- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02549872
Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries
Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries: a Cohort Study in Linked Electronic Health Records
Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records therefore provide useful information about the diagnosis and prognosis of patients who develop dementia.
In this study we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia in different age and sex groups
Přehled studie
Detailní popis
Dementia is a clinical syndrome with insidious onset that is difficult to diagnose in its earliest stages. Presentation to healthcare depends not only upon the rates of disease progression, but also on social support, recognition by clinicians, and patients' and carers' fear of diagnosis. Maintaining complete follow up in cohorts of patient with dementia is difficult, because patients with dementia are frequently lost to follow up.
Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records should therefore provide useful information about the diagnosis and prognosis of patients who develop dementia with minimal loss to follow-up rates and improved completeness of diagnosis.
Demonstrating that patients with recorded dementia have an earlier onset of typical symptoms, functional impairment and death than patients in the general population would support the veracity of diagnosed dementia recorded in electronic health records and its use as an outcome or exposure in cohort studies and for evaluating policy. Previous studies have found that dementia is poorly recorded in routine clinical practice in comparison to face-to-face studies, although this varies by setting and region. However, ascertainment may be improved by examining linked, longitudinal resources. Comparing the lifetime risk of dementia calculated from linked electronic health records with lifetime risks from other sources will also be a useful information to support the use of linked electronic health records in dementia research.
Electronic health records contain information on important health transitions in patients with dementia: from the earliest stage of the illness (depression, anxiety, memory complaints); the development of cognitive impairment that manifest as loss of capacity or missed appointments; and significant functional impairment, with admission to nursing homes or hospital admission. In this study, we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and estimate the lifetime risk of recorded dementia in different age and sex groups.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
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London, Spojené království
- London Farr Institute of Health Informatics
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients aged 18 years and over
- Registered with a participating general practice during the study period
- Minimum one year of records prior to study entry meeting CPRD data quality criteria
- Followed on or after 1 January 1997
Exclusion Criteria:
- Patients without recorded gender
- Less than 1 year of follow-up between study entry and date of administrative censoring
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Dementia
Patients with a recorded diagnosis of dementia in primary or secondary care
|
This study is based on the retrospective analysis of linked electronic health records.
|
Non-dementia
Patients without a recorded diagnosis of dementia in primary or secondary care
|
This study is based on the retrospective analysis of linked electronic health records.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care
Časové okno: 10 years
|
10 years
|
|
Factors associated with dementia diagnosis (any type) recording in mortality data only
Časové okno: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Symptoms associated with subsequent diagnosis of dementia
Časové okno: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Lifetime risk of dementia (any type)
Časové okno: 10 years
|
10 years
|
|
Lifetime risk of mortality associated with dementia (any time)
Časové okno: 10 years
|
10 years
|
|
Factors associated with dementia diagnosis (any type) recording in secondary care only
Časové okno: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Factors associated with dementia diagnosis (any type) recording in primary care only
Časové okno: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in mortality data
Časové okno: 10 years
|
10 years
|
|
Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data
Časové okno: 10 years
|
10 years
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care
Časové okno: 10 years
|
10 years
|
Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care
Časové okno: 10 years
|
10 years
|
Lifetime risk of Alzheimer's disease
Časové okno: 10 years
|
10 years
|
Lifetime risk of vascular dementia
Časové okno: 10 years
|
10 years
|
Lifetime risk of mortality associated with Alzheimer's disease
Časové okno: 10 years
|
10 years
|
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in mortality data
Časové okno: 10 years
|
10 years
|
Proportion of patients with Alzheimer's disease in secondary care that are also recorded in mortality data
Časové okno: 10 years
|
10 years
|
Proportion of patients with vascular dementia in primary care that are also recorded in secondary care
Časové okno: 10 years
|
10 years
|
Proportion of patients with vascular dementia in secondary care that are also recorded in mortality data
Časové okno: 10 years
|
10 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15_138
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