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The comparison study on accuracy of peak expiratory flow rate measurement by PRAAN, spirometry, and the mini-Wright peak flow meter  通过 PRAAN、肺活量测定法和微型莱特峰值流量计测量呼气峰值流量的准确性对比研究
F1000Research Pub Date : 2024-07-09 DOI: 10.12688/f1000research.144927.1
Sirawich Chaiparnich, O. Poachanukoon, Natcha Manasilp, N. Saiphoklang, C. Tantibundhit, P. Vatcharavongvan, Pattapol Kunumpol, Phongpan Plienphanich, A. Pugongchai, K. Leelasittikul, Nantavat Prompoom
{"title":"The comparison study on accuracy of peak expiratory flow rate measurement by PRAAN, spirometry, and the mini-Wright peak flow meter Â","authors":"Sirawich Chaiparnich, O. Poachanukoon, Natcha Manasilp, N. Saiphoklang, C. Tantibundhit, P. Vatcharavongvan, Pattapol Kunumpol, Phongpan Plienphanich, A. Pugongchai, K. Leelasittikul, Nantavat Prompoom","doi":"10.12688/f1000research.144927.1","DOIUrl":"https://doi.org/10.12688/f1000research.144927.1","url":null,"abstract":"Background PRAAN, a digital peak flow meter, was developed to measure peak expiratory flow rate (PEFR) for asthma monitoring. This study aimed to compare PRAAN’s accuracy to that of spirometry and the mini-Wright peak flow meter for PEFR measurement. Methods Two cross-sectional studies were conducted in 106 healthy adult participants. Study A (n=56) compared PRAAN with spirometry, while study B (n=50) compared PRAAN with the mini-Wright peak flow meter. PEFR values were collected using crossover studies. Pearson’s correlation and Bland-Altman plots were used to report the relationship and agreement between two measurements, respectively. Results In study A, 51.8% were female, mean age was 24.3±5.6 years, and PEFR was 480.3±86.8 L/min. PEFR measured by PRAAN had very strongly positive correlation with spirometry (r=0.980, P<0.001). Bland-Altman analysis showed that there was good agreement between them, with a low mean difference of -7.07 liters/minute (95% CI: -40.58 to 26.44 liters/minute) and 92.9%, which were within the limit of agreement (LOA). In study B, 54.0% were female, mean age was 23.5±2.4 years, and PEFR was 495.1±82.7 L/min. PEFR measured by PRAAN and by the mini-Wright peak flow meter showed very strongly positive correlation (r=0.971, P<0.001). Bland-Altman comparison of PEFR between these two measurements showed that there was a very good agreement between them, with a low mean difference of 0.84 liters/minute (95% CI: -38.68 to 40.38 liters/minute) and 94.0%, which were within LOA. Conclusions The accuracy of PRAAN is in the agreement with spirometry and the mini-Wright peak flow meter. The clinical application of PRAAN may potentially lead to a monitoring strategy that healthcare providers can use to improve the management of asthma.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141663897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluating the dynamics of fee-free higher education in South Africa: a causal loop diagram approach  评估南非免学费高等教育的动态:因果循环图法
F1000Research Pub Date : 2024-07-09 DOI: 10.12688/f1000research.152478.1
T. Ramasu, Grace Kanakana-Katumba
{"title":"Evaluating the dynamics of fee-free higher education in South Africa: a causal loop diagram approach ","authors":"T. Ramasu, Grace Kanakana-Katumba","doi":"10.12688/f1000research.152478.1","DOIUrl":"https://doi.org/10.12688/f1000research.152478.1","url":null,"abstract":"Background This research investigated the dynamics of fee-free higher education in South Africa, aiming to elucidate the complexities surrounding its implementation and impact. By employing a causal loop diagram approach, the study examined the interplay of socioeconomic, political, and institutional factors influencing the provision of fee-free higher education. Method A participatory approach to developing the CLD was used. Through an extensive literature review, the research contextualised fee-free higher education enabling a preliminary CLD to be developed. Discussions were held to improve the preliminary model based on stakeholder and expert opinion. The model was then validated by stakeholders and experts. Results The CLD has explicitly mapped out the causal relationships which play a fundamental role in fee-free higher education in South Africa. Key findings revealed that fee-free higher education initiatives, such as managing funding constraints and administrative complexities, hold promise for fostering inclusivity and socioeconomic development but are hindered by bureaucratic policy establishments and inefficiencies. These challenges underscore the gap between policy formulation and implementation, highlighting the need for comprehensive reforms to streamline administrative processes and enhance financial sustainability within the higher education sector. Conclusion This research thoroughly examined the dynamics of fee-free higher education in South Africa, highlighting both the challenges and opportunities in its implementation. The study emphasized the need for systemic reforms to improve accessibility and effectiveness, while also underscoring the potential of such initiatives to promote social mobility and economic empowerment, aligning with global goals like the SDGs and the African Agenda 2063.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141664104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Role of Self-directed Learning in Promoting Deep Learning Processes: A Systematic Literature Review 自主学习在促进深度学习过程中的作用:系统性文献综述
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.150612.1
LI Rui, Nurfaradilla Mohamad Nasri, Siti Nur Diyana Mahmud
{"title":"The Role of Self-directed Learning in Promoting Deep Learning Processes: A Systematic Literature Review","authors":"LI Rui, Nurfaradilla Mohamad Nasri, Siti Nur Diyana Mahmud","doi":"10.12688/f1000research.150612.1","DOIUrl":"https://doi.org/10.12688/f1000research.150612.1","url":null,"abstract":"<ns3:p>xx.</ns3:p>","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141668166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of skill-based educational training for ambulance personnel on neonatal transport for newborn care in coastal South India – a single arm intervention study 以技能为基础的救护人员教育培训对南印度沿海地区新生儿转运护理的影响--单臂干预研究
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.150058.1
Santosh Kalyan, S. Kamath, Subhodh Shetty S, Ramesh Holla, Leslie Lewis, Harsha Lashkari P, Suchitra Shenoy M, Shantharam Baliga B
{"title":"Effect of skill-based educational training for ambulance personnel on neonatal transport for newborn care in coastal South India – a single arm intervention study","authors":"Santosh Kalyan, S. Kamath, Subhodh Shetty S, Ramesh Holla, Leslie Lewis, Harsha Lashkari P, Suchitra Shenoy M, Shantharam Baliga B","doi":"10.12688/f1000research.150058.1","DOIUrl":"https://doi.org/10.12688/f1000research.150058.1","url":null,"abstract":"Background Education of ‘108' ambulance personnel involved in transporting neonates may improve outcomes. We assessed i) perceptions/practices of ‘108’ ambulance personnel for transporting neonates, ii) clinical parameters of transported neonates at arrival, and iii) outcomes such as survival/mortality and NICU stay (before and after skill-based educational intervention). Methods We conducted a single-arm intervention study (pre-and post) over 18 months. We assessed the perceptions and practices of 77 ambulance personnel on neonatal transport pre- versus post-intervention. Checklists assessed ambulance equipment availability/usage in both phases. We compared clinical parameters and outcomes of transported neonates between the pre-intervention (n=62) and post-intervention (n=53) phases. We analyzed data using SPSS version 25. Results Post-intervention, there was a significant reduction in the levels of hypothermia (p < 0.001), hypoglycemia (p=0.010), and prolonged capillary refill time (p=0.042), along with improvement in the use of intravenous fluids (p <0.001), a reduction in the positivity of umbilical swab growth (p=0.002) and in the duration of NICU stay (p = 0.001), significant improvement (p < 0.001) in the perceptions/practices of ambulance personnel towards neonatal transport. There was an improvement in the ambulance equipment availability/usage post-intervention. Conclusions The perceptions and practices of the ‘108’ ambulance towards transporting neonates had significantly improved post-educational intervention. Further, a significant decrease in hypothermia, hypoglycemia, and duration of NICU stay was seen in neonates transported post-intervention.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141670479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Laryngeal nerves in the cadaveric neck and its relevance to neck surgery- A descriptive study 尸体颈部的喉神经及其与颈部手术的相关性--一项描述性研究
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.148495.1
P. Dass, A. Rai, M. Pai, Muralimanju B V, G. Chettiar, R. Rai
{"title":"Laryngeal nerves in the cadaveric neck and its relevance to neck surgery- A descriptive study","authors":"P. Dass, A. Rai, M. Pai, Muralimanju B V, G. Chettiar, R. Rai","doi":"10.12688/f1000research.148495.1","DOIUrl":"https://doi.org/10.12688/f1000research.148495.1","url":null,"abstract":"Background Because of its close relationship with vessels that supply the thyroid gland, it is necessary to understand and document the course of the laryngeal nerves to prevent accidental damage. Otherwise it can lead to weakness in vocal cord function if ligated along with the arteries during thyroidectomy or other surgical procedures. The aim of our study was to examine and document the origin, relationship, and branching patterns of the laryngeal nerves on the side of the neck. Method The present cross sectional anatomical study was conducted on 64 dissected necks of formalin-fixed cadavers that were utilized for undergraduate teaching purposes. Different parameters were measured in the neck along with the relationship between the laryngeal nerves and their accompanying arteries. Results We observed usual and unusual course of laryngeal nerves along with some variations. Some of the novel findings were an internal laryngeal nerve piercing the thyroid cartilage lamina and an external laryngeal nerve communicating with the superior cervical ganglion. Conclusion The present study observed anatomical variations in the course of the laryngeal nerves, which are relevant for clinical practice. The potential risks of damage to these laryngeal nerves during various surgical procedures make it necessary to review and compile its relationship with the surrounding structures.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141666769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Case Report : Navigating the uncommon: Medicopsis romeroi-induced corneal ulcer 病例报告:不常见的导航:Medicopsis romeroi 引起的角膜溃疡
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.152941.1
Prerana A Shetty, Sowjanya Vuyyuru, Divya Tara, S. Bhalerao
{"title":"Case Report : Navigating the uncommon: Medicopsis romeroi-induced corneal ulcer","authors":"Prerana A Shetty, Sowjanya Vuyyuru, Divya Tara, S. Bhalerao","doi":"10.12688/f1000research.152941.1","DOIUrl":"https://doi.org/10.12688/f1000research.152941.1","url":null,"abstract":"Abstract* This report details a rare case of corneal infection caused by Medicopsis romeroi, highlighting clinical presentation, diagnostic methods, treatment, and outcome. An early adolescence male, after recent corneal tear repair, presented acute eye pain, redness, and decreased vision for 1 day. He underwent corneal tear repair elsewhere post vegetative matter-related swimming injury. Ophthalmic examination revealed a 2.5*3.3mm ulcer around sutures. Corneal scrapings enabled microscopy and culture. With lesion worsening, tissue adhesive (TA) and bandage contact lens (BCL) were applied. Fungal culture identified Medicopsis romeroi. Patient's history, clinical course, and treatment were documented. Microscopy unveiled fungal hyphae, later confirmed as Medicopsis romeroi. Treatment included topical/systemic antifungals. Post-TA + BCL, significant improvement followed, with re-epithelialization, scarring. This report underscores the importance of considering rare fungal pathogens like Medicopsis romeroi in cases of corneal ulcers, especially in individuals with unusual risk factors. Timely diagnosis through microscopy and fungal culture, coupled with tailored antifungal treatment led to successful management and favorable patient outcomes. This case also emphasizes the significance of vigilant clinical observation, precise laboratory analysis, and multidisciplinary collaboration between ophthalmologists and microbiologists in managing atypical ocular infections.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141668359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Investigating Participant Characteristics and Scores in Hypertension Using Multi-Attribute Utility Theory Analysis on Hypertension Patients from Pakistan 利用多属性效用理论分析法调查巴基斯坦高血压患者的特征和得分情况
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.151569.1
Sania Rauf, Desy Nuryunarsih, Heni Pujiastuti, Mahija Zaidan, L. Herawati, Okatiranti Okatiranti, Abida Arshad, Syed Shakeel Raza Rizvi
{"title":"Investigating Participant Characteristics and Scores in Hypertension Using Multi-Attribute Utility Theory Analysis on Hypertension Patients from Pakistan","authors":"Sania Rauf, Desy Nuryunarsih, Heni Pujiastuti, Mahija Zaidan, L. Herawati, Okatiranti Okatiranti, Abida Arshad, Syed Shakeel Raza Rizvi","doi":"10.12688/f1000research.151569.1","DOIUrl":"https://doi.org/10.12688/f1000research.151569.1","url":null,"abstract":"Background and aim Hypertension (HTN) is a significant public health concern worldwide, affecting approximately a third of people during their lifetimes. There are many factors that influence people with HTN to develop cardiovascular disease, such as lifestyle, genetics, economics, overall health, and medications; the authors did not find any previous study employing Multi-Attribute Utility Theory (MAUT) analysis using machine learning. There is a sense of urgency to understand the characteristics of HTN patients in Pakistan; by using MAUT to analyze and evaluate different factors related to developing HTN, we can gain valuable insights into the characteristics of HTN and cardiovascular HTN (HTN-CVD) patients in Pakistan. Methods and results This study utilized a cross-sectional survey with 98 participants diagnosed with HTN and HTN-CVD. The questionnaire included sociodemographic items, symptoms, heredity factors, and dietary habits. The study was approved by the Research Ethical Committees of Pir Mehr Ali Shah Arid Agriculture University Rawalpindi (PMAS-AAUR), Pakistan. The result shows that there is a wide difference between HTN and HTN-CVD patients’ scores for symptoms (37% vs. 63%) and economic status (39% vs. 61%) (respectively). Other than these, the attribute proportions of scores for HTN and HTN-CVD are almost the same. The highest MAUT scores were higher for patients with HTN-CVD (373) than for those with HTN alone (270), and the mean age of HTN patients is higher than HTN-CVD; almost all attributes’ groups of the 10 highest MAUT scores of HTN-CVD higher than HTN patients except for attribute of medication status. Conclusion Patients with HTN-CVD complications have higher MAUT scores for lifestyle, social status, health status, and economic status. This emphasizes the importance of educating patients (and indeed the general public) about risks, symptoms, and adopting healthy behaviors.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141667640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparative hemodynamics of ATTR and AL amyloidosis with exercise-induced pulmonary hypertension: A retrospective analysis ATTR和AL淀粉样变性伴运动性肺动脉高压的血液动力学比较:回顾性分析
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.148652.1
Arif Albulushi, Amna Al-Busaidi, Kumayl Al-Lawatia, Thuraiya Al-Rawahi, Matlooba Ayoub Al-Zadjali
{"title":"Comparative hemodynamics of ATTR and AL amyloidosis with exercise-induced pulmonary hypertension: A retrospective analysis","authors":"Arif Albulushi, Amna Al-Busaidi, Kumayl Al-Lawatia, Thuraiya Al-Rawahi, Matlooba Ayoub Al-Zadjali","doi":"10.12688/f1000research.148652.1","DOIUrl":"https://doi.org/10.12688/f1000research.148652.1","url":null,"abstract":"Background Cardiac amyloidosis, characterized by the deposition of amyloid proteins in the heart tissue, presents in two main types: transthyretin (ATTR) and light-chain (AL) amyloidosis. The hemodynamic response to exercise and the relationship with pulmonary hypertension (PH) in these patients is not well understood. Methods This retrospective study analyzed 100 patients diagnosed with either ATTR or AL amyloidosis. We assessed the prevalence of PH at rest and its induction during exercise stress tests. Hemodynamic parameters were measured to identify differences in the cardiac response to exercise between the two subtypes. Results A higher prevalence of PH was noted in the ATTR group compared to the AL group. Exercise stress tests induced significant PH, particularly in the ATTR subgroup. Subtle yet clinically relevant hemodynamic differences were observed between the amyloidosis subtypes. Conclusions Our findings suggest that the amyloidosis subtype is an important factor in the management of PH. There is a need for tailored clinical approaches to address the distinct pathophysiological mechanisms in ATTR and AL amyloidosis. This study contributes to a better understanding of the hemodynamic changes during exercise in cardiac amyloidosis and underscores the importance of subtype-specific management strategies.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141667145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quantitative assessment of the lipiodol staining after transarterial chemoembolization for hepatocellular carcinoma: can it predict tumor recurrence? 肝细胞癌经动脉化疗栓塞术后脂碘染色的定量评估:它能预测肿瘤复发吗?
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.147694.1
T. Wattanasatesiri, Patcha Faimetta, Wirana Angthong
{"title":"Quantitative assessment of the lipiodol staining after transarterial chemoembolization for hepatocellular carcinoma: can it predict tumor recurrence?","authors":"T. Wattanasatesiri, Patcha Faimetta, Wirana Angthong","doi":"10.12688/f1000research.147694.1","DOIUrl":"https://doi.org/10.12688/f1000research.147694.1","url":null,"abstract":"Background The degree of intratumoral lipiodol staining after conventional transarterial chemoembolization (cTACE) has the potential to predict tumor responses and disease prognosis. This study is aimed at evaluating the correlation between the lipiodol retention of the tumor with a complete response after cTACE and tumor recurrence by quantitative assessment. Methods From January 2013 to September 2023, every patient receiving cTACE for HCC was recognized. Inclusion criteria were patients with ≤6 HCCs and sizes 1-6 cm, with at least one tumor obtaining a complete response after cTACE, and available baseline and follow-up CT studies. Tumoral, cTACE procedural, and lipiodol staining parameters were analyzed. Using univariate and multivariate analysis, significant factors associated with tumor recurrence were identified. ROC curve analysis was used to identify the optimal cutoff point for the statistically significant factors, predicting tumor recurrence. Results The final population included 39 patients with 63 HCCs. Tumor recurrence was detected in 18/63 (28.6%) at a mean of 27.8 months. On univariate analysis, the incidence of tumor recurrence significantly increased with increased tumor size (p = 0.007), an inhomogeneous lipiodol staining pattern (p<0.001), a low minimum lipiodol radiodensity (p = 0.012), and a high lipiodol washout rate (p = 0.046). On multivariate analysis, an inhomogeneous lipiodol staining pattern (p<0.001) and a high lipiodol washout rate (p = 0.012) were significant predictors for tumor recurrence. On ROC analysis, a lipiodol washout rate of greater than 6.44 HU/month was related to tumor recurrence (sensitivity 83%, specificity 51%). Conclusions Inhomogeneous lipiodol staining pattern and lipiodol washout rate of >6.44 HU/month were predictors for recurrence of HCC after a complete response after cTACE. These correlations may provide useful guidance for subsequent imaging surveillance and treatment approaches.","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141668255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial – the study protocol 使用 Cerebri 生物反馈疗法预防发作性偏头痛成人患者的偏头痛发作(BioCer):随机、等待名单对照试验--研究方案
F1000Research Pub Date : 2024-07-08 DOI: 10.12688/f1000research.149807.1
Amalie Christine Poole, Anker Stubberud, Melanie Simpson, Lise R. Øie, Einar Tobias Vassbø Skalstad, M. Bjørk, E. Kristoffersen, K. Vetvik, A. Olsen, Iben Cornelia Keim Larsen, Mattias Linde, E. Tronvik, T. W. Meisingset
{"title":"Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial – the study protocol","authors":"Amalie Christine Poole, Anker Stubberud, Melanie Simpson, Lise R. Øie, Einar Tobias Vassbø Skalstad, M. Bjørk, E. Kristoffersen, K. Vetvik, A. Olsen, Iben Cornelia Keim Larsen, Mattias Linde, E. Tronvik, T. W. Meisingset","doi":"10.12688/f1000research.149807.1","DOIUrl":"https://doi.org/10.12688/f1000research.149807.1","url":null,"abstract":"Introduction Biofeedback is a non-pharmacological treatment option valued for its minimal risk of adverse events and offers a safe alternative for individuals seeking preventive care for migraine. Despite level A evidence for migraine prevention, biofeedback treatment is still unavailable to most patients. We developed a novel medical device (Cerebri) for multimodal biofeedback treatment that omits the need for healthcare personnel involvement. Cerebri consists of a smartphone application (app) and two wireless sensors. Unique in its approach, the Cerebri app seamlessly integrates three biofeedback modalities – heart rate variability, temperature, and electromyography – making it a comprehensive, therapist-independent solution for non-pharmacological migraine management. Methods Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (The BioCer study) was an open-label, randomized, waitlist-controlled, multicenter trial. This study investigated the safety and efficacy of daily home-based biofeedback sessions using the Cerebri device. A total of 286 participants will be randomized to either a 12-week intervention arm or waitlist control arm. The primary outcome was the change in the mean number of migraine days from baseline to the last 28-day period during the treatment phase in the treatment group compared with the control group. The primary outcome variable was prospectively collected through daily eDiary entries. Ethics and Dissemination Approval from the ethics committee and competent authorities was obtained prior to study initiation. Participation was voluntary and informed and written consent was obtained prior to inclusion. The results of this trial will be published in peer-reviewed international medical journals and communicated to patients and healthcare personnel through the relevant channels. Trial registration numbers EUDAMED: CIV-NO-22-08-040446 REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14 Trial registration: NCT05616741, 2022-11-15, https://clinicaltrials.gov/study/NCT05616741","PeriodicalId":12260,"journal":{"name":"F1000Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141668131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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