Objective – The assessment of outcome for any purpose is not undertaken routinely in European mental health services. This paper discusses the merits of using outcome data to inform the planning of mental health care for individual patients, and provides practical advice to support the implementation of this new approach to working. Method – The use of outcomes in North America and Europe is briefly reviewed. A conceptual basis is proposed for routine outcome assessment – the ongoing measurement and use of outcome data to inform decisions about whether to continue, change or curtail treatment. A cognitive psychology model is developed which indicates that the routine use of outcomes will improve mental health care. Perceived problems with routine outcome assessment are discussed, and principles for implementation are identified. Results – Outcomes are used mainly for generating local-level (rather than patient-level) data in North America, and rarely used in Europe. The use of outcome data routinely may facilitate reflective clinical practice, a model of decision-making which leads to a higher quality of clinical care than automated problem-solving. One issue relates to the use of standardised assessments designed for research purposes in clinical settings, and this is being addressed through the development of a new generation of outcome measures which are explicitly designed for clinical use. However, most clinicians remain unconvinced of the benefits of routine outcome assessment, and relevant research is currently underway across Europe which will address this concern. Scientific principles to maximise quality and pragmatic principles to maximise the chances of successful implementation are identified. Conclusions – The routine use of outcomes will become increasingly prominent in European mental health services. This provides clinicians with an opportunity to improve the quality of clinical care offered to patients.

Objective – This article critically reviews the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the conduct of clinical trials in psychiatry. The EMEA is a regulatory body which provides the institutions of the European Community with the best possible scientific advice on the quality, safety, and efficacy of medicinal products. Method – Systematic review of recommendations, guide-lines and official documents available in the EMEA web site. Results – Out of nearly 400 documents, we identified 4 documents on the conduct of clinical trials in specific psychiatric disorders and 5 on the use of placebo or active comparator in evaluating a new drug's efficacy and on methodological issues in establishing difference and equivalence of effect. The EMEA recommends clinical trials to detect a difference between the compound under investigation and placebo, and to assess at least non-inferiority against an active comparator. A placebo arm is intended to validate the study. The EMEA supports the use of placebo only when there is no serious risk for the patient. In schizophrenia, depression and bipolar disorder the Agency suggests that a three-arm study is the design of choice, to demonstrate superiority against placebo and a similar balance against an active comparator. Conclusions – Despite the many effective therapeutic options available for the pharmacological management of psychiatric disorders, the EMEA regulatory process still relies on the demonstration of efficacy in absolute terms, against a placebo. We discuss this position and put at issue the possibility of developing a new generation of trials to demonstrate superiority of effect of new compounds over reference ones.

Objective – Description of the opinions about causes and psychosocial consequences of schizophrenia in a sample of psychiatric professionals, recruited in 29 Italian Mental Health Centres (MHC). Design – Each professional was asked to read a case-vignette describing a patient who met the ICD-10 criteria for schizophrenia. Referring to case-vignette, he/she was asked to fill the Questionnaire on the Opinions about Mental Illness – Professionals' version (QO-P). Professionals' opinions were explored in relation to: a) their socio-demographic variables and professional background; b) geographic location of the MHC. Setting – 29 MHC stratified by geographic area (Northern, Central, Southern Italy) and population density of their catchment areas (> 100000 inhabitants; between 100000 and 25000 inhabitants; < 25000 inhabitants) and randomly selected. Results – Data on 465 professionals were collected. 75% of the sample identified in the vignette a case of schizophrenia, 22% of depression/anxiety disorder. Factors most frequently mentioned as causes of the detected disorder were heredity (68%), stress (61%), family difficulties (46%). More pessimistic opinions about psychosocial consequences of schizophrenia were found among nurses and among professionals of Southern Italy, among those with lower educational level, older age and among those working longer in psychiatry. No statistical difference in the opinions about psychosocial consequences of schizophrenia was found among staff who referred the case-vignette to schizophrenia and those who did not. Conclusions – The results of this study outline the need to: a) include issues such as disability and psychosocial consequences of mental disorders in the basic training of professionals; b) increase the number of professionals trained in evidence-based psychosocial interventions.

Objective – Many different factors, both related to the individual and illness (“intrinsic” factors) and to the environment (“extrinsic” factors), contribute in different ways to the development of disability. Basing on data of literature, this review focuses the main “intrinsic” factors predicting disability in schizophrenia. Method – A systematic search on Mediline of all papers published during the period 1965-2001 was performed, using “schizophrenia”, “outcome”, “psychosocial outcome”, “social disability” and “social adjustment” as key words. Only papers reporting specifically data about predictive factors and psychosocial outcome variables were considered; prospective follow-up studies were considered, but retrospective and cross-sectional studies were also taken into account when data deriving from prospective studies were inconsistent. Results – Male sex predicts a higher disability among demographic factors; lower social and occupational adjustment are premorbid personality factors associated with higher disability; among factors related to illness, younger age at onset of illess, “nuclear”, “non paranoid” and in particular “deficit” forms of schizophrenia seem to predict more disability. The latter seems to be predicted also by higher levels of negative symptoms and neuropsychological deficits ; the role of depressive symptoms seems to be less supported by follow-up data; a continuous course of the illness predicts more disability, although some evidences show a progressive reduction of disability, at least in the long term. Conclusions – Disability shows a largely autonomous course respect to symptoms and has to be considered an independent parameter of outcome. Few intrinsic factors show a predictive role also in the long term.