P133 Cognitive debriefing interviews (phase 2B) towards developing a Patient Reported Outcome measure for Paediatric ulcerative colitis- the TUMMY-UC
Bibliographic record
Abstract
Background: Under the qualification program of the FDA and EMA, we aimed to develop a Patient Reported Outcome (PRO) measure of signs and symptoms for paediatric ulcerative colitis (UC) (i.e. the TUMMY-UC index) for using in trials and clinical practice. We previously selected items to the index via concept elicitation qualitative interviews. Here we report the results of the cognitive evaluation and the final formatting of the index. Trained personnel performed Cognitive debriefing Interviews in Israel, England, Ireland, Canada and the USA with UC children 2–18 years and, in order to develop an Observer Reported Outcome (obsRO) for those ≤8 years, also their caregivers. We compiled contending scales for each item and explored the vocabulary children prefer. Clinical data including disease activity were recorded. Weights were assigned to each item based on ranking of importance on a “1” (least important) to 5 scale. Interviews were performed with 34 children (age 10.6 ± 4 years; 28% with moderate-severe disease and 55% in remission; 83% with extensive disease) and 13 caregivers (age 37 ± 5 years, 23% males). The questions were understood by all children and exact wording and response options of each item were finalised. 88% of children understood the meaning of “last 24-h since this time” as a recall period. Only 3 children (9YO, 9YO, 12YO) had difficulties recalling the last 24-h. The exact response options were amended based on the obtained feedback; all children <11 years preferred the FACES pain item and most adolescents preferred the VAS version, thus both were retained in a composite item. Rank order of the items was rectal bleeding-amount (4.5), rectal bleeding-frequency (4.3), stool frequency (4.2), abdominal pain (4), urgency (3.8), stool consistency (3.7), nocturnal stools (3.5) and weakness (3.2). Reassuringly, the same rank-order was noticed for the children younger than 11 years. Grading of the TUMMY-UC items. In this phase 2B study, the exact wording, response options and weighting of the eight TUMMY-UC items were finalised. An obsRO version of the TUMMY-UC has been developed for the younger children. The TUMMY-UC will be now validated and evaluated for cut-off scores in a phase 3 study.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.042 | 0.044 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.004 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".