Trial reportHealth and quality of life outcomes2026
Measuring health-related quality of life and well-being in adults with fecal incontinence: a comparative psychometric evaluation.
Trial report in Health and quality of life outcomes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04657588 (Controlling Faecal Incontinence With a Novel Anal Device), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhile traditional disease-management regarding fecal incontinence (FI) primarily focuses on symptom-control and health-related quality of life (HrQoL) outcomes, patients often prioritize broader aspects of health, like well-being. This study evaluates the psychometric performance of ICEpop CAPability measure for Adults (ICECAP-A), a capability-based well-being instrument, alongside two established HrQoL-instruments, EQ-5D-5L and the FI quality of life (FIQL) questionnaire, in an outpatient-population with FI.
methodsData were obtained from patients with FI recruited from a randomized-controlled trial evaluating the efficacy of anal plugs for FI ((The CONFIDEnCE trial, NCT04657588). Psychometric evaluation of ICECAP-A involved the assessment of the convergent validity, known-group validity (examined across predefined subgroups), acceptability, and floor and ceiling effects.
resultsAmong 72 participants (mean age 67.3years; 83.3% female), the mean ICECAP-A capability score (0.86, scale 0-1) exceeded the mean EQ-5D-5L utility (0.71, scale - 0.446-1) and the FIQL score (2.34, scale 1-5). ICECAP-A showed good convergent validity (76.6% predefined hypotheses confirmed). Known-group validity was comparable across instruments; ICECAP-A demonstrating significant differences by EQ-VAS, anxiety, and education level, but not outperforming EQ-5D-5L or FIQL. EQ-5D-5L showed stronger effect sizes for anxiety (p < 0.001), depression and symptom severity (non-significant), while FIQL was stronger for education level (p = 0.002). Questionnaire completion was 84.7% overall, reflecting trial dropout only (100% among completers) with no substantial floor or ceiling effects.
conclusionsIn patients with FI, ICECAP-A showed psychometric performance comparable to EQ-5D-5L and FIQL, despite its broader conceptual scope. Well-being appeared less influenced by symptom severity, possibly reflecting coping or adaptation. Further research is warranted evaluating ICECAP-A's psychometric advantage over traditional HrQoL-instruments in this clinical context.
trial registrationNot applicable.
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