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 A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease (NCT05991726), a registered phase not stated study. The primary outcome is Open Ended Free Text Question (Identifying Stakeholder Views on the 3 Most Important Outcomes for Self-management).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05991726 |
| Phase | Phase not stated |
| Condition | Chronic Kidney Diseases |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 140 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Leicester |
| Results posted | Yes |
2. Clinical Question
Population
Stakeholders in the UK connected with chronic kidney disease (CKD), including people living with CKD and informal caregivers, as well as healthcare professionals, people involved in CKD healthcare design, development, management or commissioning, and researchers interested in self-management or CKD. The study focused on earlier, non-dialysis stages of CKD.
Intervention
A survey, identified in the registry as an other-type intervention. In Round 1, participants were asked to describe the three most important outcomes for self-management in people with non-dialysis CKD from their own perspective or opinion.
Comparator
There was no randomized treatment comparison. The professional-expert and non-professional-expert cohorts represent stakeholder groups, not like-for-like control arms. Allocation is not stated, and caregivers were not analyzed as a separate study arm.
Primary question
Which outcomes do stakeholders consider important for self-management in non-dialysis CKD? The survey sought to identify priorities that could inform outcome-measure selection for research and clinical evaluations of self-management resources, and support implementation, commissioning and uptake.
This is a question about eliciting and organizing stakeholder views, not about whether a treatment changes a clinical outcome. The primary measure is described as an open-ended free-text question asking for three important outcomes. Participants’ responses were analyzed using conventional content analysis, producing 28 outcomes assigned to five themes. The record names clinical, behaviour and self-care, healthcare usage, and psychological among those themes; the remaining theme is not reported in the registry record in the available description.
The question has practical relevance because selecting outcomes determines what later evaluations will measure. A stakeholder-generated list can identify areas considered meaningful by different groups, but it does not by itself establish which outcomes should be used in every future study or how they should be measured. The registry describes perspectives from different stakeholder groups in the UK; it does not report a comparison of their answers or an agreed ranking in the primary outcome description.
3. Trial Design
This completed study was a Delphi survey titled A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease. The sponsor was the University of Leicester. The registry lists chronic kidney diseases as the condition and identifies the intervention as an other-type survey. Enrollment was 140. The study started on 2022-05-05, and primary completion was recorded as 2023-04-03.
The stated purpose was to identify priority outcomes for self-management in earlier, non-dialysis stages of CKD from the perspectives of different stakeholder groups in the UK. The professional-expert cohort included healthcare professionals who look after people with CKD in the UK, people involved in designing, developing, managing or commissioning CKD healthcare in the UK, and researchers interested in self-management or CKD. The non-professional-expert cohort comprised people living with CKD and informal caregivers, such as family members or significant others.
The registry notes that caregivers were not analyzed as a separate study arm because their enrolled number was small and roles overlapped; some participants with CKD also had caregiver roles. The number enrolled in each cohort, the number completing each survey round, and the number contributing to the primary outcome are not reported in the registry record. Allocation is not stated. The cohorts should therefore be understood as stakeholder categories, not as randomized groups or treatment and control arms.
The primary outcome description concerns Round 1, when participants were asked an open-ended question about the three most important self-management outcomes for people with non-dialysis CKD. The stated timeframe is “Between 3 to 6 month.” The record does not report further survey-round procedures, how consensus was defined, or how participants’ answers were handled across any later rounds. Those details should not be inferred from the Delphi label alone.
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 | Cohort 1: Professional Expert | Cohort 2: Non-Professional Expert |
|---|---|---|
| STARTED | 72 | 68 |
| COMPLETED | 37 | 25 |
| NOT COMPLETED | 35 | 43 |
Analysis population for the primary outcome, as defined in the registry: This was a qualitative part of the survey, in which participants' responses were analysed using conventional content analysis. Participants' responses produced 28 outcomes, each outcome fell into one of 5 themes, which were 'clinical', 'behaviour and self-care', 'healthcare usage', 'psychological and social factors' and 'knowledge, skills \& Confidence'. The numbers below shows the frequency of times the outcomes were mentioned in that participant group in qualitative analysis
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: This number differs from overall participants as some individuals initially enrolled on the study but only provided their contact details to participate in further rounds and did not engage in the study activities for data analysis. The number above includes participants that answered the questions for analysis
| Characteristic | Unit | Cohort 1: Professional Expert | Cohort 2: Non-Professional Expert | Total |
|---|---|---|---|---|
| Participants analysed | 71 | 64 | 135 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 70 | 56 | 126 |
| Age, Categorical: >=65 years | Participants | 1 | 8 | 9 |
| Sex: Female, Male: Female | Participants | 27 | 15 | 42 |
| Sex: Female, Male: Male | Participants | 44 | 49 | 93 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 71 | 64 | 135 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Open Ended Free Text Question (Identifying Stakeholder Views on the 3 Most Important Outcomes for Self-management), measured over Between 3 to 6 month.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | items |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is an open-ended free-text response about the three most important outcomes for self-management in people with non-dialysis CKD. It measures participants’ stated priorities, rather than a change in health status, a treatment response, or a numerical score. The outcome is recorded as a number-type measure with the unit described as items, but the primary description emphasizes qualitative analysis of participants’ answers.
This type of endpoint is used to generate candidate outcomes in participants’ own terms. The registry says responses were analyzed using conventional content analysis and produced 28 outcomes, each assigned to one of five themes. The named themes include clinical, behaviour and self-care, healthcare usage, and psychological. The remaining theme is not reported in the registry record in the available description.
These findings can help identify areas stakeholders regard as relevant when researchers select measures for future evaluations. The endpoint does not itself show how common each priority was, whether the two stakeholder cohorts agreed, or whether any outcome should take precedence over another. Counts, rankings, agreement criteria, and a validated scoring approach for the elicited priorities are not reported in the registry record. The stated timeframe, “Between 3 to 6 month,” does not establish a more specific assessment schedule in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main result described for the primary outcome is qualitative: participants’ free-text responses produced 28 outcomes, grouped into five themes by conventional content analysis. The record names clinical, behaviour and self-care, healthcare usage, and psychological among the themes. It does not name the fifth theme in the available outcome description. This result describes the range of outcomes identified; it is not an estimate of a treatment effect.
The study’s total enrollment was 140, but the record does not give cohort-specific enrollment or outcome-specific response counts. Consequently, the reported number of identified outcomes should not be read as showing how many participants endorsed each outcome, how many participants contributed to each theme, or how frequently any particular priority was raised. Those details are not reported in the registry record. Nor does the primary outcome description provide a quantitative comparison between professional and non-professional experts.
The record lists zero statistical analyses. It does describe conventional content analysis for the primary responses, but no inferential estimates, confidence intervals, p-values, or between-group tests are reported in the registry record. A confidence interval, in general, expresses uncertainty around an estimated quantity; without a reported estimate and interval, the precision of a numerical group difference cannot be assessed. No numerical difference between groups is described in the primary outcome information.
The distinction between identifying candidate outcomes and establishing their priority is important. Producing a set of outcomes indicates what emerged from the stated response-analysis process. It does not, on its own, indicate that all participants agreed, that one outcome ranked above another, or that the set is exhaustive. The registry record does not report a consensus threshold, a ranking procedure, or the degree of agreement among stakeholders.
There is no randomized comparison, and the two cohorts are not described as control groups. Their definitions reflect different stakeholder roles. Caregivers were not analyzed as a separate study arm because their number was small and roles overlapped. Therefore, a treatment-effect interpretation or a causal conclusion about stakeholder type is not supported by the reported design and results.
The result should be read as an outcome-generation exercise for UK stakeholders concerned with non-dialysis CKD self-management. The registry states that the findings are intended to inform outcome-measure selection for research and clinical evaluations of self-management resources and to support implementation, commissioning and uptake. Whether the identified outcomes were subsequently selected, measured, or used in later evaluations is not reported in the registry record.
9. Statistical Methods Explained
The registry describes an open-ended survey question and a qualitative analysis, rather than a conventional clinical comparison with a numerical efficacy endpoint. The primary outcome asks participants to identify three important outcomes for self-management in people with non-dialysis CKD. Responses were analyzed using conventional content analysis. The record reports that this process produced 28 outcomes assigned to five themes, but it does not describe the detailed coding procedures.
What does content analysis do?
In general, content analysis organizes text into meaningful categories. Analysts review responses, identify recurring ideas, and group related ideas so that a large body of free text can be described systematically. The resulting categories depend on the analytic approach and the decisions made during coding. For that reason, a transparent account of how responses were coded, how disagreements were handled, and whether more than one analyst contributed can help readers assess the reproducibility of qualitative findings. Those procedural details are not reported in the registry record.
Here, the record gives the broad method—conventional content analysis—and the reported output: 28 outcomes across five themes. It names four themes in the available description: clinical, behaviour and self-care, healthcare usage, and psychological. The fifth theme is not reported in the registry record in that description. Theme counts, examples of individual outcomes, and the distribution of responses among themes are also not reported.
Why is this not a treatment-effect analysis?
A treatment-effect analysis estimates how an intervention changes an outcome relative to a comparator. In general, such an analysis requires a defined comparison and a numerical result that can be interpreted as an effect. This study is described as a survey to elicit stakeholder priorities. The registry reports no randomized comparison, and allocation is not stated. The professional and non-professional cohorts differ by stakeholder role and are not like-for-like control groups. No treatment-effect estimate should be inferred from those cohort labels.
The registry lists zero statistical analyses. That does not erase the stated qualitative analysis; rather, it means the record does not list statistical analysis results for the registered outcome measures. No p-values, confidence intervals, model estimates, or numerical tests of cohort differences are reported in the registry record. In general, a p-value evaluates how compatible data are with a specified statistical model and null hypothesis; without a reported test and its assumptions, there is no such result to interpret for this outcome.
What can numerical summaries add?
For quantitative outcomes, summary statistics can describe the observed values, while uncertainty intervals can show how precisely a quantity has been estimated. A numerical count of themes or candidate outcomes is descriptive, but it does not quantify the level of agreement among respondents. In general, a confidence interval is an interval estimate intended to communicate uncertainty about a parameter; it is not a measure of stakeholder consensus. The primary outcome description gives the number of outcomes generated, but no interval or agreement statistic.
Over-dispersion is a general issue in count data: it occurs when observed variability exceeds what a chosen count model assumes, and can make standard errors and uncertainty estimates unreliable if ignored. That issue is not directly assessable from the primary result as described because participant-level counts, response distributions, and a count model are not reported. The endpoint is presented as qualitative free text, not as a modeled count outcome.
How should the planning illustration be read?
In general, sample-size planning asks how many participants would be needed to detect a specified effect under stated assumptions. The registry describes an illustrative planning approach using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. It also distinguishes total event counts for time-to-event outcomes from participants per arm for other outcomes. These are planning assumptions, not evidence that the survey was designed as a two-arm trial or that the illustration describes the original study design.
Sample-size calculations based on an observed effect are planning illustrations, not observed power. The registry does not report a statistical comparison or a numerical effect estimate for this primary qualitative endpoint. Therefore, no trial-specific numerical sample-size conclusion for detecting a treatment effect follows from the primary outcome description. The planning assumptions should not be interpreted as the study’s original sample-size justification; that justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and zero statistical analyses. The primary outcome description concerns the open-ended question about the three most important self-management outcomes. The registry record does not identify the other outcome measures in the available information or specify how multiple outcomes were prioritized in analysis. A prespecified hierarchy, adjustment for multiple statistical tests, and any multiplicity strategy are not reported in the registry record.
Multiplicity is a general concern when many statistical hypotheses are tested: the chance of at least one apparently noteworthy result can rise as the number of tests increases. Adjustments may be used in some settings, but the appropriate approach depends on the analyses and scientific goals. No inferential tests are listed for this study, so the registry does not provide a set of p-values for which an adjustment can be assessed. The qualitative generation of 28 outcomes is not itself evidence of 28 statistical tests.
Missing-data handling is not reported in the registry record. The total enrollment was 140, but numbers responding to the primary question, numbers completing each round, and numbers with incomplete responses are not reported. The record also does not say whether partially completed responses were included, excluded, or followed up. These omissions limit assessment of how fully the recorded responses represent those enrolled.
Analysis populations are not defined beyond the professional-expert and non-professional-expert stakeholder descriptions. Caregivers were not analyzed as a separate study arm because their number was small and roles overlapped. The record does not report an intention-to-treat population, a per-protocol population, or another formal analysis set. As a survey-based qualitative study without a randomized treatment comparison, those labels may not map directly to the design, but the actual inclusion rules for the analysis are not reported.
11. What the Result Does, and Does Not, Mean
The registry record supports a descriptive conclusion: the Round 1 free-text responses were analyzed using conventional content analysis and yielded 28 outcomes grouped into five themes. This gives an account of candidate outcomes raised by stakeholders about self-management in non-dialysis CKD. The stated purpose was to inform selection of outcome measures in future research and clinical evaluations of self-management resources.
The result does not establish that an intervention improves or worsens any health outcome. No treatment comparison or effect estimate is reported. It also does not establish that the two stakeholder cohorts agreed, that every candidate outcome was equally important, or that the listed outcomes form a complete set. A number of generated outcomes is not a ranking or an agreement score.
The total enrollment of 140 does not, by itself, reveal how representative the responses were or how frequently particular outcomes were identified. Cohort-specific counts, response rates, and outcome-level frequencies are not reported in the registry record. Caregivers were not separated as an analysis group because their number was small and roles overlapped, so distinct caregiver priorities cannot be assessed from the reported cohort description.
In general, qualitative findings can help frame later measurement choices, while subsequent studies are needed to establish how selected outcomes should be defined, measured, and interpreted in a given evaluation. The record does not report whether the 28 outcomes were later narrowed, validated, or adopted. Its stated aims concern supporting outcome-measure selection and implementation, commissioning and uptake; these intentions should not be mistaken for evidence that those later steps occurred.
The result is therefore best understood as a stakeholder-informed candidate outcome set, not as a clinical efficacy finding or a quantified consensus result. It describes what the analysis generated and leaves several questions open, including how common each suggestion was, whether priorities differed by stakeholder group, and what outcome measures were ultimately chosen for future use.
12. Why This Trial Matters Statistically
Choosing outcomes is a substantive part of clinical research. The outcomes selected determine which aspects of a condition or intervention later evaluations will capture. For self-management resources in CKD, the registry frames this study as a way to identify priorities from different stakeholder perspectives before selecting measures for research and clinical evaluation.
The statistical interest lies partly in the distinction between generating outcomes and measuring them. Open-ended responses can surface ideas that a fixed list of questions might not capture. Content analysis then organizes those responses into an interpretable set. The registry reports that this process produced 28 outcomes across five themes, providing a structured description of stakeholder-generated material rather than an estimate of treatment effectiveness.
Including professional and non-professional experts also recognizes that people involved in care and people living with CKD may contribute different perspectives. The record describes both groups but does not report a quantitative comparison between them. This is important when interpreting the result: the presence of multiple stakeholder groups does not itself demonstrate agreement or equal representation in the final themes.
The study’s stated purpose connects outcome identification to later work: measure selection for research and clinical evaluations, and support for implementation, commissioning and uptake. A clearly described candidate outcome set can provide a starting point for that work. However, using it responsibly requires attention to how the responses were gathered, how themes were constructed, and whether the resulting outcomes are suitable for particular later evaluations. Detailed procedures and subsequent use are not reported in the registry record.
Statistically, the study also illustrates why not every registered primary outcome is a numeric treatment endpoint. Qualitative outcomes have different reporting needs from a randomized comparison: readers need enough detail to understand the response process and analytic decisions, rather than an effect estimate alone. The registry supplies the broad analytic method and headline output, while important details about response distributions, coding, and stakeholder agreement are not reported.
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.
The registry record gives a limited account of the primary qualitative analysis. It names conventional content analysis and reports 28 outcomes in five themes, but does not describe coding steps, analyst roles, coding checks, or how the themes were finalized. The fifth theme is not reported in the available outcome description. The record also does not provide examples of the 28 outcomes or counts showing how responses were distributed across outcomes and themes.
Enrollment is reported as 140 overall, without cohort-specific totals, numbers responding to the primary question, or numbers contributing at each survey round. Response rates and missing-response handling are not reported in the registry record. This makes it difficult to assess how the analyzed responses relate to all enrolled participants or whether participation differed across stakeholder groups.
The professional and non-professional cohorts are not randomized comparison arms. Allocation is not stated, and the groups represent different stakeholder roles rather than interchangeable groups. Caregivers were not analyzed separately because their number was small and some participants with CKD also had caregiver roles. The record therefore does not support a distinct description of caregiver priorities or a causal interpretation of differences between cohorts.
The primary outcome description does not report a consensus threshold, ranking method, or quantitative measure of agreement. The record lists three outcome measures but does not identify all of them in the available information. Statistical analyses are listed as zero, so no inferential result or numerical estimate of precision is available for the primary outcome. A sample-size justification and further survey-round procedures are not reported in the registry record. These limitations concern what can be concluded from the registered information and do not establish that an unreported procedure was absent from the study itself.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease — NCT05991726.
- Registry record last updated 2026-04-30; status last verified 2026-01.
- Results first posted 2026-04-30.
- 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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17. Record Summary
NCT05991726 is a completed Delphi survey sponsored by the University of Leicester, focused on identifying priority self-management outcomes for people with non-dialysis CKD from UK stakeholder perspectives. Enrollment was 140. The study started on 2022-05-05, and primary completion was recorded as 2023-04-03. The registered intervention was a survey.
The primary outcome was an open-ended question asking participants to identify three important self-management outcomes. Responses were analyzed using conventional content analysis and produced 28 outcomes grouped into five themes. The available description names clinical, behaviour and self-care, healthcare usage, and psychological among those themes. The record lists three outcome measures and zero statistical analyses.
Stakeholder cohorts were professional experts and non-professional experts, the latter including people with CKD and informal caregivers. Caregivers were not analyzed as a separate arm because their number was small and roles overlapped. Allocation is not stated, and the cohorts are not a randomized comparison. Further information about response counts, missing data, consensus, and later use of the outcomes is not reported in the registry record.