Dataset Information

Effect of an artificial intelligence-assisted tool on non-valvular atrial fibrillation anticoagulation management in primary care: protocol for a cluster randomized controlled trial.

ABSTRACT:

Background

Atrial fibrillation (AF) is one of the most common cardiac arrhythmia diseases. Thromboembolic prophylaxis plays an essential role in AF therapy, but at present, general practitioners (GPs) are presumed to lack the knowledge and enthusiasm for AF management. Clinical decision support systems (CDSS), assisted by artificial intelligence, help primary care providers (PCPs) make quick, individualized, and correct clinical decisions. This primary aim of the study is to identify whether the promotion of the CDSS would improve the primary care provided to patients with AF. The secondary objectives are mainly to assess the health-economic and clinical benefits from using the CDSS, and the improvement of GPs' AF management capability.

Methods

This study will be a prospective cluster randomized controlled trial, conducted among 14 community health centers in Shanghai which were randomized as the intervention group and control group in a ratio of 1:1. The intervention group will use the CDSS in the consultation of patients with AF and the control group will maintain their usual care. The trial will include 498 patients with AF and the follow-up period will be 12 months. The primary outcome is set as the proportion of antithrombotic treatment prescriptions in agreement with recommendations in the latest China's AF-related guidelines. The secondary outcomes are the frequency of consultation, the compliance rate of international normalized ratio (INR) in patients with warfarin, stroke morbidity, treatment compliance, medication satisfaction, and the cost-benefit analysis. Per-protocol (PP) analysis and the intention-to-treat (ITT) analysis will be conducted.

Discussion

This study aims to identify whether the application of CDSS to manage patients with AF in China's community health centers would bring benefits for patients, physicians, and health economics.

Trial registration

Registry name: AI (Development and promotion of an AI-assisted tool for NVAF management in primary care); registry number: ChiCTR2100052307; registration date: Nov. 22^nd, 2021; http://www.chictr.org.cn/showproj.aspx?proj=133849 .

SUBMITTER: Ru X

PROVIDER: S-EPMC9013112 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Effect of an artificial intelligence-assisted tool on non-valvular atrial fibrillation anticoagulation management in primary care: protocol for a cluster randomized controlled trial.

Ru Xueying X Zhu Lan L Ma Yunhui Y Wang Tianhao T Pan Zhigang Z

Trials 20220415 1

<h4>Background</h4>Atrial fibrillation (AF) is one of the most common cardiac arrhythmia diseases. Thromboembolic prophylaxis plays an essential role in AF therapy, but at present, general practitioners (GPs) are presumed to lack the knowledge and enthusiasm for AF management. Clinical decision support systems (CDSS), assisted by artificial intelligence, help primary care providers (PCPs) make quick, individualized, and correct clinical decisions. This primary aim of the study is to identify whe ...[more]

PMID: 35428315

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Project description:BackgroundIn the context of atrial fibrillation (AF), traditional clinical practices have thus fallen short in several domains, such as identifying patients at risk of incident AF or patients with concomitant undetected paroxysmal AF. Novel approaches leveraging artificial intelligence have the potential to provide new tools to deal with some of these old problems.AimsTo discuss the roles of artificial intelligence (AI)-enabled electrocardiogram (ECG) pertaining to AF, potential roles of deep learning (DL) models in the context of current knowledge gaps, as well as limitations of these models.Materials & methodsAn extensive search and review of the currently available literature on the topics.ResultsOne key area where DL models can translate to better patient outcomes is through automated ECG interpretation. Challenges with regards to the benefits and harms of AF screening remain. In this context, a unique model was developed to detect underlying hidden AF from sinus rhythm.DiscussionKnowledge gaps remain regarding the best ways to monitor patients with embolic stroke of undetermined source (ESUS) and identifying those who would benefit most from oral anticoagulation. The AI-enabled AF model is one potential way to tackle this complex problem as it could be used to identify a subset of high-risk ESUS patients likely to benefit from empirical oral anticoagulation. The role of DL models assessing AF burden from long-duration ECG data is also discussed as a way of guiding management. There is a trend towards the use of consumer-grade wristbands and watches to detect AF from photoplethysmography data. However, ECG currently remains the gold standard to detect arrythmias including AF. Lastly, the role of adequate external validation of the models and clinical trials to study true performance is discussed.ConclusionAlgorithms using AI to interpret ECGs in various new ways have been developed. While still, much work needs to be done, these technologies have shown enormous potential in a short span of time. With further advancements and continuous research, these novel ways of interpretation may well become part of everyday clinical workflow.

Project description:OBJECTIVE:To evaluate the level of agreement between cardiologists regarding the management of oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (NVAF) in Spain. MATERIALS AND METHODS:A two-round Delphi study was performed using an online survey. In round 1, panel members rated their level of agreement with the questionnaire items on a 9-point Likert scale. Item selection was based on acceptance by ≥66.6% of panellists and the agreement of the scientific committee. In round 2, the same panellists evaluated those items that did not meet consensus in round 1. RESULTS:A total of 238 experts participated in round 1; of these, 217 completed the round 2 survey. In round 1, 111 items from 4 dimensions (Thromboembolic and bleeding risk evaluation for treatment decision-making: 18 items; Choice of OAC: 39 items; OAC in specific cardiology situations: 12 items; Patient participation and education: 42 items) were evaluated. Consensus was reached for 92 items (83%). Over 80% of the experts agreed with the use of DOACs as the initial anticoagulant treatment when OAC is indicated. Panellists recommended the use of DOACs in patients at high risk of thromboembolic complications (CHA2DS2-VASc ≥3) (83%), haemorrhages (HAS-BLED ≥3) (89%) and poor quality of anticoagulation control (SAMe-TT2R2 >2) (76%), patients who fail to achieve an optimal therapeutic range after 3 months on VKA treatment (93%), and those who are to undergo cardioversion (80%). Panellists agreed that the efficacy and safety profile of each DOAC (98%), the availability of a specific reversal agent (72%) and patient's preference (85%) should be considered when prescribing a DOAC. A total of 97 items were ultimately accepted after round 2. CONCLUSIONS:This Delphi panel study provides expert-based recommendations that may offer guidance on clinical decision-making for the management of OAC in NVAF. The importance of patient education and involvement has been highlighted.

Project description:AimsThere are limited data to support direct oral anticoagulant (DOAC) use in patients with hypertrophic cardiomyopathy (HCM) and non-valvular atrial fibrillation (NVAF). The current study investigated the safety and effectiveness of DOACs versus warfarin in patients in Japan.MethodsThis retrospective observational study assessed a Japanese cohort of patients diagnosed with HCM and NVAF between July 2011 and June 2021 using a Japanese claims database. Propensity score (PS) matching (2:1 DOAC:warfarin) using the nearest-neighbour method was applied to balance demographic and clinical characteristics between treatment groups. The primary outcomes were the risk of major bleeding and any bleeding (major or minor). Secondary outcomes included describing baseline demographic and clinical characteristics and the risk of stroke/systemic embolism (SE).ResultsAfter PS matching, 2955 DOAC- and 1603 warfarin-treated patients were assessed. The mean [standard deviation (SD)] age in the DOAC and warfarin groups was 74.8 (10.5) and 75.3 (10.2) years, respectively. The majority of patients were male (DOAC, 58.8%; warfarin, 59.6%), had comorbidities (DOAC, 97.5%; warfarin, 96.6%), and were treated with β-blockers (DOAC, 62.5%; warfarin, 62.3%). The risk of major and any bleeding was similar across cohorts [hazard ratio (HR), 0.80; 95% confidence interval (CI), 0.50-1.27; P = 0.336 and HR, 0.93; 95% CI, 0.78-1.11; P = 0.420] while the risk of stroke/SE was lower among patients treated with DOACs (HR, 0.67; 95% CI, 0.47-0.96; P = 0.027). Factors associated with an increased risk of major bleeding included prior bleeding (HR, 1.97; 95% CI, 1.22-3.17) and chronic kidney disease (HR, 1.87; 95% CI, 1.10-3.18). An increased risk of stroke/SE was associated with prior ischaemic stroke (HR, 2.97; 95% CI, 2.05-4.29), peripheral arterial disease (HR, 1.88; 95% CI, 1.22-2.88) and chronic kidney disease (HR, 1.87; 95% CI, 1.24-2.83).ConclusionsDOAC-treated patients had a lower risk of stroke/SE and a comparable risk of bleeding compared with warfarin-treated patients. Prior stroke was shown to augment stroke risk by approximately three-fold. This large real-world study suggests that patients diagnosed with HCM and NVAF can be safely and effectively treated with DOACs in Japan.

Project description:AimsAtrial fibrillation (AF) and heart failure (HF) often coexist. Older age is strongly associated with stroke, HF, and mortality. The association between coexistence of HF and a risk of clinical outcomes and the effectiveness of anticoagulation therapy including direct oral anticoagulants (DOACs) in elderly patients with AF and HF have not been investigated. We aimed to evaluate 2 years of outcomes and to elucidate the efficacy of DOACs or warfarin in elderly AF patients in the All Nippon AF In the Elderly (ANAFIE) Registry with and without a history of HF.Methods and resultsThe ANAFIE Registry is a multicentre, prospective observational study following elderly non-valvular AF patients aged ≥75 years for 2 years. Hazard ratios (HRs) were calculated based on the presence or absence of an HF diagnosis and DOAC or warfarin use at enrolment. Among 32 275 eligible patients, 12 116 (37.5%) had been diagnosed with HF. Patients with HF had significantly higher rates of HF hospitalization or cardiovascular death (HR 1.94, P < 0.001), cardiovascular events (HR 1.59, P < 0.001), cardiovascular death (HR 1.49, P < 0.001), all-cause death (HR 1.32, P < 0.001), and net clinical outcome including stroke/systemic embolism, major bleeding, and all-cause death (HR 1.23, P < 0.001), compared with those without HF; however, HRs for stroke/systemic embolism (HR 0.96, P = 0.56) and major bleeding (HR 1.14, P = 0.13) were similar. DOAC use was associated with a low risk of stroke/systemic embolism (HR 0.86, P = 0.19 in HF; HR 0.79, P = 0.016 in non-HF; P for interaction = 0.56), major bleeding (HR 0.71, P = 0.008 in HF; HR 0.75, P = 0.016 in non-HF; P for interaction = 0.74), HF hospitalization or cardiovascular death (HR 0.81, P < 0.001 in HF; HR 0.78, P < 0.001 in non-HF; P for interaction = 0.26), cardiovascular events (HR 0.83, P < 0.001 in HF; HR 0.82, P = 0.001 in non-HF; P for interaction = 0.65), cardiovascular death (HR 0.84, P = 0.12 in HF; HR 0.75, P = 0.035 in non-HF; P for interaction = 0.18), all-cause death (HR 0.89, P = 0.082 in HF; HR 0.80, P = 0.001 in non-HF; P for interaction = 0.091), and net clinical outcome (HR 0.88, P = 0.019 in HF; HR 0.81, P < 0.001 in non-HF; P for interaction = 0.21) compared with warfarin, irrespective of the presence or absence of HF. Analysis using the propensity score matching method showed similar associations.ConclusionsNon-valvular AF patients aged ≥75 years with a history of HF had higher risks of cardiovascular events and mortality. DOACs were favourable to warfarin regardless of the coexistence of HF. These results might encourage the use of DOACs in elderly patients with non-valvular AF with or without HF.

Dataset Information

Effect of an artificial intelligence-assisted tool on non-valvular atrial fibrillation anticoagulation management in primary care: protocol for a cluster randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effect of an artificial intelligence-assisted tool on non-valvular atrial fibrillation anticoagulation management in primary care: protocol for a cluster randomized controlled trial.

Similar Datasets

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