Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial.
To explore the experiences of patients with atrial fibrillation (AF) in the context of a prospective, two-parallel-armed, participant-blinded and assessor-blinded sham-controlled randomised trial.



A nested qualitative study within an ongoing randomised controlled trial to explore acupuncture's antiarrhythmic effects on drug refractory acupuncture in persistent atrial fibrillation (AF) (ACU-AF trial).



Participants were recruited using purposeful sampling and a maximum variation strategy with regard to treatment allocation (treatment or control) and protocol completion (completion or non-completion).



This was a single-centre in-depth interview qualitative study conducted at a tertiary-level university hospital in Seoul, Republic of Korea.



Data saturation was reached after 8 participants. Thematic analysis identified that most patients were not aware of their condition until medical check-up; physician referral was the main reason for trial participation, and patients had high expectations regardless of previous acupuncture experiences. Patients tended to depend on their physicians' opinions because they felt helpless of their condition. No one questioned their assigned treatment groups and generally believed acupuncture treatment was different for cardiovascular diseases. A few patients expressed disappointment in the strict and rigid protocols, in which most practitioners refrained from explaining their acupuncture procedures.



For cardiovascular patients their physician's advice was one of the biggest reasons for enrolling in the acupuncture trial therefore relying on standard recruitment methods may not be effective. Fortunately both real and sham acupuncture groups in our sample were receiving treatment as intended, but in the future, designing a more pragmatic trial (better reflecting clinical settings, expanding the inclusion criteria and using more treatment points) will allow researchers to better explore the comprehensive effects of acupuncture. The findings of this study will allow researchers to improve the currently ongoing ACU-AF trial and to further help interpretation of main trial outcomes once the trial is completed.



NCT02110537.
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Seung Min Kathy
SM
Lee
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Jungtae
0000-0003-3300-5556
J
Leem
Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Dongdaemun-gu, Republic of Korea.
Jun Hyeong
JH
Park
Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Dongdaemun-gu, Republic of Korea.
Kang Hyun
KH
Yoon
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.
Jong Shin
JS
Woo
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.
Jung Myung
JM
Lee
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.
Jin-Bae
JB
Kim
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea.
Weon
W
Kim
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Sanghoon
S
Lee
D015670:Acupuncture Therapy; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000628:therapy*; D037001:Directive Counseling; D004311:Double-Blind Method; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D009042:Motivation; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010349:Patient Compliance / Q000523:psychology; D011446:Prospective Studies; D036301:Qualitative Research; D012017:Referral and Consultation; D056910:Republic of Korea
Acupuncture; Atrial fibrillation; Cardioversion; Randomised controlled trial; qualitative study