Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area: a Descriptive Retrospective Observational Study Using Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Participants sociodemographic characteristics
研究概览
简要总结
This is a descriptive retrospective study of individuals affected with knee osteoarthritis. The aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition on the healthcare system. To achieve this, medical records will be reviewed, and the following data will be collected:
Sociodemographic and clinical participant data. Healthcare resource use. Clinical burden. Up to 400 subjects will be enrolled in the Talavera de la Reina Health Area (Toledo, Spain).
详细描述
This is a multicenter, observational, retrospective study focusing on individuals diagnosed with knee osteoarthritis. This study will be conducted in the Talavera de la Reina Health Area (Toledo, Spain). Participants will be identified through the codes assigned in the electronic database associated with knee osteoarthritis.
Data will be collected from the initial radiologic diagnostic moment to December 31, 2019. For each participant enrolled, data from medical records will be collected and entered onto an electronic case report form (REDCap).
The sociodemographic and clinical data related to the pathology will be collected, including age, weight, height, duration of the condition, and occupational activity.
The following data will be considered as direct healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals. In addition, pharmacotherapy, rehabilitation number of sessions, and work absences (temporary and permanent) will be registered.
For cost estimation, a prevalence-based approach and a bottom-up estimation will be employed in the monetary valuation of healthcare resources, utilizing official sources.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old.
- •Diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical criteria of the American College of Rheumatology.
- •Radiographic imaging diagnosis based on the Kellgren & Lawrence (K-L) classification.
排除标准
- •No available X-ray.
- •Pre-existing neurological diseases before the diagnostic date (stroke, Parkinson's, multiple sclerosis, ALS).
- •Connective tissue disorders (Ehlers-Danlos, Marfan). Secondary cause of osteoarthritis or severe osteoarthritis (ACL tears, severe traumas, infections, or sepsis).
- •Inflammatory arthropathy (any type of arthritis).
- •Genetic disorders with a higher risk of developing arthropathies (Down syndrome).
结局指标
主要结局
Participants sociodemographic characteristics
时间窗: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Age, weight, height and work activity.
Healthcare resource use
时间窗: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Healthcare resource use will be collected from medical records. The data will be collected by four collaborators from the healthcare system, filling out electronic forms on REDCap. The health direct cost will be the following: The number of visits in primary and specialized care and type of health professional, number and type of surgical interventions, and number of emergencies at both health centers and hospitals. Type and number of diagnostic tests. Pharmacotherapy (type of drug and dose). The number of sessions of physical therapy.
Participant clinical characteristics
时间窗: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Severity of knee osteoarthritis with the radiographic Kellgren and Lawrence classification. Disease progression time.
次要结局
- Work absences(Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.)
- Charlson Comorbidity Index (CCI)(Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.)
- Physical therapy treatment(Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.)
研究者
Natalia Comino Suarez
PhD
University of Castilla-La Mancha