4. Discussion
bleeding, stroke, Depression, Confusion, strokes
BLEEDING, STROKE, DISORDERS, SAID, EVENTS, STROKES
This study was a feasibility study of a cluster-randomized controlled trial which we are carrying out. The finding indicated that using the CDSS in China's primary care settings might improve the proportion of patients prescribed guideline-directed antithrombotic therapy. The GP in the AF special consulting room of the software group showed a positive attitude toward the CDSS.Thromboembolic prophylaxis, through standardized anticoagulation, can significantly reduce the risk of strokes in patients with AF [The CDSS used in this study functioned to assess the risks of stroke and bleeding and provided suggestions on AF management, like treatment decisions, follow-up time, adjustment of anticoagulants, or dosage administered. The CDSS might help GPs manage patients with AF and enhance the GPs' capabilities and confidence in the field. Thus, it was well accepted by the GP in the AF special consulting room of the software group. The finding also indicated that the CDSS might improve the proportion of patients prescribed guideline-directed antithrombotic therapy and helped GPs provide scientific and normative health education to patients with AF. The proportion of appropriate anticoagulation treatments was 75.5% in the software group and 38.7% in the control group. There were 12 patients in the software group and 17 patients in the control group with high-stroke risks but were not prescribed with anticoagulants. The common reasons for no anticoagulation treatment in both groups were mainly old age, complex comorbidities, and strong rejection from patients themselves. Besides these, the GP in the control group also said that he was not sure if it was necessary to prescribe anticoagulants for those whose CHA2DS2-VASc scores were two and those who were taking antiplatelets or NSAIDs. Due to the few adverse clinical events during the study, we used a composite outcome indicator. It seemed that the incidence of adverse clinical events in the software group was lower than that in the control group, but this potential still needed to be further validated with a larger sample size in the cluster-randomized trial.Considering the results in this study, we estimated that it should be feasible to promote the CDSS in more community health centers. In the subsequent randomized controlled study, we adjusted the protocol in the four aspects below. First, the dropout rate was high in the current study (21.5%), and one reason was that patients followed up in other hospitals. To reduce dropout rates, we will add inclusion and exclusion criteria to avoid the loss to follow-up. For example, we require that subjects be registered with a GP for at least 1 year and exclude patients whose expected survival time would be less than 1 year or those who are unable to cooperate with the study due to any reason. Second, considering that the GP in the AF special consulting room of the software group viewed the CDSS well, and patients seeking healthcare in AF special consulting rooms were few, we plan to carry out the formal trial in all general practice clinics. We want to recruit a sufficient number of participants and investigate whether using the CDSS remained effective or not in more community health centers. Therefore, in the next trial, we will set the inclusion and exclusion criteria for GPs and train them in AF management and the use of the CDSS. After training, GPs will be able to recruit patients with AF in the study. Third, based on the interview with the GP in the AF special consulting room of the software group, we will update the CDSS. Apart from its existing functions, the latest version also provides referral suggestions and tips on the interactions between anticoagulants and other drugs or food. The program also supports the assessments of the risk of falling and balancing (Tinetti Scale and Self-Rated Fall Risk Questionnaire), cognition (Mini-Mental State Examination), and emotional and psychological disorders (Geriatric Depression Scale-15 and the Confusion Assessment Method). In addition, we modified the record methods for the warfarin dosage. Fourth, GPs will be invited to complete a questionnaire on antithrombotic treatments three times before and after the training, as well as at the end of the study. Within the first week and the fourth, eighth, and twelfth months after enrollment, patients will be required to finish the satisfaction questionnaires. Through questionnaires, we hope to reduce dropouts to some extent and evaluate the effect of the CDSS in more directions. The revision for the protocol and the CDSS was approved by the Ethics Committee of Zhongshan Hospital and registered in the clinical trial registry (approval number. B2021-579(2) and registration number. The study had some strengths. First, as far as we knew, the study was the first one in China to identify the effect of an AF antithrombotic treatment-related CDSS on patients with AF in primary care. Second, the data in this study were extracted from the medical records of patients or via telephone contacts. The data were reliable and close to the real environment of China's primary care. Third, the CDSS that we used was validated by algorithm engineers and cardiological experts and was highly praised by GPs in the AF special consulting room of the software group.There also existed some shortcomings in this cohort study. First, the age and HAS-BLED score of the subjects at the baseline were not the same between the two groups. Second, the preferences for treatment choices of the subjects and GPs might influence the final treatment decisions, especially in regard to anticoagulant selection and for patients whose risk of stroke was one. However, we could not estimate the magnitude of such effects. Third, the data in this study were extracted from the medical records of each patient, and we did not have access to their socioeconomic information, such as their educational levels, incomes, and family support. However, in a previous study by Lunde et al. [