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 in Hearing
Deborah Ann HallCore Outcome Measures in Tinnitus (COMiT) initiative

Abstract

Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints ("outcome domains"). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT'ID recommendations are robust. The COMiT'ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptabl...Continue Reading

References

Dec 1, 1990·Ear and Hearing·F K KukH Jordan
Feb 1, 1996·Archives of Otolaryngology--head & Neck Surgery·C W NewmanJ B Spitzer
Sep 5, 2003·Emergency Medicine Journal : EMJ·S R JonesM Harrison
Oct 25, 2007·Progress in Brain Research·Richard S TylerHelena Ji
Jan 5, 2011·Journal of Clinical Epidemiology·Gordon H GuyattHolger J Schünemann
Oct 20, 2011·BMJ : British Medical Journal·Julian P T HigginsUNKNOWN Cochrane Statistical Methods Group
Jul 14, 2012·Journal of Psychosomatic Research·Michael LandgrebeBerthold Langguth
Jul 3, 2013·Health and Quality of Life Outcomes·Bradley C JohnstonGordon H Guyatt
Jul 6, 2013·Lancet·David BaguleyDeborah Hall
Oct 3, 2014·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·David E TunkelElizabeth J Whamond
May 10, 2017·Frontiers in Medicine·Alain Londero, Deborah A Hall
Jul 7, 2017·Trials·Paula R WilliamsonBridget Young
Mar 7, 2018·Research Involvement and Engagement·Harriet SmithUNKNOWN Core Outcome Measures in Tinnitus (COMiT) initiative
Mar 20, 2018·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·C B TerweeL B Mokkink

❮ Previous
Next ❯

Citations

Jan 8, 2020·Interactive Journal of Medical Research·Alice HibbertDeborah Ann Hall
Aug 27, 2019·Frontiers in Neuroscience·Don J McFerranDavid M Baguley
Jun 12, 2021·Frontiers in Neurology·Maaike M RademakerInge Stegeman
Jun 29, 2021·Frontiers in Aging Neuroscience·Jorge Piano SimoesEleni Genitsaridi

❮ Previous
Next ❯

Methods Mentioned

BETA
cochlear implants

Software Mentioned

COMET
COMIT
Delphi
DelphiManager
ID

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.