What Can Government-Administered Registries Learn from Quality Registries?

Marta Ebbing, MD, PhDDepartment director, Dept. of Health RegistriesNorwegian Institute of Public HealthNo conflicts of interestThanks to all my colleagues!

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Outline

Register operation with quality

GARs in Norway – S & W

How to combine the best from GARs and QRs?

Summary and conclusion

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Norwegian Advantages

All residents unique 11-digit personal IDAll residents access to public health careGovernment administered registries (6/17);

Cause of Death Registry (CoDR) (1951)Cancer Registry (CRN) (1955)Medical Birth Registry (MBRN) (1967)Prescription Database (NorPD) (2004)Patient Registry (NPR) (2008)Cardiovascular Disease Registry (NCVDR) (2012 )

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Registries Operation with Quality

• Patient data• Paper based• Electronic

Messages

• Monitoring message traffic

• QA of each message

Receiving • Linking data from different sources

• QA of aggregated data

Preparation

• Health statistics, in-house research

• Handing out data

Results

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Registries Operation with Quality

• Patient data• Paper based• Electronic

Messages

• Monitoring message traffic

• QA of each message

Receiving • Linking data from different sources

• QA of aggregated data

Preparation

• Health statistics, in-house research

• Handing out data

Results

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GARs – Legal Regulation

Wide purposesRelevant and sufficient information – “need no know”, not “nice to know”Personal integrity and data security

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GARs in Norway – S & WStrengthts WeaknessesAll individuals or events included

Lack of detailed medical information

Governmental responsibility; funding, continuity, data security, personal privacy

Lack of genuine interest from relevant health care personnel

Many different registration systems

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Two GAR Examples

Norwegian Cardiovascular Disease Registry (2012 )

Medical Birth Registry of Norway (1967 )

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CVD in Norway 2012-2013Data Source Unit 2012 2013

GPs1 Consultations for CVD or related problems 1 850 954 1 814 245

Pharmacies2 Users of CVD medications (ATC: C) 1 018 877 1 039 755

Hospitals3 Patients with CVD or related diagnoses 339 155 327 845

CoDR4 Patients diseased from CVD 13 018 12 132

1Reimbursementdata from «Kontroll og utbetaling av helserefusjoner» 2Norwegian Prescription Database3Norwegian Cardiovascular Disease Registry4Cause of Death Registry

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Norwegian CVD Registry

National, person identifiable, compulsory Established in 2012Combined registry (core + 8 QRs) The Norwegian Institute of Public Health responsible for data management

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BMJ 2005 331;942-945

based research and those who do not, or cannot, consent. Blanket requirements for explicit consent for the use of individuals' identifiable data can bias disease registers, epidemiological studies, and health services research.PMID:

16223793[PubMed - indexed for MEDLINE]

PMCID:PMC1261192

Free PMC Article•

Images from this publication.See all images (2)Free text

Fig

1

Kaplan-Meier survival curve for death from all causes among 187 adults with brain arteriovenous malformations by their consent to participate in an observational study (consenters 2 deaths, non-consenters 12 deaths; log rank=15.8, P=0.0001)Bias from requiring explicit consent from all participants in observational research: prospective, population based studyBMJ. 2005 October 22;331(7522):942-942.

Fig

2

Kaplan-Meier analysis of time to first seizure among 187 adults with brain arteriovenous malformations by their consent to participate in an observational study (consenters 42 events, non-consenters 13 events; log rank=4.1, P=0.044)Bias from requiring explicit consent from all participants in observational research: prospective, population based studyBMJ. 2005 October 22;331(7522):942-942.PUBLICATION

TYPES, MESH

TERMSPublication Types

•Multicenter

Study•Research

Support, Non-U.S. Gov'tMeSH Terms

•Adolescent•Adult•Aged•Central Nervous

System

Vascular

Malformations/complications•Central Nervous

System

Vascular

Malformations/diagnosis*•Central Nervous

System

Vascular

Malformations/mortality•Epidemiologic

Methods•Female•Humans•Informed

Consent*•Intracranial Hemorrhages/epidemiology•Intracranial Hemorrhages/etiology•Male•Middle

Aged•Patient Selection/ethics*•Prognosis•Scotland/epidemiology•Seizures/epidemiology•Seizures/etiology•Selection

BiasLINKOUT

-

MORE

RESOURCESFull Text Sources•HighWire•Europe PubMed Central•Ovid Technologies, Inc.•PubMed Central•PubMed Central Canada

Other Literature Sources•Labome Researcher Resource - ExactAntigen/Labome•Access more work from the authors - ResearchGate

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RELATED CITATIONS IN PUBMED

•Demographic and AIDS-related characteristics of consenters to a population-based HIV-survey: results from a pilot study in Arusha, Tanzania.

[East Afr Med J. 1994]

Demographic and AIDS-related characteristics of consenters to a population-based HIV-survey: results from a pilot study in Arusha, Tanzania.Ole-King'Ori N, Klepp KI, Kissila PE, Biswalo PM, Mnyika KS. East Afr Med J. 1994 Aug; 71(8):483-9.

•Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease.

[Heart. 2007]

Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease.Buckley B, Murphy AW, Byrne M, Glynn L. Heart. 2007 Sep; 93(9):1116-20. Epub 2007 May 13.

•Assessing the impact of the requirement for explicit consent in a hospital-based stroke study.

[QJM. 2008]

Assessing the impact of the requirement for explicit consent in a hospital-based stroke study.Jackson C, Crossland L, Dennis M, Wardlaw J, Sudlow C. QJM. 2008 Apr; 101(4):281-9. Epub 2008 Feb 15.

• Written informed consent and selection bias in observational studies using medical records: systematic review.

[BMJ. 2009]

Review Written informed consent and selection bias in observational studies using medical records: systematic review.Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC. BMJ. 2009 Mar 12; 338:b866. Epub 2009 Mar 12.

• Getting meaningful informed consent from older adults: a structured literature review of empirical research.

[J Am Geriatr Soc. 1998]

Review Getting meaningful informed consent from older adults: a structured literature review of empirical research.Sugarman J, McCrory DC, Hubal RC. J Am Geriatr Soc. 1998 Apr; 46(4):517-24.

See reviews...See all...CITED BY 18 PUBMED CENTRAL ARTICLES

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NPR

CoDR

CPR Core

Reg

istry

NCVDR

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Core Data

Person informationAdministrative informationMedical information

Diagnoses from the NPR for outpatient visits and hospital stays

ICD-10 Ch. IX, codes I00-I99, ++

Procedures from the NPRNCSP/NCMP Ch. F, P ++

Cause of death from the CoDRfor persons registered with or diceased from CVD

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NPR

CoDR

CPR

Stroke Registry

Heart Surgery Registry

Heart Failure Registry

Invasive Cardiology Registry

Myocardial Infarction Registry

Cardiac Arrest Registry

Vessel Surgery Registry

Pacemaker- and ICD Registry

Core

Reg

istry

NCVDR

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Quality Registry Data

Known risk factors for CVDHistory of CVDCurrent CVDMedical details on current episode/procedureResults of health careFurther treatment

MedicationsOther secondary prevention efforts

Quality of life / PROMS

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NCVDR Council (2012)

Regional Health Authorities, Universities/Research, QRs, QR Services, Central Health Authorities

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Challenges

Legal issues – personal data actTechnical issuesQuality of data in NPR and CoDRToo much focus on datacollection, and too little on analyses?Many stakeholders, consensus necessary

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755 878 episodes, 327 845 pasients

575 261 episodes withmain diagnosis fromqualifying diagnoses

385 677outpatient visits

189 584hospital stays

NCVDR Core Registry 2013

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Variable CR QR Coverage No. of patients with stroke1 9 730 7 260 74,6%No. of pasients with AMI2 14 485 12 336 85,2 %No. of PCIs at HUH3 1 325 1 290 97,4 %No. of CABGs4 1 926 1 919 99,6 %No. of pacemaker implantations5 3 468 3 459 99,7 %Abbreviations: CR, core registry; QR, quality registry; AMI, acute myocardial infarction; HUH, Haukeland University Hospital; CABG, coronary artery bypass grafting.1NCVDR Core Registry (main diagnosis) vs. Stroke Registry 2NCVDR Core Registry (main or seconrady diagnosis) vs. Myocardial Infarction Registry3NCVDR Core Registry vs. Invasive Cardiology Registry4NCVDR Core Registry vs. Heart Surgery Registry vs5NCVDR Core Registry vs. Pacemaker- and ICD Registry.

«Coverage» CR vs. QR in 2013

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NCVDR Achievements 2012-13

Improvement of quality of health care services for patients with cardiovascular disease

Surveillance; incidence and prevalence Data for research Data for evaluation of results of health care

services – National Quality Indicators Stroke, AMI

Data for planning of health care services

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NCVDR Combined Registry Model

1. Exploit existing data 2. Coordinate data capture, data

handling and analyses3. Ensure full coverage4. Ensure influence from clinical

specialists and researchers

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No. of Births in Norway

2004 2005 2006 2007 2008 2009 2010 2011 2012 201353,000

54,000

55,000

56,000

57,000

58,000

59,000

60,000

61,000

62,000

63,000

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No. of Maternity Units in Norway

2004 2005 2006 2007 2008 2009 2010 2011 2012 201346

48

50

52

54

56

58

60

62

64

66

68

≥ 10 BirthsAll

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Medical Birth Registry of Norway

National, person identifiable, compulsory Established in 1967Combined registry (core + 1 QR) The Norwegian Institute of Public Health responsible for data management (2002)

Core data collected at birth from maternity units via MBRN system (1967)QR data collected after birth from hospitals via QR system (2006)

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CPR Core

Reg

istry

MBRN

Hosp

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Hosp

CPR

Norwegian Newborn Medical QR

Core

Reg

istry

MBRN

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MBRN Council (2009 )

Obstetricians, midwifes, NIPH

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«QR Data» in MBRN Core Registry

Details on risk factorsSmoking habits (1999)Body mass index (2005)

Details on deliveriesRobson classification, gestational age ++Progress and procedures during delivery

Details on the newbornCongenital malformationsOther conditions at birth

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Statistics by Maternity Units

Since 2008, in cooperation with maternity unitsTo provide numbers for the maternity units’ evaluation on clinical practice To provide data for quality indicators published at helsenorge.noFor the care providers, health administrators and the publicHandle with care!

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0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

AlleOUS UllevålHaukelandStavangerAhusSt. OlavØstfoldOUS Rikshosp.KristiansandVestfoldDrammenTelemarkBærumHaugesund

ÅlesundTromsøLillehammerBodøArendalLevangerElverumFørdeGjøvikRingerikeMoldeVoldaHammerfestStordHarstadVossKongsvingerKristiansundNamsosFlekkefjordRanaVesterålenKongsbergSandnessjøenNarvikKirkenes

Mor røyker ved svangerskapets begynnelse, 2013 (99 % konfidensint.)

Smok

ing

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0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

AlleOUS UllevålHaukelandStavangerAhusSt. OlavØstfoldOUS Rikshosp.KristiansandVestfoldDrammenTelemarkBærumHaugesund

ÅlesundTromsøLillehammerBodøArendalLevangerElverumFørdeGjøvikRingerikeMoldeVoldaHammerfestStordHarstadVossKongsvingerKristiansundNamsosFlekkefjordRanaVesterålenKongsbergSandnessjøenNarvikKirkenes

Mor har overvekt eller fedme før svangerskapet, 2013 (99 % konfidensint.)

Ove

rwei

ght &

Obe

sity

2014-12-09

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0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

AlleOUS UllevålHaukelandStavangerAhusSt. OlavØstfoldOUS Rikshosp.KristiansandVestfoldDrammenTelemarkBærumHaugesund

ÅlesundTromsøLillehammerBodøArendalLevangerElverumFørdeGjøvikRingerikeMoldeVoldaHammerfestStordHarstadVossKongsvingerKristiansundNamsosFlekkefjordRanaVesterålenKongsbergSandnessjøenNarvikKirkenes

Keisersnitt blant alle fødsler, 2013 (99 % konfidensint.)

Caes

area

n, A

ll D

eliv

erie

s

2014-12-09 35Ebbing, NIPH

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helsenorge●no

“Several studies have shown variations in the incidence of caesarean sections at otherwise comparable maternity wards in Norway. The variations can not be explained only from patient composition of mothers and percentage of women wanting a caesarean section. The optimal level of deliveries by caesarean is not known.”

https://helsenorge.no/Kvalitetsindikatorer/graviditet-og-fodsel/kvalitetsindikator-keisersnitt

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0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

AlleOUS UllevålHaukelandStavangerAhusSt. OlavØstfoldOUS Rikshosp.KristiansandVestfoldDrammenTelemarkBærumHaugesund

ÅlesundTromsøLillehammerBodøArendalLevangerElverumFørdeGjøvikRingerikeMoldeVoldaHammerfestStordHarstadVossKongsvingerKristiansundNamsosFlekkefjordRanaVesterålenKongsbergSandnessjøenNarvikKirkenes

Keisersnitt innen Robson-gruppe 1, 2013 (99 % konfidensint.)

Cae

saer

ean

in R

obso

n 1

2014-12-09 37Ebbing, NIPH

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

AlleOUS UllevålHaukelandStavangerAhusSt. OlavØstfoldOUS Rikshosp.KristiansandVestfoldDrammenTelemarkBærumHaugesund

ÅlesundTromsøLillehammerBodøArendalLevangerElverumFørdeGjøvikRingerikeMoldeVoldaHammerfestStordHarstadVossKongsvingerKristiansundNamsosFlekkefjordRanaVesterålenKongsbergSandnessjøenNarvikKirkenes

Keisersnitt innen Robson-gruppe 3, 2013 (99 % konfidensint.)

Cae

saer

ean

in R

obso

n 3

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Summary & Conclusion

GARs – some of them with QR qualities

We must reduce the burden of reporting!

Cooperation and concensus – and linking!

Combined registries – the way to proceed?

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