Scoping review of outcome indicators in randomized controlled trials on exercise rehabilitation in patients with atrial fibrillation
10.3760/cma.j.cn115682-20231221-02716
- VernacularTitle:心房颤动患者运动康复随机对照试验研究结局指标的范围综述
- Author:
Zhanhong YOU
1
;
Zhijie TANG
;
Jie WANG
;
Yunxia LI
;
Qin WANG
;
Guozhen SUN
Author Information
1. 南京医科大学护理学院，南京 211100
- Keywords:
Review;
Atrial fibrillation;
Outcome indicators;
Core outcome set;
Exercise rehabilitation
- From:
Chinese Journal of Modern Nursing
2024;30(27):3768-3776
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the selection of outcome indicators for randomized controlled trials (RCT) on exercise rehabilitation in patients with atrial fibrillation (AF), promote the construction of the core outcome set and provide reference for the research design of subsequent RCT.Methods:The RCT literature related to exercise rehabilitation of patients with atrial fibrillation was systematically searched from CNKI, Wanfang, VIP, PubMed, Web of Science, Embase and Cochrane Library databases, and the search period was from establishment of the databases until July 31, 2023. After literature screening, Cochrane Risk of Bias Assessment Tool was used for quality evaluation, information extraction, classification of outcome indicators, frequency of use statistics, analysis and extraction of current shortcomings in the selection of outcome indicators, and corresponding suggestions were proposed.Results:A total of 32 articles were included, and 19 RCT were evaluated twice for outcome measures. The number of outcome measures ranged from 2 to 17, with 10 RCT setting outcome measures according to primary and secondary criteria and 6 RCT setting safety outcome measures. A total of 96 outcome indicators were extracted in this study, total 266 frequency, which could be divided into 4 categories, such as safety evaluation (18 times), clinical response (75 times), patient-reported outcomes (68 times) and laboratory and other examination (105 times) .Conclusions:Existing RCT outcome indicators of exercise rehabilitation in patients with atrial fibrillation emphasize the changes in subjective feelings and objective indicators of individuals, covering four aspects such as the physical condition, exercise ability, quality of life and psychological status of individuals. However, there is a lack of uniform standards and the safety evaluation indicators are fewer. The categories of exercise rehabilitation indicators for atrial fibrillation patients extracted in this paper can provide a reference for the design of future RCT studies and promote the generation of higher quality evidence-based medical evidence.
