Facilitating Research within the Current Governance Framework?

1
Facilitating Research within the Current
Governance Framework?

• Dr Davida De La Harpe
• Assistant National Director of Population Health

2
Outline

• The HSE, Health Intelligence and Population
  Health in the HSE and health service
  transformation
• Research and clinical audit
• Work so far
• Current Challenges
• Future

3
Selling health intelligence ?

• In its widest sense
• Developing and using
• knowledge to improve health outcomes for the
  population
• (Instead of following deeply held yet unexamined
  ideologies)

4
Health Services Executive

• Transition to unified health delivery system
  represents biggest change management project in
  history of the state
• Advantages uniform interpretation of policy
• Much stronger leverage to drive change, put into
  practice international evidence of best practice,
  recommendations from local studies, audits,
  transfer learning and models of good practice
• Opportunity to apply resources strategically in
  line with best intelligence
• HSE has adopted a population health approach

5
Executive Structure
Board
Audit
CEO
Office of the CEO
SPRI Steering Group Unit
Expert Advisory Groups
Corp. Plng. Ctrl. Processes
NHO
PCCC
Children
Corporate Services
Population Health
HR
Finance
Ageing
ICT
Shared Srvs.
Disability
Cancer
Procure
Estates
Surgery
Health Services
A E
Support Services
Medicine
Mental Health
Reform Innovation
Examples
6
Population Health Approach

• promotes and protects the health of the
• whole population or sub groups, with
• particular emphasis on reducing Health
• Inequalities

7
Population Health National Directorate

• Director of Population Health medical
• 3 Assistant National Directors medical
• 3 Assistant National Directors non medical 1
  transition non-medical)
• Public health doctors - subject to same
  professional standards as other specialities
  including confidentiality
• HI. SHP.HP

8
Public health practice

• Protecting the health of the public
• Epidemiology, surveillence, programmatic
  evaluations provision of clinical services
  (health protection, infectious diseases,evidence
  based care pathway development)
• Collection and analysis of identifiable health
  data for purpose of protecting health of group or
  community- not research
• But may also engage in research in these and
  other areas

9
health intelligence commitment

• Gather the facts and information necessary to
  make more informed and intelligent decisions
• Keep pace with new evidence
• Use the new facts to support updating practices

10
Health Intelligence components
11
Research

• The systematic investigation into, and study of
  materials, sources etc in order to establish
  facts and reach new conclusions.www.wit.ie/librar
  y/olas/glossary.htm
• Today's health research is tomorrow's health care

12
Our main research settings

• Population based research
• Clinical settings- hospital,primary care and
  other clinical settings and the interfaces
• Laboratory

13
Research continuum

• Biomedical and clinical research has made great
  progress in identifying ways to prevent and treat
  common and uncommon conditions and manage chronic
  illness.
• Health services research complements and builds
  on the findings of clinical and biomedical
  research.

14
The gains for our population

• Health services research, unlike biomedical
  research, can provide insight into which care
  settings, including home or community-based care,
  are best and which risk factors are associated
  with entering these settings-patient
  centred-complex settings
• Quality issues and outcomes

15
Issues for research

• Prospective research- patient consent
• Retrospective - extract information anonymise
• Follow-up- permission and consent
• Clarity and explanation about how data and
  information will be used
• Safeguards on data storage etc
• Usually clearly signalled by ethics committees if
  not already part of proposals

16
Current HSE work in research area

• Support for research
• Draft research strategy
• METR
• Ethics processes
• Commissioning
• Partnerships

17
Clinical Audit

• Clinical Audit was introduced to the NHS in
  1993.  -an essential element of professional
  practice in the Health Service. Now integral to
  HSE work
• a quality improvement process that seeks to
  improve patient care and outcomes through
  systematic review of care against explicit
  criteria and the implementation of change
• Governance of our services

18
Clinical audit vs research

• Clinical Audit and Research are closely related
  but distinct disciplines
•   Research is about creating new knowledge e.g
  about whether treatments work or whether one
  treatment works better than another
• Clinical Audit is about making sure that this
  knowledge is being used to best effect so that
  outcomes for patients are as good as they should
  be

19
Context

• patients/clients of healthcare services have
  specific rights in relation to their personal
  health information.
• Right to non-disclosure
• Right to make a complaint to the Data protection
  Commissioner if they are unhappy how their
  personal information is used.

20
Current Process

• Patients/client give personal health details to
  healthcare professionals as part of their care
  process.
• The extent to which they are informed of the
  purposes to which their information will be used
  is variable (Fair obtaining and processing -
  consent)
• Not specifically told their data may be used for
  clinical governance purposes

21
Current Process

• No written informed consent obtained for the
  future potential use of their data for clinical
  governance/audit purposes
• For prospective clinical audit work, informed
  written consent is usually obtained
• Healthcare professional and clinical audit staff
  anonymise the data (No disclosure-unless
  compatible). Are Clinical Audit staff part of the
  healthcare team? ( Regulations 1989)HSE vs HIQA?

22
Requirements under the Act and future
implementation of the EU Standards

• Patients have the right to be informed of the
  purposes to which their personal health
  information will be used
• They have the right to give written consent for
  the use of the information for the purposes of
  clinical governance/audit
• They have the right to withdraw consent at any
  time

23
Requirements under the Act and future
implementation of the EU Standards

• EU Standards on Confidentiality and Privacy in
  Healthcare
• http//www.eurosocap.org/eurosocap-standards.htm

24
Requirements under the Act and future
implementation of the EU Standards

• Recommendation 6
• Provider Institutions must ensure that the
  express consent of the patient is obtained for
  processes of clinical audit by staff not involved
  in the care of that patient.
• Ethical requirements and legal obligations to
  protect patient confidentiality

25
Patients vs staff?

• Service providers sensitivities and rights -
• E.g death rates by hospital and by e.g.
  surgeon. Needs to be carefully handled
• Public right to know
• Informed choice
• Quality

26
Impact of technologyexample

• Health Atlas Ireland
• Uses a number of databases already available
• Cannot link individuals eg RTA victim cannot be
  tracked into the hospital admission and further
• governance arrangements?
• Conceivable that where small numbers of a
  condition reported together with geographic data
  that individuals might somehow be identifiable
  rules for numbers in small areas

27
(No Transcript)
28
(No Transcript)
29
(No Transcript)
30
Existing databases?

• HSE and other institutions databases with
  individual information about for instance ,
  disability, specific disease registers etc etc
• Variable IT systems
• Variable quality
• Ownership
• Access
• Probably variable compliance with best practice
• unlinked

31
Why link?

• To allow individual to be tracked through the
  system
• linking databases so the combinations of issues
  for people can be seen and understood
• Identifying on a small area basis where people
  are coming from
• Tracking services and patterns of health and
  disease
• Audit, quality, service gaps, poor outcomes

32
Recommendations

• National Patient Information Leaflets
• Evidence Based Guideline for all healthcare
  professionals and clinical governance staff
• Training and induction
• Monitor and Review effectiveness of these
  approaches
• Develop Key Performance Indicators - e.g number
  of complaints received under the Act.

33
Issues for all our work

• Unique identifier
• Linking of databases
• Information governance
• Postcoding
• Balance between individual confidentiality and
  need to be able to track and analyse services,
  patterns of health and illness.
• What does public want us to know?
• What do they think /expect us to know?
• Ethics/research biomed vs HSR- research
  supports for all

34
Future?

• Proposal for an identity management and privacy
  protection framework
• Linking datasets- data protection and governance-
  ?HIQA
• Surveys vs inclusion of data items routinely?-
  working together for best value- CSO, ESRI, IPH
  etc
• Cohort studies?
• Genetics- will add a whole new dimension
• Horizon scanning- new and emerging technologies
  and interventions- may be put in place with
  limited research base

35
Consent? ( example)

• To help educate our staff and students and to
  teach them how to treat illnesses more
  effectively they may view your medical record.
  Your medical record may also be used for our
  quality controls and audits to help us to improve
  our services.
• To improve our understanding of illnesses we also
  sometimes carry out research using your medical
  record. Any research carried out by the hospital
  is governed by the policies of the Ethics
  Committee. We also may provide data to other
  health agencies such as the National Cancer
  Registry in order to plan for the health needs of
  patients nationally.
• How feasible is this in the hospital environment?
• What about primary care setting?

36
Other issues

• Ethics and Protocols There needs to be clear
  rules of engagement and there will need to be
  guidelines on issues such as permissions to take
  and use information. There should be explicit
  Confidentiality Agreements in place for all staff
• Training and expert advice
• Right to Access There should be a right to
  access to some information and there may be a
  need for legally underpinned accessibility.
  Equally, access to other types of information may
  have to be restricted.
•  

37
Start of public debate?

• Public Perceptions of Biomedical Research - A
  survey of the general population in Ireland, was
  conducted by a team led by Professor Hannah McGee
  2005
• public is generally aware of and committed to
  making a contribution to research and related
  activities in the healthcare system for their
  benefit and for the benefit of future patients.
• ongoing dialogue to foster research as a core
  activity of, and for the greater good of, the
  Irish and wider general public.

38
Summary

• HSE in process of transformation
• Legacy issues from former organisational
  structures
• Opportunity for excellence in health care
• Collaborative approach to issues
• Thanks for support from various agencies
  including DPC over last year
• Thanks to all with whom I work their
  contributions