Measuring the impact of trigeminal neuralgia pain: the Penn Facial Pain Scale-Revised
Authors Symonds T, Randall JA, Hoffman DL, Zakrzewska JM, Gehringer W, Lee JYK
Received 30 September 2017
Accepted for publication 18 November 2017
Published 5 June 2018 Volume 2018:11 Pages 1067—1073
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Katherine Hanlon
Tara Symonds,1 Jason A Randall,1 Deborah L Hoffman,2 Joanna M Zakrzewska,3 William Gehringer,4 John YK Lee5
1Clinical Outcomes Solutions, Clinical Outcome Assessments, Folkestone, UK; 2Biogen Inc., Cambridge, MA, USA; 3Eastman Dental Hospital – University College London Hospitals, Division of Diagnostic, Surgical and Medical Sciences, London, UK; 4Clinical Outcomes Solutions, Tucson, AZ, USA; 5University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA
Background and objective: The Penn Facial Pain Scale (Penn-FPS) was originally developed as a supplemental module to the Brief Pain Inventory Pain Interference Index (BPI-PII) in order to fully assess the impact of trigeminal neuralgia (TN) pain on patients’ health-related quality of life (HRQoL). The current objective is to create and establish the content validity of a new stand-alone version of the measure, the Penn-FPS-Revised (Penn-FPS-R).
Methods: Twenty participants (15 USA and 5 UK) with confirmed TN engaged in concept elicitation and cognitive debriefing interviews. These semi-structured interviews allowed participants to spontaneously describe the ways in which TN impacts on HRQoL and report on the extent to which the Penn-FPS and BPI-PII measure concepts are most relevant to them. Participants were also asked to report on the suitability of the instructions, recall period, and response options.
Results: Concept elicitation revealed nine themes involving TN restrictions on daily activities and HRQoL, including: “talking,” “self-care,” “eating,” “eating hard foods/chewing foods,” “daily activities,” “activities with temperature change,” “touching,” “mood,” and “relationships.” Cognitive debriefing confirmed that all of the Penn-FPS concepts and some of the BPI-PII concepts (“mood,” “general activities,” and “relations with others”) were relevant, although some items required edits to better capture individuals’ experiences. The impact of temperature and/or weather on activities was also identified as an important concept that is not captured by the Penn-FPS or BPI-PII. Participants confirmed the acceptability of recall period, instructions, and response options. Results from the interviews were applied to create the Penn-FPS-R, a new brief outcome measure that assesses the impacts of TN most important to patients.
Conclusion: The Penn-FPS-R is a new 12-item HRQoL outcome measure with content validity that can be used to assess and monitor the impact of TN treatment interventions in both clinical practice and research.
Keywords: content validity, concept elicitation, cognitive debriefing, Penn Facial Pain Scale, trigeminal neuralgia, PRO development, patient reported outcome
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]