Song, Jiali
Wang, Xiuling
Wang, Bin
Gao, Yan
Liu, Jiamin
Zhang, Haibo
Li, Xi
Li, Jing
Wang, Ji-Guang
Cai, Jun
Herrin, Jeph
Armitage, Jane
Krumholz, Harlan M.
Zheng, Xin http://orcid.org/0000-0001-5285-4989
,
Article History
Received: 27 June 2021
Accepted: 29 April 2022
First Online: 16 May 2022
Declarations
:
: 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 to send a text message as a brief medical record (e.g., blood pressure, prescriptions, and follow-up reminders) after each visit. Any substantial amendments to the protocol or the consent materials will be approved by relevant ethical review bodies. Since there are no harms to be expected resulting specifically from the trial-specific interventions, no special provisions are made for trial-specific ancillary or post-trial care.
: In the past three years, Dr. Harlan Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Aetna, Reality Labs, Tesseract/4Catalyst, F-Prime, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, and Martin/Baughman Law Firm. He is a co-founder of Refactor Health and HugoHealth, and is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Johnson & Johnson. 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-center 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-center trial on the effects of sotagliflozin; is a recipient of a research agreement with University of Oxford, through Fuwai Hospital, for a multi-center trial of empagliflozin; and was a recipient of a research agreement, through NCCD, from AstraZeneca for clinical research methods training.