Bibliographic record
Abstract
Introduction: The optimal therapeutic approach to ileocecal Crohn's disease (CD) remains unclear.Aims & Methods: The objective of this study was to compare infliximab with laparoscopic ileocecal resection in patients with thiopurine or steroid refractory recurrent CD of the terminal ileum, with respect to quality of life (QoL) and costs.A multicentre randomised controlled, open-label trial was performed in 33 centres in the Netherlands and the UK.Adult patients with CD of the terminal ileum who failed 4 3 months of thiopurine treatment or steroids without signs of a critical stricture were randomised to infliximab or laparoscopic ileocecal resection.Patients with a prior ileocecal resection, a diseased length 4 40 cm, abdominal abscesses or fluid collections or an American Society of Anaesthesiologists (ASA) score of III or IV were excluded.The primary endpoint was QoL measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) at one year follow-up.Furthermore, the mean direct costs per individual patient were prospectively documented and analysed according to intention-to-treat until one year after start of treatment.Dutch Trial Registry NTR1150.Results: Between May 2008 and October 2015, 143 patients were randomised (32.9% male) with a median age of 27.0 years (interquartile range (IQR) 22.0-40.0).Eventually, 65 patients started with infliximab treatment and 70 patients were operated.On April 28th 2016, 96.5% of the patients have completed followup.At baseline, the mean difference (MD) in IBDQ score was 4.9 points in favour of the resection group.After correction for the baseline difference, the MD at one year follow-up was 5.8 points in favour of resection (95% confidence interval (CI) À4.7 to 16.3, p ¼ 0.28).The mean direct total costs per patient at one year were E14,589 in the infliximab group and E10,318 in the resection group (MD 04,270, 95% CI 01,325 -07,126, p ¼ 0.005).Infliximab was stopped in 21 patients (30.0%) due to intolerance or insufficient response, 13 of whom underwent an ileocecal resection after a median time of 27.0 weeks (IQR 11.0-33.5)after start of infliximab treatment.CD related serious adverse events in terms of Clavien Dindo IIIb complications occurred in three patients (4.1%) in the laparoscopic ileocecal resection group and in one patient allocated to infliximab eventually going for surgery.Three patients (4.1%) in the resection group were started on infliximab within one year.Readmissions (for flares or additional surgery or dilatation) during follow-up were comparable (21.4% of patients in the infliximab versus 17.8% in the resection group).Conclusion: QoL at one year was not significantly different between the laparoscopic ileocecal resection and infliximab group.Given the lower bound of the 95% CI, laparoscopic ileocecal resection can be considered a non-inferior alternative for infliximab treatment at significantly lower cost.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.006 | 0.002 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.715 | 0.615 |
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".