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<p class="paragraph">ISARIC has partnered with global experts to adapt its clinical epidemiology expertise to guide clinical care and health policy for mpox. Dedicated to enhancing evidence generation, ISARIC provides all the necessary tools for research teams to quickly set up studies that can characterise mpox across different clades, countries, and over time and to inform clinical trial design.</p> | ||
<p class="paragraph">The ISARIC-WHO Clinical Characterisation Protocoland the ISARIC Clinical Epidemiology Platform is a suite of openly-available, standardised tools to support your research and facilitate global collaboration. Tools within this platform will help you to set up a Case Report Form (CRF), launch a database, and perform statistical analysis once you have collected data.</p> | ||
<p class="paragraph">Here are the steps to set up your mpox study:</p> | ||
<p class="paragraph">The ISARIC Mpox Response Guidance webpage is now located at <a href="https://isaricresearch.github.io/Responses/Mpox" target="_blank">https://isaricresearch.github.io/Responses/Mpox</a>. Apologies for the inconvenience!</p> | ||
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<div class="et_pb_module et_pb_toggle et_pb_toggle_0 et_pb_toggle_item et_pb_toggle_close" id="framing-your-research"> | ||
<h4 class="et_pb_toggle_title">STEP 1: Framing your research </h4> | ||
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<p class="paragraph">The ISARIC-WHO Clinical Characterisation Protocol provides a standardised approach to the rapid, coordinated clinical investigation of acute infections of public health interest. This protocol can be adapted to specific disease outbreaks, to enable research teams to add additional research questions, and customised to sites to select relevant research questions and investigations according to their priorities and available resources. An example of how the protocol can be adapted is the CCP for Dengue, developed by ISARIC's partners in Brazil and South Asia.</p> | ||
<p class="paragraph">An Mpox Template Protocol will soon be available for sites as part of Mpox Clinical Epidemiology study, currently in development. We will provide more information about this soon!</p> | ||
<p class="paragraph"><strong>Links:</strong><ul> | ||
<li><a href="https://github.com/isaric-ccp/ccp/raw/main/protocol/ISARIC_CCP_v3.3.docx" target="_blank">ISARIC-WHO Clinical Characterisation Protocol version 3.3 (draft)</a></li> | ||
<li><a href="https://isaric.org/research/dengue/dengue-clinical-characterisation-protocol/" target="_blank">Dengue CCP (an example of adapting the CCP)</a></li> | ||
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<h4 class="et_pb_toggle_title">STEP 2: Obtaining Ethics Approval </h4> | ||
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<p class="paragraph">Before implementing the study, necessary approvals should be obtained according to local legislation.</p> | ||
<p class="paragraph"><strong>Links:</strong><ul> | ||
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<div class="et_pb_module et_pb_toggle et_pb_toggle_0 et_pb_toggle_item et_pb_toggle_close" id="organising-data-collection"> | ||
<h4 class="et_pb_toggle_title">STEP 3: Organising data collection </h4> | ||
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<p class="paragraph">The Mpox Template CRF is a standardised data collection form designed to efficiently characterise the natural history of mpox, identify risk factors for severe outcomes, and inform clinical trial design. Developed from ISARIC's previous experiences and following the ISARIC CRF Creation Process, this CRF has previously been implemented in the UK in 2022, Nigeria in 2023 and Rwanda in 2024. </p> | ||
<p class="paragraph">The CRF is hosted in BRIDGE, a web-based tool that enables users to use the Mpox Template CRF without any user modifications or to customise it to meet specific research objectives, by adding or removing variables to tailor the CRF to the site's needs and context. BRIDGE generates an XML file to set up a database for the CRF in REDCap, a data dictionary for REDCap, a paper CRF, and a completion guide to ensure data quality. </p> | ||
<p class="paragraph">The XML file and data dictionary from BRIDGE are designed to set up a REDCap database. If a site doesn’t have REDCap software, please find installation and technical requirements on the Project REDCap website (link below). For sites unable to host their own REDCap database, ISARIC can offer data hosting support. Alternatively, we welcome collaboration with researchers who use any type of data system. If you would like assistance with setting up your own system, contact us at <a href= "mailto: [email protected]">[email protected]</a> for advice or support to align data variables, map your data to the ISARIC data model, or access standardised tools to support your data management.</p> | ||
<p class="paragraph"><strong>Links:</strong><ul> | ||
<li><a href="https://isaric-bridge.replit.app/main/?param=Disease_Mpox" target="_blank">Mpox Template CRF in BRIDGE</a></li> | ||
<li><a href="https://isaricresearch.github.io/Training/bridge_template_link.html" target="_blank">Quick-start guide: how to download a template CRF from BRIDGE and how to set up a REDCap project using this CRF</a></li> | ||
<li><a href="https://isaricresearch.github.io/Training/bridge_starting.html" target="_blank">Introduction guide: how to adapt the CRF in BRIDGE</a></li> | ||
<li><a href="https://projectredcap.org/software/requirements/" target="_blank">Project REDCap (external)</a></li> | ||
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<h4 class="et_pb_toggle_title">STEP 4: Analysing data </h4> | ||
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<p class="paragraph">An Mpox Template Statistical Analysis Plan (SAP) has been developed to align with the ISARIC Mpox Template Protocol and CRF. It can be tailored and used for data analysis.</p> | ||
<p class="paragraph">ISARIC also provides a set of analytic tools called VERTEX, designed to perform the analyses outlined in the SAP using ISARIC's data structures. VERTEX generates tables, visualisations, and results using Python code, and displays this information in insight panels, for each relevant research question or study endpoint.</p> | ||
<p class="paragraph">The VERTEX insight panels are built using reproducible analytical pipelines. VERTEX is designed to allow ISARIC members and the broader scientific community to develop, contribute to and share new reproducible analytical pipelines. This will help to broaden the scope of the data analysis tools.</p> | ||
<p class="paragraph"><strong>Links:</strong><ul> | ||
<li><a href="https://docs.google.com/document/d/1vgd3bfMT1eQd_ZK9qIrgtkMBRuPc5RBMwhFXdiB8qpY/edit?usp=sharing" target="_blank">ISARIC Mpox Statistical Analysis Plan (SAP) (draft)</a></li> | ||
<li><a href="https://isaricresearch.github.io/Training/vertex_starting.html" target="_blank">Quick-start guide: how to get started with VERTEX</a></li> | ||
<li><a href="https://isaricresearch.github.io/Training/insight_panel.html" target="_blank">Introduction guide: how to create a VERTEX insight panel</a></li> | ||
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<p><span class="normaltextrun">For more information or support, contact ISARIC's Global Support Centre at the Pandemic Sciences Institute, University of Oxford: <a href= "mailto: [email protected]">[email protected]</a>.</span></p> | ||
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