Edward Ted Wells, Laurence Lucats, Giovanni Abbadessa, James Turnbull, Joyce R Talavera, Sophie R Van Tomme, Paul Cordero, Benoit Arnould, Matthew Reaney, Catherine Coulouvrat
{"title":"免疫肿瘤诱导的细胞因子释放综合征患者日记：内容有效，患者报告的结果测量。","authors":"Edward Ted Wells, Laurence Lucats, Giovanni Abbadessa, James Turnbull, Joyce R Talavera, Sophie R Van Tomme, Paul Cordero, Benoit Arnould, Matthew Reaney, Catherine Coulouvrat","doi":"10.1007/s40487-025-00383-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Cytokine release syndrome (CRS) occurs when the immune system reacts excessively to infections or certain immunotherapies, leading to a systemic inflammatory response. The clinical presentation of CRS is highly variable, ranging from mild symptoms, such as fever and fatigue, to severe, life-threatening conditions. Currently, there is no standardized method for collecting patient-reported data on CRS experiences. This study aims to develop a novel patient-reported outcome measure (PROM) to capture patients' experience with CRS.</p><p><strong>Methods: </strong>A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts, advisory board meetings with clinical trial investigators, concept elicitation interviews with patients who experienced CRS, a PROM development workshop, cognitive debriefing interviews with clinical trial investigators, and cognitive debriefing interviews with patients.</p><p><strong>Results: </strong>This review identified various CRS-related signs and symptoms from literature and anonymized safety data from clinical trials. Clinical experts validated the preliminary conceptual model (CM) and identified additional relevant symptoms. Patient interviews revealed further symptoms and impacts, leading to the development of the immuno-oncology (IO)-induced CRS patient diary. This PROM was refined through iterative feedback from clinical experts and patients, ensuring it effectively captures the incidence, severity, and impact of CRS symptoms.</p><p><strong>Conclusions: </strong>The \"IO-induced CRS patient diary\" can be considered a content-valid tool for capturing and monitoring the most important patient-reportable symptoms and impacts of CRS in IO clinical trials. 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This study aims to develop a novel patient-reported outcome measure (PROM) to capture patients' experience with CRS.</p><p><strong>Methods: </strong>A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts, advisory board meetings with clinical trial investigators, concept elicitation interviews with patients who experienced CRS, a PROM development workshop, cognitive debriefing interviews with clinical trial investigators, and cognitive debriefing interviews with patients.</p><p><strong>Results: </strong>This review identified various CRS-related signs and symptoms from literature and anonymized safety data from clinical trials. Clinical experts validated the preliminary conceptual model (CM) and identified additional relevant symptoms. 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The Immuno-oncology-Induced Cytokine Release Syndrome Patient Diary: A Content-Valid, Patient-Reported Outcome Measure.
Introduction: Cytokine release syndrome (CRS) occurs when the immune system reacts excessively to infections or certain immunotherapies, leading to a systemic inflammatory response. The clinical presentation of CRS is highly variable, ranging from mild symptoms, such as fever and fatigue, to severe, life-threatening conditions. Currently, there is no standardized method for collecting patient-reported data on CRS experiences. This study aims to develop a novel patient-reported outcome measure (PROM) to capture patients' experience with CRS.
Methods: A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts, advisory board meetings with clinical trial investigators, concept elicitation interviews with patients who experienced CRS, a PROM development workshop, cognitive debriefing interviews with clinical trial investigators, and cognitive debriefing interviews with patients.
Results: This review identified various CRS-related signs and symptoms from literature and anonymized safety data from clinical trials. Clinical experts validated the preliminary conceptual model (CM) and identified additional relevant symptoms. Patient interviews revealed further symptoms and impacts, leading to the development of the immuno-oncology (IO)-induced CRS patient diary. This PROM was refined through iterative feedback from clinical experts and patients, ensuring it effectively captures the incidence, severity, and impact of CRS symptoms.
Conclusions: The "IO-induced CRS patient diary" can be considered a content-valid tool for capturing and monitoring the most important patient-reportable symptoms and impacts of CRS in IO clinical trials. This PROM can provide a standardized understanding of IO-induced CRS from the patient perspective, where to date this has been mainly clinically assessed using diverse assessments.
期刊介绍：
Now indexed in PubMed
Aims and Scope
Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology 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, allowing the advancement of clinical therapies.
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, GPP 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
Oncology 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’.
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
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 reviewer recommendations are conflicted, the editorial board 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.
Copyright
Oncology and Therapy''s content is published open access 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
Publication Fees
Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis.
Open Access
All articles published by Oncology and Therapy are published open access
Contact
For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.
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