- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02551016
Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry
Capture and Concordance of Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry: A Cohort Study In 2.1 Million People
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Heart failure (HF) is one of the leading causes of hospital admissions and mortality in modern healthcare systems. It can be viewed as a collective clinical syndrome of many signs and symptoms and is frequently the common endpoint of various heart diseases. Often, it is not diagnosed until it has reached a level whereby quality of life is significantly, and often irreversibly, impaired. Even though vast quantities of National Health Service (NHS) data concerning patients with heart failure are recorded, there are limited 'real world' longitudinal insights about the prognosis and consequences of HF. Although linked electronic health records cohorts such as the CALIBER program become increasingly available, for heart failure the overlap, risk factors and subsequent mortality have not been compared. Previous studies on heart failure using EHR sources have used ICD-9 or 10 codes for the identification of heart failure cases and the prevalence estimates of risk factors and comorbidity. Furthermore, the assessment of supporting information for heart failure present in electronic healthcare registries remains largely unknown. Currently, heart failure is typically inferred based on previous reports or the prescription of heart failure related medication. To strengthen heart failure case ascertainment in large electronic healthcare registries, linkages with primary care data such as what is done in CALIBER could allow more detailed insight in medical history, clinical diagnoses, anthropometric measures, health behaviour, laboratory tests, medical procedures and prescriptions.
In this study, the investigators assessed the distribution of recording, supportive medical information for heart failure diagnosis, risk factors and subsequent mortality of heart failure patients captured in linked EHR data from primary care, hospital admissions and/or death registry.
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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London, Storbritannia, NW1 2DA
- Farr Institute, University College London
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with a coded diagnosis for heart failure in primary care or hospital admission
- Patients with a coded diagnosis for heart failure as a cause of death in the national mortality register
- Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria.
- Patients with at least one year of follow-up in the CPRD practice CPRD.
Exclusion Criteria:
- past medical history of heart failure
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Primary care only
Patients with heart failure recorded in primary care and never hospitalized for heart failure
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Primary care and secondary care
Patients with heart failure recorded in primary care with at least one record of a heart failure related hospitalization.
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Secondary care only
Patients with heart failure recorded in at least one heart failure related hospitalization without a concurrent primary care record.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Venn diagram of heart failure recording by data source
Tidsramme: 13 years
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Frequency and overlap of heart failure patients recorded in primary care, hospital admissions and as cause of death in the national mortality registry.
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13 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Heart failure mortality
Tidsramme: 5 years
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5 year heart failure cause of death following the first recorded heart failure diagnosis
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5 years
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Cardiovascular mortality
Tidsramme: 5 years
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The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.
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5 years
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All-cause mortality
Tidsramme: 5 years
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The all cause mortality 5 years following the first recorded heart failure diagnosis
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5 years
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Stefan Koudstaal, MD PhD, University College, London
- Studieleder: Folkert W. Asselbergs, MD PhD, University College, London
- Hovedetterforsker: Harry Hemingway, PhD, University College, London
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Denaxas SC, George J, Herrett E, Shah AD, Kalra D, Hingorani AD, Kivimaki M, Timmis AD, Smeeth L, Hemingway H. Data resource profile: cardiovascular disease research using linked bespoke studies and electronic health records (CALIBER). Int J Epidemiol. 2012 Dec;41(6):1625-38. doi: 10.1093/ije/dys188. Epub 2012 Dec 5.
- Koudstaal S, Pujades-Rodriguez M, Denaxas S, Gho JMIH, Shah AD, Yu N, Patel RS, Gale CP, Hoes AW, Cleland JG, Asselbergs FW, Hemingway H. Prognostic burden of heart failure recorded in primary care, acute hospital admissions, or both: a population-based linked electronic health record cohort study in 2.1 million people. Eur J Heart Fail. 2017 Sep;19(9):1119-1127. doi: 10.1002/ejhf.709. Epub 2016 Dec 23.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14_149SK
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