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Sökning: onr:"swepub:oai:DiVA.org:uu-378677" > Frequency, Regional...

  • Fanaroff, Alexander C.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)

Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials : A Pooled Analysis of 9259 Deaths in 9 Trials

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • 2019
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-378677
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-378677URI
  • https://doi.org/10.1161/CIRCULATIONAHA.118.037202DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed. METHODS: Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Patient-and trial-level variables associated with undetermined cause of death were identified using a logistic model. RESULTS: Across 127 049 enrolled participants from 9 trials, there were 9259 centrally adjudicated deaths: 5012 (54.1%) attributable to cardiovascular causes, 2800 (30.2%) attributable to noncardiovascular causes, and 1447 (15.6%) attributable to undetermined causes. There was variability in the proportion of deaths ascribed to undetermined causes by trial therapeutic area, region of enrollment, and year of trial manuscript publication. On multivariable analysis, acute coronary syndrome or atrial fibrillation trial (versus atherosclerotic vascular disease or diabetes mellitus/pre-diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (versus Western Europe), female sex, and older age were associated with greater likelihood of death of undetermined cause. CONCLUSIONS: In 9 cardiometabolic clinical trials with long-term followup, approximately 16% of deaths had undetermined causes. This provides a baseline for quality assessment of clinical trials and informs operational efforts to potentially reduce the frequency of undetermined deaths in future clinical research.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Clare, RobertDuke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Pieper, Karen S.Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Mahaffey, Kenneth W.Stanford Univ, Sch Med, Stanford Ctr Clin Res, Stanford, CA 94305 USA (författare)
  • Melloni, ChiaraDuke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Green, Jennifer B.Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA;Duke Univ, Div Endocrinol, Sch Med, Durham, NC USA (författare)
  • Alexander, John H.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Jones, W. SchuylerDuke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Harrison, Robert W.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Mehta, RaJendra H.Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Povsic, Thomas J.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Moreira, Humberto G.Univ Sao Paulo, Heart Inst InCor, Med Sch, Sao Paulo, Brazil (författare)
  • Ai-Khatib, Sana M.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Roe, Matthew T.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Kong, David F.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Mathews, RobinDuke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Tricoci, PierluigiCSL Behring, King Of Prussia, PA USA (författare)
  • Holman, Rury R.Univ Oxford, Diabet Trials Unit, Oxford Ctr Diabet Endocrinol & Metab, Oxford, England (författare)
  • Wallentin, Lars,1943-Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)larswall (författare)
  • Held, Claes,1956-Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)clahe947 (författare)
  • Califf, Robert M.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA;Verily Life Sci, San Francisco, CA USA (författare)
  • Alexander, Karen P.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Lopes, Renato D.Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (författare)
  • Duke Univ, Sch Med, Div Cardiol, Durham, NC USA;Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USADuke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Circulation139:7, s. 863-8730009-73221524-4539

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