# International Ototoxicity Management Group (IOMG)

The International Ototoxicity Management Group (IOMG) is a global consortium created to address a gap in healthcare regarding the treatment of individuals who experience hearing difficulties following the administration of ototoxic medications or exposure to ototoxicants in the environment. The group is composed by volunteers from universities, health foundations, professional societies, and government agencies. It is led by an overall chair with co-chairs leading each work group that focuses on specific areas of ototoxicity management.
Ototoxicity management (OtoM) includes the clinical and therapeutic management of these cases. Clinical practice in these situations, particularly in the case of adult patients and infectious disease populations, is not consistent across countries. Guided by an international team of clinicians, pharmacists, researchers, and patient stakeholders the group plans to develop and disseminate evidence-based information on OtoM in traditional and non-traditional formats with an emphasis on provider- and patient-centric educational materials. The first meeting of the group was held at the National Center for Rehabilitative Auditory Research (NCRAR) in the United States on September 28, 2019.
Protocols

## Objectives and Strategies

The long-term goal of the IOMG is to develop and implement a cohesive set of position statements that will address OtoM care gaps and harmonize with the priorities of the medical specialties providing ototoxic therapies. To reach this goal, near-term objectives are to establish best practices for widespread implementation of OtoM in specific clinical environments (e.g., medical oncology, pulmonology, otology, cystic fibrosis and infectious disease clinics), health care structures (e.g., community-based, occupational health programs, government, third party payer), and regional economies (emerging, transitional, strong). Work groups have been established to focus on the following projects:
Project 1. Conduct an environmental scan of ototoxicity management (OtoM) practices across myriad countries, clinical environments and patient populations to identify OtoM care gaps, barriers and facilitators in relation to best practice guidelines. Established qualitative methods will be used to obtain and analyze survey and interview data in order to gain the perspectives of patient, provider and policy-maker stakeholders. Care will be taken to get input that can inform on a range of health care structures in countries with emerging, transitional and strong economies.
Project 2. Conduct literature reviews to synthesize OtoM guidelines, strategies and clinical practices as well as evidence on the efficacy and effectiveness of OtoM for improving patient- and treatment-level outcomes. In order to efficiently search for relevant literature, the PICOT framework will be utilized. This involves defining the patient problem, intervention, comparison, outcome and type of question to be answered and using these key structures as search criteria.
Project 3a. Develop a cohesive set of guidelines and position statements in collaboration with representatives from the specific clinical specialties and/or community health care workers providing ototoxic therapies to promote widespread OtoM and prevent inconsistent practices.
Project 3b. Develop patient- and provider-facing educational materials using traditional and non-traditional formats to facilitate stakeholder involvement and maintain continuity of OtoM care.
Projects 3a and 3b will involve determining appropriate OtoM schedules and methods that maximize patient outcomes while minimizing preventable ototoxicity, are tolerable for the patient and logistically feasible. This aim will be accomplished by addressing the specific populations of medically complex patients receiving ototoxic therapies, the health care structures in which the OtoM is administered, and by incorporating patient, provider and policy-maker input.

## Focus areas
### Ototoxicity of cancer treatment (chemo/radiation therapy)

Cancer treatment has both immediate and late effects that impact quality of life if left untreated. These can include hearing loss, tinnitus and balance problems. Consensus for clinical care, enhanced tools and health promotion are needed to manage ototoxicity from cancer treatment. This group's goals are to develop a roadmap/call to action to a global template for implementation of ototoxicity management for cancer treatment, identify solutions to address gaps in ototoxicity research and management across the lifespan (including impacts to quality of life beyond hearing loss and recognition of immediate and late effects), identify effective tools, policy enhancements, and delivery frameworks for universal ototoxicity management, and develop resources and strategies that educate, empower, and engage stakeholders (including patients, families, and care teams).

#### Relevant publications:

* Poling, G. L., Vlosich, B., & Dreisbach, L. E. (2019). Emerging distortion product otoacoustic emission techniques to identify preclinical warning signs of basal cochlear dysfunction due to ototoxicity. Applied Sciences, 9(15), 3132. https://www.mdpi.com/2076-3417/9/15/3132
* DeBacker, J. R., McMillan, G. P., Martchenke, N., Lacey, C. M., Stuehm, H. R., Hungerford, M. E., & Konrad-Martin, D. (2023). Ototoxicity prognostic models in adult and pediatric cancer patients: a rapid review. Journal of cancer survivorship : research and practice, 17(1), 82–100. https://doi.org/10.1007/s11764-022-01315-8Konrad-Martin, D., Poling, G. L., Garinis, A. C., Ortiz, C. E., Hopper, J., O’Connell Bennett, K., & Dille, M. F. (2018). Applying US national guidelines for ototoxicity monitoring in adult patients: perspectives on patient populations, service gaps, barriers and solutions. International journal of audiology, 57(sup4), S3-S18. https://www.tandfonline.com/doi/full/10.1080/14992027.2017.1398421
* Konrad-Martin, D., Polaski, R., DeBacker, J. R., Theodoroff, S. M., Garinis, A., Lacey, C., Johansson, K., Mannino, R., Milnes, T., Hungerford, M., & Clark, K. D. (2023). Audiologists' perceived value of ototoxicity management and barriers to implementation for at-risk cancer patients in VA: the OtoMIC survey. Journal of cancer survivorship : research and practice, 17(1), 69–81. https://doi.org/10.1007/s11764-022-01316-7
* Konrad-Martin, D., O'Connell Bennett, K., Garinis, A., & McMillan, G. P. (2021). A Randomized Controlled Trial Using Automated Technology for Improving Ototoxicity Monitoring in VA Oncology Patients. American journal of audiology, 30(3S), 870–886. https://doi.org/10.1044/2021_AJA-21-00032
* Kros CJ, Steyger PS. Aminoglycoside- and Cisplatin-Induced Ototoxicity: Mechanisms and Otoprotective Strategies. Cold Spring Harb Perspect Med. 2019 Nov 1;9(11):a033548. doi: 10.1101/cshperspect.a033548.

### Aminoglycoside-induced ototoxicity

Patients who are treated with aminoglycosides are more likely to develop hearing loss, tinnitus and/or balance problems than those who do not receive aminoglycoside treatment. Patients are not routinely monitored for hearing loss, tinnitus and/or balance problems. This group's goals are to collate/review existing recommendations, work with patients and providers to develop and disseminate evidence-based position statements for applying audiology practice guidelines for ototoxicity management in patients treated with aminoglycosides, survey patients and providers regarding the acceptance and utility of recommendations, and submit consensus document for publication.

#### Relevant publications:

* "Functional Impacts of Aminoglycoside Treatment on Speech Perception and Extended High-Frequency Hearing Loss in a Pediatric Cystic Fibrosis Cohort" AJA, 2021 Jan 19;1-20. doi: 10.1044/2020_AJA-20-00059
* "Cost-effectiveness of implementing routine hearing screening using a tablet audiometer for pediatric cystic fibrosis patients receiving high-dose IV aminoglycosides" JMCP, Volume 27 Issue (2) Huang, McKinzie, Tak.
* "An Ototoxicity Grading System Within a Mobile App (OtoCalc) for a Resource-Limited Setting to Guide Grading and Management of Drug-Induced Hearing Loss in Patients With Drug-Resistant Tuberculosis: Prospective, Cross-Sectional Case Series" (Monitoring Editor: Gunther Eysenbach)
* Harris, T., Bardien, S., Schaaf, H. S., Petersen, L., De Jong, G., & Fagan, J. J. (2012). Aminoglycoside-induced hearing loss in HIV-positive and HIV-negative multidrug-resistant tuberculosis patients. South African Medical Journal, 102(6). https://www.ajol.info/index.php/samj/article/view/79022
* Petersen, L., & Rogers, C. (2015). Aminoglycoside-induced hearing deficits-a review of cochlear ototoxicity. South African Family Practice, 57(2), 1-6. https://journals.co.za/doi/abs/10.1080/20786190.2014.1002220ï»¿
* Garinis, A. C., Poling, G. L., Rubenstein, R. C., Konrad-Martin, D., Hullar, T. E., Baguley, D. M., Burrows, H. L., Chisholm, J. A., Custer, A., Hawe, L. D., Hunter, L. L., Marras, T. K., Ortiz, C. E., Petersen, L., Steyger, P. S., Winthrop, K., Zettner, E. M., Clark, K., Hungerford, M., Vachhani, J. J., … Brewer, C. C. (2021). Clinical Considerations for Routine Auditory and Vestibular Monitoring in Patients With Cystic Fibrosis. American journal of audiology, 30(3S), 800–809. https://doi.org/10.1044/2021_AJA-21-00031
* Garinis, Angela C.; Poling, Gayla L.; Rubenstein, Ronald C.; Konrad-Martin, Dawn; Hullar, Timothy E.; Baguley, David M.; et al. (2021). Ototoxicity management and cystic fibrosis (Garinis et al., 2021). ASHA journals. Dataset. https://doi.org/10.23641/asha.16624366.v1

### Environmental and occupational ototoxicants

Some pollutants and chemicals at work can cause damage to different parts of the ear. Exposure to theses ototoxicants has be found to be associated with hearing loss and balance difficulties. Sometimes, exposure to chemicals can make ears more sensitive to the harmful effects of noise. There are no standard methods for the auditory and vestibular surveillance of individuals exposed to environmental or occupational chemicals. Consensus guidelines for the clinical care of exposed persons and tools for implementation and health promotion are needed to manage ototoxicity from environmental and occupational exposures. This group's goals are to collate existing recommendations, update reviews, work with stakeholders in the fields of occupational health, hearing care and audiology to develop and disseminate evidence-based position statements for applying audiology practice guidelines for ototoxicity management at work and in the clinic.

#### Relevant publications:

* Bohn V, Morata TC, Roggia S, Zucki F, Pouyatos B, Venet T, Krieg E, José MR, de Lacerda ABM. Temporary and Permanent Auditory Effects Associated with Occupational Coexposure to Low Levels of Noise and Solvents. International Journal of Environmental Research and Public Health. 2022; 19(16):9894. https://doi.org/10.3390/ijerph19169894
* Occupational exposure to chemical and hearing impairment from The Nordic Expert Group for Criteria Documentation of Health Risks from Chemicals, 2010.
* Hemmativaghef E. Exposure to lead, mercury, styrene, and toluene and hearing impairment: evaluation of dose-response relationships, regulations, and controls. J Occup Environ Hyg. 2020 Nov-Dec;17(11-12):574-597. doi: 10.1080/15459624.2020.1842428.
* Hong, O., Kerr, M. J., Poling, G. L., & Dhar, S. (2013). Understanding and preventing noise-induced hearing loss. Disease-a-month, 59(4), 110-118. https://www.sciencedirect.com/science/article/abs/pii/S0011502913000217
* Morata TC, Hungerford M, Konrad-Martin D. Potential Risks to Hearing Functions of Service Members From Exposure to Jet Fuels. Am J Audiol. 2021 Oct 11;30(3S):922-927. doi: 10.1044/2021_AJA-20-00226. Epub 2021 Aug 18. PMID: 34407375.
* Roggia, Simone Mariotti; Zucki, Fernanda; Fuente, Adrian; Lacerda, Adriana Bender Moreira de; Gong, Wei; Carlson, Krystin; Morata, Thais C. (2023-11). "Audiological Tests Used in the Evaluation of the Effects of Solvents on the Human Auditory System: A Mixed Methods Review". Seminars in Hearing 44 (04): 437–469. doi:10.1055/s-0043-1769585. ISSN 0734-0451. PMID 37818148. PMC PMC10562058.
* Zarus GM, Ruiz P, Benedict R, Brenner S, Carlson K, Jeong L, Morata TC. Which Environmental Pollutants Are Toxic to Our Ears?—Evidence of the Ototoxicity of Common Substances. Toxics. 2024; 12(9):650. https://doi.org/10.3390/toxics12090650

### International considerations

Patients treated with ototoxic medications get their healthcare differently depending on the health care structures in their regions and their access to care. Practice recommendations and implementation toolkits tailored to the healthcare structures and global region are needed to increase access and value of ototoxicity management. This group's goals are to collate/review existing recommendations, survey patients and providers to develop recommendations for applying ototoxicity management guidelines in different health care structures and global regions, and submit findings for publication.

#### Relevant publications:

* Lindeborg, M. M., Jung, D. H., Chan, D. K., & Mitnick, C. D. (2022). Prevention and management of hearing loss in patients receiving ototoxic medications. Bulletin of the World Health Organization, 100(12), 789–796A. https://doi.org/10.2471/BLT.21.286823
* Meijer AJM, van den Heuvel-Eibrink MM, Brooks B, et al. Recommendations for Age-Appropriate Testing, Timing, and Frequency of Audiologic Monitoring During Childhood Cancer Treatment: An International Society of Paediatric Oncology Supportive Care Consensus Report. JAMA Oncol. 2021;7(10):1550–1558. doi:10.1001/jamaoncol.2021.2697 Pediatric
* Núñez-Batalla, Faustino; Jáudenes-Casaubón, Carmen; Sequí-Canet, Jose Miguel; Vivanco-Allende, Ana; Zubicaray-Ugarteche, Jose (2022-07). "Ototoxicity in childhood: Recommendations of the CODEPEH (Commission for the Early Detection of Childhood Hearing Loss) for prevention and early diagnosis". Acta Otorrinolaringologica (English Edition) 73 (4): 255–265. doi:10.1016/j.otoeng.2022.07.002 Pediatric

## External Links

* International Ototoxicity Management Group, National Center for Rehabilitative Auditory Research (NCRAR)
* International Ototoxicity Management Working Group leadership and organization, including subgroups and focus areas
* A Framework To Facilitate the Use of Systematic Reviews and Meta-Analyses in the Design of Primary Research Studies Research White Papers Investigators: Matthew Thompson, MBChB, MPH, DPhil, MRCGP, Arpita Tiwari, MHS, Rongwei Fu, PhD, Esther Moe, PhD, MPH, and David I Buckley, MD, MPH. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jan. Report No.: 12-EHC009-EF.
* Groupe international de gestion de l'ototoxicité