Cystic Fibrosis Australia
Expression of Interest
Management of the
Australian Cystic Fibrosis
Data Registry
Briefing Pack
July 2015
Management of the Australian Cystic Fibrosis Data Registry
1. Introduction
Cystic Fibrosis (CF) is the most common life-limiting disease in Australia – it primarily affects the
lungs and digestive system because of a malfunction in the exocrine system, responsible for
producing saliva, sweat, tears and mucus.
There is currently no cure. People with CF develop an abnormal amount of excessively thick and
sticky mucus within the lungs, airways and the digestive system. The mucus causes impairment of
the digestive functions of the pancreas and traps bacteria in the lungs resulting in recurrent
infections leading to irreversible damage. Lung failure is the major cause of death for someone
with CF.
From birth, a person with CF undergoes constant medical treatments and physiotherapy.
On average one in 25 people carry the CF gene. As the gene is recessive it must be inherited from
both parents for a child to be born with CF. At 31 December 2013 the ACFDR held records of
3,235 people with cystic fibrosis.
2. Overview of the Australian Cystic Fibrosis Data Registry
The Australian Cystic Fibrosis Data Registry (ACFDR) has operated since 1998 as a collaboration
between Cystic Fibrosis Australia (CFA), as data custodian and manager of the registry, and the
Directors of Australia’s specialist CF treatment centres. Now a mature registry, the ACFDR
measures well against Strategic and Operating Principles for Australian Clinical Quality Registries
that were endorsed by Australian Health Ministers in 2010 (Reference http://www.safetyandquality.gov.au/our-work/information-strategy/clinical-qualityregistries/strategic-operating-principles-for-clinical-quality-registries/).
The ACFDR records a range of information about the CF population that is used to compile reports
used by stakeholders including government, health sector, industry and the CF community in
Australia and internationally. Data is held in de-identified, coded patient records that can be reidentified at source and linked longitudinally. A secure database with online browser access is
used by 23 contributing centres for data entry and own-data downloads, and by registry
managers/administrators for data management, analysis and reporting.
The main statistical output in annual reports can be summarized as follows:
1.
2.
3.
4.
People with CF – Age distribution, adult marital status, education and activity.
Diagnosis – Age at diagnosis, presentation, pancreatic insufficiency and genotype.
Health – Respiratory infections, other medical complications, lung function and nutrition.
Treatment – Visits to clinics, therapy, hospitalisation, home therapy and non-transplant
surgery.
5. Organ Transplants – Patients assessed for transplant and transplants undertaken.
6. Mortality – Deaths recorded and cause of death.
Page 2 3. Invitation to manage the ACFDR
Cystic Fibrosis Australia is seeking expressions of interest from providers to manage the registry
going forward and work with our current contractor on a transition process.
Database development, maintenance and hosting are managed by CFA under a separate ongoing
contract.
CFA will assess the responses on the following criteria:
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Demonstrated capacity and ability to manage a clinical registry in accordance with best
practice, and/or relevant other experience.
Understanding of clinical registry governance and ethics matters.
Demonstrated capacity to work with clinicians, collectively through the registry’s Advisory
Committee and individually, and to respond to their data needs.
Sound understanding of clinical data, with demonstrated capacity to process and analyse
data for descriptive reporting, research support, quality improvement activities and for
meeting ad-hoc requests.
Willingness to keep up to date with developments in cystic fibrosis disease management
and with major research, e.g. through the CF literature and participation in occasional
international conferences.
Ability to administer and provide training and help desk services for an online data
collection system, to liaise and oversee system development and to manage data transfers
from electronic medical records systems.
Quality and appropriateness of plans for a managed transition from CFA’s current provider.
CFA and CF Centre Directors expect a managed transition and will require that a new
provider agree to engage and work with CFA’s current contractor throughout this transition
period.
Capacity to apply staffing appropriate for the full range of ACFDR management tasks (see
below for indicative task and time allocations).
Acceptability of plans, if any, for future changes to the ICT platform and/or database hosting
(note: existing arrangements are in place – see below for description).
Any specific value adding that the provider would draw from its other activities and
capability.
Cost.
4. Response Requirements
An EOI response form is provided with this briefing pack and this Response Form should be used
as the template for all responses. Further documents can be attached to the Response Form when
further detail is required.
Organisations wishing to express interest in this process must lodge their response via email to
Simon Martin - [email protected] - by 5pm Australian Eastern Standard Time on 7th August
2015.
Any enquiries regarding the EOI process must be in writing and emailed to Simon Martin [email protected] - before 31st July 2015.
Page 3 5. Confidentiality of responses
The organisational details for each respondent will be regarded as commercial in confidence while
they are being considered. It is important that responses to this EOI do not contain any intellectual
property of the respondent that cannot be used publicly. There will be opportunities in the next
stages of this process where respondents will be able to discuss innovative approaches and any
intellectual property issues that may be involved.
6. Contractor responsibilities – ACFDR contract deliverables
Committed deliverables from management of the ACFDR have evolved over time in pursuit of a
best practice management model. Deliverables have generally been agreed around consultation
with the registry’s Advisory Committee. A fairly stable situation has been reached in recent years,
with deliverables as follows:
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An annual data report of about 40 pages, prepared in MS Word and PDF files for printing
and release within 12 months of the reference year. Report content is mainly current year
descriptive analysis in tables, charts and text, plus some charts showing trends in crosssectional outcome data over time.
o Note: In odd numbered years, an informal commitment has been made to release
the Annual Report in time for the biennial Australasian CF Conference, which takes
place in mid-August.
Annual State-level reports containing summary data, mainly demographic in nature and
including regional distribution of the CF population.
A set of supplementary tables compiled as a by-product of the Annual Report preparation
and published on CFA’s ACFDR web page. These tables may extend the Annual Report
summary tables into finer categories or add other cross-tabulations of information. Some
provide a specific focus on subgroups of the CF population.
Current year comparisons of key clinical outcome indicators at CF centre level, distributed
to Centre Directors.
o Note: it remains an intention to deliver these comparisons in ‘transparent’ form for
public access on the CFA website, but further analysis for risk adjustment has been
requested by the Advisory Committee and Centre Directors.
Support to data input staff in CF centres, including training and problem resolution and
monitoring of data entry progress.
Perform administrator tasks associated with the online data entry system, including
controlling system security (user accreditation and login arrangements).
Ad hoc data services for CFA and contributing centres (up to an agreed limit).
Support for ACFDR Advisory Committee – includes agenda preparation and background
papers for up to 2 meetings per year, drafting of meeting minutes and follow up of
decisions. Occasional single issue consultations have occurred out of session, via email.
Occasional support for CFA’s bi-annual meetings of CF Centre Directors, generally to
explain new developments or plans for the ACFDR.
Reports as needed to the CFA Board.
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An unquantified commitment to some new development for the registry each year, mainly
affecting output products and usually as an outcome of ACFDR Advisory Committee
discussions.
Support for the biennial Australasian CF Conference, in the form of arrangement of a CF
registry session, presentation(s) on new developments affecting the registry, usually one or
two posters and/or presentations of analysis of a topical issue and perhaps a tutorial for
ACFDR system users.
Advice to CFA as required on matters related to ACFDR governance and policies.
7. Indicative Task and Time Allocations
The following indicative allocation of time to tasks assumes a staffing configuration as the current
contractor applied in 2014. At that time the Clinical Data Coodinator also had data management
skills. A new provider may allocate tasks differently, utilising skills of a wider range of staff.
FTE percentage
Task group:
Project management/governance
User support/routine system maint.
Data management
Administration (committees, etc)
Analysis and reporting
Research support
Director
CDC*
5
2.5
20
12.5
25
5
2.5
30
20
5
60.0
67.5
* Clinical Data Coordinator
8. Centre responsibilities - ACFDR
The following is a general description of how responsibilities have evolved to the present. There
are 23 contributing centres, most of which are in state capital cities or large metropolitan areas.
Commitment by the centres can be described as strong, despite resource constraints at many.
• Administer consent agreements with patients or their parents/guardians, in accordance with
their own institution’s policies and requirements.
• Enter patient data via online data entry screens
o Note1: Two contributing centres, with more expecting to join, have arranged to
provide data through direct upload of an entire annual data set from a cystic fibrosis
electronic medical records (EMR) system installed and used at their centre.
Transport is via an XML file formatted to CFA’s specifications. Some issues with this
process remain to be fully resolved. The onus is on centres using the system, with
reasonable technical support from the ACFDR manager.
o Note 2: Some centres have taken advantage of provision that CFA has made for
batched upload of certain ‘transactions’ data (mainly sets of clinical measures that
can be taken multiple times in a year) from MS Excel files formatted to fixed
specifications.
• Meet data entry targets for annual reporting.
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o Note: A two-stage process has been used successfully in recent years, requiring all
patients who were ‘current’ in the reference (calendar) year to be reconciled with
previous year’s population, with their records open and ready for detailed data entry
by the end of the following February, and with complete data entry finished by the
end of June.
Respond to queries from the ACFDR data manager, for data cleaning.
Attain and maintain proficiency, with ACFDR data manager training and support as
required, in the use of the online data entry system and of facilities for download of ‘own
centre’ data and individual ‘own centre’ patient reports.
9. CFA responsibilities – ACFDR management
The following is a general description of how CFA responsibilities have evolved to the present:
• Maintain understandings with CF Centre Directors about CFA’s custodian role for the
registry, which keeps de-identified patient data submitted from the centres.
• Obtain commitments from CF Centre Directors about their contribution of de-identified
patient data.
• Publish an ACFDR Annual Report (data report) and supplementary data provided through
its website.
• Make available to contributing centres more detailed outcome reports containing centrespecific data in comparisons and trends for major indicators.
• Make provision for ‘own centre’ data held in the registry to be accessed by contributing
centre staff, and provide reporting services.
• Establish and maintain an ACFDR Advisory Committee.
• Publish and keep current, with advice from the Advisory Committee and administrative
support from the registry manager, a set of policies describing ACFDR practices.
• Contract a manager for the ACFDR.
• Contract an ICT services provider for software development and maintenance.
o Note: Since 2005, when the registry was redeveloped on a web-accessible platform,
the ICT development has been provided by IS Group Pty Ltd of Sydney, which has
absorbed former entities Listening Post Pty Ltd and Prowess Pty Ltd. The ICT
provider also provides secure hosting services for the registry’s Microsoft SQL
Server database and system maintenance support under an annual maintenance
contract with CFA.
• Maintain an arrangement with an NHMRC-recognised Ethics Review Committee, for ethical
oversight of registry practices
o Note: A renewed arrangement with the Sydney Area Health Services (RPA Zone)
Ethics Committee was signed in 2012, updating an arrangement first made in 2002.
• Provide the ACFDR manager with access to CFA’s Medical Advisor for advice about the CF
disease and clinical treatment.
Page 6 10. IS Platform Specifications
An upgrade to ACFDR system software is ready for implementation. The application has been
built using the following technology components.
Technology Description Function Version Microsoft SQL Server Database Server 2008R2 Microsoft SQL Server Reporting Services Microsoft SQL Server Service Broker Microsoft Internet Information server (IIS) Microsoft Windows 2008 Microsoft .Net framework Reporting Services Store all application data Supplies fixed format/pdf reports for asynchronous processing Displays the web pages that make up the application Service Broker Web Server Base server operating system Development platform Microsoft supplied software components to interface to the operating system Listening Post ASP.Net Listening Post Base application framework development toolkit components on which the application is built Listening Post Pre-­‐built Client, database admin Application Modules components that and reporting modules will be configured for client requirements 2008R2 2008R2 7.5 Windows 2008 V.4.5 Current release Current release Data extracts are downloaded by ACFDR managers into MS Excel tables through SQL reporting
services set up by the ITC developers. Current and historical ACFDR processing files and
processed data are in Stata v13 (Statacorp, College Station Texas).
11. ACFDR Outputs
Copies of ACFDR Annual Reports, various supplementary reports and technical notes are
available on CFA’s registry webpage at http://www.cysticfibrosis.org.au/data-registry
Page 7 12. References
1. Cystic Fibrosis Australia. (2015). Cystic Fibrosis in Australia 2013, 16th annual report from the
Australian Cystic Fibrosis Data Registry, Baulkham Hills NSW: Cystic Fibrosis Australia. Available
at http://www.cysticfibrosis.org.au/data-registry
2. Bell, S.C.; Bye, P.T.; Cooper, P.J.; et al. Cystic Fibrosis in Australia 2009: results from a data
registry Medical Journal of Australia, 195: 396-400. doi:10.5694/mja11.10719
3. Sims, G.,: (2015) The Australian Cystic Fibrosis Data Registry: More than just descriptive
emidemiology. The Health Advocate, 29 (April 2015), Deakin ACT: Australian Healthcare and
Hospitals Association. Available at http://ahha.asn.au/publication/health-advocate
4. Australian Commission on Safety and Quality in Health Care. (2014) A Framework for
Australian Clinical Quality Registries. Available at: http://www.safetyandquality.gov.au/ourwork/information-strategy/clinical-quality-registries/
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