Development and initial validation of the Cat HEalth and Wellbeing (CHEW) Questionnaire: a generic health-related quality of life instrument for cats.

OBJECTIVES: The aims of the study were to define factors that owners consider relevant to the health-related quality of life (HRQoL) of cats, to develop an instrument based on this information, and to evaluate the validity and reliability of the final instrument (the Cat HEalth and Wellbeing [CHEW] Questionnaire). METHODS: Psychometric research techniques and guidance from the US Food and Drug Administration on outcome measures were used to develop a valid and reliable instrument. Fifty-four cat owners and caregivers participated in the qualitative research, while 1303 cat owners were included in the quantitative validation phase (development dataset, n = 648; validation dataset, n = 655). A random subset of cat owners (n = 391) also participated in test-retest evaluation. Qualitative research was used to generate a draft instrument, which was then subjected to quantitative validation techniques. These included item reduction, domain identification, data quality assessment, and exploratory and confirmatory analysis to develop a final instrument, which underwent confirmatory reliability and validity assessment. RESULTS: A draft instrument with 11 domains and 100 items based on qualitative research underwent online quantitative validation testing which refined the instrument to eight domains and 33 items. Confirmatory reliability and validity assessment showed that the final instrument had good validity, was able to discriminate between cats by age and overall health status, and demonstrated good internal and test-retest reliability. CONCLUSIONS AND RELEVANCE: The CHEW Questionnaire was developed and validated. Additional research is needed to verify its ability to differentiate cats with and without disease, and to assess its potential as a screening tool.

Translation and validation of the Farage Quality of Life (FQoL™) instrument for consumer products into traditional Chinese.

The Farage Quality of Life™ questionnaire (FQoL™) was developed specifically to assess the impact of consumer products. The objective of this investigation was to achieve a Chinese language instrument. The FQoL™ underwent a forward and backward translation, with cognitive testing by 13 subjects. Slight modifications were made to the instrument, and an implementation study was conducted with 800 participants having a mean (±SD) age of 34.22 (±9.28) years. The subjects were randomly assigned to use 1 of 4 ultra absorbency pad products for the length of one menstrual cycle. Three pads (coded N, S and C) were products currently available on the retail market, a fourth (coded M) was an experimental product improvement on Product N. Subjects were asked to complete the FQoL™ once before (T1) and once after (T2) the start of their period, and the Least Square (LS) Means were determined. Within group comparisons for each item and FQoL™ subscale were conducted by comparing the LS Means for T1 vs. T2. Participants using Product N showed the highest number of significant (p<0.05) changes (11 items), demonstrating these subjects felt worse about items mainly in the subdomains for Emotions, Personal Pleasure, and Physical State. Participants using Product C showed significant changes in 7 items mainly in the subdomains for Emotion and Physical State. Participants using Product S and the experimental Product M showed significant changes in only 4 and 3 individual items, respectively. These were not associated with any particular domain or subdomain. Between group comparisons were conducted by comparing the LS Means for the T2 responses for each group. The group using Product N had LS Mean responses that were significantly worse than the group using Product M for the Emotion, Personal Pleasure and Physical State subdomains, the Energy/Vitality domain, and 2 individual items. The Product S group was worse than the Product M group for 2 individual items. The Product C group was worse than the Product M group for the Personal Pleasure and Physical State subdomains and 5 individual items. We found that the Chinese language FQoL™ detected changes in HRQoL during menstruation compared with before menstruation. Further, the measure was able to detect differences among groups of subjects using different menstrual protection products.

Dermatological testing of an improved apertured film surface for feminine hygiene pads.

CONTEXT: Apertured polyethylene films (AF) have been used as a surface for sanitary pads for decades because they are compatible with the skin and keep the pad surface drier. A modified film (AF-plus) with improved fluid handling and a smoother, suppler texture has been developed. We hypothesized that these changes would improve both performance and skin compatibility. However, distinguishing the skin effects of materials that are inherently mild is a challenge. OBJECTIVES: (i) To compare the skin irritation potential of pads with AF-plus modified film relative to the standard AF film and (ii) to assess the potential for the AF-plus film to induce delayed contact hypersensitivity. MATERIALS AND METHODS: Pads bearing the AF-plus film were compared to pads with the standard AF film in a behind-the-knee (BTK) test, which assesses the combination of chemical irritation and frictional effects of materials applied to the popliteal fossa under a semi-occlusive bandage. Erythema on the skin surface was scored with the naked eye and subsurface tissue erythema was visualized and scored using cross-polarized illumination. Skin dryness was scored with the naked eye only. One-sided statistical evaluations were performed to test the hypothesis of AF-plus film superiority. The potential of the AF-plus film to induce delayed contact hypersensitivity was assessed by a human repeat insult patch test (HRIPT). RESULTS: Pads with the AF-plus surface were significantly milder to skin in the BTK test, producing lower levels of both surface and subsurface tissue erythema. Moreover, subjects with preexisting erythema on the skin surface at study start developed comparatively less erythema over the course of the study overall with the AF-plus pad compared to the AF pad. No significant difference in skin dryness was observed between product groups. The AF-plus pad showed no evidence of inducing delayed contact hypersensitivity. CONCLUSIONS: The AF-plus pad was superior to the AF pad in terms of skin mildness as discerned by objectively scored surface and subsurface tissue erythema. In subjects with preexisting erythema, the AF-plus pad appeared to contribute less to the further development of inflammation under the test conditions. Given the compositional similarities in the two films, the results could point to more limited contribution of the AF-plus film to skin friction, one of the factors simulated by the BTK test protocol.