Construction of ethics in clinical research - Clinical trials registration

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

A clinical decision support system for cancer diseases

The second main cause of death in Brazil is cancer, and according to statistics disclosed by National Cancer Institute from Brazil (INCA) 466,730 new cases of cancer are forecast for 2008. The analysis of tumour tissues of various types and patients' clinical data, genetic profiles, characteristics of diseases and epidemiological data may lead to more precise diagnoses, providing more effective treatments. In this work we present a clinical decision support system for cancer diseases, which manages a relational database containing information relating to the tumour tissue and their location in freezers, patients and medical forms. Furthermore, it is also discussed some problems encountered, as database integration and the adoption of a standard to describe topography and morphology. It is also discussed the dynamic report generation functionality, that shows data in table and graph format, according to the user's configuration. © ACM 2008.

A medical information system to manage a cancer database

Cancer is the second main cause of death in Brazil, and according to statistics disclosed by INCA - National Cancer Institute 466,730 new cases of the disease are forecast for 2008. The storage and analysis of tumour tissues of various types and patients' clinical data, genetic profiles, characteristics of diseases and epidemiological data may provide more precise diagnoses, providing more effective treatments with higher chances for the cure of cancer. In this paper we present a Web system with a client-server architecture, which manages a relational database containing all information relating to the tumour tissue and their location in freezers, patients, medical forms, physicians, users, and others. Furthermore, it is also discussed the software engineering used to developing the system.

Mild cognitive impairment (part 1): Clinical characteristics and predictors of dementia

Objective: To critically review and evaluate existing knowledge on the conceptual limits and clinical usefulness of the diagnosis of mild cognitive impairment (MCI) and the neuropsychological assessment and short- and long-term prognosis thereof. Methods: We conducted a systematic search of the PubMed and Web of Science electronic databases, limited to articles published in English between 1999 and 2012. Based on the search terms mild cognitive impairment or MCI and epidemiology or diagnosis, we retrieved 1,698 articles, of which 248 were critically eligible (cross-sectional and longitudinal studies); the abstracts of the remaining 1,450 articles were also reviewed. Results: A critical review on the MCI construct is provided, including conceptual and diagnostic aspects; epidemiological relevance; clinical assessment; prognosis; and outcome. The distinct definitions of cognitive impairment, MCI included, yield clinically heterogeneous groups of individuals. Those who will eventually progress to dementia may present with symptoms consistent with the definition of MCI; conversely, individuals with MCI may remain stable or return to normal cognitive function. Conclusion: On clinical grounds, the cross-sectional diagnosis of MCI has limited prognostic relevance. The characterization of persistent and/or progressive cognitive deficits over time is a better approach for identification of cases at the pre-dementia stages, particularly if these cognitive abnormalities are consistent with the natural history of incipient Alzheimer's disease. © 2013 Associação Brasileira de Psiquiatria.

Systematic reviews showed insufficient evidence for clinical practice in 2004: What about in 2011? the next appeal for the evidence-based medicine age

Rationale and aim The aims of the Cochrane systematic reviews are to make readily available and up-to-date information for clinical practice, offering consistent evidence and straightforward recommendations. In 2004, we evaluated the conclusions from Cochrane systematic reviews of randomized controlled trials in terms of their recommendations for clinical practice and found that 47.83% of them had insufficient evidence for use in clinical practice. We proposed to reanalyze the reviews to evaluate whether this percentage had significantly decreased. Methods A cross-sectional study of systematic reviews published in the Cochrane Library (Issue 7, 2011) was conducted. We randomly selected reviews across all 52 Cochrane Collaborative Review Groups. Results We analyzed 1128 completed systematic reviews. Of these, 45.30% concluded that the interventions studied were likely to be beneficial, of which only 2.04% recommended no further research. In total, 45.04% of the reviews reported that the evidence did not support either benefit or harm, of which 0.8% did not recommend further studies and 44.24% recommended additional studies; the latter has decreased from our previous study with a difference of 3.59%. Conclusion Only a small number of the Cochrane collaboration's systematic reviews support clinical interventions with no need for additional research. A larger number of high-quality randomized clinical trials are necessary to change the 'insufficient evidence' scenario for clinical practice illustrated by the Cochrane database. It is recommended that we should produce higher-quality primary studies in active collaboration and consultation with global scholars and societies so that this can represent a major component of methodological advance in this context. © 2012 John Wiley & Sons Ltd.

Testing search strategies for systematic reviews in the Medline literature database through PubMed

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)