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Record W3004897282 · doi:10.1056/nejmoa1803537

Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis

2020· article· en· W3004897282 on OpenAlexafffund
Michael Walsh, Peter A. Merkel, Chen Au Peh, Wladimir Szpirt, Xavier Puéchal, Shouichi Fujimoto, Carmel M. Hawley, Nader Khalidi, Oliver Floßmann, Ron Wald, Louis Girard, Adeera Levin, Gina Gregorini, Lorraine Harper, William F. Clark, Christian Pagnoux, Ulrich Specks, Lucy Smyth, Vladimı́r Tesař, Toshiko Ito‐Ihara, Janak de Zoysa, Wojciech Szczeklik, Luis Felipe Flores-Suárez, Simon Carette, Loı̈c Guillevin, Charles D. Pusey, Alina Casian, Biljana Brezina, Andrea Mazzetti, Carol A. McAlear, Elizabeth Broadhurst, Donna Reidlinger, Samir Mehta, Natalie Ives, David Jayne

Bibliographic record

VenueNew England Journal of Medicine · 2020
Typearticle
Languageen
FieldMedicine
TopicVasculitis and related conditions
Canadian institutionsWestern UniversityUniversity of TorontoHamilton Health SciencesUniversity of British ColumbiaSt. Joseph’s Healthcare HamiltonUniversity of CalgaryImpactMcMaster UniversityPopulation Health Research Institute
FundersMedical Research CouncilCanadian Institutes of Health ResearchBaxter Healthcare CorporationGenentechU.S. Food and Drug AdministrationPfizerBiogenInflaRxMinistry of Health, Labour and WelfareCSL BehringNational Institute for Health and Care ResearchInsmedBoehringer Ingelheim JapanMinistère des Affaires Sociales et de la SantéHealth Technology Assessment ProgrammeFresenius Medical Care North AmericaNational Health and Medical Research CouncilTerumo BCTAstraZenecaBarts CharityJapan Agency for Medical Research and DevelopmentEli Lilly and CompanyBristol-Myers SquibbNational Center for Research ResourcesAsahi Kasei Pharma CorporationNational Institute of Arthritis and Musculoskeletal and Skin DiseasesSanofiCelgeneGlaxoSmithKlineAmgenNational Institutes of HealthU.S. Department of Health and Human Services
KeywordsVasculitisANCA-Associated VasculitisAnti-neutrophil cytoplasmic antibodyMedicineImmunologyDermatologyInternal medicineDisease

Abstract

fetched live from OpenAlex

BACKGROUND: More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. METHODS: of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD). RESULTS: Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Direct model labels (unvalidated)

Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.

Model armCategoriesStudy designConfidence
gemmano category
Domain: not available · Genre: Empirical
About the Canadian research system: no · About a Canadian topic: no
Randomized triallow
gptno category
Domain: not available · Genre: Empirical
About the Canadian research system: no · About a Canadian topic: no
Other designlow
models splitAgreement compares identical category sets and study designs across arms.

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.002
Threshold uncertainty score0.010

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

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.

Opus teacher head0.019
GPT teacher head0.249
Teacher spread0.229 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Labeled directly by 2 models reading the full record.

The models applied no category: nothing in the taxonomy fit this work.

The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.

Study designRandomized trial · Other design
Domainnot available
GenreEmpirical

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".

Quick stats

Citations861
Published2020
Admission routes2
Has abstractyes

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