Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability (NCT02361580), a randomized na study. The primary outcome is Upper Extremity Disability Measured by PROMIS Upper Extremity.

2. Clinical Question

The registry record also identifies two secondary questions at eight weeks: whether diary keeping affected avoidance of painful activities, measured with PROMIS Pain Interference, and symptoms of depression, measured with PROMIS Depression. It additionally names a question about factors associated with upper-extremity disability. No results for these secondary questions or the association question are reported in the registry record.

The clinical question is therefore clear at the level of the planned comparison: diary versus no diary, with disability assessed at a specified follow-up time. The available record does not establish whether the comparison was completed, what measurements participants might have made before loss to follow-up, or what the outcomes were. The reported loss to follow-up means the primary question cannot be answered from the posted results. It does not show that diary keeping had no effect; it means that an effect estimate is not available in the registry record.

3. Trial Design

This was a randomized, parallel-group study with no masking reported. The two groups were Diary and No Diary. Participants assigned to Diary were told to keep a record of their recovery; the control group is described as a control group, without further detail. The stated enrollment was 9. The condition was acute injury of the upper extremity, and the primary endpoint was scheduled for eight weeks after injury.

The registry record lists the study status as terminated. It gives a start date of 2015-01 and a primary completion date of 2016-01. These dates do not by themselves describe how long each participant was followed or why the study was terminated. The reason for termination is not reported in the registry record.

Random allocation is intended, in general, to create groups that are comparable on average with respect to measured and unmeasured characteristics. In a small study, chance differences between groups can nevertheless be substantial. The record does not report how the random sequence was generated, whether allocation was concealed, or whether any stratification or blocking was used. Those design details are not reported in the registry record.

The record specifies no masking. This means the design is listed as unmasked; it does not establish what participants, outcome assessors, or analysts knew at every point. Details about who was aware of assignment are not reported in the registry record. The enrollment count and the absence of outcome analyses limit what can be inferred about the balance of the groups or the effect of the intervention. No comparison of baseline characteristics is reported in the registry record.

The study lists three outcome measures: the primary PROMIS Upper Extremity disability measure and two secondary measures, PROMIS Pain Interference and PROMIS Depression. The registry record does not report a completed outcome comparison for any of them. It also does not report a separate analysis of factors associated with disability. The design identifies a relevant research question, but the available results do not supply an estimate of the diary-versus-control contrast.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All of the subjects were lost to follow up in both groups.

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 Upper Extremity Disability Measured by PROMIS Upper Extremity, measured over 8 weeks.

The primary endpoint was upper-extremity disability measured with PROMIS Upper Extremity at eight weeks. The registry record describes the measure as an assessment of upper-extremity disability, but does not report a unit, scoring direction, score interpretation, or threshold for an important difference. Those measurement details are not reported in the registry record.

In general, a patient-reported outcome measure captures a participant’s account of their health or functioning. Such measures can be useful when the outcome of interest is the person’s experience of disability, rather than a finding made only by an examiner. PROMIS instruments are named for this endpoint and for the two secondary outcomes, but the record does not give instrument versions, item sets, administration procedures, or scoring rules. No further measurement properties should be inferred from the registry record.

An endpoint measured at a fixed follow-up time provides a way to compare outcomes between assigned groups at that time, provided the measurements and analysis are available. Here, the planned assessment time was eight weeks after injury. However, the primary outcome description states that all subjects were lost to follow-up in both groups. There is consequently no reported endpoint value or group comparison to interpret. The registry record does not establish whether any participants completed the PROMIS measure before being lost, or how missing measurements were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized, parallel-group design. In general, randomization assigns participants to groups using a chance-based process. Its purpose is to reduce systematic differences in prognostic characteristics between groups, so that a group comparison can be interpreted as an estimate of the effect of assignment, subject to the study’s conduct and missing data. Randomization does not guarantee that groups will look similar in every feature, particularly in a small study. The record does not report the sequence-generation method, allocation concealment, or any procedures intended to balance groups.

What does a parallel-group comparison estimate?

In a parallel design, each participant is assigned to one group and the groups are compared at the planned endpoint. Here, the assigned strategies were diary and no diary, and the primary endpoint was PROMIS Upper Extremity at eight weeks after injury. A group contrast could describe the difference in measured disability between assigned groups if the outcome data and analysis were available. The registry record reports neither a numerical contrast nor the data needed to calculate one.

In general, an analysis plan specifies the outcome summary, the comparison, the statistical model, and the handling of missing observations. These choices affect the interpretation of an estimate and its uncertainty. The statistical analysis plan and the analysis methods used for this study are not reported in the registry record. The record lists zero analyses, and it does not provide outcome estimates, confidence intervals, or hypothesis-test results.

Why do confidence intervals matter?

In general, a confidence interval expresses uncertainty around an estimated effect under the assumptions of the chosen method. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance. Intervals can also help distinguish a result that is compatible with a range of effects from one that is precise enough to rule out effects of concern. No interval is reported for the primary outcome, so neither the size nor the precision of a possible diary-versus-control effect can be assessed from the registry record.

What does a hypothesis test tell us?

In general, a hypothesis test evaluates data against a specified null hypothesis, using a model and a chosen significance threshold. A p-value is not the probability that the null hypothesis is true, and it does not state the size of an effect. Interpretation requires the estimate, uncertainty, analysis assumptions, and study context. The brief summary states null hypotheses for the primary and secondary questions. Those statements are planned questions, not reported test results. A significance threshold, test procedure, and p-value for the outcomes are not reported in the registry record.

How should the sample-size assumptions be read?

In general, sample-size planning uses assumptions about the target effect, variability, significance level, allocation, and desired power to illustrate how many participants might be needed under a specified design. Such an illustration is not an observed result and is not evidence that a study had a particular probability of detecting its effect. The registry record describes planning illustrations based on fractions of an observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. It also states that the actual study’s design basis is not what those illustrations represent. The record does not report the trial’s own sample-size justification or target. The primary result is unavailable, so no observed primary effect is reported for interpreting those assumptions.

Over-dispersion is a general concern for count outcomes when variability exceeds what a simple count model assumes; it can make standard errors too small if ignored. That concept does not establish that over-dispersion affected this study. The primary endpoint is described as a PROMIS disability measure, and the registry record does not report a count-data analysis or any model diagnostics.

What can be concluded from the posted analysis information?

The posted results do not provide an outcome analysis to evaluate. The primary outcome description states that all subjects were lost to follow-up in both groups, and the record lists no analyses. Without an endpoint comparison, readers cannot assess the estimated effect, uncertainty, model fit, or sensitivity to alternative assumptions. The statistical plan, missing-data methods, and analysis population are not reported in the registry record. General statistical principles explain what those methods would address, but they cannot fill in methods or results that the record does not report.

10. Multiplicity, Missing Data and Analysis Populations

The record identifies a primary outcome and two secondary outcomes, as well as a secondary question about factors associated with disability. When multiple outcomes or questions are examined, multiplicity can arise: repeated testing can increase the chance of at least one apparently unusual result under a set of null hypotheses. In general, a statistical plan may specify which outcome is primary, whether secondary analyses are confirmatory or exploratory, and whether any adjustment or hierarchical testing approach will be used. Such procedures are not reported in the registry record. No multiple-testing adjustment should be assumed.

The primary outcome description states that all subjects were lost to follow-up in both groups. The record does not explain when or why participants were lost, whether any outcome measurements were obtained, or whether loss was related to group assignment or health status. It does not report a missing-data method, imputation, sensitivity analysis, or an analysis restricted to participants with observed outcomes. These details are not reported in the registry record.

In general, missing outcome data can undermine a group comparison, especially if the chance of an outcome being observed is related to the outcome itself. Statistical methods can address some missing-data settings, but their validity depends on assumptions that cannot be checked from an absent outcome comparison. With all subjects described as lost for the primary outcome, the registry record does not provide a basis for estimating the planned contrast or judging how missingness might have affected it.

The analysis population is also not reported in the registry record. The record does not say whether an intention-to-treat, per-protocol, or other population was planned or used. No adjusted or unadjusted outcome analysis is reported. Consequently, neither multiplicity handling nor missing-data assumptions can be evaluated from the posted results.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry record lists serious adverse event figures separately for the Diary and No Diary groups. For Diary, it lists 6 at risk and 0 serious events; for No Diary, it lists 3 at risk and 0 serious events. It also lists 0 deaths in each group. These are the figures recorded for safety; they should not be treated as proof that no adverse events of any kind occurred.

The record also lists 0 other adverse events for each group, with 6 at risk in Diary and 3 at risk in No Diary. It does not provide serious adverse event terms, and it does not explain the safety observation period, event-collection procedures, or whether the at-risk counts represent all enrolled participants. Those details are not reported in the registry record.

In general, an adverse-event count is interpreted in relation to the people observed, the time under observation, and the rules used to collect and classify events. With a small number listed at risk, zero recorded events cannot establish that an event is impossible or that two groups have equivalent safety. Here, no outcome comparison or detailed safety narrative is reported. The figures are a limited description of events recorded in the registry, not a basis for a broad conclusion about safety.

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

The record establishes that a randomized parallel-group study was registered to compare keeping a personal recovery diary with a no-diary control among people with acute upper-extremity injury. Its primary question concerned PROMIS Upper Extremity disability eight weeks after injury. It also named pain interference, depression symptoms, and factors associated with disability as secondary questions.

The main limitation for interpretation is that all subjects were reported lost to follow-up in both groups for the primary outcome. No primary endpoint comparison, estimate, confidence interval, or p-value is posted. No secondary outcome results are reported either. As a result, the posted results do not show whether the groups differed, how large any difference might have been, or how precisely it could be estimated.

This is not evidence that diary keeping has no effect. Absence of a reported comparison is different from a measured result that is close to zero. It is also not evidence that the diary strategy caused harm or benefit. The available outcome information cannot support any of those conclusions.

The enrollment of 9 and the terminated status provide context, but the reason for termination and the intended sample-size justification are not reported in the registry record. It is therefore not possible to determine why the trial stopped or whether its enrollment reflected a planned target. Likewise, the safety counts are limited registry figures and do not replace a detailed assessment of adverse events.

In general, a well-interpreted trial result requires an estimate of the comparison, an account of its uncertainty, and enough information about outcome measurement and missing data to assess the assumptions. Those elements are not available for the primary question in this record. The defensible conclusion is narrow: the study was designed to investigate the question, but the posted results do not provide an answer.

13. Why This Trial Matters Statistically

This trial is statistically instructive because it separates a clearly stated research question from an interpretable outcome result. The registry record specifies a randomized comparison, the two assigned strategies, a primary disability measure, and an assessment time. Those design elements define what investigators intended to compare. They do not, by themselves, establish what the study found.

The reported loss to follow-up is central. Statistical methods can estimate a contrast only when there are outcome data or when an explicit missing-data approach is supported by information and assumptions. With all subjects reported lost for the primary outcome and no analysis results posted, there is no estimate to summarize. A null hypothesis in a study description should therefore not be mistaken for a null finding.

The case also illustrates why uncertainty matters. Even when an estimate is available, its precision shapes what conclusions are reasonable. A confidence interval can show which effect sizes remain compatible with the data and assumptions. Here, no interval is reported, so the statistical precision of the intended comparison is unknown. The enrollment count alone cannot substitute for an outcome estimate or establish how much information was obtained.

Finally, the record names multiple outcomes and an additional association question, but does not report an analysis plan or results for them. Without that information, readers cannot assess how the questions were prioritized, how multiplicity was handled, or whether the secondary analyses were exploratory. The trial thus highlights a practical principle: design, outcome ascertainment, and transparent reporting all contribute to whether a clinical question can be answered. In this registry record, the intended comparison is identifiable, while its result is not.

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 principal trial-specific limitation is the stated loss to follow-up of all subjects in both groups for the primary endpoint. The registry record does not give reasons for loss, timing of the loss, or details about any outcome data collected before it occurred. It therefore does not permit assessment of whether missingness could have been related to assignment or disability.

The study is listed as terminated, but the reason for termination is not reported in the registry record. The record lists enrollment of 9, but does not report a target enrollment or the trial’s own sample-size justification. Without those details, the enrollment cannot be judged against the intended design.

Important design and analysis details are also absent. The randomization method, allocation concealment, precise masking procedures, outcome scoring details, statistical analysis plan, analysis population, and missing-data methods are not reported in the registry record. No primary or secondary outcome estimates are posted, and the record lists no analyses. These gaps prevent assessment of effect size, precision, model assumptions, or multiplicity handling.

The safety information is limited to group counts for participants at risk and recorded events. The record does not describe event definitions, observation duration, or ascertainment procedures. The small enrollment and absence of detailed outcome results further restrict interpretation. These limitations are specific to what the registry record reports; they do not establish what may have occurred outside the posted record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability — NCT02361580.
• Registry record last updated 2017-03-28; status last verified 2017-02.
• Results first posted 2017-03-28.
• 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.

18. Record Summary

NCT02361580, titled “Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability,” is listed as a randomized, unmasked, parallel-group study of people with acute upper-extremity injury. Enrollment was 9, and the study status is terminated. The registry record lists a start date of 2015-01 and a primary completion date of 2016-01.

The planned primary endpoint was PROMIS Upper Extremity disability at eight weeks after injury. Secondary outcomes were PROMIS Pain Interference and PROMIS Depression. The primary outcome description states that all subjects were lost to follow-up in both groups. No outcome analyses or numerical efficacy results are reported in the registry record.

The listed safety figures are 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. The reason for termination, the statistical analysis plan, the sample-size justification, and the handling of missing outcomes are not reported in the registry record. The posted results therefore do not answer the primary diary-versus-control question.