Karen Charlesworth, David J Torgerson, Judith M Watson
{"title":"Sessions of acupuncture and nutritional therapy evaluation for atrial fibrillation (Santé-AF): a randomised feasibility study.","authors":"Karen Charlesworth, David J Torgerson, Judith M Watson","doi":"10.1186/s40814-025-01604-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.</p><p><strong>Design and methods: </strong>A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45-70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants' willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.</p><p><strong>Results: </strong>Five feasibility objectives' progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.</p><p><strong>Conclusion: </strong>A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.</p><p><strong>Trial registration: </strong>ISRCTN13671984. Registered on June 04, 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"21"},"PeriodicalIF":1.6000,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11854018/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01604-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.
Design and methods: A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45-70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants' willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.
Results: Five feasibility objectives' progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.
Conclusion: A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.
Trial registration: ISRCTN13671984. Registered on June 04, 2020.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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