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Introduction: Vitiligo can be associated with a psychological burden, stigmatization and impaired quality of life. Tools to assess the impact of vitiligo exist; however, none were developed in line with the FDA's patient-reported outcome (PRO) Guidance for Industry. This study aimed to explore the content validity of two newly developed PRO measures to assess the impact of facial and total body vitiligo on how patients feel and function. Methods: Draft PRO measures were developed from existing literature and input from PRO experts, a patient advocate and a clinical expert. Qualitative interviews were conducted with US participants living with vitiligo and international dermatologists with vitiligo expertise. Concept elicitation methodology explored the relevance of concepts in the draft PRO, while cognitive debriefing assessed conceptual relevance and understanding/interpretation. Items were iteratively amended/added throughout the interview study. Results: The 60 participants included adults (n = 48, 63% female, 18–62 years old) and adolescents (n = 12, 67% female, 12–17 years old) with Fitzpatrick Skin Types I–VI. Expert dermatologists from the US (n = 8), EU (n = 4), India (n = 1) and Egypt (n = 1) participated. Concept elicitation was utilized to confirm the signs/symptoms of vitiligo and the associated impact on emotional/psychological wellbeing, social functioning, daily life and work/school. Conceptual saturation was achieved. Most participants reported impacts on their emotional/psychological wellbeing (n = 57, 95%), e.g. feeling self-conscious (n = 35, 58%). Participants reported impacts on social functioning (n = 53, 88%), e.g. vitiligo being noticed by others (n = 42, 70%). There was general consensus between participants and expert dermatologists. Cognitive debriefing confirmed that the items were well understood. Most items were conceptually relevant; feeling self-conscious and feeling frustrated were highly endorsed. Items were removed based on low conceptual relevance (feeling abandoned, skin roughness) and expected redundancy (four items), resulting in two measures with three proposed domain scores: Emotional/Psychological Wellbeing; Social Functioning; and Physical Sensation. No comprehension concerns were observed in relation to the 7-day recall period or the item response scale/options. Eight dermatologists reviewed the PRO measures, confirming comprehensiveness and relevance. Conclusion: The draft Vitiligo Patient Priority Outcomes (ViPPO) measures evaluate the impact of facial (ViPPO-F) and total body (ViPPO-T) vitiligo on emotional/psychological and social functioning. The ViPPO measures are well understood, comprehensive and content valid for adults and adolescents with vitiligo. [ABSTRACT FROM AUTHOR]

Introduction: The Menopause-specific Quality of Life (MENQOL) questionnaire was developed in 1996 to assess the health-related quality of life (QOL) in the menopausal transition and it addresses the degree to which menopausal symptoms had bothered women. The objective of this study was to translate the MENQOL questionnaire in the Odia- regional language of India and validate it for usage in the Odia-speaking menopausal women. Methods: The original English questionnaire MENQOL with 1-month recall period was translated by the researchers. According to instructions by Mapi Research Trust, the questionnaire was forward and backward translated, followed by participant testing and proofreading. Validity and reliability were evaluated by the following tests: internal consistency (reliability), stability (test-retest reliability) with Cronbach's alpha correlations, Pearson's correlation coefficients, and content validity index. Results: A total of 80 postmenopausal women participated in the study. The ICC score and Cronbach's alpha value of all the four domains such as vasomotor, psychosocial, physical, and sexual of both MENQOL English and Odia (MENQOL-E and MENQOL-O) versions recommended excellent homogeneity. The internal consistency using the Cronbach's alpha showed high reliability (0.993) between the MENQOL-E and MENQOL-O questionnaires. Conclusion: The MENQOL-O questionnaire will be used at the individual to community health-care settings to measure QOL and those identified with lower menopause-related QOL, they may get support and care. [ABSTRACT FROM AUTHOR]

Background: The Global Program to Eliminate Lymphatic Filariasis aims to interrupt transmission of lymphatic filariasis and manage morbidity in people currently living with the disease. A component of morbidity management is improving health-related quality of life (HRQoL) in patients. Measurement of HRQoL in current management programs is varied because of the lack of a standard HRQoL tool for use in the lymphatic filariasis population. Methodology/Principal Findings: In this study, the psychometric properties of three health status measures were compared when used in a group of lymphatic filariasis patients and healthy controls. The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), the Dermatology Life Quality Index (DLQI), and the Lymphatic Filariasis Quality of Life Questionnaire (LFSQQ) were administered to 36 stage II and stage III lymphatic filariasis subjects and 36 age and sex matched controls in Kerala, India. All three tools yielded missing value rates lower than 10%, suggesting high feasibility. Highest internal consistency was seen in the LFSQQ (α = 0.97). Discriminant validity analysis demonstrated that HRQoL was significantly lower in the LF group than in controls for the WHODAS 2.0, DLQI, and LFSQQ, but total HRQoL scores did not differ between stage II and stage III lymphedema subjects. The LFSQQ total score correlated most strongly with the WHODAS 2.0 (r = 0.91, p<0.001) and DLQI (r = 0.81, p<0.001). Conclusions/Significance: The WHODAS 2.0, DLQI, and LFSQQ demonstrate acceptable feasibility, internal consistency, discriminate validity, and construct validity. Based on our psychometric analyses, the LFSQQ performs the best and is recommended for use in the lymphatic filariasis population. Author Summary: Lymphatic filariasis affects approximately 120 million people and is the second leading cause of life-long disability worldwide. Because lymphatic filariasis is one of the World Health Organization's six eradicable diseases, much effort has been placed into reducing transmission of the disease and managing morbidity. Novel interventions frequently use health-related quality of life as an outcome measure to monitor efficacy of the intervention. In an effort to delineate the strengths and weaknesses of health status measures and recommend use of a single tool in the lymphatic filariasis population, we compared the use of three health status tools (The World Health Organization Disability Assessment Schedule 2.0, the Dermatology Life Quality Index, and the Lymphatic Filariasis Quality of Life Questionnaire) in lymphatic filariasis subjects and healthy controls in Kerala, India. The Lymphatic Filariasis Quality of Life Questionnaire performed the best by discriminating well between subjects and controls, possessing significant content overlap with the other two tools, yielding a low missing value rate, and being internally consistent. This is the first study to compare health status measures in lymphatic filariasis subjects and provides insight into the use of the tools in quality of life analysis. [ABSTRACT FROM AUTHOR]