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


CONCLUSIONS
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.
Yueh
Bevan
B
Health Services Research and Development Service, VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA 98108, USA. byueh@u.washington.edu
Collins
Margaret P
MP
Souza
Pamela E
PE
Heagerty
Patrick J
PJ
Liu
Chuan-Fen
CF
Boyko
Edward J
EJ
Loovis
Carl F
CF
Fausti
Stephen A
SA
Hedrick
Susan C
SC
D005260:Female; D005500:Follow-Up Studies; D006310:Hearing Aids; D034381:Hearing Loss / Q000175:diagnosis* / Q000628:therapy; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D018579:Patient Selection; D012107:Research Design; D011795:Surveys and Questionnaires; D014728:Veterans; D014861:Washington