A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS)

BMC Ear, Nose and Throat Disorders

Valerie Looi²  Josephine Wyss³  Thathya V Ariyaratne¹  Georgina Sanderson¹ 

[1]Cochlear Limited, Asia Pacific Region, Macquarie University, 1 University Avenue, Sydney, NSW 2109, Australia

[2]Sydney Cochlear Implant Centre, Macquarie University, Ground Floor, The Australian Hearing Hub, 16 University Avenue, Sydney, NSW 2109, Australia

[3]Cochlear AG Europe, Middle East and Africa Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland

关键词: Multi-attribute utility index;    Patient reported outcome;    Multi-centre;    Quality of life;    Patient registry;    Prospective observational study;    Bone conduction hearing systems;    Cochlear implants;    Paediatrics;    Hearing outcomes;   

Others  :  1084604
DOI  :  10.1186/1472-6815-14-10

 received in 2014-06-02, accepted in 2014-10-01,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Sanderson et al.; licensee BioMed Central Ltd.

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