Ethics approval and consent to participate
The ethics committee of Fuwai Hospital approved both trials. All sites accepted this ethics approval or obtained local approval by internal ethics committees as appropriate. Given that guideline-based recommendations provided by CDSS was considered to have minimal risk for the patients, informed consent for implementing the CDSS in both trials is waived. A simple written informed consent for participants was acquired for the purpose of sending a text message as a brief medical record (e.g., blood pressure, prescriptions and follow-up reminders) after each visit.
Consent for publication
Availability of data and materials
The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Dr. Krumholz works under contract with the Centers for Medicare & Medicaid Services to support quality measurement programs; was a recipient of a research grant, through Yale, from Medtronic and the US Food and Drug Administration to develop methods for post-market surveillance of medical devices; was a recipient of a research grant with Medtronic and is the recipient of a research grant from Johnson & Johnson, through Yale University, to support clinical trial data sharing; was a recipient of a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; receives payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation, from the Martin/Baughman Law Firm for work related to the Cook IVC filter litigation, and from the Siegfried and Jensen Law Firm for work related to Vioxx litigation; chairs a Cardiac Scientific Advisory Board for UnitedHealth; was a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science, the Advisory Board for Facebook, and the Physician Advisory Board for Aetna; and is the founder of HugoHealth, a personal health information platform, and co-founder of Refactor Health, an enterprise healthcare AI-augmented data management company. Dr. Jing Li discloses that she is a recipient of research grants from the government of China, through Fuwai Hospital, for research to improve the management of hypertension and blood lipids, and to improve care quality and patient outcomes of cardiovascular disease; is a recipient of research agreements with Amgen, through National Center for Cardiovascular Diseases (NCCD) and Fuwai Hospital, for a multi-centre trial to assess the efficacy and safety of Omecamtiv Mecarbil, and for dyslipidemic patient registration; is a recipient of a research agreement with Sanofi, through Fuwai Hospital, for a multi-centre trial on the effects of sotagliflozin; is a recipient of a research agreement with University of Oxford, through Fuwai Hospital, for a multi-centre trial of empagliflozin; and was a recipient of a research agreement, through NCCD, from AstraZeneca for clinical research methods training.
This project was supported by the CAMS Innovation Fund for Medical Science (2016-I2M-1-006) and the 111 Project (B16005) from the Ministry of Education of China. These funding have no role in the design of the study, collection, analysis, or interpretation of data or in writing the manuscript.
HMK, JA, and XZ designed the study. XZ acted as the principal investigator to take responsibility for all respect of the study. JS, HMK, JA, and XZ conceived of this article. JS wrote the manuscript with further contributions from XZ, JA, HMK, JH, JW, JC, JL, XL, HZ, JL, BW, XW and YG. JH calculated the sample size and provided advice in randomization method of the study. YG performed daily data monitoring and completed all the statistical analysis. XZ, LJ, HZ, JS, XW, and BW developed the algorithm of the CDSS. All authors contributed to critical revisions and approved the final version of the article.
We appreciate the steering committee member of the study: Robert Clarke from University of Oxford, Sharon-Lise T. Normand from the Harvard T.H. Chan School of Public Health, Frederick A. Masoudi from University of Colorado School of Medicine, Songtao Tang from the Community Health Center of Liaobu County, Wenjun Ma from the Fuwai Hospital, and Jian Xu from the Center for Chronic Disease Control of Shenzhen for their support and advice. We thank Lawrence J. Fine and George A. Mensah from National Institutes of Health for their contributions in study design. We appreciate the multiple contributions made by study teams at the National Clinical Research Center of Cardiovascular Diseases in the realms of study design and operation, particularly site management and coordination by Bo Gu, Yilan Ge, Fuyu Jing, Lei Bi, Huijun Jin, Teng Li, and Liyuan Sui, and IT development and maintenance by Shuyang Hua and Mengnan Zhu. We thank the local sites in the collaborative network for their support and data collection.