2015 ERS EVENTS

DATE: SATURDAY SEPTEMBER 26TH

VENUE: Wyndham Apollo Hotel, Amsterdam

ROOM: Boardroom

TIME: 2:30-3.00PM

CHAIR: Katia Verhamme, Department of Medical

Informatics, Erasmus MC Rotterdam, The Netherlands

DATABASES & CODING VALIDATION WORKING GROUP MEETING

Agenda

• Respiratory Database Registry • Database Criteria Checklist: “TORPEDO” proposal

Review of Rotterdam Discussions

Inventory of databases suitable for research within field of respiratory (pharmaco)epidemiology

Already existing inventories: Free access e.g. ENCePP http://www.encepp.eu/encepp/search.htm

Inventories with subscription:

Inventory of existing databases

Which info do we need? Type of database i.e. electronic medical record database vs. claims

database Country Number of patients Start of data collection Coding system Frequency of updates Info on exposure Info on outcomes Covariates: blood values, pulmonary function, smoking status,

asthma/COPD control

Meeting Minutes – “Next steps”• Database Checklist

o Database working group to finalise database checklisto Checklist to be sent to all contact personnel at known

databases with request to complete for inclusion in the REG respiratory database inventory

• Respiratory database registryo Review the ISPOR inventory and ENCePP databases

and the need to further develop, or work collaboratively with these organisations (and/or) BridgetoData to curate information about respiratory databases.

4

XDelphi Proposal

developed; activity pending funding

XDelayed pending funding/resource

Checklist for an “ideal” database (I)Database Category

Type of database

Electronic Medical RecordClaimsDisease registryOther (eg cohort studies)

Country / countries of data originNumber of patientsStart of data collection (date)Data updatesUnique identifier / anonymisationFamily history / linksEthical approval for sharing Review board for protocol approvalDeath and cause of death documented?Ability to link dataset

Coding system

ICD-10ReadATCOther

Exposures

PrescribedDispensedPrescribed & dispensedIndication of useDrugDose / dosingDeviceOTC medicationsInhaler techniqueAdherenceAction PlanSelf-management plan

Checklist for an “ideal” database (II)Database Category

Outcomes

Exacerbations

Treatment-based

SteroidsAntibioticsSABAO2 usage

Health Resource Utilisation

Primary Care ConsultationsSecondary care consultationsConsultations coded by diseaseConsultations coded by routine/emergencyHospitalisationsHospitalisations coded by diseaseHospitalisations durationEmergency roomICUICU coded by diseaseICU durationRehabRehab coded by diseaseRehab coded by durationPhysiotherapyPhysiotherapy coded by diseasePhysiotherapy duration

Patient-reported

MRCAsthma control measure (ACQ, ACT)CATCCQNasal Hyper-ReactivityBronchial Hyper-ReactivityNasal SymptomsSputum ColourRCP3Sick days

Checklist for an “ideal” database (III)Database Category

Covariates

Spirometry

FEV1FVCFEV1/FVCReversibility (%, or ml)

Demographics

AgeGenderHeightWeightBMI

Comorbidities

DiabetesHeart DiseaseRhinitisOsteoporosisNasal PolypsDepression / AnxietyReflux (GERD)CKDLung CancerAnaemiaCognitive Dysfunction

Lifestyle Smoking statusAudio Assessment Lung crackles / velcoVaccination history

Socioeconomic status

Post code / area codeEducation levelEmployment statusSalary range

Laboratory tests (+ units)

Full blood count with differentiation (for eosinophils)CreatinineCRPFeNOIgE (total, specific)Skin prick test DPPIVSerum periostinVitamin DNeutrophilsO2 saturation

Imaging CRXHRCT

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 optimum and minimum reporting items of

respiratory databases

2. Establish a repository in which the characteristics of existing respiratory databases, reported in a standard way using the new checklist, can be stored and accessed

• Project leads:o Job van Boven: University of Groningen, The Netherlandso 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. • In parallel – creation of 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.

• Recommendationso 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: +/- 50 members

TORPEDO proposal: Aim 2

Aim 2: Database repository

• Collecting databaseso Elicit databases and characteristics from REG members

and through literature search.

• Applying the checklisto Collaborators will complete the checklist on these

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

Meantime… optimise the REG network?• Database Checklist

o Database working group to finalise database checklisto Checklist to be sent to all contact personnel at known

databases with request to complete for inclusion in the REG respiratory database inventory

• Respiratory database registryo Review the ISPOR inventory and ENCePP databases

and the need to further develop, or work collaboratively with these organisations (and/or) BridgetoData to curate information about respiratory databases.

4

XDelayed pending funds for a Delphi

XDelayed pending funding/resource

Meantime… optimise the REG network?• Curate information on databases that:

o Are owned by REG collaboratorso Have been used by REG collaboratorso Have been included in abstracts submitted to REG

summits

• Characterise them against key criteria (see next slide)

ADM = Administrative; ATC = Anatomical Therapeutic Chemical; BNF = British National Formulary; ICD= International classification of disease, ICPC = International Classification of Primary Care; MR = Medical Records

Database Characteristics

High-level summary

• Example – approaches used by EU-ADR• Other approaches used by working group members• Projects…?

Harmonisation of coding systems

Adverse event coding principles and differences• ADR coding

MedDRAWHO-ARTCOSTART

• Other coding systems in medical field e.g. drug coding (ATC, BNF...), disease coding (ICD 9, ICD 10, READ, …)

• Linkage of differentterminologies throughUMLS (Unified MedicalLanguage System)

Harmonisation of codes example from EMC• Definition of outcomes e.g. definition of stroke,

MI

• Search for codes via UMLS

Unified Medical Language System (UMLS) - Home

UMLS time consuming

• ʺCode mapperʺ http://aneurist.erasmusmc.nl/CodeMapper/

• Code mapping added as addendum to the protocol

Code mapping as addendum protocol

UMLS time consuming

• ʺCode mapperʺ http://aneurist.erasmusmc.nl/CodeMapper/

• Code mapping added as addendum to the protocol

• Compare incidence rates (= ‴harmonisation‴)

Other Updates & Opportunities

• Items of interest from the FARR Institute Conference• PatientsLikeMe – linking patient-centric data?

Other updates and opportunities

• Items of interest from the FARR Institute Conference

• Linking with patient-centric data – PatientLikeMe