The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.

Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.

Avaliação da efetividade das tecnologias de terapia nutricional enteral / Evaluation of the effectiveness of enteral nutritional therapy technologies

Tecnologias como cateter nasoentérico, equipo de infusão, bomba infusora e dieta enteral são constantemente substituídas por novos produtos, ou por atualizações, sem que haja avaliação da efetividade das mesmas. O objetivo principal desta pesquisa é delinear o cenário em que a incorporação e utilização das tecnologias de Terapia Nutricional Enteral (TNE) acontece em um hospital geral de grande porte, no Município do Rio de Janeiro. Atualmente, elas são avaliadas na fase de incorporação, de forma superficial, e na fase de utilização, somente em caso de intercorrências, quando é feita a crítica de material, negativa ao produto. A pesquisa foi realizada de setembro a dezembro de 2009, no Hospital Federal do Andaraí (HFA). Responderam à pesquisa, quarenta e três enfermeiros de setores com Terapia Nutricional Enteral (TNE), sete nutricionistas da Comissão de Avaliação e Suporte Nutricional Enteral e Parenteral (CASNEP), e quatro Chefias de Serviços, envolvidas com a incorporação dessas tecnologias. Os profissionais entrevistados confirmaram a pouca influência de suas opiniões técnicas na aquisição e interrupção do uso dessas tecnologias, mas acreditam na importância do monitoramento das mesmas. As entrevistas, com questionários semi-estruturados possibilitaram a identificação do fluxo de incorporação existente, que não é padronizado para todas as tecnologias. Foi proposta a inserção de um impresso, criado a partir dos resultados da pesquisa, como ferramenta de avaliação da efetividade das tecnologias de TNE. O instrumento deverá ser introduzido no fluxo de incorporação e difusão destas tecnologias. A utilização da gestão participativa na avaliação da efetividade das tecnologias utilizadas em TNE, por sistema fechado no HFA, será fundamental na normatização do atendimento ao paciente com desnutrição protéico-calórica, assistido pela CASNEP, e poderá servir como modelo para outras comissões multidisciplinares assistenciais.

Technologies such nasoenteric catheter, infusion set and pump and enteral nutrition formulas are constantly replaced by new products or updates without evaluation of their effectiveness. They are currently assessed superficially at the incorporation phase, only in case of complications, through criticism of negative material to product. The use ofparticipatory management in evaluating the effectiveness of advanced nutrition through a closed system in the Andaraí Federal Hospital (an important hospital in Rio de Janeiro), where this research happened, is fundamental to the standardization of care for patients withprotein-energy malnutrition. Nurses of the sectors responsible for 90% of enteral nutritional support in addition to dietitians of the enteral nutrition team (CASNEP) and service managersinvolved in the incorporation and diffusion responded to the survey. The professionals confirmed the low influence of their expert opinions on the acquisition and cessation of use oftechnologies in Enteral Nutrition Therapy. (ENT), but they believe in the importance of their monitoration. Now, we will create a form for evaluating the effectiveness of the technologies to be introduced in the flow of incorporation and use. Although they represent a vision of a group of professionals, the results can improve the quality of enteral nutrition therapy inside a closed system, and may serve as a mirror for the management of other technologies used by the multidisciplinary team care.

[The concept of "evidence-based medicine" in psychiatry. A path to a more rational psychiatry?]. / Das Konzept der "Evidence-based Medicine" in der Psychiatrie. Ein Weg zu einer rationaleren Psychiatrie?

Many of the diagnostic and therapeutic procedures in psychiatry and psychotherapy are based on opinion rather than evidence. The concept of evidence-based medicine aims to bridge the gap between clinical research and clinical decision-making by integrating the best available external evidence with personal expertise. In this article, we demonstrate several examples of the non-evidence-based medicine paradigm. Then we show the usefulness and practicability of the new evidence-based medicine paradigm by using a clinical example. Finally, we discuss the consequences, chances, and limitations of this new model. We also examine the role of the individual clinician's viewpoint as well as the need of institutional re-engineering and the possible restructuring of the entire health care system towards evidence-based methods.

Health care's quality improvement imperative.

In health care, as quality improves, costs tend to decline. The goals of excellent care and affordable costs are not mutually exclusive. Borrowing quality improvement techniques from manufacturing industries, physicians and other health care professionals are achieving breakthroughs in improving the quality and reducing the cost of care. Quality improvement continues the tradition of scientific inquiry in medicine and places new emphasis on accountability to the customers of health care: patients and payers. By examining processes, clinicians look at the delivery of care across different treatment modalities and rely on the insights of employees involved at every stage of the processes. Intermountain Health Care is one American health care organization that has experienced significant success in improving quality and reducing cost through the use of quality improvement methods.