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Transcript of Www.crc.gov.my. National Transplant Registry Methodology Dr Jamaiyah Haniff Head, Disease &...
www.crc.gov.my
National Transplant Registry
Methodology
Dr Jamaiyah Haniff
Head,
Disease & Treatment Registry Unit
Methodology
• Background
• Components
• Organisation
• Operations
• Oct 2003…. NTR 1st sponsor meeting …. appointed CRC as designated collaborating unit
• 3 rd Nov 2003….. CRC established …. Transplant Registry Unit (TRU) under the Disease & Treatment Registry Unit (DTRU)
Background
CARTA ORGANISASI RANGKAIAN PUSAT PENYELIDIKAN KLINIKAL INSTITUT KESIHATAN KEBANGSAAN (NATIONAL INSTITUTES OF HEALTH) MALAYSIA
Institut Penyelidikan Perubatan (IMR)
Institut Kesihatan Umum (IKU)
Institut Pengurusan Kesihatan (IHM)
Rangkaian Pusat Penyelidikan
Klinikal (CRC)
Institut Penyelidikan Sistem Kesihatan
(IHSR)
Institut Promosi Kesihatan (IHP)
Institut Kebangsaan Produk Asli dan Vaksinologi
Institut Kesihatan Kebangsaan
CRC HospitalPulau Pinang
CRC Hospital Ipoh Perak
CRC Hospital Kota Bharu Kelantan
CRC HospitalKuantan Pahang
CRC HospitalKuching Sarawak
CRC Hospital Sultanah Aminah JB
Rangkaian
CRC in NIH
TRU in DTRU
1. Renal Registry Unit
2. Cancer Registry Unit
3. Cataract Surgery Registry Unit
4. Neonatal Registry Unit
5. Mental Health Registry Unit
6. HIV/AIDS Treatment Registry Unit
7. Transplant Registry Unit
DTRU Mission statement
• The DTRU aims to serve as the national centre for key diseases and treatment registration in the country by providing a range of services starting “from concept to operations” of these registries and through ensuring high quality standards right “from data to report” which would be used to finally effect patients’ outcome improvement programmes.
“DATA IN,
REPORT OUT”
Objectives of the TRU in CRC
To achieve the objectives of the NTR, the tasks of the TRU are to ensure:
1. The complete ascertainment of all new cases of transplant performed by all the SDP
2. The validity of the data collected on these cases of transplant
3. Timely data capturing and analysing and timely reporting
Data
INPUT OUTPUT
REPORTManpower
Physical Facilities & Hardware
Software
Work Process
TRU
Components of a registry unit
Manpower 1. Clinical Registry Manager
(CRM)
2. Clinical Registry Coordinator (CRC)
3. Clinical Registry Assistant (CRA)
4. Epidemiologist
5. Biostatistician
6. Report editor
7. Desktop publisher
8. Webmaster
8. Clinical Data Manager
9. Database Administrator
10. Programmer
11. Network administrator
12. Security officer
13. Regulatory / Compliance officer
Physical Facilities & Hardware
1. Office space
2. IT infra: Server, VPN , network, workstation, etc
3. Communication infra - direct lines, broad band
4. Archive
5. Security infrastructure
Office
Security measures (1)
Security measures (2)
Security measure (3) – Fire safety facilities
Office space
On-site Server
Archive Facilities
Software
1. Database management
2. Business administration
3. Record linkage
4. Auto encoding
Contact / Hospital Management
SDP Identification / Enlistment
Identified a new SDP: Department of Pathology, Hospital Ipoh
To add a contact (SDP / Donor / EPM / Sponsor / etc), click on Contacts.
Click on Add New button to enlist a new SDP.Click Exit to Save this SDP record
The SDP will appear in SDP Evaluation listSelect the SDP as
‘Yes’ for Prospective SDP
Send an ‘Invitation to Participate Letter” to this
SDP.
If response is not received from the identified prospective SDP, data manager will
try other means to enlist site.
If response is received from the
Identified prospective SDP,register the SDP as participant.
Tick Confirm SDP as ‘Yes’ to register the SDP as participant.
The SDP has been enlisted into the NCR.
Monthly Data Submission Tracking and Data Entry Module
Data Submission Tracking
Click this to log a monthly
submission by SDP
Click on the SDP link and a popup to log
monthly data submission will appear
Select ‘Yes’ for the month when data is
received
Type the date data was received
Click Exit to save
An acknowledgement of data submission letter will appear.
This letter is printed out and sent to the
SDP.
When the letter is sent, the date will
be recorded within the system
At the end of each month, this report will be reviewed by Data Manager to identify the progress of data submission
Data manager will also review the number of data returns (# of patient records) to date.
At the beginning of each month, data
manager will identify who are the SDPs that have not submitted their data
The letter will be
printed out and sent to
the SDP
Data Review and Coding Module
Data Review and Coding
Upon clicking this button, the system will automatically code the specimen and HPE data
to ICD-10 Major site code based on a pre-
defined keyword dictionary.
Here, CRC’s medical offier willverify the codes that has been
autocoded by the system.They may select one of the following
Options: (1) Verified (2)Recode to another major site code (3)Uncertain (4)Query data
For records that were not autocodedby the system, the reviewer will code
specimen/HPE based on their judgement
The data will be printed out and sent to Expert Panel
Members for verification, review and coding.
In the meantime whilewaiting for data to be
reviewed by EPM, dataManager will resolve queries
arising from patient data.
After data has been received from EPM, data will be entered into the system.
During de-duplication, patients with duplicateRecords will be identified.
1. To assure the data quality in the database,there should be no duplicate of record
1) SDP Identification, recruitment and initiation
2) Data reporting by SDP & Tracking submission
4) Visual review, Data entry / verification & Updates
5) Edit checks run
6) Data review and Coding
8) Active case finding and site monitoring
7) Deduplicate records
11) Data analysis and Report writing
10) Database lock
9) Data Query
Work process
1) SDP Identification, recruitment and initiation
1. Definition of SDP: Treating physicians or surgeons who manage cases of transplant (organ and tissue)
2. TRU would identify and enlist all SDP 3. TRU would ensure continuous flow of data by
continuing motivation: - KOL, peer and Professional society- Meaningful involvement: Governance Board,
Expert panel, NTR supported Transplant Research group
- Timely feedback and report- Marketing: web, NTR events etc
2) Data reporting by SDP & Tracking submission
1. Case definition: - All new cases of transplant (lung, heart, heart and lung,
liver, cornea, bone marrow, tissue, bone) performed in current calendar year irrespective of type of facility MOH or non MOH, govt or non-govt, local or abroad irrespective of age or nationality
- Principle : Liberal: When in doubt, report2. Types of reporting
i. Minimal Data set: Common data ii.Organ Specific form iii. Annual Census and Centre Survey
2) Data reporting by SDP & Tracking submission
3. Frequency of submissionFor i and ii minimally monthly submission is requested otherwise if not possible ad hoc reporting. For iii. Annual at year end
4.Methods of reporting: -electronic data capture -paper based
2) Data reporting by SDP & Tracking submission
3. Data management (steps 4-10)1. Visual review for error2. Login into an automated data tracking system (prompt and
reminders)3. Data entry / verification & updates 4. Run edit checks for non-allowed codes, extreme values,
inconsistent data etc5. Data review and coding6. Search for duplicate records7. Periodic intensive Active case finding and site monitoring
to round up all the unreported cases & late notifications and other Data Query (need for Direct access to source data and SDP cooperation)
8. Database lock
Conclusion
• The challenge ……..to commence data collection from 1.1.2004
• The deliverable …….. 1 st first National Transplant Registry Report by July 2005
Thank you
www.crc.gov.my