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HNO

, Volume 67, Supplement 2, pp 59–61 | Cite as

ADANO recommendations for the selection of target parameters and measurement processes for the use of auditory evoked potentials, otoacoustic emissions, and impedance audiometry in clinical trials

Prepared by the ERA consortium (AG-ERA)* of ADANO#. Confirmed by the board of ADANO on 18.01.2019
  • T. RahneEmail author
  • O. Dziemba
  • A. Lodwig
  • D. Polterauer
  • R. Thie
  • M. Walger
  • T. Wesarg
  • S. Hoth
Guidelines
  • 21 Downloads

Preamble

In the design of clinical studies, definitions of the target parameters (end points) to be measured are required. These serve as a basis for the selection of suitable statistical methods and thus the calculation of necessary sample sizes. The choice of the target parameters suitable for the respective question is based on relevant previous studies and on any available meta-analyses. The freedom of choice of target parameters is thus constrained by boundary conditions.

We consider the standardization of target parameters as necessary for a number of reasons, notably the comparability of different studies. So far, great heterogeneity has been observed in terms of target parameter choice (e.g., [10]). Dependent on the respective hypothesis, target parameter selection also has a significant impact on sample size planning in clinical trials [13].

As a result of an open process within the German Working Group for Evoked Response Audiometry (AG-ERA) of the Working Group of...

Empfehlungen der Arbeitsgemeinschaft Deutschsprachiger Audiologen, Neurootologen und Otologen (ADANO) zur Auswahl von Zielparametern und Prozessempfehlungen beim Einsatz von akustisch evozierten Potentialen, otoakustischen Emissionen und der Impedanzaudiometrie in klinischen Studien

Erarbeitet von der Arbeitsgruppe ERA (AG-ERA) der ADANO. Bestätigt vom Vorstand der ADANO am 18.01.2019

Notes

Compliance with ethical guidelines

Conflict of interest

T. Rahne, O. Dziemba, A. Lodwig, D. Polterauer, R. Thie, M. Walger, T. Wesarg, and S. Hoth declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

The supplement containing this article is not sponsored by industry.

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2019

Authors and Affiliations

  • T. Rahne
    • 1
    Email author
  • O. Dziemba
    • 2
  • A. Lodwig
    • 3
  • D. Polterauer
    • 4
  • R. Thie
    • 5
  • M. Walger
    • 6
  • T. Wesarg
    • 7
  • S. Hoth
    • 8
  1. 1.Department of Otorhinolaryngology, Head and Neck SurgeryMartin Luther University Halle-Wittenberg, University Medicine Halle (Saale)HalleGermany
  2. 2.Department of ENT, Head & Neck SurgeryUniversity Medicine GreifswaldGreifswaldGermany
  3. 3.PATH medical GmbHGermeringGermany
  4. 4.Department of OtorhinolaryngologyUniversity of MunichMunichGermany
  5. 5.Pilot Blankenfelde medizinisch elektronische Geräte GmbHBlankenfeldeGermany
  6. 6.Department of Otorhinolaryngology, Head and Neck SurgeryUniversity of CologneCologneGermany
  7. 7.Department of Otorhinolaryngology, Medical Center—University of Freiburg, Faculty of MedicineUniversity of FreiburgFreiburgGermany
  8. 8.ENT HospitalUniversitätsklinikumHeidelbergGermany

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