Construct | Evaluation tool | Reference | Categories of data collected | Scales used |
---|---|---|---|---|
Clinical/surgical information, device-related data | Clinician Baseline Form | Sponsor generated forms | • implantable hearing device details | - |
Clinician Follow-up Form | ||||
• surgical approach used | ||||
• general medical and hearing history | ||||
• source of referral | ||||
• source of funding for implantation | ||||
• compliance to therapy/rehabilitation | ||||
• clinician satisfaction with progress | ||||
Patient demographics, hearing history and habilitation | Implant Recipient Baseline Form | Sponsor generated forms | • hearing-aid use | |
• communication mode | ||||
• type of habilitation | ||||
• patient’s educational placement | ||||
Implant Recipient Follow-up Form | • family composition | |||
• socio economic variables | ||||
• parent/carer satisfaction with child’s progress | ||||
Auditory Performance | Categories of Auditory Performance-II (CAP-II) Questionnaire | [41] | Child’s functional use of audition in everyday situations | CAP–II score over 10-point scale (Range 0 to 9) |
Self-reported hearing function | Speech Spatial Qualities– Parents’ Version (SSQ-P) Questionnaire | [38] | Auditory disability across a wide variety of domains, representing hearing in the everyday situations. | SSQ-P score over 3 domains |
Speech Spatial Qualities (SSQ) – optional for children 10 years or older | [36] | Auditory disability across a wide variety of domains, reflecting the reality of hearing in everyday situations. | SSQ score over 3 domains | |
Quality of life | Children using Hearing Implants Quality of Life Questionnaire (CuHI-QoL) | Sponsor generated form Additional file 1 | The impact of hearing implants on the: | CuHI-QoL score over 3 domains |
• quality of life of very young children, | ||||
• their parents’ expectations and | ||||
• their immediate family. | ||||
Health Utility Index Mark III (HUI3) – optional for children 10 years or older | [48] | The HUI3 includes eight attributes of health status: | Health Utility Score (Range 0.00 to 1.00) | |
• vision | ||||
• hearing | ||||
• speech | ||||
• ambulation | ||||
• dexterity | ||||
• emotion | ||||
• cognition | ||||
• pain and discomfort | ||||
Unaided Hearing Threshold | Unaided Hearing Threshold Form | Sponsor generated form | • Otoacoutsic Emissions (OAE) and Auditory Brainstem Responses (ABR) may be recorded for very young children. | |
• Unaided air-conduction hearing-threshold measurements, pre- and post-implantation. | ||||
• Unaided bone-conduction hearing threshold measurements, pre- and post-implantation. | ||||
Aided Hearing Threshold | Aided Hearing Threshold Form | Sponsor generated form | • Aided air-conduction thresholds, pre and post-surgery. | - |
• Aided bone-conduction thresholds, pre and post-surgery. |