A National Prospective Service Evaluation of severe GI Bleeding Requiring Upper GI Endoscopy plus Emergency Endoscopy in under 16s On behalf of the British Association of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) and British Association of Paediatric Surgeons (BAPS) and JAG Investigators: Lead applicant names Role Organisation Prof Nick Croft PI QMUL & Barts Health NHS Trust QMUL, BSPGHAN Council Barts Health NHS trust Dr Ramiya Kirupananthan Clinical Fellow Barts Health NHS Trust Barts Health NHS trust Mr Chronis Kemos Investigator - Data manager and statistician QMUL Prof Mike Thomson Co-Investigator EWG, BSPGHAN Sheffield Dr David Devadason Co-investigator EWG, BSPGHAN EWG, BSPGHAN Nottingham Dr Priya Narula Co-Investigator Chair BSPGHAN EWG, Paed member on JAG Sheffield Mr Mike Stanton Co-Investigator British Association Paediatric Surgeons Southampton NHS Trust Dr Alastair Baker Co-I Paed-Hepatology representative BSPGHAN (Hepatology) Kings College Hospital Prof Siwan Gibson-Thomas Co-I JAG/BSG Northwick Park 1
1) Background BSPGHAN/RCPCH Standards 2017 have highlighted the need for appropriate availability of emergency upper GI endoscopy for children. Standard 4: Paediatric endoscopies must be undertaken in a child-friendly environment with appropriate facilities. In an emergency, timely access to an endoscopy must be available through clear and agreed pathways within the network. In an emergency, timely access to an endoscopy must be available through clear and agreed pathways within the network. However the provision of this service is patchy around the UK, in previous BSPGHAN audits in 2014/2015 of 200 trusts, there were about 25 paed gastro units plus 3 paed liver units of which only 33% had 24 hours rotas for on call. Of these 80% undertake <7 interventions per year for GI bleeds and 60% less than 3. So as well as having only very limited availability of on call rotas the level of exposure to and therefore expertise for managing severe GI bleeding by paediatric endoscopists is felt to be low. These are similar data to that reported in 2012 by the Toronto sick children s one of the largest Children s Hospitals in the world who over 7 years had 617 children present with GI bleeds, 20% of whom were admitted but there were only 4 interventions per year for GI bleeds. One of the key issues is that a severe bleed may present to any A&E with or without paed gastro services or adult bleeding rotas. In recent years there has been a major focus on adult emergency endoscopy rotas via JAG and the BSG but thus far the needs of under 16s have been excluded from this planning. The National Institute of Clinical Effectiveness (NICE) have published treatment guidelines for those above 16 years of age in this area and the guidance indicates intervention within 4 hours of the presentation of an adult with an upper GI bleed as the ideal. The absolute lack of data on the incidence of the problem in children is significant and extrapolation of practice in adults is unhelpful. In order to sensibly plan for services we need some reliable data about incidence of these most severe bleeds but also the needs for emergency endoscopy for other indications. To do this requires a collaborative study include paed surgeons, paed gastro, paed gastro SPIN and adult gastro. This will also be unique and important data in literature and worthy of publication in its own right. 2) Aims and Objectives Identify the services available for emergency endoscopy in under 16s across the UK, include expertise and training of individuals in the unit. Prospectively estimate the incidence of severe GI bleeds in under 16s requiring endoscopy Estimate the incidence (and indications for) other emergency upper GI endoscopy in under 16s. Examine the 1 month outcomes of these patients Examine variation in indications for emergency endoscopy across the UK 2
Establish a network for system for future online studies for paediatric endoscopy in the UK. 3) Methods Summary: Using openly available software Redcap we will design and undertake a prospective 6 month survey across the UK. At the outset a short survey will collect data on the availability and provision of services with reference to the BSPGHAN RCPCH standards. This will include collecting denominator data for each centre to allow estimates of incidence. This methodology is already being used at QMUL for a pan- European safety survey in paediatric IBD and so is easily translated to this project. CRFs for the cases will be designed and set up in Redcap. No patient identifiable information will be collected. 1. Case definitions: a. Inclusion criteria i. <16 years of age at the time of the endoscopy AND either b. Exclusion criteria 2. Collaborators 1. Upper GI bleed requiring endoscopy (ie with signficant haematemesis/melaena/other suspicion of upper GI bleed) OR 2. Urgent upper GI endoscopy performed for other reasons (eg foreign body) (defined as performed within 24 hours of the event leading to the procedure) i. Routine or semi elective endoscopy delayed but done for convenience on ii. out of hours (eg waiting list initiatives) While we aim to include all the paed gastro & hepatology units (20-25) plus most of the paed surgical units we would not expect to cover 100% of the UK. Quality and reliability of data from each centre is more important than universal coverage. We will gather a range of large tertiary units, stand-alone children s or within the adult hospitals, plus DGHs. In order to gather data on emergency endoscopies in under 16s we propose to include adult GI lead in collaboration with JAG. The following leads will be identified but may delegate to a specified person (eg trainee) in each unit. This will depend on the local arrangements and be agreed before data is collected. 1. A lead for each paed gastro/liver centre performing endoscopy will be identified and will take responsibility for ensuring all cases are reported in their centre. 3
2. A Paed Surgical lead will be identified for each paed surgical centre 3. Adult endoscopy leads for adult GI unit (identified via JAG) will be asked to report any emergency endoscopies performed in under 16 year olds in their units during this period. It is expected that these numbers will be very small and should be easy for endoscopy leads to be aware of. 3. Ethics a. This will be a service evaluation as defined by NRES and no patient identifiable information will be collected so it is expected ethical approval is not required, this will be clarified before the start of the project. 4. Data Online forms will be developed using REDCap hosted at QMUL. a. Initial online survey (takes about 15 minutes to complete) will be performed to get basic data on the centre, networking arrangements and facilities (facilities, staffing, rota s). This will be designed to examine the relevant BSPGHAN and JAG/GRS standards. This will include denominator (referral population of the unit) data using a web based system already set up in Queen Mary, University of London. i. The denominator data will collect details of the population that the endoscopy unit covers, The forms will be designed in accordance to the denominator forms used already in another project *. This system has been used successfully already, several responders are likely expected to be familiar with it. In addition, this approach will allow direct comparisons (and/or combinations of) data between the different areas and the Eurostat datasets. b. Once the collaborators have been identified and confirmed they are willing to participate a fortnightly email will be sent asking if there have been any endoscopies fitting the defined criteria, initially all that is required is a yes/no answer. If they answer is yes then they will be asked to complete a short on line CRF for each patient. If no no other response action is required but the negative response is important. For the adult units it is expected no will be the vast majority. This is the system used by the BPSU across all paediatricians which gets a roughly 90% response rate to the emails. c. The electronic case record form will be finalised over the first 2 months of the project if the recipient of the email reports yes then this will be completed To include a. Venue of the initial bleed and where first seen by medic b. Initial Clinical Data and management including o age, sex, medication 4
o Presenting symptoms o Sheffield score o HR/BP o Need for boluses / transfusion (Y/N then ml/kg); o Presenting and follow up Hb levels; clotting screens if done, platelets o Need for other medications to combat blood loss before endoscopy (Y/N and details of meds); o Previous personal history of liver disease or GI bleeding. o Family history of GI bleeding diseases or coagulation problems; c. Details of any transfers (including timing of initial communications and transfers) d. Details of the endoscopy o Timing o source of referral o Location o Macroscopic findings o Endoscopic intervention where this was required. o Grade/ background of endoscopist(s) involved i. Case outcome at 28 days will be recorded. Including any consequent morbidity or mortality, and any need for repeat endoscopy or surgical intervention. 4) Plan of project Before starting confirm via NRES / Trust Audit office this is a Service Evaluation, if IRAS application required will add at least 4 months to the study a. Months 1-3 b. Months 3-10 c. Months 9-12 ii. Design initial survey form (against BSPGHAN/JAG standards) for current facilities and denominator data iii. Identify all collaborators, gain their agreement to participate iv. Design CRF for data collection v. Test sending fortnightly email vi. Send fortnightly email to all investigators over a 7 month period, if endoscopy reported then connect the collaborators to the e-crf for completion. Reminders if no response will be automatically sent out vii. Data cleansing throughout viii. Data cleansing and lock down 5
ix. Statistical analysis and estimations of incidence and prevalence The incidence will be calculated and analysed using the Poisson distribution. The collected data will meet the Poisson postulates ** and therefore justify formal application of the Poisson distribution. The Poisson parameter will be calculated and subsequently interpreted as the incidence rate multiplied by the person-time. Depending on the sample size, we will also calculate, 'exact' confidence limits, and where the size of the cohort allows it, approximate confidence limits based on the Gaussian approximation to the Poisson distribution. x. Drafting of abstracts and papers * Classification of Territorial Units for Statistics established by Eurostat **Since we can assume that the severe GI bleeding occurs independently in different patients and in the same patient at different time points as well as that the likelihood that a new case will occur in a short period is proportional to the number of people, and that disease risks are homogeneous across people and time for patient with similar characteristics. 5) Finances required and roles 12,000 (6000 BSPGHAN and 6000 BAPS) This pays for one day a week of data manager and statistical support for one year who will: Support the overall project, assist with any ethics/other approvals Assist in the development design of the Web based case report form (within Redcap), Set up Redcap (based in QMUL), test and ensure data entry is reliable Set up sites (individuals) to access the web entry site and trouble shoot if problems Develop some simple training materials Set up and run the survey with reminders to ensure completion of data Cleanse and finalise data throughout (with queries etc) Report on the data quality and completeness monthly to feed back to each site With Dr Croft statistical analysis of the data once cleansed Unfunded time at Barts/QMUL/collaborating sites Clinical fellow With Prof Croft and the collaborators the clinical fellow will help coordinate and identify the centres and the leads in each centre Ensure approvals as required in place Support the design of the CRF in collaboration with the database manager and the above collaborators 6
Data entry at Barts Health With database manger design the Help draft abstracts/papers 6) Final Comments This proposal has been extensively reviewed and has provisional support from many people and will generate new prospective data of a kind not published before but of great importance in planning our endoscopy services for the future. This project will not be eligible for the NIHR portfolio (and therefore support from the CRN), so each site/collaborator will have to commit to ensuring completeness of data from their unit, how they do this will be up to them, we envisage most sites would have 2 people leading but larger ones may have more. For this reason the study has been made only over 6 months as we hope the amount of patients will not be unmanageable and we will ensure in the design the data collection is as quick and easy as is possible. This will also set a template with the potential for taking other similar projects nationally as once the systems and contacts are set up then it would seem advisable to use them for other studies of importance 7