- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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London, Storbritannien, NW1 2DA
- Farr Institute, University College London
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Venn diagram of heart failure recording by data source
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Heart failure mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Stefan Koudstaal, MD PhD, University College, London
- Studierektor: Folkert W. Asselbergs, MD PhD, University College, London
- Huvudutredare: Harry Hemingway, PhD, University College, London
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14_149SK
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