What is it about?
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.
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Why is it important?
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. Dependent on the respective hypothesis, target parameter selection also has a significant impact on sample size planning in clinical trials.
Perspectives
As a result of an open process within the German Working Group for Evoked Response Audiometry (AG-ERA) of the Working Group of German-Speaking Audiologists, Neurotologists, and Otologists of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (ADANO), uniform minimum standards have been specified.
Daniel Polterauer
Ludwig-Maximilians-Universitat Munchen
Read the Original
This page is a summary of: 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, HNO, May 2019, Springer Science + Business Media,
DOI: 10.1007/s00106-019-0647-1.
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