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National Orthopaedic Registry of Malaysia (NORM)

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National Orthopaedic Registry of Malaysia (NORM) National Orthopaedic Why do we need NORM? Polish away the ‘guess estimate’ attitude - Registry of Malaysia morbidity of hip fracture and diabetic foot/hand in country (NORM) Focus on the real risk of hip fracture and diabetic foot/hand Dr.Ahmad Tajuddin b.Abdullah Determine the burden of hip fracture and Hospital Sultanah Nur Zahirah diabetic foot/hand among Malaysian Kuala Terangganu Promote effective treatment & prevention programs Facilitate research NORM Objectives Determine the number and the trend of hip fracture and diabetic foot/hand in Malaysia. Determine the socio demographic and identify the high-risk group in our Malaysian population. Determine the efficiency and adherence to current treatment guidelines Determine the cost burden to the nation and the cost-effectiveness of treatment and prevention programs E-NORM consists of 2 registries Determine the burden- Cost/OT/Resources Registries Project Management Hip Fracture Registry Dr Jaya Purany Stanley Ponniah Chaired by Dr Ahmad Tajuddin Abdullah CRC HKL Site data provider : 18 sites (Registry Manager) Diabetic Foot/Hand Registry Chaired by Dr Mohammad Anuar Hau En Mohd Asrul bin Sani Abdullah CRC HKL (Assistant Registry Manager) Site data provider : 18 sites 1 Steering Committee Board Governance Board (KIV) Name Specialty 1 Dr. Mohammad Anwar Hau Abdullah Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan # (Chairman) 1 Dr Lim Teck Onn Director of CRC Network 2 Dr. Zulkiflee Osman Hospital Kuala Lumpur. FRCP, M Stat (Co-Chairman) 2 Datuk Dr Teoh Siang Chin PJN Ex-President MMA 3 Dr. Ahmad Tajuddin Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu. MBBS, MSc HHSM 4 Dr. Se To Boon Chong Hospital Pulau Pinang. 3 Dr Jamaiyah Haniff Pakar Kesihatan Umum 5 Dr. Pan Chee Huan Hospital Tuanku Fauziah, Perlis M Clin Epid 6 Dr. Mohamad Yazid b Din Hospital Sultanah Bahiyah, Alor Setar, Kedah. 4 Datuk Dr Burhan Tan Abdullah Pakar Bedah Ortopedik, HKL 7 Dr. Joehaimey Johari Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan. 8 Dr. Saadon Ibrahim Hospital Sultanh Ismail, Johor. 5 Presiden Majlis Paralimpik (cadangan) 9 Dr. Mohd Zamzuri b. Mohd Zain Hospital Tengku Ampuan Afzan, Kuantan, Pahang. 10 Dr.Tan Boon Chong Hospital Pulau Pinang. 6 Ketua Rehabilitasi (cadangan) 11 Dr.Abdul Rauf Ahmad Hospital Tuanku Jaafar, Seremban, Negeri Sembilan. 7 Presiden Persatuan Ortopedik Malaysia (cadangan) Source Data Providers (SDP) 18 participating Sites………. Tuanku Fauziah H Raja Perempuan Currently 18 MOH Hospitals Sultanah Bahiyah H Zainab II H Penang H Sultanah Nur Raja Permaisuri Bainon H Later others Zahirah H Serdang H Sg Buloh H – Private Ampang H Klang H Queen – Universities Kuala Lumpur H Elizabeth H – armed forces Tuanku Jaafar H Sarawak General H Melaka H Tengku Ampuan Afzan H Sultan Ismail H Sultanah Aminah H Site PI. Site PI (cont.)… 10. Dr. Basir Towil Hospital Serdang, Selangor. Investigator(s) Clinical Site 11. Dr. Ng Yue Onn Hospital Ampang, Selangor. 1. Dr. Zulkiflee Osman Hospital Kuala Lumpur 2. Dr. Faris Kamaruddin Hospital Umum Sarawak 12. Dr. Abdul Rauf Ahmad Hospital Tuanku Jaafar, N.Sembilan. 3. Dr. Nahulan A/L V.Theva Rajah Hospital Queen Elizabeth, Kota Kinabalu, Sabah 13. Dr. N.Sivapathasundram Hospital Melaka, Melaka. 4. Dr. Saadon Ibrahim Hospital Sultan Ismail, Johor. 14. Dr. Thevarajaan Karuppiah Hospital Sultanah Aminah, Johor Bharu, 5. Dr. Pan Chee Huan Hospital Tuanku Fauziah, Kangar. Johor. 6. Dr. Se To Boon Chong Hospital Pulau Pinang. 15. Dato’ Dr. Premchandran A/L P.S. Menon Hospital Tengku Ampuan Afzan, Kuantan, 7. Dato’ Dr Suresh Chopra Hospital Bahiyah, Alor Star, Kedah. Pahang 8. Dato’ Dr. Ramanathan A/L Ramaiah Hospital Ipoh, Perak. 16. Dr. Ahmad Tajuddin Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu. 9. Dr. Mohd Zamzuri b. Mohd Zain Hospital Tengku Ampuan Rahimah, Klang. 17. Dr. Mohammad Anwar Hau Abdullah Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan. 18. Dr. Zamyn Zuki Mohd Zuki Hospital Sungai Buloh, Selangor. 2 E-norm security features NORM DATA FLOW Web application owner authentication using SSL (Secure SDP Sockets Layer) Electronic Data Capture Return processed certificate is applied (EDC) internet data to conduct an authenticated, NORM Data processing strongly encrypted office online transaction. This certificate Real time analysis internet Online data access ensures that the web Report site does not belong to an impostor and Users message privacy. Communication Flow MOH/NIH/CRC financial report milelestone report project activity report PRINCIPAL INVESTIGATOR (PI) progress report & monthly progress meetings everyday PROJECT MANAGER (PM) monthly report SITE phone calls / email COORDINATOR weekly SITE ASSISTANT BENEFITS with e-NORM What is the Benefit ? REAL TIME REPORT •For clinicians: collect data about disease presentation and outcome in a real world picture YOUR OWN •For organization: Determine the degree in which CENTRE DATA at the clinician are managing cases /OT burden- FINGER TIPS compare with guidelines. •For MOH –Burden-standard care for patient- Compare YOUR resources-cost CENTRE STATISTICS with NATIONAL •For Drug/device manufacturer- performance,help STATISTICS develop hypotheses, post marketing. 3 Benefits continues… RESULT 9 CAPABLE of DOWNLOADING YOUR • Only aggregated OWN CENTRE DATA statistical result will - For further analysis be reported by the - For your own research use registry. - Improvement of treating skills - Increase Publication • No result that can 9 Invitation to all function organized identify patient will by NORM be published. 9 Acknowledgment in all publication of NORM Compare data Patient Consent • This is an observational study-no intervention therefore no need informed consent . • However we will need to request waiver from MREC • All SDP will have to place PUBLIC NOTICE at their site –informing the centre is participating in NORM and we are collecting Pt. data. • However if patient is not keen they can request their data not to be included. Sample of Public Notice Milestones # Project Activities Date 1 Preparation of proposal September 2007 2 Paper CRF drafted & revised September 2007 3 Proposal approved (by sponsors) and funding November 2007 4 Participation of all SDP secured June 2008 5 Pilot study July 2008 6 NORM national launch August 2008 7 First report of data October 2009 4 Gantt Chart Achievement Pilot: 1st July 2008 – today Active SDP: Tengku Ampuan Rahimah Hospital, Klang Raja Perempuan Zainab II Hospital, Kota Bharu Current cases notified: Hip Fracture TAR Hosp, Klang - 6 RPZII Hosp, Kota Bharu - 7 Diabetic Foot/Hand RPZII Hosp, Kota Bharu - 104 Thank you & G’day Acknowledgement Ministry of Health Malaysia NIH Clinical Research Centre, HKL Participating centres – Nurses, Doctors Datamed Computing Services Sdn. Bhd. ClinResearch Sdn. Bhd. 5.
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