Measuring the impact of trigeminal neuralgia pain: the Penn Facial Pain Scale-Revised

Tara Symonds, Jason A Randall, Deborah L Hoffman, Joanna M Zakrzewska, William Gehringer, John Yk Lee, Tara Symonds, Jason A Randall, Deborah L Hoffman, Joanna M Zakrzewska, William Gehringer, John Yk Lee

Abstract

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: PRO development; Penn Facial Pain Scale; cognitive debriefing; concept elicitation; content validity; patient reported outcome; trigeminal neuralgia.

Conflict of interest statement

Disclosure Joanna M Zakrzewska undertook this work at University College London/University College London Hospitals Trust, the recipients of a proportion of funding from the UK Department of Health’s National Institute for Health Research Biomedical Research Centre funding scheme. Deborah L Hoffman was an employee of Biogen Inc. at the time of the study, but is no longer an employee of Biogen Inc. The other authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Measures to be debriefed. Abbreviations: BPI-PII, Brief Pain Inventory Pain Interference Index; NRS, numeric rating scale; Penn-FPS, Penn Facial Pain Scale.

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