Quality of life in RCT of pasireotide to reduce pancreatic complications following resection.
Bibliographic record
Abstract
393 Background: A recent trial demonstrated that prophylactic pasireotide reduces pancreatic complication (PC) rates (primary objective). In this secondary analysis, we describe quality of life (QoL) in this population before and after resection using a standard instrument (the EORTC QLQ-C30) and the EORTC pancreatic cancer module (PAN26), which was recently developed to address the unmet need for QoL assessment in this subpopulation. Also of interest is assessing the association between PC and QoL and testing the hypothesis that pasireotide improves QoL. Methods: We conducted a randomized, double-blind, placebo-controlled trial of preoperative subcutaneous pasireotide in 300 patients undergoing pancreaticoduodenectomy or distal pancreatectomy. Participants completed the C30 and PAN26 preoperatively and on postoperative days 14 and 60. Scores were compared using paired t-tests. Results: All patients completed at least one questionnaire and 87% of patients completed all three. No major differences in QoL were seen between treatment groups so pooled results were reported. A significant worsening of function at 14 days was detected on all PAN26 and C30 function scales except hepatic and emotional functioning (EF), and all C30 symptom scales (all p<.01). These effects lessened by 60 days, but scores remained significantly worse than baseline with the exception of the sexuality, cognitive functioning, nausea and vomiting, insomnia and constipation scales, which returned to near baseline, and EF, which was significantly better than baseline (p=0.03). PC occurred in 45 patients and was associated with worse body image, dyspnea, financial difficulties and physical, role, emotional and social functioning at 14 and 60 days (all p<.05). Conclusions: During the first 14 days following resection, patients can be expected to have a significant decline in QoL. Many symptoms abate by 60 days, and EF improves. Although pasireotide effectively reduced PC, its effect did not appear to translate to improved QoL based on this sample of 300 patients. While PC was associated with worse QoL, most patients in both pasireotide and placebo groups did not experience PC, which may explain why no significant difference in QoL was observed. Clinical trial information: NCT00994110.
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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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".