Cochlear Implants International

An Interdisciplinary Journal

ISSN: 1467-0100 (Print) 1754-7628 (Online) Journal homepage: http://www.tandfonline.com/loi/ycii20

Review of outcomes and measurement

instruments in cochlear implantation studies

Simone Schaefer, Lise Henderson, John Graham, Stephen Broomfield, Helen

Cullington, David Schramm, Susan Waltzman & Iain Bruce

To cite this article: Simone Schaefer, Lise Henderson, John Graham, Stephen Broomfield,
Helen Cullington, David Schramm, Susan Waltzman & Iain Bruce (2017) Review of outcomes and
measurement instruments in cochlear implantation studies, Cochlear Implants International, 18:5,
237-239, DOI: 10.1080/14670100.2017.1353761

To link to this article: http://dx.doi.org/10.1080/14670100.2017.1353761

Published online: 25 Jul 2017.

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 Editorial
Review of outcomes and measurement
instruments in cochlear implantation studies
The field of Cochlear Implantation (CI) continues to
rapidly evolve, with professionals and industry explor-
ing novel technologies, extended applications of exist-
ing technologies and other means of optimizing CI
outcome. Such developments will have a financial
impact upon healthcare systems and providers, and
demand the development of evidence of efficacy,
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with evidence-based practice remaining the ultimate
goal. Currently, effective comparison between CI tech-
nologies, populations, and evaluation of the added
value of novel technologies is significantly hindered
by heterogeneity in outcomes used and corresponding
measurement instruments. Ultimately, this negatively
impacts the shared decision-making (SDM) process
between professionals and patients, because of the
lack of definitive evidence.
A previous Editorial in this journal stressed the
importance of developing agreed sets of outcomes
(e.g. Core Outcome Sets (COS), http://www.comet-
initiative.org) to standardize reporting of effectiveness,
and enable the meaningful combination and compari-
son of data from multiple studies (Bruce et al., 2015).
Other fields of medicine, such as Rheumatology and
Gynecology, have embraced this approach to good
effect (Boers et al., 2014; The CROWN Initiative,
2014).
To illustrate the extent of unmet need in the field
of CI, we have conducted a review of outcome
reporting in Cochlear Implants International (CIM).
Studies published in this journal in 2015 (Vol 16:
1–6, S1, S2, S4) were included, with the exclusion
of reviews with lack of new patient data, lack of
effectiveness evaluation and those not involving CI
recipients. All articles were reviewed for outcomes,
corresponding choice of measurement instrument,
time point of measurement, study design, study
description, study sample, and age group of
participants.
A total of 43 articles were reviewed, in which 17
different outcomes were used. Even greater variability
was seen in the corresponding measurement instru-
ments used, with a total of 72 instruments/tools
© 2017 Informa UK Limited, trading as Taylor & Francis Group
DOI 10.1080/14670100.2017.1353761
recorded (Table 1). The most common outcome was
speech perception (24/43 publications), with 25
measurement instruments being used for this
outcome (Table 1). Furthermore, there was a lack of
standardized time points for outcome measurement,
with time points varying between 0 and 20 years
after CI surgery. This wide variation in outcome
domains and corresponding measurement instruments
is in agreement with the findings of the systematic
review of adult CI studies by Vila et al. who found
11 domains in only 8 studies (Vila et al., 2016).
Although, only publications in CIM in 2015 were
included, the inclusion of more volumes was deemed
unlikely to lead to any major changes in our findings.
Review of the first three issues of CIM in 2015 resulted
in a total number of 15 outcomes, with only 2 out-
comes added after analyzing the other issues.
This review also highlighted the significant
numbers of different measurement instruments used
in CI studies. To an extent, this variation is inevita-
ble, reflecting the need to use speech and language
tests in the patient’s native language. The nature of
some measurement instruments allows for translation
into different languages without affecting the validity
of the measurement instrument. While other instru-
ments (e.g. speech perception tests) may not be
readily translated, as they are specific to the under-
standing of words and phrases in a particular
language. In such circumstances, it may be useful
to compare the proportion of CI patients within 1
and 2 standard deviations of the mean for normal
hearing patients, when ‘non-translatable’ instruments
are being compared. Alternatively, the design and
use of novel measurement instruments not reliant
upon understanding of language (e.g. phoneme
tests), could address some of these difficulties.
Similarly, speech understanding with digits may be
an alternative to ‘traditional’ speech perception
tests, with digits representing familiar stimuli
known to people with even limited language ability,
with testing having a smaller learning effect
(Cullington and Aidi 2017).
Cochlear Implants International 2017 VOL. 18 NO. 5 237
 Editorial

Table 1 Overview of outcomes and measurement instruments, CIM 2015.

Outcome No. of studies Methods of measurement

Hearing 18 Aided thresholds

Warble tones free field
Electrical auditory brainstem response (EABR)
Perceptual threshold (T-level)
Loudest comfortable level (C-level)
Fitting to outcomes expert (FOX)
Stimulus recognition
Visual analog scale (VAS)
Pure tone audiometry
Customized nucleus 5 and nucleus 6 questionnaires
APHAB questionnaire
Telephone profile
Evoked compound action potentials (ECAP)
Electrically evoked stapedius reflex threshold (ESRT)
Speech perception 24 Sound field speech perception test
Hochmair–Schult–Moser (HSM) sentence test
Sentence test with adaptive randomized roving levels (STARR)
Fitting to outcomes expert (FOX)
Bamford–Kowal–Bench (BKB) sentence test
Open-set speech recognition
Oldenburger Satztest (OlSa)
list of 50 phonetically balanced French words’ (no further details)
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Freiburger monosyllables
Arthur Boothroyd words
Lafon words
Marginal benefit from acoustic amplification sentences
List 16 consonants (no further details)
List 12 vowels (no further details)
AzBio score
Consonant-nucleus-consonant (CNC)
Flemish recordings of the Dutch word test (NVA test)
Monosyllabic word scores
Bi-syllabic word testing
Three-digit test
Telephone profile
Iowa closed-set sentence test
Speech, Spatial, and Other Qualities of Hearing Scale for parents (SSQ-P)
Adaptive McCormick Toy Test (MTT)
The Chear Auditory Performance Test
Complications of surgery 12 Medical records reviewed
Subjective rates of post-operative dizziness
Pain score (1–10)
Subjective description of pain
Social functioning 1 Focus group interviews with professionals
Academic functioning 1 Focus group interviews with professionals
Communication 1 Focus group interviews with professionals
Expressive language 2 Rosetti Infant Toddler Language scale
Counting spoken word use and manual signs from 14 m video
Receptive language 2 MacArthur–Bates Communication Development Inventory: Words and Sentences
Rosetti Infant Toddler Language scale
Compliance 4 Scale (poor-average-good)
Medical records reviewed
Diary
Data logging Custom Sound Database
Non-validated in house questionnaires
Auditory perception 5 Categories of Auditory Performance (CAP) scores
Adaptive two-alternative forced choice staircase procedure
Categories of Auditory Performance (CAP) – II scores
Fitting time 1 Fitting time noted
Listening effort 2 Meaningful Auditory Integration Scale (MAIS)
Speech, Spatial, and Other Qualities of Hearing Scale for parents (SSQ-P)
Duration of surgery 1 Medical records reviewed
Quality of Life 4 Un-validated in house questionnaire
SF-36 quality of life testing
Hearing Handicap Inventory (HHI) for Adults
Semi structured interview technique
Glasgow Benefit Inventory
Tinnitus 2 Medical records reviewed
Sound localization 1 Speech, Spatial, and Other Qualities of Hearing Scale for parents (SSQ-P)
Hearing in difficult conditions 3 Hearing-In-Noise testing (HINT)
Flemish sentences-in-noise test (LIST)

238 Cochlear Implants International 2017 VOL. 18 NO. 5


The development and adoption of standardized
sets of core outcomes has the potential to reduce
the current levels of heterogeneity in outcome
reporting for evaluations of new technologies and
novel applications of existing cochlear implants. It
should be noted that the use of a ‘general’ set of
core outcomes may not be appropriate for all
studies, as determined by the primary objective of
the evaluation (e.g. music appreciation). Likewise,
the benefits of CI in patients with additional needs
(e.g. cognitive impairment) may not be best evalu-
ated using a ‘general’ set of outcomes and measure-
ment instruments. Benefit in this group of patients
can be under-estimated if the chosen outcome
domains and corresponding measurement instru-
ments are inappropriate and/or unrealistic (Bruce
et al., 2013).
Ultimately, the implementation of standardized sets
of core outcomes and corresponding measurement
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instruments in effectiveness studies for CI in children,
young people, and adults, would help to maximizing
patient access and benefit from CI, by optimizing the
evidence available to professionals and healthcare
commissioners.
Editorial
References
Boers, M., Kirwan, J.R., Wells, G., Beaton, D., Gossec, L.,
d’Agostino, M.A., et al. 2014. Developing core outcome
measurement sets for clinical trials: OMERACT filter 2.0.
Journal of Clinical Epidemiology, 67(7): 745–753.
Bruce, I.A., Cooper, H., Waltzman, S., Schramm, D., Graham, J.
2015. Maximising research value in the field of hearing implan-
tation: a call for ‘big data’. Cochlear Implants International, 16
(6): 301–302.
Bruce, I.A., Markey, A., Henderson, L., Green, K.M.J. 2013. The
need for specific outcome measures when evaluating cochlear
implantation in hearing impaired children with cerebral palsy.
Cochlear Implants International, 14(S3): S35–S37.
Cullington, H.E., Aidi, T. 2017. Is the digit triplet test an effective
and acceptable way to assess speech recognition in adults
using cochlear implants in a home environment? Cochlear
Implants International, 18(2): 97–105.
The CROWN Initiative. 2014. The core outcomes in women’s health
(CROWN) initiative. European Journal of Obstetrics &
Gynecology and Reproductive Biology, 180: A1–A2.
Vila, P.M., Hullar, T.E., Buchman, C.A., Lieu, J.E. 2016. Analysis
of outcome domains in adult cochlear implantation: a systema-
tic review. Otolaryngology-Head and Neck Surgery, 155(2):
238–245.
Simone Schaefer, Lise Henderson
Manchester, UK
with the CIM Editorial team: John Graham,
Stephen Broomfield, Helen Cullington,
David Schramm, Susan Waltzman and Iain Bruce
iain.bruce@manchester.ac.uk
Cochlear Implants International 2017 VOL. 18 NO. 5 239