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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

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