Electronic  solu-ons  to  clinical  problems?  An  integrated  approach  to  clinical  data  collec0on  and  analysis  

Alexis Joannides Michael Gifford

Email:  aj238@cam.ac.uk  

The  challenge  of  clinical  data  flow  

Clinical  audit  

Service  evalua-on  

Registry  submission  

Transfer  documenta-on  

Research  study  

Data  capture  

Service devolution across multiple sites across multiple specialties

Data duplication

operational service audit and evaluation academic research

Technical challenges

system compatibility data compatibility cost

Commissioning  

Cost  Inaccuracy  

Healthcare  records  

Audit  and  research  data  

X  X  

1/4/11 – 1/4/12 n = 5099

Real-­‐-me  monitoring  of  neurosurgical  emergency  prac-ce  from  opera-onal  data  

0%  

25%  

50%  

75%  

100%  

Other  

No  involvement  

Follow-­‐up  

Transfer  

0  

600  

1200  

1800  

Approaches  to  mul--­‐site  healthcare  data  collec-on  

User  familiarity  Single  point  of  data  capture  

 Limited  by  quality  of  local  data  

Individual  interfacing  requirements    

Control  over  data  quality  Rapidly  scalable  and  adaptable  

 User  training  

Local  unit  engagement  

Factors to consider Scalability Portability Cost-effectiveness Adaptability User involvement

Outcome  Registry,  Interven-on  and  Opera-on  Network  (ORION)  a  na-onal  plaTorm  for  integra-ng  clinical  data  collec-on  for  mul-ple  uses  

Data  input  

Longitudinal    analysis  

Cross-­‐sec-onal    analysis  

Interfacing  

Cloud  repository  

Print output Electronic records

Trial protocol Disease registry!

Care pathway!Clinical review!

Desktop  and  tablet  interface  No  local  so8ware  requirement  Two-­‐factor  authen0ca0on  Pa0ent-­‐facing  interface          Data  valida0on  Controlled  modular  access  Single  common  dataset                PDF,  CSV,  graph  output    

Key  features  

•  Cloud-­‐based  applicaCon  allowing  secure  and  controlled  access  to  structured  healthcare  informaCon  across  mul-ple  sites  

 •  Custom  applicaCon  modules  u-lising  common  dataset  

•  Flexible  paCent  idenCficaCon  via  mulCple  unique  idenCfiers  

•  In-­‐built  record  duplicaCon  safeguards  

•  OpCmisCc  and/or  pessimisCc  concurrency  checks  to  enable  collaboraCve  work      •  Email  communicaCon  to  paCents  /  users  

•  AutomaCc  PDF  generaCon  for  output  to  other  systems  /  prinCng  

•  Temporary  local  storage  and  synchronisaCon  for  offline  data  capture  –  Prepared  entries  via  token  code  or  pre-­‐loading  –  DraQ  mode  for  later  online  reconciliaCon  

•  Custom  filters  for  real-­‐Cme  analysis  and  CSV  export  for  external  analysis  

 

Reconciling  data  protec-on  and  analysis  

Web

app

licat

ion

Dat

abas

e U

sers

Data input

On-screen view

Document generation

Data export

Validation

Metadata specification

Decryption

Identifier encryption

Storage Backup

Service Admin Analysis

Regulatory  framework  

Steering  CommiVee  

SoWware  Development  

Team  

Network  Administra-on  

Team  

Outcome  Research  

Consor-um  

Applica-on  support  

Log  and  backup  monitoring  

Module  development  

Record  administra-on  

Pilots  and  module  rollout  

User  administra-on  Grants  

Publica-ons  

Annual  reports  

Engagement  and  publicity  

Data  Monitoring  and  Oversight  CommiVee  

Policies  and  procedures  Technical  and  Security  SpecificaCon  SubscripCon  Terms  and  CondiCons  OperaConal  Policy  System  Access  and  Data  Policy    Annual  IG  toolkit  submissions  

Society of British Neurological Surgeons British Neurotrauma Group British Skullbase Society

Current  work  

 •  Network  referral  system  –  neurosurgery  and  neurology  (regional)  •  VesCbular  schwannoma  registry  (naConal)  •  Major  trauma  rehabilitaCon  (regional)  •  SBNS/BNTRC  chronic  subdural  haematoma  audit  (naConal)  •  UK  shunt  registry  (naConal)    •  Childrens  Epilepsy  Surgery  Service  (naConal)  •  NF2  outcome  and  QoL  registry  (regional)  •  Integrated  neuro-­‐oncology  care  pathway  (regional)  •  Impaired  consciousness  clinical  database  (local)    •  Pituitary  surgery  outcome  registry  (naConal)  •  UK  cranial  reconstrucCon  registry  (naConal)  •  UK  TSHoma  database  (local)  •  PSA  community  monitoring  (local)  

 

   Develop

men

t                                Pilo

t                                                            Live  

 

0  

10  

20  

30  

40  

50  

60  

70  

Pa-e

nts  recruite

d  

Speed  of  deployment  UK  na4onal  chronic  subdural  haematoma  audit  recruitment  

Preven-on  

Acute  care  

Prognosis  

Recovery  

Long-­‐term  care  

ABI  

EducaCon  Risk  straCficaCon      Early  detecCon  ResuscitaCon        -­‐  Major  Trauma  Centre  MulCmodality  bedside  monitoring  FuncConal  neuroimaging    Emergence  from  coma  States  of  impaired  consciousness  Late  sequelae            -­‐  hydrocephalus,  epilepsy,  demenCa      RehabilitaCon              -­‐  physical,  cogniCve,  emoConal,  behavioural  Community  re-­‐integraCon        Ongoing  paCent  and  carer  support  AcCve  surveillance                -­‐  UK  shunt  registry              -­‐  EHIG  head  injury  database    

DBI  

NRS  

eRP  

CRIC  

UKSR  

DoS  

Data  synergy  Piecing  together  a  heterogeneous  brain  injury  pathway  

Mobile  devices:  pa-ent  interac-on  Presen4ng  symptom  pa>erns  in  neuro-­‐oncology  (EORTC  QLQ-­‐C30  /  BN20)  

0  

20  

40  

60  

80  

100  0  

20  

40  

60  

80  

100  

0  

20  

40  

60  

80  

100  

n=154  

Mobile  devices:  clinician  interac-on  Rehabilita4on  complexity  following  major  trauma  

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Achieving  sufficient  resolu-on  Trade-­‐offs  in  developing  complex  datasets  

•  PracCcality  –  Who  and  when?  

 •  UClity  

–  Does  it  jusCfy  the  required  resources?  –  Can  this  be  useful  for  mulCple  purposes?  

 •  Applicability  

–  To  what  proporCon  of  paCents  will  this  apply?  

 

•  Accuracy  –  How  correct  is  the  data  likely  to  be?  

 

Content  

Par--on  

Structure  

Flow  

Collec-ng  the  right  data  Defining  a  minimum  dataset  for  accurate  outcome  interpreta4on    

Baseline Intervention Outcome

Stratification Disease stage Disease subtype

Co-morbidity

Procedure Complications Adjuncts

Co-treatment

CROMS Survival Imaging Molecular markers Biological assays

PROMS

Quality of life Disease specific

IdenCfy  paCent  subsets  amenable  to  novel  intervenCons  

Con-nuous  evalua-on  of  high  resolu-on  

datasets  

Evaluate  impact  of  newly  established  

approaches  Monitor  intervenCon  effecCveness  and  

safety  

Evidence-­‐based  healthcare  policy  and  

service  delivery  

Healthcare  provision   Clinical  research  

U-lity  beyond  the  UK  healthcare  se_ng?    

 •  PotenCal  applicaCons  

–  Cost-­‐effecCve  approach  to  capture  large-­‐scale  observaConal  data  from  rouCne  pracCce  –  Outcome  reporCng  for  long-­‐term  condiCons  –  Complex  datasets  for  bespoke  research  studies    

 

•   Barriers  to  consider  –  Local  infrastructure  and  setup  –  Route  to  delivery  and  implementaCon  –  PaCent  idenCficaCon  and  cross-­‐referencing  –  Funding  model  and  sustainability