| Summary: | Helen Nothnagel,1,2,* Christian Puta,1,3,* Thomas Lehmann,4 Philipp Baumbach,5 Martha B Menard,6,7 Brunhild Gabriel,1 Holger H W Gabriel,1 Thomas Weiss,8 Frauke Musial2 1Department of Sports Medicine and Health Promotion, Friedrich Schiller University, Jena, Germany; 2Department of Community Medicine, National Research Center in Complementary and Alternative Medicine, UiT, The Arctic University of Norway, Tromsø, Norway; 3Center for Interdisciplinary Prevention of Diseases Related to Professional Activities, 4Department of Medical Statistics, Computer Sciences and Documentation, Friedrich Schiller University, 5Department of Anesthesiology and Intensive Care Medicine, University Hospital Jena, Germany; 6Crocker Institute, Kiawah Island, SC, 7School of Integrative Medicine and Health Sciences, Saybrook University, Oakland, CA, USA; 8Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany *These authors contributed equally to this work Background: Quantitative sensory testing (QST) is a diagnostic tool for the assessment of the somatosensory system. To establish QST as an outcome measure for clinical trials, the question of how similar the measurements are over time is crucial. Therefore, long-term reliability and limits of agreement of the standardized QST protocol of the German Research Network on Neuropathic Pain were tested. Methods: QST on the lower back and hand dorsum (dominant hand) were assessed twice in 22 healthy volunteers (10 males and 12 females; mean age: 46.6±13.0 years), with sessions separated by 10.0±2.9 weeks. All measurements were performed by one investigator. To investigate long-term reliability and agreement of QST, differences between the two measurements, correlation coefficients, intraclass correlation coefficients (ICCs), Bland–Altman plots (limits of agreement), and standard error of measurement were used. Results: Most parameters of the QST were reliable over 10 weeks in healthy volunteers: Almost-perfect ICCs were observed for heat pain threshold (hand) and mechanical pain sensitivity (back). Substantial ICCs were observed for heat pain threshold (back), pressure pain threshold (back), mechanical pain sensitivity (hand), and vibration detection threshold (back and hand). Some QST parameters, such as cold detection threshold, exhibited low ICCs, but also very low variability. Generally, QST measures exhibited narrow limits of agreement in the Bland–Altman plots. Conclusion: The standardized QST protocol of the German Research Network on Neuropathic Pain is feasible to be used in treatment trials. Moreover, defining a statistically meaningful change is possible, which is a prerequisite for the use of QST in clinical trials as well as in long-term investigations of disease progression. Keywords: QST, healthy volunteers, test–retest reliability, intraclass correlations, Bland–­Altman plot, limits of agreement, standard error of measurement, minimum detectable difference
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