917 resultados para Human Research Ethics Committee


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

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BACKGROUND: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied. METHODS: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications. RESULTS: 299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0-1151). CONCLUSIONS: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research.

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OBJECTIVES To identify factors associated with discrepant outcome reporting in randomized drug trials. STUDY DESIGN AND SETTING Cohort study of protocols submitted to a Swiss ethics committee 1988-1998: 227 protocols and amendments were compared with 333 matching articles published during 1990-2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes. RESULTS Overall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined. CONCLUSION Discrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.

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This study developed proxy measures to test the independent effects of medical specialty, institutional ethics committee (IEC) and the interaction between the two, upon a proxy for the dependent variable of the medical decision to withhold/withdraw care for the dying--the resuscitation index (R-index). Five clinical vignettes were constructed and validated to convey the realism and contextual factors implicit in the decision to withhold/withdraw care. A scale was developed to determine the range of contact by an IEC in terms of physician knowledge and use of IEC policy.^ This study was composed of a sample of 215 physicians in a teaching hospital in the Southwest where proxy measures were tested for two competing influences, medical specialty and IEC, which alternately oppose and support the decision to withhold/withdraw care for the dying. A sub-sample of surgeons supported the hypothesis that an IEC is influential in opposing the medical training imperative to prolong life.^ Those surgeons with a low IEC score were 326 percent more likely to continue care than were surgeons with a high IEC score when compared to all other specialties. IEC alone was also found to significantly predict the decision to withhold/withdraw care. Interaction of IEC with the specialty of surgery was found to be the best predictor for a decision to withhold/withdraw care for the dying. ^

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The objective was to understand the process of caring for a center for cancer treatment from the perspective of nurses and patients. This is a qualitative research, xploratory and descriptive, performed in a cancer treatment center in Natal / RN / Brazil. Data collection occurred between August 2013 and February 2014, being effected by means of two techniques: photographic record and projective interviews with nurses and patients. Social actors included in the study were ten professional nursing and ten patients admitted to the surgical department of the institution. The criteria used for inclusion of professionals were: be professional in the field of nursing, being an employee of the hospital, to be inserted in the scale of nurses of the institution at the time of data collection. For the patients were included who had preserved their cognitive abilities and who were hospitalized and at any stage of treatment. We used content analysis proposed by Bardin, for the analysis of material collected during projective interview. The research followed the ethical and legal principles that govern scientific research on human beings, being conducted by the project approval by the Research Ethics Committee of the Northern League Against Cancer Riograndense with 295 673 and look CAAE 16104313.0.0000.5293. Referring to nurses, they demonstrated different views about care, which sprouted from a holistic, multidisciplinary approach and welcoming, as well as linked to the performance of procedures and compliance with the requirements technicality. Furthermore, these subjects also showed that care unfolds through the actions of management in carrying out the records in the humanization of care by meeting the needs of the patient and ambience. Front of patients, it is noteworthy that, for them, care happens through attitudes of caring and professional approach, and by performing procedures, being mentioned as a careless lack of structure of the institution and the discomfort caused by this condition factors. It was evident also that the actors involved in the care, the perception of professionals and patients, are represented by nurses, doctors, psychologists, nutritionists, as well as kitchen assistants and cleaners; beyond family companion, the individual himself as responsible for their care and volunteer caregiver. In this opportunity, it is concluded 9 that an understanding of care from the perspective of nurses and patients involves broad issues ranging from perceptions of care that embraces a dynamic complex elements and attitudes imbued with meanings, in which those involved can assume both the role of carers as care beings, even a carefully tied to prescribed routines and performing procedures. Thus, the findings described refer to reflections on the care provided to cancer patients and whether this, in fact, translates principles of a humane practice

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The sizing of nursing human resources is an essential management tool to meet the needs of the patients and the institution. Regarding to the Intensive Care Unit, where the most critical patients are treated and the most advanced life-support equipments are used, requiring a high number of skilled workers, the use of specific indicators to measure the workload of the team becomes necessary. The Nursing Activities Score is a validated instrument for measuring nursing workload in the Intensive Care Unit that has demonstrated effectiveness. It is a cross-sectional study with the primary objective of assessing the workload of nursing staff in an adult Intensive Care Unit through the application of the Nursing Activities Score. The study was conducted in a private hospital specialized in the treatment of patients with cancer, which is located in the city of Natal (Rio Grande do Norte – Brazil). The study was approved by the Research Ethics Committee of the hospital (Protocol number 558.799; CAAE 24966013.7.0000.5293). For data collection, a form of sociodemographic characteristics of the patients was used; the Nursing Activities Score was used to identify the workload of nursing staff; and the instrument of Perroca, which classifies patients and provides data related to the their need for nursing care, was also used. The collected data were analyzed using a statistical package. The categorical variables were described by absolute and relative frequency, while the number by median and interquartile range. Considering the inferential approach, the Spearman test, the Wald chi-square, Kruskal Wallis and Mann-Whitney test were used. The statistically significant variables were those with p values <0.05. The evaluation of the overall averages of NAS, considering the first 15 days of hospitalization, was performed by the analysis of Generalized Estimating Equations (GEE), with adjust for the variable length of hospitalization. The sample consisted of 40 patients, in the period of June to August 2014. The results showed a mean age of 62,1 years (±23,4) with a female predominance (57,5%). The most frequent type of treatment was clinical (60,0%), observing an average stay of 6,9 days (±6,5). Considering the origin, most patients (35%) came from the Surgical Center. There was a mortality rate of 27,5%. 277 measures of NAS score and Perroca were performed, and the averages of 69,8% (±24,1) and 22,7% (±4.2) were obtained, respectively. There was an association between clinical outcome and value of the Nursing Activities Score in 24 hours (p <0.001), and between the degree of dependency of patients and nursing workload (rp 0,653, p<0,001). The achieved workload of the nursing staff, in the analyzed period, was presented high, showing that hospitalized patients required a high demand for care. These findings create subsidies for sizing of staff and allocation of human resources in the sector, in order to achieve greater safety and patient satisfaction as a result of intensive care, as well as an environment conducive to quality of life for the professionals

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This study aimed to evaluate the work of professionals to care for families in Psychosocial Care Centers ( C APS) of Rio Grande do Norte ( RN), from the roles and functions performed by these professional services. For this, it was pointed out the following objectives: To describe the profile and the activities conducted by mental health teams in the RN CAPS ; Know the opinion of professionals in the mental health teams of the poli ti c , practices and training in mental health; Check the suitability of the roles and functions of professionals working in the RN CAPS in relation to care for families . This is an analytic al cross - sectional study of quantitative and qualitative approach . Data were c ollected through a questionnaire in 33 CAPS RN, between March and October 2014 , after being approved by the Research Ethics Committee / UFRN , opinion nº217.808 , CAAE : 10650612.8. 1001.5537 , on March 1 2013. T he sample was adopted , defined by inclusion and exclusion criteria , and is composed of 183 professionals. The database preparation followed two steps: 1. Preparation and processing of data of closed questions of the questionnai re concerning the characterization and practices in mental health research subjects through informational resource Statistical Package for Social Scienses (SPSS) Statistics version 20.0 ; 2. To check the significance level was chosen by applying the chi - squ are test. Preparation and treatment of the corpus formed by the answers to open questions relating to the policies, practices and training in psychiatry through Analyse lexicale pair Contexte software d' un Ensemble of Segments of Texte ( ALCESTE) together a nd categorized by content analysis technique , Bardin (2004) . The data analysis is supported in the literature . It m ade explicit the results through three articles waxing the following results. In the first, participants profile was characterized by a predo minance of females (76.5 %), aged 40 - 58 years ( 61.7 %). They work between 30 and 40 hours per week (63.5 %), working in mental health for over 10 years ( 98.4%). The sample directs the care of family groups ( 65.7%), predominantly the care team of social worke rs, nurses, psychologists and occupational therapists . The doctor performs emergency care without interaction with the staff (48.6%) . On the difficulties encountered in services are ranked in : materials and supplies ( 75.1%), financial ( 78.5%) and structura l ( 66.9%). The second article contains qualitative data organized into five categories : Promoting the rehabilitation of users of CAPS ; Needs training ; Conflicts and satisfactions of teamwork ; Practices developed in CAPS ; Effective difficulties of Mental He alth Policy . The third article highlights the inadequacy of care for families ( 93.4%) and comparing the care families and groups in CAPS both types show to be inadequate : family ( 92.63%), groups ( 92, 60%). The main data obtained reveal the urgent need for transformation in psychosocial care . It shows also the importance of investments in inputs, physical structure and training of human resources for the CAPS.