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Background: Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations., Objective: This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials., Methods: The development of the VVSymQ ® instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ ® instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument., Results: Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI™]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ ® instrument queries patients on the HASTI™ symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from "None of the time" to "All of the time," and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ ® instrument., Conclusion: Content validity was established for the VVSymQ ® instrument, which assesses the five HASTI™ symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice., Competing Interests: Compliance with Ethical StandardsFundingThis study was sponsored by BTG International and conducted by ERT and United BioSource Corporation. Tuli Ahmed, JetStream Clinical, LLC, provided editorial assistance funded by Biocompatibles, Inc., a BTG International group company.Conflict of interestJP, CAE, and DMT-B are current or former employees of ERT, a recipient of funding for the study. JP is currently affiliated with Quintiles, Hawthorne, New York, NY, and DMT-B is currently affiliated with Adelphi Values, Boston, MA.Informed consentWritten informed consent was obtained from all patients included in the study.

Background and Objectives: Characterized by sudden onset of severe joint pain, swelling, redness, and tenderness to touch, gout 'flare ups' have a substantial impact on quality of life (QoL). This research employed a patient-centered approach to explore the symptoms and impacts of gout, and assess the content validity of existing patient-reported outcomes (PROs)., Methods: Qualitative interviews were conducted with 30 US gout patients (non-tophaceous: n = 20, tophaceous: n = 10) and five expert rheumatologists. Each interview included both concept elicitation (CE) questioning to learn about the patient experience and cognitive debriefing to assess the content validity of three PRO instruments (HAQ-DI, GAQ, and TIQ-20). Nine of the patients provided further real-time qualitative data through a smart phone application. All qualitative data were subject to thematic analysis using Atlas.ti. Two patient advisors and three expert clinicians were engaged as advisors at key stages throughout the research., Results: Interview and real-time data identified the same core symptoms and proximal impact concepts. Severe pain (typically in joints of extremities) was described as the cardinal symptom, often accompanied by swelling, redness, heat, sensitivity to touch, and stiffness. Domains of QoL impacted included physical functioning, sleep, daily activities, and work. The PRO instruments were generally well-understood by patients, but each included items with questionable relevance to at least some of the sample, dependent on the specific joints affected., Conclusions: Gout patients experience severe pain in affected joints, resulting in substantial limitations in physical functioning. Both the HAQ-DI and the TIQ-20 are useful for specific research purposes in the gout population, although modifications are recommended., Competing Interests: Compliance with Ethical Standards This study was sponsored by Pfizer. Katja Rudell and Tara Symonds were employees of Pfizer Ltd when the research was conducted and were shareholders of Pfizer. Sophi Tatlock, Charlotte Panter, and Rob Arbuckle are employees of Adelphi Values who were paid consultants to Pfizer in connection with the development of this manuscript. Leslie Harold and Will Taylor were financially compensated by Pfizer for their participation in the clinicians interviews; however, they were not financially compensated for their involvement in the study or their development of this manuscript. The study was approved and overseen by an Independent Review Board in the US (approval codes: ADE1-14-472, ADE2-14-168) and was performed in accordance with the ethical standards of the Declaration of Helsinki. Written informed consent was obtained prior to the collection of any data.