Subjects
One study group initially comprised 60 participants who either visited or were admitted to a hospital that was located in an urban area, namely Gwangju city (referred to forthwith as area A) between November and December 2001. Of these 60 participants, 37 were diagnosed with Alzheimer's disease or vascular dementia, 11 had mental illness such as schizophrenia or depression, 7 had organic brain disease such as cerebral apoplexy or Parkinson's disease, and 5 were alcoholics.
Another study group initially comprised 412 participants who were recruited from all residents of Jangseong-county, Jeonnam province, South Korea, aged 65 and over in 2002(referred to forthwith as area B). The area consists of 11 towns and had an estimated population 54,528 of whom about 16.5% were aged 65 and over. The subjects were selected from each stratum (town) using cluster sampling. All subjects in whom vision or hearing was impaired were excluded from the study. We selected 59 (of 60) and 405 (of 412) participants from area A and B, respectively. All participants gave informed consent, and when participants with dementia cannot provide informed consent, caregivers were asked to provide it.
The Time and Change test
The 'time' component of the T&C test evaluated the ability of a subject to comprehend that the hands of a clock indicated 11:10. The diameter of the clock was 15 cm, and the distance between the clock and the participant was 25–35 cm (in consideration of the visual deficits of the older subjects). When the subject responded incorrectly on the first attempt, the interviewer posed the same question, i.e., a second attempt was permitted. The time (in seconds) that it took for the participant to respond correctly was recorded. A time limit of 60 s for a response was imposed.
In the 'change' component of the T&C test, the participants were required to make 1,000 Won from a group of coins of several smaller denominations, namely one 500, seven 100, and seven 50 Won coins, that were placed on a table in front of the participant. The participants were given 120 s to complete the task, and an additional 120 s was granted if the subject failed to complete the task at the first attempt. The time (in seconds) that it took for the participant to complete the task was recorded by the interviewer.
The participants who completed both of the aforementioned tasks of the T&C test successfully were determined to be negative for suspected dementia, whereas participants who failed to complete either or both of the tasks were determined to be positive for suspected dementia. The T&C test was performed prior to the other cognitive tests by an interviewer who was unaware of the results of the other tests.
Measurement
In the participants from area A, the T&C test was conducted by a nurse, while a physician who were blinded to the result of the T&C test performed a clinical examination and neuropsychiatric inventory. The diagnostic criteria for dementia were based on those of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) [14]. To detect the causative diseases of dementia, the following were carried out: general blood and chemical tests (including VDRL, Vitamin B12, T3, T4, TSH); a chest radiograph; an electrocardiogram; a brain computerized tomography scan; and psychometric tests including the K-MMSE [15]. Alzheimer's dementia was diagnosed based on the guidelines of the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) [16]. Vascular dementia was diagnosed based on the guidelines of the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) [17]. The CDR developed by Hughes et al. [18] was used to determine the progression of dementia.
The participants from area B were interviewed by interviewers who had undergone sufficient training to be able to conduct the K-MMSE and T&C test.
All participants were interviewed for data on social and demographic factors such as address, age, sex, educational status, and the number of family members living together.
Assessment of the validity of the T&C test
To assess the validity of the T&C test as a method to screen for dementia in the participants from area A, we compared the results of the test to a reference standard (diagnosed by a physician), and evaluated sensitivity, specificity, and positive and negative predictive values. To assess the test-retest reliability, the one type of interviewer (specifically, physicians) conducted the same test twice at an interval of 24 h (n = 22 participants). To assess the interobserver reliability, two different types of interviewer (specifically, physicians and psychometrists) conducted the same test, at an interval of 24 h (n = 22 participants).
To assess the applicability of the T&C test as a method to screen for dementia in the participants from area B, the association between the T&C and K-MMSE test scores was evaluated.
Statistical analysis
The sensitivity, specificity, and positive and negative predictive values and 95% Confidence interval of the T&C test were analyzed. After classifying the participants from area B into a group in which dementia was suspected, and another group in which dementia was not suspected based on the results from the T&C test, a Student's t-test was used to compare the total K-MMSE score with the scores for each of the components of the K-MMSE test, and Spearman's rank correlation was used to analyze the correlation between the T&C and K-MMSE test scores. SPSS for Windows (version 10.0; SPSS Inc., Chicago, IL, USA) and Stata Software 6.0 (Stata Corporation, College Station, Texas) were used to analyze data and statistics.