CURRENT ENVIRONMENT Patient Registries In Malaysia Environment... · CURRENT ENVIRONMENT Patient...
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Situational Analysis on Patient Registry Validation & Visioning Workshop CURRENT ENVIRONMENT Patient Registries In Malaysia 28 February 2011 Putrajaya International Convention Center
Transcript of CURRENT ENVIRONMENT Patient Registries In Malaysia Environment... · CURRENT ENVIRONMENT Patient...
Situational Analysis on Patient
Registry
Validation & Visioning Workshop
CURRENT ENVIRONMENT
Patient Registries In Malaysia
28 February 2011
Putrajaya International Convention Center
CONTENT
• OVERVIEW
• KEY FINDINGS
• ISSUE & CHALLENGES
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Overview – Patient Registries
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� Patient Registry objectives :
o Research
o Policy and service planning
o To measure quality of care
o To measure safety and harm
� 31 patient registries currently under CRC
Overview-Roles of CRC regarding registries
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1. Administrative roleo Initiate and maintained establishment of patient
registries
o Focus on keeping Patient registries alive - Keep the
data resources flowing
o Plan and maintain infrastructure required to support the
operations of the registry
2. Training roleo Research services including project oversight &
management, protocol development, etc.
o Help in coordinating the writing sessions
3. Technical role –Ensuring registries produce the promised results
and comply with applicable regulations, ethical
guidelines and best practices
4. Reporting role: Maintain line of communication between registry , MOH on related activities
…Overview – Patient Registries
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� Stakeholders
o CRC
o Registry Owner
o SDP
o Bahagian Pengurusan Maklumat, MOH
o Pusat Informatik Kesihatan, MOH
o Various Clinical Group
o Users (Researchers, policy makers)
o Professional Bodies (eg.Association Foundation, Association Clinical Registries Malaysia (ACRM), National
Heart Association Malaysia (NHAM))
o Industries (eg. Pharma , Medical devices)
…Overview – Patient Registries
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•Source of Funding : MOH, NGO and Private Sector
•Estimated yearly cost Per Registry : RM 100,000 –RM 300,000 ���� link to estimated cost
•Average number of centers (Source Data Providers (SDP) reporting to registries : 25-50
» Min : 2
» Max :701 ���� list no. of SDP
� Clinic & hospital based;
� SDP belong to MOH, University & Private Sector.
Others : Armed Force & NGO
FINDINGS – Data Collection
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• Each Patient Registry is managed independently by Principal Investigator (PI) and Project Manager (PM) at the registry office
• Day to day management of registry data at SDP :
o Nurses (31%) and Doctors (30%)
• Average amount of time spent daily on registry data:
o > 5 hours (Registry Office – 39%, SDP – 15%)
o 1-3 hours ( Registry Office – 30%, SDP – 44%)
• Average number of records captured monthlyo 10 – 100 data ( Registry Office – 56%) ���� Link
o 10- 100 (SDP – 46%)
• Type of information captured o Disease, Treatment and Outcome
o Individual Patient data
o Follow up (62%) , One off (38%)
FINDINGS – …Data Collection
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• Data collection made by SDP (n = 131):
o Filling of form before capturing to system (81)
o Filling of form (44)
o Direct capture to system (25)
FINDINGS –Data Management
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• Data Standard
� Metadata is not standard across registry
� Do not comply to DDSA (Data Dictionary Sektor Awam/
National Health Data Dictionary)
• Data storage
� Electronic Data (77%) and Paper Form (23%)
� Network computer (54%), Offsite Data Centre (38%),
Stand Alone Computer (8%)
• Security Control
� ID & Password
� Access level
� Authentication code
� Secured Socket Layer (SSL)
FINDINGS –Data Quality
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• Data Validation
o Validated (Registry - 65%, SDP - 59% )
o No validation (Registry - 35%, SDP - 41%)
o Range check, consistency check & accuracy of
data
– Link data validation
• Data collected - good evidence eligible
population is representative (16 registries)
FINDINGS –Data Privacy
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• Records stored in database
o Reversibly anonymised (11)
o Identifiable (7)
o Irreversibly anonymised (5)
����link
• Patient consent on data collected
o No signed consent obtained
» Signed consent not obtained but option to opt out (79%)
» Signed consent not obtained and no option to opt out (21%)
o Legal view : Should obtain consent from citizen
– ����link
FINDINGS –Data Sharing
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• Data release
o Has agreement to data release (Registry 85%, SDP 58%) ���� link
o Data release according to CRC guideline (96%) ���� link
o Data not linked to other database (67%)
• Type of data sharedo Reports (Registry 37%, SDP 32%)
o Aggregated data (Registry 30%, SDP 22%)
o Anonymous raw data (Registry 24%, SDP 17%)
o Format of sharing : Soft copy 69%, Hardcopy 19 %, On line 12%
• Agencies receiving patient datao Government (45%), Individual (18%), NGO (14%)
o Purpose : Research (39%), Planning (27%)
• Data shared to registry
o Jabatan Pendaftaran Negara – citizen’s status (death record)
FINDINGS – ICT Environment
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• System Application
o System developed within registries
o Web Application (ASP.NET ; MS SQL)
o Operating System - Windows
• Data Storage
o Varied across registry
» Data reside at data Center (30 Registries)
» Data reside in Registry Custodian Premise and Source Data
Provider
• User of the system
o Registry: Principal Investigator, Project Manager
o SDP: Doctors, Nurses & RA/RO
FINDINGS – Policy & Legislation
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• Data collection by registries for research purposes
o According to common law, hospital should get patient consent for data usage other than health care purpose
o Opt out option is not according to law - Patient should give informed consent
o Waiver of inform consent was obtained from Medical
Research Ethic Committee (MREC) compliance to the
criteria set, Opt out is advised
• Pekeliling Ketua Pengarah Kesihatan Bil 17/2010 - Garispanduan
Pengendalian Dan Pengurusan Rekod Perubatan Pesakit Bagi Hospital-hospital Dan Institusi Perubatan Kementerian Kesihatan
Malaysia
o Patient Medical Record is categorised as “SULIT”
o Data for research purpose should get approval from Hospital Director
o Ownership
» Physical Record – Hospital
» Information - Patient
…FINDINGS – Policy & Legislation
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• Pekeliling Ketua Pengarah Kesihatan Bil 16/2010 -Garispanduan Penyediaan Laporan Perubatan Di Hospital-hospital Dan Institusi Perubatan Kementerian Kesihatan Malaysia
o Potential integration of registry data
“Sekiranya bagi satu kemasukan, pesakit dirawat oleh pelbagai
disiplin, Pegawai / Pegawai Perubatan dari disiplin utama
yang merawat pesakit hendaklah menyediakan laporan yang
menyeluruh termasuk menyatakan rujukan pesakit ke lain-lain
disiplin dan keputusan pemeriksaan pengimejan dan makmal
diagnostik.”
• Currently there is no law regarding privacy of data
ISSUES & CHALLENGES
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• Lack of resource in managing Registries
o Man power
» No dedicated post to manage registries at Registry
Office
» Capturing of data is additional task to existing role in
SDP
» Inadequate manpower at central level to coordinate &
facilitate
» Lack of manpower in data manager, data quality,
statisticians & IT personnel
o Funding
» No stable funding sources
» CRC provide funding to front end & back end
» Possible terminating of inactive registry due to funding
o ICT Infrastructure
» Inadequate network bandwidth slow down the usage of
application
» Insufficient PC to capture data
…ISSUES & CHALLENGES
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• Governance
o CRC play the role to initiate and maintain registries (without official mandate)
o Overall coordination of funding & planning of registries is not clearly defined
o The implementation of registries did not go through JPICT
except for Suicide & Mental Health Registry
• Management of Data
o Data collected through registries belong to the Source Data Providers
o Custodian of data is PM & PI
o Data Ownership in not clearly defined
o Registries data is in silos and not integrated across registries
o Usage of registries data is limited within registries discipline
o Metadata for registries varied – do not comply to DDSA
o Currently role regarding management of data is not within MOH’s CIO
Conclusion
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The finding of current environments of
Patient Registries in Malaysia is presented
for the participants feedback and comments
