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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.

ABSTRACT: OBJECTIVE: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. DESIGN: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: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). SETTING:This was a single-centre in-depth interview qualitative study conducted at a tertiary-level university hospital in Seoul, Republic of Korea. RESULTS: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. CONCLUSIONS: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. TRIAL REGISTRATION NUMBER:NCT02110537.

SUBMITTER: Lee SM

PROVIDER: S-EPMC5293996 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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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.

Lee Seung Min Kathy SM Leem Jungtae J Park Jun Hyeong JH Yoon Kang Hyun KH Woo Jong Shin JS Lee Jung Myung JM Kim Jin-Bae JB Kim Weon W Lee Sanghoon S

BMJ open 20170203 2

<h4>Objective</h4>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.<h4>Design</h4>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).<h4>Participants</h4>Participants were recruited using purposeful ...[more]

PMID: 28159849

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Project description:IntroductionDepression and pain frequently occur together and impact on outcomes of existing treatment for depression. Additional treatment options are required. This study aimed to explore patients' experiences of depression, the processes of change within acupuncture and counselling, and the elements that contributed to longer-term change.MethodsIn a substudy nested within a randomised controlled trial of acupuncture or counselling compared with usual care alone for depression, semistructured interviews of 52 purposively sampled participants were conducted and analysed using thematic analysis.ResultsDifferences were reported by participants regarding their experience of depression with comorbid pain compared with depression alone. Along with physical symptoms often related to fatigue and sleep, participants with depression and comorbid pain generally had fewer internal and external resources available to manage their depression effectively. Those who had physical symptoms and were receiving acupuncture commonly reported that these were addressed as part of the treatment. For those receiving counselling, there was less emphasis on physical symptoms and more on help with gaining an understanding of themselves and their situation. Over the course of treatment, most participants in both groups reported receiving support to cope with depression and pain independently of treatment, with a focus on relevant lifestyle and behaviour changes. The establishment of a therapeutic relationship and their active engagement as participants were identified as important components of treatment.ConclusionsParticipants with and without comorbid pain received acupuncture or counselling for depression, and reported specific identifiable treatment effects. The therapeutic relationship and participants' active engagement in recovery may play distinct roles in driving long-term change. Patients who present with depression and physical symptoms of care may wish to consider a short course of acupuncture to relieve symptoms prior to a referral for counselling if needed.Trial registration numberISRCTN63787732.

Project description:IntroductionThe National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients' positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment.MethodsThe study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis.Results and discussionThree over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient's active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain.ConclusionThe acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients' self-efficacy in pain management in the longer term. Unpleasant treatment related effects do not necessarily detract from patients' overall perception of acceptability.

Project description:BackgroundAtrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence.ObjectiveThis study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence.MethodsParticipants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants' use and acceptability of the intervention.ResultsA total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy.ConclusionsIndividuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.

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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.

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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.

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