Project Summary

Project Title

General Project Information

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Project Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><strong>Aim</strong><br>To improve outcomes for surgical patients with a large efficient clinical trial (PROTECT).<br><br><strong>Background</strong><br>Five million NHS patients have surgery each year. One in six patients experience complications like infections, heart-attacks or strokes, which reduce their quality and quantity of life, and limit the benefits of surgery. New treatments to prevent and treat complications must be tested in clinical trials before routine use. Traditional clinical trials are slow and expensive, delaying benefits for patients. Some groups within society are less likely to take part in these trials, for example people from ethnic minorities or with low incomes. It is important to know whether new treatments work for everyone.<br><br>Platform trials are a new approach, used successfully during the pandemic (e.g. RECOVERY trial). Instead of running for a short, defined period to test one treatment, platform trials compare many different treatments at the same time and run for as long as needed. Fewer patients are required overall, and the time and cost of testing each treatment is reduced. They also allow us to include a patient group which better represents all of society.<br><br>I have already started work on a national platform trial called PROTECT. I am developing a database (to collect patient information) and a protocol (procedure document). My next step is to test the platform works properly with two small clinical trials of patients undergoing surgery. Once this work is complete, we will be able to use PROTECT to run all our large national perioperative clinical trials.<br><br><strong>Methods</strong><br>I will undertake three distinct projects:<br>1. Launch a national database of surgical patients, initially in 10 NHS hospitals. This is important underpinning infrastructure for the platform trial.<br><br>2. Describe the diversity of surgical patients (e.g. ethnicity, socio-economic deprivation) to show which NHS hospitals are important to include in the trial, and test whether consent documents in multiple languages can improve patient diversity in surgical research.<br><br>3. Test the platform in two small clinical trials of a drug and a medical device, each in 200 patients. One group will receive a higher level of oxygen after surgery (high flow nasal oxygen) and one group will receive a commonly used painkiller (ibuprofen) after surgery.<br><br><br><strong>Patient, carer and public involvement</strong><br>My programme team includes a diverse advisory group of three patient researchers with lived experience of surgery. If funded, this will be expanded to eight members to further improve diversity and inclusion. The proposal has been reviewed by the RCoA Patient, Carer and Public Involvement &amp; Engagement panel, who agreed this is important research, and provided guidance on study design.<br><br><br><strong>Dissemination</strong><br>The PROTECT platform trial will be a major national resource to improve clinical trials in anaesthesia and surgery. All researchers with a robust trial idea will be able to use the platform. Results will be widely shared with NHS staff and policy-makers via the Centre for Perioperative Care. Advised by our patient group, we will use social and mainstream media to make sure people know about PROTECT and our research findings.</div></div>

Detailed Project Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div>Five million NHS patients have surgery each year. One in six patients experience complications like infections, heart attacks or strokes, which reduce quality and quantity of life. There is an urgent need for new treatments to improve patient outcomes.<br><br><strong>Challenge the project addresses</strong><br>Surgery and anaesthesia follow highly standardised pathways. Small improvements in multiple care processes could have substantial incremental impact on clinical outcomes. However, due to small effect sizes, numerous large clinical trials are needed. Traditional clinical trials require new research infrastructure, including trial databases, protocols and governance frameworks, for each new research question. Research participants often undertake multiple additional hospital visits with data collected by research nurses, in addition to substantial data already collected as part of routine clinical care, but which is held on multiple, siloed, electronic health record systems and difficult to access for multi-centre clinical trials. These processes are time-consuming and expensive, and impair the ability of some groups within society to take part. For example, people from ethnic minorities or with low incomes, who have worse health outcomes report that multiple visits and lengthy follow-up are barriers to inclusivity. Surgical trials are particularly vulnerable because of historically poor reporting of diversity data. A research data platform supporting multiple clinical trials, will make surgical research much quicker and cheaper, while making it easier for patients to participate, improving research diversity and inclusivity.<br><br><strong>Aim</strong><br>To improve outcomes for surgical patients, and diversity of surgical research, with a national perioperative data platform for clinical trials.<br><br><br><strong>Objectives</strong><br>1. To make perioperative clinical trials better, cheaper and faster to deliver, we will establish a research data platform to support a national perioperative platform trial using a trial within a cohort (TWIC) design. Patient-level data will be linked to national health systems data (e.g. HES/ONS) and electronic patient questionnaires within a single research database. This will change the current reliance on research nurses to collect and input data. We will pilot this platform using two small clinical trials: a drug trial of postoperative ibuprofen to reduce pain after abdominal surgery and a device trial of high flow oxygen therapy to reduce breathing complications after abdominal surgery. This will start in 10 NHS hospitals in England and expand to 50 hospitals in England, Scotland and Wales by the end of the funded period. The research costs, excluding the data platform, are already funded through two competitive funding awards.<br><br>2. To make perioperative research more inclusive and diverse, we will create a database including all ~5 million patients undergoing surgery in England, Scotland and Wales each year, using linked national health systems data (e.g. HES/ONS). We will use this cohort to map diversity characteristics (sex, age, ethnicity, socioeconomic deprivation, disability etc) and areas of health need for surgical patients. It will provide a unique resource to inform the ideal design and delivery of trials testing new research questions.<br><br>3. To directly address the current challenges of accessing electronic health record data collected as part of routine clinical care, and often held in siloed databases, for use in clinical trials, we will develop a prototype digital research database integrating electronic patient record (EPR) data from secondary care and primary care, linked with national health systems data (e.g. HES/ONS). The database will use infrastructure developed through the Barts Life Science Precision Medicine Platform and include inpatient data from five secondary care hospitals at Barts Health NHS Trust, GP records from the East London primary care record and national Hospital Episode statistics for a population of 2.5m people in East London.<br><br><br><strong>Potential applications and benefits</strong><br>We are designing a routine NHS data platform to support a UK-wide perioperative platform trial (the PROTECT programme). Platform clinical trials, advocated by NIHR, are much more efficient, providing opportunities to improve participant inclusion. Instead of examining one treatment at a time and running for a short, defined period, platform trials compare many different treatments and run for as long as needed. Fewer patients are required overall and the time and cost of testing each treatment is reduced. The programme will be regulated as a clinical trial, which will facilitate the testing of new treatments within a single data/governance infrastructure. This will make research easier for patients and involve a wider selection of society, making the results relevant to a larger number of surgical patients.</div></div>

Requested Data Summary

As part of project 3, we plan to pilot a protype electronic-health-record-based database to support clinical trials. We will need access to Barts Health EPR data including demographic data, comorbidities, hospital procedures, laboratory results, outpatient/ED attendances and vital status.

Technical Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-size:9pt"><span ccindex="0" class="BCX9 ContentControlBoundarySink SCXW233394479" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-text-stroke-width:0px; -webkit-user-drag:none; background-color:#e6e6e6; color:#2b579a; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:400; letter-spacing:normal; line-height:20.7px; margin:0px; orphans:2; padding:0px; text-align:left; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; user-select:text; white-space:pre-wrap; widows:2; word-spacing:0px" xml:lang="EN-GB"></span><span aria-label="Rich text content control" ccappearance="boundingbox" cceid="{24773d7e-0242-415a-af74-0d4395bfd9a0}{10}" cclevel="1" class="BCX9 ContentControl SCXW233394479" role="group" style="-webkit-tap-highlight-color:transparent; -webkit-text-stroke-width:0px; -webkit-user-drag:none; background-color:#ffffff; color:#000000; font-family:&quot;Segoe UI&quot;,&quot;Segoe UI Web&quot;,Arial,Verdana,sans-serif; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:400; letter-spacing:normal; margin:0px; orphans:2; padding:0px; text-align:left; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; user-select:text; white-space:pre-wrap; widows:2; word-spacing:0px"><span ccindex="1" class="BCX9 ContentControlBoundarySink SCXW233394479" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; background-color:#e6e6e6; color:#2b579a; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; line-height:20.7px; margin:0px; padding:0px; user-select:text" xml:lang="EN-GB"></span><span class="BCX9 SCXW233394479 TextRun" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; color:#000000; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; font-variant-ligatures:none !important; line-height:20.7px; margin:0px; padding:0px; user-select:text" xml:lang="EN-GB"><span class="BCX9 NormalTextRun SCXW233394479" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text">The database will be hosted by the SAIL databank at the University of Swansea. Data linkage to NHS Hospital Episode data will be carried out and anonymised data will be held within the Secure Anonymised Information Linkage (SAIL) databank, where it will be analysed </span><span class="BCX9 NormalTextRun SCXW233394479" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text">in accordance with</span><span class="BCX9 NormalTextRun SCXW233394479" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text"> SAIL standard operating procedures.</span></span><span ccindex="1" class="BCX9 ContentControlBoundarySink SCXW233394479" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; background-color:#e6e6e6; color:#2b579a; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; line-height:20.7px; margin:0px; padding:0px; user-select:text" xml:lang="EN-GB"></span></span><span class="BCX9 EOP SCXW233394479" data-ccp-props="{}" style="-webkit-tap-highlight-color:transparent; -webkit-text-stroke-width:0px; -webkit-user-drag:none; background-color:#ffffff; color:#000000; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:400; letter-spacing:normal; line-height:20.7px; margin:0px; orphans:2; padding:0px; text-align:left; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; user-select:text; white-space:pre-wrap; widows:2; word-spacing:0px">&nbsp;</span></span></div></div>

Public and Patient Involvement and Engagement Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div>Patient, public and carer involvement and engagement activities to date<br><br>Selection of research topics<br>Patients, carers and the public have been fully involved in selecting and prioritising research topics in perioperative medicine. This proposal addresses several 'Top 10' subjects identified by the James Lind Alliance priority setting partnership for Perioperative Care:</div><ul>	<li style="list-style-position: inside;">What long-term harm may result from anaesthesia?</li>	<li style="list-style-position: inside;">What outcomes should we use to measure the success of anaesthesia and perioperative care?</li>	<li style="list-style-position: inside;">How can we improve recovery from surgery for elderly patients?</li></ul><div><br><em>Leadership of patient-public involvement</em><br>Jenny Dorey, Yvette Hendricks and David Hepworth are experienced patient representatives providing PPI leadership for this project. Mr Hepworth and Ms Dorey, have previously participated in the Patient Carer and Public Involvement and Engagement group at the Royal College of Anaesthetists. Ms Hendricks is a NHS volunteer research champion, Ms Dorey provides valuable lived experience as a research participant and I have worked with Mr Hepworth on previous projects as a steering committee member. This experienced team have provided valuable feedback on this proposal, particularly with reference to acceptability of the interventions to patients, and they have voiced strong support of our efforts to improve participant diversity in surgical research.<br><br><em>Study design input from inception</em><br>I presented this proposal to the Patient, Carer and Public Involvement and Engagement (PCPIE) in research group at the Royal College of Anaesthetists, who agreed that a perioperative platform trial is important for improving outcomes for NHS surgical patients and that improving inclusivity in clinical trials was vital. As part of the preliminary work we are co-designing the master protocol with the patient representatives, who have provided valuable constructive feedback on the platform trial design. For example, the timing of approaching patients for inclusion. They have also given feedback on this application and co-written the lay abstract.<br><br><em>Improving diversity and inclusivity</em><br>Evidence suggests that consent materials only in English could be a barrier to research participation for patients where English is not their first language. To develop a solution to this problem I have discussed this with our patient advisory group who were very supportive of routine electronic and multi-lingual consent materials. Our patient representatives welcomed the use of routinely-collected NHS data and patient questionnaires administered via text message or email to collect follow-up data and reduce the burden of patient visits for clinical trials.<br><br><strong>Planned patient, public and carer involvement and engagement if successfully funded:</strong><br><br><em>Platform steering committee.</em><br><span style="font-size:9pt"><span aria-label="Rich text content control paragraph" ccappearance="boundingbox" cceid="{24773d7e-0242-415a-af74-0d4395bfd9a0}{44}" cclevel="1" class="BCX9 ContentControl SCXW178467235" role="group" style="-webkit-tap-highlight-color:transparent; -webkit-text-stroke-width:0px; -webkit-user-drag:none; background-color:#ffffff; color:#000000; font-family:&quot;Segoe UI&quot;,&quot;Segoe UI Web&quot;,Arial,Verdana,sans-serif; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:400; letter-spacing:normal; margin:0px; orphans:2; padding:0px; text-align:justify; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; user-select:text; white-space:pre-wrap; widows:2; word-spacing:0px"><span ccindex="1" class="BCX9 ContentControlBoundarySink SCXW178467235" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; color:#000000; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; line-height:20.7px; margin:0px; padding:0px; user-select:text" xml:lang="EN-GB"></span><span class="BCX9 SCXW178467235 TextRun" data-contrast="none" lang="EN-GB" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; color:#000000; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; font-variant-ligatures:none !important; line-height:20.7px; margin:0px; padding:0px; user-select:text" xml:lang="EN-GB"><span class="BCX9 NormalTextRun SCXW178467235" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text">Two patient representatives will sit on the platform steering committee, bringing perspectives to ensure that research </span><span class="BCX9 NormalTextRun SCXW178467235" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text">remains</span><span class="BCX9 NormalTextRun SCXW178467235" style="-webkit-tap-highlight-color:transparent; -webkit-user-drag:none; margin:0px; padding:0px; user-select:text"> relevant to patients.</span></span></span><span class="BCX9 EOP SCXW178467235" data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}" style="-webkit-tap-highlight-color:transparent; -webkit-text-stroke-width:0px; -webkit-user-drag:none; background-color:#ffffff; color:#000000; font-family:Calibri,Calibri_EmbeddedFont,Calibri_MSFontService,sans-serif; font-style:normal; font-variant-caps:normal; font-variant-ligatures:normal; font-weight:400; letter-spacing:normal; line-height:20.7px; margin:0px; orphans:2; padding:0px; text-align:justify; text-decoration-color:initial; text-decoration-style:initial; text-decoration-thickness:initial; text-indent:0px; text-transform:none; user-select:text; white-space:pre-wrap; widows:2; word-spacing:0px">&nbsp;</span></span><br>Two patient representatives will sit on the platform steering committee, bringing perspectives to ensure that research remains relevant to patients.<br><br><em>Patient advisory group</em><br>I will expand my preliminary patient advisory group from three to eight patients, to increase diversity (age, sex, ethnicity, socioeconomic status, geography) and represent a wider scope of lived experience. This group will meet twice per year and support the development and delivery of each project. For example, contributing to: protocol design, data applications, ethics committee submissions, patient facing documents, electronic consent materials and lay summaries.<br><br><em>Research champions</em><br>QMUL/Barts Health Research Champions and volunteers will support a range of PPI-led initiatives, including promoting research in QMUL/Barts Health, supporting patient follow-up and participating in stakeholder groups. The Patient, Carer and Public Involvement and Engagement (PCPIE) Working Group (Royal College of Anaesthetists), comprising lay representatives and patients with direct experience of surgery, will provide high-quality objective lay guidance on study design.<br><br><em>Training for patient representatives</em><br>PPI representatives will be invited to attend a research methods course at QMUL which provides an introduction to research design. We will provide induction to research leadership and management, and training sessions to ensure patient representatives are prepared for their role and can contribute fully. This will run over two half-day sessions. Our research group has previous experience of establishing a PPI group and delivering such training.<br><br><em>Dissemination and communication</em><br>I will work with the patient advisory group to co-produce lay summaries of our study documents and research outputs, which will be published on our website and social media. We will hold patient communication events at participating hospitals and a community event at the Centre of the Cell community science space at Barts Health. All publications linked to this project will include PPI representatives as authors.<br><br><em>Development of protocols for definitive trials</em><br>I will consult the patient advisory group on full trial proposals and future plans for comparisons of interventions proposed by colleagues and collaborators.</div></div>

Reporting

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><strong>Dissemination</strong><br>The findings from each work package will be disseminated as open access publications with plain English summaries, co-written with patient researchers. I will use social media for rapid distribution of key messages; press releases for traditional media; circulation to professionals via the Centre for Perioperative Care; direct communication with patients via a series of meetings at participating hospitals; and dissemination via our website (www.qmul.ac.uk/ccpmg).<br><br><strong>Impact</strong><br>The impact of this programme on the healthcare of patients, carers and the public will be substantial because it develops significant national digital research infrastructure. This novel national data platform will fundamentally transform the development of new treatments, the delivery of clinical trials and post-market surveillance for surgical patients, generating international impact for several generations. The development of this data efficient infrastructure, which will substantially reduce the cost of clinical trials and increase NHS research capacity. This directly benefits patients by making new treatments available more quickly and cheaply, through national collaborations, including development of public-industry partnerships.</div></div>

Contact Points

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Mile End Road, London, UK

Secure Data Environment (SDE)

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.