多发性硬化症的高效疾病改善疗法的管理和监测负担：来自沙特阿拉伯临床专家的德尔菲共识。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY Neurology and Therapy Pub Date : 2025-02-01 Epub Date: 2025-01-04 DOI:10.1007/s40120-024-00707-5

Seraj Makkawi, Ahmad Abulaban, Yaser Al Malik, Ebtesam Alshehri, Ahmed Althobaiti, Salman Aljarallah, Ahmed Elboghdady, Lynn AlHajjar, Sahar Shami, Saeed Bohlega, Mohammed Aljumah

{"title":"多发性硬化症的高效疾病改善疗法的管理和监测负担：来自沙特阿拉伯临床专家的德尔菲共识。","authors":"Seraj Makkawi, Ahmad Abulaban, Yaser Al Malik, Ebtesam Alshehri, Ahmed Althobaiti, Salman Aljarallah, Ahmed Elboghdady, Lynn AlHajjar, Sahar Shami, Saeed Bohlega, Mohammed Aljumah","doi":"10.1007/s40120-024-00707-5","DOIUrl":null,"url":null,"abstract":"Introduction: The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden of the therapies. This article presents the results of the Delphi consensus method to generate insights from experts on the administration and monitoring burden of HE DMT in Saudi Arabia with a special focus on cladribine.Methods: Between January and March 2023, a two-round modified Delphi method was used to establish consensus regarding the administration and monitoring burden of HE DMTs used for MS. Through a questionnaire, the advisors evaluated 17 properties of six individual HE DMTs on the basis of their clinical experience. Advisors were required to rank each property on a scale of 1-5, with 1 being the lowest burden and 5 being the highest burden.Results: Experts ranked cladribine as having the lowest monitoring burden, followed by ofatumumab and ocrelizumab. Natalizumab and fingolimod were ranked fourth, and alemtuzumab had the highest burden. During the first round, experts agreed on the scores of the administration burden properties, except for hospital visit time and facility use during administration for ofatumumab, route of administration for fingolimod, monitoring of specific side effects and frequency of lab tests at follow-up, and the washout period for natalizumab. During the second round, there was agreement on all properties.Conclusion: In the absence of alternative scientific data, recommendations from experts and their consensus provide useful insights into the administration and monitoring burden of HE DMTs used for MS in Saudi Arabia.","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"413-427"},"PeriodicalIF":3.9000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762031/pdf/","citationCount":"0","resultStr":"{\"title\":\"Administration and Monitoring Burden of High-Efficacy Disease-Modifying Therapies for Multiple Sclerosis: A Delphi Consensus of Clinical Experts from Saudi Arabia.\",\"authors\":\"Seraj Makkawi, Ahmad Abulaban, Yaser Al Malik, Ebtesam Alshehri, Ahmed Althobaiti, Salman Aljarallah, Ahmed Elboghdady, Lynn AlHajjar, Sahar Shami, Saeed Bohlega, Mohammed Aljumah\",\"doi\":\"10.1007/s40120-024-00707-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction: The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden of the therapies. This article presents the results of the Delphi consensus method to generate insights from experts on the administration and monitoring burden of HE DMT in Saudi Arabia with a special focus on cladribine.Methods: Between January and March 2023, a two-round modified Delphi method was used to establish consensus regarding the administration and monitoring burden of HE DMTs used for MS. Through a questionnaire, the advisors evaluated 17 properties of six individual HE DMTs on the basis of their clinical experience. Advisors were required to rank each property on a scale of 1-5, with 1 being the lowest burden and 5 being the highest burden.Results: Experts ranked cladribine as having the lowest monitoring burden, followed by ofatumumab and ocrelizumab. Natalizumab and fingolimod were ranked fourth, and alemtuzumab had the highest burden. During the first round, experts agreed on the scores of the administration burden properties, except for hospital visit time and facility use during administration for ofatumumab, route of administration for fingolimod, monitoring of specific side effects and frequency of lab tests at follow-up, and the washout period for natalizumab. During the second round, there was agreement on all properties.Conclusion: In the absence of alternative scientific data, recommendations from experts and their consensus provide useful insights into the administration and monitoring burden of HE DMTs used for MS in Saudi Arabia.\",\"PeriodicalId\":19216,\"journal\":{\"name\":\"Neurology and Therapy\",\"volume\":\" \",\"pages\":\"413-427\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762031/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40120-024-00707-5\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40120-024-00707-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/4 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

摘要

简介：多发性硬化症（MS）的高效疾病修饰疗法（HE DMT）的出现可能对治疗的管理和监测负担构成挑战。本文介绍了德尔菲共识方法的结果，以产生专家对沙特阿拉伯HE DMT的管理和监测负担的见解，特别关注克拉宾。方法：在2023年1月至3月期间，采用两轮修正德尔菲法，对用于ms的HE dmt的管理和监测负担建立共识。通过问卷调查，顾问根据他们的临床经验评估了6个HE dmt的17个特性。顾问被要求按照1-5的等级对每个物业进行排名，1代表最低负担，5代表最高负担。结果：专家将克拉德宾列为监测负担最低的药物，其次是ofatumumab和ocrelizumab。Natalizumab和fingolimod排名第四，阿仑单抗负担最高。在第一轮中，专家们就管理负担特性的评分达成一致，但不包括ofatumumab给药期间的医院就诊时间和设施使用情况、fingolimod的给药途径、特定副作用的监测和随访时实验室检查的频率，以及natalizumab的洗脱期。在第二轮谈判中，双方就所有财产达成了协议。结论：在缺乏替代科学数据的情况下，专家的建议及其共识为沙特阿拉伯用于多发性硬化症的HE dmt的管理和监测负担提供了有用的见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

Administration and Monitoring Burden of High-Efficacy Disease-Modifying Therapies for Multiple Sclerosis: A Delphi Consensus of Clinical Experts from Saudi Arabia.

Introduction: The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden of the therapies. This article presents the results of the Delphi consensus method to generate insights from experts on the administration and monitoring burden of HE DMT in Saudi Arabia with a special focus on cladribine.

Methods: Between January and March 2023, a two-round modified Delphi method was used to establish consensus regarding the administration and monitoring burden of HE DMTs used for MS. Through a questionnaire, the advisors evaluated 17 properties of six individual HE DMTs on the basis of their clinical experience. Advisors were required to rank each property on a scale of 1-5, with 1 being the lowest burden and 5 being the highest burden.

Results: Experts ranked cladribine as having the lowest monitoring burden, followed by ofatumumab and ocrelizumab. Natalizumab and fingolimod were ranked fourth, and alemtuzumab had the highest burden. During the first round, experts agreed on the scores of the administration burden properties, except for hospital visit time and facility use during administration for ofatumumab, route of administration for fingolimod, monitoring of specific side effects and frequency of lab tests at follow-up, and the washout period for natalizumab. During the second round, there was agreement on all properties.

Conclusion: In the absence of alternative scientific data, recommendations from experts and their consensus provide useful insights into the administration and monitoring burden of HE DMTs used for MS in Saudi Arabia.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model, this allows for the rapid and efficient communication of the latest research and reviews to support scientific discovery and clinical practice. Open Access All articles published by Neurology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital Features and Plain Language Summaries Neurology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case-by-case basis. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviews conflict, an Editorial Board Member will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed. Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised, it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor, and authors are welcome to make rebuttals against individual reviewer comments, if appropriate. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Neurology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.