Development and preliminary validation of the patient-reported Chronic Itch Burden Scale assessing health-related quality of life in chronic pruritus.

BACKGROUND: Chronic pruritus (CP) significantly affects patients' health-related quality of life (HRQoL). Very few self-reported HRQoL questionnaires exploring CP have been developed according to international guidelines, thus limiting their use in preauthorization trials. OBJECTIVES: To develop a self-reported HRQoL questionnaire in patients with CP owing to psoriasis, atopic dermatitis, seborrhoeic dermatitis of the scalp or idiopathic dermatitis, and to explore the preliminary psychometric properties of the questionnaire. METHODS: The study was performed in France. A conceptual framework was developed based on a structured literature review and expert insight, and was improved using three focus groups involving 19 participants. A 50-item questionnaire was created and tested with 21 participants using cognitive debriefings; 11 items were removed. A cross-sectional study including 251 participants was performed to explore the preliminary psychometric properties of the 39-item questionnaire. Dimensionality was explored using principal component analysis. Cronbach's alpha and correlation coefficients (interitem, item-total score and item-dimension score) were measured. The number of items was reduced through expert consensus. RESULTS: In the 39-item version, three main dimensions were identified (Cronbach's alpha = 0·94) and all correlation coefficients were > 0·34. Upon review, 13 items were deleted owing to poor quality and six items were deleted by the team, generating a 20-item version. The questionnaire's factorial structure was best reflected with a two-dimension solution, i.e. (i) social and emotional repercussions and (ii) relation to others, fear of judgement. CONCLUSIONS: The Chronic Itch Burden Scale patient-reported questionnaire explores broad aspects of HRQoL that are relevant for patients with various skin diseases. Its good cross-sectional validity makes it useful for trials and practitioners.

Trajectories of antipsychotic response in drug-naive schizophrenia patients: results from the 6-month ESPASS follow-up study.

OBJECTIVE: The aim of this study was to explore any heterogeneity in the 6-month clinical response in patients with antipsychotic drug-naive schizophrenia and to determine predictors of that outcome. METHOD: 467 patients with antipsychotic drug-naive schizophrenia were included in France nationwide and followed up over 6 months. To identify trajectories of clinical response, a latent class growth analysis (LCGA) was performed using the Clinical Global Impression-Severity (CGI-S) scores at baseline, 1, 3, and 6 months. Regression models were used to identify predictors of trajectory membership. RESULTS: Five trajectory groups were identified: a rapid response group (n = 45), a gradual response group (n = 204), patients remaining mildly ill (n = 133), patients remaining very ill (n = 23), and a group with unsustained clinical response (n = 62). Predictors of the 6-month clinical response were baseline CGI-S score (odds ratio: 3.1; 95% confidence interval, 2.1-4.4) and negative symptoms (OR, 1.5; 95% CI, 1.2-1.9). The sole predictor of rapid response as compared to gradual response was employment (OR, 2.5; 95% CI, 1.2-4.9). CONCLUSION: Clinical response in patients with schizophrenia 6 months after a first-ever antipsychotic drug initiation is heterogeneous. Therapeutic strategies in first episode should take account of symptom severity and early clinical response, to maximize the chances of recovery.

Patient satisfaction with psychotropic drugs: Validation of the PAtient SAtisfaction with Psychotropic (PASAP) scale in patients with bipolar disorder.

PURPOSE: The PAtient SAtisfaction with Psychotropic (PASAP) scale is a self-completed questionnaire measuring satisfaction with psychotropic medication. The aim of the study was to describe its development in French and its psychometric properties. MATERIALS AND METHODS: Scale construction was based on an extensive search of the literature. The item reduction process required semi-structured interviews of psychiatric outpatients (n=30). The final version of the PASAP is a 9-item, 5-point Likert-type scale, covering the scope of effectiveness and adherence. To assess the psychometric properties of the scale, French patients with an acute manic episode (n=314) from a large European observational cohort completed the PASAP scale 3 months after psychotropic treatment initiation/change. Internal validity and reliability were assessed using principal component analysis (PCA). Concurrent validity was assessed using comparisons to physician-rated satisfaction with life, illness severity, mood relapse, compliance and side effects. RESULTS: Participation rate was 68.4%. PCA was in favour of uni-dimensionality. Cronbach's α coefficient was 0.85 (95%CI 0.83-0.88). All five concurrent measures were significantly associated with the PASAP score. CONCLUSION: The PASAP scale showed good psychometric properties in a large bipolar population and thus seems adequate for evaluating treatment satisfaction. Its short length and good acceptability makes it suitable for clinical research.