary measures contribute?

The registry names measures of self-efficacy, depressive symptoms, health-related quality of life, and burnout: the Scleroderma Support Group Leader Self-efficacy Scale, PHQ-8, PROMIS-29 Profile Version 2.0, and OLBI. In general, validated questionnaires can operationalize constructs that are not directly observed, but interpretation depends on scoring details, timing, completeness, and the analysis used. The registry record does not report secondary outcome values, changes, uncertainty estimates, or analyses. The measure names alone do not show whether any construct changed.

Repeated measurements can be useful for describing how outcomes vary over time. However, a change within one group is not equivalent to a controlled estimate of an intervention effect. Without a comparator, other influences over time cannot be ruled out by the design. The registry record does not report the schedule of secondary measure assessments or the statistical approach for analyzing them.

How should planning calculations be read?

The registry’s accompanying planning note describes illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that this trial used a two-arm design: the actual trial is listed as single-group and not randomized.

In general, a sample-size calculation estimates how many participants a future study might need under specified assumptions about the effect, variability, significance level, and design. Such illustrations are not observed power and do not show that a study detected an effect. The planning note says that time-to-event illustrations refer to total events, while other illustrations refer to participants per arm. The record does not report a trial-specific sample-size justification or statistical plan, and the planning assumptions should not be presented as the trial’s own design.

The record does not give the underlying observed effect or numeric planning outputs in the trial details. Consequently, those illustrations cannot be interpreted as a numeric recommendation for this intervention from the registry record alone. A reader should distinguish a planning scenario for a possible future study from observed results of the feasibility trial.

What does a confidence interval usually express?

In general, a confidence interval describes the range of estimates compatible with the observed data under a specified statistical method. A wider interval indicates less precision than a narrower one, while the interval’s location describes which effect values are compatible with the data. A confidence interval does not correct design limitations, establish causality, or guarantee that the true effect falls within its endpoints. No confidence interval for the primary or secondary outcomes is reported in the registry record.

For event counts, statistical methods may need to account for the distribution of the outcome and the way participants were observed. General methods can be affected by over-dispersion, meaning variability greater than a simple model assumes; that can make standard errors too small if not accommodated. This trial’s primary endpoint is a participant count, but the record does not report enough outcome data or an analysis method to assess a count model, over-dispersion, or any uncertainty calculation.

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("SPIN-SSLED Program")
n      <- c(10)
events <- c(10)
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  SPIN-SSLED Program  10  10  100.0  69.2  100.0  72.2  100.0  71.5  99.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures, along with a primary usability endpoint and secondary measures. When a study examines multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately without a prespecified strategy. In general, investigators may define a hierarchy of outcomes or use an adjustment procedure. The registry record does not report a multiplicity strategy, so it is not possible to determine how the outcome set was handled analytically.

The record lists no analyses and does not report results for the primary or secondary outcomes. It therefore does not show which outcomes were analyzed, what statistical tests or models were used, or whether any adjustment was applied. No inference about statistical significance across multiple endpoints can be made from the outcome names alone.

Missing data handling is also not reported in the registry record. For the interview endpoint, the record does not give the number interviewed, the number responding to the usefulness question, or how absent or ambiguous responses were treated. For the secondary measures, it does not describe missing questionnaires, incomplete scales, or the analysis population used.

In general, an analysis population describes which participants contribute to an analysis, such as everyone enrolled or only those with an observed measurement. The registry record does not state an analysis population for any endpoint. Enrollment should not be assumed to equal the number analyzed. Without this information, readers cannot assess whether the reported outcome data, if available elsewhere, reflect all enrolled participants or a subset.

No imputation method, sensitivity analysis, or missing-data assumption is reported in the registry record. These are important because the interpretation of observed outcomes can depend on why data are missing and how the analysis treats them. The record does not provide enough information to assess those issues.

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 the SPIN-SSLED Program group as having 10 participants at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the event figures recorded for the group. The record does not list serious adverse event terms.

In general, an event count of zero means that no events in that category were recorded in the reported data. It does not demonstrate that no participant experienced any symptom or unwanted experience. That interpretation depends on how events were defined, monitored, reported, and collected. The registry record does not provide those details.

The at-risk figure is a safety denominator, not a reported denominator for the primary usability endpoint. It should not be used to infer how many participants completed interviews or contributed secondary outcome data. The record also has no control group, so the safety entries cannot establish a comparative difference in event risk. The posted safety figures are descriptive observations from this single group, not proof of safety or evidence about comparative harms.

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

This feasibility trial is relevant because it focused on an educational program intended for leaders of peer support groups for people with scleroderma. The record describes a practical question about whether participants found program materials useful, rather than a randomized test of clinical effectiveness. It also identifies secondary measures relevant to leader self-efficacy, health, and burnout.

The results that can be described from this record are limited. Enrollment was 10, and the intervention is described as a 13-session program. The primary endpoint definition is available, but its observed count and denominator are not reported in the registry record. Secondary outcome results are also not reported. The posted record therefore does not show whether participants found the materials useful or whether the listed questionnaire outcomes changed.

The study’s single-group structure matters for interpretation. Without a concurrent comparator, outcomes cannot establish what would have happened under another condition. Even a reported change over time would be descriptive rather than a controlled estimate of the program’s effect. No treatment effect, between-group difference, or causal conclusion can be obtained from the information in the record.

The safety entries show 0 serious adverse events, 0 other adverse events, and 0 deaths recorded in the listed group. Those figures should be read as event counts, with the limits of the registry’s reporting in mind. They do not establish that no adverse experiences occurred or provide a comparison with another intervention.

Thus, the record explains the feasibility rationale and intended measurements, but does not publish the outcome evidence needed to answer its primary usability question. It does not show that the program works or does not work. Nor does the absence of a reported outcome count mean that the result was zero; the result is simply not reported in the registry record.

14. Why This Trial Matters Statistically

Feasibility studies address questions that are important before a larger evaluation: whether an intervention can be delivered and whether its materials are usable to the people expected to engage with them. For a program aimed at support group leaders, user feedback can inform the practical acceptability of the educational materials. The SPIN-SSLED trial’s primary endpoint was designed around that kind of question.

Statistically, it is important to distinguish the feasibility purpose from an effectiveness claim. A single-group study can describe participants’ experiences, but it lacks the concurrent comparison needed to estimate a controlled treatment effect. Its results, even if fully reported, would need to be interpreted within that design. In this registry record, the primary usability count and secondary outcome results are not reported, which further narrows the conclusions available.

The record also illustrates why outcome definitions and results must be read separately. It specifies the question asked in interviews and the count intended for the primary endpoint. That description clarifies the planned measurement, but does not tell readers what participants said. A result requires the observed count, a relevant denominator, and enough information to understand how responses were handled.

The distinction between trial data and future-study planning is also important. Planning illustrations can help frame a possible later study under stated assumptions, but they are not observed power and do not replace actual outcome reporting. The registry’s planning note describes a hypothetical two-arm setup even though this feasibility study itself is single-group. Keeping those two purposes separate prevents a planning scenario from being mistaken for evidence about the trial’s findings.

For clinical researchers and statisticians, this record underscores the value of transparent reporting of participant flow, outcome denominators, missing data, analysis populations, and statistical methods. Those details are necessary to judge how precise and complete a result is, especially when a small feasibility study is intended to inform later research.

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 principal limitation of the available record is that it defines the primary usability endpoint without reporting the observed count or its denominator. The intended interview question is described, but the registry record does not report response frequency, interview completion, or a summary of participant feedback. As a result, the primary feasibility outcome cannot be evaluated from the posted results.

The single-group design is an additional limitation for interpreting effects. There is no concurrent control group and no randomized comparison. The study can therefore not isolate program-related changes from other influences. This design is consistent with a feasibility question, but it does not support a comparative effectiveness estimate.

The record lists secondary questionnaires but does not report their results, assessment schedule, scoring, or analysis. It does not state how many participants completed each instrument or how incomplete responses were handled. Enrollment is reported, but it should not be treated as the denominator for every outcome.

Further details about participant characteristics, recruitment, eligibility, engagement with the 13-session program, and completion of sessions are not reported in the registry record. The record also does not report an analysis population, statistical plan, missing-data approach, or multiplicity strategy. These omissions make it difficult to assess selection, adherence, precision, and the robustness of any outcomes.

Finally, the safety information consists of recorded event counts without reported event terms or further monitoring details. The absence of recorded events in the listed categories is not equivalent to evidence that no adverse experiences occurred. Together, these limitations mean that the registry record supports a description of the study’s aims and design, but provides little basis for judging its observed feasibility outcomes.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial — NCT03508661.
• Registry record last updated 2020-02-12; status last verified 2020-02.
• Results first posted 2020-02-12.
• 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 Scleroderma Patient-centered Intervention Network Support Group Leader Education Program Feasibility Trial was a completed, single-group study of the SPIN-SSLED Program. The record lists enrollment of 10 and describes a 13-session intervention. The listed study start was 2018-04-18, and the primary completion date was 2018-08-10.

The primary outcome concerned interview feedback on whether participants found the materials useful, at the 13 week timeframe. The observed count and denominator are not reported in the registry record. Secondary measures included scales addressing self-efficacy, depressive symptoms, health-related quality of life, and burnout, but their results are not reported.

The safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths. With no control group, these are descriptive figures only. Overall, the registry record describes a feasibility study and its intended measurements, but does not report the primary outcome result or enough analysis detail to assess outcome precision.