BackgroundWith the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research.MethodsWe conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model.ResultsFive studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians.ConclusionOur study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

Systematic reviews and meta-analyses constitute one of the central pillars of evidence-based medicine. However, clinical trials are poorly reported which delays meta-analyses and consequently the translation of clinical research findings to clinical practice. We propose a Center of Excellence in Research Reporting in Neurosurgery (CERR-N) and the creation of a clinically significant computational ontology to encode Randomized Controlled Trials (RCT) studies in neurosurgery. A 128 element strong computational ontology was derived from the Trial Bank ontology by omitting classes which were not required to perform meta-analysis. Three researchers from our team tagged five randomly selected RCT's each, published in the last 5 years (2004-2008), in the Journal of Neurosurgery (JoN), Neurosurgery Journal (NJ) and Journal of Neurotrauma (JoNT). We evaluated inter and intra observer reliability for the ontology using percent agreement and kappa coefficient. The inter-observer agreement was 76.4%, 75.97% and 74.9% and intra-observer agreement was 89.8%, 80.8% and 86.56% for JoN, NJ and JoNT respectively. The inter-observer kappa coefficient was 0.60, 0.54 and 0.53 and the intra-observer kappa coefficient was 0.79, 0.82 and 0.79 for JoN, NJ and JoNT journals respectively. The high degree of inter and intra-observer agreement confirms tagging consistency in sections of a given scientific manuscript. Standardizing reporting for neurosurgery articles can be reliably achieved through the integration of a computational ontology within the context of a CERR-N. This approach holds potential for the overall improvement in the quality of reporting of RCTs in neurosurgery, ultimately streamlining the translation of clinical research findings to improvement in patient care.

Background: Telemental Health Care has reported very good results and is included within mental health priorities by the World Health Organization. Objective: To provide an overview of the current situation of the integration of Brazilian telemedicine activities into primary health care. Methods: Critical review based on MEDLINE database, using the keywords "telemedicine", "primary health care" "mental health" and "telemental health", on websites of the Brazilian Ministry of Health and Brazilian Telehealth Network Program, and on personal communication. Results: The Brazilian Telehealth Network Program is well positioned and connects primary health care with academic centers. Regulations standards allow a broader scope of activities for psychologists, however, are more restrictive for physicians. In Brazil most of telemental health activities are focused on education and second opinion consulting. A huge challenge must be overcome considering the regional differences and the telehealth implementation experience. Research initiatives have been initiated both in the implementation and evaluation of the mental health assistance into primary health care. Discussion: Brazilian Telemental Health initiatives into Primary Care are aligned with other examples around the world, have a great potential for improving mental health care service delivery, and access to proper mental health care, especially if articulated in a national program and coordinated research.

BackgroundThe inherent complexity of statistical methods and clinical phenomena compel researchers with diverse domains of expertise to work in interdisciplinary teams, where none of them have a complete knowledge in their counterpart's field. As a result, knowledge exchange may often be characterized by miscommunication leading to misinterpretation, ultimately resulting in errors in research and even clinical practice. Though communication has a central role in interdisciplinary collaboration and since miscommunication can have a negative impact on research processes, to the best of our knowledge, no study has yet explored how data analysis specialists and clinical researchers communicate over time.Methods/Principal FindingsWe conducted qualitative analysis of encounters between clinical researchers and data analysis specialists (epidemiologist, clinical epidemiologist, and data mining specialist). These encounters were recorded and systematically analyzed using a grounded theory methodology for extraction of emerging themes, followed by data triangulation and analysis of negative cases for validation. A policy analysis was then performed using a system dynamics methodology looking for potential interventions to improve this process. Four major emerging themes were found. Definitions using lay language were frequently employed as a way to bridge the language gap between the specialties. Thought experiments presented a series of “what if” situations that helped clarify how the method or information from the other field would behave, if exposed to alternative situations, ultimately aiding in explaining their main objective. Metaphors and analogies were used to translate concepts across fields, from the unfamiliar to the familiar. Prolepsis was used to anticipate study outcomes, thus helping specialists understand the current context based on an understanding of their final goal.Conclusion/SignificanceThe communication between clinical researchers and data analysis specialists presents multiple challenges that can lead to errors.

BackgroundThe interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective.Questions/purposesTo the best of our knowledge, no previous studies have developed standards that allow for the comparison of workflow models derived from clinical and research tasks toward the improvement of data collection processesMethodsIn this study we used the term dissonance for the occurrences where there was a discord between clinical and research workflows. We developed workflow models for a translational research study in psychiatry and the clinic where its data collection was carried out. After identifying points of dissonance between clinical and research models we derived a corresponding classification system that ultimately enabled us to re-engineer the data collection workflow. We considered (1) the number of patients approached for enrollment and (2) the number of patients enrolled in the study as indicators of efficiency in research workflow. We also recorded the number of dissonances before and after the workflow modification.ResultsWe identified 22 episodes of dissonance across 6 dissonance categories: actor, communication, information, artifact, time, and space. We were able to eliminate 18 episodes of dissonance and increase the number of patients approached and enrolled in research study trough workflow modification.ConclusionThe classification developed in this study is useful for guiding the identification of dissonances and reveal modifications required to align the workflow of data collection and the clinical setting. The methodology described in this study can be used by researchers to standardize data collection process.