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Databases and Coding Validation Working Group Meeting
1. 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)
2. Agenda
• TOWARDS OPTIMUM REPORTING OF
PULMONARY EFFECTIVENESS DATABASES
AND OUTCOMES (TORPEDO)
• INVENTORY OF DATABASES
• CODE SHARING
3. 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”
4. 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
6. 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
8. WHAT IS THE IDEAL
RESPIRATORY DATABASE?
TOWARDS OPTIMUM REPORTING OF PULMONARY
EFFECTIVENESS DATABASES AND OUTCOMES
(TORPEDO)
9. 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.
10. 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
11. 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
12. 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
13. 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
14. 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.
15. 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
16. 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
17. 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
22. The CDM is organized into domains
CONDITION
A condition represents a patient’s diagnosed and self-
reported health conditions and diseases. The patient’s
medical history and current state may both be
represented.
DEATH
Reported mortality information for patients.
DEATH_CAUSE
The individual causes associated with a reported death.
DEMOGRAPHIC
Demographics record the direct attributes of individual
patients.
DIAGNOSIS
Diagnosis codes indicate the results of diagnostic
processes and medical coding within healthcare delivery.
DISPENSING
Outpatient pharmacy dispensing, such as prescriptions
filled through a neighborhood pharmacy with a claim
paid by an insurer. Outpatient dispensing is not
commonly captured within healthcare systems.
ENROLLMENT
Enrollment is a concept that defines a period of time
during which all medically-attended events are expected
to be observed. This concept is often insurance-based,
but other methods of defining enrollment are possible.
ENCOUNTER
Encounters are interactions between patients and
providers within the context of healthcare delivery.
HARVEST
Attributes associated with the specific PCORnet datamart
implementation
LAB_RESULT_CM
Laboratory result Common Measures (CM) use specific
types of quantitative and qualitative measurements from
blood and other body specimens. These standardized
measures are defined in the same way across all PCORnet
networks.
ENROLLMENT
Enrollment is a concept that defines a period of time
during which all medically-attended events are expected
to be observed. This concept is often insurance-based,
but other methods of defining enrollment are possible.
ENCOUNTER
Encounters are interactions between patients and
providers within the context of healthcare delivery.
HARVEST
Attributes associated with the specific PCORnet datamart
implementation
LAB_RESULT_CM
Laboratory result Common Measures (CM) use specific
types of quantitative and qualitative measurements from
blood and other body specimens. These standardized
measures are defined in the same way across all PCORnet
networks.
PCORNET_TRIAL
Patients who are enrolled in PCORnet clinical trials.
PRESCRIBING
Provider orders for medication dispensing and/or
administration.
PRO_CM
Patient-Reported Outcome (PRO) Common Measures
(CM) are standardized measures that are defined in the
same way across all PCORnet networks. Each measure is
recorded at the individual item level: an individual
question/statement, paired with its standardized
response options.
PROCEDURES
Procedure codes indicate the discreet medical
interventions and diagnostic testing, such as surgical
procedures, administered within healthcare delivery.
VITAL
Vital signs (such as height, weight, and blood pressure)
directly measure an individual’s current state of
attributes.
PCORNET_TRIAL
Patients who are enrolled in PCORnet clinical trials.
PRESCRIBING
Provider orders for medication dispensing and/or
administration.
PRO_CM
Patient-Reported Outcome (PRO) Common Measures
(CM) are standardized measures that are defined in the
same way across all PCORnet networks. Each measure is
recorded at the individual item level: an individual
question/statement, paired with its standardized
response options.
PROCEDURES
Procedure codes indicate the discreet medical
interventions and diagnostic testing, such as surgical
procedures, administered within healthcare delivery.
VITAL
Vital signs (such as height, weight, and blood pressure)
directly measure an individual’s current state of
attributes.
v1.0
v2.0
v3.0
v3.0
v3.0
v3.0
v3.0
v1.0
v1.0
v2.0
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v2.0
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Cross-reference other work…?
24. 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.
26. 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
27. 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/
29. 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.
30. 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
31. 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.