Diego Novick

The Clinical Global Impression-Schizophrenia scale: a simple instrument to measure the diversity of symptoms present in schizophrenia.

Objective:  To describe the development and validation of the Clinical Global Impression–Schizophrenia (CGI‐SCH) scale, designed to assess positive, negative, depressive and cognitive symptoms in schizophrenia.

Predictors and clinical consequences of non-adherence with antipsychotic medication in the outpatient treatment of schizophrenia

To assess baseline predictors and consequences of antipsychotic adherence during the long-term treatment of schizophrenia outpatients, data were taken from the 3-year, prospective, observational, European Schizophrenia Outpatients Health Outcomes (SOHO) study, in which outpatients starting or changing antipsychotics were assessed every 6 months. Physician-rated adherence was dichotomized as adherence/non-adherence. Regression models tested for predictors of adherence during follow-up, and associations between adherence and outcome measures. Of the 6731 patients analysed, 71.2% were adherent and 28.8% were non-adherent over 3 years. The strongest predictor of adherence was adherence in the month before baseline assessment. Other baseline predictors of adherence included initial treatment for schizophrenia and greater social activities. Baseline predictors of non-adherence were alcohol dependence and substance abuse in the previous month, hospitalization in the previous 6 months, independent housing and the presence of hostility. Non-adherence was significantly associated with an increased risk of relapse, hospitalization and suicide attempts. In conclusion, non-adherence is common but can partly be predicted. This may allow strategies to improve adherence to be targeted to high-risk patients. Also, reversal of some risk factors may improve adherence. Non-adherence is associated with a range of poorer long-term outcomes, with clinical and economic implications.

Rates and predictors of remission and recovery during 3 years in 392 never-treated patients with schizophrenia

Objective:  Few studies have prospectively examined remission and recovery as well as their predictors in schizophrenia simultaneously. Aims of the study were to identify remission and recovery rates as well as their predictors in schizophrenia.

Remission and relapse in the outpatient care of schizophrenia: three-year results from the Schizophrenia Outpatient Health Outcomes study.

Remission and relapse are clinical outcomes of increasing interest in schizophrenia. We analyzed remission and relapse, and the sociodemographic and clinical factors associated with these outcomes, in the usual care of schizophrenia using the 3-year, follow-up data from a large cohort of outpatients with schizophrenia taking part in the prospective, observational, European Schizophrenia Outpatient Health Outcomes study. Of the 6516 patients analyzed for remission, 4206 (64.6%) achieved remission during the 3-year, follow-up period. Logistic regression analysis revealed that being female, having a good level of social functioning at study entry, and a shorter duration of illness were factors significantly associated with achieving remission. Treatment with olanzapine was also associated with a higher frequency of remission compared with other antipsychotic agents. A Kaplan-Meier survival curve estimated that relapse occurred in approximately 25% of the patients who achieved remission, with the risk of relapse remaining constant during the follow-up period. Shorter duration of illness, having hostile behaviors, and substance abuse were factors associated with a higher risk of relapse, whereas good level of social functioning and the use of olanzapine and clozapine were associated with a lower risk of relapse. In conclusion, the 3-year results of the Schizophrenia Outpatient Health Outcomes study indicate that the likelihood of remission decreases over the longitudinal course of schizophrenia, but risk of relapse is maintained even after 3 years of achieving remission severity levels. Results suggest that treatment with olanzapine is associated with a better chance of achieving remission than other antipsychotics. Moreover, the use of olanzapine and clozapine is associated with a lower risk of relapse compared with risperidone, quetiapine, and typical antipsychotics. The results should be interpreted conservatively because of the observational, nonrandomized study design.

Three-year antipsychotic effectiveness in the outpatient care of schizophrenia: observational versus randomized studies results.

Antipsychotic discontinuation rates are a powerful indicator of medication effectiveness in schizophrenia. We examined antipsychotic discontinuation in the Schizophrenia Outpatient Health Outcomes (SOHO) study, a 3-year prospective, observational study in outpatients with schizophrenia in 10 European countries. Patients (n=7728) who started antipsychotic monotherapy were analyzed. Medication discontinuation for any cause ranged from 34% and 36% for clozapine and olanzapine, respectively, to 66% for quetiapine. Compared to olanzapine, the risk of treatment discontinuation before 36 months was significantly higher for quetiapine, risperidone, amisulpride, and typical antipsychotics (oral and depot), but similar for clozapine. Longer medication maintenance was associated with being socially active and having a longer time since first treatment contact for schizophrenia, whereas higher symptom severity, treatment with mood stabilizers, substance abuse, having hostile behaviour were associated with lower medication maintenance. Antipsychotic maintenance in SOHO was higher than the results of previous randomized studies.

Recovery in the outpatient setting: 36-month results from the Schizophrenia Outpatients Health Outcomes (SOHO) study.

Recovery is an important outcome of schizophrenia that has not been well defined or researched. Using a stringent definition of recovery that included long-lasting symptomatic and functional remission as well as an adequate quality of life for a minimum of 24 months and until the 36-month visit, we determined the frequency and predictors of recovery in patients with schizophrenia during 3 years of antipsychotic treatment in the prospective, observational Schizophrenia Outpatients Health Outcomes (SOHO) study. Of the 6642 patients analysed, 33% achieved long-lasting symptomatic remission, 13% long-lasting functional remission, 27% long-lasting adequate quality of life, and 4% achieved recovery during the 3 year follow-up period. Logistic regression analysis revealed that social functioning at study entry (having good occupational/vocational status, living independently and being socially active) and adherence with medication were factors significantly associated with achieving recovery. Higher negative symptom severity, higher BMI and lack of effectiveness as the reason for change of medication at baseline were baseline factors associated with a lower likelihood of achieving recovery. Treatment with olanzapine was also associated with a higher frequency of recovery compared with risperidone, quetiapine, typical antipsychotics (oral, depot) and patients taking two or more antipsychotic medications. There were no differences among the patients taking olanzapine, clozapine and amisulpride. Predictors of long-lasting symptomatic remission, functional remission and adequate quality of life were also independently analysed. Although the results should be interpreted conservatively due to the observational, non-randomised study design, they indicate that only a small proportion of patients with schizophrenia achieve recovery and suggest that social functioning, medication adherence and type of antipsychotic are important predictors of recovery.

Effectiveness of antipsychotic treatment for schizophrenia: 6-Month results of the Pan-European Schizophrenia Outpatient Health Outcomes (SOHO) study

Objective:  To present the 6‐month outcomes associated with antipsychotic treatment of patients participating in the Schizophrenia Outpatient Health Outcomes (SOHO) study.

Costs associated with treatment of chronic low back pain: an analysis of the UK General Practice Research Database.

Study Design. Retrospective cohort study of health care costs associated with the treatment of chronic low back pain (CLBP) in the United Kingdom. Objective. To assess 12-month health care costs associated with the treatment of CLBP, using the UK General Practice Research Database. Summary of Background Data. CLBP is a common health problem. Methods. Data were obtained from the General Practice Research Database, a computerized database of UK primary care patient data. Patients with CLBP were identified for the study period (January 1, 2007, to December 31, 2009) using diagnostic records and pain relief prescriptions (n = 64,167), and 1:1 matched to patients without CLBP (n = 52,986) on the basis of age, sex, and general practitioners practice. Index date was defined as the first date of CLBP record; the same index date was assigned to matched controls. Multivariate analyses were performed to compare resource use costs (2009 values) in the 12 months after the index date between patients with and without CLBP. A sensitivity analysis was carried out with a more stringent definition for the control group by excluding a broad range of pain conditions. Results. Total health care costs for patients with CLBP were double those of the matched controls (£1074 vs. £516; P < 0.05). Of the cost difference, 58.8% was accounted for by general practitioners consultations, 22.3% by referrals to secondary care, and the rest by pain relief medications. The sensitivity analysis revealed an even greater cost difference between the 2 groups (£1052 vs. £304; P < 0.05). Because of the use of a retrospective administrative claims database, this study is subject to selection bias between study cohorts, misidentification of comorbidities, and an inability to confirm adherence to therapy or assess indirect costs and costs of over-the-counter medications. Conclusion. Our findings confirm the substantial economic burden of CLBP, even with direct costs only.

Olanzapine vs. other antipsychotics in actual out‐patient settings: six months tolerability results from the European Schizophrenia Out‐patient Health Outcomes study

Objective:  The European Schizophrenia Out‐patient Health Outcomes study is an observational study investigating treatment in schizophrenia. We report treatment‐emergent adverse events during the first 6 months of treatment.

Pharmacological treatment and other predictors of treatment outcomes in previously untreated patients with schizophrenia: results from the European Schizophrenia Outpatient Health Outcomes (SOHO) study.

The present study aimed to compare health outcomes and tolerability according to antipsychotic medication (olanzapine, risperidone or an oral typical antipsychotic) after 6 months of treatment in a group of 919 schizophrenic patients who had never previously been treated with antipsychotics. Demographic and clinical predictors of outcome were also identified. Data were extracted from the Schizophrenia Outpatient Health Outcomes (SOHO) study, a prospective, observational study of schizophrenia treatment in 10 European countries. Patients who initiated olanzapine were more likely to have a clinical response than those in the risperidone cohort, and had a greater improvement in quality of life than patients in the risperidone or typical antipsychotic cohorts. High negative and depression symptom scores at baseline and the presence of extrapyramidal symptoms at baseline predicted a worse clinical response, whereas hostile behaviour, paid employment and substance abuse predicted a better clinical outcome. The olanzapine cohort gained more weight than patients in the risperidone cohort, but no significant difference in weight gain was observed between olanzapine and the oral typical antipsychotic cohort. The results should be interpreted conservatively due to the observational study design.