低收入和中等收入国家5个月至<15岁儿童血小板减少症背景率估计方案

Protocol on estimationof thrombocytopeniabackground rates in childrenaged 5months to <15yearsin low- and middle-income countries Protocol on estimation of thrombocytopenia background rates in children aged 5 months to <15 years in low- and middle-income countriesISBN 978-92-4-011188-2 (electronic version)ISBN 978-92-4-011189-9 (print version)© World Health Organization 2025Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence(CCBY-NC-SA3.0IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the workis appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specificorganization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license yourwork under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the followingdisclaimer along with the suggested citation:“This translation was not created by the World Health Organization (WHO). WHO isnot responsible for the content or accuracy of this translation. The original English edition shall be the binding and authenticedition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of theWorld Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/).Suggested citation. Protocol on estimation of thrombocytopenia background rates in children aged 5 months to <15 years in low-and middle-income countries. Geneva: World Health Organization; 2025. Licence: CCBY-NC-SA3.0IGO.Cataloguing-in-Publication (CIP) data.CIP data are available at https://iris.who.int/.Sales, rights and licensing.To purchase WHO publications, see https://www.who.int/publications/book-orders. To submitrequests for commercial use and queries on rights and licensing, see https://www.who.int/copyright.Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such as tables, figures orimages, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from thecopyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely withthe user.General disclaimers.The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of itsauthorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximateborder lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommendedby WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietaryproducts are distinguished by initial capital letters.All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the publishedmaterial is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretationand use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. ContentsAcknowledgementsAbbreviations1.Synopsis2.Use of this protocol3.Background and rationale4.Objectives5.Methodology5.1Study setting5.2Study design5.3Study population5.3.1Source population5.3.2Inclusion criteria5.3.3Exclusion criteria5.3.4Study sites5.3.5Country and site selection criteria5.4Study period5.5Catchment area and population size5.6Study outcomes5.6.1Thrombocytopenia5.6.2Classification of thrombocytopenia5.7Study flow: case identification and data collection5.7.1Recruitment5.7.2Study enrolment and withdrawal5.7.3Screening for suspected cases of AESI5.7.4Thrombocytopenia case identification5.7.5Data sources5.7.6Data collection and generation5.7.7Case report form completion5.8Statistical methods5.8.1Sample size calculation5.8.2Statistical analyses5.9Data management5.9.1Electronic data capture system5.9.2Data quality5.9.3Data security5.10Monitoring and quality assurance 5. Methodology1579111111111111111212121213131314141415161717171818181919191920 6.Study management216.1Study implementation structure216.1.1Scientific advisory committee216.1.2WHO Pharmacovigilance team216.1.3National focal points216.1.4Site team216.1.5Changes to the protocol216.2Guiding principles216.3Respecting participant autonomy216.4Maintaining participant confidentiality226.5Data sharing226.6Independent ethics committee or institutional review board227.Dissemination of study results237.1Study repor