4.1 Study design and ethical approval
The study was approved by the Ethics Committee of the Faculty of Medicine of the University of Brasilia (Approval Number: 43188021-9-1001-5558). All methods were performed in accordance with the guidelines and regulations of the National Council of Research Ethics and the Declaration of Helsinki, and informed consent was obtained from all participants. Participant data are protected by national data protection legislation. The study had a cross-sectional observational design and utilized nonprobabilistic convenience sampling by quotas. In the following sections, we provide a detailed description of the experimental methodology and preliminary results.
4.2 Participant enrolment and inclusion criteria
To be eligible for participation, individuals had to be at least 18 years of age and native speakers of Portuguese. The study participants consisted of healthcare professionals from the university hospital, medical students, administrative staff, and employees from a glass factory. We excluded participants who provided careless or potentially biased responses to the olfactory function test, such as selecting answers at random or choosing the same option for all responses. We purposely did not exclude individuals who had a recent cold or flu or who reported olfactory loss because a sample with sufficient variability in test performance is essential to evaluate the test’s ability to measure the loss of the sense of smell.
However, for the normative curve of the test, other inclusion and exclusion criteria were established to ensure the inclusion of normosmic individuals. Participants had to be 18 or older, native speakers of Portuguese, and free of any known impairment of smell or taste. Participants who had been sick (with a cold or flu) within 15 days prior to the exam were excluded, as were those who reported neurological or psychiatric diseases and those with a history of head trauma. Participants who demonstrated negligent performance in the exam were also excluded. Additionally, those aged above 60 years and scoring below 24 points on the MMSE were excluded19.
4.3 Description of device features
The Multiscent-20 is a dedicated tablet featuring a 7-inch touchscreen specifically designed for use in the cosmetics industry to present perfume fragrances to customers (Fig. 5)5.
The Multiscent-20 is a portable tablet computer with an integrated hardware system consisting of a central processing unit, touchscreen, Wi-Fi antenna, USB dock, power supply, and rechargeable battery. Additionally, it contains an odour system composed of 20 microcartridges, an air filter, a system that generates a dry air stream, and an odour-dispensing opening. The device is capable of presenting 20 different odours from individual odour capsules, which store the olfactory stimuli by incorporating the odours into an oil-resistant polymer. The capsules are loaded through an insertion port on the back of the device.
A software-controlled processing unit governs the flow of dry air, generating a constant air stream that passes through the capsule, releasing individual odours through a small opening at the upper front of the device. In this study, each scent was presented for 5 seconds, with an interval of at least 6 seconds between odour presentations. Each capsule contained 35 µL of oil-based odour solution, allowing the device to maintain consistent odour intensity and identifiability for up to 100 activations, as per the manufacturer's instructions. The Givaudan Corporation prepared the odours used in the capsules.
A digital application (software) was developed to present odours and record olfactory function test results. The device delivers odours through a dry air system, leaving no residue in the environment or on users. Users can access the test using an application on the device (screen version) or mobile phone. The results are accessible through the integrated software, allowing for storage and analysis of the data.
4.4 Selection of the “universal” odours
For this study, 20 odours were selected based on the criteria used in the International Odour Identification Test for Children (Universal Sniff Test)6. These criteria encompassed factors such as global prevalence, stimulus-semantic specificity, exclusion of semantically generic odours, olfactory performance, familiarity among the general population, and commercial availability across five continents. In addition to the selected fragrances, universal semantic distractors were included (Supplementary Table S1). The selected odours were Smoked, Lavender, Coconut, Mint, Vanilla, Tire, Rose, Coffee, Grass, Bubble-gum, Menthol, Grape, Clove, Strawberry, Banana, Orange, Cinnamon, Garlic, Pizza, and Onion.
4.5 Experimental setup
The Multiscent-20 odour identification test commences with the participant reviewing the step-by-step instructions displayed on the initial screen. These instructions are presented below:
1. This assessment consists of a test containing 20 distinct odours.
2. Enter your identification information and press the "next" button.
3. The next screen will show a "Try it" button, the phrase "This smell resembles," and with four alternative answers. Please reading all the choices before pressing the "Try it" button.
4. Upon pressing the "Try it" button, a small opening at the top front of the device will release the odour for 5 seconds. You can press the "Try it" button up to three times. Please maintain the device approximately 10 cm from your nostrils after pressing the button. After perceiving the odour, please select one of the alternatives, touch the corresponding letter, and press the "next odour" button to proceed.
5. The number of correct responses will be displayed upon completion of the test.
This assessment was a 4-AFC test, meaning that participants were asked to choose one of the four alternatives to advance to the next odour. The software was specifically developed to present questions and manage responses on the device. After the test, the results are displayed, and the device automatically synchronizes with the database stored in the cloud.
4.6 Data analysis (descriptive statistics and dimensionality assessment)
For the descriptive analysis, categorical variables are presented as the frequency (n) and percentage (%). Continuous variables are either described as the mean and standard deviation (SD) or median and interquartile range (IQR), depending on the normality of the data, as determined with the Shapiro‒Wilk test. Data analysis was mainly performed in R software (v4.3.0, R Foundation for Statistical Computing, Vienna, Austria). All statistical tests were two-sided, with a significance threshold set at 0.05.
To assess the dimensionality of the dataset, a CFA was performed using JASP20. Model fit indices, such as the SRMSR, TLI, and RMSEA, were examined to evaluate the model fit. This procedure aimed to evaluate the suitability of the dataset for further analysis using an IRT model.
4.7 Item response theory analysis
To conduct the IRT analysis, the 'mirt' package21 in R was utilized. The following steps were followed for the analysis:
(a) Data preparation: Data were organized into a matrix format, with rows representing individual participants, and columns representing dichotomous responses (correct/incorrect) to each of the 20 odour items.
(b) Model estimation: Using the 'mirt' function, the parameters of the 1PL, 2PL, and 3PL models were estimated. The 1PL model assumed a constant discrimination parameter across items, while the 2PL model allowed for variation in discrimination parameters. The 3PL model additionally included a guessing parameter, accounting for the possibility that participants may have guessed the correct answer by chance.
(c) Model comparison: To determine the best-fitting model for the present dataset, goodness-of-fit statistics were compared, such as the AIC and BIC. Lower values of these statistics indicated a better-fitting model.
(d) Item analysis: For the best-fitting model, the ICCs were examined. These provide information about the relationship between participant latent trait levels and their probability of correctly identifying each odour. Item information functions (IIFs) were examined to understand the precision of each item in measuring the latent trait.
4.8 Influence of demographic factors (sex, age, and educational attainment)
To investigate the relationship between participant educational attainment and the number of correct answers on the administered test, a one-way ANOVA was conducted. Participants were divided into three categories based on their educational attainment: primary (the fundamental level in Brazil), secondary (high school), and tertiary (college) education. The dependent variable was the number of correct answers in the odour identification test. Subsequently, Tukey's HSD test was employed to identify pairwise differences between the three educational attainment groups, provided that the ANOVA yielded significant results.
A multiple linear regression model was employed to investigate the relationship between the Multiscent-20 identification scores (dependent variable) and sex, age group, and educational attainment (independent variables). The dataset was analysed using R software, with the “lm” function utilized to create the regression model.