Sills Marion R, Kwan Bethany M, Yawn Barbara P, Sauer Brian C, Fairclough Diane L, Federico Monica J, Juarez-Colunga Elizabeth, Schilling Lisa M
University of Colorado School of Medicine.
Olmstead Medical Center.
EGEMS (Wash DC). 2013 Dec 18;1(3):1032. doi: 10.13063/2327-9214.1032. eCollection 2013.
This paper describes the methods for an observational comparative effectiveness research study designed to test the association between practice-level medical home characteristics and asthma control in children and adults receiving care in safety-net primary care practices.
This is a prospective, longitudinal cohort study, utilizing survey methodologies and secondary analysis of existing structured clinical, administrative, and claims data. The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) is a safety net-oriented, primary care practice-based research network, with federated databases containing electronic health record (EHR) and Medicaid claims data. Data from approximately 20,000 patients from 50 practices in four healthcare organizations will be included. Practice-level medical home characteristics will be correlated with patient-level asthma outcomes, controlling for potential confounding variables, using a clustered design. Linear and non-linear mixed models will be used for analysis. Study inception was July 1, 2012. A causal graph theory approach was used to guide covariate selection to control for bias and confounding.
Strengths of this design include a priori specification of hypotheses and methods, a large sample of patients with asthma cared for in safety-net practices, the study of real-world variations in the implementation of the medical home concept, and the innovative use of a combination of claims data, patient-reported data, clinical data from EHRs, and practice-level surveys. We address limitations in causal inference using theory, design and analysis.
本文描述了一项观察性比较效果研究的方法，该研究旨在测试在安全网初级保健机构接受治疗的儿童和成人中，实践层面的医疗之家特征与哮喘控制之间的关联。
这是一项前瞻性纵向队列研究，采用调查方法并对现有的结构化临床、行政和索赔数据进行二次分析。联邦转化性询问网络的可扩展架构（SAFTINet）是一个以安全网为导向、基于初级保健实践的研究网络，其联邦数据库包含电子健康记录（EHR）和医疗补助索赔数据。将纳入来自四个医疗保健组织中50个实践机构的约20000名患者的数据。实践层面的医疗之家特征将与患者层面的哮喘结局进行相关性分析，采用聚类设计控制潜在的混杂变量。将使用线性和非线性混合模型进行分析。研究起始于2012年7月1日。采用因果图理论方法指导协变量选择以控制偏倚和混杂。
该设计的优点包括假设和方法的先验设定、在安全网实践中接受治疗的大量哮喘患者样本、对医疗之家概念实施中的实际差异的研究，以及对索赔数据、患者报告数据、EHR临床数据和实践层面调查数据组合的创新运用。我们通过理论、设计和分析来解决因果推断中的局限性。
