A Qualitative Concept Elicitation Study to Understand Patient-Reported Symptoms and Impacts of Neisseria Gonorrhoeae Infections in the United States.

Background: Gonorrhea is the second most common bacterial sexually transmitted infection in the United States, with rising rates. Emerging antimicrobial resistance threatens public health, and vaccines are in development. This study documents patient-reported gonorrhea symptoms and health-related quality-of-life (HRQoL) impact in women who have sex with men (WSM), men who have sex with women (MSW), and men who have sex with men (MSM). Methods: Semistructured qualitative interviews were conducted (April 2021-March 2022) among US adults with recent (<= 6 months) confirmed gonorrhea. Concept saturation was achieved, confirming adequate participant numbers to meet objectives. Elicited symptom and HRQoL impacts were used to develop a conceptual disease model. Common patient-reported outcome measure (PROM) items were compared with elicited concepts. Results: Thirty-two participants (15 WSM, 8 MSW, and 9 MSM) were included. Eight were asymptomatic, 6 had repeat infections, and 5 women and 4 men had complications (i.e., infertility or pelvic inflammatory disease, and urethritis, respectively).The most frequently reported symptoms were vaginal discharge (n = 11 of 12), dysuria (n = 10 of 12), and abdominal/vaginal pain (n = 9 of 12) for symptomatic WSM; dysuria (n = 5 of 6) and penile discharge (n = 4 of 6) for symptomatic MSW; and throat, testicular, or rectal pain (n = 4 of 6) for symptomatic MSM. All (symptomatic and asymptomatic) participants reported HRQoL impacts including negative emotional experiences (n = 31 of 32), and interference with sexual activity (n = 30 of 32), relationships (n = 24 of 32), and social life (n = 17 of 32). Concepts were poorly represented in existing PROMs. Results: Thirty-two participants (15 WSM, 8 MSW, and 9 MSM) were included. Eight were asymptomatic, 6 had repeat infections, and 5 women and 4 men had complications (i.e., infertility or pelvic inflammatory disease, and urethritis, respectively). The most frequently reported symptoms were vaginal discharge (n = 11 of 12), dysuria (n = 10 of 12), and abdominal/vaginal pain (n = 9 of 12) for symptomatic WSM; dysuria (n = 5 of 6) and penile discharge (n = 4 of 6) for symptomatic MSW; and throat, testicular, or rectal pain (n = 4 of 6) for symptomatic MSM. All (symptomatic and asymptomatic) participants reported HRQoL impacts including negative emotional experiences (n = 31 of 32), and interference with sexual activity (n = 30 of 32), relationships (n = 24 of 32), and social life (n = 17 of 32). Concepts were poorly represented in existing PROMs. Conclusions: Participants reported a diverse range of symptoms and HRQoL impacts, to help inform the value of new treatment and prevention options. More research is needed to quantify patient burden and develop PROMs.