What are evidence-based treatment recommendations?
ABSTRACT In recent years new methodologies for developing treatment recommendations that give consideration to evidence, values, preferences and feasibility issues have been developed. One of the most well-developed approaches is the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. This article briefly presents how this methodology may be employed to develop treatment recommendations that might constitute a permanent infrastructure between primary research and everyday clinical practice.
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ABSTRACT: INTRODUCTION: In recent years the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology has often been used by international or national health authorities, or scientific societies, for developing evidence-based treatment recommendations. However, the GRADE approach has never been used by practicing physicians who aim at harmonizing their prescribing behaviours paying due attention to the best available evidence. This paper describes the experience of a working group of psychiatrists who adopted the GRADE approach to develop clinical recommendations on the use of psychotropic drugs in specialist mental healthcare.Case description: The project was conducted in the Department of Mental Health of Verona, Italy, a city located in the north of Italy. At the beginning of 2012, psychiatrists with a specific interest in the rational use of psychotropic drugs were identified and appointed as members of a Guideline Development Group (GDG). The first task of the GDG was the identification of controversial areas in the use of psychotropic drugs, the definition of scoping questions, and the identification of outcomes of interest. The GDG was supported by a scientific secretariat, who searched the evidence, identified one or more systematic reviews matching the scoping questions, and drafted GRADE tables.Discussion and evaluation: On the basis of efficacy, acceptability, tolerability and safety data, considering the risk of bias and confidence in estimates, and taking also into consideration preferences, values and practical aspects in favour and against the intervention under scrutiny, a draft recommendation with its strength was formulated and agreed by GDG members. Recommendations were submitted for consideration to all specialists of the Department, discussed in two plenary sessions open to the whole staff, and finally approved at the end of 2012. CONCLUSION: The present project of guideline development raised several challenging and innovating aspects, including a "bottom-up" approach, as it was motivated by reasons that found agreement among specialists, those who developed the recommendations were those who were supposed to follow them, and values, preferences and feasibility issues were considered paying due attention to local context variables.International Journal of Mental Health Systems 05/2013; 7(1):14. · 1.06 Impact Factor
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ABSTRACT: A new resolution on mental, neurological and substance use disorders was adopted in January 2012 by the World Health Organization (WHO) Executive Board. The resolution urges WHO and Member States to collaborate in the development of a comprehensive mental health action plan, to be submitted for discussion and approval to the WHO World Health Assembly. This commentary aims at rising awareness on the risk that this resolution may not fulfil its potential. Lack of political awareness and visibility of the resolution is a first major issue. Theoretically, Member States should be aware of the resolution and support its implementation at their respective national level, but in practice political commitment may not be high enough, and technical and financial resources made available may be limited. A second challenge is that the resolution suggests to work with Member States and technical agencies to promote academic exchange through which to contribute to policy-making in mental health. It is not straightforward, however, how such a statement may be effectively translated into action. A third key methodological aspect is how scientific evidence and factors other than scientific evidence will be handled. This seems particularly relevant in the field of mental health, where value-based decisions together with resource and feasibility considerations may be unavoidable. We argue that WHO and Member States should work together to increase the visibility of the resolution, ensuring that Ministries of Health and other relevant components of the health systems are aware of the resolution and its implications. As the resolution urges for academic exchange, WHO should develop a plan for an explicit, inclusive and open call for support and collaboration, so that partners willing to contribute are not kept out from the process. The production of an action plan for mental disorders should be based on scientifically sound methodology. Such a methodology should be transparently described, for example in a WHO process document, to make it clear how individual-level recommendations and policy-level guidance are developed. WHO should establish and maintain an open forum of experts, scientists, health officials and user groups worldwide to interact and agree on values, preferences, feasibility, acceptability, implementability, equity and economic issues that should inform the action plan.International Journal of Mental Health Systems 06/2012; 6(1):6. · 1.06 Impact Factor
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ABSTRACT: BACKGROUND: Long-term studies for patients with resistant schizophrenia are necessary to assess the effectiveness of combination strategies on persisting positive symptoms. AIMS AND METHODS: This multicenter, naturalistic, randomized, superiority study (ClinicalTrials.gov identifier: NCT00395915) aimed to compare clinical efficacy and tolerability of haloperidol versus aripiprazole as combination treatment with clozapine in patients with resistant schizophrenia. RESULTS: One hundred six patients were followed up for 12 months. After 12 months, the proportion of patients who discontinued treatment was not significantly different between aripiprazole and haloperidol (37% vs 28%, respectively; P = 0.431). The change in the Brief Psychiatric Rating Scale score was similar in the aripiprazole and haloperidol groups (-7.0 vs -7.9, respectively; P = 0.389), whereas the tolerability total score decreased significantly more in the aripiprazole group (-7.2 vs -2.3; P = 0.008). CONCLUSIONS: While the effectiveness of clozapine augmentation with a second antipsychotic agent is not clearly demonstrated yet, results from this study suggest that augmentation with aripiprazole offers no substantial benefit over haloperidol in efficacy. Aripiprazole was perceived more tolerable than haloperidol, but it is uncertain how this finding may translate into the real world of clinical practice.Journal of clinical psychopharmacology 06/2013; · 5.09 Impact Factor