Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability

Professional Decision-Making in Research (PDR): The validity of a new measure

In this paper, we report on the development and validity of the Professional Decision-Making in Research (PDR) measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability (alpha = .84) and parallel form correlation (r = .70). As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research

The demise of the randomised controlled trial: bibliometric study of the German-language health care literature, 1948 to 2004

BACKGROUND: In order to reduce systematic errors (such as language bias) and increase the precision of the summary treatment effect estimate, a comprehensive identification of randomised controlled trials (RCT), irrespective of publication language, is crucial in systematic reviews and meta-analyses. We identified trials in the German general health care literature. METHODS: Eight German language general health care journals were searched for randomised controlled trials and analysed with respect to the number of published RCTs each year and the size of trials. RESULTS: A total of 1618 trials were identified with a median total number of 43 patients per trial. Between 1970 and 2004 a small but constant rise in sample size from a median number of 30 to 60 patients per trial can be observed. The number of published trials was very low between 1948 and 1970, but increased between 1970 and 1986 to a maximum of 11.2 RCTs per journal and year. In the following time period a striking decline of the number of RCTs was observed. Between 1999 and 2001 only 0.8 RCTs per journal and year were published, in the next three years, the number of published trials increased to 1.7 RCTs per journal and year. CONCLUSION: German language general health care journals no longer have a role in the dissemination of trial results. The slight rise in the number of published RCTs in the last three years can be explained by a change of publication language from German to English of three of the analysed journals

Pré-tratamento de águas residuárias da suinocultura para aumentar a disponibilidade de fósforo e magnésio.

Este trabalho avaliou a influência da adição de ácido sulfúrico para o ajuste de pH e sua relação com a concentração de fósforo total (Ptotal), magnésio (Mg), Cálcio (Ca), amônia (NH3) e carbono orgânico total (COT) contido na água residuária proveniente da suinocultura

Conceptual knowledge for understanding other’s actions is organized primarily around action goals

Semantic knowledge about objects entails both knowing how to grasp an object (grip-related knowledge) and what to do with an object (goal-related knowledge). Considerable evidence suggests a hierarchical organization in which specific hand-grips in action execution are most often selected to accomplish a remote action goal. The present study aimed to investigate whether a comparable hierarchical organization of semantic knowledge applies to the recognition of other’s object-directed actions as well. Correctness of either the Grip (hand grip applied to the object) or the Goal (end-location at which an object was directed) were manipulated independently in two experiments. In Experiment 1, subjects were required to attend selectively to either the correctness of the grip or the goal of the observed action. Subjects were faster when attending to the goal of the action and a strong interference of goal-violations was observed when subjects attended to the grip of the action. Importantly, observation of irrelevant goal- or grip-related violations interfered with making decisions about the correctness of the relevant dimension only when the relevant dimension was correct. In contrast, in Experiment 2, when subjects attended to an action-irrelevant stimulus dimension (i.e. orientation of the object), no interference of goal- or grip-related violations was found, ruling out the possibility that interference-effects result from perceptual differences between stimuli. These findings suggest that understanding the correctness of an action selectively recruits specialized, but interacting networks, processing the correctness of goal- and grip-specific information during action observation