Randomized controlled trials in schizophrenia: a critical perspective on the literature

Abstract

Explanatory designs are a necessary but insufficient step in establishing the true worth of interventions in schizophrenia. Research from other spheres of mental health and wider health care suggest that pragmatic trials are feasible. This design allows large scale trials to be conducted which include patients which we would recognize from routine practice and which record outcomes which are of genuine interest to decision-makers.

The effects of antipsychotic treatment on quality of life of schizophrenic patients under naturalistic treatment conditions: An application of random effect regression models and propensity scores in an observational prospective trial

“…Moreover, the effects of antipsychotic treatment on quality of life have been examined mainly in randomised clinical trials. However, it has been argued by some authors that the results of RCTs can not be generalised to real world conditions in any case [14][15][16][17][18]. In psychiatric outpatient treatment it is particularly difficult to estimate how a clinically tested intervention works in everyday treatment due to a lack of standardised therapeutic guidelines and a high risk of patient non-compliance.…”

“…The difficulties increase when the outcome criteria are non-biological and subjective, as in the case of quality of life, because the responsiveness of these criteria often depends on complex interactions between the individual and the environment [19]. Longitudinal observational studies with less rigid control of entry criteria and assignment to treatment but with the inclusion of a great variety of individual and environmental covariates are therefore regarded by some researchers as more suitable to obtain effects of treatment on non-biological outcome variables under routine practice than RCT [15][16][17][18].…”

Avaliação neuropsicológica na esquizofrenia: revisão sistemática

“…Em uma revisão, Gilbody et al 3 identificaram a citação de 640 escalas psicométricas variando de complexidade e indicações. Segundo os autores, a maioria dessas escalas parece ter sido elaborada para a proposta do próprio estudo, sem a obtenção de validade e confiabilidade, sendo que um em cada três estudos havia elaborado uma nova escala não publicada previamente.…”

The Current View of Evidence and Evidence‐Based Practice

“…Such RCTs are conventionally larger than traditional tightly controlled RCTs, and the inclusion criteria are very broad such that they reflect the type of participant upon whom the intervention will eventually be used in the real world (involving co-morbidities -such as mixed depression and anxiety, or the presence of alcohol problems -both common exclusion criteria in traditional RCTs). Such RCTs are few and far between in psychological therapy, but have been successfully used in primary care mental health trials (Simon, Wagner & Von Korff, 1995), addressing the concerns that trials do not reflect real world practice or effectiveness (Gilbody, Wahlbeck & Adams, 2002b).…”