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To compare CATIE, a randomized double blind study, and SOHO, a 3-year prospective non-randomized observational European study of outpatients with schizophrenia, on the Number Needed to Treat (NNT) for all-cause medication discontinuation. NNTs place data into a clinically meaningful context - the number of patients needed to be treated with one antipsychotic instead of another to prevent one negative outcome, defined here as one additional medication discontinuation for any cause.
Rate of medication discontinuation for any cause during the 18 months post initiation was calculated for patients newly initiated on olanzapine (N=4247), risperidone (N=1549), quetiapine (N=583), amisulpride (N=256), clozapine (N=274), oral typicals (N=471) or depot typicals (N=348). Cox models were employed to adjust for treatment group differences at baseline. NNTs with their 95% confidence intervals were calculated and compared with published NNTs for CATIE (Phase 1).
The NNTs for all-cause discontinuation of olanzapine vs. each studied atypical antipsychotic during the 18 month following medication initiation in SOHO were comparable to CATIE: 4.3(95% CI: 3.6–5.3) for olanzapine vs. quetiapine (5.5 in CATIE); 16.1(11.0–28.1) for olanzapine vs. risperidone (10.1 in CATIE); 6.9(5.2–10.1) for olanzapine vs. oral typicals (9.0 in CATIE for olanzapine vs. perphenazine).
The NNTs for all-cause medication discontinuation based on CATIE appeared comparable to NNTs based on SOHO. The NNTs for olanzapine therapy were consistently better when compared to each studied atypical antipsychotic (except clozapine) and when compared to typical antipsychotics. Results should be interpreted conservatively, due to the observational design of SOHO.
Patient satisfaction with treatment is a pertinent outcome for evaluating the effectiveness of psychotropic medication. The current study evaluated the psychometric properties of a new multi-item scale of PAtient SAtisfaction with Psychotropic treatment (PASAP).
ESPASS is a, prospective, national observational study conducted in France on adult patients with schizophrenia (n=6007) requiring initiation or switch of antipsychotic medication. Demographics, psychiatric history, clinical status (CGI, IAQ) and pharmacological treatment patterns were recorded by psychiatrists at inclusion, 1, 3 and 6-months. Patients previously treated with an antipsychotic (n=4631) also completed a questionnaire on compliance, sexual problems, satisfaction with care and the 9-item PASAP scale (6 items evaluating their opinion of treatment and 3 items evaluating the prescriber). Each PASAP item is rated on a 5-point Likert scale. Patients who completed the 9-items were called PASAP completers.
63% of patients completed the PASAP scale at inclusion (2924/4631) and 53% at 6-months (2031/3829). PASAP completers were similar to non-completers for gender and marital status but were different for age, income level, duration of psychiatric care and severity of symptoms (p<0.001). Response rate to each item was ≥99%. At inclusion, principal component analysis suggested unidimensionality of the scale (Cronbach alpha=0.84). Inter-item correlation was satisfactory (>0.3) for most items. Responsiveness (sensitivity to change) at 6 months was good with the PASAP (effect size=0.731) and equivalent to the CGI (effect size=0.783).
The psychometric characteristics of the PASAP scale are good. French and English versions are available free on request.
Better understanding of functional outcome predictors in schizophrenia has become key in order to face new challenges of the disease. The ESPASS survey aimed at evaluating the impact of antipsychotic therapy initiation or switch on psychosocial functioning in a sample of schizophrenic patients.
The primary objective was to evaluate the change from baseline to 6 months in EAS total score (psychosocial functioning scale). Other criteria were the change in the IAQ total score, CGI-S, and PASAP (satisfaction with care)
Results (baseline visit)
5962 were included by 1169 investigators. Mean age was 37±12, 62% were male, 72% single, 62% were outpatients, 34% of the patients were on therapy for 10 years or more, 47% had paranoid schizophrenia subtype. Prior to baseline, 23% had no antipsychotic therapy, 25% had a conventional and 52% had an atypical antipsychotic. 8% of the total sample were naïve to antipsychotic therapy.
Obesity mostly affected patients treated with atypicals in comparison to conventional antipsychotics (20% vs. 15%). The EAS total score was 46±20 with lower sub-scores in following domains: money earning, management of belongings, social and private relationships. Mean CGI-S score was 4.7±1.0 and IAQ total score was 22±4. 26% of the patients participated in a psychosocial rehabilitation program for 3 to 4 years.
While improving social functioning has clearly become key in the treatment of schizophrenia, only 26% of the patients were involved in an adequate rehabilitation program and 25% had a conventional antipsychotic.
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.
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.
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.
The relationship between mental and physical disorders is well established, but there is less consensus as to the nature of their joint association with disability, in part because additive and interactive models of co-morbidity have not always been clearly differentiated in prior research.
Eighteen general population surveys were carried out among adults as part of the World Mental Health (WMH) Survey Initiative (n=42 697). DSM-IV disorders were assessed using face-to-face interviews with the Composite International Diagnostic Interview (CIDI 3.0). Chronic physical conditions (arthritis, heart disease, respiratory disease, chronic back/neck pain, chronic headache, and diabetes) were ascertained using a standard checklist. Severe disability was defined as on or above the 90th percentile of the WMH version of the World Health Organization Disability Assessment Schedule (WHODAS-II).
The odds of severe disability among those with both mental disorder and each of the physical conditions (with the exception of heart disease) were significantly greater than the sum of the odds of the single conditions. The evidence for synergy was model dependent: it was observed in the additive interaction models but not in models assessing multiplicative interactions. Mental disorders were more likely to be associated with severe disability than were the chronic physical conditions.
This first cross-national study of the joint effect of mental and physical conditions on the probability of severe disability finds that co-morbidity exerts modest synergistic effects. Clinicians need to accord both mental and physical conditions equal priority, in order for co-morbidity to be adequately managed and disability reduced.
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