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Project Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="font-size:12pt"><span style="line-height:normal"><span style="color:#252525">Cytomegalovirus&nbsp;(CMV) - one of the diseases found in the herpesvirus family, affects approximately 3–4 in every 1,000 babies born in the UK and is the leading non-genetic cause of hearing loss and neurodevelopmental impairment. Most women with CMV infection remain asymptomatic and despite its significant prevalence, awareness remains insufficient among both healthcare professionals and the public.</span></span></span></span><br>&nbsp;</div><div><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="font-size:12pt"><span style="line-height:normal"><span style="color:#252525">This project aims to retrospectively assess the proportion of pregnant women who received CMV-related information during their pregnancy. This includes analysing CMV screening practices and evaluating associated clinical outcomes in both pregnant women and newborns.</span></span><br><br><span style="line-height:normal"><span style="color:#252525">To aid the NHS England Saving Babies’ Lives Care Bundle, we aim to utilising computational tools to investigate prevalence and provide valuable insights into pathology testing and CMV screening services within the NHS. </span></span></span></span></div></div>

Detailed Project Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif">This Project primarily aims to retrospectively assess the proportion of pregnant women who received cytomegalovirus (CMV) related information during their pregnancy. We also aim to use the notes and reports available in CRS and any adjacent EPR available in the trust (Free text docs) analyse CMV screening practices and clinical outcomes in both pregnant women and newborns.</span></span></div><div>&nbsp;</div><div><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif">By applying large language models, the study will help in the development of CMV screening frameworks. Providing the service improvement of disease incidence reporting and tracking; were publicly available CMV testing data is unavailable.&nbsp;</span></span></div><div>&nbsp;</div><div><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal"><strong>Problem Statement:</strong></span></span></span></div><ul style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">There is a lack of systematic data regarding CMV prevalence, counselling, and screening practices within the East London maternity population.</span></span></span></li>	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Without these insights, it's challenging to evaluate the feasibility and impact of introducing routine CMV screening or improving antenatal education and testing pathways.</span></span></span></li></ul><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal"><strong>Primary Objective:</strong></span></span></span><ul style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">To determine the proportion of pregnant women who received information or counselling regarding CMV risks during their pregnancy.</span></span></span></li></ul><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"> <span style="line-height:normal"><strong>Secondary Objectives:</strong></span></span></span><ol style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">To assess the prevalence of CMV testing among pregnant women and identify the clinical or laboratory indicators that prompted testing.</span></span></span></li>	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">To evaluate the rationale for neonatal CMV screening and analyse clinical and demographic outcomes in CMV-positive infants.</span></span></span></li>	<li style="margin-top:13px; margin-right:11px; margin-left:16px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">To identify gaps in counselling, screening, and follow-up practices for CMV within current maternity care pathways.</span></span></span></li></ol><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"> <span style="line-height:normal"><strong>Methodology:</strong><br><strong>Design:</strong></span></span></span><ul style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:22px; margin-left:24px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Retrospective audit assess&nbsp;the&nbsp;clinical, demographic, and laboratory data from the past 5 years, across maternity services in East London (BARTS Health NHS Trust and affiliated services).</span></span></span></li></ul><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"> <span style="line-height:normal"><strong>Cohort:</strong></span></span></span><ul style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:22px; margin-left:24px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">All pregnant women who received antenatal care during the audit period.</span></span></span></li>	<li style="margin-top:13px; margin-right:22px; margin-left:24px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Subgroups for analysis include:</span></span></span>	<ul style="list-style-type:circle">		<li style="margin-top:13px; margin-right:33px; margin-left:16px; margin-bottom:13px; list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Women who received documented CMV counselling.</span></span></span></li>		<li style="margin-top:13px; margin-right:33px; margin-left:16px; margin-bottom:13px; list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Women who underwent CMV testing.</span></span></span></li>		<li style="margin-top:13px; margin-right:33px; margin-left:16px; margin-bottom:13px; list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Infants for whom CMV testing was requested or performed.</span></span></span></li>	</ul>	</li></ul><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"> <span style="line-height:normal"><strong>Analysis:</strong></span></span></span><ul style="margin-bottom:13px; margin-top:13px">	<li style="margin-top:13px; margin-right:33px; margin-left:32px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Descriptive and inferential statistics to explore prevalence, trends, and associations.</span></span></span></li>	<li style="margin-top:13px; margin-right:33px; margin-left:32px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Thematic categorisation of indications for testing.</span></span></span></li>	<li style="margin-top:13px; margin-right:33px; margin-left:32px; margin-bottom:13px;list-style-position:inside"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:normal">Comparative analysis of outcomes in CMV-positive versus CMV-negative infants.</span></span></span></li></ul></div>

Requested Data Summary

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing:1.5em; --ck-inline-image-style-spacing:calc(var(--ck-image-style-spacing) / 2); font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="line-height:86%">We require all available free text documents containing demographic, pathology and clinical data relevant to Cytomegalovirus testing (CMV).</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="line-height:86%">We request information between December 2019 - December 2024 in CRS; but not within Winpath Enterprise.&nbsp;</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="line-height:86%">Ideally this will contain a threshold of 1000 Documents of viable data for sub analysis - (If not, documents before Dec 2019 can be included)</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">&nbsp;</div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span lang="EN-US"><span style="letter-spacing:-.1pt">Where available – all associated Clinical, demographic and pathology data specified in cCMV_CRF_ datafields_V1 available on CEU Clinical Audit Submission</span></span></span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">&nbsp;</div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="line-height:86%">We want to collect information from:</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="line-height:86%">All Pregnant&nbsp;</span><span lang="EN-US">women, 18 years old and above&nbsp;</span><span lang="EN-US" style="line-height:86%">with CMV test requests;&nbsp; (Positive and Negative results for CMV testing).&nbsp;</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt">&amp;</span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US">All babies&nbsp;+ Infants, 0-28 days </span><span lang="EN-US" style="letter-spacing:-.25pt">old</span><span lang="EN-US"> tested for CMV test requests (Positive and Negative results for CMV </span><span lang="EN-US" style="letter-spacing:-.1pt">testing).</span></span></div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">&nbsp;</div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">&nbsp;</div><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif; font-size:12pt"><span lang="EN-US" style="letter-spacing:-.1pt">Post- DAC:</span><span lang="EN-US"> As Direct care team members who will use the secure data environment (BARTS Health data Platform) for analysis, the need to anonymise the data isn't necessary - considering there are other members of staff that analyse open free text here without need for anonymisation.</span></span></div></div>

Technical Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif">The data analysis methodology will be centred around Large language models (LLM's) of the available documentation on CMV alongside statistical inference models. Using the the BARTS health Data Platform and recruit Tensorflow and&nbsp;R Studio/ R&nbsp;&nbsp;as the cloud based tools on the platform&nbsp; -&nbsp; We aim to use these tools for a r<span style="line-height:normal">etrospective audit on clinical, demographic, and laboratory data from the past 5 years, across maternity services in East London (BARTS Health NHS Trust and affiliated services). Subsequently,&nbsp;</span></span></span><span style="font-size:11pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="line-height:86%"><span lang="EN-US"><span style="line-height:86%">to explore prevalence, trends and <span style="letter-spacing:-.1pt">thematic associations that can help</span> indicate features in <span style="letter-spacing:-.1pt">testing practices.</span></span></span></span><br><span style="line-height:86%"><span lang="EN-US"><span style="line-height:86%">Comparative analysis of outcomes in CMV-positive versus CMV-negative <span style="letter-spacing:-.1pt">infants.</span></span></span></span></span></span></div><div>&nbsp;</div><div><span style="font-size:12pt"><span style="font-family:'Calibri Light','Helvetica Light',sans-serif">Github is also a desired platform to have demonstrated the application of LLM's for our Quality Improvement Project. It would act as a digital portfolio for subsequent Machine Learning Models.</span></span></div><div>&nbsp;</div></div>

Public and Patient Involvement and Engagement Summary

<div data-wrapper="true"><span style="font-family:Calibri Light, Helvetica Light, sans-serif"><span style="font-size:16px">Not undertaking PPIE. It is a short scope project - to be considered after report.</span></span></div>

Reporting

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-family:'Calibri Light','Helvetica Light',sans-serif"><span style="font-size:12pt"><span style="line-height:normal">The findings from the LLM’s analysis will be reported locally to support service improvement efforts and inform decision-making. Additionally, they may be shared more broadly, including at national conferences, to contribute to sector-wide learning and development.</span></span></span></div></div>

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Will you be using the BH SDE

NoYes

Details of the location and IT system (the SDE) where the data extract will be kept and processed.