CRS combined with HIPEC versus palliative chemotherapy in pediatric patients (&lt;18 years) with peritoneal carcinomatosis
Creators: name: Ibargoyen-Roteta, Nora
name: López, Luz Angela Torres
name: Rispau, Ariadna Auladell
name: Reyes, María Ximena Rojas
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: living evidence synthesis
subject: living systematic review
subject: pediatric peritoneal carcinomatosis
subject: porotocol

description: Title: CRS combined with HIPEC versus palliative chemotherapy in pediatric patients (&lt;18 years) with peritoneal carcinomatosis AUTHORS: Nora Ibargoyen-Roteta Affiliation: Osteba, Knowledge Management and Evaluation, Basque Foundation for Health Innovation and Research (BIOEF), Barakaldo, Spain. Josune Domínguez-García Affiliation: Osteba, Knowledge Management and Evaluation, Basque Foundation for Health Innovation and Research (BIOEF), Barakaldo, Spain. Ainhoa Jausoro-Zubiaga Affiliation Osteba, Heath Department, Basque Govnernment, Vitoria-Gasteiz, Spain. Lorea Galnares-Cordero Affiliation: Osteba, Knowledge Management and Evaluation, Basque Foundation for Health Innovation and Research (BIOEF), Barakaldo, Spain. AND The Living Evidence to Inform Health Decision program (LE-IHD) research group* Corresponding author: Nora Ibargoyen Roteta Email address: nibargoyen@bioef.eus Postal address: BEC (Bilbao Exhibition Centre), Ronda de Azkue, 1 48902 Barakaldo, Spain * María Ximena Rojas-Reyes, Luz Angela Torres, Maria Soledad Isern, Ariadna Auladell-Rispau Funding sources/sponsors This evidence synthesis informs a Health Technology Assessment Report on CRS and HIPEC in paediatric patients with peritoneal supported commissioned and funded by the by the Spanish Ministry of Health. Madrid, Spain This work is being developed as part of the project “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” that received funding from the Spanish Government through the “Plan Estatal de Investigación Científica y Técnica y de Innovación-Acción Estratégica en Salud. Co-funded by FONDOS FEDER. Instituto de Salud Carlos III (ISC-III), Madrid, Spain. Grant PI21/01564; 2021 call. The funders and institutions did not take any part in the development of this study. Conflicts of interest: None known ABSTRACT Objective To provide a timely, rigorous, and continuously updated summary of the evidence available on the role of the Cytoreductive surgery and Hyperthermic intraperitoneal chemotherapy in children and adolescents with peritoneal carcinomatosis. Design This is a Living Evidence Synthesis (LES), which will start with a baseline synthesis report. For the baseline report, we will include systematic reviews, randomized and non-randomized studies evaluating the effect of CRS and HIPEC versus palliative chemotherapy in pediatric patients (&lt;18 years) with peritoneal carcinomatosis. Main outcomes defined as critical or important for decision making include: disease-free survival, overall survival, survival rate at 3 years, survival rate at 5 years; quality of life; and adverse effects. Based on its conclusions, we will set up the living evidence approach, and the evidence monitoring will begin. Evidence identification The evidence identification, screening, and selection will be supported by technological enablers developed by the Epistemonikos Foundation and included in its "Living Overview of Evidence (L.OVE) platform. The team maintaining the L·OVE platform will devise the literature search. An automated living search will be performed in relevant databases following high-standard procedures. Its results will be automatically incorporated into the L·OVE platform where two reviewers will then screen the titles and abstracts against selection criteria. We will continuously monitor the evidence by performing daily searches and a monthly screening of the retrieved references. To support the screening and monitoring, we will use an automatic classifier based on artificial intelligence (AI) algorithm and other technologies, that excludes references with a low probability of being relevant when appropriate. Additionally, every three months we will manually search for ongoing studies in the International Clinical Trials Registry Platform and other trial registries. Study selection and data extraction Two reviewers will independently screen each study for eligibility, extract data, and assess its methodological quality using appropriate tools. For the baseline synthesis report, we will include eligible systematic reviews, randomized and non-randomized studies identified up to July 30th 2023. We will perform meta-analyses of the study’s results for each outcome of interest when pertinent. We will assess the certainty of the evidence for each outcome by applying the GRADE approach. These findings will be used to refine the parameters for setting up the living evidence approach. Living evidence approach We will continuously monitor the evidence for 12 months. If a new study is identified as eligible, we will follow the same procedures described above prior to updating the metanalysis of the outcomes reported. We will follow a systematic and reproducible process for taking decisions related to incorporating or postponing the incorporation of new studies, updating of conclusions or recommendations this synthesis informs and for periodically reviewing the question to define its continuation, changes, or withdrawal of the living mode. The question will withdraw according to predefined specific criteria. Results For the baseline synthesis and the subsequent synthesis updates, the estimates for all outcomes evaluated will be presented in the GRADE summary of findings tables. Regular updates will include key messages on changes in the evidence synthesis conclusions. We will resubmit new complete updates every time the conclusions change or whenever there are substantial updates for the main outcomes of interest. Keywords: “Cytoreductive surgery”, “Hyperthermic intraperitoneal chemotherapy (HIPEC)”, “Pediatric surgery”, “Peritoneal surface malignancies”, “Oncological surgery”, “Systematic Review”, “living evidence”