Analysis of the Time Taken for Newly Diagnosed COPD Patients to be Prescribed Triple Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20,154
- 试验地点
- 1
- 主要终点
- Triple Therapy Status
研究概览
简要总结
The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:
- The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.
- For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.
- The variation in treatment pathways.
- The factors associated with time taken to triple therapy.
详细描述
Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 <50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy.
To allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include:
- Disease severity markers:
- Confirmation of a COPD diagnosis at initial date of COPD diagnosis
- Standard co-morbidities fields
- Demographic fields
This retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint.
Specific questions that will be asked are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥40 years at initial date of COPD diagnosis
- •COPD diagnosis with Quality Outcome Framework (QoF) approved read code
- •has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted)
- •Patient has one year of data prior to initial date of COPD diagnosis
- •Patient has a minimum of two years of data post initial date of COPD diagnosi
排除标准
- •Patients whose initial date of COPD diagnosis is before 1997
结局指标
主要结局
Triple Therapy Status
时间窗: 1 year
The proportion of patients prescribed triple therapy and whether they were prescribed it prior to, at, or after initial date of COPD diagnosis.
Initial date of COPD diagnosis
时间窗: 1 year
The date that patients were initially diagnosed with COPD. Categorised into cohorts- 1997-2001, 2002-2006, 2007-2010.
次要结局
- Lung function grade(1 year)
- Asthma Diagnosis(1 year)
- COPD patient group(1 year)
- COPD exacerbations (Clinical experience based)(1 year)
- Smoking Status(1 year)
- BMI(1 year)
- COPD co-morbidities(1 year)