Developing an Individualized Clinical Prediction Rules of Antihypertensive Drugs: A Study Protocol Based on Real-world Practice

Abstract Background Hypertension is one of the most urgent public health challenges, and drug therapy is the primary method to control blood pressure for patients. However, blood pressure control rate is still poor with antihypertensive drugs use. Although Clinical Prediction Rules (CPR) is useful to help clinicians make more appropriate decisions at the point of medication, the evidence is still limited in china. The objective of this study is to develop an CPR of antihypertensive drugs in individualized application of patients based on real-world practice. Methods A two-way cohort study has been conducted in one China’s large tertiary hospital using clinical information on patient characteristics, drug use and clinical outcome. Data extraction is through ICD-10 disease codes of hypertension from Electronic Medical Record System. Eligible patients admitted from September 2016 to August 2018 who have received at least one antihypertensive drug therapy is included. Patients were grouped into several exposure groups according to medications. COX regression model and clinical specialty survey is applied to identify Influencing Factors (IF) in different study groups, and the discriminant model was used to construct a CPR according IF. The accuracy of the CPR is analyzed by sensitivity, specificity, Youden’s index and Receiver Operating Characteristic (ROC) curve. Discussion Result is expected to provide valuable CPR for physicians and policymakers with respect to treating hypertension according characteristic of individual patients. By developing a predictive method for clinical outcomes and treatment costs of antihypertensive medication, we expect to discriminate those patients who would profit from specific scheme of antihypertensive drugs to minimal incidence probability of costs and complications in region of china. Trial registration This study was registered at www.chictr.org as a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), and the registered number is ChiCTR1900026339. Highlights Although Clinical Prediction Rules (CPR) could recognize individual patient risk and help clinicians to make more appropriate decision at the point of medication as part of clinical decision support systems, the evidence in this respect is still limited in China. This study is first going to construct the CPR of multiple antihypertensive drugs in real world practice of China. The highlights of this study is aimed to provide a pragmatic method to support clinical decisions for patients who has received antihypertensive drugs before long-term diagnosis of hypertension in real world practice according to their characteristics that are accessible to clinicians.