Matthijs L Siegenbeek van Heukelom1, Olivier Richel, Pythia T Nieuwkerk, Henry J C De Vries, Jan M Prins. 1. 1 Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands 2 Center for Infection and Immunology Amsterdam (CINIMA), Academic Medical Center, Amsterdam, The Netherlands 3 Department of Dermatology, Academic Medical Center, Amsterdam, The Netherlands 4 Department of Psychology, Academic Medical Center, Amsterdam, The Netherlands 5 Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands.
Abstract
BACKGROUND: The impact of the treatment of precursor lesions of anal cancer (anal intraepithelial neoplasia) on health-related quality of life has not been investigated. OBJECTIVE: This study aimed to evaluate the impact of 3 treatment options for anal intraepithelial neoplasia on health-related quality of life and sexual functioning in HIV-positive men who have sex with men. DESIGN: The prospective cohort was embedded in a randomized clinical trial evaluating the optimal treatment of anal intraepithelial neoplasia. SETTING: This study was performed at the HIV outpatient clinic of the Academic Medical Center, Amsterdam, the Netherlands. PATIENTS: Included in the study were HIV-positive men who have sex with men with anal intraepithelial neoplasia. INTERVENTION: Treatment with imiquimod (n = 54), topical fluorouracil (n = 48), or electrocautery (n = 46) was given for 16 weeks. MAIN OUTCOME MEASURES: Health-related quality of life and sexual functioning were assessed before, during, and 4 weeks after treatment. Health-related quality of life was assessed using the EQ5D, sexual functioning was assessed using items derived from the International Index of Erectile Function, and the female sexual function index adapted for anal intercourse. RESULTS:One hundred forty-five patients (98%) completed at least 1 questionnaire. There was a significant different pattern of change over time in health-related quality of life among the 3 treatment groups. Patients in the imiquimod group were more likely to report pain/discomfort at week 8 than patients in the electrocautery group. Patients in the electrocautery group were more likely to report anxiety/depression and were less satisfied with their overall sex life at week 16 than patients in the imiquimod and fluorouracil groups, and patients in the electrocautery group were also more likely to report pain/discomfort and problems with usual activities at week 20 than patients in the fluorouracil group. LIMITATIONS: The follow-up method differed slightly among treatment groups. There is no standardized, validated sexual functioning questionnaire for HIV-positive men who have sex with men. CONCLUSIONS: All treatment options have a negative impact on aspects of health-related quality of life. Electrocautery has significantly more negative effects on health-related quality of life than imiquimod and fluorouracil and also has a negative effect on sexual functioning.
RCT Entities:
BACKGROUND: The impact of the treatment of precursor lesions of anal cancer (anal intraepithelial neoplasia) on health-related quality of life has not been investigated. OBJECTIVE: This study aimed to evaluate the impact of 3 treatment options for anal intraepithelial neoplasia on health-related quality of life and sexual functioning in HIV-positive men who have sex with men. DESIGN: The prospective cohort was embedded in a randomized clinical trial evaluating the optimal treatment of anal intraepithelial neoplasia. SETTING: This study was performed at the HIV outpatient clinic of the Academic Medical Center, Amsterdam, the Netherlands. PATIENTS: Included in the study were HIV-positive men who have sex with men with anal intraepithelial neoplasia. INTERVENTION: Treatment with imiquimod (n = 54), topical fluorouracil (n = 48), or electrocautery (n = 46) was given for 16 weeks. MAIN OUTCOME MEASURES: Health-related quality of life and sexual functioning were assessed before, during, and 4 weeks after treatment. Health-related quality of life was assessed using the EQ5D, sexual functioning was assessed using items derived from the International Index of Erectile Function, and the female sexual function index adapted for anal intercourse. RESULTS: One hundred forty-five patients (98%) completed at least 1 questionnaire. There was a significant different pattern of change over time in health-related quality of life among the 3 treatment groups. Patients in the imiquimod group were more likely to report pain/discomfort at week 8 than patients in the electrocautery group. Patients in the electrocautery group were more likely to report anxiety/depression and were less satisfied with their overall sex life at week 16 than patients in the imiquimod and fluorouracil groups, and patients in the electrocautery group were also more likely to report pain/discomfort and problems with usual activities at week 20 than patients in the fluorouracil group. LIMITATIONS: The follow-up method differed slightly among treatment groups. There is no standardized, validated sexual functioning questionnaire for HIV-positive men who have sex with men. CONCLUSIONS: All treatment options have a negative impact on aspects of health-related quality of life. Electrocautery has significantly more negative effects on health-related quality of life than imiquimod and fluorouracil and also has a negative effect on sexual functioning.
Authors: Jack E Burkhalter; Thomas M Atkinson; J Berry-Lawhorn; Stephen Goldstone; Mark H Einstein; Timothy J Wilkin; Jeannette Lee; David Cella; Joel M Palefsky Journal: Value Health Date: 2018-04-11 Impact factor: 5.725
Authors: Thomas M Atkinson; Joel Palefsky; Yuelin Li; Andrew Webb; J Michael Berry; Stephen Goldstone; Rebecca Levine; Timothy J Wilkin; Gary Bucher; David Cella; Jack E Burkhalter Journal: Qual Life Res Date: 2019-01-07 Impact factor: 4.147
Authors: Fernando Dias Gonçalves Lima; Ramon P van der Zee; Stèfanie Dick; Carel J M van Noesel; Johannes Berkhof; Maarten F Schim van der Loeff; Jan M Prins; Renske D M Steenbergen; Henry J C de Vries Journal: BMJ Open Date: 2022-08-03 Impact factor: 3.006
Authors: Danielle R L Brogden; Una Walsh; Gianluca Pellino; Christos Kontovounisios; Paris Tekkis; Sarah C Mills Journal: Int J Colorectal Dis Date: 2020-09-26 Impact factor: 2.796