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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

  • D. Rosenkranz
  • J. Bünger
  • F. Hoffmeyer
  • C. Monsé
  • V. van Kampen
  • M. Raulf
  • T. Brüning
  • K. SuckerEmail author
Chapter
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 1271)

Abstract

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.

Keywords

Clinical examination Clinical outcome Exposure study Health Self-report Sensory irritation 

Notes

Conflicts of Interest

The authors declare no conflicts of interest in relation to this article.

Ethical Approval

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.

Informed Consent

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.

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • D. Rosenkranz
    • 1
  • J. Bünger
    • 1
  • F. Hoffmeyer
    • 1
  • C. Monsé
    • 1
  • V. van Kampen
    • 1
  • M. Raulf
    • 1
  • T. Brüning
    • 1
  • K. Sucker
    • 1
    Email author
  1. 1.Institute for Prevention and Occupational Medicine of the German Social Accident InsuranceInstitute of the Ruhr University Bochum (IPA)BochumGermany

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