The case for practical clinical trials in psychiatry
ABSTRACT Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians, or, stated differently, available evidence is not perceived by clinicians (and other decision makers) as sufficiently relevant to clinical practice, thereby diluting its impact. To attain maximum clinical relevance and acceptability, researchers must conduct clinical trials designed to meet the needs of clinicians and others who are making decisions about patients' care. The authors present the case for psychiatry's adoption of the practical clinical trials model, which is widely used in research in other areas of medicine.
The authors outline the characteristics and scope of practical clinical trials, give examples of practical clinical trials, and discuss the challenges of using the practical clinical trials model in psychiatry, including issues of funding.
Practical clinical trials, which are intended to provide generalizable answers to important clinical questions without bias, are characterized by eight key features: a straightforward clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest clinically relevant effects, randomization to protect against bias, clinical uncertainty regarding the outcome of treatment at the patient level, assessment and treatment protocols that enact best clinical practices, simple and clinically relevant outcomes, and limited subject and investigator burden.
To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus methodological innovation in governance and trial selection, assessment, treatment, data management, site management, and data analytic procedures.
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ABSTRACT: Clotiapine is a classic neuroleptic with a chemical structure similar to clozapine. It was said that patients unresponsive to other neuroleptics respond to clotiapine although it causes extrapyramidal syndromes (EPS) like other typical neuroleptics. We conducted a study of clotiapine vs. chlorpromazine in severe chronic active psychotic hospitalized schizophrenia patients. The design was double-blind crossover of clotiapine vs chlorpromazine. No washout was necessary from previous neuroleptic treatment, and flexible overlap with the study medication was individualized for each patient. Patients were treated after reaching neuroleptic monotherapy for 3 months with clotiapine and 3 months with chlorpromazine, in random order. Medication was supplied in identical capsules of 100 mg chlorpromazine or 40 mg of clotiapine. Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI) were rated every 2 weeks and Nurse's Observation Scale for Inpatient Evaluation (NOSIE) every month. Fifty-eight patients were randomized. Forty-three patients completed at least one phase of the study, and thirty-three completed both phases. Because of the small number of hostel patients and the very high dropout rate in the hostel patients, data analysis was done separately for inpatients and hostel patients. Clotiapine was significantly superior to chlorpromazine in 26 inpatients completing the crossover, on the PANSS, NOSIE and CGI. Clotiapine was also superior to chlorpromazine in an analysis of the parallel inpatient groups in the first three months before the crossover. Some classic neuroleptic compounds may have superiority to chlorpromazine in a "clozapine-like" manner, despite a typical profile for EPS.Schizophrenia Research 01/2006; 80(2-3):343-7. DOI:10.1016/j.schres.2005.07.007 · 4.43 Impact Factor
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ABSTRACT: To date only a few studies investigated the clinical reasons supporting and explaining non-classical antipsychotic prescriptions. The present study was carried out to develop concepts which help understand this phenomenon in a natural setting, giving emphasis to views of clinicians according to quali - quantitative research methodologies. From the South-Verona Psychiatric Case Register all antipsychotic prescriptions issued during 2005 were extracted. Concurrent prescribing of two or more antipsychotics, prescribing antipsychotic drugs outside the licensed indications, and outside the licensed ranges of doses reported in the Italian National Formulary, were considered non-classical prescriptions. Reasons for non-classical prescriptions were collected by means of brainstorming sessions with clinicians. Non-classical prescriptions and the corresponding reasons were grouped according to whether they were "clinically sound" or "clinically not sound". During 2005 a total of 259 patients received 376 non-classical prescriptions. The most frequently reported reasons for non-classical prescribing were that prescriptions were inherited from another clinician with or without benefit, and that prescriptions were motivated by the need of reducing psychotic symptoms. More than 60% of these non-classical prescriptions were categorised as "clinically sound". Clinically not sound prescriptions were related with negative clinicians' views and opinions about the patient/clinician relationship. Clinically not sound prescriptions appeared just a reflection of a problematic doctor/patient relationship, where no individual treatment plan existed and psychiatric visits had the only goal of monitoring ongoing prescriptions.Epidemiologia e psichiatria sociale 09/2008; 17(3):236-41. DOI:10.1017/S1121189X00001330 · 3.16 Impact Factor
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ABSTRACT: At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.Psychological Medicine 06/2014; 45(02):1-6. DOI:10.1017/S0033291714001275 · 5.43 Impact Factor