The Development of the Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) to Assess the Impact of Genital Psoriasis on Sexual Health.
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SUBMITTER: Gottlieb AB
PROVIDER: S-EPMC5825317 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundEpithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health.ObjectiveTo evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12.MethodsThis post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ).ResultsAt baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline.ConclusionIxekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.
| S-EPMC7318177 | biostudies-literature
Project description:IntroductionPatient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described.MethodsIn this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs.ResultsRelevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS.ConclusionThe GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs.FundingEli Lilly & Company. Plain language summary available for this article.
| S-EPMC5825318 | biostudies-literature
Project description:BackgroundSeveral questionnaires have been used to measure health related quality of life (HRQoL) in patients with psoriasis, few have been adapted for use in Spain; none of them was developed specifically for the Spanish population. The purpose of the study was to validate and assess the sensitivity to change of a new questionnaire to measure HRQOL in patients with psoriasis (PSO-LIFE).MethodsObservational, prospective, multicenter study performed in centers around Spain. Patients with active or inactive psoriasis completed the PSO-LIFE together with other Dermatology Quality of Life Index (DLQI) and Psoriasis Disability Index (PDI). A control group of patients with urticaria or atopic dermatitis was also included. Internal consistency and test-retest reliability of the PSO-LIFE were assessed by calculating Cronbach's alpha and Intraclass Correlation Coefficient (ICC). Validity was assessed by examining factorial structure, the capacity to discriminate between groups, and correlations with other measures. Sensitivity to change was measured using effect sizes.ResultsThe final sample included for analysis consisted of 304 patients and 56 controls. Mean (SD) age of psoriasis patients was 45.3 (14.5) years compared to 38.8 (14) years for controls (p < 0.01). Cronbach's alpha for the PSO-LIFE was 0.95 and test-retest reliability using the ICC was 0.98. Factor analysis showed the questionnaire to be unidimensional. Mean (SD) PSO-LIFE scores differed between patients with psoriasis and controls (64.9 [22.5] vs 69.4 [17.3]; p < 0.05), between those with active and inactive disease (57.4 [20.4] vs 76.4 [20.6]; p < 0.01), and between those with visible and non-visible lesions (63.0 [21.9] vs. 74.8 [23.9]; p < 0.01). The correlation between PSO-LIFE and PASI scores was moderate (r = -0.43) while correlations with DLQI and PDI dimensions ranged from moderate to high (between 0.4 and 0.8). Effect size on the PSO-LIFE in patients reporting 'much improved' health status at study completion was 1.01 (large effect size).ConclusionsThe present results provide substantial support for the reliability, validity, and responsiveness of the PSO-LIFE questionnaire in the population for which it was designed.
| S-EPMC3458920 | biostudies-literature
Project description:INTRODUCTION:Plaque psoriasis is a chronic skin disease where genital involvement is relatively common. Yet health care providers do not routinely evaluate psoriasis patients for genital involvement and patients do not readily initiate discussion of it. METHODS:A qualitative study of 20 US patients with dermatologist-confirmed genital psoriasis (GenPs) and self-reported moderate-to-severe GenPs at screening was conducted to identify key GenPs symptoms and their impacts on health-related quality of life (HRQoL). RESULTS:Patients had a mean age of 45 years, 55% were female, and patients had high rates of current/recent moderate-to-severe overall (65%) and genital (70%) psoriasis. Patients reported the following GenPs symptoms: genital itch (100%), discomfort (100%), redness (95%), stinging/burning (95%), pain (85%), and scaling (75%). Genital itching (40%) and stinging/burning (40%) were the most bothersome symptoms. Impacts on sexual health included impaired sexual experience during sexual activity (80%), worsening of symptoms after sexual activity (80%), decreased frequency of sexual activity (80%), avoidance of sexual relationships (75%), and reduced sexual desire (55%). Negative effects on sexual experience encompassed physical effects such as mechanical friction, cracking, and pain as well as psychosocial effects such as embarrassment and feeling stigmatized. Males reported a higher burden of symptoms and sexual impacts. Other HRQoL impacts were on mood/emotion (95%), physical activities (70%), daily activities (60%), and relationships with friends and family (45%). These impacts significantly affected daily activities. Physical activities were affected by symptoms and flares, and increased sweat and friction worsened symptoms. Patients reported daily practices to control outcomes. CONCLUSION:The high level of reported symptoms and sexual and nonsexual impacts reflects the potential burden of moderate-to-severe GenPs. GenPs can impact many facets of HRQoL and providers should evaluate their patients for the presence of genital psoriasis and its impact on their quality of life. FUNDING:Eli Lilly and Company.
| S-EPMC5698203 | biostudies-literature
Project description:AimIn New Zealand, there are few adequate food frequency questionnaires for assessing dietary intake. This study aimed to develop and assess the relative validity of a multi-nutrient, culturally appropriate, semi-quantitative food frequency questionnaire for use in young adult New Zealand women (the New Zealand Women's Food Frequency Questionnaire (NZWFFQ)).MethodsWomen (n?=?110) aged 16-45?years of M?ori, Pacific or European ethnicity completed a NZWFFQ assessing dietary intake over the previous month, and a 4-day weighed food record. Relative validity was evaluated by comparing nutrient intakes from the NZWFFQ with the food record using Spearman's rank correlation coefficients, cross-classification, the weighted kappa statistic and Bland-Altman analysis.ResultsNutrient intake was higher from the NZWFFQ compared with the food record for all nutrients (range: 1%-64% difference) except alcohol (-16% difference). Energy-adjusted correlations ranged from 0.23 to 0.67 (average 0.48). Correct classification into same and adjacent quartiles was over 70% for all nutrients except folate and vitamin D. Gross misclassification into opposite quartiles ranged from 1% (monounsaturated fat, magnesium, calcium) to 10% (iron). The weighted kappa showed poor agreement for vitamin D and folate, fair agreement for most nutrients, and moderate agreement for fibre, vitamin E, magnesium, calcium and phosphorus.ConclusionsThe NZWFFQ overestimated intake of nearly all nutrients. While not suitable for assessing absolute intake, the NZWFFQ is suitable for ranking individuals based on nutrient intake demonstrating reasonable relative validity for this purpose.
| S-EPMC7187395 | biostudies-literature
Project description:BackgroundBronchiolitis is a distressing respiratory condition and the most common cause of hospitalization during the first year of life. The hospitalization of an infant is a stressful event for parents and deserves careful consideration. The objective of this work was to develop and validate a self-administered instrument that comprehensively assesses the impact on parents of the hospitalization of their infant for bronchiolitis.MethodsThe Impact of Bronchiolitis Hospitalization Questionnaire (IBHQ©) was developed using a literature review and pre-study interviews with both parents and clinicians. For finalization and psychometric validation, it was included in a multicenter, longitudinal, observational study conducted in France. Parents of infants under the age of 1 year and hospitalized for bronchiolitis were asked to complete the questionnaire at hospital discharge, and 3 months after.ResultsSeven hundred and seven questionnaires were completed by the parents of the 463 eligible infants. After finalization, based on principal component analyses, the IBHQ included 30 core items allowing the calculation of 7 dimension core scores (Worries and distress; Fear for future; Guilt; Impact on daily organization; Physical impact; Impact on behavior with hospitalized infant; Financial impact), as well as 16 optional items, allowing the calculation of 5 optional dimension scores (Disturbed breastfeeding; Physical reaction of hospitalized infant; Impact on feeding; Impact on behavior with other infants; Siblings' reaction). Internal consistency reliability and construct validity of the IBHQ were satisfactory. The highest impact was observed for "Worries and distress", "Fear for future" and "Impact on daily organization" scores.ConclusionsThe IBHQ is a reliable and valid instrument for assessing the multifaceted impact on parents of the hospitalization of their infant for bronchiolitis.
| S-EPMC3717097 | biostudies-literature
Project description:Dietary assessment in infants is challenging but necessary to understand the relationship between nutrition and growth and development. Currently no simple, validated methods exist to assess nutrient intake in New Zealand (NZ) infants. Therefore, this study aimed to assess the relative validity and reproducibility of a Complementary Food Frequency Questionnaire (CFFQ) to determine nutrient intakes of NZ infants. Ninety-five parent-infant pairs (infant age 10 ± 1 months) completed the CFFQ twice (CFFQ-1 and CFFQ-2), 4 weeks apart (to assess reproducibility). A 4-day weighed food record (4dWFR) was collected between CFFQ administrations (to assess validity). Validity and reproducibility were assessed for intakes of energy and 18 nutrients using Bland-Altman analysis, Pearson's correlation coefficients, cross-classification, and weighted Kappa (?). The CFFQ showed acceptable validity: Nutrients from the CFFQ were comparable with the 4dWFR (bias, 9-28%), correlation between methods ranged from r = .18 (saturated fat) to r = .81 (iron; mean r = .52), 54% (mean) of participants were correctly classified (range 39% to 67%), and 7.1% (mean) misclassified into opposite tertiles (range 2.1% to 14.7%). There was acceptable agreement between the CFFQ and 4dWFR (? = 0.20-0.60). The CFFQ showed good reproducibility: Correlations ranged from r = .34 (folate) to r = .80 (zinc); for 16 nutrients, >50% of participants were correctly classified, and for all nutrients, <10% of participants were grossly misclassified. All nutrients showed acceptable to good agreement (? > 0.20). The CFFQ has acceptable relative validity and good reproducibility for assessing nutrient intake in NZ infants aged 9-12 months, making it a useful tool for use in future research.
| S-EPMC7038889 | biostudies-literature
Project description:The present study aims to develop a quantitative food frequency questionnaire (FFQ) to assess free sugar intake as a whole and at the food group levels, retrospectively, over the past 3 months among 4 to 5-year-old preschool children in the Colombo district, Sri Lanka. Then, to assess its reliability and relative validity. In the development phase, three 24-hour dietary recalls (24 hDRs) of 518 preschool children were collected from caregivers. Based on that, a 67-item FFQ was developed, including commonly consumed free sugar-containing food items. The validation study was conducted among another 108 preschool children. The relative validity of the FFQ was assessed by comparing it with the 24 hDRs. The test-retest reliability was assessed by repeated application of the FFQ to the same population after 6 weeks. Wilcoxon sign rank test, cross-classification with weighted Kappa statistic, Spearman rank correlation and Bland-Altman plots were used for comparison. Comparing the free sugar intake calculated by the two methods showed no difference (P = 0⋅13), a good correlation (0⋅89), good agreement in cross-classifying participants (78⋅4 % correctly classified) and a good agreement in Bland-Altman plots. Repeated application of the FFQ yielded; no differences in free sugar intake values (P = 0⋅45) a good correlation (0⋅71), acceptable agreement in cross-classifying participants (52⋅3 % correctly classified) and acceptable agreement in the Bland-Altman plot. Results were the same for all food groups. According to the results, the newly developed quantitative FFQ provides a relatively valid and reliable measure for quantifying free sugar intake among preschool children as a whole or by food group.
| S-EPMC9947589 | biostudies-literature
Project description:Background: Dental research into early childhood caries is hindered by a lack of suitable dietary assessment tools that have been developed and validated for the population and outcomes of interest. The aim of this study was to develop and investigate the relative validity and reproducibility of the Study of Mothers' and Infants' Life Events Food Frequency Questionnaire (SMILE-FFQ), to assess the total and free sugars intakes of Australian toddlers. Methods: The SMILE-FFQ was designed to capture the leading dietary contributors to dental caries risk in toddlers aged 18-30 months via a proxy report. Ninety-five parents of Australian toddlers completed the questionnaire online before and after providing three 24-h recalls (24HR), collected on non-consecutive days using the multipass method. Total and free sugars were compared between the two SMILE-FFQ administrations and between each SMILE-FFQ and the 24HR using multiple statistical tests and standardised validity criteria. Correlation (Pearson), mean difference (Wilcoxon rank test) and Bland Altman analyses were conducted to compare absolute values, with cross-classification (Chi-Square and Weighted Kappa) used to compare agreement across tertiles. Results: All reproducibility tests showed good agreement except weighted kappa, which showed acceptable agreement. Relative validity tests revealed a mix of good and acceptable agreement, with total sugars performing better at the individual level than free sugars. Compared to the 24HR, the SMILE-FFQ tended to underestimate absolute values at lower levels and overestimate them at higher levels. Conclusions: The combined findings of the various tests indicate that the SMILE-FFQ performs comparably to the 24HR for assessing both total and free sugars among individuals, is most effective for ranking participants rather than determining absolute intakes, and is therefore suitable for use in observational studies of Australian toddlers.
| S-EPMC5708000 | biostudies-literature
Project description:Assessing habitual food consumption is challenging in multi-ethnic cosmopolitan settings. We systematically developed a semi-quantitative food frequency questionnaire (FFQ) in a multi-ethnic population in Singapore, using data from two 24-h dietary recalls from a nationally representative sample of 805 Singapore residents of Chinese, Malay and Indian ethnicity aged 18-79 years. Key steps included combining reported items on 24-h recalls into standardized food groups, developing a food list for the FFQ, pilot testing of different question formats, and cognitive interviews. Percentage contribution analysis and stepwise regression analysis were used to identify foods contributing cumulatively ?90% to intakes and individually ?1% to intake variance of key nutrients, for the total study population and for each ethnic group separately. Differences between ethnic groups were observed in proportions of consumers of certain foods (e.g., lentil stews, 1%-47%; and pork dishes, 0%-50%). The number of foods needed to explain variability in nutrient intakes differed substantially by ethnic groups and was substantially larger for the total population than for separate ethnic groups. A 163-item FFQ covered >95% of total population intake for all key nutrients. The methodological insights provided in this paper may be useful in developing similar FFQs in other multi-ethnic settings.
| S-EPMC5037515 | biostudies-literature