Objectives: To identify and examine the methodologic issuesrelated to evaluating the effectiveness of treatment adherence toclinical guidelines. The example of antiretroviral therapy guidelinesfor human immunodeficiency virus (HIV) disease is used to illustratethe points.
Methods: Regression analysis was applied to observational HIV clinic datafor patients with CD4+ cell counts less than 500 per μL and greaterthan 50 per μL at baseline (n = 704),using Cox proportional hazardstime-varying covariates models controlling for baseline risk. Theresults are compared with simpler models (Cox model [withouttime-varying covariates] and logistic regression). In addition, theeffect of including a measure of exposure to antiretroviralguidelines in the model is explored.
Results: This study has three implications for modelingclinical guideline effectiveness. To capture events that are time-sensitive, a duration model should be used, and covariates that aretime-varying should be modeled as time-varying. Thirdly,incorporating a threshold measure of exposure to reflect the minimumperiod of time for guideline adherence required for a measurableeffect on patient outcome should be considered.
Conclusions: The methods proposed in this paper are importantto consider if guidelines are to evolve from being a tool forsummarizing and transferring the results of research from theliterature to clinicians into a practical tool that influencesclinical practice patterns. However, the methodology tested in thisstudy needs to be validated using additional data on similar patientsand using data on patients with other diseases.