Screening for Auditory Impairment — Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics

• Published in: Contemporary clinical trials 2007-05, Vol.28 (3), p.303-315
• Main Authors: Yueh, Bevan, Collins, Margaret P, Souza, Pamela E, Heagerty, Patrick J, Liu, Chuan-Fen, Boyko, Edward J, Loovis, Carl F, Fausti, Stephen A, Hedrick, Susan C
• Format: Article
• Language: English
• Subjects: Adult and adolescent clinical studies; Biological and medical sciences; Cardiovascular; Depression; Ear, auditive nerve, cochleovestibular tract, facial nerve: diseases, semeiology; Female; Follow-Up Studies; Hearing Aids; Hearing loss; Hearing Loss - diagnosis; Hearing Loss - therapy; Hematology, Oncology and Palliative Medicine; Humans; Male; Mass Screening - methods; Medical sciences; Middle Aged; Mood disorders; Non tumoral diseases; Otorhinolaryngology. Stomatology; Patient compliance; Patient outcome assessment; Patient Selection; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Quality of life; Randomized controlled trials; Rehabilitation of hearing impaired; Research Design; Screening; Surveys and Questionnaires; Treatment effectiveness; Veterans; Washington
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2006.08.008

Abstract Background Effective screening programs should not merely detect presence of disease, but also lead to long-term benefit. We describe the rationale and design of the first randomized clinical trial to study the long-term effects of routine screening for hearing loss. We also describe the baseline characteristics of the randomized cohort. Methods We randomized 2305 veterans age 50 years or older to a control arm without screening, or to screening with: physiologic testing (AudioScope), a self-administered questionnaire (Hearing Handicap Inventory for the Elderly-Screening version [HHIE-S]), or both tests. The primary outcome measure will be hearing aid use one year after screening. We will also study a number of secondary outcomes, including appointments made with and visits to an audiologist, cases of aidable hearing loss, hearing aids dispensed, self-rated communication ability, and hearing-related quality of life. Results Baseline demographic and health status measures were evenly distributed across the screening arms. The percentage of patients who screened positive for hearing loss was 18.6%, 59.2%, and 63.6% for the AudioScope, HHIE-S, and combined screening arms, respectively. Implications Long-term results are needed to gain insight into whether the AudioScope is associated with high rates of false negative screening, the HHIE-S is associated with high rates of false positive screening, or a combination of both. Identifying the best screening program will depend on determining which strategy leads to successful hearing aid use.