The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions, and Common Infections in Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51,955
- 试验地点
- 1
- 主要终点
- Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata
研究概览
简要总结
This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and incidence of psychiatric co-morbidities in people with alopecia areata, (3) the prevalence and incidence of autoimmune and atopic conditions in people with alopecia areata, and (4) the incidence of common infections in people with alopecia areata.
详细描述
The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.
The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.
The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.
The overall purpose of the fourth study (Study 4) is to assess the incidence of common infections in adult patients diagnosed with AA relative to a control population of patients without AA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.
- •Only patients aged ≥18 will be eligible for studies 2 and
- •Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2)
排除标准
- •People with the alternative non-AA diagnoses.
- •People with AA diagnosis within 6 months of registration.
- •People with less than 1 year of follow up available
结局指标
主要结局
Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata
时间窗: Within two years of diagnosis of Alopecia Areata
Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors
时间窗: Overall during 2009-2018 inclusive
This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.
Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata.
时间窗: Within two years of diagnosis of Alopecia Areata
This will comprise of the number of medications used to treat mental health conditions in patients diagnoses with Alopecia Areata. Antidepressant medication classes to be examined comprise; selective serotonin reuptake inhibitors and related medications (serotonin and norepinephrine reuptake inhibitors (SNRIs)), tricyclic antidepressants and related medications (tetracyclic antidepressant), and monoamine oxidase inhibitors. Anxiolytic medications to be examined comprise all benzodiazepines and other related medications indicated for use in anxiety states.
Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.
时间窗: Within two years of diagnosis of Alopecia Areata
This will comprise of the number of psychological interventions used to treat mental health conditions in patients diagnoses with Alopecia Areata. Psychological interventions comprise of counselling, Cognitive Behavioural Therapy, and psychotherapy.
Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
时间窗: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata in a contemporary real-world population at diagnosis compared with matched controls.
Study 1: The incidence of Alopecia Areata
时间窗: Overall during 2009-2018 inclusive
The incidence of Alopecia areata within the study cohort during the study period
Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.
时间窗: Within five years of Alopecia Areata diagnosis
Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Study 1:The annual rate of primary care visits for people with Alopecia Areata.
时间窗: Within one year of diagnosis of Alopecia Areata
The annual rate of visits to primary care for any reason within one year of diagnosis.
Study 1: Secondary care dermatology service utilisation
时间窗: Within one year of diagnosis of Alopecia Areata
The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata
Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
时间窗: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with Alopecia Areata in a contemporary real-world population compared with matched controls.
Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata
时间窗: Within five years of Alopecia Areata diagnosis
Incidence of a composite of any common infection (composite comprising a diagnosis of: upper and lower respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex and herpes zoster) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata
时间窗: Within five years of Alopecia Areata diagnosis
Incidence of a composite of any viral infection (composite comprising a diagnosis of: influenza, herpes simplex and herpes zoster infections, bronchitis, and any upper respiratory tract infections specifically coded as being viral) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
次要结局
- Study 4: The incidence of influenza infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.(Overall during 2009-2018 inclusive)
- Study 2: Prevalence (percentage) of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder), by socio-demographic factors, in adult patients diagnosed with Alopecia Areata.(At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive)
- Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.(Within one year of diagnosis of Alopecia Areata)
- Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.(Within one year of diagnosis of Alopecia Areata)
- Study 4: The incidence of pneumonia in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of genital infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of skin infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)
- Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata(Within five years of Alopecia Areata diagnosis)