Psychometric validation of the Psoriasis Symptom Scale, Functional Assessment of Chronic Illness Therapy-Fatigue and pain-Visual Analogue Scale in patients with generalized pustular psoriasis.

BACKGROUND: Generalized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and pain-Visual Analogue Scale (pain-VAS) are patient-reported outcomes (PROs) that have not yet been validated in patients with GPP. OBJECTIVES: To evaluate the psychometric properties of the PSS, FACIT-Fatigue and pain-VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate-to-severe GPP. METHODS: Inter-item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's α coefficient using baseline and Week 1 data. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank-order correlations. Known-groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance. RESULTS: Inter-item and item-to-total correlations were moderate or strong for most PSS and FACIT-Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT-Fatigue, with high factor loadings for most items (PSS range, 0.75-0.94; FACIT-Fatigue range, 0.11-0.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's α, 0.71 and 0.95, respectively). The PSS, FACIT-Fatigue and pain-VAS demonstrated test-retest reliability (ICCs ≥0.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, p < 0.0001-0.0225) and detect changes in symptom severity from baseline to Week 1 (range, p < 0.0001-0.0002). CONCLUSIONS: Overall, these results support the reliability, validity and ability to detect change of the PSS, FACIT-Fatigue and pain-VAS as PROs in patients with GPP.

Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial.

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg (N = 44) or placebo (N = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling compared changes in HRQOL over-time and ANCOVA compared HRQOL between those getting an ICD shock or not. Over 24-months, there were no differences in HRQOL between the spironolactone versus placebo groups. Those with at least one ICD shock reported significantly lower HRQOL and more symptoms at 6- and 24-months. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.

Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation.

This study examined mechanisms by which social cognitive theory (SCT) interventions influence health outcomes and the importance of involving partners in recovery following the patients' receipt of an initial implantable cardioverter defibrillator (ICD). We compared direct and indirect intervention effects on patient health outcomes with data from a randomized clinical trial involving two telephone-based interventions delivered during the first 3 months post-ICD implant by experienced trained nurses: P-only conducted only with patients, and P + P conducted with patients and their intimate partners. Each intervention included the patient-focused component. P + P also included a partner-focused intervention component. ICD-specific SCT-derived mediators included self-efficacy expectations, outcome expectations, self-management behavior, and ICD knowledge. Outcomes were assessed at discharge, 3- and 12-months post ICD implant. Patients (N = 301) were primarily Caucasian, male, 64 (± 11.9) years of age with a mean ejection fraction of 34.08 (± 14.3). Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (ß = 0.04, p = 0.04; ß = 0.02, p = 0.04, respectively) and for psychological adjustment (ß = 0.06, p = 0.04; ß = 0.03, p = 0.04, respectively). SCT interventions show promise for improving ICD patient physical and psychological health outcomes through self-efficacy and outcome expectations. Including partners in post-ICD interventions may potentiate positive outcomes for patients.Trial registration number (TRN): NCT01252615 (Registration date: 12/02/2010).