Quality of Life-CI: Development of an Early Childhood Parent-Proxy and Adolescent Version

Abstract

Objectives: Severe to profound hearing loss is associated with communication, social, and behavioral difficulties that have been linked to worse health-related quality of life (HRQoL) compared to individuals with normal hearing. HRQoL has been identified as an important health outcome that measures functional ability, particularly for chronic conditions and disabilities. The current study developed the QoL-cochlear implant (CI) for early childhood and adolescents using the recommended Food and Drug Administration and European Medicines Agency guidelines on patient-reported outcomes. Design: Three phases of instrument development were conducted for both the early childhood (0 to 5 years old; parent proxy) and adolescent/young adult (13 to 22 years old) versions of the QoL-CI. Phase 1 included the development of our conceptual framework, which informed the discussion guides for stakeholder focus groups (e.g., audiologists, physicians, and therapists) at CI clinics in Miami and Philadelphia (n = 39). Open-ended interviews with parents (N = 18 for early childhood; N = 6 for adolescent/young adult version) and adolescents/young adults using CIs (n = 17) were then completed at both sites during phase 2. All interviews were transcribed and coded to identify common themes, which were then used to draft items for the QoL-CI. Both versions of the QoL-CI were developed using Qualtrics to allow for quick, easy electronic administration of the instruments on a tablet device. Last, phase 3 included cognitive testing in a new sample (N = 19 early childhood, N = 19 adolescent) to ensure that the draft instruments were clear, comprehensive, and easy to use. Results: Participant responses obtained via the open-ended interviews yielded an early childhood and adolescent version of the QoL-CI that was reportedly easy to complete and comprehensive. The final QoL-CI Early Childhood instrument yielded 35 questions across eight functional domains (environmental sounds, communication, social functioning, behavior, CI device management and routines, school, CI benefits, and early intervention). Similarly, the final QoL-CI adolescent/young adult version consisted of 46 items across eight domains (noisy environments, communication, CI usage and management, advocacy, social functioning, emotional functioning, acceptance, and independence). Conclusions: The QoL-CI is a condition-specific QoL instrument that can be used for children ages birth through 22 years. These instruments capture the “whole” child by not only focusing on communication and auditory skills but also academic, social and emotional functioning. Once validated, these CI-specific measures will enable providers to track long-term outcomes and evaluate the efficacy of new interventions to improve overall CI use and QoL for pediatric and young adult users.

Development and Implementation of the Cochlear Implant Quality of Life (CIQOL) Functional Staging System

“…6,7 Recently, an increased emphasis has been placed on understanding the broader impact of cochlear implantation through the use of patient-reported outcome measures (PROMs). [8][9][10][11][12][13][14][15][16][17][18][19][20] This is consistent with evidence of weak associations between speech recognition scores and self-reported realworld functional abilities of CI users, which suggests that PROMs provide unique information not available from speech recognition scores. 14,17,18,[21][22][23] The increased emphasis of PROMs is not unique to cochlear implantation.…”

“…While cochlear implants (CIs) have demonstrated an impact on patients' lives, 1–5 outcomes have primarily focused on speech recognition ability improvement measured in controlled, clinical settings 6,7 . Recently, an increased emphasis has been placed on understanding the broader impact of cochlear implantation through the use of patient‐reported outcome measures (PROMs) 8–20 . This is consistent with evidence of weak associations between speech recognition scores and self‐reported real‐world functional abilities of CI users, which suggests that PROMs provide unique information not available from speech recognition scores 14,17,18,21–23 …”

Parent-reported quality of life in children with cochlear implants differs across countries

“…Validated condition-specific questionnaires are common for chronic conditions such as cancer and diabetes but sparse for other conditions such as cochlear implantation. The last 25 years has seen the development of several CI-specific QoL measures for children (presented here in chronologic order): Survey of Parents of Pediatric Cochlear Implantees ( Gallaudet Research Institute, 1999 ), Cochlear Implant Expectations Questionnaire ( Zaidman-Zait and Most, 2005 ); Children with Cochlear Implants: Parental Perspectives ( CCIPP ; Archbold et al, 2008 ), Parent Expectations Questionnaire for Cochlear Implants ( Nemours Children’s Clinic, 2010 ), Parental Attitudes of Various Aspects of Cochlear Implantation ( Soleimanifar et al, 2015 ), Brief Assessment of Parental Perception ( Samuel et al, 2016 ), and Quality of Life—Cochlear Implant ( Cejas et al, 2021 ). All these measures use parent proxy reports, in which parents appraise their child’s QoL; only one instrument ( Quality of Life—Cochlear Implant ) also has a self-report option for pediatric CI users to rate their own well-being relative to cochlear implantation.…”

“…All these measures use parent proxy reports, in which parents appraise their child’s QoL; only one instrument ( Quality of Life—Cochlear Implant ) also has a self-report option for pediatric CI users to rate their own well-being relative to cochlear implantation. Fewer than five studies report on parent proxy QoL outcomes using each of the following measures: Survey of Parents of Pediatric Cochlear Implantees ( Christiansen and Leigh, 2004 ; Hyde et al, 2010 ); the Cochlear Implant Expectations Questionnaire ( Zaidman-Zait and Most, 2005 ; Hyde et al, 2010 ; Punch and Hyde, 2010 ), Parent Expectations Questionnaire for Cochlear Implants ( Kumar et al, 2016 ; Alam et al, 2019 ; Alkhatani, 2021 ; Halawani et al, 2021 ), and the Quality of Life—Cochlear Implant ( Hoffman et al, 2019 ; Cejas et al, 2021 ). The CCIPP reflects the most frequently used CI-specific QoL instrument worldwide (e.g., Incesulu et al, 2003 ; Nicholas and Geers, 2003 ; O’Neill et al, 2004 ; Nunes et al, 2005 ; Archbold et al, 2006 , 2008 ; Damen et al, 2007 ; Huttunen et al, 2009 ; Fortunato-Tavares et al, 2012 ; Sparreboom et al, 2012 ; Stefanini et al, 2014 ; de Almeida et al, 2015 ; Kumar et al, 2015 ; Yorgun et al, 2015 ; Asfour et al, 2018 ; Byckova et al, 2018 ; Zhao et al, 2018 ; Hassuji, 2019 ; Molla et al, 2019 ; Tokat et al, 2019 ; Brewis et al, 2020 ; Peker et al, 2020 ; Shahmahmood et al, 2020 ; Silva et al, 2020 , 2021 ; Anne et al, 2021 ; Yang et al, 2022 ; Zhang et al, 2022 ; Zhumabayev et al, 2022 ).…”

Cochlear implant-specific risks should be considered, when assessing the quality of life of children and adolescents with hearing loss and cochlear implants–not just cochlear implant-specific benefits–Perspective

“…Recently, the development of pediatric CI-specific QoL instruments was initiated ( Hoffman et al, 2019 ; Cejas et al, 2021 ). In these instruments, some burdens were also considered (e.g., “fatigue” Hoffman et al, 2019 ).…”