This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Personalized Risk Estimator for Rheumatoid Arthritis Family Study (NCT02046005), a randomized na study. The primary outcome is Contemplation Ladder.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02046005 |
| Phase | NA |
| Condition | First Degree Relatives of Rheumatoid Arthritis Patients |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 238 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Brigham and Women's Hospital |
| Results posted | Yes |
2. Clinical Question
Population
People with a first-degree relative with rheumatoid arthritis (RA) who do not have RA themselves and meet the study’s eligibility requirements. Further eligibility details are not reported in the registry record.
Intervention
Personalized RA risk education through the PRE-RA online risk tool, either on its own or with guidance from a health educator.
Comparator
General information about RA, described as the comparison arm.
Primary question
Does willingness to change RA-related behaviors, measured against baseline, differ over follow-up for the PRE-RA groups compared with general RA education?
The study’s stated focus is willingness to change behaviors associated with RA risk, not the development of RA. The primary measure is called the Contemplation Ladder. Its registry description says it assesses willingness to change any of four RA-related behaviors compared with baseline. The planned comparisons are between each PRE-RA group and the comparison arm, using measurements taken immediately after the intervention, at 6 weeks, and at 6 months.
The investigators hypothesized that participants receiving the online risk tool with health education would be more willing to change RA-related behaviors than participants receiving general RA information. That statement describes the study hypothesis, not a finding. The registry record does not report primary-outcome estimates, uncertainty intervals, or test results, so it does not establish whether the observed data supported the hypothesis. The size and direction of any difference in willingness are not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group behavioral study with no masking. The registry lists enrollment as 238 and identifies the study as completed. The study began in 2014-01, and primary completion was recorded as 2016-09. The registry lists the phase as NA, which is consistent with the behavioral intervention descriptions and should not be read as a drug-development phase.
Participants were assigned to one of three groups. General Rheumatoid Arthritis Education provided general information about RA. PRE-RA used an online tool to communicate personalized RA risk education. PRE-RA Plus combined the PRE-RA tool with guidance from a health educator. The registry does not report the allocation ratio, the method used to generate or conceal the random assignment, or whether assignment was stratified.
The comparison is therefore not simply between receiving information and receiving none: all three groups had an educational component, but its form differed. The two personalized-risk groups can be compared separately with the general-information group, as specified in the outcome description. A direct comparison between PRE-RA and PRE-RA Plus is not described as the primary comparison in the registry record.
Follow-up for the primary measure was scheduled immediately after the intervention, at 6 weeks, and at 6 months. The registry describes the measure as a comparison with baseline, but does not report the detailed timing of baseline assessment, the number of participants assessed at each follow-up, or the analysis population. It also does not report the intervention delivery procedures beyond the arm descriptions. Those omissions limit how fully the conduct of the trial can be reconstructed from the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | General Rheumatoid Arthritis Education | PRE-RA | PRE-RA Plus |
|---|---|---|---|
| STARTED | 80 | 78 | 80 |
| COMPLETED | 72 | 71 | 70 |
| NOT COMPLETED | 8 | 7 | 10 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | General Rheumatoid Arthritis Education | PRE-RA | PRE-RA Plus | Total |
|---|---|---|---|---|---|
| Participants analysed | 80 | 78 | 80 | 238 | |
| Age, Continuous | years | 43.4 (SD 14.7) | 45.0 (SD 14.9) | 48.3 (SD 13.7) | 45.6 (SD 14.5) |
| Sex: Female, Male: Female | Participants | 63 | 62 | 57 | 182 |
| Sex: Female, Male: Male | Participants | 17 | 16 | 23 | 56 |
| Race/Ethnicity, Customized: White | Participants | 69 | 65 | 73 | 207 |
| Race/Ethnicity, Customized: Non-White | Participants | 11 | 13 | 7 | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Contemplation Ladder, measured over Immediately, 6 weeks, and 6 months after intervention.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary measure is the Contemplation Ladder, described as measuring participants’ willingness to change any of four RA-related behaviors compared with baseline. It is assessed immediately after the intervention, at 6 weeks, and at 6 months. The stated analysis uses generalized estimating equations (GEE) to compare the PRE-RA groups with the general-information comparison arm.
Willingness is relevant to the study’s behavioral question because the investigators wanted to assess whether personalized communication about risk was associated with participants’ readiness to change behaviors. It is not the same as measuring whether a behavior actually changed, whether a biological risk factor changed, or whether someone developed RA. The registry description does not give the four behaviors, the ladder’s scoring rules, the threshold used to define a change, or how the endpoint was converted into the reported count of participants.
Repeated measurements can describe how responses vary across follow-up rather than relying on a single post-intervention assessment. However, the registry record does not report a single numerical primary-outcome comparison or results at the listed time points. Those outcome results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and describes the intended primary analysis, but it does not report the primary-outcome results. There is no reported estimate of the difference in willingness to change, no confidence interval, and no test result for either PRE-RA group compared with general RA education. Consequently, the direction, magnitude, and precision of the primary finding cannot be assessed from this record. A hypothesis is not evidence that the hypothesized result occurred.
The enrollment entry is 238, but the record does not state how many participants contributed primary-outcome data at baseline or at each follow-up. Nor does it report outcome counts by arm or time point. Without those details, the size of any observed change, the amount of missing follow-up information, and the extent to which results might be affected by missingness cannot be evaluated.
The recorded endpoint concerns willingness, not behavior change itself or RA incidence. Even if an outcome estimate were available, it would need to be interpreted as evidence about the measure and the follow-up period studied. It would not by itself establish changes in actual behavior or future disease risk. The registry’s description does not report a validated mapping from a change in the Contemplation Ladder to either of those outcomes.
The primary outcome description names two comparisons against the general-information arm and repeated follow-up assessments. The registry record does not report whether the investigators adjusted for multiple comparisons, which time point or summary was treated as the main contrast, or whether the reported analysis followed an intention-to-treat approach. These details matter when interpreting the strength and scope of any statistical claim, but cannot be inferred from the stated use of GEE.
The adverse-event entries list zero serious events, zero other adverse events, and zero deaths in each group’s recorded at-risk population. These are registry counts, not evidence that the interventions have no risks. The record does not provide further detail on adverse-event collection, definitions, or follow-up completeness. Overall, the registry supports a description of the trial question and design, but not a conclusion about the primary outcome’s result or precision.
9. Statistical Methods Explained
The registry describes the primary analysis as using generalized estimating equations (GEE) to compare the PRE-RA groups with the comparison arm. It does not give the full statistical analysis plan. In particular, the outcome description does not specify the link function, working correlation structure, covariates, handling of missing measurements, or the exact contrast used to summarize change. Those choices are not reported in the registry record.
What does GEE do?
In general, GEE is a method for estimating average relationships when observations are correlated within a participant. Repeated measurements from the same person are usually more alike than measurements from different people. Treating every measurement as independent can understate uncertainty. GEE accounts for the repeated-observation structure when estimating average differences or associations across groups and time.
In this study, measurements were planned at baseline and at multiple follow-up points, and the registry describes comparisons of the PRE-RA groups with general RA education. That makes a repeated-measures approach relevant in principle. The registry record does not say how the correlation among a participant’s measurements was modeled, or whether the analysis focused on group differences at each visit, an overall group effect, or a group-by-time pattern. Those are distinct statistical questions, and the method name alone does not identify which one was reported.
What does a confidence interval mean?
In general, a confidence interval describes the statistical uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. Its interpretation depends on the outcome definition, analysis population, model, and data completeness. No primary-outcome estimate or confidence interval is reported in the registry record, so the precision of the study’s main comparison cannot be judged.
Why does the outcome definition matter?
The outcome is titled Contemplation Ladder and described as a measure of willingness to change any of four RA-related behaviors. The registry also characterizes the primary result as a count of participants. It does not explain how ladder responses or changes across the four behaviors were classified to form that count. Without scoring and classification details, it is not possible to determine precisely what an event in the analysis represents or how much change the measure captures.
For a binary outcome, a model generally compares the probability of a defined event between groups, potentially accounting for repeated observations. That general description should not be mistaken for a report of the exact model used in this study: the registry does not specify the event threshold, link function, or whether the estimates were expressed on an absolute or relative scale. No such estimate is reported.
Why can over-dispersion matter?
In general, over-dispersion occurs when the variation in an outcome is greater than a model assumes. If it is not accounted for, standard errors and confidence intervals can be misleading. The registry identifies the primary measure as a count of participants, but does not report a dispersion estimate or say that over-dispersion was assessed. The outcome description alone is not enough to decide whether it was a practical concern in the analysis.
Randomization is intended to make assigned groups comparable on average, but it does not guarantee that every characteristic is balanced in a particular trial. The record says the study was randomized; it does not report baseline characteristics or any adjustment strategy. Likewise, the use of GEE does not by itself establish that all participants were analyzed according to assignment or indicate how data from participants with incomplete follow-up were handled.
Any sample-size calculations based on an observed effect are planning illustrations, not observed power and not a substitute for the trial’s original design rationale. The registry record does not report the original sample-size justification or whether the study used interim analyses. It also does not report enough primary-outcome results to assess the precision achieved. These limitations mean that a statistical interpretation should remain tied to what is actually documented: the planned comparisons, measurement schedule, and stated analysis method.
10. Multiplicity, Missing Data and Analysis Populations
The primary description includes two personalized-risk groups compared with the general-information group, as well as repeated assessments immediately after the intervention, at 6 weeks, and at 6 months. It also refers to willingness to change any of four RA-related behaviors. Considering multiple groups, time points, or behavioral measures can create multiple opportunities to identify a result that appears statistically notable by chance.
In general, multiplicity can be addressed by prespecifying one primary contrast or time point, adjusting the statistical threshold, or using a method that accounts for multiple comparisons. The registry record does not report whether any adjustment was planned or used, nor does it identify a hierarchy among the listed comparisons and time points. It would therefore be inappropriate to assume that the reported analysis controlled the overall false-positive risk.
The record does not report the number of participants with outcome data at each assessment, the reasons for missing measurements, or the method used to handle missing data. In general, complete-case analysis can be biased if the availability of measurements is related to outcomes or group assignment. Other approaches require assumptions about the missingness process. The registry does not identify which approach, if any, was used.
The analysis population is also not reported. The record does not state whether participants were analyzed in their randomized groups, whether eligibility or follow-up exclusions were applied, or how deviations from assigned intervention were treated. These details are needed to understand the scope of any estimate and its relation to the randomized comparison. The primary results and their analysis population are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| General Rheumatoid Arthritis Education | 0 | 80 | 0.0% |
| PRE-RA | 0 | 78 | 0.0% |
| PRE-RA Plus | 0 | 80 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| General Rheumatoid Arthritis Education | 0 of 80 |
| PRE-RA | 0 of 78 |
| PRE-RA Plus | 0 of 80 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| General Rheumatoid Arthritis Education | 0 of 80 |
| PRE-RA | 0 of 78 |
| PRE-RA Plus | 0 of 80 |
The registry lists serious adverse events, other adverse events, and deaths separately for each group. For General Rheumatoid Arthritis Education, 80 participants were listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For PRE-RA, 78 were listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For PRE-RA Plus, 80 were listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths.
These are the recorded counts in the registry, and they should be read as such. A zero count does not establish that no event occurred outside the captured reporting process, or that the interventions carry no risk. The record does not describe the adverse-event collection procedures, the definitions used, the observation period for safety, or the completeness of reporting. It also does not give event-level descriptions because no serious-event terms are listed.
The at-risk counts are presented by group; they should not be mistaken for the primary-outcome analysis population or follow-up completion counts. The registry does not provide a safety comparison with uncertainty estimates. Thus, the entries offer a concise account of reported event counts, but they do not support a detailed comparison of safety between groups.
12. What the Result Does, and Does Not, Mean
This trial asks a focused communication question: whether personalized RA risk education, with or without health-educator guidance, is associated with a change in participants’ willingness to modify RA-related behaviors compared with general RA information. Its randomized, parallel-group design and repeated outcome assessments are relevant to that question. The registry record, however, does not report the numerical primary-outcome findings.
Because the primary estimates, confidence intervals, and test results are absent, the record cannot establish whether willingness changed differently across groups, how large any difference was, or how precisely it was estimated. The investigators’ stated hypothesis about PRE-RA Plus remains a hypothesis in the absence of reported outcome results. Nor can the record establish whether PRE-RA and PRE-RA Plus differed from each other; the described primary comparisons are each against the general-information arm.
The endpoint concerns willingness as measured by the Contemplation Ladder, not completed behavior change. It also does not measure RA onset. A change in a willingness measure should not be treated as proof of a change in health behavior or disease risk. The record does not report a follow-up result for either of those outcomes.
The safety entries show zero recorded serious adverse events, other adverse events, and deaths in each listed group. They do not establish absence of risk, and the record lacks details needed to assess the completeness or precision of safety monitoring.
In general, results from a study of first-degree relatives without RA would be most directly informative about the population and educational interventions actually studied. The registry does not report detailed eligibility criteria or participant characteristics, so the reach of any eventual findings cannot be assessed from this entry. The evidence that can be read from the record is therefore mainly about the study’s question and design, rather than its effectiveness or broader implications.
13. Why This Trial Matters Statistically
Statistically, the trial is notable for asking about a communication intervention using a randomized comparison rather than simply describing participants’ reactions to risk information. Its three arms distinguish general RA education, personalized education through an online tool, and personalized education paired with a health educator. This structure can help separate the question of personalized risk communication from the additional role of educator guidance, although the registry’s primary description specifies comparisons against general education rather than a direct PRE-RA versus PRE-RA Plus comparison.
The planned outcome also spans follow-up: willingness is assessed immediately after the intervention, at 6 weeks, and at 6 months. Repeated measurements can help distinguish an initial response from a response that persists or changes over time. GEE is a general approach for analyzing correlated repeated observations, but the registry does not report the model details or results needed to judge how that approach was implemented.
The trial highlights an important distinction in outcome interpretation. Willingness to change is a behavioral intention measure, while actual behavior and disease outcomes are different endpoints. A statistical difference in intention, if reported, would answer a narrower question than whether participants changed behavior or experienced a change in RA risk. The registry does not report those downstream outcomes.
Finally, the record illustrates why a trial’s design description and its results must be considered separately. Randomization and a stated analysis method do not, on their own, reveal the size or certainty of an effect. Since the primary-outcome results are not reported in the registry record, statistical conclusions about the intervention comparison remain unavailable.
14. 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 most important limitation for interpreting this trial entry is that it does not report the primary-outcome results. No group estimates, changes from baseline, uncertainty intervals, or statistical test results are included. The registry therefore does not permit assessment of effect direction, magnitude, or precision.
The outcome description leaves important measurement details unspecified. It names the Contemplation Ladder and refers to willingness to change any of four RA-related behaviors, but does not identify those behaviors, give the scoring procedure, define what counted as change, or explain the reported participant-count format. This makes it difficult to determine exactly what the primary endpoint represents.
The statistical description is also incomplete. Although GEE is named, the registry does not report the model specification, covariates, correlation structure, contrast definition, multiplicity strategy, or missing-data approach. It does not state the analysis population or provide participant counts for outcome assessments at each follow-up. The allocation ratio and randomization procedures are not reported either.
For safety, the record lists zero events in each group but does not describe event definitions, ascertainment, or completeness of follow-up. Further participant characteristics and detailed eligibility criteria are not reported in the registry record. These omissions limit assessment of the enrolled population, robustness of the analysis, and applicability beyond the study participants.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Personalized Risk Estimator for Rheumatoid Arthritis Family Study — NCT02046005.
- Registry record last updated 2018-08-08; status last verified 2018-07.
- Results first posted 2018-06-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02046005 is a completed, randomized, parallel-group behavioral study of personalized RA risk education for first-degree relatives of people with RA who do not themselves have RA. The registry lists enrollment as 238 and describes three groups: general RA education, the PRE-RA online risk tool, and PRE-RA Plus, which adds health-educator guidance.
The primary measure is the Contemplation Ladder, described as willingness to change any of four RA-related behaviors compared with baseline. Assessments were scheduled immediately after intervention, at 6 weeks, and at 6 months; the analysis description names GEE comparisons of the PRE-RA groups with general education. Primary-outcome results are not reported in the registry record.
Recorded serious adverse events, other adverse events, and deaths are each zero for every listed group. The registry does not provide further details on safety ascertainment, missing outcome data, or the statistical analysis plan.