J. Park’s research while affiliated with EMD Serono and other places

Background Cutaneous lupus erythematosus (CLE) causes various skin manifestations. Painful skin lesions, dyspigmentation, scarring, itch, hair loss, and photosensitivity negatively impact quality of life of patients with CLE. A literature review, a social listening study, and a qualitative interview study explored key symptoms and their impact on patients with CLE and potentially relevant patient-reported outcome measures (PROMs) comprehensively covering CLE symptoms and impacts. Three candidate PROMs used in CLE were identified in the literature review, and the Skindex 29 + 3 was determined to be the most appropriate for further investigation. Objectives We report on the cognitive debriefing interviews (CDIs) conducted in patients with CLE to assess the relevance, comprehensibility and completeness of the Skindex 29 + 3 for this population. Methods Twenty adults in the United States diagnosed with moderate or severe CLE (subacute and discoid subtypes) reviewed the Skindex 29 + 3 during individual interviews. A semi structured interview guide was developed to guide the CDIs. Study participants were asked to “think aloud,” describing their thought processes as they read and responded to the items. Additionally, interviewers explored participant interpretations of the instructions, item content, and response options with probe questions and asked about any important missing concepts. The interview data were evaluated using thematic analysis. Results The only change made to the Skindex 29 + 3 based on participant feedback was decreasing the recall period from 4 weeks to 7 days. The instructions, items, and response options were reported to be clear and were interpreted as intended. The items were determined to be relevant, understandable and comprehensive by most participants; no missing concepts were noted. The relevance of the CLE-specific items assessing photosensitivity was endorsed by all participants. Hair loss was not relevant for all participants but was an important CLE symptom for those who experienced it. Conclusion This study confirms the Skindex-29 + 3 to be a relevant and appropriate PROM for use in studies of CLE treatment as it includes items specific to CLE, such as hair loss and photosensitivity, and the remaining items developed to assess common skin condition symptoms and impacts were all relevant for patients with CLE. REFERENCES NIL Acknowledgements This study was sponsored by Merck (CrossRef Funder ID: 10.13039/100009945). Disclosure of Interests Paul Kamudoni is an employee of Merck Healthcare KGaA, Darmstadt, Germany, Oyebimpe Olayinka-Amao is an employee of RTI Health Solutions which received research funding from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Amy Barrett is an employee of RTI Health Solutions which received research funding from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Josephine Park is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.

Background Itch is a cardinal symptom of cutaneous lupus erythematosus (CLE) associated with reduced quality of life. Given the prominence of this symptom, a single patient-reported item assessing itch severity at its worst was evaluated with patients with CLE. The Worst Itch Numeric Rating Scale (NRS) is a potentially relevant patient-reported outcomes measure (PROM) assessing the severity of itch on a scale from 0 (no itch) to 10 (worst imaginable itch). Objectives Herein, we report the cognitive debriefing interviews (CDIs) conducted with patients with CLE to assess the relevance and comprehensibility of the Worst Itch NRS for this population. Methods Individual interviews were conducted with 20 adults in the United States diagnosed with moderate or severe CLE (subacute and discoid subtypes). Participants reviewed the Worst Itch NRS in three rounds of interviews between February and June 2022. A semistructured interview guide was developed to guide the interviews. Study participants were asked to “think aloud,” describing their thought processes as they read and responded to the item. Additionally, the instructions, item wording, 24-hour and 7-day recall periods, and response options were debriefed for appropriateness and comprehensibility. Interviewers explored participants’ interpretations of item content and response options. The interview data were evaluated using thematic analysis. Results The single item Worst Itch NRS was well understood and interpreted as intended by study participants. Participants reported that remembering experiences with their CLE-related worst itch over the past 7 days was not difficult. Item wording, instructions, and response options with anchors of 0 (no itch) and 10 (worst imaginable itch) and both the 24-hour and 7-day recall periods were understood and interpreted as intended. No changes were made to the Worst Itch NRS item or instructions based on the feedback gathered in the CDIs. Conclusion This study provides evidence that itch is an important symptom in CLE and should be evaluated in the clinical trials of CLE treatment. Moreover, this study confirms the Worst Itch NRS with a 7-day recall to be a relevant and appropriate PROM for use in studies of CLE. Funding This study was sponsored by Merck (CrossRef Funder ID: 10.13039/100009945). REFERENCES NIL Acknowledgements NIL Disclosure of Interests Paul Kamudoni is an employee of Merck Healthcare KGaA, Darmstadt, Germany, Oyebimpe Olayinka-Amao is an employee of RTI Health Solutions which received research funding from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Amy Barrett is an employee of RTI Health Solutions which received research funding from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Josephine Park is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.