Delayed-Start Study Design for Balloon Dilation of the Eustachian Tube: Alternative for a Randomized Controlled Trial

Shari Van Roeyen, Paul Van de Heyning, Vincent Van Rompaey, Shari Van Roeyen, Paul Van de Heyning, Vincent Van Rompaey

No abstract available

Keywords: Eustachian tube; diagnosis; questionnaires; research design; tests.

Figures

Figure 1
Figure 1
Delayed-start study design. Blinded assessment at T1 with subsequent randomization. One group will receive treatment (empty circle) shortly after T1 and will be evaluated again at T2 and T3. The dotted line suggests the potential improvement in Eustachian Tube Dysfunction Questionnaire (ETDQ-7) in this group. The other group will be put on a waiting list and reevaluated at T2. The solid line suggests that these patients have stable symptoms at T2. Shortly after T2 they will receive treatment (empty circle). The latter group will be evaluated again at T3.

References

    1. Leuwer R, Koch U. Anatomy and physiology of the auditory tube. Therapeutic possibilities in chronic disorders of tubal function. HNO (1999) 47:514–23.
    1. Browning GG, Gatehouse S. The prevalence of middle ear disease in the adult British population. Clin Otolaryngol Allied Sci (1992) 17:317–21.
    1. Snow JB, Wackym P. Diagnosis and tests of function. In: Wackym PA, Snow J, editors. Ballenger’s Otolaryngology – Head and Neck Surgery. People’s Medical Publishing House; (2009). p. 113–37.
    1. McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol (2012) 2:191–8.10.1002/alr.21007
    1. Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation Eustachian tuboplasty: a clinical study. Laryngoscope (2010) 120:1411–6.10.1002/lary.20950
    1. Llewellyn A, Norman G, Harden M, Coatesworth A, Kimberling D, Schilder A, et al. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess (2014) 18:1–180, v–vi.10.3310/hta18460
    1. D’Agostino RB. The delayed-start study design. N Engl J Med (2009) 361:1304–6.10.1056/NEJMsm0904209
    1. Poe DS, Silvola J, Pyykko P. Balloon dilation of the cartilaginous Eustachian tube. Otolaryngol Head Neck Surg (2011) 144:563–9.10.1177/0194599811399866
    1. Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the Eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol (2011) 32:115–23.10.1016/j.amjoto.2009.11.008
    1. Augustine AM, Varghese L, Michael RC, Albert RR, Job A. The efficacy of dynamic slow motion video endoscopy as a test of Eustachian tube function. J Laryngol Otol (2013) 127:650–5.10.1017/S0022215113001023
    1. Schröder S, Reineke U, Lehmann M, Ebmeyer J, Sudhoff H. Chronic obstructive Eustachian tube dysfunction in adults: long-term results of balloon Eustachian tuboplasty. HNO (2013) 61:142–51.10.1007/s00106-012-2573-3
    1. Jurkiewicz D, Bień D, Szczygielski K, Kantor I. Clinical evaluation of balloon dilation Eustachian tuboplasty in the Eustachian tube dysfunction. Eur Arch Otorhinolaryngol (2013) 270:1157–60.10.1007/s00405-012-2243-9
    1. Smith ME, Tysome JR. Tests of Eustachian tube function: a review. Clin Otolaryngol (2015) 40:300–11.10.1111/coa.12428
    1. Schilder AG, Bhutta MF, Butler CC, Holy C, Levine LH, Kvaerner K, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol (2015) 40:407–11.10.1111/coa.12475
    1. Grøntved A, Krogh HJ, Christensen PH, Jensen PO, Schousboe HH, Hentzer E. Monitoring middle ear pressure by tympanometry. A study of middle ear pressure variation through seven hours. Acta Otolaryngol (1989) 108:101–6.
    1. Schröder S, Lehmann M, Korbmacher D, Sauzet O, Sudhoff H, Ebmeyer J. Evaluation of tubomanometry as a routine diagnostic tool for chronic obstructive Eustachian tube dysfunction. Clin Otolaryngol (2015) 40:691–7.10.1111/coa.12451
    1. Finkelstein Y, Talmi YP, Zohar Y, Laurian N. Study of Toynbee phenomenon by combined intranasopharyngeal and tympanometric measurements. Ann Otol Rhinol Laryngol (1988) 97:199–206.
    1. Schröder S, Lehmann M, Sudhoff H, Ebmeyer J. Assessment of chronic obstructive Eustachian tube dysfunction: evaluation of the German version of the Eustachian Tube Dysfunction Questionnaire. HNO (2014) 62:162–4.10.1007/s00106-013-2764-6
    1. Van Roeyen S, Van de Heyning P, Van Rompaey V. Value and discriminative power of the seven-item Eustachian Tube Dysfunction Questionnaire. Laryngoscope (2015) 125:2553–6.10.1002/lary.25316
    1. Van Roeyen S, Van de Heyning P, Van Rompaey V. Responsiveness of the 7-item Eustachian Tube Dysfunction Questionnaire. J Int Adv Otol (2016) 12:106–8.10.5152/iao.2016.2086
    1. Schröder S, Lehmann M, Sauzet O, Ebmeyer J, Sudhoff H. A novel diagnostic tool for chronic obstructive Eustachian tube dysfunction – the Eustachian tube score. Laryngoscope (2015) 125:703–8.10.1002/lary.24922

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel