Methods and Protocols最新文献_第7页

Prophylactic Administration of Perampanel for Post-Stroke Epilepsy (PROPELLER Study): A Trial Protocol. 中风后癫痫预防性用药 Perampanel（PROPELLER 研究）：试验方案。

IF 2.3

Methods and Protocols Pub Date : 2024-10-05 DOI: 10.3390/mps7050079

Shuichi Yamada, Ichiro Nakagawa, Masashi Kotsugi, Kiyoshi Asada, Masato Kasahara

{"title":"Prophylactic Administration of Perampanel for Post-Stroke Epilepsy (PROPELLER Study): A Trial Protocol.","authors":"Shuichi Yamada, Ichiro Nakagawa, Masashi Kotsugi, Kiyoshi Asada, Masato Kasahara","doi":"10.3390/mps7050079","DOIUrl":"https://doi.org/10.3390/mps7050079","url":null,"abstract":"Background: Post-stroke epilepsy can reduce patients' abilities to carry out various activities of daily living. Despite their importance in preventing the onset of post-stroke epilepsy, the prophylactic administration of antiepileptic drugs is controversial due to a lack of high-level clinical research. In this study, we initiated a prospective interventional study of prophylactic antiepileptic drug administration in patients with a subcortical hemorrhage, who are at the highest risk of developing epilepsy after experiencing a stroke.Methods: The study was conducted in a single-center setting and was a single-arm study with no control group; the case entry period started in November 2023 and is due to end in March 2025. Only cases with a subcortical hemorrhage will be included. The treatment regimen used in this study is 2 mg of perampanel per day. Perampanel will be administered for one year, followed by two years of follow-up, for a total study period of three years. The primary endpoint will be the development of epilepsy.Results: Perampanel administration is expected to reduce the incidence of post-stroke epilepsy in comparison to the results of previous reports on the use of alternative treatments.Conclusions: The results of this study will provide new insights into the prevention of post-stroke epilepsy. The relatively small size of this study makes it difficult to provide strong evidence of the efficacy of perampanel, but it may serve as a basis for larger clinical trials.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11510630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effect of Telenursing on Supportive Care Needs in Patients with Melanoma and Lung Cancer on Targeted Therapies: A Randomised Controlled Trial Study Protocol. 远程护理对接受靶向治疗的黑色素瘤和肺癌患者辅助护理需求的影响：随机对照试验研究方案》。

IF 2.3

Methods and Protocols Pub Date : 2024-10-03 DOI: 10.3390/mps7050078

Aurora De Leo, Gloria Liquori, Alessandro Spano, Nicolò Panattoni, Sara Dionisi, Laura Iacorossi, Noemi Giannetta, Irene Terrenato, Emanuele Di Simone, Marco Di Muzio, Fabrizio Petrone

{"title":"Effect of Telenursing on Supportive Care Needs in Patients with Melanoma and Lung Cancer on Targeted Therapies: A Randomised Controlled Trial Study Protocol.","authors":"Aurora De Leo, Gloria Liquori, Alessandro Spano, Nicolò Panattoni, Sara Dionisi, Laura Iacorossi, Noemi Giannetta, Irene Terrenato, Emanuele Di Simone, Marco Di Muzio, Fabrizio Petrone","doi":"10.3390/mps7050078","DOIUrl":"https://doi.org/10.3390/mps7050078","url":null,"abstract":"Background: Telenursing comprises a set of tools and interventions enabling nurses to provide remote care. This study aims to assess the impact of telenursing interventions on the supportive care needs of patients with melanoma and lung cancer who are receiving targeted therapies. Methods: This six-month monocentric, double-arm, randomised, controlled trial study protocol will assess the effect of telenursing on the supportive care needs (primary outcome) in 40 patients (20 in each group) after one month. The secondary outcomes will be monitored at baseline, one, three and six months: supportive care needs (at three and six months), therapeutic adherence, quality of life, usability and satisfaction, performance status, patient-reported outcomes and main adverse events. The SPIRIT guidelines will be used for the reporting. Results: The results from this trial will assess the impact of a telenursing intervention on cancer care. Conclusions: This trial could be a starting point for more extensive studies on telenursing interventions to promote nurses' skills, as well as the quality and safety of care in patients with cancer, highlighting the impact of more outstanding nursing contributions on cancer care. Trial and Protocol Registration: The study protocol was approved by the relevant Italian Ethics Committee Lazio Area 5 (RS1851/23, 2773; 6 September 2023) and was registered on ClinicalTrials.gov (trial registry number NCT06254196).","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11510742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Oral Pre-Exposure Prophylaxis Innovative Interventions among Adolescent Girls and Young Women in South Africa: A Protocol Paper. 南非少女和年轻妇女口服暴露前预防创新干预措施：协议文件。

IF 2.3

Methods and Protocols Pub Date : 2024-09-29 DOI: 10.3390/mps7050077

Lerato Lucia Olifant, Edith Phalane, Refilwe Nancy Phaswana-Mafuya

{"title":"Oral Pre-Exposure Prophylaxis Innovative Interventions among Adolescent Girls and Young Women in South Africa: A Protocol Paper.","authors":"Lerato Lucia Olifant, Edith Phalane, Refilwe Nancy Phaswana-Mafuya","doi":"10.3390/mps7050077","DOIUrl":"https://doi.org/10.3390/mps7050077","url":null,"abstract":"Although South Africa was the first country to register and roll out oral pre-exposure prophylaxis (PrEP) biomedical human immunodeficiency virus (HIV) prevention intervention in sub-Saharan Africa (SSA), its uptake remains low, particularly among adolescent girls and young women (AGYW). The uptake of PrEP may have worsened during the Coronavirus disease 2019 (COVID-19) pandemic. Some innovative interventions to improve PrEP uptake among AGYW have been implemented. This study aims to evaluate the effectiveness of PrEP innovative interventions implemented during COVID-19 towards reducing the risk of HIV infection among AGYW in South Africa. An exploratory, descriptive design will be conducted to carry out four study objectives. Firstly, to carry out a systematic review of innovative PrEP interventions implemented during COVID-19 in SSA countries. Secondly, to conduct a stakeholder analysis to identify PrEP stakeholders and interview them on their views on the implemented interventions. Thirdly, to assess the implementation outcomes of the innovative interventions using document reviews and Consolidated Framework for Implementation Research. Fourthly, to develop a framework for an improved PrEP service delivery among AGYW. Qualitative data will be captured in ATLAS.ti software (Technical University, Berlin, Germany) version 23 and analysed via thematic analysis. A statistical software package (STATA) version 18 (College Station, TX, USA) will be used to capture quantitative data and analyse them via descriptive analysis. The generated evidence will be used towards the development of framework, guidelines, and policies to strengthen the uptake of, scale-up, and adherence to PrEP among AGYW.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11510152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Use of Decellularized Bio-Scaffolds for the Generation of a Porcine Artificial Intestine. 利用脱细胞生物支架生成猪人工肠道

IF 2.3

Methods and Protocols Pub Date : 2024-09-27 DOI: 10.3390/mps7050076

Sharon Arcuri, Georgia Pennarossa, Madhusha Prasadani, Fulvio Gandolfi, Tiziana A L Brevini

{"title":"Use of Decellularized Bio-Scaffolds for the Generation of a Porcine Artificial Intestine.","authors":"Sharon Arcuri, Georgia Pennarossa, Madhusha Prasadani, Fulvio Gandolfi, Tiziana A L Brevini","doi":"10.3390/mps7050076","DOIUrl":"https://doi.org/10.3390/mps7050076","url":null,"abstract":"In recent years, great interest has been focused on the development of highly reproducible 3D in vitro models that are able to mimic the physiological architecture and functionality of native tissues. To date, a wide range of techniques have been proposed to recreate an intestinal barrier in vitro, including synthetic scaffolds and hydrogels, as well as complex on-a-chip systems and organoids. Here, we describe a novel protocol for the generation of an artificial intestine based on the creation of decellularized bio-scaffolds and their repopulation with intestinal stromal and epithelial cells. Organs collected at the local slaughterhouse are subjected to a decellularization protocol that includes a freezing/thawing step, followed by sequential incubation in 1% SDS for 12 h, 1% Triton X-100 for 12 h, and 2% deoxycholate for 12 h. At the end of the procedure, the generated bio-scaffolds are repopulated with intestinal fibroblasts and then with epithelial cells. The protocol described here represents a promising and novel strategy to generate an in vitro bioengineered intestine platform able to mimic some of the complex functions of the intestinal barrier, thus constituting a promising 3D strategy for nutritional, pharmaceutical, and toxicological studies.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11510128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Scalable Method to Fabricate 2D Hydrogel Substrates for Mechanobiology Studies with Independent Tuning of Adhesiveness and Stiffness. 为机械生物学研究制造二维水凝胶基底的可扩展方法，可独立调节粘附性和硬度。

IF 2.3

Methods and Protocols Pub Date : 2024-09-26 DOI: 10.3390/mps7050075

Alessandro Gandin, Veronica Torresan, Tito Panciera, Giovanna Brusatin

{"title":"A Scalable Method to Fabricate 2D Hydrogel Substrates for Mechanobiology Studies with Independent Tuning of Adhesiveness and Stiffness.","authors":"Alessandro Gandin, Veronica Torresan, Tito Panciera, Giovanna Brusatin","doi":"10.3390/mps7050075","DOIUrl":"https://doi.org/10.3390/mps7050075","url":null,"abstract":"Mechanical signals from the extracellular matrix are crucial in guiding cellular behavior. Two-dimensional hydrogel substrates for cell cultures serve as exceptional tools for mechanobiology studies because they mimic the biomechanical and adhesive characteristics of natural environments. However, the interdisciplinary knowledge required to synthetize and manipulate these biomaterials typically restricts their widespread use in biological laboratories, which may not have the material science expertise or specialized instrumentation. To address this, we propose a scalable method that requires minimal setup to produce 2D hydrogel substrates with independent modulation of the rigidity and adhesiveness within the range typical of natural tissues. In this method, norbornene-terminated 8-arm polyethylene glycol is stoichiometrically functionalized with RGD peptides and crosslinked with a di-cysteine terminated peptide via a thiol-ene click reaction. Since the synthesis process significantly influences the final properties of the hydrogels, we provide a detailed description of the chemical procedure to ensure reproducibility and high throughput results. We demonstrate examples of cell mechanosignaling by monitoring the activation state of the mechanoeffector proteins YAP/TAZ. This method effectively dissects the influence of biophysical and adhesive cues on cell behavior. We believe that our procedure will be easily adopted by other cell biology laboratories, improving its accessibility and practical application.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11510107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142504287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Co-Culture of Gut Bacteria and Metabolite Extraction Using Fast Vacuum Filtration and Centrifugation. 利用快速真空过滤和离心法联合培养肠道细菌并提取代谢物

IF 2.3

Methods and Protocols Pub Date : 2024-09-19 DOI: 10.3390/mps7050074

Asha Guraka, Richard Duff, Joe Waldron, Gyanendra Tripathi, Ali Kermanizadeh

{"title":"Co-Culture of Gut Bacteria and Metabolite Extraction Using Fast Vacuum Filtration and Centrifugation.","authors":"Asha Guraka, Richard Duff, Joe Waldron, Gyanendra Tripathi, Ali Kermanizadeh","doi":"10.3390/mps7050074","DOIUrl":"10.3390/mps7050074","url":null,"abstract":"This protocol describes a robust method for the extraction of intra and extracellular metabolites of gut bacterial mono and co-cultures. In recent years, the co-culture techniques employed in the field of microbiology have demonstrated significant importance in regard to understanding cell-cell interactions, cross-feeding, and the metabolic interactions between different bacteria, fungi, and microbial consortia which enable the mimicking of complex co-habitant conditions. This protocol highlights a robust reproducible physiologically relevant culture and extraction protocol for the co-culture of gut bacterium. The novel extraction steps are conducted without using quenching and cell disruption through bead-cell methods, freeze-thaw cycles, and sonication, which tend to affect the physical and biochemical properties of intracellular metabolites and secretome. The extraction procedure of inoculated bacterial co-cultures and monocultures use fast vacuum filtration and centrifugation. The extraction methodology is fast, effective, and robust, requiring 4 h to complete.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142291449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Microneedle System Coated with Hydrogels Containing Protoporphyrin IX for Potential Application in Pharmaceutical Technology. 涂有原卟啉 IX 水凝胶的微针系统在制药技术中的潜在应用。

IF 2.3

Methods and Protocols Pub Date : 2024-09-13 DOI: 10.3390/mps7050073

Beata Czarczynska-Goslinska, Tomasz Goslinski, Agata Roszak, Anna Froelich, Piotr Szyk, Dariusz T Mlynarczyk, Lukasz Sobotta, Irena Budnik, Oliwia Kordyl, Tomasz Osmałek

{"title":"Microneedle System Coated with Hydrogels Containing Protoporphyrin IX for Potential Application in Pharmaceutical Technology.","authors":"Beata Czarczynska-Goslinska, Tomasz Goslinski, Agata Roszak, Anna Froelich, Piotr Szyk, Dariusz T Mlynarczyk, Lukasz Sobotta, Irena Budnik, Oliwia Kordyl, Tomasz Osmałek","doi":"10.3390/mps7050073","DOIUrl":"10.3390/mps7050073","url":null,"abstract":"The article aims to outline the potential of treating malignant skin cancer with microneedles covered with polymer layers containing a photosensitizer-protoporphyrin IX disodium salt (PPIX). The usefulness of stereolithography (SLA), which is a form of 3D-printing technology, for the preparation of a microneedle system with protoporphyrin IX was demonstrated. The SLA method allowed for pyramid-shaped microneedles to be printed that were covered with three different 0.1% PPIX hydrogels based on sodium alginate, xanthan, and poloxamer. Rheological tests and microscopic analysis of the hydrogels were performed. Microneedles coated with two layers of poloxamer-based hydrogel containing 0.1% PPIX were subjected to release tests in Franz diffusion cells. The release profile of PPIX initially increased and then remained relatively constant. The amount of substance released after a four-hour test in three Franz cells was 0.2569 ± 0.0683 mg/cm2. Moreover, the acute toxicity of this type of microneedle was assessed using the Microtox system. The obtained results show the usefulness of further development studies on microneedles as carriers of photosensitizing agents.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142291453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Generating Cytokines and Growth Factors for Functional Activity: Feasibility of Method Using MIF Protein. 产生细胞因子和生长因子的功能活性：使用 MIF 蛋白的方法的可行性。

IF 2.3

Methods and Protocols Pub Date : 2024-09-12 DOI: 10.3390/mps7050072

Hiba Osmani, Ishrya Sharma, Shannon Moonah

{"title":"Generating Cytokines and Growth Factors for Functional Activity: Feasibility of Method Using MIF Protein.","authors":"Hiba Osmani, Ishrya Sharma, Shannon Moonah","doi":"10.3390/mps7050072","DOIUrl":"10.3390/mps7050072","url":null,"abstract":"Cytokines and growth factors are signaling molecules that regulate a variety of biological processes. Understanding their role is essential for basic research and clinical utilization. Thus, cytokines and growth factors are widely used throughout research labs in a significant number of applications. Additionally, genetic polymorphisms result in variant forms of cytokines and growth factors, which can alter their function. Becoming more common, researchers will need to generate these important proteins and their variants themselves in functional forms for activity studies. The expression systems used to generate these proteins can have a major impact on their function. In some instances, post-translational modifications are needed to produce a functionally active protein, which can only be conducted using eukaryotic expression systems. Ideally, for functional relevance, a human expression system should be used for human-related research and applications. Most human cell-based expression systems primarily use HEK (Human Embryonic Kidney) cells; however, relying on just one cell type can lead to several issues, considering the variety of proteins derived from various cell sources. Here, we provide a protocol to effectively and efficiently generate functional recombinant proteins, taking into consideration the diverse range of proteins from different cell types throughout the human body.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142291452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

FAMS-A Targeted Fatty Acid Mass Spectrometry Method for Monitoring Free Fatty Acids from Polysorbate Hydrolysis. FAMS- 用于监测聚山梨醇酯水解游离脂肪酸的定向脂肪酸质谱法。

IF 2.3

Methods and Protocols Pub Date : 2024-09-07 DOI: 10.3390/mps7050071

Anja Bathke, Sina Hoelterhoff, Jan Wendler, Inn H Yuk, Christian H Bell

{"title":"FAMS-A Targeted Fatty Acid Mass Spectrometry Method for Monitoring Free Fatty Acids from Polysorbate Hydrolysis.","authors":"Anja Bathke, Sina Hoelterhoff, Jan Wendler, Inn H Yuk, Christian H Bell","doi":"10.3390/mps7050071","DOIUrl":"10.3390/mps7050071","url":null,"abstract":"Polysorbates are the predominant surfactants used to stabilize protein formulations. Unfortunately, polysorbates can undergo hydrolytic degradation, which releases fatty acids that can accumulate to form visible particles. The detection and quantitation of these fatty acid degradation products are critical for assessing the extent of polysorbate degradation and the associated risks of particle formation. We previously developed a user-friendly mass spectrometric method called Fatty Acids by Mass Spectrometry (FAMS) to quantify the free fatty acids. The FAMS method was validated according to ICH Q2 (R1) guidelines and is suitable for a wide range of products, buffers and protein concentrations. The end-to-end workflow can be automated from sample preparation to data analysis. To broaden method accessibility, the QDa detector selected for fatty acid measurement does not require specific mass spectrometry experience. We provide here a detailed procedure for both manual and automated sample preparation for high-throughput analysis. In addition, we highlight in this protocol the critical operational details, procedural watchouts and troubleshooting tips to support the successful execution of this method in another laboratory.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142291451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Burden of Sleep/Wake Disorders: Excessive Daytime Sleepiness and Insomnia Project. 睡眠/觉醒障碍的负担：白天过度嗜睡和失眠项目。

IF 2.3

Methods and Protocols Pub Date : 2024-09-06 DOI: 10.3390/mps7050070

Marina Tüzün, Ulf Kallweit, Stefan Seidel, Olga Endrich, Sven Trelle, Maurizio A Leone, Oliviero Bruni, Richard Dodel, Maria Konti, Maria Lolich, Elisabetta Pupillo, Dauren Ramankulov, Luca Vignatelli, Carla Meyer-Massetti, Markus Schmidt, Claudio L A Bassetti

{"title":"The Burden of Sleep/Wake Disorders: Excessive Daytime Sleepiness and Insomnia Project.","authors":"Marina Tüzün, Ulf Kallweit, Stefan Seidel, Olga Endrich, Sven Trelle, Maurizio A Leone, Oliviero Bruni, Richard Dodel, Maria Konti, Maria Lolich, Elisabetta Pupillo, Dauren Ramankulov, Luca Vignatelli, Carla Meyer-Massetti, Markus Schmidt, Claudio L A Bassetti","doi":"10.3390/mps7050070","DOIUrl":"10.3390/mps7050070","url":null,"abstract":"Excessive daytime sleepiness (EDS) and insomnia (IN) complaints represent the most common sleep/wake disorders. Currently, the specific needs of these patients and their relatives, as well as the overall socio-economic burden of IN and EDS remains widely unexplored. This pilot study to be carried out in Switzerland is a retro- and prospective, national, one-center cohort observational study for the systematic evaluation of the burden of EDS and IN and its evolution 12 months after the first assessment. Patient recruitment will be organized through 7-8 primary care providers (primary/general care practitioners and pharmacies). Primary outcomes are the prevalence of EDS/IN in the primary care setting and the association between EDS/IN with health-related quality of life (QOL) as assessed with the established instruments. Secondary outcomes are the association between EDS/IN with the presence of comorbidities, number of injuries/accidents, and number of sick/leave days for the subgroup of working subjects. Calculation of direct per-patient costs will be undertaken to analyze the economic implications of sleep/wake disorders, providing valuable insights into the financial burden experienced by affected individuals within the healthcare system. This research will provide information on the feasibility of such a study and inform on aspects of the QOL most associated with EDS/IN. Based on this pilot project, a European multicenter study on the burden of sleep/wake disorders will be conducted by the European Academy of Neurology.","PeriodicalId":18715,"journal":{"name":"Methods and Protocols","volume":"7 5","pages":""},"PeriodicalIF":2.3,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11417944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142291456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0