Transcript Presentation IIPOSI Meeting Dublin 10 May 2011

Presentation MRCG
October 2012
Fionnuala Donohue
Presentation Outline
 Requirements
 Description
 Research
Research Components
Findings
 Recommendations
Requirements

Thorough assessment of patient registries in Ireland

Agreed definition of registry

Identification of registries that currently exist

Detailed inventory of registries in Ireland via questionnaire

Literature review & expert opinion on critical issues

Research to provide recommendations for future
development of registries
Definition
“an organized system that uses observational
study methods to collect uniform data (clinical
and other) ….. for a population defined by a
particular disease, condition or exposure, and
that serves one or more predetermined
scientific, clinical or policy purposes.”
Association for Healthcare Quality and Research in
America (AHRQ 2007)
Research Components

International Guidelines for registries

Identification of Registers in Ireland

Survey with Registers

Stakeholder Interviews

Focus Groups with Patients
Guidelines
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
circumstances
Require 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 & Appropriate
multidisciplinary
Funding
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 Coordination
Not covered.
These guidelines
act as national
resource.
National registry
of registries.
National body for
funding registries &
providing support to
registries.
Central coordination of
policy & practice.
National register
of registries.
Identification of Registries
Identification of Registries





Previous work by Newton & Garner in UK 2002
(postal survey) and National Health and Medical
Research Council in Australia 2007 (peer
consultation & search strategy)
The establishment of an information board at the
2008 Healthcare Informatics Society of Ireland
annual meeting
The examination of the website of the Office of
the Data Protection Commissioner.
A search in PubMed and a web based search
A canvas of 250 stakeholders from healthcare
services, academic bodies and clinical societies.
Outcome of identification process
 Canvas
 102
response rate 70% (175/250)
provided information on registries
 Smaller
number of additional registries
identified through search strategy
 Process
 End
validation & de-duplication
outcome 47 registries currently active
Survey Results
Survey Results General
 Response
 75.8%
 42%
rate 70.2% (33/47)
National/Regional
≤ 100 new cases/year
 58%
held on server, 1 on paper & 71%
paper element in data transfer
 21%
had web enabled data access
Year data collection started
16
14
12
10
8
No. of registries
6
4
2
0
pre 1980 1980-89 1990-99 2000-09
Survey Results Uses
Function
Listed as
primary
function
n=33
Listed as
secondary
function
n=32
Listed as
tertiary
function
n=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 standards

39% registries 100% coverage, 30% < 50%
 60% assessed coverage within 12 mths

58% used a case definition
 51% used a data dictionary
 54% carried out regular data validation

70% carried out data de-duplication (70%
software)
 77% followed up missing data (58% contact with
original clinical source
Survey Results Standards
Case definition
Data Dictionary
Yes
No
Yes
No
All registers
58%
42%
41%
59%
Management
committee
56%
44%
40%
60%
Clinical/Scientific
committee
53%
47%
41%
59%
Steering Group
65%
35%
44%
56%
Ethical Approval
69%
31%
47%
54%
Survey Results Consent
 73%
used some form of consent
 46% used written consent
 75% had an “opt out” system
 Of
the 27% with no consent 55% also did
not have an opt out system
Consent
Written(%) Verbal (%) Implied (%)
All registries (n=33)
None (%)
15 (45.5)
2 (6.1)
7 (21.2)
9 (27.3)
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)
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)
Registry Size
No. WTE employed by registry
Registry 0 WTE (n=7)
Governance structures & processes
Feature
No of
responses
YES
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 Resources
 21%
of registers had no staff directly
employed
 For those with staff (79%)
69% two or less staff members
27% between three and ten staff
 88%
of registers (including 71% of those with
no staff) had a named administrator.
 Availability of expertise
• 30% no statistical support
• 3% no clinical support
• 6% no IT support
Survey Results Resources








Initial Funding
68% state funds
12% commercial funding
20% funding through a charity
Ongoing Funding
72% state funding
12% funding through a charity
4% commercial funding
12% no funding
3 registers had dual funding
Comparative 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
0.512.69
0.50
Anonymise data
31
0.25
0.04-1.55
0.05
31
0.54
0.281.07
0.10
Encrypt data
31
0.43
0.13-1.43
0.09
31
0.51
0.310.85
0.03
Password protection
32
0.74
0.46-1.20
0.11
32
0.87
0.741.02
0.36
Oversight Committee
32
0.68
0.35-1.32
0.16
32
0.68
0.510.91
0.05
Ethics Approval
28
0.73
0.31-1.72
0.36
28
0.95
0.531.69
0.60
Case Definition
31
0.72
0.42-1.26
0.18
31
0.64
0.371.11
0.15
Data Standardisation
33
0.29
0.05-1.83
0.10
33
0.58
0.271.23
0.17
Data Validation
processes
33
0.29
0.09-0.96
0.001
33
0.87
0.651.17
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 Learnt
 63%
good quality consistent data that is
used
 37%
stakeholder involvement improves
data quality & utility
 26%
resources esp for staff training to ensure
quality data
 19% importance of giving enough resources
to planning and implementation phase
Way Forward
 26%
continuity in resource
allocation
 22% improved IT
 22% introduction of national
standards
 19% legislation
Focus Groups
Methodology
 Focus
groups with patients with
experience of chronic illness
 Participants identified through patient
support organisations
 Two groups held in neutral venue with
facilitator and note taker present
 Tapes transcribed by commercial company
 Thematic content analysis supported by
Weft QDA software package
Focus Groups Main Themes
Main 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
interviews
Semi structured interviews
 13
interviews over 6 months
 Interviews by phone or in person
 Male:Female 10:3 Dublin:Outside Dublin 7:6
 Variety of backgrounds
 Interviews recorded, transcribed and
analysed using thematic content analysis
 Weft QDA software used to support analysis
Themes
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 3.1 Data Protection a
trust in patient registries.
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.
Recommendations
Role of patient registries

A planned approach to the establishment of new
registries.
 Existing work (IPH (2007) and HIQA (2010a))
should be used to establish areas where a
registry is the appropriate solution to information
deficits.
 Existing registries should be examined to identify
possible opportunities for merger, rationalisation
or economies of scale.
 Registries that are found not to be fit for purpose
should be re-vamped or closed.
Consent

Legislation to clearly outline the circumstances in which
registries can operate without consent & to address
areas where there is ambiguity regarding an individual’s
ability to consent
 Registries that are permitted to operate without consent
must undergo an approval and on-going evaluation
process.
 Law Reform Commission proposals relating to those
aged 16 & 17 yrs of age & those > 18 yrs deemed to lack
capacity to consent and the Health Information Bill in
relation to those aged 16 & 17 years of age should be
implemented.
 Where a person < 18 years is currently enrolled in a
registry their assent should be sought & documented
with their parent’s consent.
 Registries should have procedures in place to ensure
consent is obtained as soon as practicable after an
individual reaches the age of 18 years.
Data Linkage

Introduction of legislation proposed in the Health
Information Bill to govern circumstances & rules
under which data linkage/data matching can
occur.
 Enactment of the Health Information Bill (part
five) to allow for the introduction of a unique
health identifier in accordance with the
recommendations of the HIQA report
 Continued introduction of information standards
across the healthcare system to allow
meaningful sharing & comparability of data
National policy for patient registries
A national policy should be developed to address;

Priority areas for registry development having regard to:







National Health Information Strategy.
Current available information systems.
Impact of the health issue concerned on the population.
Potential for registry to drive change in the health system.
Description & designation of a central oversight function
for registries.
Description of priority areas for inclusion in national
guidelines for registries & designation of the role of
guideline development & implementation
Determination of sustainable & transparent funding
process that is linked to approval & evaluation
National guidelines


National guidelines for patient registries in Ireland
informed by the international guidelines and cognisant of
Irish legal & ethical obligations
The guidelines should be compatible with




Department of Health and Health Service Executive policy and
Current & emerging legislation (particularly the Health
Information Bill)
Work by HIQA in the area of health information technical
standards and health information governance.
The guidelines should cover areas including:







Consent
Ethics
Security
Data standards
Governance (structures and processes)
Evaluation
Dissemination of registry outputs.
Central oversight
A national function for the oversight of patient registries
should be established encompassing the following;







Development of national guidelines for patient registries.
Approval of new registries and evaluation of pre-existing
registries.
Approval of registry funding based on evaluation outcomes
Identification of appropriate registry data standards with
HIQA to facilitate sharing of data & comparability between
registries.
Dissemination and promotion of best practice guidelines to
registries.
Maintenance of a directory of approved registries, a “registry
of registries”.
Facilitation of access to specialised expertise (e.g.
biostatistics, epidemiology)
Confidentiality & security





Registries should undergo regular security audits to
identify & address potential threats to data security.
All registries should carry out regular access audits to
ensure that inappropriate access to data does not occur.
The legal position around court ordered disclosure
should be clarified and if necessary legislation enacted
to protect against this.
Exploration of the feasibility of limiting the scope of
compelled authorisation of access to personal health
information.
Implementation of the statutory prohibition on the
advertisement for sale or the sale of personal health
information and on the disclosure of personal health
information for direct or indirect financial benefit in the
proposed Health Information Bill. This proposal should
be supported.
Registry Funding
 Development
of a centralised funding
mechanism linked to the outcome of registry
approval & evaluation processes.
 Uniform and transparent application
procedures with set deadlines for submission
of applications.
 Security of funding to registries that meet
priority target areas identified in the national
policy for patient registries subject to
successful evaluation outcomes.
Approval & Evaluation
Approval for new registries & ongoing evaluation for preexisting registries.
 Approval process for new registries should include
• Evaluation of the relevance of the registries stated purpose

Consideration of existing data sources

Review of the function, duration and scope of the registry

Assessment of the practical feasibility of the registry

Probability of the availability of sufficient start up and maintenance
funding

Evaluation of the cost effectiveness of the registry.

The evaluation of existing registries should include;





Continued relevance of the stated purpose of the registry
Data quality
Governance
Dissemination of findings.
Outcome of evaluation/approval linked to funding & available to
the public.
Thanks!
 Research
participants; registers,
interviewees and the patients who so
freely gave of their time/knowledge
 MRCG
Working Group on Patient
Registers
 Dr
Howard Johnson/Dr Máire O’Connor
Contact Details
 [email protected]
 Health
Intelligence Unit, Dr Steevens
Hospital