Motivation, Brain Function and Mood in Individuals With Cold and/or Flu: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Motivation, Brain Function and Mood in Individuals With Cold and/or Flu (NCT02860169), a non-randomized na study. The primary outcome is Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely).

2. Clinical Question

3. Trial Design

The registry describes a non-randomized, unmasked, parallel study sponsored by GlaxoSmithKline. Its title concerns motivation, brain function and mood in individuals with cold and/or flu; the official title also identifies cognitive performance in otherwise healthy individuals. The registry lists the phase as NA and the condition as cognition. These labels do not supply a more detailed account of the design or its scientific rationale.

The study planned assessments in eligible participants with cold and flu and eligible healthy participants. Both groups were instructed to complete a self-administered questionnaire and participate in assessments. The listed procedures included Picture Rating, the Picture Surfing Task, questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT and RVP. The intervention is categorized as behavioral, rather than as a medication or device treatment.

The record lists a start date of 2016-03-11, a primary completion date of 2016-11-24, enrollment of 114, and status of terminated. Those dates and the enrollment entry do not establish how many people completed each assessment or contributed usable measurements. The record says that no participant data were analysed because of concerns relating to data-collection procedures. GlaxoSmithKline was not confident that collected data could support reliable interpretation of assessments and conclusions.

Because allocation was non-randomized and masking was absent, comparisons between the illness and healthy groups could be affected by differences between participants beyond illness status. The registry record does not report a matching method or a statistical adjustment strategy. It also does not report the recruitment setting, the detailed eligibility criteria, or the planned duration of participation.

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: This study was divided in 3 parts (A, B and C). Part A was an online survey, Parts B and C. Participants recruited separately for each part of the study based on the inclusion and exclusion criteria of respective part of the study. (46 \[part A\] + 20 \[part B\] + 48 \[part C\] = 114 enrolled in the study)

Part A

Reasons for not completing this period:

Part B

Reasons for not completing this period:

Part C

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GlaxoSmithKline (GSK) is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the 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.

Population: All the participants who participated in any part of the study (part A, B or C).

6. Primary Endpoint

The registry lists the primary outcome as Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely), measured over At Screening.

The primary outcome was a liking rating for images relevant to cold and flu. At screening, participants were to rate how much they liked each image on an 11 point Likert scale, with 0 meaning not at all and 10 meaning like extremely. This endpoint records a participant's stated preference for the images; it is not itself a direct measure of motivation, mood, cognitive performance, or force exertion.

The rating was intended as part of Part A of the study. Asking about cold- and flu-related images could provide information about responses to illness-relevant material, while the Picture Surfing Task was intended to assess motivation more broadly and in relation to cold and flu. The broader study aim also included a general tendency to exert force as a control. These are stated aims, not demonstrated properties of the rating or task.

The registry does not report a scoring summary, a planned comparison, or a threshold for interpreting a rating. More importantly, it states that no participant data were analysed. Consequently, there is no reported endpoint estimate or evidence in the record about the distribution of ratings.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the design imply for a comparison?

In general, a non-randomized comparison describes differences between groups as they were formed; it does not ensure that the groups are comparable in all other respects. Random allocation is one way to reduce systematic baseline differences, but allocation in this study was non-randomized. The registry record does not report how participants entered either group or whether groups were matched. A statistical adjustment can sometimes account for measured differences, but the variables measured and any adjustment plan are not reported. Even an adjusted association would require cautious interpretation and would not by itself establish that illness status caused a difference.

The parallel design indicates that the groups were assessed in separate arms rather than through a reported crossover sequence. The record does not describe repeated measurements or a within-person comparison plan. The absence of masking also matters generally: awareness of group status can influence participant responses or assessment procedures. The registry does not report safeguards to limit those influences.

How should the primary scale be understood?

In general, a Likert rating is an ordered response scale: higher values indicate more of the response named by the question, while the distance between adjacent response options is not guaranteed to represent an equal change in subjective preference. The endpoint asks how much participants like images, using the stated 0-to-10 response range. Researchers can describe such data using the response distribution or a prespecified summary. Which summary is appropriate depends on the analysis question, the scale's behavior, and the analysis plan. The registry record does not report the planned summary statistic or model, and the absence of analysed participant data means no such summary is available to assess.

A confidence interval, in general, describes the uncertainty around an estimated quantity under the assumptions of the analysis. It would help readers judge the precision of a reported difference or summary, but no confidence interval is reported for this endpoint. A p-value, in general, assesses how compatible data are with a specified null model; it does not measure the size or importance of an effect. No p-value or inferential result is available in the registry record. Neither measure can be reconstructed from the enrollment entry alone.

What can planning calculations establish?

In general, sample-size planning connects a target effect, variability assumptions, a significance threshold, and a desired probability of detecting that effect under a specified model. A planning illustration is conditional on its assumptions; it is not a result from participants and is not observed power. The planning assumptions recorded for this study describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. They also distinguish between per-arm participant counts for non-time-to-event outcomes and total event counts for time-to-event calculations. These conventions describe planning calculations, not the trial's own design justification.

The registry does not report a sample-size justification for the study. Moreover, no participant data were analysed, and the record does not report an outcome estimate that can be interpreted as an observed trial effect. Accordingly, planning illustrations cannot establish how precise a study result would have been or whether a target effect was detected. They should not be presented as evidence of success, failure, or adequate statistical power.

Why does data quality matter?

Statistical inference depends on measurements being collected and recorded in a way that supports the intended interpretation. If collection procedures raise concerns, a numerical estimate may be precise in a formal sense yet still fail to represent the intended construct reliably. The sponsor's stated concern was that collected data might not support reliable interpretation of assessments and conclusions. The record does not describe the specific procedural problems, so their exact consequences for individual measures cannot be assessed. The decision not to analyse participant data means that no estimate, model fit, uncertainty interval, or sensitivity analysis can resolve that concern from the posted results.

In general, an analysis plan would specify how outcomes are summarized, which comparisons are primary, how covariates are handled, and how uncertainty is quantified. The registry does not report those statistical details, nor does it report interim analyses. With no participant-level analysis reported, there is no basis for judging whether the planned analysis assumptions were met or whether alternative analyses would change an outcome interpretation.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, with the liking rating for cold- and flu-relevant images identified as the primary outcome. It does not report a multiplicity strategy. In general, when several outcomes or comparisons are examined, the chance of finding an apparently unusual result can increase; prespecifying a primary outcome and a method for handling multiple tests helps readers interpret inferential results. Here, no participant data were analysed and no analysis records are listed, so the record contains no set of outcome tests on which to assess multiplicity adjustment.

Handling of missing data is not reported in the registry record. The record does not provide outcome denominators, completion rates, reasons for missing assessments, or a method for handling incomplete observations. The enrollment entry of 114 cannot be treated as the number with data for the primary rating or any other assessment. The statement that no participant data were analysed also means that observed missingness patterns cannot be evaluated from reported analyses.

Analysis populations are not reported. The record does not say whether any planned population would have included all eligible participants, only those who completed assessments, or another defined subset. It does not report exclusions or analysis-specific denominators. Interim analyses are not reported, and the statistical analysis plan is not reported in the registry record. These omissions prevent assessment of how outcome selection, missingness, and participant inclusion would have affected a statistical conclusion.

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

The record establishes the study's intended questions and why its results were not analysed, but it does not establish whether the Picture Surfing Task measured motivation as intended, whether image ratings differed between groups, or whether mood or cognitive assessments differed. No effect estimate or uncertainty measure is reported. It would be incorrect to interpret the lack of an analysed result as evidence of no difference or no association.

The study was designed to examine people with cold and flu alongside healthy participants, but the comparison was non-randomized. The registry does not provide results that would allow even a descriptive contrast, and it does not report an adjustment plan. The healthy group therefore cannot be treated as a causal control comparison on the basis of this record.

The termination and the sponsor's concern about data-collection procedures limit the conclusions that can be drawn. The registry does not explain the specific procedures at issue or identify which assessments may have been affected. It does state that the sponsor was not confident that collected data could support reliable interpretation. That statement is the reason results should not be inferred from the enrollment entry or the planned outcome definitions.

Zero values in the adverse-event fields are not a finding that no adverse events occurred, particularly given that the record states that participant data were not analysed. The record supports no conclusion about safety, efficacy, or the practical value of the task. It is best read as documentation of an intended assessment study that did not produce interpretable analysed outcomes in the registry record.

12. Why This Trial Matters Statistically

This study is statistically notable because it separates a planned measurement question from a usable outcome result. The Picture Surfing Task was intended to assess general motivation, motivation specific to cold and flu, and a general tendency to exert force as a control. The registry also identifies a liking rating as the primary outcome. Those aims describe what investigators wanted to measure; they do not establish that the measures were valid or that the assessments produced interpretable data.

The record makes data integrity part of the interpretation. Statistical methods cannot compensate for measurements that the sponsor considers unreliable for drawing conclusions. A calculation may produce a group estimate or a significance test, but meaningful interpretation depends on the quality and relevance of the underlying observations. Here, the sponsor's concern led to no participant data being analysed, leaving neither a result to interpret nor an empirical estimate of uncertainty.

The design also highlights the distinction between a comparison group and a randomized control. Healthy participants provide a reference group in the study description, but non-randomized allocation means other group differences could influence outcomes. Statistical adjustment might be useful if relevant variables were measured and a suitable plan prespecified, but neither a matching nor an adjustment strategy is reported.

For clinical researchers, the record is a reminder that enrollment and a detailed list of assessments do not guarantee an interpretable analysis. Clear measurement procedures, prespecified analysis methods, and transparent handling of incomplete data are essential to connect an intended question to credible statistical evidence. This record does not document those links in a way that supports outcome conclusions.

13. 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.

Several limitations are specific to this study record. The design was non-randomized and unmasked, so the illness and healthy groups were not established as like-for-like through random allocation. The record does not report matching, covariate adjustment, or other methods intended to address group differences. Any group comparison, had one been reported, would therefore require caution about confounding.

The study was terminated because of concerns relating to data-collection procedures. The record does not detail which procedures raised concern, how many assessments were affected, or whether concerns applied equally across measures or groups. The sponsor stated that it was not confident that collected data could support reliable interpretation of the assessments and conclusions. No participant data were analysed, preventing an independent outcome-level assessment of data quality or sensitivity to analysis choices.

Although enrollment is listed as 114, the record does not report how many participants completed the primary rating, how many had complete assessments, or the denominators for any outcome. The eligibility criteria and recruitment details are also not reported, limiting assessment of how well the intended population was represented. The endpoint's timing is specified as screening, but other follow-up timing is not reported.

Finally, the record does not report the statistical analysis plan, missing-data methods, multiplicity handling, analysis populations, interim analyses, or a sample-size justification. The adverse-event fields contain zero entries, but in the context of no analysed participant data they do not support an inference about event occurrence. Together, these limitations leave the intended measurement questions unresolved.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Motivation, Brain Function and Mood in Individuals With Cold and/or Flu — NCT02860169.
• Registry record last updated 2019-04-11; status last verified 2018-01.
• Results first posted 2019-04-11.
• 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.

17. Record Summary

NCT02860169 was a GlaxoSmithKline-sponsored, non-randomized, unmasked, parallel study of motivation, mood and cognitive performance in otherwise healthy individuals with cold and flu and healthy participants. The registry lists enrollment of 114, a start date of 2016-03-11, a primary completion date of 2016-11-24, and terminated status.

The primary outcome was a screening rating of liking for cold- and flu-relevant images on an 11 point Likert scale from 0 to 10. The study also planned the Picture Surfing Task and other questionnaire and cognitive assessments. The record states that no participant data were analysed because of concerns about data-collection procedures; the sponsor was not confident the data could support reliable interpretation. Consequently, the registry reports no interpretable outcome estimates and supports no conclusion about group differences, task performance, or safety.