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**Background:** Hepatitis C virus (HCV) infection and its treatments are associated with significant symptoms, side effects and impact on patients functioning. The Hepatitis C Symptom and Impact Questionnaire version 4 (HCV-SIQv4) was developed according to FDA Patient Reported Outcomes (PRO) Guidance, for evaluating chronic HCV infection and its treatment. **Objectives:** This study evaluated the psychometric properties and clinically important change (CIC) thresholds of the measure. **Methods:** PRO data were pooled from three Phase IIb and III trials evaluating interferon-free simeprevircontaining regimens for treatment of chronic HCV infection. Scale range adequacy, reliability, validity, responsiveness and CIC thresholds were assessed incorporating knowledge of the appropriate measurement model. **Results:** Data from 437 patients were analyzed. Stage of liver disease was associated with symptom severity and functioning at baseline. Reliability was acceptable (test-retest ICC ≥0.7) for most scores except the Gastrointestinal and Integumentary domains. Convergent validity was observed between HCV-SIQv4 scores and concurrent measures of conceptual similarity. Greater symptom severity and worse impact scores were associated with liver cirrhosis, depression, severe fatigue and health limitations. Patients who achieved SVR12 had better outcomes than those failing to. HCV-SIQv4 symptom and domain scores were responsive to changes in health state (effect sizes ≥0.5). Exploratory thresholds for change in scores indicating a clinically important improvement and worsening were HCV-SIQv4 Overall Body System Score (BSS), 8 and 8; Constitutional BSS, 10 and 10; Gastrointestinal BSS, 5 and 5; Psychiatric BSS, 8 and 8; Neurocognitive BSS, 8 and 8; and Integumentary BSS, 5 and 5. **Conclusions:** The HCV-SIQv4 offers reliable, responsive assessments within HCV clinical development. CIC thresholds are now available to aid score interpretation.

BackgroundThis study explored the degree of views towards supportive workplace policies among employees during coronavirus disease 2019 (COVID-19) pandemic and its association with health-related quality of life (HRQoL) in Hong Kong. MethodsA cross-sectional study was conducted in 1049 employees using online self-administered questionnaire. Views on workplace policies were measured in term of agreement on its comprehensiveness, timeliness and transparency whereas HRQoL was measured using EQ-5D-5L Hong Kong version. Univariate estimates on the impact of HRQoL from views of measures in workplace was done. Qualitative comments on the suggestions to strengthen workplace measures were collected and presented descriptively. ResultsOf 1048 respondents, 16% reported that no workplace measures nor guidelines were existed in their company related to the COVID-19 pandemics. Those who reported having workplace policy were not satisfied with the arrangement in term of comprehensiveness (36%), timeliness (38%), and transparency (63%). Regarding to the policy measure, only 68% respondents reported that their workplace supplied face masks to them. The health index was 0897, which was lower than the norm of 0.924. 64% of respondents reported having a health problem in at least 1 of 5 dimension of EQ-5D-5L with the highest proportion of having problem in anxiety/depression (55%). In addition, the workplace policy and measure had a direct effect of 0.131 on health outcome. Perception of infection risk had a direct effect of 0.218 on health outcome and partly mediated the relationship between workplace policy and measure and health outcome (0.066). ConclusionThe study highlighted the workplace policy and measure is an important mean to minimize infection risk at workplace so as to reduce tremendous stress and health outcome caused by a COVID-19 pandemic. Workplace measures related to COVID-19 pandemic should be further strengthen to mitigate the risk of infection and protect employee’s health.

Background: This study explored the degree of views towards supportive workplace policies among employees during coronavirus disease 2019 (COVID-19) pandemic and its association with health-related quality of life (HRQoL) in Hong Kong. Methods: A cross-sectional study was conducted in 1049 employees using online self-administered questionnaire. Views on workplace policies were measured in term of agreement on its comprehensiveness, timeliness and transparency whereas HRQoL was measured using EQ-5D-5L Hong Kong version. Univariate estimates on the impact of HRQoL from views of measures in workplace was done. Qualitative comments on the suggestions to strengthen workplace measures were collected and presented descriptively. Results: Of 1048 respondents, 16% reported that no workplace measures nor guidelines were existed in their company related to the COVID-19 pandemics. Those who reported having workplace policy were not satisfied with the arrangement in term of comprehensiveness (36%), timeliness (38%), and transparency (63%). Regarding to the policy measure, only 68% respondents reported that their workplace supplied face masks to them. The health index was 0897, which was lower than the norm of 0.924. 64% of respondents reported having a health problem in at least 1 of 5 dimension of EQ-5D-5L with the highest proportion of having problem in anxiety/depression (55%). In addition, the workplace policy and measure had a direct effect of 0.131 on health outcome. Perception of infection risk had a direct effect of 0.218 on health outcome and partly mediated the relationship between workplace policy and measure and health outcome (0.066). Conclusion: The study highlighted the workplace policy and measure is an important mean to minimize infection risk at workplace so as to reduce tremendous stress and health outcome caused by a COVID-19 pandemic. Workplace measures related to COVID-19 pandemic should be further strengthen to mitigate the risk of infection and protect employee's health. [ABSTRACT FROM AUTHOR]

OBJECTIVE To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. SUBJECTS AND METHODS Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE, 201; non-PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo-controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five-point response scales. Test-retest reliability, known-groups validity, and ability to detect a patient-reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. RESULTS All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non-PE groups ( P < 0.001). Men who reported a reduction in PE with treatment in the phase III trial had significantly greater scores on each of the four measures. The PEP profiles of men with and without PE differed significantly ( P < 0.001) in both observational studies; higher levels of PGI were associated with higher PEP profiles ( P < 0.001). The PEP index score also showed acceptable reliability and was significantly different between the PE and non-PE groups ( P < 0.001). Men who reported an improvement in PE with treatment in the phase III trial had significantly greater PEP index scores. In the phase III trial, nausea was the most common adverse event with dapoxetine. CONCLUSION The PEP provides a reliable, valid, and interpretable measure for use in monitoring outcomes of men with PE. [ABSTRACT FROM AUTHOR]

Premature ejaculation (PE) is the most common male sexual dysfunction affecting men and their partners. Lack of community-based data describing this condition limits understanding of PE and its outcomes.To characterize PE in a large population of men with and without PE using patient-reported outcome (PRO) measures elicited from men and their partners.4-week, multicenter, observational study of males (≥18 years) and their female partners in monogamous relationships (≥6 months). Screening, baseline, and follow-up visits scheduled at 2-week intervals. Clinicians diagnosed PE utilizing DSM-IV-TR criteria. Intravaginal ejaculatory latency time (IELT), measured by a stopwatch held by the partner, was recorded for each sexual intercourse experience. Subject and partner independently assessed PROs:control over ejaculationandsatisfaction with sexual intercourse(0 = very poor to 4 = very good),personal distressandinterpersonal difficulty(0 = not at all to 4 = extremely), andseverity of PE(0 = none to 3 = severe).Of the total study population (N = 1,587), 207 subjects were diagnosed with PE and 1,380 were assigned to the non-PE group. Median IELT (min) was 1.8 (range, 0–41) for PE and 7.3 (range, 0–53) for non-PE subjects (P < 0.0001). More PE vs. non-PE subjects gave ratings of“very poor” or“poor” forcontrol over ejaculation(72% vs. 5%;P < 0.0001) andsatisfaction with sexual intercourse(31% vs. 1%;P < 0.0001). More subjects in the PE vs. non-PE group gave ratings of“quite a bit” or“extremely” forpersonal distress(64% vs. 4%;P < 0.0001) andinterpersonal difficulty(31% vs. 1%;P < 0.0001). Subject and partner assessments showed similar patterns and correlated moderately (0.36–0.57).PE subjects reported significantly shorter IELT. Overlap in IELT distributions was observed between the PE and non-PE groups, indicating the need for additional PRO measures to characterize PE. Shorter IELT was significantly associated with reduced ejaculatory control and sexual satisfaction and increased distress and interpersonal difficulty. [ABSTRACT FROM AUTHOR]