How Healthy Is Healthy? Comparison Between Self-Reported Symptoms and Clinical Outcomes in Connection with the Enrollment of Volunteers for Human Exposure Studies on Sensory Irritation Effects
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Controlled human exposure studies on sensory irritation effects are usually performed with healthy volunteers. Therefore, in most studies pre-screening by a health questionnaire and a detailed medical examination are combined. The aim of this report is to investigate whether self-reported information about smoking and health status is sufficient or whether additional clinical tests are necessary for a successful and safe enrollment of healthy volunteers. There were 409 volunteers (55% female; 17–57 years; 79% non-smokers) who declared interest in participation in the study. However, 87 subjects failed to meet specific inclusion criteria, and further 138 had to be excluded due to the presence of chronic health problems. In effect, 184 subjects passed the initial questionnaire screening and proceed to further examination. Medical examination included electrocardiogram, blood and urine screening, and an olfactory function test. Atopy status was assessed by skin prick or specific IgE testing. Lung function and a methacholine challenge test were performed to assess respiratory health and bronchial hyperresponsiveness. Overall, only 107 non-smoking subjects (58% female; 19–40 years) who had no respiratory diseases, allergies, or chronic illnesses could be finally selected. Out of the 107 subjects, 8 were excluded due to positive cotinine tests, laboratory test results outside the reference range, or atypical ECGs. In another 12 subjects, obstruction or a bronchial hyperreactivity was diagnosed. Among the remaining 87 healthy subjects, 26 were classified as atopic and further two as hyposmic. In conclusion, although young and non-smoking volunteers considered themselves healthy by questionnaire, 20% showed signs of a heart, liver, or airway disease, and additional 24% were classified as atopics. This suggests that more detailed clinical testing may be necessary to safely exclude those who may adversely react to controlled exposure with sensory irritants.
KeywordsClinical examination Clinical outcome Exposure study Health Self-report Sensory irritation
Conflicts of Interest
The authors declare no conflicts of interest in relation to this article.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The recruiting and testing procedures were reviewed and approved by the Ethics Committee of the Ruhr University Bochum, Germany.
All individual participants included in the study gave written informed consent. Prior to participation, the participants received information on the study requirements and a written declaration of consent. They were informed verbally and in writing about the study design, possible dangers, and their freedom to withdraw at any time. They received financial compensation for participation.
- ATS (1995) American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 152(5 Pt 2):S77–S121Google Scholar
- Borkenau P, Ostendorf F (2008) NEO-Fünf-Faktoren-Inventar nach Costa und McCrae. Hogrefe (Article in German), GöttingenGoogle Scholar
- Brüning T, Bartsch R, Bolt HM, Desel H, Drexler H, Gundert-Remy U, Hartwig A, Jäckh R, Leibold E, Pallapies D, Rettenmeier AW, Schlüter G, Stropp G, Sucker K, Triebig G, Westphal G, van Thriel C (2014) Sensory irritation as a basis for setting occupational exposure limits. Arch Toxicol 88(10):1855–1879PubMedPubMedCentralGoogle Scholar
- Fahrenberg J, Hampel R, Selg H (1994) Das Freiburger Persönlichkeitsinventar. Revidierte Fassung. Hogrefe (Article in German), GöttingenGoogle Scholar
- Kiesswetter E, Sietmann B, Zupanic M, van Thriel C, Golka K, Seeber A (1999) Neurobehavioral aspects of the prevalence and etiology of multiple chemical sensitivity. Allergologie 22(12):719–735Google Scholar
- Kleinbeck S, Pacharra M, Schäper M, Blaszkewicz M, Golka K, Brüning T, van Thriel C (2018) Sensorische Irritationen durch Ameisensäure: Reagieren allergische Probanden stärker auf kontrollierte Expositionen? (Sensory irritations due to formic acid: Do allergic subjects react more strongly to controlled exposures?) In: Deutschen Gesellschaft für Arbeitsmedizin und Umweltmedizin e.V. (Hrsg.): Dokumentation der 58. Jahrestagung der DGAUM, 7–9. März 2018 in München (page 50) (Article in German)Google Scholar
- Laux L, Glanzmann P, Schaffner P, Spielberger CD (1981) Das state–trait–Angstinventar. Beltz (Article in German), WeinheimGoogle Scholar
- Müller JU, Bruckner T, Triebig G (2013) Exposure study to examine chemosensory effects of formaldehyde on hyposensitive and hypersensitive males. Int Arch Occup Environ Health 86(1):107–117Google Scholar
- Pacharra M, Kleinbeck S, Schäper M, Juran SA, Hey K, Blaszkewicz M, Lehmann ML, Golka K, van Thriel C (2016b) Interindividual differences in chemosensory perception: toward a better understanding of perceptual ratings during chemical exposures. J Toxicol Environ Health A 79(22–23):1026–1040PubMedGoogle Scholar
- Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J, ERS Global Lung Function Initiative (2012) Multi–ethnic reference values for spirometry for the 3–95–yr age range: the global lung function 2012 equations. Eur Respir J 40(6):1324–1343PubMedPubMedCentralGoogle Scholar
- Sucker K, Hoffmeyer F, Monsé C, Jettkant B, Berresheim H, Rosenkranz N, Raulf M, Bünger J, Brüning T (2019) Ethyl acrylate: influence of sex or atopy on perceptual ratings and eye blink frequency. Arch Toxicol 93(10):2913–2926Google Scholar