TY - JOUR
T1 - The tinnitus retraining therapy trial’s standard of care control condition
T2 - Rationale and description of a patient-centered protocol
AU - Erdman, Sue Ann
AU - Scherer, Roberta W.
AU - Sierra-Irizarry, Benigno
AU - Formby, Craig
N1 - Funding Information:
This study was funded by National Institute on Deafness and Other Communication Disorders Grant U01DC007411 awarded to Craig Formby, Tinnitus Retraining Therapy Trial Study Chair, and Grant U01DC007422 awarded to Roberta W. Scherer, Data Coordinating Center Director. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Departments of the Navy and Air Force, Department of Defense, or the U.S. Government. This work was prepared as part of official duties performed by the military service members and civilian employees participating in the tinnitus retraining therapy trial project. Title 17 U.S.C. 105 provides that “Copyright protection under this title is not available for any work of the United States Government.” Title 17 U.S.C. 101 defines a U.S. Government
Funding Information:
This study was funded by National Institute on Deafness and Other Communication Disorders Grant U01DC007411 awarded to Craig Formby, Tinnitus Retraining Therapy Trial Study Chair, and Grant U01DC007422 awarded to Roberta W. Scherer, Data Coordinating Center Director. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Departments of the Navy and Air Force, Department of Defense, or the U.S. Government. This work was prepared as part of official duties performed by the military service members and civilian employees participating in the tinnitus retraining therapy trial project. Title 17 U.S.C. 105 provides that “Copyright protection under this title is not available for any work of the United States Government.” Title 17 U.S.C. 101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties. The authors wish to thank the military and civilian clinicians whose esponses to our inquiries and feedback from training workshops contributed to the content of the tinnitus retraining therapy trial’s standard of care. We are also indebted to the late Gordon Hughes, MD, National Institute on Deafness and Other Communication Disorders’ original project officer for the tinnitus retraining therapy trial, for his invaluable guidance on the development of the standard of care script.
Publisher Copyright:
© 2019 American Speech-Language-Hearing Association.
PY - 2019/9
Y1 - 2019/9
N2 - Purpose: The selection and design of control conditions are critical factors in minimizing the influence of unwanted variables in randomized controlled trials (RCTs). This article describes the rationale, design, and content of a standard of care control condition in a Phase III RCT of tinnitus retraining therapy. Method: Existing tinnitus practices at military hospitals were identified and aligned with the American Speech-Language-Hearing Association’s (2006) preferred practice patterns for tinnitus management and counseling and embedded in a patient-centered protocol to ensure uniformity and treatment fidelity. Results: For those involved in the design of behavioral RCTs, the article identifies options and methods to consider in the selection and design of control conditions. Conclusion: For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically.
AB - Purpose: The selection and design of control conditions are critical factors in minimizing the influence of unwanted variables in randomized controlled trials (RCTs). This article describes the rationale, design, and content of a standard of care control condition in a Phase III RCT of tinnitus retraining therapy. Method: Existing tinnitus practices at military hospitals were identified and aligned with the American Speech-Language-Hearing Association’s (2006) preferred practice patterns for tinnitus management and counseling and embedded in a patient-centered protocol to ensure uniformity and treatment fidelity. Results: For those involved in the design of behavioral RCTs, the article identifies options and methods to consider in the selection and design of control conditions. Conclusion: For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically.
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U2 - 10.1044/2019_AJA-18-0068
DO - 10.1044/2019_AJA-18-0068
M3 - Article
C2 - 31425658
AN - SCOPUS:85072227471
SN - 1059-0889
VL - 28
SP - 534
EP - 547
JO - American journal of audiology
JF - American journal of audiology
IS - 3
ER -