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Table 3 A description of evaluation tools used in the Cochlear P-IROS for longitudinal assessment of speech perception, language development, auditory performance, educational placement, quality of life, device use and associated clinical and demographic covariates

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

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.