Clinical trial of biopsies in oncology: Patient-reported impact (BIOPSY).
Bibliographic record
Abstract
e17034 Background: Modest prospective data reports the impact of biopsies on patients (pts) with respect to adverse events (A/E) and anxiety. With increasing use of biopsies in clinical practice and trials, BIOPSY was designed to prospectively assess this. Methods: Pts undergoing a biopsy for diagnosis and/or research at Princess Margaret Cancer Centre were eligible. Surveys at 1 wk prior to biopsy and 1 wk and 1 mth post-biopsy assessed anxiety, A/E and pt experience. Anxiety was measured with a modified hospital anxiety and depression scale (HADS) score. Results: From 3/2015 to 1/2017, 51, 47 and 39 pts completed 1, 2 and 3 surveys respectively. Median age was 61 years. 40 biopsies were for research (78%) and 11 for diagnosis (22%). 46 pts were involved in a clinical trial (90%). 47 pts had a gynecological cancer (92%). 45 pts felt well-informed of the possible risks of the biopsy (88%). 23 pts noted the biopsy would not impact them directly (45%). 48 pts supported the use of tissue for future unrelated research (94%). Feelings of anxiety about the biopsy improved with time (table 1). 28 pts had pain 1 wk post-biopsy (60%) which was a moderate or major problem in 9 pts (19%). 2 pts reported reduced dignity with the biopsy (4%). 12 pts at 1 wk (26%) felt another biopsy would be a moderate-major issue. At 1 mth 3 of these pts reported a biopsy was now a mild problem. No significant A/E occurred. At baseline only 2 pts felt a biopsy would deter them from entering a clinical trial (4%). 42 pts at 1 wk (89%) and 30 pts at 1 mth (77%) felt they would consent to another biopsy for research. On univariate analysis pts with at least moderate pain post-biopsy at 1 wk or 1 mth (p=0.03) or an elevated HADS score at 1 mth (p=0.02) appeared less likely to agree to a further research biopsy but numbers were small. Conclusions: Anxiety and pain are potentially modifiable A/E that impact whether a pt will agree to a further biopsy. Overall, most pts tolerated their biopsy well, supported its use for future unspecified research and were open to further biopsies. [Table: see text]
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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 | 0.013 | 0.041 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 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) | 0.036 | 0.003 |
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".