Presentation MRCG Presentation MRCG October 2012October 2012

Fionnuala DonohueFionnuala Donohue

Presentation OutlinePresentation Outline

RequirementsRequirements

Description Research ComponentsDescription Research Components

Research FindingsResearch Findings

RecommendationsRecommendations

RequirementsRequirements

Thorough assessment of patient registries in IrelandThorough assessment of patient registries in Ireland

Agreed definition of registryAgreed definition of registry

Identification of registries that currently existIdentification of registries that currently exist

Detailed inventory of registries in Ireland via questionnaireDetailed inventory of registries in Ireland via questionnaire

Literature review & expert opinion on critical issuesLiterature review & expert opinion on critical issues

Research to provide recommendations for future Research to provide recommendations for future development of registriesdevelopment of registries

DefinitionDefinition

““an organized system that uses observational an organized system that uses observational study methods to collect uniform data (clinical study methods to collect uniform data (clinical and other) ….. for a population defined by a and other) ….. for a population defined by a

particular disease, condition or exposure, and particular disease, condition or exposure, and that serves one or more predetermined that serves one or more predetermined scientific, clinical or policy purposes.”scientific, clinical or policy purposes.”

Association for Healthcare Quality and Research in Association for Healthcare Quality and Research in America (AHRQ 2007)America (AHRQ 2007)

Research ComponentsResearch Components

International Guidelines for registriesInternational Guidelines for registries

Identification of Registers in IrelandIdentification of Registers in Ireland

Survey with RegistersSurvey with Registers

Stakeholder InterviewsStakeholder Interviews

Focus Groups with PatientsFocus Groups with Patients

GuidelinesGuidelines

England United States Australia Sweden

Ethics & privacy

Freely given fully informed consent, waiver if disproportionate effort/methodological problems involved. Anonymisation or separation of identifiable data Research Ethics approval if involved in research.

Freely given fully informed consent unless waiver granted. Anonymisation or separation of identifiable data and use of crosswalk files to link to clinical file with restricted access. Must have ethical approval.

Consent best practice, but can be waived under certain circumstancesRequire ethical approval for data collection at each site unless covered by legislation

Generally consent required for data processing, but the quality registries are exempt from this obligation (section 18 Personal Data Act) Must have ethical approval

Data Standards

Written data standards.Multiple sources of case ascertainment.Validation to ensure correctness of data. Case definition essential.

Existing data standards, or develop standards & use data dictionary & data map. Documented data validation/cleaning. Staff training & supervision.Defined target population clear inclusion & exclusion criteria.

Use existing standards or develop standards & use data dictionary.Data validation.Training & supervision of staff.Published eligibility criteria.

Written agreed data elements. In built data validation. Meet end users to ensure data validity & completeness. Defined system cases lost to follow up.

Evaluation Regular evaluation to ensure aims & objectives still valid & being met. If not close/revamp registry.

Regular evaluation to assess quality including purpose & context, data validity, resources and costs.

Regular evaluation to ensure that it is meeting key functions in order to receive funding.

Registries must complete evaluation when applying for continued funding.

Governance Compliance with data protection, security & ethical requirements. Oversight & accountability of staff. Publication & wide use of registry data.

Governance functions include executive, scientific, liaison, adjudication, data access, use & publication should be established.

Formal governance structure (must be legal entity) to include executive & management functions. Publication of registry findings.

Compliance with data protection, public record regulations & encryption standards. Accountability of staff & management.

Resources & Funding

Appropriate multidisciplinary team. Robust and secure funding allocation system, with 3-5 yearly funding, for approved registries.

Multidisciplinary team including clinical, registry science, database management, legal, QA.Mixed funding methods.

Mix of disciplines including Clinical, epidemiology & health informatics. Secure funding subject to review of relevance and quality.

Central allocation of funding based on transparent criteria with deadline for applications in October & decisions in December.

Central Co-ordination

Central co-ordination of policy & practice. National register of registries.

Not covered. These guidelines act as national resource. National registry of registries.

National body for funding registries & providing support to registries.

Identification of RegistriesIdentification of Registries

Identification of RegistriesIdentification of Registries Previous work by Newton & Garner in UK 2002 Previous work by Newton & Garner in UK 2002

(postal survey) and National Health and Medical (postal survey) and National Health and Medical Research CouncilResearch Council in Australia 2007 (peer in Australia 2007 (peer consultation & search strategy)consultation & search strategy)

The establishment of an information board at the The establishment of an information board at the 2008 Healthcare Informatics Society of Ireland 2008 Healthcare Informatics Society of Ireland annual meetingannual meeting

The examination of the website of the Office of The examination of the website of the Office of the Data Protection Commissioner.the Data Protection Commissioner.

A search in PubMed and a web based searchA search in PubMed and a web based search A canvas of 250 stakeholders from healthcare A canvas of 250 stakeholders from healthcare

services, academic bodies and clinical societies.services, academic bodies and clinical societies.

Outcome of identification processOutcome of identification process

Canvas response rate 70% (175/250)Canvas response rate 70% (175/250)

102 provided information on registries102 provided information on registries

Smaller number of additional registries Smaller number of additional registries identified through search strategyidentified through search strategy

Process validation & de-duplicationProcess validation & de-duplication

End outcome 47 registries currently activeEnd outcome 47 registries currently active

Survey ResultsSurvey Results

Survey Results GeneralSurvey Results General

Response rate 70.2% (33/47)Response rate 70.2% (33/47)

75.8% National/Regional75.8% National/Regional

42% 42% ≤≤ 100 new cases/year 100 new cases/year

58% held on server, 1 on paper & 71% 58% held on server, 1 on paper & 71% paper element in data transferpaper element in data transfer

21% had web enabled data access21% had web enabled data access

Year data collection startedYear data collection started

0

2

4

6

8

10

12

14

16

pre 1980 1980-89 1990-99 2000-09

No. of registries

Survey Results UsesSurvey Results Uses

Function Listed as primary function

n=33

Listed as secondary function

n=32

Listed as tertiary

functionn=31

Improving patient safety/quality of care

15 (45.5%) 6 (18.8%) 2 (6.4%)

Disease surveillance /disease control

6 (18.2%) 9 (28.1%) 4 (12.9%)

Health service planning 4 (12.1%) 6 (18.7%) 6 (19.4%)

Describing natural history of disease

4 (12.1%) 0 (0%) 2 (6.5%)

Research 3 (9.1%) 8 (25.0%) 15 (48.4%)

Determining clinical and/or cost effectiveness of an intervention

1 (3.0%) 3 (9.4%) 2 (6.4%)

Survey results standardsSurvey results standards 39% registries 100% coverage, 30% < 50% 39% registries 100% coverage, 30% < 50% 60% assessed coverage within 12 mths60% assessed coverage within 12 mths

58% used a c58% used a case definitionase definition 51% used a data dictionary51% used a data dictionary 54% carried out regular data validation 54% carried out regular data validation

70% carried out d70% carried out data de-duplication (70% software)

77% followed up missing data (58% contact with 77% followed up missing data (58% contact with original clinical sourceoriginal clinical source

Survey Results StandardsSurvey Results StandardsCase definitionCase definition Data DictionaryData Dictionary

YesYes NoNo YesYes NoNo

All registersAll registers 58%58% 42%42% 41%41% 59%59%

Management Management committeecommittee

56%56% 44%44% 40%40% 60%60%

Clinical/Scientific Clinical/Scientific committeecommittee

53%53% 47%47% 41%41% 59%59%

Steering GroupSteering Group 65%65% 35%35% 44%44% 56%56%

Ethical ApprovalEthical Approval 69%69% 31%31% 47%47% 54%54%

Survey Results ConsentSurvey Results Consent

73% used some form of consent 73% used some form of consent 46% used written consent 46% used written consent 75% had an “opt out” system 75% had an “opt out” system

Of the 27% with no consent 55% also did Of the 27% with no consent 55% also did not have an opt out system not have an opt out system

Written(%) Verbal (%) Implied (%) None (%)

All registries (n=33) 15 (45.5) 2 (6.1) 7 (21.2) 9 (27.3)

Registry Size

Registry =/<500 new cases/yr (n=18)

9 (50.0) 1 (5.6) 4 (22.2) 4 (22.2)

Registry >500 new cases/yr (n=10)

2 (20.0) 0 (0) 3(30.0) 5 (50.0)

No. WTE employed by registry

Registry 0 WTE (n=7) 2 (28.6) 0 (0) 3 (42.9) 2 (28.6)

Registry <3 WTE (n=18) 9 (50) 2 (11.1) 2 (11.1) 5 (27.8)

Registry >/= 3 WTE (n=8) 4 (50) 0 (0) 2 (25) 2 (25)

ConsentConsent

Governance structures & processesGovernance structures & processesFeature No of

responsesYES NO

n % n %

Management Committee 30 16 53.3 14 46.6

Steering Group 31 20 64.5 11 35.5

Scientific committee/clinical support 31 19 61.3 12 38.7

Ethical committee approval 28 18 64.3 10 35.7

Constitution 27 11 40.7 16 59.3

Minutes 32 20 62.5 12 37.5

Patient representation 31 11 35.5 20 62.5

Registration with the Data Protection Commissioner *

29 23 79.3 6 20.7

Staff trained in data protection 30 20 66.7 10 33.3

Staff confidentiality contract 33 26 78.8 7 21.2

Written access protocol 30 13 43.3 17 56.7

Password protection 32 30 93.8 2 6.3

Data encryption 31 17 54.8 14 45.1

Data anonymisation 31 17 54.8 14 45.2

Disaster recovery mechanism 33 29 87.9 4 12.1

Survey Results ResourcesSurvey Results Resources 21% of registers had no staff directly 21% of registers had no staff directly

employedemployed For those with staff (79%) For those with staff (79%)

69% two or less staff members 69% two or less staff members 27% between three and ten staff27% between three and ten staff

88% of registers (including 71% of those with 88% of registers (including 71% of those with no staff) had a named administrator. no staff) had a named administrator.

Availability of expertiseAvailability of expertise• 30% no statistical support30% no statistical support• 3% no clinical support3% no clinical support• 6% no IT support6% no IT support

Survey Results ResourcesSurvey Results ResourcesInitial FundingInitial Funding

68% state funds68% state funds 12% commercial funding 12% commercial funding 20% funding through a charity20% funding through a charity

Ongoing FundingOngoing Funding 72% state funding72% state funding 12% funding through a charity 12% funding through a charity 4% commercial funding 4% commercial funding 12% no funding 12% no funding 3 registers had dual funding 3 registers had dual funding

Comparative AnalysisComparative Analysis

Registry with no staff V with staff

Registry with <2 staff V 2 or more staff

N RR 95% CI Fisher Exact

N RR 95% CI Fisher Exact

Operate without consent

32 1.62 0.85-3.09 0.20 32 1.17 0.51-2.69

0.50

Anonymise data 31 0.25 0.04-1.55 0.05 31 0.54 0.28-1.07

0.10

Encrypt data 31 0.43 0.13-1.43 0.09 31 0.51 0.31-0.85

0.03

Password protection 32 0.74 0.46-1.20 0.11 32 0.87 0.74-1.02

0.36

Oversight Committee 32 0.68 0.35-1.32 0.16 32 0.68 0.51-0.91

0.05

Ethics Approval 28 0.73 0.31-1.72 0.36 28 0.95 0.53-1.69

0.60

Case Definition 31 0.72 0.42-1.26 0.18 31 0.64 0.37-1.11

0.15

Data Standardisation 33 0.29 0.05-1.83 0.10 33 0.58 0.27-1.23

0.17

Data Validation processes

33 0.29 0.09-0.96 0.001 33 0.87 0.65-1.17

0.40

Large registries V small registries *

N RR 95% CI Fisher Exact

Operate without consent 28 2.06 1.07-3.97

0.04

Anonymise data 27 0.68 0.29-1.60

0.29

Encrypt data 27 1.50 0.75-3.00

0.25

Password protection 27 1.20 0.98-1.48

0.28

Oversight Committee 28 0.68 0.40-1.15

0.10

Ethics Approval 25 0.46 0.21-1.01

0.02

Case Definition 26 1.47 0.83-2.59

0.21

Data Standardisation 28 1.13 0.50-2.52

0.54

Data Validation processes 28 0.79 0.51-1.22

0.23

Lessons LearntLessons Learnt

63% good quality consistent data that is 63% good quality consistent data that is usedused

37% stakeholder involvement37% stakeholder involvement improves improves data quality & utilitydata quality & utility

26% resources esp for staff training to 26% resources esp for staff training to ensure quality dataensure quality data

19% importance of giving enough resources 19% importance of giving enough resources to planning and implementation phaseto planning and implementation phase

Way ForwardWay Forward

26% continuity in resource 26% continuity in resource allocationallocation

22% improved IT 22% improved IT 22% introduction of national 22% introduction of national

standardsstandards19% legislation19% legislation

Focus GroupsFocus Groups

MethodologyMethodology Focus groups with patients with Focus groups with patients with

experience of chronic illnessexperience of chronic illness Participants identified through patient Participants identified through patient

support organisationssupport organisations Two groups held in neutral venue with Two groups held in neutral venue with

facilitator and note taker presentfacilitator and note taker present Tapes transcribed by commercial Tapes transcribed by commercial

companycompany Thematic content analysis supported by Thematic content analysis supported by

Weft QDA software packageWeft QDA software package

Focus Groups Main ThemesFocus Groups Main ThemesMain theme Sub-theme

1. Support for patient registries. 1.1 Recognition of the value of registries.1.2 Factors that would reduce support for

registries.

2. Consent not an absolute requirement.

2.1 Why Consent should be obtained.2.2 Disadvantages to seeking consent.

3. Patient registries should be regulated.

3.1 Regulation to ensure quality and value.3.2 Regulation to protect confidentiality.

4. Data linkage can be beneficial. 4.1 Unique identifiers to facilitate linkage.4.2 Issues with linkage.

Semi structured Semi structured interviewsinterviews

Semi structured interviewsSemi structured interviews

13 interviews over 6 months13 interviews over 6 months Interviews by phone or in personInterviews by phone or in person Male:Female 10:3 Dublin:Outside Dublin 7:6Male:Female 10:3 Dublin:Outside Dublin 7:6 Variety of backgrounds Variety of backgrounds Interviews recorded, transcribed and Interviews recorded, transcribed and

analysed using thematic content analysisanalysed using thematic content analysis Weft QDA software used to support Weft QDA software used to support

analysisanalysis

ThemesThemes

Main Theme Sub-theme

1. Perceived positive role for patient registries with some reservations.

1.1 To have a role must contain high quality data.1.2 Require resources for data analysis and dissemination of findings.1.3 Registries are not the solution to all information deficits in the health services.

2. Support for a waiver from the requirement for consent.

2.1 Circumstances where a waiver could be justified.2.2 If waiver system allowed, specific systems should be in place.2.3 Capacity issues with consent that need to be addressed.

Main Theme Sub-theme

3. Good governance is key to public trust in patient registries.

3.1 Data Protection a cornerstone of good governance. 3.2 Good governance essential if data linkage to occur.

4. Legislation for registries is urgently required.

4.1 Legislation needs to facilitate different types of registries.4.2 Should allow for an approval process linked to transparent funding system.

RecommendationsRecommendations

Role of patient registriesRole of patient registries A planned approach to the establishment of new A planned approach to the establishment of new

registries. registries. Existing work (IPH (2007) and HIQA (2010a)) Existing work (IPH (2007) and HIQA (2010a))

should be used to establish areas where a should be used to establish areas where a registry is the appropriate solution to information registry is the appropriate solution to information deficits.deficits.

Existing registries should be examined to identify Existing registries should be examined to identify possible opportunities for merger, rationalisation possible opportunities for merger, rationalisation or economies of scale. or economies of scale.

Registries that are found not to be fit for purpose Registries that are found not to be fit for purpose should be re-vamped or closed.should be re-vamped or closed.

ConsentConsent Legislation to clearly outline the circumstances in which Legislation to clearly outline the circumstances in which

registries can operate without consent & to address registries can operate without consent & to address areas where there is ambiguity regarding an individual’s areas where there is ambiguity regarding an individual’s ability to consent ability to consent

Registries that are permitted to operate without consent Registries that are permitted to operate without consent must undergo an approval and on-going evaluation must undergo an approval and on-going evaluation process.process.

Law Reform Commission proposals relating to those Law Reform Commission proposals relating to those aged 16 & 17 yrs of age & those > 18 yrs deemed to lack aged 16 & 17 yrs of age & those > 18 yrs deemed to lack capacity to consent and the Health Information Bill in capacity to consent and the Health Information Bill in relation to those aged 16 & 17 years of age should be relation to those aged 16 & 17 years of age should be implemented. implemented.

Where a person < 18 years is currently enrolled in a Where a person < 18 years is currently enrolled in a registry their assent should be sought & documented registry their assent should be sought & documented with their parent’s consent. with their parent’s consent.

Registries should have procedures in place to ensure Registries should have procedures in place to ensure consent is obtained as soon as practicable after an consent is obtained as soon as practicable after an individual reaches the age of 18 years.individual reaches the age of 18 years.

Data LinkageData Linkage

Introduction of legislation proposed in the Health Introduction of legislation proposed in the Health Information Bill to govern circumstances & rules Information Bill to govern circumstances & rules under which data linkage/data matching can under which data linkage/data matching can occur. occur.

Enactment of the Health Information Bill (part Enactment of the Health Information Bill (part five) to allow for the introduction of a unique five) to allow for the introduction of a unique health identifier in accordance with the health identifier in accordance with the recommendations of the HIQA reportrecommendations of the HIQA report

Continued introduction of information standards Continued introduction of information standards across the healthcare system to allow across the healthcare system to allow meaningful sharing & comparability of datameaningful sharing & comparability of data

National policy for patient registriesNational policy for patient registries

A national policy should be developed to address;A national policy should be developed to address;

Priority areas for registry development having regard to:Priority areas for registry development having regard to: National Health Information Strategy.National Health Information Strategy. Current available information systems.Current available information systems. Impact of the health issue concerned on the population.Impact of the health issue concerned on the population. Potential for registry to drive change in the health system.Potential for registry to drive change in the health system.

Description & designation of a central oversight function Description & designation of a central oversight function for registries.for registries.

Description of priority areas for inclusion in national Description of priority areas for inclusion in national guidelines for registries & designation of the role of guidelines for registries & designation of the role of guideline development & implementationguideline development & implementation

Determination of sustainable & transparent funding Determination of sustainable & transparent funding process that is linked to approval & evaluationprocess that is linked to approval & evaluation

National guidelinesNational guidelines National guidelines for patient registries in Ireland National guidelines for patient registries in Ireland

informed by the international guidelines and cognisant of informed by the international guidelines and cognisant of Irish legal & ethical obligations Irish legal & ethical obligations

The guidelines should be compatible with The guidelines should be compatible with Department of Health and Health Service Executive policy and Department of Health and Health Service Executive policy and Current & emerging legislation (particularly the Health Current & emerging legislation (particularly the Health

Information Bill)Information Bill) Work by HIQA in the area of health information technical Work by HIQA in the area of health information technical

standards and health information governance.standards and health information governance. The guidelines should cover areas including:The guidelines should cover areas including:

ConsentConsent EthicsEthics SecuritySecurity Data standardsData standards Governance (structures and processes)Governance (structures and processes) EvaluationEvaluation Dissemination of registry outputs.Dissemination of registry outputs.

Central oversightCentral oversightA national function for the oversight of patient registries A national function for the oversight of patient registries

should be established encompassing the following;should be established encompassing the following;

Development of national guidelines for patient registries.Development of national guidelines for patient registries. Approval of new registries and evaluation of pre-existing Approval of new registries and evaluation of pre-existing

registries.registries. Approval of registry funding based on evaluation outcomesApproval of registry funding based on evaluation outcomes Identification of appropriate registry data standards with Identification of appropriate registry data standards with

HIQA to facilitate sharing of data & comparability between HIQA to facilitate sharing of data & comparability between registries.registries.

Dissemination and promotion of best practice guidelines to Dissemination and promotion of best practice guidelines to registries.registries.

Maintenance of a directory of approved registries, a “registry Maintenance of a directory of approved registries, a “registry of registries”.of registries”.

Facilitation of access to specialised expertise (e.g. Facilitation of access to specialised expertise (e.g. biostatistics, epidemiology)biostatistics, epidemiology)

Confidentiality & securityConfidentiality & security Registries should undergo regular security audits to Registries should undergo regular security audits to

identify & address potential threats to data security.identify & address potential threats to data security. All registries should carry out regular access audits to All registries should carry out regular access audits to

ensure that inappropriate access to data does not occur.ensure that inappropriate access to data does not occur. The legal position around court ordered disclosure The legal position around court ordered disclosure

should be clarified and if necessary legislation enacted to should be clarified and if necessary legislation enacted to protect against this.protect against this.

Exploration of the feasibility of limiting the scope of Exploration of the feasibility of limiting the scope of compelled authorisation of access to personal health compelled authorisation of access to personal health information.information.

Implementation of the statutory prohibition on the Implementation of the statutory prohibition on the advertisement for sale or the sale of personal health advertisement for sale or the sale of personal health information and on the disclosure of personal health information and on the disclosure of personal health information for direct or indirect financial benefit in the information for direct or indirect financial benefit in the proposed Health Information Bill. This proposal should proposed Health Information Bill. This proposal should be supported.be supported.

Registry FundingRegistry Funding

Development of a centralised funding Development of a centralised funding mechanism linked to the outcome of registry mechanism linked to the outcome of registry approval & evaluation processes.approval & evaluation processes.

Uniform and transparent application Uniform and transparent application procedures with set deadlines for submission procedures with set deadlines for submission of applications.of applications.

Security of funding to registries that meet Security of funding to registries that meet priority target areas identified in the national priority target areas identified in the national policy for patient registries subject to policy for patient registries subject to successful evaluation outcomes.successful evaluation outcomes.

Approval & EvaluationApproval & EvaluationApproval for new registries & ongoing evaluation for pre-Approval for new registries & ongoing evaluation for pre-existing registries.existing registries.

Approval process for new registries should include Approval process for new registries should include • Evaluation of the relevance of the registries stated purposeEvaluation of the relevance of the registries stated purpose Consideration of existing data sourcesConsideration of existing data sources Review of the function, duration and scope of the registryReview of the function, duration and scope of the registry Assessment of the practical feasibility of the registryAssessment of the practical feasibility of the registry Probability of the availability of sufficient start up and maintenance Probability of the availability of sufficient start up and maintenance

fundingfunding Evaluation of the cost effectiveness of the registry.Evaluation of the cost effectiveness of the registry.

The evaluation of existing registries should include;The evaluation of existing registries should include; Continued relevance of the stated purpose of the registryContinued relevance of the stated purpose of the registry Data qualityData quality GovernanceGovernance Dissemination of findings.Dissemination of findings.

Outcome of evaluation/approval linked to funding & available to Outcome of evaluation/approval linked to funding & available to the public.the public.

Thanks!Thanks!

Research participants; registers, Research participants; registers, interviewees and the patients who so interviewees and the patients who so freely gave of their time/knowledgefreely gave of their time/knowledge

MRCG Working Group on Patient MRCG Working Group on Patient RegistersRegisters

Dr Howard Johnson/Dr Máire O’ConnorDr Howard Johnson/Dr Máire O’Connor

Contact DetailsContact Details

fionnuala.donohue2@hse.iefionnuala.donohue2@hse.ie

Health Intelligence Unit, Dr Steevens Health Intelligence Unit, Dr Steevens HospitalHospital