National Orthopaedic Registry of Malaysia (NORM)
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1 National Orthopaedic Registry of Malaysia (NORM) Dr.Ahmad Tajuddin b.abdullah Hospital Sultanah Nur Zahirah Kuala Terangganu Why do we need NORM? Polish away the guess estimate attitude - morbidity of hip fracture and diabetic foot/hand in country Focus on the real risk of hip fracture and diabetic foot/hand Determine the burden of hip fracture and diabetic foot/hand among Malaysian 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 Determine the burden- Cost/OT/Resources E-NORM consists of registries Registries Hip Fracture Registry Chaired by Dr Ahmad Tajuddin Abdullah Site data provider : 8 sites Project Management Dr Jaya Purany Stanley Ponniah CRC HKL (Registry Manager) Diabetic Foot/Hand Registry Chaired by Dr Mohammad Anuar Hau Abdullah Site data provider : 8 sites En Mohd Asrul bin Sani CRC HKL (Assistant Registry Manager)
2 Governance Board (KIV) Steering Committee Board # Dr Lim Teck Onn FRCP, M Stat Datuk Dr Teoh Siang Chin PJN MBBS, MSc HHSM Dr Jamaiyah Haniff M Clin Epid Name Datuk Dr Burhan Tan Abdullah Specialty Director of CRC Network Ex-President MMA Pakar Kesihatan Umum Pakar Bedah Ortopedik, HKL Dr. Mohammad Anwar Hau Abdullah (Chairman) Dr. Zulkiflee Osman (Co-Chairman) Dr. Ahmad Tajuddin Dr. Se To Boon Chong Dr. Pan Chee Huan Dr. Mohamad Yazid b Din Dr. Joehaimey Johari Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan Hospital Kuala Lumpur. Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu. Hospital Tuanku Fauziah, Perlis Hospital Sultanah Bahiyah, Alor Setar, Kedah. Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan. Presiden Majlis Paralimpik (cadangan) 8 9 Dr. Saadon Ibrahim Dr. Mohd Zamzuri b. Mohd Zain Hospital Sultanh Ismail, Johor. Hospital Tengku Ampuan Afzan, Kuantan, Pahang. Ketua Rehabilitasi (cadangan) 0 Dr.Tan Boon Chong Dr.Abdul Rauf Ahmad Hospital Tuanku Jaafar, Seremban, Negeri Sembilan. Presiden Persatuan Ortopedik Malaysia (cadangan) Source Data Providers (SDP) 8 participating Sites. Currently 8 MOH Hospitals Tuanku Fauziah H Sultanah Bahiyah H Raja Perempuan Zainab II H Penang H Later others Private Universities Raja Permaisuri Bainon H Serdang H Sg Buloh H Ampang H Klang H Kuala Lumpur H Sultanah Nur Zahirah H Queen 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.) Investigator(s) Dr. Zulkiflee Osman Dr. Faris Kamaruddin Dr. Nahulan A/L V.Theva Rajah Dr. Saadon Ibrahim Dr. Pan Chee Huan Dr. Se To Boon Chong Dato Dr Suresh Chopra Dato Dr. Ramanathan A/L Ramaiah Dr. Mohd Zamzuri b. Mohd Zain Clinical Site Hospital Kuala Lumpur Hospital Umum Sarawak Hospital Queen Elizabeth, Kota Kinabalu, Sabah Hospital Sultan Ismail, Johor. Hospital Tuanku Fauziah, Kangar. Hospital Bahiyah, Alor Star, Kedah. Hospital Ipoh, Perak. Hospital Tengku Ampuan Rahimah, Klang. 0. Dr. Basir Towil. Dr. Ng Yue Onn. Dr. Abdul Rauf Ahmad. Dr. N.Sivapathasundram. Dr. Thevarajaan Karuppiah. Dato Dr. Premchandran A/L P.S. Menon. Dr. Ahmad Tajuddin. Dr. Mohammad Anwar Hau Abdullah 8. Dr. Zamyn Zuki Mohd Zuki Hospital Serdang, Selangor. Hospital Ampang, Selangor. Hospital Tuanku Jaafar, N.Sembilan. Hospital Melaka, Melaka. Hospital Sultanah Aminah, Johor Bharu, Johor. Hospital Tengku Ampuan Afzan, Kuantan, Pahang Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu. Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan. Hospital Sungai Buloh, Selangor.
3 E-norm security features Web application owner authentication using SSL (Secure Sockets Layer) certificate is applied to conduct an authenticated, strongly encrypted online transaction. This certificate ensures that the web site does not belong to an impostor and message privacy. Electronic Data Capture (EDC) Data processing Real time analysis Report NORM DATA FLOW SDP internet NORM office internet Users Return processed data Online data access Communication Flow MOH/NIH/CRC financial report milelestone report project activity report PRINCIPAL INVESTIGATOR (PI) progress report & meetings monthly progress PROJECT MANAGER (PM) everyday monthly report SITE COORDINATOR phone calls / weekly SITE ASSISTANT What is the Benefit? For clinicians: collect data about disease presentation and outcome in a real world picture For organization: Determine the degree in which the clinician are managing cases /OT burdencompare with guidelines. For MOH Burden-standard care for patientresources-cost For Drug/device manufacturer- performance,help develop hypotheses, post marketing. REAL TIME REPORT YOUR OWN CENTRE DATA at FINGER TIPS Compare YOUR CENTRE STATISTICS with NATIONAL STATISTICS BENEFITS with e-norm
4 Benefits continues CAPABLE of DOWNLOADING YOUR OWN CENTRE DATA - For further analysis - For your own research use - Improvement of treating skills - Increase Publication Invitation to all function organized by NORM Acknowledgment in all publication of NORM Only aggregated statistical result will be reported by the registry. No result that can identify patient will be published. RESULT 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 Preparation of proposal Paper CRF drafted & revised Proposal approved (by sponsors) and funding Participation of all SDP secured Pilot study NORM national launch First report of data Date September 00 September 00 November 00 June 008 July 008 August 008 October 009
5 Gantt Chart Achievement Pilot: st July 008 today Active SDP: Tengku Ampuan Rahimah Hospital, Klang Raja Perempuan Zainab II Hospital, Kota Bharu Current cases notified: Hip Fracture TAR Hosp, Klang - RPZII Hosp, Kota Bharu - Diabetic Foot/Hand RPZII Hosp, Kota Bharu - 0 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.
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