Affiliations 

  • 1 Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, United Kingdom. Electronic address: [email protected]
  • 2 Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, United Kingdom
  • 3 Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, United Kingdom; National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom; University of Nottingham Malaysia, Semenyih, Selangor Darul Ehsan, Malaysia
Prog Brain Res, 2021;262:209-224.
PMID: 33931180 DOI: 10.1016/bs.pbr.2021.01.027

Abstract

The Core Outcome Measures in Tinnitus (COMiT) initiative has recommended a minimum standard of five outcomes when designing a clinical trial to assess the efficacy of sound-based interventions. These are: ability to ignore, concentration, quality of sleep, sense of control and tinnitus intrusiveness. The next stage is to consider what measurement instruments might be appropriate for assessing these constructs. The current study aimed to systematically gather existing instruments used to assess concentration. A total of 6240 potentially relevant records were identified. Duplicates and non-published works were removed, leaving a total of 3599 records. A procedure was developed to sample a subset of records, in order to identify relevant instruments without exhaustively reading all 3599 texts. Initially 559 records were identified by screening 1000 articles; 500 of which were randomly selected, and 500 were the most recent publications identified from the PubMed database. Using predefined criteria for data saturation, information about measures of concentration was extracted from the 559 full texts. However, data saturation was reached by 240. Thirteen candidate instruments were identified. The next step will be to assess content validity and feasibility of administration for all these candidate instruments. Findings will inform future recommendations for how to measure concentration in clinical trials to ensure results of trials can be easily compared, contrasted, and synthesized.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.