docINBANK: a national musculoskeletal information platform
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INBANK: a national musculoskeletal information platform
INBANK Alan Silman Medical Director, Arthritis Research UK Will Dixon Scientific Lead for INBANK, The University of Manchester 18 May 2012 Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Why INBANK What is INBANK? A national research infrastructure to facilitate coordinated musculoskeletal research, including i) a searchable catalogue of extant studies and ii) a prospective research database recruitment to bespoke studies clinician- and patient-reported outcomes biological samples linkage to national datasets - Policy makers/ Regulators Pharma Patients INBANK Funders Researchers Clinicians/ Specialist nurses • Lorem ipsum dolor sic - Ut velunt sed diam in molestas Lorem ipsum dolor sic Ut velunt sed diam in molestas Lorem ipsum dolor sic Ut velunt sed diam in molestas Lorem ipsum dolor sic Ut velunt sed diam in molestas Capturing Clinical Experience • Specific patient groups for recruitment • Outcome (‘natural history’) • Response to therapy - Overall - Predictors • Co-morbidity - Disease related - Treatment related Current problems & barriers Researcher/Funder • Maximal use of existing resources • Access to number of patients • Approvals processes time-consuming • Establishing infrastructure for multi-centre studies daunting • Standardisation/quality - Clinical data - Biological samples Current problems & barriers Clinician • Bureaucracy • Patient inclusion criteria • Data capture in routine care • ‘What’s in it for me/my Trust?’ Current problems & barriers Specialist Nurses • Data entry duplication - Clinical care - Audit - Research • Research data not available for clinical care • Many different systems for different studies - Electronic - Paper-based Current problems & barriers Patients • Desire to contribute to knowledge • Unaware of their eligibility for existing studies • Feedback from real time research not available Options • Do nothing • Develop infrastructure that meets these challenges INBANK into practice Aims 1. Reducing barriers to research to increase numbers of consented patients 2. Higher quality and breadth of coordinated data 3. Platform to translate results in clinical practice Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement INBANK infrastructure Informatics platform Disease hubs Central biobanking Progress Last 12 months • Scoping work by - Informatics platform (NorthWest eHealth) - Biobanking platform (UK Biocentre) • Development of organisational structure - Project team - Project Steering Group - Oversight and Governance Committee Progress March 2012 • Funding approval for first three years Spring/ Summer 2012 • External commissioning of providers • Development of disease hubs Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Aims 1. Reducing barriers to research - Enabling increased participation - Widened access to shared resource 2. Higher quality and breadth of coordinated data 3. Platform to translate results in clinical practice Enabling increased participation Existing studies • Signposting researchers to existing studies Enabling increased participation Existing studies • Signposting researchers to existing studies Removing barriers for participation • INBANK ethics & CLRN approvals • Single R&D approval per site • Reducing burden of data entry - Re-using data for multiple purposes and across studies - Collecting electronic patient-reported outcomes Widened access to shared resource Clinical data • Summary data available for clinicians - Patient-level - Across all clinicians’ patients Anonymised datasets • Access policy that promotes optimal widespread use of pseudonymised data • Ensuring optimal use and re-use of finite biological samples Aims 1. Reducing barriers to research 2. Higher quality and breadth of coordinated data - Disease-specific information from • Clinicians • Patients - Linkage to national datasets 3. Platform to translate results in clinical practice Coordinated data collection Minimum Core Dataset +/- sample Predictors of treatment response in RA 20--Epigenetic predictors of disease severity Minimum Core Dataset Add-on study Epigenetics 15--- Bolt-on dataset 10--- Recruitment Progression of RA-ILD Minimum Core Dataset Add-on study PFTs Bolt-on dataset 5--Predictors of treatment response in RA Minimum Core Dataset CV risk factors Imaging Adverse events Lifestyle factors Food diaries Minimum Core Dataset PFTs Epigenetics DEXA 20--- 15--- 10--- 5--- CPRD (Clinical Practice Research Datalink) • Primary care records • Mortality • Cancer register • Hospital Episode Statistics (HES) • National audits Patient-reported outcomes • Data direct from the source • Collect outcomes important to patients • Informs consultation • Reduces burden of clinician data entry • Two-way communication - Data collection - Dissemination of knowledge DANBIO Courtesy of Merete Hetland Aims 1. Reducing barriers to research 2. Higher quality and breadth of coordinated data 3. Platform to translate results in clinical practice - Existing tools Future developments eg FRAX http://www.shef.ac.uk/FRAX/index.jsp eg FRAX http://www.shef.ac.uk/FRAX/index.jsp Communicating benefits and harms • Present benefits and harms together • Combine numbers and stories • Personalise risk using patient’s INBANK data 10 in 100 chance of nausea What it feels like to have nausea Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Additional benefits • Presentation of some possible benefits • Vote on importance of functionality after each description Additional benefits Research • Identifying patients for studies Monitoring ARUK investment Identifying patients for studies • Declining UK involvement in pharmaceutical trials VOTE NOW 1– • Feasibility tests - Very important How many in INBANK fulfil eligibility criteria? 2 – Quite important How many of those consented to be approached? 3 - Not very important • Practical local recruitment - Generation of patient lists fulfilling criteria Additional benefits Research • Identifying patients for studies • Identifying studies for patients Digital platform for translation of results Clinical Identifying studies for patients • Automated matching of patient characteristics to active studies VOTE NOW • Flagging studies for individual patients during consultation • 1 – Very important Empowering patients to contribute to research 2 – Quite important - What studies are they eligible for? - Not very important - What does it 3 involve? - Where are they being run? Additional benefits Research • Identifying patients for studies • Identifying studies for patients Clinical • Presentation of longitudinal data (activity, Rx) DANBIO Courtesy of Merete Hetland VOTE NOW 1 – Very important 2 – Quite important 3 - Not very important DANBIO Courtesy of Merete Hetland Additional benefits Research • Identifying patients for studies • Identifying studies for patients Clinical • Presentation of longitudinal data (activity, Rx) • Summary data for clinicians (no patients recruited)National audit VOTE NOW 1 – Very important 2 – Quite important 3 - Not very important Additional benefits Research • Identifying patients for studies • Identifying studies for patients Clinical • Presentation of longitudinal data (activity, Rx) • Summary data for clinicians (no patients recruited) • National audit reactions to policy Monitoring ARUK investment 20--National audit: early inflammatory arthritis Minimum Core Dataset Add-on study AHP data 15--- Bolt-on dataset 10--- Recruitment VOTE NOW Minimum Core Dataset 1 – Very important Add-on study 2 – Quite important Bolt-on dataset 3 - Not very important Progression of RA-ILD PFTs 5--Predictors of treatment response in RA Minimum Core Dataset Additional benefits Research • Identifying patients for studies • Identifying studies for patients Clinical • Presentation of longitudinal data (activity, Rx) • Summary data for clinicians (no patients recruited) • National audit Other stakeholders • Adverse drug reactions to MHRAatasets to policy ARUK investment CV risk factors Lifestyle factors Imaging VOTE NOW Adverse events Minimum 1 – Very important Core Dataset Food DEXA 2 – Quite important diaries 3- Not very important PFTs AHP visits Additional benefits Research • Identifying patients for studies • Identifying studies for patients Clinical • Presentation of longitudinal data (activity, Rx) • Summary data for clinicians (no patients recruited) • National audit Other stakeholders • Adverse drug reactions to MHRA • Datasets to policy makers Imaging CV risk factors Lifestyle factors VOTE NOW DAS 28 Adverse events 1 – Very important Food DEXA 2 – Quite important diaries 3- Not very important Trans-hub: EQ5D Rx PFTs AHP visits Request for input Focus groups at the AGM Tue 1st May • Campanile Hotel Glasgow 13.30 – 14.15 Clinicians 14.30 – 15.15 Specialist nurses 15.30 – 16.15 Clinicians 16.15 – 17.00 Researchers Gillian Armitt & Hawys Williams Wed 2nd May • SECC Carron 1 14.45 – 15.45 15.55 – 16.40 Researchers Patients Please book places at the Arthritis Research UK stand Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Next steps • Development of disease hubs - Exemplar hub in inflammatory arthritis - Steps for all hubs • Developing data items and data entry screens • Approvals (ethics, CLRN) • Three clinical test sites • Tendering process for informatics and biobanking • Policy development - Access & publication; ethics & governance Development of disease hubs • Arthritis Research UK Clinical Study Groups to hold workshops - To be advertised widely to academics and clinicians - To identify • Disease areas • Primary research questions • Hub leads • Hub management teams – Academics; Clinicians; AHPs; Patients Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Clinical involvement • Involvement in defining the user requirements - Focus groups - Email feedback • Participation in the hub workshops • Membership of Hub Management Teams • Test Centre for specific hub • Part of INBANK Network of Clinical Centres Network of Clinical Centres • R&D approval with support from INBANK • Agreement to contribute data to high standard • Easy to use system for data entry • Patient reported outcomes collected directly • Clear process for biological sample collection • Easy access to individual and summary data Outline • What is INBANK? • Rationale • Infrastructure - Informatics platform, biobanking, disease hubs • How INBANK will be used for research • Additional benefits - Voting • Next steps • Clinical involvement Acknowledgements Project Steering Group Local Management Team • Duncan Porter (chair) • Gillian Armitt (Project Manager) • Simon Bowman • Wendy Thomson (Biobanking) • David Ford • • Hawys Williams (Ethics and Governance) Ian Ford • Daniel Glaser • Judith Jones • Alex Macgregor • Ian Rowe • • Oversight and Governance Committee • John Williams (chair) • Paul Burton Matt Sims • George Davey-Smith Peter Taylor • Charles Gutteridge • Sylvie Jackson Arthritis Research UK • Graeme Laurie • • Genevra Richardson • David Scott Sarah Rudkin Reminder - Focus groups Tue 1st May • Campanile Hotel Glasgow 13.30 – 14.15 Clinicians 14.30 – 15.15 Specialist nurses 15.30 – 16.15 Clinicians 16.15 – 17.00 Researchers Please book places at the Arthritis Research UK stand Wed 2nd May • SECC Carron 1 14.45 – 15.45 15.55 – 16.40 Researchers Patients Email us at: [email protected]
