Brian Zenger, John A Spertus, Michael Torre, Ann Lyons, T Jared Bunch, Rachel Hess, Yue Zhang, Jonathan P Piccini, Morgan M Millar, Trudie Lobban, Benjamin A Steinberg
{"title":"心房颤动患者不一致的治疗目标与临床试验指标。","authors":"Brian Zenger, John A Spertus, Michael Torre, Ann Lyons, T Jared Bunch, Rachel Hess, Yue Zhang, Jonathan P Piccini, Morgan M Millar, Trudie Lobban, Benjamin A Steinberg","doi":"10.1016/j.jacep.2024.06.026","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Most clinical trials define successful atrial fibrillation (AF) treatment as no AF episodes longer than 30 seconds. Yet, there has been minimal study of how patients define successful treatment and whether their perspectives align with trial outcomes.</p><p><strong>Objectives: </strong>Survey patients with AF to identify: 1) what aspect of AF is most important to address (frequency, duration, or severity of AF episodes); 2) what AF burden would be considered acceptable to consider treatment successful; and 3) to establish patient preferences for successful treatment thresholds for a validated patient-reported outcome (PRO) score.</p><p><strong>Methods: </strong>We surveyed patients receiving active care for AF at a single tertiary care center modeled after the Toronto AF Severity Scale (AFSS). The survey consisted of current and \"successful treatment\" AF frequency, burden, and symptom domains; and baseline socioeconomic information.</p><p><strong>Results: </strong>Of 7,000 invitations, 852 individuals completed the survey (12% response) with a mean age of 65 ± 13 years, 36.5% were female, and they had a mean CHA<sub>2</sub>DS<sub>2</sub>-VAsc score of 2.9 ± 1.9. Overall, 114 (13%) selected a decrease in AF episode duration as their top treatment priority, 505 (59%) episode frequency, and 230 (27%) episode severity. Overall, 207 (24%) patients would only consider a treatment successful if they never had AF again, whereas 645 (76%) patients considered success to be fewer AF episodes. A total of 341 (40%) patients would only consider a treatment successful if AF episodes lasted less than a few minutes, whereas 509 (60%) patients would accept AF episodes lasting >30 minutes. An AFSS symptom score ≤5 was considered a good outcome by 80% of respondents.</p><p><strong>Conclusions: </strong>Patients prioritize decreased AF frequency over improvements in severity or duration, and an AFSS ≤5 would be a reasonable outcome of AF treatment. Most patients would consider treatment successful if they had more than 1 AF episode lasting longer than 30 seconds. Future clinical trial design should consider patients' perspectives when designing outcomes.</p>","PeriodicalId":14573,"journal":{"name":"JACC. Clinical electrophysiology","volume":null,"pages":null},"PeriodicalIF":8.0000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Discordant Treatment Goals for Patients With Atrial Fibrillation and Clinical Trials Metrics.\",\"authors\":\"Brian Zenger, John A Spertus, Michael Torre, Ann Lyons, T Jared Bunch, Rachel Hess, Yue Zhang, Jonathan P Piccini, Morgan M Millar, Trudie Lobban, Benjamin A Steinberg\",\"doi\":\"10.1016/j.jacep.2024.06.026\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Most clinical trials define successful atrial fibrillation (AF) treatment as no AF episodes longer than 30 seconds. Yet, there has been minimal study of how patients define successful treatment and whether their perspectives align with trial outcomes.</p><p><strong>Objectives: </strong>Survey patients with AF to identify: 1) what aspect of AF is most important to address (frequency, duration, or severity of AF episodes); 2) what AF burden would be considered acceptable to consider treatment successful; and 3) to establish patient preferences for successful treatment thresholds for a validated patient-reported outcome (PRO) score.</p><p><strong>Methods: </strong>We surveyed patients receiving active care for AF at a single tertiary care center modeled after the Toronto AF Severity Scale (AFSS). The survey consisted of current and \\\"successful treatment\\\" AF frequency, burden, and symptom domains; and baseline socioeconomic information.</p><p><strong>Results: </strong>Of 7,000 invitations, 852 individuals completed the survey (12% response) with a mean age of 65 ± 13 years, 36.5% were female, and they had a mean CHA<sub>2</sub>DS<sub>2</sub>-VAsc score of 2.9 ± 1.9. Overall, 114 (13%) selected a decrease in AF episode duration as their top treatment priority, 505 (59%) episode frequency, and 230 (27%) episode severity. Overall, 207 (24%) patients would only consider a treatment successful if they never had AF again, whereas 645 (76%) patients considered success to be fewer AF episodes. A total of 341 (40%) patients would only consider a treatment successful if AF episodes lasted less than a few minutes, whereas 509 (60%) patients would accept AF episodes lasting >30 minutes. An AFSS symptom score ≤5 was considered a good outcome by 80% of respondents.</p><p><strong>Conclusions: </strong>Patients prioritize decreased AF frequency over improvements in severity or duration, and an AFSS ≤5 would be a reasonable outcome of AF treatment. Most patients would consider treatment successful if they had more than 1 AF episode lasting longer than 30 seconds. Future clinical trial design should consider patients' perspectives when designing outcomes.</p>\",\"PeriodicalId\":14573,\"journal\":{\"name\":\"JACC. Clinical electrophysiology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":8.0000,\"publicationDate\":\"2024-08-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JACC. 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Discordant Treatment Goals for Patients With Atrial Fibrillation and Clinical Trials Metrics.
Background: Most clinical trials define successful atrial fibrillation (AF) treatment as no AF episodes longer than 30 seconds. Yet, there has been minimal study of how patients define successful treatment and whether their perspectives align with trial outcomes.
Objectives: Survey patients with AF to identify: 1) what aspect of AF is most important to address (frequency, duration, or severity of AF episodes); 2) what AF burden would be considered acceptable to consider treatment successful; and 3) to establish patient preferences for successful treatment thresholds for a validated patient-reported outcome (PRO) score.
Methods: We surveyed patients receiving active care for AF at a single tertiary care center modeled after the Toronto AF Severity Scale (AFSS). The survey consisted of current and "successful treatment" AF frequency, burden, and symptom domains; and baseline socioeconomic information.
Results: Of 7,000 invitations, 852 individuals completed the survey (12% response) with a mean age of 65 ± 13 years, 36.5% were female, and they had a mean CHA2DS2-VAsc score of 2.9 ± 1.9. Overall, 114 (13%) selected a decrease in AF episode duration as their top treatment priority, 505 (59%) episode frequency, and 230 (27%) episode severity. Overall, 207 (24%) patients would only consider a treatment successful if they never had AF again, whereas 645 (76%) patients considered success to be fewer AF episodes. A total of 341 (40%) patients would only consider a treatment successful if AF episodes lasted less than a few minutes, whereas 509 (60%) patients would accept AF episodes lasting >30 minutes. An AFSS symptom score ≤5 was considered a good outcome by 80% of respondents.
Conclusions: Patients prioritize decreased AF frequency over improvements in severity or duration, and an AFSS ≤5 would be a reasonable outcome of AF treatment. Most patients would consider treatment successful if they had more than 1 AF episode lasting longer than 30 seconds. Future clinical trial design should consider patients' perspectives when designing outcomes.
期刊介绍:
JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.