Reporting Bleeding Outcomes in Adult and Pediatric Studies of Primary Immune Thrombocytopenia: A Systematic Review
Bibliographic record
Abstract
Abstract Abstract 4281 Background: Bleeding is arguably the most clinically meaningful outcome in ITP clinical studies since it impacts morbidity, mortality and quality of life. Yet, the measurement of bleeding is not standardized, and its prevalence as a study outcome has not been well characterized. Methods: We performed a systematic review of all English language, prospective clinical studies enrolling 20 or more adults or children with primary ITP to determine if and how bleeding data were reported. In duplicate and independently, we searched MEDLINE, EMBASE, Cochrane and Cinahl databases until January 2012. Titles were screened for relevance and abstracts and full text articles were reviewed in duplicate for eligibility. Study selection and data abstraction were performed in duplicate. Patient demographics, use of a bleeding measurement tool and frequency of bleeding were collected from all studies. Results: We identified 167 prospective studies, including 29 (33%) randomized trials enrolling 13,976 patients with primary ITP (including 3,723 adults; 9,730 children; and 523 combined adults and children). Of 167 studies, 87 (52.1%) reported bleeding either as an efficacy endpoint (n=77), a safety endpoint (n=5) or both (n=5). Of the 87 studies that reported bleeding, 17 (19.5%) used an ITP-specific bleeding measurement tool. Such a tool was used in 4 of the 29 randomized trials. Less common were the Common Terminology Criteria for Adverse Events score (n=4) and the World Health Organization score (n=4); but the majority of studies did not use a predefined tool to measure bleeding. Bleeding was reported as present or absent (n=8 studies, 9.1%); by anatomical site only (n=39, 44%); by severity only (n=1, 1.1%); or by severity and anatomical site (n=29, 33%). Ten (29.8%) studies did not specify how bleeding was measured. Forty-three studies reported some association between platelet count and bleeding; however, none provided a statistical association with severity of thrombocytopenia. Summary: This study represents a summative description of the English-language world literature on bleeding outcomes in ITP studies. Of all studies, just over half (52.1%) reported bleeding outcomes. Only 20% of studies used a bleeding measurement tool that was specific for ITP patients. A standardized approach to bleeding and other patient-centered outcomes will help direct future research in ITP. Funding support from the McMaster Division of Hematology & Thromboembolism. Disclosures: Arnold: Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees, Research Funding; Hoffman-LaRoche: Research Funding.
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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 | 0.032 | 0.148 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.010 |
| Bibliometrics | 0.014 | 0.015 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
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".