The content validity of the PSS in patients with plaque psoriasis.

BACKGROUND: The primary objective of this study was to evaluate the content validity of the Psoriasis Symptom Scale (PSS), with a specific focus on understanding of the content of the PRO measure by conducting one-on-one interviews with patients with moderate to severe plaque psoriasis. This was a cross-sectional, qualitative study conducted with 20 patients with plaque psoriasis who participated in in-person, one-on-one interviews. Participants were asked to describe their psoriasis symptoms, completed the PSS, and were cognitively debriefed on its content. Interviews were conducted in two separate rounds. Following Round 1, the study data were examined to determine if modifications to the PSS were required. All interviews were audio-recorded and transcribed. Sociodemographic and clinical data were collected for sample descriptive purposes. RESULTS: The 20 study participants had a mean age of 50.2 ± 12.0 years (range: 25.0-73.0), and 55% were female. Thirty-five percent of the sample reported their psoriasis severity as moderate or severe. The average time since diagnosis of plaque psoriasis was almost 18 years, ranging from less than one to over 38 years. The most frequently reported symptoms and signs during the concept elicitation portion of the interviews included redness (N = 20, 100%), itching (n = 20, 100%), pain (n = 15, 75%), burning (n = 13, 65%), and flaking (n = 11, 55%). Overall, participants provided positive feedback on the PSS and felt that it was comprehensive and relevant to their experience with psoriasis. The item meaning and response options were well-understood for the majority of the items. Findings indicate that for the patient-reported symptom of redness, which is also a sign that can be reported by clinicians, redness or the perception of redness is most accurately captured by patient report. Study results did not support modifications to the instrument and no changes to the PSS were recommended. CONCLUSION: The evidence gained in this study provided support for the content validity of the PSS for use as clinical trial endpoint among patients with plaque psoriasis. This study found that the symptoms included in the PSS are important to and well-understood by patients with plaque psoriasis. The PSS is appropriate for inclusion in future studies designed to measure the effect of treatment on psoriasis-related symptoms.

Use of Cognitive Interviews to Adapt PROMIS Measurement Items for Spanish Speakers Living with HIV.

Purpose. To use cognitive interviewing techniques to assess comprehension of existing Patient-Reported Outcomes Measurement Information System (PROMIS) items among Latinos living with HIV and then refine items based on participant feedback. Methods. Latino monolingual Spanish speakers living with HIV (n = 56) participated in cognitive interviews. Items from four PROMIS domains, including depression, anxiety, fatigue, and alcohol use, were assessed for comprehension. Audiotaped interviews and handwritten notes were subjected to content analysis to identify problems specific to each instrument for each domain. Results. The assessments from the cognitive interviews identified areas for improvement in each domain. We present data on the type of items that were difficult to comprehend and provide examples for how items were refined based on participants' and PROMIS Statistical Coordinating Center (PSCC) feedback. Six out of 48 depression items, 7 out of the 61 anxiety items, 18 out of 42 fatigue items, and 7 out of 44 alcohol use items were found to have poor comprehension. These items were refined based on participant feedback; the items were then submitted to the PSCC for additional guidance on linguistics and grammar to improve comprehension. Conclusions. Cognitive interviews may be used to enhance comprehension of PROMIS items among Latinos.

Mode of communication, perceived level of understanding, and perceived quality of life in youth who are deaf or hard of hearing.

Given the important role of parent-youth communication in adolescent well-being and quality of life, we sought to examine the relationship between specific communication variables and youth perceived quality of life in general and as a deaf or hard-of-hearing (DHH) individual. A convenience sample of 230 youth (mean age = 14.1, standard deviation = 2.2; 24% used sign only, 40% speech only, and 36% sign + speech) was surveyed on communication-related issues, generic and DHH-specific quality of life, and depression symptoms. Higher youth perception of their ability to understand parents' communication was significantly correlated with perceived quality of life as well as lower reported depressive symptoms and lower perceived stigma. Youth who use speech as their single mode of communication were more likely to report greater stigma associated with being DHH than youth who used both speech and sign. These findings demonstrate the importance of youths' perceptions of communication with their parents on generic and DHH-specific youth quality of life.

Weight loss and changes in generic and weight-specific quality of life in obese adolescents.

PURPOSE: To investigate how weight loss correlates with changes in generic and weight-specific quality of life (QoL). METHODS: Youth generic (YQOL-S) and weight-specific instruments (YQOL-W) from 133 youth age 11-19 were analyzed at the beginning and end of 4-week immersion camp sessions known to produce weight loss. Paired samples t tests were used to test mean difference between baseline and final Body Mass Index (BMI) and YQOL-S and YQOL-W scores. YQOL-S and YQOL-W scores were transformed to values between 0 and 100, with higher values indicating better QOL. Cohen's d effect sizes were calculated to assess magnitude of effects. Percent weight loss (as % of baseline weight), change in BMI (baseline kg/m²-follow-up kg/m²), and change in % overweight ((BMI-50th% BMI for age and sex)/50th% BMI for age and sex × 100) were calculated. Multiple regressions were used to model final YQOL scores in the 11-14 and 15-19 age groups as functions of each measure of weight change, sex, age, and baseline YQOL score. RESULTS: Youth experienced significant reductions in BMI (Mean change = 3.7, SD = 1.4, t = 34.1, P < 0.001) and in the other measures of weight change. YQOL-S and YQOL-W scores improved significantly (P < 0.001), and effect sizes were 0.61 and 0.66, respectively. CONCLUSION: Changes in generic and weight-specific quality of life scores are associated with weight loss. The weight-specific measure is slightly more sensitive to weight changes; however, when controlling for modifiers, the YQOL-W remained significantly associated with weight loss, while the generic QoL measure did not.