Abstract
Objective:
PainDETECT (PD-Q) is a patient reported screening questionnaire to identify patients with neuropathic pain based on questions regarding typically sensory symptoms of neuropathic pain. The aim of the present investigation was to assess the test–retest stability of pain descriptors of the PD-Q within a time window of 1–3 weeks.
Methods:
Data sets of 74 chronic pain patients sampled in an open pain register at two visits were analyzed and compared. Patients with change of pain localization between visits were excluded from analysis. Beside conventional measures (Pearson correlation coefficient r, intraclass correlation coefficient ICC, kappa), also calculated measures known from method comparison were used.
Results:
The mean duration between visits was 15 days. The measures were in the range of r = 0.72–0.86, ICC = 0.71–0.86, and kappa = 0.62–0.72 for PD-Q pain descriptors (burning, prickling, mechanical allodynia, pain attacks, thermal hyperalgesia, numbness, pressure induced pain).
Conclusion:
The individual PD-Q pain descriptors showed accurate test–retest stability as a prerequisite for use in repeated measurements (e. g. post baseline or follow up data) in clinical trials.
Transparency
Declaration of funding
This project was funded by Pfizer Germany and Pfizer Europe. The funding source had no role in study design, data collection and analysis, or writing of the report.
Author contributions
The lead investigators (R.B., R.F., T.R.T., and T.K.) designed the study in collaboration with the DFNS. Data were collected by about 900 investigators (the complete data set was held at the central data-processing facility at StatConsult GmbH, Magdeburg, Germany) and were analyzed statistically by T.K., P.H. and P.M. T.K., R.F., T.R.T., I.L., P.M., P.H., U.G., E.S., and R.B. interpreted the data, drafted the paper and gave final approval of the version to be published. U.G. developed, programmed and supported the technical devices.
Declaration of financial/other relationships
T.K. has disclosed that he is a statistical consultant to StatConsult GmbH, which paid for his services in relation to this study. R.F. has disclosed that he is a consultant to and is on the Speakers’ Bureau of Pfizer, Lilly, Grunenthal, and Astellas. T.R.T. has disclosed that she/he is a consultant to and is on the Speakers’ Bureau of Grunenthal, Mundipharma, Esteve, Pfizer and Lilly, and is also on the Speakers’ Bureau of Allergan. I.L. and P.M. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. R.B. has disclosed that he has received grants from Pfizer, Genzyme, Grünenthal, Mundipharma, and is a member of the EU Project DOLORisk, Innovative Medicines Initiative Europain (collaboration and industry members of this are: Astra Zeneca, Pfizer, Esteve, UCB-Pharma, Sanofi Aventis, Grünenthal, Eli Lilly and Boehringer Ingelheim), German Federal Ministry of Education and Research (BMBF): Member of the ERA_NET NEURON / IM-PAIN Project, German Research Network on Neuropathic Pain, NoPain system biology and German Research Foundation (DFG). He is also a consultant to Pfizer, Genzyme, Grünenthal, Mundipharma, Allergan, Sanofi Pasteur, Medtronic, Eisai, Lilly, Boehringer Ingelheim, Astellas, Novartis, Bristol-Myers Squibb, Biogenidec, AstraZeneca, Merck, Abbvie, Daiichi Sankyo, Glenmark Pharmaceuticals and bioCSL. He is also on the speakers` bureau of Pfizer, Genzyme, Grünenthal, Mundipharma, Sanofi Pasteur, Medtronic, Eisai, Lilly, Boehringer Ingelheim, Astellas, Desitin, Teva Pharma, Bayer-Schering, MSD and bio CSL. U.G. has disclosed that he received payments from Pfizer for his contribution to this manuscript. E.S. has disclosed that he was an employee of Pfizer at the time this study was conducted and the manuscript developed. PH has received speaking fees from Pfizer and Genzyme and travel reimbursement from Grünenthal.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors thank all participating patients, colleagues and the staff of the institutions for their contributions to data collection. We thank Maria Kabelitz and Martin Hukauf (StatConsult GmbH) for performing the SAS programming. In memory of our friend and colleague Uwe Schmidt, who helped to develop the PD-Q.