Information System for the Enhancement of Research in Primary Care

www.sidiap.org

”14th Action Group A1. European Innovation Partnership on Active and Healthy Ageing“

September 14th, 2018, Facultade de Farmácia, Universidade do PortoMaria Garcia Gil, SIDIAP database

mgarcia@idiapjgol.info

Outline

1. Brief introduction to the Catalan Health Service

2. Electronic medical records

3. SIDIAP

structure and contents

added value

examples

administrative issues

Catalan Health Service

Catalan Health Service Structure

USERS

CatSalut

public insurance

Private Insurances

Institut Català de la Salut

Centres contracted by CatSalut

Centres without an agreement

Public System

Private System

AGENTS PROVIDERS

5.000 - 25.000 people C: Primary Care CenterIsochrone 30’ PHCT= C1+C2+C3+C4

Basic Health Area

C1

C3

C2

C4

Primary Care

The PHCT: Multidisciplinary Team

GPs, Paediatricians, Nurses, dentists, social workers and ancillary staff:

GP= 1/1.500-2.000 inhab.>14

Paediatrician=1/1.250-1.500 inhab. =<14.

Ratio of 1 nurse/1 physician approx.

Social workers= 1/25.000 inhab.

Ancillary staff

Dentist=1/11.000 inhab.

Creation of the Basic Health Unit composed by the physician and the nurse, in charge of a list of patients according to their specific functions.

Customer-oriented organization

C

I

T

I

Z

E

N

S

EMERGENCIES

PRIMARY

HEALTH CENTERLONG-TERM CARE

CENTER

MENTAL HEALTH

CENTER

HOSPITALS

H1 H2 H3

Catalan Health Service Structure

USERS

CatSalut

public insurance

Private Insurances

Institut Català de la Salut

Centres contracted by CatSalut

Centres without an agreement

Public System

Private System

AGENTS PROVIDERS

The ICS: the main Catalan Public Healthcare

Provider

Public Healthcare Provider

Main healthcare provider of the Catalan Healthcare network

Attending 80% of the Catalan population (6 million).

Over 40.000 professionals.

Primary Healthcare

80% of the primary healthcare teams

(285)

8 Hospitals:

Over 4.000 beds

Over 130 operating rooms

Over 700 medical offices

32% of the public bed endowment

50% of the high tech bed

endowment

Hospital care

23 low-risk emergency units with 162

attention points:

15 low-risk level emergency centres

(CUAP)

Continuous attention to low-risk

emergency in 130 primary healthcare

centres (PAC)

17 isolated units (mountain)

12 Rehabilitation centres

13 Clinical laboratories

29 Radiology services

35 ASSIR units (sexual and

reproductive health): gynaecologists

and midwifes

13 PADES (home terminal care)

8 mental health units

3 labour health units

Penitentiary healthcare

The ICS

Electronic medical recordshealth research

Routinely collected. Secondary data.

» Primary care (BIFAP, THIN, SIDIAP, CPRD, Pedianet)

» Hospital (GePARD)

» Vaccines (Statens Serum Institut)

» Mutual insurance (Kaiser Permanente)

» Combinations: vaccines + discharge + mortality + primary care etc.

(PHARMO, FISABIO, Aragón)

Electronic medical records. Characteristics

Real World Data

Fin colaboraciónPACIENTE 6

PACIENTE 7

PACIENTE 10

NeumoníaPACIENTE 8

1er ADO

1er ADO

1er ADO

1er ADO

Enero 2002Enero 2001 Diciembre 2013

CancerPACIENTE 91er ADO

muertePACIENTE 1

Fin colaboraciónPACIENTE 2

PACIENTE 3

PACIENTE 5

Registro con médico

Registro con

médico

Registro

con

médico

<1 año

1er ADO

No ADO

PACIENTE 4

17 años

1er ADO

Registro con médico

1 año

registro

18

años

Registro

1 año

registro18

añosRegistro

1 año

registro

18

años

Registro

Electronic medical records. Characteristics

Longitudinality

Europe

• UK: CPRD (Clinical Practice Research Database), THIN (The Health Improvement Network), QRESEARCH (Universitat de Nottingham)

• The Netherlands: IPCI (Integrated Primary Care Information Database), PHARMO

• Denmark: Danish health registries (Aarhus University)

• Italy: HSD, Pedianet

• Germany: GePaRD (German Pharmacoepidemiological Research Database)

Electronic medical records. Real World Data

Public:

• Department of Defense Comprehensive

Clinical Evaluation Program

• Healthcare Cost and Utilization Project

• HMO Research Network

• Medicare

• SEER-Medicare Linked Database

• SEER-Medicaid Bibliography

• Vaccine Safety Datalink

• Veterans Administration Databases

USA

Private:

• AMGA's Anceta Collaborative Data Warehouse

• Group Health Cooperative of Puget Sound

• Harvard Pilgrim Health Care

• Healthcore (Wellpoint/Blue Cross/Blue Shield)

• Henry Ford Health Systems

• HMO Research Network (HMORN)

• Indiana Health Information Exchange

• Kaiser Permanente Medical Care Programs

• Kaiser Permanente Northwest

• UnitedHealth Group

Electronic medical records. Real World Data

SIDIAP

SIDIAP was created in 2010 under the auspices of the Primary Care Research Institute Jordi Gol (IDIAP JordiGol) and the Catalan Institute of Health (ICS)

It aims to promote the development of research based on clinical data from electronic clinical records (eCAP) and other complementary sources of data

SIDIAP

One primary care health provider using the same e-records software (eCAP system)

274 Primary Care Centres in Catalonia

>3,400 BHU

>5.8 million patients (>80% population)

SIDIAP

www.sidiap.org

SIDIAP

Available Information (I)

VARIABLES SOURCE OF

INFORMATION

AVAILA

-BILITY

Socio-demographics (date of birth,

gender, country of origin, PHC centre)

SIAP (Catalan Health

Service)

>2000

Clinical data

• Primary care visits (date, #, type, ..)

• Referrals to secondary care and

diagnostic services (date, service, ICD10)

• Vaccines (type, date)

• Life-style: BMI, etc

• Routine measurements: blood pressure,

•Clinical events: ICD-10 codes

•Prescriptions

•Patient complexity: CRG

•ASSIR pregnancy and reproductive

health

eCAP (Primary Care

e-records)

>2005

Available Information (II)

VARIABLES SOURCE OF INFORMATION AVAILA

-

BILITY

Drugs dispensed (in

community pharmacies)

Official Pharmacy Invoice

Database (Catalan Health

Service)

>2005

Primary care lab tests Primary Care Lab Database >2006

Socioeconomic status =

Ecologic MEDEA Index

Census data >2001

Hospital Admissions: up to 10

diagnoses + up to 10

procedures (ICD-9)

Inpatient Care MBDS

(Catalan Health Service)

>2004

Inpatient Care: Primary Care Centers with > 50% of their hospital

discharges coming from ICS hospitals.

- 853 pediatricians and nurses

- 826,940 children

SIDIAP-Pediatrics

Available Information (III)

VARIABLES SOURCE OF

INFORMATION

AVAILA

-BILITY

Socio-demographics (date of birth,

gender, country of origin, PHC centre)

SIAP (Catalan Health

Service)

>2000

Clinical data

• Primary care visits (date, #, type, ..)

• Referrals to secondary care and

diagnostic services (date, service, ICD10)

• Vaccines (type, date)

• Life-style: BMI, etc

• Routine measurements: blood pressure,

•Clinical events: ICD-10 codes

•Prescriptions

•Patient complexity: CRG

eCAP (Primary Care

e-records)

>2005

Available Information (III)

VARIABLES SOURCE OF INFORMATION AVAILA-

BILITY

Drugs dispensed (in

community pharmacies)

Official Pharmacy Invoice

Database (Catalan Health

Service)

>2005

Primary care lab tests Primary Care Lab Database >2006

Socioeconomic status =

Ecologic MEDEA Index

Census data >2001

Hospital Admissions: up to 10

diagnoses + up to 10

procedures (ICD-9)

Inpatient Care MBDS

(Catalan Health Service)

>2004

Available Information (III)

Inpatient Care: Primary Care Centers with > 50% of their hospital

discharges coming from ICS hospitals.

• Vaccines: >85% vacunal coverage

• Healthy children program

Available Information (III)

SIDIAP-Pediatrics. Specific information

Available Information (IV)

Prescription. Specific information

• Patient ID

• National code

• Initial date

• Final date

• ATC code

• General practitioner

• Health center

From 2009

Available Information (IV)

Dispensation. Specific information

• Patient ID

• National code

• Initial date

• Final date

• ATC code

• Cost

• Number of packages

From 2005 and monthly basis

• Prescription and dispensation

• Prescription but not dispensation (no initiation?, proxy of non-

adherence?)

• No prescription but dispensation

Before 2009

Manual prescription

Prescription and Dispensation. Specificinformation

General strengths

Real-life clinical conditions

Very large data set

High external validity

Time and costs

Most of epidemiological study designs may be conducted

Allows to link with other data sources

Focus on clinical practice: register of relevant events to patient’s

care

Focus on activity

Underreporting

Missclassification

Confounding

Missing data

Socioeconomic status: aggregated level

Validity of exposures and outcomes

Potential limitations

SIDIAP: main added value

» Symbiosis with the health provider to

improve the quality of the information

Learning Health System

SIDIAP: main added value

Learning Health System

Research

eCAP

System

Innovation

New knowledge

New tools

Researchprojects

Quality of care

Available

information

Quality of

registration

SIDIAP: main added value

Learning Health System

• Quality control mechanisms

• Validation studies

SIDIAP: added value 1

Quality control mechanisms

» CODES OF THE

VARIABLES

» TIME

Quality control mechanisms

» Values of the variables

Quality control mechanisms

SIDIAP completeness: Qual Prim Care. 2012;20(2):135-45

Code validations:

» External source linkage: cancer (Plos One 2014;9(10)), osteoporotic

fractures (BMC Musculoskelet Disord. 2012 May 28;13:79) and

osteoarthritis (Ann Rheum Dis. 2013 Jun;72(6):911-7)

» Free text analysis: Osteoarthritis (Ann Rheum Dis. 2014

Sep;73(9):1659-64)

» Rates comparisons (vs reliable cohort or previous literature) : CVD

(Rev Esp Cardiol. 2012 Jan;65(1):29-37), rheumatoid arthritis (Clin

Rheumatol. 2014 Oct 26).

Diagnostic algorithms: Endocrinol Nutr 2016 Sep 6. pii: S1575-

0922(16)30111-5

New variables: MEDEA (deprivation index) Plos One 2014;9(10)

Validation

SIDIAP: added value 2

Vectorial maps available

» Province.

» Region.

» Primary Health Area (ABS).

» Municipality.

» Census Section.

SIDIAP: added value 3

• GP questionnaires:

– AGICAP Network of GP and nurses that participate in

clinical trials (>100 GP): validation of patient

diagnosis, opinions, etc.

– Access to specific PHC centres

• Patient questionnaires and procedures

(through their GP)

Possibility to obtain direct data from GPs

SIDIAP: added value 4

1. Population and time period definition

2. A third party extract free text matching this population (ICS)

3. Free text is anonimysed

4. SIDIAP highlights relevant concepts associated with the disease

of interest (defined by the research team)

5. Someone from the research ‘team reads and identifies cases

6. Free text gets back to SIDIAP and eliminates not 'validated' cases

Free text analysis

Mother-child linkage

Validated algorithm to link mother and child pairs in SIDIAP for children born from 2005 to 2016 .

SIDIAP: added value 5

Linkage with other sources: only public institutions

C

I

T

I

Z

E

N

S

EMERGENCIES

PRIMARY

HEALTH CENTERLONG-TERM CARE

CENTER

MENTAL HEALTH

CENTER

HOSPITALS

H1 H2 H3

Public Data Analysis for Health Research and Innovation

Program. PADRIS

SIDIAP: added value 6

• Cancer registry of Parc Salut Mar (hospital basis)

• Registry of patients with renal failure (RMRC) (only public

institutions. PADRIS program)

• ARTPER cohort: cohort of patients with Peripheral Artery

Disease

• Low birth weight babies of a specific hospital

• The Catalan Registry of Arthroplasties (only public institutions.

PADRIS program)

• ReDeGi: Registry of patients with Dementia in Girona

• Metereological and environmental data

• Inpatient Care: Primary Care Centers with > 50% of their hospital

discharges coming from ICS hospitals.

• Spanish mortality registry

SIDIAP: added valueLinkage with other sources (any

institution)

<CODIPROJECTE>

SIDIAP: added value 7

- Project oriented quality control

- Data management and final table for analyses

- Statistical suport and/or analysis

- Methodological suport (RECORD guidelines)

Suport Unit

1. Health management: resources and costs

2. Incidence and prevalence

3. Geographical distribution

4. Risk and prognostic factors

5. Evaluation of health care interventions

6. Pharmacoepidemiology6.1. Drug use

6.2. Prescription evaluation

6.3. Effectiveness and safety

Any epidemiological study

SIDIAP: added value 8

<CODIPROJECTE>

Aznar-Lou I, Iglesias-González M, Gil-Girbau M, Serrano-Blanco A,

Fernández A, Peñarrubia-María MT, Sabés-Figuera R, Murrugarra-

Centurión AG, March-Pujol M, Bolívar-Prados M, Rubio-Valera M.

Impact of initial medication non-adherence to SSRIs on medical

visits and sick leaves. J Affect Disord. 2018;226:282-286.

PMID:29024901.

Several examples

Aznar-Lou I, Pottegård A, Fernández A, Peñarrubia-María MT, Serrano-

Blanco A, Sabés-Figuera R, Gil-Girbau M, Fajó-Pascual M, Moreno-

Peral P, Rubio-Valera M. Effect of copayment policies on initial

medication non-adherence according to income: a population-

based study. BMJ quality & safety. 2018 Mar; doi:10.1136/bmjqs-2017-

007416. Epub 2018 Mar 15. PMID:29545326.

Participant Every patient with a new prescription issued between 2011 and

2014 (3 million patients and 10 million prescriptions).

Outcomes IMNA was estimated throughout dispensing and invoicing

information. Changes in IMNA prevalence after the introduction of copayment

policies (immediate level change and trend changes) were estimated through

segmented logistic regression. The regression models were stratified by economic

status and medication groups.

Mata-Cases M, Franch-Nadal J, Real J, Gratacòs M, López-

Simarro F, Khunti K, Mauricio D. Therapeutic inertia in

patients treated with two or more antidiabetics in primary

care: Factors predicting intensification of treatment.

Diabetes, obesity & metabolism. 2018 Jan; 20(1):103-112.

doi:10.1111/dom.13045. Epub 2017 Jul 28. PMID:28656746.

Aznar-Lou I, Fernández A, Gil-Girbau M, Fajó-Pascual M, Moreno-Peral

P, Peñarrubia-María MT, Serrano-Blanco A, Sánchez-Niubó A, March-

Pujol MA, Jové AM, Rubio-Valera M. Initial medication non-adherence:

prevalence and predictive factors in a cohort of 1.6 million primary

care patients. Br J Clin Pharmacol. 2017 Jun;83(6):1328-1340. doi:

10.1111/bcp.13215. Epub 2017 Feb 24. PubMed PMID: 28229476;

PubMed Central PMCID: PMC5427227

All SIDIAP participants starting an anti-osteoporosis drug between 1/1/2007

and 30/06/2011 (with 2 years wash-out) were included. We modelled

persistence as the time between first prescription and therapy discontinuation

(refill gap of at least 6 months) using Fine and Gray survival models with

competing risk for death.

Carbonell-Abella C, Pages-Castella A, Javaid MK, Nogues X,

Farmer AJ, Cooper C, Diez-Perez A, Prieto-Alhambra D. Early (1-

year) Discontinuation of Different Anti-osteoporosis

Medications Compared: A Population-Based Cohort Study.

Calcified tissue international. 2015 Dec; 97(6):535-41.

doi:10.1007/s00223-015-0040-3. Epub 2015 Jul 23.

PMID:26202819

Garcia-Gil M, Comas-Cufí M, Blanch J, Martí R, Ponjoan A, Alves-

Cabratosa L, Petersen I, Marrugat J, Elosua R, Grau M, Ramos R.

Effectiveness of Statins as Primary Prevention in People With Different

Cardiovascular Risk: A Population-Based Cohort Study. Clin Pharmacol

Ther. 2017 Dec 1. doi: 10.1002/cpt.954. [Epub ahead of print] PubMed

PMID: 29194590.

New users were categorized according to their medical possession ratio (MPR).

The main outcome was atherosclerotic cardiovascular disease

(ASCVD) (myocardial infarction and ischemic stroke).

In adherent patients (MPR 70%), statin treatment decreased ASCVD risk across

the range of coronary risk (from 16-30%).

Reyes C, Tebe C, Martinez-Laguna D, Ali MS, Soria-Castro A,

Carbonell C, Prieto-Alhambra D. One and two-year persistence

with different anti-osteoporosis medications: a retrospective

cohort study. Osteoporosis international : a journal established as

result of cooperation between the European Foundation for

Osteoporosis and the National Osteoporosis Foundation of the USA.

2017 Oct; 28(10):2997-3004. doi:10.1007/s00198-017-4144-7. Epub

2017 Jul 16. PMID:28714038.

Barrecheguren M, Monteagudo M, Ferrer J, Borrell E, Llor C,

Esquinas C, Miravitlles M. Treatment patterns in COPD

patients newly diagnosed in primary care. A population-

based study. Respiratory medicine. 2016 Feb; 111:47-53.

doi:10.1016/j.rmed.2015.12.004. Epub 2015 Dec 23.

PMID:26758585.

Ramos R, Comas-Cufí M, Martí-Lluch R, Balló E, Ponjoan A, Alves-Cabratosa L,

Blanch J, Marrugat J, Elosua R, Grau M, Elosua-Bayes M, García-Ortiz L,

Garcia-Gil M. Statins for primary prevention of cardiovscular events in old

and very old adults with and without type 2 diabetes: retrospective cohort

Study. BMJ. 2018 Sep 5;362:k3359. doi: 10.1136/bmj.k3359.

In participants older than 74 years without type 2 diabetes, statin treatment was not

associated with a reduction in atherosclerotic CVD or in all cause mortality,

even when the incidence of atherosclerotic CVD was statistically significantly

higher than the risk thresholds proposed for statin use. In the presence of diabetes,

statin use was statistically significantly associated with reductions in the incidence

of atherosclerotic CVD and in all cause mortality. This effect decreased

after age 85 years and disappeared in nonagenarians.

Giner-Soriano M, Vedia Urgell C, Roso-Llorach A, Morros R, Capellà D,

Castells X, Ferreira-González I, Troncoso Mariño A, Diògene E, Elorza

JM, Casajuana M, Bolíbar B, Violan C. Effectiveness, safety and costs

of thromboembolic prevention in patients with non-valvular atrial

fibrillation: phase I ESC-FA protocol study and baseline

characteristics of a cohort from a primary care electronic database.

BMJ open. 2016 ; 6(1):e010144. doi:10.1136/bmjopen-2015-010144.

pii:bmjopen-2015-010144. PMID:26823179.

Losada-Grande E, Hawley S, Soldevila B, Martinez-Laguna D, Nogues

X, Diez-Perez A, Puig-Domingo M, Mauricio D, Prieto-Alhambra D.

Insulin use and Excess Fracture Risk in Patients with Type 2

Diabetes: A Propensity-Matched cohort analysis. Scientific reports.

2017 Jun; 7(1):3781. doi:10.1038/s41598-017-03748-z. Epub 2017

Jun 19. pmc:PMC5476619. PMID:28630427.

Fàbregas M, Berges I, Fina F, Hermosilla E, Coma E, Méndez L, Medina M,

Calero S, Serrano E, Morros R, Monteagudo M, Bolíbar B. Effectiveness of

an intervention designed to optimize statins use: a primary prevention

randomized clinical trial. BMC family practice. 2014 ; 15:135.

doi:10.1186/1471-2296-15-135. pii:1471-2296-15-135. pmc:PMC4112648.

PMID:25027229.

Wilson N, Sanchez-Riera L, Morros R, Diez-Perez A, Javaid MK,

Cooper C, Arden NK, Prieto-Alhambra D. Drug utilization in

patients with OA: a population-based study. Rheumatology

(Oxford, England). 2015 May; 54(5):860-7.

doi:10.1093/rheumatology/keu403. pii:keu403. PMID:25339639.

IDIAP primary care researchers (main focus)

Electronic medical records

National: BIFAP

European: CPRD (United Kingdom), THIN Database (United Kingdom), IPCI

(Netherlands), Danish registries (Aarhus University)

Public Universities, Research Institutes, Associations

National : Valld’Hebron Research Institute, Catalan Institute of Pharmacology of the

Valld’Hebron, Municipal Institute of Medical Research (IMIM) - Parc de Salut Mar,

Polytechnic University of Catalonia, University of Girona, Barcelona Agency of Public

Health, University Autonomous of Barcelona, Centre de Recerca Matemàtica

International : University of Oxford, Erasmus University, Utrecht University, Aarhus

University, ENCEPP (European Network of Centres for Pharmacoepidemiology and

Pharmacovigilance), EU-ADR Alliance

Drug and other private companies

Sanofi, Astra, Bioiberica, AMGEN, Novartis, MSD, Bayer, Grifols, Servier, Boeringher,

Almirall, IMS Health, RTI Health Solutions

SIDIAP: collaborations

AUH-AS

IPCITHIN

HSD PEDIANET

SIDIAP

SIDIAP: collaborations

EU-ADR Alliance

Data sourcesNetherlands UK Denmark

HSD PEDIANET IPCI THIN Aarhus SIDIAP SIDIAP PEDIATRICS

Type of datasourceElectronic

medical record

Pediatrician

records

Electronic

medical record

Electronic

medical recordRecord linkage

Electronic medical

record +

pharmacy invoice

Electronic medical

record +

pharmacy invoice

Period covered From 1998 From 2002 From 1996 From 1990 From 1998 From 2005 From 2006

Population1.5 million

(active)

200.000 (active),

pediatric

1.1 million

(active)

3.5 million

(active)

9 million total

1.8 million (active) 5.1 million (active) 826,940 (active)

Setting Primary care Outpatient care Primary care Primary care Dynamic cohorts

Primary care

linked to hospital

admissions data

Primary care

pediatrics linked

to hospital

admissions data

Type of diagnoses Outpatient Outpatient In-outpatient In-outpatient In-outpatient In-outpatient Outpatient

Causes of death Incomplete Yes Yes Yes YesYes (linked with

mortality register)

Yes (linked with

mortality register)

Vaccinations Yes for now partiallyYes (to be

linked)Yes Yes (selected) Yes Yes

Drugs Prescriptions Prescriptions Prescriptions Prescriptions Prescriptions

Prescriptions and

Community

pharmacy

dispensings

Prescriptions and

Community

pharmacy

dispensings

Laboratory values Yes Yes Yes Yes YesYes (primary care

labs)

Yes (primary care

labs)

Frequency of updates Every 6 months ContinuousEvery 6

months

Every 3

monthsEvery 12 months Every 12 months Every 12 months

SpainItaly

SIDIAP: collaborations

• Research projects: 241 national and

international projects

• Papers published: 95 papers

6

2

SIDIAP: some results

SIDIAP: how to get data

SIDIAP: how to get data

sidiap@idiapjgol.org

Data

management

Database

Application

form+project

- SC

- EC

- Agreements

Research team

SIDIAP: how to get data

Fees depending on:

- Data complexity and number of downloads

- Extent of data management, statistical issues

- Degree of IDIAP group involvement:

study design, reports, papers, seminars...

1. Validation studies: coronary heart disease, dementia,

peripheral venous insufficiency

2. New variables: smoking, BMI, alcohol, deprivation index: update

3. SIDIAP-’prospective’: validations, interventions, pragmatic clinical trials

4. Free text

5. OHDSI: common data model

6. Machine learning: outlier detection

SIDIAP: work in progress

Obrigada

mgarcia@idiapjol.info