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 Hospital Pulau Pinang CRC Hospital Ipoh Perak CRC Hospital Kota Bharu Kelantan CRC Hospital Kuantan Pahang CRC Hospital Kuching 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 INPUTOUTPUT  REPORT Manpower 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 list Select 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 will verify 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 autocoded by 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 while waiting for data to be reviewed by EPM, data Manager 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 duplicate Records will be identified. 1. To assure the data quality in the database, there should be no duplicate of record

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, report 2. 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 submission For 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 error 2. 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 etc 5. Data review and coding 6. Search for duplicate records 7. 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 The deliverable …….. 1 st first National Transplant Registry Report by July 2005

Thank you