Researchers conducted an observational study to determine the effectiveness of various antipsychotic treatment strategies for schizophrenia. They found that injectable antipsychotics and clozapine were the most effective treatments.
Large scale randomized clinical trials are considered the gold standard in clinical research because they ensure that all variables are accounted for and there are no biases inherent to the methodology. Unfortunately, randomized clinical trials are simply not possible or appropriate with some patient populations and research questions. The authors of this study have recognized that, due to the very nature of schizophrenia, randomized control trials may not be the most effective way of comparing treatment strategies.
To ensure statistical validity every randomized clinical trial will have “exclusion criteria” to identify participants who cannot be included in the clinical trial for a scientific reason. For example, a study on the effects of a reading strategy on dyslexia may choose to exclude children who also have other diagnosed learning disorders, or children who have already tried that particular strategy.
Randomized control trials of psychiatric patients generally exclude participants who are unwilling to participate, taking other prescription or non-prescription medications or street drugs, or have a history of not reliably taking their medication. In fact, up to 80% -90% of schizophrenic patients can be excluded from a trial due to refusal, substance abuse, suicidal or antisocial behavior, or mental or physical comorbidity (having another physical or mental health illness in addition to schizophrenia). In addition, up to 50% of the study participants will drop out of the study before completion, resulting in missing data. Unfortunately, the result is that the patients who are included in the studies are, in fact, not typical schizophrenic patients.
Even large scale…