DATABASES & CODING

VALIDATION WORKING GROUP MEETING

DATE: Saturday September 3rd

TIME: 9.30–10.30am

VENUE: Royal College of General Practitioners; 30 Euston

Square, London, UK

Towards Optimum Reporting of Pulmonary Effectiveness Databases and Outcomes (TORPEDO)

Agenda

•  TOWARDS OPTIMUM REPORTING OF PULMONARY EFFECTIVENESS DATABASES AND OUTCOMES (TORPEDO)

•  INVENTORY OF DATABASES

•  CODE SHARING

Background

•  “We performed an epidemiological study with data obtained from the Information System for the Development in Research in Primary Care (SIDIAP), a population database that contains information of 5.8 million inhabitants (80% of the population of Catalo

•  “Data for this study was obtained from the PHARMO Database Network, which includes drug dispensing records from pharmacies, hospitalization records and information from general practitioners.”

•  “Patients identified from the Optimum Patient Care Research Database (OPCRD) with a diagnostic code for COPD and a forced expiratory volume in 1 second/forced vital capacity ratio <0.7 were included in this historical follow-up study”

Background

•  Increasing need, called for by researchers, editors, industry and regulators, for a validated tool that enables:

-  characterization -  validation -  cross-comparison of respiratory databases

around the world àRespiratory data standardizing & merging

Example: CHEERS

CHEERS methods

•  Request of medical editors •  Identification of previous checklists (review) •  List of possible items (44)

•  Two-round Delphi panel (academia, clinicians, government, industry, editors) to identify minimum set of variables and accompanying recommendations (24)

•  Specific recommendations for specific studies

No funding yet but...get ready for the launch of TORPEDO

WHAT IS THE IDEAL RESPIRATORY DATABASE? TOWARDS OPTIMUM REPORTING OF PULMONARY

EFFECTIVENESS DATABASES AND OUTCOMES (TORPEDO)

Concept / Principle •  REG advocates for high quality real-life research

•  REG has a role to play in:

o  Providing tools to identify quality in both research and research tools (including databases)

o  Offering guidance to – Researchers with less experience of real-world research methods and

tools

– Countries (or regions) keen to establish clinical databases that may have potential utility for research in the future

•  REG will provide a “checklist” outlining the maximal and minimal variables required to conduct real-life respiratory research.

Working Group Meeting Rotterdam 2015: Checklist for an “ideal” database (I)

Database Category

Type of database

Electronic Medical Record Claims Disease registry Other (eg cohort studies)

Country / countries of data origin Number of patients Start of data collection (date) Data updates Unique identifier / anonymisation Family history / links Ethical approval for sharing Review board for protocol approval Death and cause of death documented? Ability to link dataset

Coding system

ICD-10 Read ATC Other

Exposures

Prescribed Dispensed Prescribed & dispensed Indication of use Drug Dose / dosing Device OTC medications Inhaler technique Adherence Action Plan Self-management plan

Working Group Meeting Rotterdam 2015: Checklist for an “ideal” database (II)

Database Category

Outcomes

Exacerbations

Treatment-based

Steroids Antibiotics SABA O2 usage

Health Resource Utilisation

Primary Care Consultations Secondary care consultations Consultations coded by disease Consultations coded by routine/emergency Hospitalisations Hospitalisations coded by disease Hospitalisations duration Emergency room ICU ICU coded by disease ICU duration Rehab Rehab coded by disease Rehab coded by duration Physiotherapy Physiotherapy coded by disease Physiotherapy duration

Patient-reported

MRC Asthma control measure (ACQ, ACT) CAT CCQ Nasal Hyper-Reactivity Bronchial Hyper-Reactivity Nasal Symptoms Sputum Colour RCP3 Sick days

Working Group Meeting Rotterdam 2015: Checklist for an “ideal” database (III)

Database Category

Covariates

Spirometry

FEV1 FVC FEV1/FVC Reversibility (%, or ml)

Demographics

Age Gender Height Weight BMI

Comorbidities

Diabetes Heart Disease Rhinitis Osteoporosis Nasal Polyps Depression / Anxiety Reflux (GERD) CKD Lung Cancer Anaemia Cognitive Dysfunction

Lifestyle Smoking status Audio Assessment Lung crackles / velco Vaccination history

Socioeconomic status

Post code / area code Education level Employment status Salary range

Laboratory tests (+ units)

Full blood count with differentiation (for eosinophils)

Creatinine CRP FeNO IgE (total, specific) Skin prick test DPPIV Serum periostin Vitamin D Neutrophils O2 saturation

Imaging CRX HRCT

Formalise the process: the TORPEDO checklist proposal (I)

Towards Optimum Reporting of Pulmonary Effectiveness Databases and Outcomes: checklist

•  Aims: 1.  Development of a checklist with:

1.  Optimum/ideal and 2.  Minimum required Variables for respiratory research

2.  Develop a repository of respiratory databases in which each database is characterised against this new checklist

•  Project leads: o  Job van Boven: University of Groningen, The Netherlands o  Jonathan Campbell: Skaggs School of Pharmacy, Denver

TORPEDO checklist proposal (II) Aim 1: Checklist development:* •  Develop a draft checklist through systematic search:

o  For existing tools to report the characteristics of respiratory databases. o  In parallel – create a list of current databases and available parameters.

•  Develop minimum/maximum checklists via a Delphi procedure: o  A Delphi panel involving: editors, governmental decision makers,

healthcare professionals, academia, industry, guideline and respiratory association representatives, from a broad geographical area.

o  Delphi methodology (and use of Likert scales with cut-offs) will be used to establish a set of minimum and optimum parameters.

•  Recommendations o  Delphi panellists review the final list and provide recommendations for

use and implementation.

o  Results and recommendations will be summarized in a manuscript that will be submitted to some selected medical and health outcomes journals.

*Methods similar to those applied in the development of the CHEERS-statement for health economic reporting (Husereau D, et al, CHEERS Task Force: Consolidated Health Economic

Evaluation Reporting Standards (CHEERS) statement. BMJ 2013; 346: f1049.

TORPEDO proposal – Delphi Panelists

Potential participants:

•  Editors (AJCCRM, Thorax, ERJ, Chest, PCRM, JACI, Value in Health, etc)

•  Governmental/Health authority/insurance decision makers (NICE etc)

•  Guidelines representatives (GOLD, GINA)

•  Association representatives (ATS, ERS, APPS, EACCI, IPCRG)

•  Pharmaceutical industry Academia (respiratory medicine, epidemiologist, health economist)

•  Healthcare professionals (pulmonologist, allergist, paediatrician, GP, pharmacist, nurse, physiotherapist)

•  Total panel aim: +/- 30 members

Delphi Panel Methodology

•  ≥10 panel members must reply •  ≥1 panel member from:

o Each discipline: – Asthma, COPD, ILD, Allergy, Child Health, Health

Economics, Primary Care, Databases

o Each continent

o A Society o A Guideline Group

Potential Panelists (identified June 2015) Topic Name Continent Other Allergy Nikos Papadopoulos Europe EAACI Allergy Walter Canonica Europe WAO Allergy Pete Smith Oceania Asthma Emilio Pizzichini S-America Asthma Gary Wong Asia Editor NEJM Asthma Helen Reddel Oceania GINA Asthma Jerry Krishnan N-America AJCCRM editor Asthma Mark Fitzgerald N-America GINA Asthma Michael Schatz N-America Editor JACI in P Child health Wim van Aalderen Europe Child health Steve Turner Europe

COPD Bruce Kirenga Africa Director Makerere Lung Institute COPD Chin Kook Rhee Asia HIRA expert COPD Guy Brusselle Europe ERS research agency COPD Joan Soriano Europe ERJ editor

COPD Marc Miravitlles Europe SIDIAP database, COPD editor COPD Nicholas Roche Europe GOLD Databases Katia Verhamme Europe WG lead Health economics Jon Campbell N-America ISPOR ILD/IPF Alan Kaplan N-America ILD/IPF Andrew Wilson Europe ILD/IPF Ian Glaspole Oceania ILD/IPF Luca Richeldi Europe ERJ editor ILD/IPF Toby Maher Europe Primary care Niels Chavannes Europe Editor PCRM/ UNLOCK Primary care David Price Europe RIRL/OPRI/Editor J Thor Dis Primary care Dermot Ryan Europe OPC Databases Eric van Ganse Europe Bridge to Data Databases Faisal Yunus Asia Databases Jennifer Quint Europe Editor Thorax Databases/health economics Job van Boven Europe Dutch FDA Databases Miguel Roman-Rodriguez Europe MAJORICA Primary care Thys van der Molen Europe IPCRG/PRO

Online Delphi Tool

•  Qualtrics online survey tool in development: https://respiratoryeffective.co1.qualtrics.com/SE/?SID=SV_4Sz9cOsLfmgbAfr

Panel Member Details

IfyouDONOTTHINKastatedvariablehaspoten:alimportanceforrespiratoryresearch,pleaseindicatebycheckingthebox.IfyouthinkthevariableISpoten3allyvaluable,thereisnoneedtodoanything

Lifestyle & Demographics

Example of TORPEDO Delphi

Survey Page

Lung function

Example of TORPEDO Delphi

Survey Page

The CDM is organized into domains

CONDITIONAconditionrepresentsapatient’sdiagnosedandself-reportedhealthconditionsanddiseases.Thepatient’smedicalhistoryandcurrentstatemaybothberepresented.

DEATHReportedmortalityinformationforpatients.

DEATH_CAUSETheindividualcausesassociatedwithareporteddeath.

DEMOGRAPHICDemographicsrecordthedirectattributesofindividualpatients.

DIAGNOSISDiagnosiscodesindicatetheresultsofdiagnosticprocessesandmedicalcodingwithinhealthcaredelivery.

DISPENSINGOutpatientpharmacydispensing,suchasprescriptionsfilledthroughaneighborhoodpharmacywithaclaimpaidbyaninsurer.Outpatientdispensingisnotcommonlycapturedwithinhealthcaresystems.

ENROLLMENTEnrollmentisaconceptthatdefinesaperiodoftimeduringwhichallmedically-attendedeventsareexpectedtobeobserved.Thisconceptisofteninsurance-based,butothermethodsofdefiningenrollmentarepossible.

ENCOUNTEREncountersareinteractionsbetweenpatientsandproviderswithinthecontextofhealthcaredelivery.

HARVESTAttributesassociatedwiththespecificPCORnetdatamartimplementation

LAB_RESULT_CMLaboratoryresultCommonMeasures(CM)usespecifictypesofquantitativeandqualitativemeasurementsfrombloodandotherbodyspecimens.ThesestandardizedmeasuresaredefinedinthesamewayacrossallPCORnetnetworks.

ENROLLMENTEnrollmentisaconceptthatdefinesaperiodoftimeduringwhichallmedically-attendedeventsareexpectedtobeobserved.Thisconceptisofteninsurance-based,butothermethodsofdefiningenrollmentarepossible.

ENCOUNTEREncountersareinteractionsbetweenpatientsandproviderswithinthecontextofhealthcaredelivery.

HARVESTAttributesassociatedwiththespecificPCORnetdatamartimplementation

LAB_RESULT_CMLaboratoryresultCommonMeasures(CM)usespecifictypesofquantitativeandqualitativemeasurementsfrombloodandotherbodyspecimens.ThesestandardizedmeasuresaredefinedinthesamewayacrossallPCORnetnetworks.

PCORNET_TRIALPatientswhoareenrolledinPCORnetclinicaltrials.

PRESCRIBINGProviderordersformedicationdispensingand/oradministration.

PRO_CMPatient-ReportedOutcome(PRO)CommonMeasures(CM)arestandardizedmeasuresthataredefinedinthesamewayacrossallPCORnetnetworks.Eachmeasureisrecordedattheindividualitemlevel:anindividualquestion/statement,pairedwithitsstandardizedresponseoptions.

PROCEDURESProcedurecodesindicatethediscreetmedicalinterventionsanddiagnostictesting,suchassurgicalprocedures,administeredwithinhealthcaredelivery.

VITALVitalsigns(suchasheight,weight,andbloodpressure)directlymeasureanindividual’scurrentstateofattributes.

PCORNET_TRIALPatientswhoareenrolledinPCORnetclinicaltrials.

PRESCRIBINGProviderordersformedicationdispensingand/oradministration.

PRO_CMPatient-ReportedOutcome(PRO)CommonMeasures(CM)arestandardizedmeasuresthataredefinedinthesamewayacrossallPCORnetnetworks.Eachmeasureisrecordedattheindividualitemlevel:anindividualquestion/statement,pairedwithitsstandardizedresponseoptions.

PROCEDURESProcedurecodesindicatethediscreetmedicalinterventionsanddiagnostictesting,suchassurgicalprocedures,administeredwithinhealthcaredelivery.

VITALVitalsigns(suchasheight,weight,andbloodpressure)directlymeasureanindividual’scurrentstateofattributes.

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Cross-reference other work…?

Process-relateddataDatacapturedfromhealthcaredelivery,directencounterbasisDatacapturedfromprocesses

associatedwithhealthcaredelivery

Datacapturedwithinmultiplecontexts:healthcaredelivery,

registryactivity,ordirectlyfrompatients

Fundamentalbasis

PATIDBIRTH_DATEBIRTH_TIMESEXHISPANICRACEBIOBANK_FLAG

DEMOGRAPHIC

PATIDENR_START_DATEENR_END_DATECHARTENR_BASIS

ENROLLMENT

ENCOUNTERIDPATIDADMIT_DATEADMIT_TIMEDISCHARGE_DATEDISCHARGE_TIMEPROVIDERIDFACILITY_LOCATIONENC_TYPEFACILITYIDDISCHARGE_DISPOSITIONDISCHARGE_STATUSDRGDRG_TYPEADMITTING_SOURCE

ENCOUNTERVITALIDPATIDENCOUNTERID (optional)MEASURE_DATEMEASURE_TIMEVITAL_SOURCEHTWTDIASTOLICSYSTOLICORIGINAL_BMIBP_POSITIONSMOKINGTOBACCOTOBACCO_TYPE

VITAL

DIAGNOSISIDPATIDENCOUNTERIDENC_TYPE (replicated)ADMIT_DATE (replicated)PROVIDERID (replicated)DXDX_TYPEDX_SOURCEPDX

DIAGNOSIS

PROCEDURESIDPATIDENCOUNTERIDENC_TYPE (replicated)ADMIT_DATE (replicated)PROVIDERID (replicated)PX_DATEPXPX_TYPEPX_SOURCE

PROCEDURES

DISPENSINGIDPATIDPRESCRIBINGID (optional)DISPENSE_DATENDCDISPENSE_SUPDISPENSE_AMT

DISPENSING

LAB_RESULT_CM_IDPATIDENCOUNTERID (optional)LAB_NAMESPECIMEN_SOURCELAB_LOINCPRIORITYRESULT_LOCLAB_PXLAB_PX_TYPELAB_ORDER_DATESPECIMEN_DATESPECIMEN_TIMERESULT_DATERESULT_TIMERESULT_QUALRESULT_NUMRESULT_MODIFIERRESULT_UNITNORM_RANGE_LOWNORM_MODIFIER_LOWNORM_RANGE_HIGHNORM_MODIFIER_HIGHABN_IND

LAB_RESULT_CM

CONDITIONIDPATIDENCOUNTERID (optional)REPORT_DATERESOLVE_DATEONSET_DATECONDITION_STATUSCONDITIONCONDITION_TYPECONDITION_SOURCE

CONDITION

PRO_CM_IDPATIDENCOUNTERID (optional)PRO_ITEMPRO_LOINCPRO_DATEPRO_TIMEPRO_RESPONSEPRO_METHODPRO_MODEPRO_CAT

PRO_CM

PCORnet Common Data Model v3.0

PRESCRIBINGIDPATIDENCOUNTERID (optional)RX_PROVIDERIDRX_ORDER_DATERX_ORDER_TIMERX_START_DATERX_END_DATERX_QUANTITYRX_REFILLSRX_DAYS_SUPPLYRX_FREQUENCYRX_BASISRXNORM_CUI

PRESCRIBING

AssociationswithPCORnetclinicaltrials

PATIDDEATH_DATEDEATH_DATE_IMPUTEDEATH_SOURCEDEATH_MATCH_CONFIDENCE

DEATH

PATIDTRIALIDPARTICIPANTIDTRIAL_SITEIDTRIAL_ENROLL_DATETRIAL_END_DATETRIAL_WITHDRAW_DATETRIAL_INVITE_CODE

PCORNET_TRIAL

NETWORKIDNETWORK_NAMEDATAMARTIDDATAMART_NAMEDATAMART_PLATFORMCDM_VERSIONDATAMART_CLAIMSDATAMART_EHRBIRTH_DATE_MGMTENR_START_DATE_MGMTENR_END_DATE_MGMTADMIT_DATE_MGMTDISCHARGE_DATE_MGMTPX_DATE_MGMTRX_ORDER_DATE_MGMTRX_START_DATE_MGMTRX_END_DATE_MGMTDISPENSE_DATE_MGMTLAB_ORDER_DATE_MGMTSPECIMEN_DATE_MGMTRESULT_DATE_MGMTMEASURE_DATE_MGMTONSET_DATE_MGMTREPORT_DATE_MGMTRESOLVE_DATE_MGMTPRO_DATE_MGMTREFRESH_DEMOGRAPHIC_DATEREFRESH_ENROLLMENT_DATEREFRESH_ENCOUNTER_DATEREFRESH_DIAGNOSIS_DATEREFRESH_PROCEDURES_DATEREFRESH_VITAL_DATEREFRESH_DISPENSING_DATEREFRESH_LAB_RESULT_CM_DATEREFRESH_CONDITION_DATEREFRESH_PRO_CM_DATEREFRESH_PRESCRIBING_DATEREFRESH_PCORNET_TRIAL_DATEREFRESH_DEATH_DATEREFRESH_DEATH_CAUSE_DATE

HARVEST

PATIDDEATH_CAUSEDEATH_CAUSE_CODEDEATH_CAUSE_TYPEDEATH_CAUSE_SOURCEDEATH_CAUSE_CONFIDENCE

DEATH_CAUSE

Bold font indicates fields that cannot be null due to primary key definitions or record-level constraints.http://www.pcornet.org/pcornet-common-data-model/

ICD-9/10 codes

TORPEDO proposal: Aim 2

Aim 2: Database repository •  Collecting databases

o  Elicit databases and characteristics from: –  REG members –  Through literature search –  Through Bridge to Data, ENCePP search engines

•  Applying the checklist o  Collaborators will complete the checklist on these

databases and will present the overview on a web-based REG/UNLOCK platform.

OPTIMISE THE REG WEBSITE LINKS

CODE SHARING

New REG Website

•  Launched June 2016

•  Webpage for each group o  Key links o  Upcoming

meetings o  Information

sharing o  File sharing, e.g.

code sharing

Main site: www.effectivenessevaluation.org

Working Group Page

Features: •  WG meetings •  Members •  Useful links:

o  Bridge-to-Data o  ENCePP

–  Database registry (not uniquely respiratory)

–  Quality “EnCePP Seal” o  Code Mapper o  ClincialCodes

•  Code sharing feature •  Customise further?

http://effectivenessevaluation.org/working-groups-committees/databases-coding-working-group/

File (Code list) sharing feature

File (Code list) sharing feature You’ll see the Working Group sites you have access to (i.e. that you’re a member of) down the side

Click on the working group name to access any files shared among working group members.

File (Code list) sharing feature Click on the filename to Download the file Click on the New Folder to create a new folder within the share space Click Upload to upload a file to share with the group

File (Code list) sharing feature

To customize your space, go to your account – top right hand corner Click on “My Account” and you then have the option to reset your password, opt in for notifications when others upload files, etc.