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Who is healthy? Aspects to consider when including healthy volunteers in QST-based studies—a consensus statement by the EUROPAIN and NEUROPAIN consortia

Gierthmühlen, Jannea; Enax-Krumova, Elena K.b,c,*; Attal, Nadined,e; Bouhassira, Didierd,e; Cruccu, Giorgiof; Finnerup, Nanna B.g; Haanpää, Maijah,i; Hansson, Peri,j,k; Jensen, Troels S.g; Freynhagen, Rainerl; Kennedy, Jeffrey D.m; Mainka, Tinac; Rice, Andrew S. C.n; Segerdahl, Märtao,p; Sindrup, Søren H.q; Serra, Jordir; Tölle, Thomass; Treede, Rolf-Detleft; Baron, Ralfa; Maier, Christophc

doi: 10.1097/j.pain.0000000000000227
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Clinical and human experimental pain studies often include so-called “healthy” controls in investigations of sensory abnormalities, using quantitative sensory testing (QST) as an outcome measure. However, the criteria for what is considered “healthy” vary among the different studies and between study centers and investigators, partly explaining the high variability of the results. Therefore, several aspects should be considered during inclusion of healthy volunteers in QST-based trials to have homogenous groups of healthy controls with less variability between human experimental studies, so that results are less likely to be false negative or false positive because of subject-related factors. The EUROPAIN and NEUROPAIN consortia aimed to define factors influencing the variability in selection of healthy subjects in QST-based studies before the start of both projects and to give recommendations how to minimize it based on the current literature and expertise of the participants. The present suggestions for inclusion criteria of healthy volunteers into QST-based trials describe a 2-level approach including standardized questionnaires enabling the collection of relevant information on sociodemographic data, medical history, current health status, coping strategies in dealing with pain, and the motivation of the volunteer to participate in the study. These suggestions are believed to help researchers interpret their results in comparison with others and improve the quality of clinical studies including healthy volunteers as controls or in human experimental pain studies. They aim to reduce any confounding factors. Furthermore, the acquired information will allow post hoc analyses of variance for different potential influencing factors.

This consensus statement for definition of healthy volunteers represents list of items that may affect sensory functioning. They should be considered when designing QST-based studies.

aDivision of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany

bDepartment of Neurology, BG University Hospital Bergmannsheil GmbH, Ruhr-University Bochum, Bochum, Germany

cDepartment of Pain Medicine, BG University Hospital Bergmannsheil GmbH, Ruhr-University Bochum, Bochum, Germany

dINSERM U-987, Centre d'Evaluation et de Traitement de la Douleur, CHU Ambroise Paré, Boulogne-Billancourt, France

eUniversité Versailles-Saint-Quentin, Versailles, France

fDepartment Neurology and Psychiatry, Sapienza University, Roma, Italy

gDepartment of Neurology and Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark

hDepartment of Neurosurgery, Helsinki University Central Hospital, Helsinki, Finland

iEtera Mutual Pension Insurance Company, Helsinki, Finland

jDepartment of Pain Management and Research, Oslo University Hospital, Oslo, Norway

kDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

lDepartment of Anaesthesiology, Critical Care Medicine, Pain Therapy & Palliative Care, Pain Center Lake Starnberg, Benedictus Hospital, Tutzing, Germany

mNeuroscience Discovery Research, Eli Lilly and Company, Indianapolis, IN, USA

nPain Research, Department of Surgery and Cancer, Imperial College, London, United Kingdom

oH. Lundbeck A/S, Copenhagen, Denmark

pDepartment of Physiology and Pharmacology, Karolinska Institute, Stockholm, Sweden

qDepartment of Neurology, Odense University Hospital, Odense, Denmark

rNeuroscience Technologies, Barcelona, Spain

sDepartment of Neurology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

tChair of Neurophysiology, Center of Biomedicine and Medical Technology Mannheim CBTM, Medical Faculty Mannheim, Heidelberg University, Germany (T. Mainka is now with the Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany)

Corresponding author. Address: Department of Neurology, BG University Hospital Bergmannsheil GmbH, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Tel.: 0049-234-302-3402; fax: 0049-302-6888. E-mail address: elena.krumova@rub.de (E. K. Enax-Krumova)

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.painjournalonline.com).

The EUROPAIN consortium: http://www.imieuropain.org/consortium/. The NEUROPAIN consortium: N. Attal, R. Baron, D. Bouhassira, G. Cruccu, R. Freynhagen, M. Haanpää, P. Hansson, T. S. Jensen, C. Maier, A. Rice, J. Serra, R.-D. Treede, and T. Tölle.

Received January 17, 2015

Received in revised form May 04, 2015

Accepted May 05, 2015

© 2015 International Association for the Study of Pain
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