Crown Copyright 2007 Lessons learnt on secondary usage of data from the UK CRC/CfH study …enhancing clinical research

Crown Copyright 2007

Lessons learnt on secondary usage of data from the

UK CRC/CfH study…enhancing clinical research


General Practice Research Database

John Parkinson BSc PhD([email protected])

tel.020 7084 2698


Background

▐ Connecting for Health▐ ? The worlds largest IT project▐ Many billions of £▐ Creating full e-health

▐ All data held electronically▐ Do it once and record…share▐ Clinically shared as appropriate▐ Make data available for research

▐ Public health▐ Academic▐ Commercial

▐ e-Health Record


UKCRC-CfH Simulations

▐ Surveillance▐ Clinical Trials▐ Record Linkage▐ Biobank- Genetic


Primary use Secondary use

European Interoperability

Makes good sense1. Transfer of

FULL record to new doctor in NEW country

2. Emergency use- SUMMARY HR across Europe

SAME

Across the UK

Some big questionsNSAIDsGenetics

Small Rx in each countryDifferences in HC deliveryDifferent dosesDifferent usage patternsCluster trials


European Interoperability

▐ In particular, a major benefit of eHealth interoperability lies in improving patient safety.



Must haves- Data Sources- Medicine surveillance

Primary care 2/3 o care

Pharmacy care Other care

NHS Contracted out care

Non-NHS

Professional care

NHS

HospitalisedClinicDay cases- cancer haematology

Dispensed ETPdataPharmacy Rx

Dentist Rx

Self- care via

HealthSpace

Walk in centresOther services

Herbal and otherTreatments

OTC medicationsAspirin/ paracetamol

UKCRC-CfH


Must haves- What data -GP

Coded

Text

30,000 lines= 1 file ex 9, 1 practice for 3 months =5 thousand million lines of data/year

BP code BP readingsPatientANON

ID

SED001 Symptom

SED002 Examination

SED003 Diagnosis

SED004 Intervention

SED005 Management

SED006 Administration

SED007 Presenting

UKCRC-CfH


Must haves- e-Yellow Card

Patient 8956RXDrug X………?Event Y

Patient CVR459 sex age

Drug xxxxxxxxx route dose date

Event xxxxxxxxx dateOutcome xxxxxxOther drugsxxxxx

Other information

NHSnet

MHRA

Auto-populate

UKCRC-CfH


Must haves- suitable access

Business Tools

will NOT work

Via Specific, high end, healthcare PROVEN,

Data manipulation and analysis Tools

GRID enabled for future

UKCRC-CfH

© Crown Copyright 2007


TAKE ONE BETWEEN 4-6 PMTAKE ONE AT NIGHT BETWEEN 7 AND 11PM

1 AT NIGHT REMEMBER TO GET A BLOOD TEST EVERY 4 MONTHS1 EVERY DAY. REMEMBER TO GET YOUR BLOOD CHECKED EVERY 4 MONTHSTAKE ONE AT NIGHT REMEMBER TO HAVE A BLOOD TEST EVERY 3 MONTHS

ONE WITH EVENING MEAL , REGULARLY, AS WELL AS STICKING TO A LOW FAT DIET, TO LOWTAKE ONE DAILY PLEASE SEE DOCTOR FOR REVIEW IN 1 MONTH

TAKE ONE AT NIGHT TO LOWER CHOLESTEROL AND REDUCE RISK EVERY FORTNIGHT 1 ON MDUTAKE ONE AT NIGHT TO LOWER CHOLESTEROL AND REDUCE RISK EVERY FORTNIGHT HEART DIS

TAKE ONE AT NIGHT FOR TEN DAYS THE 2 EVERY NIGHT.1 AT NIGHT DISP WEEKLY

1 EVERY NIGHT WEEKLY DISPONE EVERY NIGHT WEEKLY DISPENSE NOTES FOR PATIENT: PLEASE REPORT ANY UNEXPLAINEDONE EVERY NIGHT WEEKLY DISPENSE VIA DOSETTE BOX NOTES FOR PATIENT: PLEASE REPORT

TAKE ONE AT NIGHT DISPENCE WEEKLYTAKE ONE/TWO ALTERNATE DAYS

10NTAKE ONE AT NIGHT 10 PM

EVERY DAY...CHECK CHOLESTEROL LEVEL 6 WEEKS10 EVERY DAY



Comparison of SUPERMARKET and NHS-GP dataSUPERM Factor cumulative factor GPs NHS

of GP complexityNumber of stores 2200 3.64 8000 Number of practices

Number of users (card holders) 10,000,000 5.00 18 50,000,000 NHS Ids

Number of ways of using 3 3.33 61 10 #consulation types

# Stock keeping units (max in store) 40000 6.25 379 250,000 # major READ/ OXMIS/ICD/MEDRA codes used

No equivs 500? 30,000 # drug codesNo equivs 5000? 1,000 # dose instructionsNo equivs *? 1000 # entitry listNo equivs *? 1000 #expression pick listNo equivs *? 10 #intervention typesNo equivs *? 10 #added data coded data collection areasNo equivs *? 10 # added imummisation varaiablesNo equivs

error and change rate of data

practically zero- bar

coded

up to 10%,little or

no bar coding,

transcription errors,

incorrect birthdays etc error and change rate of data

UKCRC-CfH


Active surveillanceMedicines

▐ Move from current PASSIVE system to ACTIVE▐ FROM Yellow card + hypothesis testing study▐ TO e Yellow Card +Data Mining on full record + hypothesis testing studies

▐ Availability of e- person level data from:▐ Hospitals HES, Labs, Rx

▐ Pharmacy dispensed and prescribed + OTC Pharmacy

▐ Other HealthCare Professionals nurses, dentists ++

▐ Other Paradigms▐ HealthSpace aspirin/paracetamol

▐ Improved and new Rx decision support tools▐ Automated on screen “instant warning/alert system”▐ Improved, specified standard incident reporting system▐ Maintained position as having the gold standard system

UKCRC-CfH


Active surveillanceDevices

▐ An all incident single NHS reporting system▐ Agreed standards coding▐ Automated delivery to responsible agency▐ Patient reporting via HealthSpace▐ Detailed implanted/integral device coding to be part of e-record

UKCRC-CfH


HEADLINE ISSUES 1.

▐ RESEARCH LEADS DIRECTLY TO:▐ Improve care,▐ Improved safety ▐ Improved efficiency▐ And therefore benefits to patients. ▐ It is NOT a SECONDARY use….., RATHER A FUNDAMENTAL

PART OF PATIENTS’ OVERALL LIFETIME CARE within a health system such as the NHS.

▐ Accepting that it is not usually about 1 on 1 care rather related to groups and cohorts.

▐ Additionally, except where consent is obtained, as in interventional studies, the actual research takes place with data subjects (effectively anonymised) rather than patients.

UKCRC-CfH


Helsinki Declaration

▐ Currently creates a difficulty as written before the era of her/observational data

▐ In the main is about “interventional research” on persons that quite correctly needs consent

▐ E-Observational research does not deal with patients

▐ Lines of Data Subject data


Headline Issues 2.▐ Mandate use of NHS number on all events▐ Ensure mother-baby and family links are enabled in system▐ Accept a federated approach using record linkage may be the most appropriate

and workable solution to maximally enabling the VISIONS▐ Mandate a standardised “Incident reporting “ system be included in all clinical systems▐ Ensure that there is compatibility related to provision of UK wide data (E, W,S, NI),

particularly for issues where there is UK wide remit and to gain most of the whole process▐ Build upon existing database/system strengths. (Knowledge, utility, now, historical data)▐ Ensure suitable governance arrangements are in place (Full time staff, related to scientific approval)▐ All discussions about centralised IT solutions to aid research should be inclusive to gain

synergies… some already know more than others.

▐ Take on board that there is a large pool of research knowledge about data, data linkage, data validation, data storage, and analysis – the wheel does not need to be re-invented

▐ Ensure that clinical trials can benefit from rapid screening to improve recruitment, centralised recruitment and even a portal based clinical trials system directly linked into all clinical systems

▐ Talk loud and often about the benefits of the research uses of data- we have nothing to hide▐ Get all hospitals to adopt personal level e Rx and lab systems asap.▐ Prevent/stop silo mentality about use and ownership of data▐ Accept that some types of research (drug related) have a commercial association and are

conducted as part of the legally required process.

UKCRC-CfH


Quick wins

▐ Patient safety

▐ Medicine related▐ E-yellow cards into all clinical systems▐ Improved safety related decision support systems in all clinical systems▐ Enablement of close to real time active surveillance (of new medications)

▐ Incident reporting…prevention▐ Mandating the inclusion of approved incident reporting software in all

clinical systems…..web to central database with adequate coding▐ Disease related

▐ Enablement of nationwide reporting systems via all relevant systems▐ Rapidly enable record linkage of existing resources to gain the

win-win synergies▐ Foster the creativity that will allow “Privacy enhancing

technologies” to maximally enable recruitment to clinical trials and Biobank

UKCRC-CfH


Who owns the data?

▐ Some commercial IT/database companies seem to have a hold over the data

▐ MY data belongs to me▐ With my consent it may be used for bone-fide research

▐ Implicit consent ▐ based upon anonymous to researcher use


Data from many systemsDB1 DB2 DB3 DB4

SQL Tool

Research

Dataset

Ask the right question……………..get just the data required

Tayside, Scotland- GENIE

England and Wales - Apollo


Thank you

Documents

Crown Copyright 2007 Lessons learnt on secondary usage of data from the UK CRC/CfH study …enhancing clinical research