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Introduction | malignant hemopathies, hematologic disorders, pain | HEMATOLOGIC DISORDERS, CREST | Bone marrow biopsy is a routine procedure for the exploration of hematologic disorders and malignant hemopathies. Biopsy is generally performed on the anterior or posterior iliac crest, and despite local analgesia with lidocaine, the pain level still remains high [ | PMC9978987 |
Methods | PMC9978987 | |||
Study Design | MAY | We conducted an open-label, prospective study between September 6, 2018, and May 18, 2020, in 5 centers in France. | PMC9978987 | |
Ethical Considerations | The trial was conducted in accordance with the Declaration of Helsinki of 1975, as revised in 2008, and the International Conference on Harmonization Good Clinical Practice guidelines for biomedical research. The “Sud-Méditerranéen I” Regional Ethics Committee approved the study on February 14, 2018 (2017-A02701-52), a... | PMC9978987 | ||
Study Population and Inclusion and Exclusion Criteria | coagulation deficit, iliac lymphoma, malignant hemopathy, thrombocytopenia | ONCOLOGY, THROMBOCYTOPENIA | Eligible patients were aged 18 years and older with previously documented or suspected untreated malignant hemopathy with an indication for a bone marrow biopsy. An Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2 and normal biological coagulation parameters were required. Clinical examinati... | PMC9978987 |
Randomization | hemopathy, pain | Randomization was planned by minimization upon inclusion of patients in the study and programmed using ENNOV clinical data management software (ENNOV; Paris, France). Patients were randomly assigned 1:1 to a pain prevention program using MEOPA or VR. Treatment allocation was stratified by center, age, sex, and hemopath... | PMC9978987 | |
Primary and Secondary End Points | anxiety, pain | SECONDARY | The primary endpoint was a pain reduction of 1.5 points on the VAS for patients included in the VR group in comparison with the MEOPA group. The secondary objectives were the number of lidocaine vials used; duration of exposure to MEOPA (not evaluated in the VR arm); tolerance of the VR session; anxiety level before an... | PMC9978987 |
Bone Marrow Procedure | pain | All patients were lying face down with their hands positioned under the head (based on the French Society of Hematology guidelines) [In the MEOPA group, administration was started at the same time as the local anesthesia. In the VR group, a 5-minute demonstration session was proposed on the day of randomization to asse... | PMC9978987 | |
Description of VR Programs | Papillon | Bliss is a type 1 medical device with European accreditation (EN 50581: 2012; manufacturer: Effet Papillon Company, Laval, France). It is a 3-dimensional interactive VR application. The program runs on a smartphone and a GearVR head-mounted display. We proposed 4 imaginary VR environments with a median duration of 15 m... | PMC9978987 | |
Data Recorded the Day of the Biopsy | Anxiety, pain | BLOOD | Blood pressure was measured before the biopsy and 15 minutes after the biopsy. Anxiety was assessed using 2 questionnaires: a local fear of pain questionnaire before the biopsy (presence of fear, intensity of fear by VAS, and causes of fear) and the adapted Spielberger State-Trait Anxiety Inventory (STAI) form Y before... | PMC9978987 |
Data Recorded 1 Month After the Biopsy | pain | The level of residual pain and the memory of pain were assessed by the investigators 1 month after the biopsy (responses: yes or no; if yes, the intensity level was assessed using a VAS). | PMC9978987 | |
Statistical Analysis | pain | The primary end point was to measure the intensity of pain in each group using the VAS and to demonstrate a 1.5-point reduction in pain in the VR group. We enrolled 120 patients to validate this hypothesis with an SD of 2.5, power of 90%, and type I error rate of 5%. We included 6 more patients, considering that 5% cou... | PMC9978987 | |
Results | PMC9978987 | |||
Sample | anxiety, pain | MAY, RECRUITMENT | A total of 126 patients were enrolled between September 6, 2018, and May 18, 2020, in 5 centers in France: Le Mans (n=80), Strasbourg (n=32), Bordeaux (n=8), Saint-Mandé (n=5), and Angers (n=1). Trial recruitment stopped after inclusion of the target population. We excluded 3 patients before randomization (2 patients d... | PMC9978987 |
Biopsy Procedure | ≥140/90 mm Hg, Hypertension | HYPERTENSION | Bone marrow biopsy was performed for all patients, and the median blood pressure was 141/79 mm Hg before and after biopsy for all patients, without a significant difference between the groups. Hypertension (≥140/90 mm Hg) was documented in 59.4% (63/118) of patients before biopsy (34/60, 63% in the MEOPA group, 29/58, ... | PMC9978987 |
Tolerance of the VR Session and Feeling Immersed | anxiety | ADVERSE EVENTS, ADVERSE EVENT | Patients enrolled in the VR group received a short demonstration of VR (5 minutes) to assess their tolerance. During the VR demonstration, most (57/59, 97%) of them watched the entire session, while 2 patients stopped the session: The first patient felt intolerance during the demonstration, and the second patient final... | PMC9978987 |
Discussion | ascites, fatigue, anxiety, Pain, pain, depression | ASCITES | REVEH is the first randomized study to compare VR with standard MEOPA in preventing pain during bone marrow biopsy. The intensity of pain did not significantly differ between VR and MEOPA: 3.0 versus 3.5 (The main technical difficulty was related to the handling of the phone (connection and start of the VR program); a ... | PMC9978987 |
Conclusion | opioid dependence, fatigue, anxiety, Pain, cancer, FM, ALS, pain, depression | CHRONIC PAIN, EVENTS, CANCER | Pain intensity did not significantly differ between VR and MEOPA arms during bone marrow biopsy in this study. The VR-based distraction method was safe and appreciated by patients and caregivers. Digital therapeutics could be an alternative treatment in case of contraindication or intolerance to MEOPA and could be inte... | PMC9978987 |
Abbreviations | Anxiety | ONCOLOGY | Eastern Cooperative Oncology Groupmixture of nitrous oxide/oxygenPreferred Reporting Items for Systematic Reviews and Meta-AnalysesSpielberger State-Trait Anxiety Inventoryvisual analog scalevirtual reality | PMC9978987 |
Data Availability | All data from the study are freely available upon request to the corresponding author. | PMC9978987 | ||
Subject terms | We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessme... | PMC10235118 | ||
Introduction | lung cancer, premature death | HEART DISEASE, CHRONIC BRONCHITIS, LUNG CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DISEASES | Cigarette smoking is a leading cause of preventable premature death, and significantly increases the risk of developing lung cancer, heart disease, chronic bronchitis, chronic obstructive pulmonary disease and other serious diseases and adverse health conditionsThis publication is part of a three-part series describing... | PMC10235118 |
Results | PMC10235118 | |||
Study population | A total of 148 subjects were enrolled and randomized; all subjects were randomized to one of four Vuse Solo investigational products (IPs) and 122 (82.4%) subjects completed all scheduled PK assessments. A total of 26 randomized subjects (17.6%) withdrew or early termed from the study for reasons unrelated to study pro... | PMC10235118 | ||
Adverse events | oropharyngeal pain | ADVERSE EVENTS, GASTROESOPHAGEAL REFLUX, OCULAR HYPEREMIA | Nine of 148 (6%) subjects experienced nine adverse events during the study. Gastroesophageal reflux (one subject) and oropharyngeal pain (one subject) were each considered by the principal investigator (PI) to be possibly related and related to IP, respectively. All other adverse events were judged by the PI not to be ... | PMC10235118 |
Discussion | AUCAs, NRS | We evaluated PK parameters of four flavor variants of e-liquids used in Vuse Solo ENDS which include 4.8% nicotine by weight (~ 57 mg/mL), and contain nicotine salts following an acute exposure in predominately ENDS naïve smokers. Our data showed that subjects achieved similar overall nicotine exposure (AUCAs stated ab... | PMC10235118 | |
Methods | ICH | This study was a single-center study (ClinicalTrials.gov identifier: NCT03234010, 31/07/ 2017) designed to evaluate plasma nicotine uptake and overall product liking with use of four flavor variants of the Vuse Solo ENDS (Vuse Solo Original, Mint, Tropical and Fusion) in tobacco consumers who were exclusive smokers or ... | PMC10235118 | |
Study product | Each Vuse Solo ENDS consist of power unit and a cartridge. Each cartridge is a sealed unit containing 0.5 mL of e-liquid comprising 4.8% nicotine by weight (~ 57 mg/mL), and containing nicotine salts, propylene glycol, glycerin, flavorings, and water. The products were powered by a rechargeable power unit and included ... | PMC10235118 | ||
Study design | ADVERSE EVENTS | The study was designed as a randomized, open-label, parallel-cohort study to assess nicotine uptake in human subjects following ENDS use. The study examined plasma nicotine PK parameters in Vuse Solo ENDS with four flavor variants: Original, Mint, Tropical and Fusion.Subjects were given a 1-week at-home trial period to... | PMC10235118 | |
Statistical analysis | ® | The primary PK parameters (CThe pharmacokinetic (PK) analyses were performed by Nuventra Pharma Sciences, Inc. located in Durham, NC. PK parameters were derived from the baseline-adjusted plasma nicotine concentrations-time data by noncompartmental methods using Phoenix® WinNonlin® (Version 6.3; Certara USA Inc., Princ... | PMC10235118 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-35439-3. | PMC10235118 | ||
Acknowledgements | P. | The authors wish to acknowledge Megan J. Whelen and Sarah Baxter-Wright for medical writing assistance, critical review, and editing of the manuscript; Gregory P. Tarleton, MD for providing medical expertise to ensure subject safety; and Jeff Coffield for maintaining the study Trial Master Files and managing other stud... | PMC10235118 | |
Author contributions | Study concept and design: K.S.H., P.D., B.A.J., E.R., P.N. Acquisition of data: E.S. Drafting of the manuscript: K.S.H., B.M.K. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: T.J. All authors have read and approved the final manuscript. | PMC10235118 | ||
Competing interests | Nelson | NELSON, SCHMIDT | Brian M. Keyser, Kyung Soo Hong, Patricia DeLuca, Tao Jin, Bobbette A. Jones, Paul Nelson, Eckhardt Schmidt and Elaine K. Round were all full employees of RAI Services Company during the execution of the study. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is a wholly owned subsidia... | PMC10235118 |
References | PMC10235118 | |||
Key Points | PMC9929699 | |||
Question | uveitis | DISEASE, UVEITIS | Is there any difference in uveitis outcomes between patients with inactive disease given recommendations for early and deferred non–messenger RNA (mRNA) COVID-19 vaccination? | PMC9929699 |
Findings | uveitis | DISEASE, UVEITIS | In this open-label, randomized clinical trial involving 543 patients, recommendation for early vaccination resulted in an increased incidence of self-reported worsening of symptomatic uveitis compared with deferred vaccination, but no differences were observed in disease and visual prognosis at 3 months. | PMC9929699 |
Meaning | uveitis | ADVERSE EFFECTS, DISEASE, UVEITIS | These findings suggest that recommendation for early non-mRNA COVID-19 vaccination in patients with inactive uveitis may lead to subjective uveitis symptoms but no adverse effects on disease and visual prognosis at 3 months.This randomized clinical trial compares recommendations for early and deferred non–messenger RNA... | PMC9929699 |
Importance | immune-mediated adverse, uveitis | REMISSION, UVEITIS | Improper host response to COVID-19 vaccines could trigger immune-mediated adverse events. The question remains whether COVID-19 vaccination should be postponed until complete remission in patients with uveitis, a preexisting immune-related condition. | PMC9929699 |
Objective | uveitis | UVEITIS | To compare recommendations for early and deferred COVID-19 vaccination with respect to uveitis outcomes. | PMC9929699 |
Design, Setting, and Participants | uveitis | UVEITIS | This open-label, randomized clinical trial at a large, specialized teaching center for uveitis care in China enrolled unvaccinated patients with inactive uveitis between August 10, 2021, and February 22, 2022, with follow-up to June 6, 2022. | PMC9929699 |
Interventions | uveitis | REMISSION, UVEITIS | Participants were randomly assigned to receive recommendation for early or deferred COVID-19 vaccination after complete remission of uveitis. Non–messenger RNA (non-mRNA) COVID-19 vaccines were available in China during the trial. | PMC9929699 |
Main Outcomes and Measures | uveitis | UVEITIS | The primary outcome was the time to symptomatic uveitis worsening during 3 months of follow-up. Secondary outcomes included uveitis activity and best-corrected visual acuity at 3 months. | PMC9929699 |
Results | uveitis | UVEITIS | Of the 543 participants (304 women [56.0%]; median age, 35 [IQR, 26-49] years), 262 were recommended for early vaccination and 281 for deferred vaccination. By month 3, 109 patients (41.6%) in the early group had been vaccinated compared with 14 (5.0%) in the deferred recommendation group. In the intention-to-treat pop... | PMC9929699 |
Conclusions and Relevance | uveitis | ADVERSE EFFECTS, DISEASE, UVEITIS | In this randomized clinical trial of patients with inactive uveitis, recommendation for early non-mRNA COVID-19 vaccination resulted in a higher incidence of self-reported symptomatic uveitis worsening with possible reporting bias compared with recommendation for deferred vaccination, but no adverse effects were observ... | PMC9929699 |
Trial Registration | Chinese Clinical Trial Registry: | PMC9929699 | ||
Introduction | vision-threatening intraocular inflammation, death, illness, immune-related disorder, SARS-CoV-2.Uveitis | COVID-19 vaccines remain the cornerstone of effective prevention of severe illness and death due to SARS-CoV-2.Uveitis is an immune-related disorder characterized by vision-threatening intraocular inflammation, which has a wide association with systemic inflammatory conditions. | PMC9929699 | |
Methods | PMC9929699 | |||
Trial Design | uveitis | UVEITIS | This open-label randomized clinical trial was conducted at The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. The hospital has set up a large, specialized teaching center for uveitis care and has treated 15 373 patients with uveitis across mainland China as of 2018. | PMC9929699 |
Trial Population | uveitis | UVEITIS | Eligible participants were 12 years or older, had not yet received COVID-19 vaccines, and were diagnosed with any form of uveitis in an inactive status. | PMC9929699 |
Randomization, Assignment, and Follow-up | redness, uveitis, floaters, pain | ADVERSE EVENTS, REMISSION, UVEITIS, DECREASED VISION | Participants underwent simple randomization to receive the recommendation for early or deferred COVID-19 vaccination in a 1:1 ratio. Random assignment sequence was computer-generated, and individual allocations were known by telephone from a designated staff who kept the sequence and had no involvement in other parts o... | PMC9929699 |
Outcomes | redness, uveitis, pain, haze, floaters | ADVERSE EVENTS, UVEITIS, DECREASED VISION, SECONDARY, DISEASES | The primary outcome was the time to worsening of symptomatic uveitis, defined by 1 of the following new-onset symptoms occurring in at least 1 eye and lasting for at least 2 days: eye redness, eye pain, decreased vision, light sensitivity, or floaters, as confirmed by blinded review by an adjudication committee. The ad... | PMC9929699 |
Statistical Analysis | REGRESSION, EVENT | Assuming that the cumulative incidence would be 10% in the deferred vaccination group during the month 3 follow-up and the proportion dropping out in both groups would be 15%, we estimated that an overall sample of 1314 participants would provide 80% power to detect a hazard ratio (HR) for early vaccination recommendat... | PMC9929699 | |
Results | PMC9929699 | |||
Patients | A total of 543 patients were formally assessed for eligibility and enrolled. The median age was 35 (IQR, 26-49) years; 304 patients (56.0%) were female and 239 (44.0%) were male. Two hundred sixty-two patients were recommended for early COVID-19 vaccination and 281 for deferred vaccination. The baseline characteristics... | PMC9929699 | ||
Baseline Characteristics of the Intention-to-Treat Population | HEPATITIS B, VIRUS | Abbreviations: BCVA, best-corrected visual acuity; HBV, hepatitis B virus.Unless otherwise specified, data are expressed as No. (%) of patients. Percentages have been rounded and may not total 100.Includes Chinese Dong, Hani, Hui, Li, Lisu, Man, Mongolian, Miao, Tibetan, Tujia, Uygur, Yi, and Zhuang peoples.Data were m... | PMC9929699 | |
Randomization, Follow-up, and Analysis Populations | The intention-to-treat (ITT) population included 543 patients who underwent randomization. The modified ITT population excluded 32 persons who were identified as being vaccinated before randomization. The per-protocol population included the patients in the modified ITT population except 160 persons who did not adhere ... | PMC9929699 | ||
COVID-19 Vaccine Uptake | By month 3, 109 patients (41.6%) of the patients assigned to early vaccination recommendation had received at least 1 dose of non-mRNA COVID-19 vaccine compared with 14 (5.0%) of those assigned to a deferred vaccination recommendation ( | PMC9929699 | ||
Secondary Outcomes | uveitis | REMISSION, UVEITIS | Abbreviations: BCVA, best corrected visual acuity; LogMAR, log of the minimum angle of resolution.Unless otherwise indicated, data are expressed as No. (%) of patients.COVID-19 vaccination schedule included 2 primary doses of inactivated vaccines (CoronaVac [Sinovac Biotech] and BBIBP-CorV [Sinopharm]) or 3 doses of a ... | PMC9929699 |
Primary Outcome | uveitis | UVEITIS | Symptomatic uveitis worsening occurred in 51 patients (19.5%) recommended for early COVID-19 vaccination and in 34 (12.1%) recommended for deferred COVID-19 vaccination (between-group difference, 7.4% [95% CI, 1.2%-13.6%]). In the intention-to-treat analysis, the time to symptomatic uveitis worsening was shorter in the... | PMC9929699 |
Kaplan-Meier Estimates of the Time to Symptomatic Uveitis Worsening | HR indicates hazard ratio. | PMC9929699 | ||
Estimates of Primary Outcome Across Analysis Populations | HR indicates hazard ratio; ITT, intention-to-treat. | PMC9929699 | ||
Secondary Outcomes | haze, uveitis, floaters | UVEITIS | Patients in the early vaccination group more frequently reported new onset of floaters as one of the reasons for symptomatic uveitis worsening (difference, 4.2% [95% CI, 1.7%-7.5%]). The ocular conditions, including changes in anterior chamber cells, vitreous haze, and BCVA from baseline to month 3, appeared similar be... | PMC9929699 |
Discussion | uveitis, COVID-19 illness | SARS-COV-2 INFECTION, DISEASE, UVEITIS, ADVERSE EFFECTS, SECONDARY | This open-label, randomized clinical trial showed that recommendation for early non-mRNA COVID-19 vaccination to patients with inactive uveitis led to earlier self-reported symptomatic uveitis worsening than the recommendation for deferred vaccination. We found no evidence that uveitis activity and visual acuity at 3 m... | PMC9929699 |
Limitations | inflammation, uveitis | INFLAMMATION, DISEASE, UVEITIS, SECONDARY | This study has some limitations. First, interpretation of the outcomes was limited by the open nature of the trial, especially when interpreting results for a subjective outcome in the context of COVID-19 vaccination. Moreover, all symptoms were based on self-report, and we lacked data regarding clinical evaluation to ... | PMC9929699 |
Conclusions | uveitis | ADVERSE EFFECTS, DISEASE, UVEITIS | In this randomized clinical trial of patients with inactive uveitis, recommendation for early non-mRNA COVID-19 vaccination resulted in a higher incidence of self-reported symptomatic uveitis worsening with possible reporting bias compared with recommendation for deferred vaccination, but no adverse effects were observ... | PMC9929699 |
Keywords | prostate | PROSTATE | Radiotherapy treatment planning based only on magnetic resonance imaging (MRI) has become clinically achievable. Though computed tomography (CT) is the gold standard for radiotherapy imaging, directly providing the electron density values needed for planning calculations, MRI has superior soft tissue visualisation to g... | PMC10480277 |
Introduction | MR, prostate | PROSTATE | Radiotherapy treatment planning based only on magnetic resonance imaging (MRI), or MRI-only radiotherapy, has recently become clinically achievable [There are various approaches which have been utilised for sCT generation, such as bulk density correction methods, atlas methods, deep learning algorithms or a combination... | PMC10480277 |
Method | prostate | PROSTATE | Ten prostate radiotherapy patients were included in the study. These patients were recruited to the NINJA (Novel Integration of New prostate radiation therapy schedules with adjuvant Androgen deprivation) clinical trial (ACTRN12618001806257) which had local ethics approval (HREC/18/LPOOL/420), investigating stereotacti... | PMC10480277 |
Results | The Fast sequence scan was able to be completed on all patients with no modifications required by the system. This sequence was able to be converted to sCT as per Dowling et al. [
An example of the (a) standard MRI and (b) S-sCT and the (c) fast MRI and (d) F-sCT for the same corresponding slice for one patient. The bo... | PMC10480277 | ||
Discussion | prostate | PROSTATE | This study demonstrates clinical application and validation of the results from the previous volunteer study. It provides clinical data, using a patient cohort, regarding a time-reduced MRI sequence for sCT generation for prostate MR-only treatment planning. In an MRI-only workflow, additional sequences may be required... | PMC10480277 |
Conclusion | In this clinical validation study, the fast sequence, which reduced the required imaging time by approximately a factor of 4, produced an sCT with similar clinical dosimetric results compared to the standard sCT, demonstrating its potential for clinical use for treatment planning. | PMC10480277 | ||
Funding | Cancer | CANCER | The authors received no funding for this study. The NINJA Trial receives some grant funding from Cancer Australia (GA52651). Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10480277 |
Data availability | Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available. | PMC10480277 | ||
Declarations | PMC10480277 | |||
Conflicts of interest | Cancer | CANCER | Authors declare no conflicts of interest. Liverpool Cancer Therapy Centre has a master research agreement with Siemens, unrelated to this study. | PMC10480277 |
Research involving humans and animal rights | Patient data was acquired with local ethics committee approval, HREC/18/LPOOL/420. This clinical trial is registered with ANZCTR (ACTRN12618001806257). | PMC10480277 | ||
Consent to participate | Informed consent was obtained from all individual participants included in the study. | PMC10480277 | ||
Consent to publish | The authors affirm that human research participants provided informed consent for publication of data. | PMC10480277 | ||
References | PMC10480277 | |||
Key Points | PMC10709770 | |||
Question | ATRIAL FIBRILLATION (AF), CARDIAC ARRHYTHMIA | Can clinician-created, video-based education improve knowledge of atrial fibrillation (AF), the most common cardiac arrhythmia? | PMC10709770 | |
Findings | In this randomized clinical trial including 204 patients with AF, patients offered video-based education developed by treating clinicians were 23% more likely to correctly answer AF knowledge questions 3 months after their clinic visit, a statistically significant difference. | PMC10709770 | ||
Meaning | AF | ATRIAL FIBRILLATION (AF), DISEASES | These findings suggest that the clinician-created, video-based education concept could be implemented in other diseases and care settings.This randomized clinical trial assesses whether clinician-created video-based atrial fibrillation (AF) education is feasible and improves knowledge of AF among patients treated in an... | PMC10709770 |
Importance | ATRIAL FIBRILLATION (AF) | Patient education is a critical aspect of atrial fibrillation (AF) management. However, there is limited time to provide effective patient education during routine care, and resources available online are of variable quality. | PMC10709770 | |
Objective | To determine whether clinician-led creation of video-based AF education is feasible and improves knowledge of AF. | PMC10709770 | ||
Design, Setting, and Participants | stroke, thromboembolism, diabetes | TRANSIENT ISCHEMIC ATTACK, STROKE, VASCULAR DISEASE, CONGESTIVE HEART FAILURE, THROMBOEMBOLISM, HYPERTENSION, DIABETES | This single-center randomized clinical trial was conducted between 2020 and 2022. Outcomes were assessed prior to their clinic visit and 2 and 90 days after the visit by blinded assessors. Participants included adults with AF and congestive heart failure, hypertension, age at least 75 years (doubled), diabetes, prior s... | PMC10709770 |
Intervention | PATHOPHYSIOLOGY | Intervention participants viewed a series of 4 videos designed and narrated by clinicians that aimed to improve understanding of AF pathophysiology, clinical presentation, diagnosis, and management. After viewing the videos, participants received weekly email links to review the videos. The control group received usual... | PMC10709770 | |
Main Outcomes and Measures | Atrial Fibrillation | ATRIAL FIBRILLATION | The prospectively selected primary outcome was AF knowledge at 90 days, measured by the validated Jessa Atrial Fibrillation Knowledge Questionnaire (JAFKQ). | PMC10709770 |
Results | Among 657 individuals screened, 208 adults with AF were randomized (mean [SD] age, 65.0 [12.2] years; 133 [65.2%] male) and included in analysis. Participants were randomized 1-to-1, with 104 participants in the control group and 104 participants in the video intervention group. At 90 days after the baseline clinic vis... | PMC10709770 | ||
Conclusions and Relevance | In this randomized clinical trial of patients with AF, remotely delivered, clinician-created video education improved medium-term AF knowledge beyond usual care of standard in-clinic education. The improvement demonstrated in this study provides support for the implementation of clinician-created educational resources ... | PMC10709770 | ||
Trial Registration | anzctr.org.au Identifier: ANZCTRN12620000729921 | PMC10709770 | ||
Introduction | stroke, AF, thromboembolism | ATRIAL FIBRILLATION (AF), STROKE, DISEASE, CARDIAC ARRHYTHMIA, THROMBOEMBOLISM | Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting approximately 40 million people worldwide.Poor patient understanding of AF is a significant barrier to achieving these goals. Up to 50% of patients with new AF are unaware of their diagnosis, and more than one-third of patients are unaware of the... | PMC10709770 |
Methods | This randomized clinical trial was approved by the Western Sydney Local Health District Human Research Ethics Committee. All participants provided written informed consent electronically. The full trial protocol and statistical analysis plan are available in | PMC10709770 | ||
Study Design | The Educate-AF study was a single-center, single-blind randomized clinical trial of patients with AF accessing clinical outpatient care within a tertiary teaching hospital in Sydney, Australia ( | PMC10709770 | ||
Study Recruitment Flowchart | PMC10709770 | |||
Patient Population | stroke, thromboembolism, diabetes | TRANSIENT ISCHEMIC ATTACK, STROKE, VASCULAR DISEASE, FLUTTER, CONGESTIVE HEART FAILURE, THROMBOEMBOLISM, HYPERTENSION, DIABETES | Eligible patients were aged 18 years and older with electrocardiography-confirmed AF or flutter of any clinical subtype (paroxysmal, persistent, and permanent); congestive heart failure, hypertension, age 75 years or older (doubled), diabetes, prior stroke or transient ischemic attack or thromboembolism (doubled), vasc... | PMC10709770 |
Recruitment and Consent | Eligible patients were recruited prior to in-person or telehealth outpatient appointments by trained research staff. Screening of all outpatient cardiology clinics was performed to identify eligible participants who were provided with study information and, if agreeable, emailed a link to facilitate participation. This... | PMC10709770 | ||
Randomization and Masking | RECRUITMENT, BLIND | Randomization occurred centrally via a sequence generated within the randomize R library of R statistical software version 3.5.1 (R Project for Statistical Computing) by S.M. Randomization was 1:1 in permuted blocks of 2 and 4 to reduce predictability and ensure balance between study groups. Study staff responsible for... | PMC10709770 |
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