Nader Saki1, Arash Bayat1, Soheila Nikakhlagh1, Majid Karimi1, Mohammad Nikafrooz2,3, Ahmad Daneshi4, Masoud Motesadi Zarandi5, Mohammad Ajalloueyan6, Seyed Basir Hashemi7, Mohammad Mehdi Ghasemi8, Ali Eftekharian9, Seyyed Hamidreza Abtahi10, Maryam Amizadeh11, Farhad Farahani12, Masoud Naderpour13. 1. Hearing Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Hearing Research Center Ahvaz Jundishapur University of Medical Sciences Ahvaz Iran. 2. Department of Education, University of Farhangian Teacher Education, Chamran Branch, Iran Department of Education University of Farhangian Teacher Education Chamran Branch Iran. 3. Special Education Organization, Tehran, Iran Special Education Organization Tehran Iran. 4. ENT and Head & Neck Research Center and Department, The Five Senses Institute, Iran University of Medical Sciences, Tehran, Iran ENT and Head & Neck Research Center and Department The Five Senses Institute Iran University of Medical Sciences Tehran Iran. 5. Department of Cochlear Implant Center and Otorhinolaryngology, Tehran University of Medical Sciences, Tehran, Iran Department of Cochlear Implant Center and Otorhinolaryngology Tehran University of Medical Sciences Tehran Iran. 6. Department of Otorhinolaryngology, Baqiyatallah University of Medical Sciences, Tehran, Iran Department of Otorhinolaryngology Baqiyatallah University of Medical Sciences Tehran Iran. 7. Department of Otorhinolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran Department of Otorhinolaryngology Shiraz University of Medical Sciences Shiraz Iran. 8. Sinus and Surgical Endoscopic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran Sinus and Surgical Endoscopic Research Center Mashhad University of Medical Sciences Mashhad Iran. 9. Department of Otorhinolaryngology, Shahid Beheshti University of Medical Sciences, Tehran, Iran Department of Otorhinolaryngology Shahid Beheshti University of Medical Sciences Tehran Iran. 10. Department of Otolaryngology, Isfahan University of Medical Sciences, Isfahan, Iran Department of Otolaryngology Isfahan University of Medical Sciences Isfahan Iran. 11. Department of Otorhinolaryngology Head and Neck Surgery, Kerman University of Medical Sciences, Kerman, Iran Department of Otorhinolaryngology Head and Neck Surgery Kerman University of Medical Sciences Kerman Iran. 12. Hearing Disorders Research Center, Hamadan University of Medical Sciences, Hamadan, Iran Hearing Disorders Research Center Hamadan University of Medical Sciences Hamadan Iran. 13. Department of Otorhinolaryngology Head and Neck Surgery, Tabriz University of Medical Sciences, Tabriz, Iran Department of Otorhinolaryngology Head and Neck Surgery Tabriz University of Medical Sciences Tabriz Iran.
Abstract
BACKGROUND AND OBJECTIVE: Patients who receive cochlear implants (CIs) constitutes a significant population in Iran. This population needs regular monitor on long-term outcomes, educational placement and quality of life. Currently, there is no national or regional registry on the long term outcomes of CI users in Iran. The present study aims to introduce the design and implementation of a national patient-outcomes registry on CI recipients for Iran. This Iranian CI registry (ICIR) provides an integrated framework for data collection and sharing, scientific communication and collaboration inCI research. METHODS: The national ICIR is a prospective patient-outcomes registry for patients who are implanted in one of Iranian centers. The registry is based on an integrated database that utilizes a secure web-based platform to collect response data from clinicians and patient's proxy via electronic case report forms (e-CRFs) at predefined intervals. The CI candidates are evaluated with a set of standardized and non-standardized questionnaires prior to initial device activation(as baseline variables) and at three-monthly interval follow-up intervals up to 24 months and annually thereafter. RESULTS: The software application of the ICIR registry is designed in a user-friendly graphical interface with different entry fields. The collected data are categorized into four subsets including personal information, clinical data, surgery data and commission results. The main parameters include audiometric performance of patient, device use, patient comorbidities, device use, quality of life and health-related utilities, across different types of CI devices from different manufacturers. CONCLUSION: The ICIR database could be used by the increasingly growing network of CI centers in Iran. Clinicians, academic and industrial researchers as well as healthcare policy makers could use this database to develop more effective CI devices and better management of the recipients as well as to develop national guidelines.
BACKGROUND AND OBJECTIVE:Patients who receive cochlear implants (CIs) constitutes a significant population in Iran. This population needs regular monitor on long-term outcomes, educational placement and quality of life. Currently, there is no national or regional registry on the long term outcomes of CI users in Iran. The present study aims to introduce the design and implementation of a national patient-outcomes registry on CI recipients for Iran. This Iranian CI registry (ICIR) provides an integrated framework for data collection and sharing, scientific communication and collaboration inCI research. METHODS: The national ICIR is a prospective patient-outcomes registry for patients who are implanted in one of Iranian centers. The registry is based on an integrated database that utilizes a secure web-based platform to collect response data from clinicians and patient's proxy via electronic case report forms (e-CRFs) at predefined intervals. The CI candidates are evaluated with a set of standardized and non-standardized questionnaires prior to initial device activation(as baseline variables) and at three-monthly interval follow-up intervals up to 24 months and annually thereafter. RESULTS: The software application of the ICIR registry is designed in a user-friendly graphical interface with different entry fields. The collected data are categorized into four subsets including personal information, clinical data, surgery data and commission results. The main parameters include audiometric performance of patient, device use, patient comorbidities, device use, quality of life and health-related utilities, across different types of CI devices from different manufacturers. CONCLUSION: The ICIR database could be used by the increasingly growing network of CI centers in Iran. Clinicians, academic and industrial researchers as well as healthcare policy makers could use this database to develop more effective CI devices and better management of the recipients as well as to develop national guidelines.