BMC Ear Nose Throat Disord. 2014 Oct 06;14:10. doi: 10.1186/1472-6815-14-10. eCollection 2014.
A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear(™) P-IROS).
BMC ear, nose, and throat disorders
Georgina Sanderson, Thathya V Ariyaratne, Josephine Wyss, Valerie Looi
Affiliations
Affiliations
- Cochlear Limited, Asia Pacific Region, Macquarie University, 1 University Avenue, Sydney, NSW 2109, Australia.
- Cochlear AG Europe, Middle East and Africa Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland.
- Sydney Cochlear Implant Centre, Macquarie University, Ground Floor, The Australian Hearing Hub, 16 University Avenue, Sydney, NSW 2109, Australia.
PMID: 25317075
PMCID: PMC4196206 DOI: 10.1186/1472-6815-14-10
Abstract
BACKGROUND: Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described.
METHODS/DESIGN: The Cochlear(™) Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia.
DISCUSSION: The use of a registry such as the Cochlear P-IROS will generate valuable data to support research interests of academics and clinicians around the globe. The data generated will be relevant for a wide range of stakeholders including regulators, payers, providers, policy makers, patients and their families, each with a different perspective for the acceptance and adoption of implantable hearing devices for the treatment of hearing loss.
Keywords: Bone conduction hearing systems; Cochlear implants; Hearing outcomes; Multi-attribute utility index; Multi-centre; Paediatrics; Patient registry; Patient reported outcome; Prospective observational study; Quality of life
References
- Otol Neurotol. 2011 Jan;32(1):39-47 - PubMed
- Otolaryngol Head Neck Surg. 2000 Dec;123(6):756-65 - PubMed
- J Epidemiol Community Health. 2005 Jan;59(1):75-82 - PubMed
- Pediatrics. 2000 Sep;106(3):E43 - PubMed
- Int J Audiol. 2004 Feb;43(2):85-99 - PubMed
- Dev Med Child Neurol. 2011 Jan;53(1):81-8 - PubMed
- PLoS One. 2012;7(11):e48739 - PubMed
- Med Care. 1992 Jun;30(6):473-83 - PubMed
- Cochlear Implants Int. 2014 Sep;15(5):246-53 - PubMed
- Ear Hear. 2013 Jul-Aug;34(4):402-12 - PubMed
- Cochlear Implants Int. 2006 Dec;7(4):194-201 - PubMed
- Acta Otorhinolaryngol Ital. 2011 Oct;31(5):273-80 - PubMed
- Int J Pediatr Otorhinolaryngol. 2004 Feb;68(2):149-60 - PubMed
- Acta Otorhinolaryngol Ital. 2011 Oct;31(5):328-40 - PubMed
- Clin Otolaryngol. 2009 Apr;34(2):113-9 - PubMed
- Int J Pediatr Otorhinolaryngol. 2006 Oct;70(10):1695-706 - PubMed
- Cochlear Implants Int. 2013 Nov;14 Suppl 4:S22-6 - PubMed
- Otolaryngol Head Neck Surg. 2008 May;138(5):655-61 - PubMed
- Arch Otolaryngol Head Neck Surg. 2005 Mar;131(3):251 - PubMed
- Laryngoscope. 2012 Aug;122(8):1852-7 - PubMed
- Eur Arch Otorhinolaryngol. 1999;256(3):128-32 - PubMed
- Ugeskr Laeger. 2003 Apr 14;165(16):1659-62 - PubMed
- Cochlear Implants Int. 2013 Jun;14(3):135-41 - PubMed
- J Clin Epidemiol. 1990;43(1):87-91 - PubMed
- Health Policy. 1996 Jul;37(1):53-72 - PubMed
- Otolaryngol Clin North Am. 2001 Apr;34(2):455-67 - PubMed
- Int J Pediatr Otorhinolaryngol. 2005 Aug;69(8):1089-101 - PubMed
- Otol Neurotol. 2013 Jul;34(5):790-4 - PubMed
- Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1255-62 - PubMed
- Eur J Public Health. 2013 Feb;23(1):146-52 - PubMed
- Value Health. 2012 Mar-Apr;15(2):217-30 - PubMed
- Acta Otolaryngol. 2002 Jun;122(4):356-62 - PubMed
- Otolaryngol Clin North Am. 2001 Apr;34(2):337-64 - PubMed
- Ann R Coll Surg Engl. 2011 Oct;93(7):548-50 - PubMed
- Ann Otol Rhinol Laryngol Suppl. 2005 Dec;195:2-12 - PubMed
- Ear Hear. 2007 Dec;28(6):740-53 - PubMed
- Otol Neurotol. 2002 Nov;23(6):885-90 - PubMed
- Ann Otol Rhinol Laryngol Suppl. 1995 Sep;166:312-4 - PubMed
- Pediatrics. 2013 Sep;132(3):e677-88 - PubMed
- Value Health. 2013 Jun;16(4):461-79 - PubMed
- Arch Otolaryngol Head Neck Surg. 2007 Jan;133(1):51-5 - PubMed
- Health Technol Assess. 2009 Sep;13(44):1-330 - PubMed
- Pain Pract. 2012 Apr;12(4):255-65 - PubMed
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