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Published in: Trials 1/2020

01-12-2020 | Rehabilitation | Study protocol

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey

Authors: Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick

Published in: Trials | Issue 1/2020

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Abstract

Background

Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions.

Methods/design

The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked.

Discussion

The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.
Appendix
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Literature
1.
van de Heyning P, Tavora-Vieira D, Mertens G, Van Rompaey V, Rajan GP, Muller J, Hempel JM, Leander D, Polterauer D, Marx M, Usami SI, Kitoh R, Miyagawa M, Moteki H, Smilsky K, Baumgartner WD, Keintzel TG, Sprinzl GM, Wolf-Magele A, Arndt S, Wesarg T, Zirn S, Baumann U, Weissgerber T, Rader T, Hagen R, Kurz A, Rak K, Stokroos R, George E, Polo R, Medina MDM, Henkin Y, Hilly O, Ulanovski D, Rajeswaran R, Kameswaran M, Di Gregorio MF, Zernotti ME. Towards a unified testing framework for single-sided deafness studies: a consensus paper. Audiol Neurootol. 2016;21(6):391–8.PubMed
2.
Daniels RL, Swallow C, Shelton C, Davidson HC, Krejci CS, Harnsberger HR. Causes of unilateral sensorineural hearing loss screened by high-resolution fast spin echo magnetic resonance imaging: review of 1,070 consecutive cases. Otol Neurotol. 2000;21(2):173–80.
3.
Staecker H, Nadol JB Jr, Ojeman R, Ronner S, McKenna MJ. Hearing preservation in acoustic neuroma surgery: middle fossa versus retrosigmoid approach. Otol Neurotol. 2000;21(3):399–404.
4.
Wu Q, Li X, Sha Y, Dai C. Clinical features and management of Meniere’s disease patients with drop attacks. Eur Arch Otorhinolaryngol. 2019;276(3):665–72.PubMed
5.
Schreiber BE, Agrup C, Haskard DO, Luxon LM. Sudden sensorineural hearing loss. Lancet. 2010;375(9721):1203–11.PubMed
6.
Baguley DM, Bird J, Humphriss RL, Prevost AT. The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol. 2006;31(1):6–14.PubMed
7.
Dwyer NY, Firszt JB, Reeder RM. Effects of unilateral input and mode of hearing in the better ear: self-reported performance using the speech, spatial and qualities of hearing scale. Ear Hear. 2014;35(1):126–36.PubMed
8.
Hawley ML, Litovsky RY, Culling JF. The benefit of binaural hearing in a cocktail party: effect of location and type of interferer. J Acoust Soc Am. 2004;115(2):833–43.PubMed
9.
Levitt HR, Rabiner L. Predicting binaural gain in intelligibility and release from masking for speech. J Acoust Soc Am. 1967;42(4):820–9.PubMed
10.
Agterberg MJ, Snik AF, Hol MK, Van Wanrooij MM, Van Opstal AJ. Contribution of monaural and binaural cues to sound localization in listeners with acquired unilateral conductive hearing loss: improved directional hearing with a bone-conduction device. Hear Res. 2012;286(1–2):9–18.PubMed
11.
Hoth S, Rosli-Khabas M, Herisanu I, Plinkert PK, Praetorius M. Cochlear implantation in recipients with single-sided deafness: audiological performance. Cochlear Implants Int. 2016;17(4):190–9.PubMed
12.
Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011;32(1):39–47.PubMed
13.
Harford E, Barry J. A rehabilitative approach to the problem of unilateral hearing impairment: the contralateral routing of signals. J Speech Hear Disord. 1965;30:121–38.PubMed
14.
Giolas TG, Wark DJ. Communication problems associated with unilateral hearing loss. J Speech Hear Disord. 1967;32(4):336–43.PubMed
15.
Welsh LW, Welsh JJ, Rosen LF, Dragonette JE. Functional impairments due to unilateral deafness. Ann Otol Rhinol Laryngol. 2004;113(12):987–93.PubMed
16.
Lucas L, Katiri R, Kitterick PT. The psychological and social consequences of single-sided deafness in adulthood. Int J Audiol. 2018;57(1):21–30.PubMed
17.
Carlsson PI, Hall M, Lind KJ, Danermark B. Quality of life, psychosocial consequences, and audiological rehabilitation after sudden sensorineural hearing loss. Int J Audiol. 2011;50(2):139–44.PubMed
18.
Kitterick PT, Lucas L, Smith SN. Improving health-related quality of life in single-sided deafness: a systematic review and meta-analysis. Audiol Neurootol. 2015;20(1):79–86.PubMed
19.
Peters JP, Smit AL, Stegeman I, Grolman W. Review: bone conduction devices and contralateral routing of sound systems in single-sided deafness. Laryngoscope. 2015;125(1):218–26.PubMed
20.
Leterme G, Bernardeschi D, Bensemman A, Coudert C, Portal JJ, Ferrary E, Sterkers O, Vicaut E, Frachet B, Grayeli AB. Contralateral routing of signal hearing aid versus transcutaneous bone conduction in single-sided deafness. Audiol Neurootol. 2015;20(4):251–60.PubMed
21.
Lin LM, Bowditch S, Anderson MJ, May B, Cox KM, Niparko JK. Amplification in the rehabilitation of unilateral deafness: speech in noise and directional hearing effects with bone-anchored hearing and contralateral routing of signal amplification. Otol Neurotol. 2006;27(2):172–82.PubMed
22.
van de Heyning P, Rajan G, Arndt S, Skarzynski P. Extended indications of cochlear implantation [abstract]. J Laryngol Otol. 2016;130(Suppl 3):S40.
23.
Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, Clarke M, Gargon E, Gorst S, Harman N, Kirkham JJ, McNair A, Prinsen CAC, Schmitt J, Terwee CB, Young B. The COMET Handbook: version 1.0. Trials. 2017;18(Suppl 3):280.PubMedPubMedCentral
24.
Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003;24(1):73–8.PubMed
25.
Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, Brackmann DE, Soli SD. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg. 2003;129(3):248–54.PubMed
26.
Desmet JB, Wouters K, De Bodt M, van de Heyning P. Comparison of 2 implantable bone conduction devices in patients with single-sided deafness using a daily alternating method. Otol Neurotol. 2012;33(6):1018–26.PubMed
27.
Jacob R, Stelzig Y, Nopp P, Schleich P. Audiological results with cochlear implants for single-sided deafness [in German]. HNO. 2011;59(5):453–60.PubMed
28.
Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012;33(8):1339–46.PubMedPubMedCentral
29.
Härkönen K, Kivekäs I, Kotti V, Sivonen V, Vasama JP. Hybrid cochlear implantation: quality of life, quality of hearing, and working performance compared to patients with conventional unilateral or bilateral cochlear implantation. Eur Arch Otorhinolaryngol. 2017;274(10):3599–604.PubMed
30.
Krempaska S, Koval J, Schmid C, Pfiffner F, Kurz A, Kompis M. Influence of directionality and maximal power output on speech understanding with bone anchored hearing implants in single sided deafness. Eur Arch Otorhinolaryngol. 2014;271(6):1395–400.PubMed
31.
Mertens G, Kleine Punte A, De Ridder D, Van de Heyning P. Tinnitus in a single-sided deaf ear reduces speech reception in the nontinnitus ear. Otol Neurotol. 2013;34(4):662–6.PubMed
32.
Grossmann W, Brill S, Moeltner A, Mlynski R, Hagen R, Radeloff A. Cochlear implantation improves spatial release from masking and restores localization abilities in single-sided deaf patients. Otol Neurotol. 2016;37(6):658–64.PubMed
33.
Pfiffner F, Kompis M, Flynn M, Asnes K, Arnold A, Stieger C. Benefits of low-frequency attenuation of Baha® in single-sided sensorineural deafness. Ear Hear. 2011;32(1):40–5.PubMed
34.
Popelka GR. SoundBite hearing system by Sonitus Medical: a new approach to single-sided deafness. Semin Hear. 2010;31(4):393–409.
35.
Laske RD, Roosli C, Pfiffner F, Veraguth D, Huber AM. Functional results and subjective benefit of a transcutaneous bone conduction device in patients with single-sided deafness. Otol Neurotol. 2015;36(7):1151–6.PubMed
36.
Moore BC, Popelka GR. Preliminary comparison of bone-anchored hearing instruments and a dental device as treatments for unilateral hearing loss. Int J Audiol. 2013;52(10):678–86.PubMed
37.
Snapp HA, Hoffer ME, Xuezhong L, Rajguru SM, Liu X. Effectiveness in rehabilitation of current wireless CROS technology in experienced bone-anchored implant users. Otol Neurotol. 2017;38(10):1397–404.PubMedPubMedCentral
38.
Snapp HA, Holt FD, Liu X, Rajguru SM. Comparison of speech-in-noise and localization benefits in unilateral hearing loss subjects using contralateral routing of signal hearing aids or bone-anchored implants. Otol Neurotol. 2017;38(1):11–8.PubMedPubMedCentral
39.
Weber BA, Roush J, McElveen JT. Application of an implantable bone conduction hearing device to patients with unilateral sensorineural hearing loss. Laryngoscope. 1992;102(5):538–42.PubMed
40.
Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss - German version [in German]. HNO. 2017;65(7):586–98.PubMed
41.
Döge J, Baumann U, Weissgerber T, Rader T. Single-sided deafness: impact of cochlear implantation on speech perception in complex noise and on auditory localization accuracy. Otol Neurotol. 2017;38(10):e563–9.PubMed
42.
Linstrom CJ, Silverman CA, Yu GP. Efficacy of the bone-anchored hearing aid for single-sided deafness. Laryngoscope. 2009;119(4):713–20.PubMed
43.
Newman CW, Sandridge SA, Wodzisz LM. Longitudinal benefit from and satisfaction with the Baha system for patients with acquired unilateral sensorineural hearing loss. Otol Neurotol. 2008;29(8):1123–31.PubMed
44.
Saliba I, Nader ME, El Fata F, Leroux T. Bone anchored hearing aid in single sided deafness: outcome in right-handed patients. Auris Nasus Larynx. 2011;38(5):570–6.PubMed
45.
Schafer EC, Baldus N, d’Souza M, Algier K, Whiteley P, Hill M. Behavioral and subjective performance with digital CROS/BiCROS hearing instruments. J Acad Rehabil Audiol. 2013;46:62–93.
46.
Grantham DW, Ashmead DH, Haynes DS, Hornsby BWY, Labadie RF, Ricketts TA. Horizontal plane localization in single-sided deaf adults fitted with a bone-anchored hearing aid (Baha). Ear Hear. 2012;33(5):595–603.PubMed
47.
Ryu NG, Moon IJ, Byun H, Jin SH, Park H, Jang KS, Cho YS. Clinical effectiveness of wireless CROS (contralateral routing of offside signals) hearing aids. Eur Arch Otorhinolaryngol. 2015;272(9):2213–9.PubMed
48.
Távora-Vieira D, De Ceulaer G, Govaerts PJ, Rajan GP. Cochlear implantation improves localization ability in patients with unilateral deafness. Ear Hear. 2015;36(3):e93–8.PubMed
49.
Bosman AJ, Hol MKS, Snik AFM, Mylanus EAM, Cremers CWRJ. Bone-anchored hearing aids in unilateral inner ear deafness. Acta Otolaryngol. 2003;123(2):258–60.PubMed
50.
Wazen JJ, Ghossaini SN, Spitzer JB, Kuller M. Localization by unilateral BAHA users. Otolaryngol Head Neck Surg. 2005;132(6):928–32.PubMed
51.
Schmerber S, Deguine O, Marx M, Van de Heyning P, Sterkers O, Mosnier I, Garin P, Godey B, Vincent C, Venail F, Mondain M, Deveze A, Lavieille JP, Karkas A. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. 2017;274(4):1835–51.PubMed
52.
Härkönen K, Kivekäs I, Rautiainen M, Kotti V, Sivonen V, Vasama JP. Single-sided deafness: the effect of cochlear implantation on quality of life, quality of hearing, and working performance. ORL J Otorhinolaryngol Relat Spec. 2015;77(6):339–45.PubMed
53.
Kleine Punte A, Vermiere K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011;12(Suppl 1):S26–9.
54.
Kleine Punte A, De Ridder D, Van de Heyning P. On the necessity of full length electrical cochlear stimulation to suppress severe tinnitus in single-sided deafness. Hear Res. 2013;295:24–9.
55.
Song JJ, Kim K, Sunwoo W, Mertens G, Van de Heyning P, De Ridder D, Vanneste S, Lee SY, Park KJ, Choi H, Choi JW. A quantitative electroencephalography study on cochlear implant-induced cortical changes in single-sided deafness with tinnitus. Front Hum Neurosci. 2017;11:210 A published erratum appears in Front Hum Neurosci. 2018;12:46.PubMedPubMedCentral
56.
Song JJ, Kleine Punte A, De Ridder D, Vanneste S, Van de Heyning P. Neural substrates predicting improvement of tinnitus after cochlear implantation in patients with single-sided deafness. Hear Res. 2013;299:1–9.PubMed
57.
Távora-Vieira D, Marino R, Acharya A, Rajan GP. The impact of cochlear implantation on speech understanding, subjective hearing performance, and tinnitus perception in patients with unilateral severe to profound hearing loss. Otol Neurotol. 2015;36(3):430–6.PubMed
58.
Indeyeva YA, Diaz A, Imbrey T, Gao G, Coelho DH. Tinnitus management with percutaneous osseointegrated auditory implants for unilateral sensorineural hearing loss. Am J Otolaryngol. 2015;36(6):810–3.PubMed
59.
Holder JT, O’Connell B, Hedley-Williams A, Wanna G. Cochlear implantation for single-sided deafness and tinnitus suppression. Am J Otolaryngol. 2017;38(2):226–9.PubMed
60.
Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. 2016;331:1–6.PubMed
61.
Kitterick PT, Smith SN, Lucas L. Hearing instruments for unilateral severe-to-profound sensorineural hearing loss in adults: a systematic review and meta-analysis. Ear Hear. 2016;37(5):495–507.PubMedPubMedCentral
62.
63.
64.
Hall DA, Kitterick PT, Heffernan E, Fackrell K, Lucas L, Ferguson M. How do we know that our patients have benefitted from our ENT/audiological interventions? Presented at the annual meeting of ADANO 2016 in Berlin. Otol Neurotol. 2019;40(4):e474–81.PubMed
65.
66.
Sinha IP, Williamson PR, Smyth RL. Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. PLoS One. 2009;4(7):e6276.PubMedPubMedCentral
67.
Gandhi GY, Murad MH, Fujiyoshi A, Mullan RJ, Flynn DN, Elamin MB, Swiglo BA, Isley WL, Guyatt GH, Montori VM. Patient-important outcomes in registered diabetes trials. JAMA. 2008;299(21):2543–9.PubMed
68.
Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, Williamson PR. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9(6):e99111.PubMedPubMedCentral
69.
Serrano-Aguilar P, Trujillo-Martin MM, Ramos-Goni JM, Mahtani-Chugani V, Perestelo-Perez L. Posada-de la Paz M. Patient involvement in health research: a contribution to a systematic review on the effectiveness of treatments for degenerative ataxias. Soc Sci Med. 2009;69(6):920–5.PubMed
70.
Kirwan JR, Hewlett SE, Heiberg T, Hughes RA, Carr M, Hehir M, Kvien TK, Minnock P, Newman SP, Quest EM, Taal E, Wale J. Incorporating the patient perspective into outcome assessment in rheumatoid arthritis -progress at OMERACT 7. J Rheumatol. 2005;32(11):2250–6.PubMed
71.
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.PubMedPubMedCentral
72.
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393.PubMedPubMedCentral
73.
Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, Abetz L, Martin SA. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;59(7):952–60.PubMed
74.
Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.PubMedPubMedCentral
75.
76.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.PubMedPubMedCentral
77.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentral
78.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.PubMedPubMedCentral
79.
Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981;47(1):207–14.PubMed
80.
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Daniel B, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1):9–19.PubMed
81.
Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, Conaghan PG, Bingham CO 3rd, Brooks P, Landewé R, March L, Simon LS, Singh JA, Strand V, Tugwell P. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol. 2014;67(7):745–53.PubMed
82.
Schmitt J, Apfelbacher C, Spuls PI, Thomas KS, Simpson EL, Furue M, Chalmers J, Williams HC. The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. J Invest Dermatol. 2015;135(1):24–30.PubMed
83.
Alkhaffaf B, Glenny AM, Blazeby JM, Williamson P, Bruce IA. Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study). Trials. 2017;18:370.PubMedPubMedCentral
84.
Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, Londero A, Mazurek B, Thacker B, Fackrell K, Core Outcome Measures in Tinnitus (COMiT) initiative. The COMiT’ID study: developing core outcome domains sets for clinical trials of sound-, psychology-, and pharmacology-based interventions for chronic subjective tinnitus in adults. Trends Hear. 2018;22:2331216518814384..PubMedPubMedCentral
85.
Hall DA, Smith H, Heffernan E, Fackrell K, Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) Research Steering Group. Recruiting and retaining participants in e-Delphi surveys for core outcome set development: evaluating the COMiT’ID study. PLoS One. 2018;13(7):e0201378..PubMedPubMedCentral
86.
Brookes ST, Macefield RC, Williamson PR, McNair AG, Potter S, Blencowe NS, Strong S, Blazeby JM. Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development. Trials. 2016;17:409..PubMedPubMedCentral
87.
Kirkham JJ, Gorst S, Altman DG, Blazeby J, Clarke M, Devane D, Gargon E, Williamson PR. COS-STAR: a reporting guideline for studies developing core outcome sets. Trials. 2015;16:373..PubMedPubMedCentral
88.
Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, Williamson PR. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 2017;14(11):e1002447.PubMedPubMedCentral
89.
Keeley T, Williamson P, Callery P, Jones LL, Mathers J, Jones J, Young B, Calvert M. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials. 2016;17:230.PubMedPubMedCentral
90.
91.
Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol. 2008;117(9):645–52.PubMed
92.
93.
Keeney S, Hasson F, McKenna HP. A critical review of the Delphi technique as a research methodology for nursing. Int J Nurs Stud. 2001;38(2):195–200.PubMed
94.
Young B, Bagley H. Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates. Res Involv Engagem. 2016;2:25.PubMedPubMedCentral
95.
Smith H, Horobin A, Fackrell K, Colley V, Thacker B, Hall DA, Core Outcome Measures in Tinnitus (COMiT) initiative. Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains. Res Involv Engagem. 2018;4:8.PubMedPubMedCentral
96.
97.
Vas V, Akeroyd MA, Hall DA. A data-driven synthesis of research evidence for domains of hearing loss, as reported by adults with hearing loss and their communication partners. Trends Hear. 2017;21:2331216517734088.PubMedPubMedCentral
98.
Blackwood B, Ringrow S, Clarke M, Marshall J, Rose L, Williamson PR, McAuley D. Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study. Trials. 2015;16:368.PubMedPubMedCentral
99.
Gargon E, Crew R, Burnside G, Williamson PR. Higher number of items associated with significantly lower response rates in COS Delphi surveys. J Clin Epidemiol. 2019;108:110–20.PubMedPubMedCentral
100.
Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, Alderson P, Glasziou P, Falck-Ytter Y, Schunemann HJ. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395–400.PubMed
101.
Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Moher D, Schmitt J, Tugwell P, Tunis S, Williamson PR. Core Outcome Set–STAndards for Reporting: the COS-STAR statement. PLoS Med. 2016;13(10):e1002148.PubMedPubMedCentral
102.
Fackrell K, Smith H, Colley V, Thacker B, Horobin A, Haider HF, Londero A, Mazurek B, Hall DA. 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. 2017;18:388.PubMedPubMedCentral
103.
104.
Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, Bennett AM, Chorbachi R, Hall PN, Harding-Bell A, Parfect VH, Rumsey N, Sell D, Sharma R, Williamson PR. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514..PubMedPubMedCentral
105.
106.
Harman NL, Bruce IA, Callery P, Tierney S, Sharif MO, O’Brien K, Williamson PR. MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70.PubMedPubMedCentral
107.
Bruce I, Harman N, Williamson P, Tierney S, Callery P, Mohiuddin S, Payne K, Fenwick E, Kirkham J, O’Brien K. The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation. Health Technol Assess. 2015;19(68):1–374.PubMedPubMedCentral
108.
Hall DA, Hibbert A, Smith H, Haider HF, Londero A, Mazurek B, Fackrell K, Core Outcome Measures in Tinnitus (COMiT) initiative. One size does not fit all: developing common standards for outcomes in early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions for chronic subjective tinnitus in adults. Trends Hear. 2019;23:2331216518824827.PubMedPubMedCentral
109.
Turk DC, Dworkin RH. What should be the core outcomes in chronic pain clinical trials? Arthritis Res Ther. 2004;6(4):151–4.PubMedPubMedCentral
Metadata
Title
Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey
Authors
Roulla Katiri
Deborah A. Hall
Nora Buggy
Nicholas Hogan
Adele Horobin
Paul van de Heyning
Jill B. Firszt
Iain A. Bruce
Pádraig T. Kitterick
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4094-9

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