Working group established at the 2009 ICRA meeting. Current members are Deborah Hall, Louise Hickson, Gabriella Saunders, Theresa Chisolm, Jean-Pierre Gagné, Ruth Bentler and Sophia Kramer (coordinator).
Background
Hearing loss is usually assessed by psycho-acoustic measurements such as pure-tone and speech audiometry. These examinations only provide a very limited description of the consequences of hearing loss (Danermark et al., 2010). The World Health Organization’s (WHO) International Classification of Functioning, Disability and Health (ICF) presents a multifactorial understanding of functioning and disability and describes a person’s functioning in terms of the person’s body (Body Functions and Structures component) and in terms of the activities the person engages in (Activity and Participation). The ICF provides a unified and standard language and framework for the description of functioning and disability. Because of its exhaustive nature, the generic ICF framework is too complex for use in daily practice. This is true for hearing-related conditions such as tinnitus. Hence, Core Sets have been developed. Core Sets facilitate the description of functioning in clinical practice by providing lists of domains carefully selected from a larger set because they are directly relevant for a specific health condition.
Hearing loss
The ICF Core Sets for Hearing Loss (ICF CS-HL) were developed according to a standard procedure covering four preparatory studies and a consensus conference (Granberg, 2015). The comprehensive ICF Core Set for Hearing Loss consists of 117 ICF categories, and the Brief one consists of 27 (of the 117) categories (Danermark et al., 2013). For a free download go to: https://www.icf-research-branch.org/icf-core-sets-projects2/other-health-conditions/icf-core-set-for-hearing-loss. The ICF CS-HL are lists of codes indicating what to measure, but not how to measure. The next phase in the development of the CS-HL therefore requires several decisions on how to use it in clinical practice and research. It is envisaged that the ICF CS-HL can be used as a checklist during the clinical assessment or admission interview by the health professional (Van Leeuwen et al., 2017). It can also be used as a patient reported outcome measure (PROM). In case of the latter, the CS-HL codes need to be transformed into questions. New items can be developed or items from appropriate measurement instruments can be selected. New items and scales based on the ICF CS-HL still have to undergo extensive testing and psychometric evaluation to prove their reliability and validity clinically and cross culturally. Also, strategies for the implementation of the ICF Core Sets for HL in clinical practice should be developed.
Tinnitus
The Core Outcome Measures in Tinnitus (COMiT) have been developed according to a standard procedure described by Williamson et al. the COMET Handbook: version 1.0. Trials. 2017 Jun 20;18(Suppl 3):280 (Hall et al., 2015; Hall 2017). At present these address minimum standards of assessing and reporting outcomes from sound-based, psychology-based and pharmacology-based interventions for clinical trials of chronic subjective tinnitus in adults (Fackrell et al., 2017). There are five ‘sound-based’ domains, five ‘psychology-based’ domains, and two ‘drug-based’ domains. Publications are currently being prepared, but a short description can be accessed here: http://tinnet.tinnitusresearch.net/index.php/2015-10-29-10-22-16/wg-5-outcome-measurement
Again, the COMiT recommendations so far address what to measure, but not how to measure. Measurement instruments are currently under consideration since there is unacceptable heterogeneity in usage (Hall et al., 2016). The COMiT recommendations differ from the ICF CS-HL in that they are being designed specifically with clinical trials in mind, rather than clinical practice.
Other Core Sets outwith ICRA include those for aural rehabilitation (http://www.auronet.org/) and for adults with unilateral severe-to-profound hearing loss (http://www.comet-initiative.org/studies/details/1084?result=true) .
Objectives of Core Sets working group:
1. To promote and guide further development of Core Sets for use in clinical practice, research and education in the field of Audiology.
2. To develop strategies for the implementation of the ICF Core Sets for HL in clinical practice
3. To encourage international collaboration and alignment in these processes
4. To promote (and support where ever possible) use of guidelines for translation and cross-cultural adaptation to enhance confidence in the functional equivalence of translated versions of the same hearing-related instrument for use in different language and cultures.
References
Danermark, B., Möller, C., Gagné, J-P, Hickson, L. Swanepoel, D., Cieza, A., Kramer, S.E., Stucki, G., Strömberg, J-P, Gimigliano, F. (2010) International classification of functioning, disability and health core sets for hearing loss: a discussion paper and invitation. Int J Audiol, 49(4):256-62.
Danermark, B. Granberg, S., Kramer, S.E., Selb, M., Möller, C. (2013). The Creation of a Comprehensive and a Brief Core Set for Hearing Loss Using the International Classification of Functioning, Disability and Health. Am J Audiol, Vol. 22, 323-328. doi:10.1044/1059-0889 (2013/12-0052)
Granberg, S. Functioning and disability in adults with hearing loss. Preparatory studies in the ICF Core Sets for hearing loss project. Doctoral Dissertation. Orebro University 2015.
Fackrell K, Smith H, Colley V, Thacker B, Horobin A, Haider HF, Londero A, Mazurek B, Hall DA. (2017) Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT’ID study protocol for using a Delphi process and face-to-face meetings to establish consensus. Trials 18(1):388. doi:10.1186/s13063-017-2123-0.
Hall DA, Domingo SZ, Hamdache LZ, Manchaiah V, Thammaiah S, Evans C, Wong LLN. (2017) A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures. Int J Audiol. 21:1-15. [Epub ahead of print] Doi:10.1080/14992027.2017.1393565
Hall DA. (2017) Designing clinical trials for assessing the effectiveness of interventions for tinnitus. Trends Hear, 21:1-12. doi: 10.1177/2331216517736689.
Hall DA, Haider H, Szczepek AJ, Lau P, Rabau S, Jones-Diette J, Londero A, Edvall NK, Cederroth CR, Mielczarek M, Fuller T, Batuecas-Caletrio A, Brueggemen P, Thompson DM, Norena A, Cima RFF, Mehta RL, Mazurek B. (2016) Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults. Trials 17:270. doi: 10.1186/s13063-016-1399-9.
Hall DA, Haider H, Kikidis D, Mielczarek M, Mazurek B, Szczepek AJ, Cederroth CR. (2015) Towards a global consensus on outcome measures for clinical trials in tinnitus: report from the first international meeting of the COMiT initiative 14 November 2014, Amsterdam, The Netherlands. Trends Hear 19:1-7. doi: 10.1177/2331216515580272.
Leeuwen L. van, Merkus P, Pronk M, VanderTorn M, Maré M, Goverts ST, Kramer SE. (2017). Overlap and non- overlap between the ICF Core Sets for Hearing Loss and the Otology and Audiology intake documentation: towards an integrated tool. Ear Hear, 38(1):103-116.