This document provides an agenda and minutes from a working group meeting focused on respiratory databases and coding validation. The agenda includes discussions around developing a respiratory database registry, a proposed "TORPEDO" database checklist, and next steps. Key discussions centered around finalizing a database checklist, reviewing existing respiratory database inventories, and potentially working with other organizations to curate respiratory database information. The minutes outline a proposal to use a Delphi process to develop an "ideal" database checklist, and to establish an online repository to report database characteristics using the checklist. Developing ways to characterize existing databases of REG collaborators was also discussed as an interim step.

1. 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

2. Agenda

3. • Respiratory Database Registry
• Database Criteria Checklist: “TORPEDO” proposal
Review of Rotterdam Discussions

4. 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:

6. 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

7. Meeting Minutes – “Next steps”
• Database Checklist
o Database working group to finalise database
checklist
o 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 registry
o 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
X
Delphi Proposal
developed; activity
pending funding
X
Delayed pending
funding/resource

8. 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

9. 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

10. 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

11. 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 Netherlands
o Jonathan Campbell: Skaggs School of Pharmacy, Denver

12. 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.
• 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.

13. 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

14. TORPEDO proposal: Aim 2
Aim 2: Database repository
• Collecting databases
o Elicit databases and characteristics from REG members
and through literature search.
• Applying the checklist
o Collaborators will complete the checklist on these
databases and will present the overview on a web-based
REG/UNLOCK platform.

15. Meantime… optimise the REG network?
• Database Checklist
o Database working group to finalise database
checklist
o 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 registry
o 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
X
Delayed pending
funds for a Delphi
X
Delayed pending
funding/resource

16. Meantime… optimise the REG network?
• Curate information on databases that:
o Are owned by REG collaborators
o Have been used by REG collaborators
o Have been included in abstracts submitted to REG
summits
• Characterise them against key criteria
(see next slide)

17. NL UK DK IT IT-P Spain
Name of the
database
IPCI CPRD Aarhus HSD Pedianet SIDIAP
Region or
Country
Netherlands
United
Kingdom
Central
Denmark
Region
and the
North
Denmark
Region
Italy Italy
Catalonia,
Spain
Type of
database
MR MR ADM MR
Longitudinal
population
database
MR
Number of
patients,
millions
1.2 12.0 1.8 1.5
<0.5 million
(364,610) 5.1
Date in Yes Yes Yes Yes Yes Yes
Date out Yes Yes Yes Yes Yes Yes
Date of death Yes Yes Yes Yes Yes Yes
Cause of death Yes No Yes No Yes No
Updates Bi-annually Bi-annually
Yearly
(April)
Bi-annually:
(30/06 and
31/12)
Pedianet
receives
new data
from FPs
every day,
so the
database is
continually
update.
Yearly
(April/May)
Prescriptions
Outpatient Rx
Yes
(specialist
incomplete
Yes
(specialist
incomplete)
Yes
Yes
(specialist
incomplete)
Yes
Yes
(specialist
incomplete)
Coding of
drugs
ATC ATC ATC ATC ATC ATC
Dosing regimen Yes
Yes
(incomplete)
No
Yes
(incomplete)
Yes
Yes
(incomplete)
Outcomes
Hospitalizations Yes Yes Yes
Yes
(incomplete) Yes Yes
Outpatient
diagnoses
Yes Yes Yes Yes Yes Yes
Coding of
disease
ICPC READ ICD-10 ICD-9 CM ICD-9 ICD-10
Measurements
Lab data (IgE,
blood
eosinophilia)
Yes Yes
Yes (on
a subset
1.2
million of
the 1.8
million)
Yes Yes Yes
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

18. • Example – approaches used by EU-ADR
• Other approaches used by working group members
• Projects…?
Harmonisation of coding systems

19. Adverse event coding principles and
differences
• ADR coding
MedDRA
WHO-ART
COSTART
• Other coding systems in medical field
e.g. drug coding (ATC, BNF...), disease coding
(ICD 9, ICD 10, READ, …)
• Linkage of different
terminologies through
UMLS (Unified Medical
Language System)

20. 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

22. UMLS  time consuming
• ʺCode mapperʺ 
http://aneurist.erasmusmc.nl/CodeMapper/
• Code mapping added as addendum to the
protocol

24. Code mapping as addendum protocol

25. UMLS  time consuming
• ʺCode mapperʺ 
http://aneurist.erasmusmc.nl/CodeMapper/
• Code mapping added as addendum to the
protocol
• Compare incidence rates (= ‴harmonisation‴)

27. Other Updates & Opportunities
• Items of interest from the FARR Institute Conference
• PatientsLikeMe – linking patient-centric data?

28. Other updates and opportunities
• Items of interest from the FARR Institute Conference
• Linking with patient-centric data – PatientLikeMe