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

Abstract

BackgroundCurrently, 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/DesignThe 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.DiscussionThe 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.

One-year experience with the Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) in New Delhi, India

“…Severe to profound hearing loss is defined as hearing loss of 61 dBHL or more in the better ear ( Mathers et al., 2000 ). Its incidence is estimated to be 4.8% in children aged 0–1 years and 6.4% in children aged 1–4 years ( Sanderson et al., 2014 ). Prevalence and severity of hearing loss vary with some factors including socioeconomic status, exposure to infections, and consanguinity ( Stevens et al., 2013 ).…”

Design and rationale of a prospective, multi-institutional registry for patients with sinonasal malignancy

“…Prospective, multicenter registry‐based studies are an important research tool for the study of aggregated patient data, especially in studying clinical outcomes of rare diseases. Although registry‐based studies have been widely published in the cardiopulmonary literature and other medical disciplines, clinical registries specific to otolaryngology are relatively uncommon . In head and neck oncology, national databases such as the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program have been important sources of retrospective outcomes data, but large general cancer databases such as SEER lack the granularity required for detailed QoL and oncologic outcomes analysis specific to sinonasal malignancy …”

“…Although registry-based studies have been widely published in the cardiopulmonary literature and other medical disciplines, clinical registries specific to otolaryngology are relatively uncommon. [22][23][24][25][26] In head and neck oncology, national databases such as the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program have been important sources of retrospective outcomes data, but large general cancer databases such as SEER lack the granularity required for detailed QoL and oncologic outcomes analysis specific to sinonasal malignancy. 2 The CORSICA registry has been designed to balance granularity and practicality, and has been intentionally launched on a small scale to optimize participation and compliance before scaling the registry to a larger consortium.…”

Clinical and socio-demographic profile of children with hearing impairment who had undergone cochlear implant surgery

“…1,2 Estimated incidence of hearing loss is 4.8% in children 0-1 year and 6.4% in 1-4 age group. 3 Prevalence of severity of hearing loss depends upon factors including socioeconomic status, ear infection and consanguinity. Prevalence for disability hearing loss in children is highest in South-Asia region followed by Subsaharan Africa.…”