875 resultados para good clinical practice
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Prediction of psychosis in patients at clinical high risk (CHR) has become a mainstream focus of clinical and research interest worldwide. When using CHR instruments for clinical purposes, the predicted outcome is but only a probability; and, consequently, any therapeutic action following the assessment is based on probabilistic prognostic reasoning. Yet, probabilistic reasoning makes considerable demands on the clinicians. We provide here a scholarly practical guide summarising the key concepts to support clinicians with probabilistic prognostic reasoning in the CHR state. We review risk or cumulative incidence of psychosis in, person-time rate of psychosis, Kaplan-Meier estimates of psychosis risk, measures of prognostic accuracy, sensitivity and specificity in receiver operator characteristic curves, positive and negative predictive values, Bayes’ theorem, likelihood ratios, potentials and limits of real-life applications of prognostic probabilistic reasoning in the CHR state. Understanding basic measures used for prognostic probabilistic reasoning is a prerequisite for successfully implementing the early detection and prevention of psychosis in clinical practice. Future refinement of these measures for CHR patients may actually influence risk management, especially as regards initiating or withholding treatment.
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We read with great interest the large-scale network meta-analysis by Kowalewski et al. comparing clinical outcomes of patients undergoing coronary artery bypass grafting (CABG) operated on using minimal invasive extracorporeal circulation (MiECC) or off-pump (OPCAB) with those undergoing surgery on conventional cardiopulmonary bypass (CPB) [1]. The authors actually integrated into single study two recently published meta-analysis comparing MiECC and OPCAB with conventional CPB, respectively [2, 3] into a single study. According to the results of this study, MiECC and OPCAB are both strongly associated with improved perioperative outcomes following CABG when compared with CABG performed on conventional CPB. The authors conclude that MiECC may represent an attractive compromise between OPCAB and conventional CPB. After carefully reading the whole manuscript, it becomes evident that the role of MiECC is clearly undervalued. Detailed statistical analysis using the surface under the cumulative ranking probabilities indicated that MiECC represented the safer and more effective intervention regarding all-cause mortality and protection from myocardial infarction, cerebral stroke, postoperative atrial fibrillation and renal dysfunction when compared with OPCAB. Even though no significant statistical differences were demonstrated between MiECC and OPCAB, the superiority of MiECC is obvious by the hierarchy of treatments in the probability analysis, which ranked MiECC as the first treatment followed by OPCAB and conventional CPB. Thus, MiECC does not represent a compromise between OPCAB and conventional CPB, but an attractive dominant technique in CABG surgery. These results are consistent with the largest published meta-analysis by Anastasiadis et al. comparing MiECC versus conventional CPB including a total of 2770 patients. A significant decrease in mortality was observed when MiECC was used, which was also associated with reduced risk of postoperative myocardial infarction and neurological events [4]. Similarly, another recent meta-analysis by Benedetto et al. compared MiECC versus OPCAB and resulted in comparable outcomes between these two surgical techniques [5]. As stated in the text, superiority of MiECC observed in the current network meta-analysis, when compared with OPCAB, could be attributed to the fact that MiECC offers the potential for complete revascularization, whereas OPCAB poses a challenge for unexperienced surgeons; especially when distal marginal branches on the lateral and/or posterior wall of the heart need revascularization. This is reflected by a significantly lower number of distal anastomoses performed in OPCAB when compared with conventional CPB. Therefore, taking into consideration the literature published up to date, including the results of the current article, we advocate that MiECC should be integrated in the clinical practice guidelines as a state-of-the-art technique and become a standard practice for perfusion in coronary revascularization surgery.
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Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase of the off-label uses, a topic dealt with in another contribution to this special issue of Frontiers in Immunology. A part of the success is the adverse event (AE) profile of IgG concentrates which is, even at life-long need for therapy, excellent. Transmission of pathogens in the last decade could be entirely controlled through the antecedent introduction by authorities of a regulatory network and installing quality standards by the plasma fractionation industry. The cornerstone of the regulatory network is current good manufacturing practice. Non-infectious AEs occur rarely and mainly are mild to moderate. However, in recent times, the increase in frequency of hemolytic and thrombotic AEs raised worrying questions on the possible background for these AEs. Below, we review elements of non-infectious AEs, and particularly focus on hemolysis and thrombosis. We discuss how the introduction of plasma fractionation by ion-exchange chromatography and polishing by immunoaffinity chromatographic steps might alter repertoire of specificities and influence AE profiles and efficacy of IgG concentrates.
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AIM Depending on intensity, exercise may induce a strong hormonal and metabolic response, including acid-base imbalances and changes in microcirculation, potentially interfering with the accuracy of continuous glucose monitoring (CGM). The present study aimed at comparing the accuracy of the Dexcom G4 Platinum (DG4P) CGM during continuous moderate and intermittent high-intensity exercise (IHE) in adults with type 1 diabetes (T1DM). METHODS Ten male individuals with well-controlled T1DM (HbA1c 7.0±0.6% [54±6mmol/mol]) inserted the DG4P sensor 2 days prior to a 90min cycling session (50% VO2peak) either with (IHE) or without (CONT) a 10s all-out sprint every 10min. Venous blood samples for reference glucose measurement were drawn every 10min and euglycemia (target 7mmol/l) was maintained using an oral glucose solution. Additionally, lactate and venous blood gas variables were determined. RESULTS Mean reference blood glucose was 7.6±0.2mmol/l during IHE and 6.7±0.2mmol/l during CONT (p<0.001). IHE resulted in significantly higher levels of lactate (7.3±0.5mmol/l vs. 2.6±0.3mmol/l, p<0.001), while pH values were significantly lower in the IHE group (7.27 vs. 7.38, p=0.001). Mean absolute relative difference (MARD) was 13.3±2.2% for IHE and 13.6±2.8% for CONT suggesting comparable accuracy (p=0.90). Using Clarke Error Grid Analysis, 100% of CGM values during both IHE and CONT were in zones A and B (IHE: 77% and 23%; CONT: 78% and 22%). CONCLUSIONS The present study revealed good and comparable accuracy of the DG4P CGM system during intermittent high intensity and continuous moderate intensity exercise, despite marked differences in metabolic conditions. This corroborates the clinical robustness of CGM under differing exercise conditions. CLINICAL TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT02068638.
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CONTEXT Radiolabelled choline positron emission tomography has changed the management of prostate cancer patients. However, new emerging radiopharmaceutical agents, like radiolabelled prostate specific membrane antigen, and new promising hybrid imaging will begin new challenges in the diagnostic field. OBJECTIVE The continuous evolution in nuclear medicine has led to the improvement in the detection of recurrent prostate cancer (PCa), particularly distant metastases. New horizons have been opened for radiolabelled choline positron emission tomography (PET)/computed tomography (CT) as a guide for salvage therapy or for the assessment of systemic therapies. In addition, new tracers and imaging tools have been recently tested, providing important information for the management of PCa patients. Herein we discuss: (1) the available evidence in literature on radiolabelled choline PET and their recent indications, (2) the role of alternative radiopharmaceutical agents, and (3) the advantages of a recent hybrid imaging device (PET/magnetic resonance imaging) in PCa. EVIDENCE ACQUISITION Data from recently published (2010-2015), original articles concerning the role of choline PET/CT, new emerging radiotracers, and a new imaging device are analysed. This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. EVIDENCE SYNTHESIS In the restaging phase, the detection rate of choline PET varies between 4% and 97%, mainly depending on the site of recurrence and prostate-specific antigen levels. Both 68gallium (68Ga)-prostate specific membrane antigen and 18F-fluciclovine are shown to be more accurate in the detection of recurrent disease as compared with radiolabelled choline PET/CT. Particularly, Ga68-PSMA has a detection rate of 50% and 68%, respectively for prostate-specific antigen levels < 0.5ng/ml and 0.5-2ng/ml. Moreover, 68Ga- PSMA PET/magnetic resonance imaging demonstrated a particularly higher accuracy in detecting PCa than PET/CT. New tracers, such as radiolabelled bombesin or urokinase-type plasminogen activator receptor, are promising, but few data in clinical practice are available today. CONCLUSIONS Some limitations emerge from the published papers, both for radiolabelled choline PET/CT and also for new radiopharmaceutical agents. Efforts are still needed to enhance the impact of published data in the world of oncology, in particular when new radiopharmaceuticals are introduced into the clinical arena. PATIENT SUMMARY In the present review, the authors summarise the last evidences in clinical practice for the assessment of prostate cancer, by using nuclear medicine modalities, like positron emission tomography/computed tomography and positron emission tomography/magnetic resonance imaging.
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The level of compliance with clinical practice guidelines for patients with Type II Diabetes Mellitus was evaluated in 157 patients treated at BAMC from 1 January 2006 to 1 January 2007. This retrospective analysis was conducted reviewing data from medical records and following the VA/DOD protocols that health care providers are expected to follow at this facility. Data collected included patient’s age and gender, presence or absence of complications of diabetes, physical examination findings, glycemic and lipid control, eye care, foot care, kidney function, and self-management and education. Subjects were selected performing systematic random sampling, and included both male and female patients, from a variety of ages and ethnic groups. The Diabetes complications screened for included glycemic and lipid complications, retinopathy, cardiovascular complications, peripheral circulation complications, and nephropathy. The results revealed that 19.10% had no complications and that the most common complications were: cardiovascular (49.68%), glycemic and lipid control (10.82%), retinopathy and peripheral circulation (8.28% each), and nephropathy (2.54%). Only 2.54% of the records reviewed did not include information on complications. Strictly following the Department of Defense guidelines, six treatment modules were evaluated independently and together to get a final percentage of adherence to the clinical practice guidelines. It was established that the level of adherence was going to be graded as follows: Extremely deficient: 0-15%; very poor: 16-30%; Poor and in need of improvement: 31-45%. Acceptable: 46-60%; Good: 61-80%, and Excellent: 81-100%. The results indicated that the percentage of physicians' adherence to each protocol was as follows: 88.31%, 89.93%, 90.63%, 89.42%, 89.42% and 89.64%. When the results were pooled, the level of adherence to the clinical practice guidelines was 89.55%, proving my hypothesis that Brooke Army Medical Center physicians have excellent adherence to the standard protocols for Diabetes Type II to treat their patients. ^
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Background: The Institute of Medicine estimates that only a maximum of 25% of clinical research findings are incorporated into practice by physicians. To improve clinical practice, efforts have been made to promote evidence-based medicine and the use of clinical guidelines. Despite these efforts, the gap between research and clinical practice remains wide.^ Objective: To systematically review the literature describing the factors which influence the use of clinical research recommendations by American physicians.^ Hypothesis: Barriers exist in the application of clinical research into clinical practice, and are multifactorial. The establishment of the Clinical and Translational Awards (CTSA; special federal grants awarded to selected institutions to support clinical and translational research) has reduced the effect of these barriers and improved the process of clinical research translation into practice among American physicians.^ Aims: Identify barriers and facilitators of the use of research findings in clinical practice by American physicians. Contrast studies published six years before and after the creation of the CTSA.^ Methods: The sources of data include published literature from Medline, PubMed and PsycINFO. Selected studies must be qualitative, a survey of American clinicians, based on evidence-based medicine practice, clinical guidelines or treatment pathways. Systematic reviews and reports were excluded, as well as studies with less than 100 respondents.^ Results: In total, 1036 abstracts were reviewed; 115 full text potential articles were identified and reviewed, and a total of 31 studies met all criteria for inclusion in the final review.^ Conclusions: The barriers against the application of clinical research findings, in the forms of clinical guidelines, evidence-based medicine guides and clinical pathways, can be divided broadly into physician barriers, practice/system barriers and patient barriers. Physician barriers are the most common barriers, especially the lack of familiarity with guidelines and the lack of time. Of the factors which improve the use of research based guidelines, physician factors such as younger age, lower duration of clinical practice, specialty training, and practice in large group Health Maintenance Organization (HMO) settings with fewer patients seen were the most commonly cited.^
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Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^
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Ante la necesidad de disponer de instrumentos que permitan medir calidad de vida relacionada con la salud (CVRS) de una manera ágil y rápida, nos planteamos estudiar, en un grupo de pacientes en hemodiálisis, las propiedades de medición de las láminas Coop-Wonca con el objetivo de establecer si reúnen las condiciones para su uso rutinario en este tipo de pacientes. Métodos: Estudio transversal en 163 pacientes de hemodiálisis (106 varones y 57 mujeres) procedentes de 3 centros. Para medir la CVRS de la población estudiada se ha utilizado la versión validada española de las láminas Coop-Wonca completa. Este cuestionario comprende nueve dimensiones de función y bienestar de un único ítem: 1.– Forma física; 2.–Sentimientos; 3.–Actividades cotidianas; 4.–Actividades sociales; 5.–Cambio en el estado de salud; 6.–Estado de salud; 7.–Dolor; 8.–Apoyo social; y 9.–Calidad de vida en general. Las posibles respuestas se puntúan de 1 a 5, siendo las puntuaciones mayores las que reflejan una peor salud percibida. El instrumento permite la obtención de un índice (Coop total) que es un sumatorio de las puntuaciones de todas las dimensiones salvo la 5 (Cambio en el estado de salud). Resultados: El tiempo medio de cumplimentación del cuestionario fue inferior a 5 minutos. Las láminas resultaron fácilmente comprensibles para los pacientes y la autoadministración de las mismas no planteó problemas. Las puntuaciones más altas (peor CVRS) se obtuvieron en las dimensiones «forma física» (3,66 ± 0,8) y «estado de salud» (3,43 ± 0,8), y la menor (mejor CVRS) en la dimensión «actividades sociales» (1,98 ± 1,3). Entre los principales factores asociados a un peor estado de salud percibida figuran el sexo (mujer), la comorbilidad (presencia de diabetes y/o hepatopatía), la situación laboral (pensionista) y el medio de transporte (taxi-ambulancia). Un mayor tiempo en hemodiálisis se asoció a peores puntuaciones en las dimensiones «calidad de vida en general» y «Dolor». Los pacientes que se trasladaban en taxi o ambulancia presentaban peores puntuaciones en las dimensiones «Forma física», «Actividades cotidianas» y «Estado de salud». Una mayor se asoció a peor puntuación en «Forma física». Un número elevado de fármacos prescritos (más de seis) se asoció a peor puntuación en las dimensiones «Forma física», «Actividades sociales» y «Apoyo social». Los varones, los viudos y los solteros puntuaron peor en «Apoyo social». Los pacientes con mayor nivel de estudios mostraron puntuaciones más altas (peor CVRS) en la dimensión «Forma física». Conclusiones: Las láminas Coop-Wonca podrían ser un buen instrumento de medida de CVRS en los pacientes de hemodiálisis, por la rapidez de su cumplimentación y por ser de fácil comprensión lo que favorece la autoadministración que evita el posible sesgo del entrevistador. Todo ello favorecería su uso rutinario como indicador par valorar la evolución en el tiempo de la CVRS de los pacientes en hemodiálisis. No obstante, se precisan estudios ulteriores que permitan evaluar en mayor profundidad las propiedades psicométricas del instrumento en este tipo de pacientes.
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The Evidence-Based Practice (EBP) aims to combine a form methodological process of professional experience in health with the most current information on the clinical situation. The professional novice can make better decisions despite lacking sufficient years in clinical practice. We then train the student in correct habits within the methodological process by which you can strengthen both their knowledge and their attitude and ability, allowing secure customs, where all of your work is based on PBE.
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Degree in nursing from the Universitat Jaume I (UJI) maintains the continuity of learning with an integrated learning methodology (theory, simulated practice and clinical practice). The objective of this methodology is to achieve consistency between the knowledge, abilities and skills acquired in the classroom, laboratory and clinic to ensure skills related. Reference Nurse is a key figure in this process, you receive accredited training on Educational Methods, assessment of competence, and Evidence-Based Practice that plays the role of evaluating in conjunction with the subjects. It does not perceive economic remuneration. The main objective of this study is to determine the level of satisfaction of clinical nurses on the Nurses Training Program Reference in UJI (Castellon- Spain). A cross sectional study was performed and conducted on 150 nurses. 112 questionnaires were completed, collected and analysed at the end of training. The survey consists of 12 items measured with the Likert scale with 5 levels of response and two open questions regarding the positive and negative aspects of the course and to add in this formation. The training is always performed by the same faculty and it's used four sessions of 2012. We perform a quantitative analysis of the variables under study using measures of central tendency. The completion rate of the survey is 95.53% (n=107). Anonymity rate of 54,14% The overall satisfaction level of training was 3.65 (SD = 0.89) on 5 points. 54.2% (n = 58) of the reference nurses made a contribution in the open questions described in the overall results. The overall satisfaction level can be considered acceptable. It is considered necessary to elaborate a specific survey to detect areas of improvement of nurse training program reference and future recruitment strategies. The main objective of the present work is the selection and integration of different methodologies among those applicable within the framework of the European Higher Education Area to combine teaching methods with high implication from both lecturers and students.
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Objective. To determine the level of involvement of clinical nurses accredited by the Universitat Jaume I (Spain) as mentors of practice (Reference Nurses) in the evaluation of competence of nursing students. Methodolgy. Cross-sectional study, in which the “Clinical Practice Assessment Manual” (CPAM) reported by reference 41 nurses (n=55) were analyzed. Four quality criteria for completion were established: with information at least 80% of the required data, the presence of the signature and final grade in the right place. Verification of learning activities was also conducted. Data collection was performed concurrently reference for nurses and teachers of the subjects in the formative evaluations of clinical clerkship period in the matter “Nursing Care in Healthcare Processes “, from March to June 2013. Results. 63% of CPAM were completed correctly, without reaching the quality threshold established (80%). The absence of the signature is the main criteria of incorrect completion (21%). Nine learning activities do not meet the quality threshold set (80%) (p < 0.05). There are significant differences according to clinical units p < 0.05. From the 30 learning activities evaluated in the CPAM, it can be stated that nine of them do not reach the verification threshold established (80%), therefore it cannot be assumed that these activities had been completed by students and evaluated by the RefN throughout the clinical clerkship period. Conclusion. The level of involvement of Reference Nurse cannot be considered adequate, although strategies to encourage involvement through collaboration and training must be developed.
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Background: The “Mackey Childbirth Satisfaction Rating Scale” (MCSRS) is a complete non-validated scale which includes the most important factors associated with maternal satisfaction. Our primary purpose was to describe the internal structure of the scale and validate the reliability and validity of concept of its Spanish version MCSRS-E. Methods: The MCSRS was translated into Spanish, back-translated and adapted to the Spanish population. It was then administered following a pilot test with women who met the study participant requirements. The scale structure was obtained by performing an exploratory factorial analysis using a sample of 304 women. The structures obtained were tested by conducting a confirmatory factorial analysis using a sample of 159 women. To test the validity of concept, the structure factors were correlated with expectations prior to childbirth experiences. McDonald’s omegas were calculated for each model to establish the reliability of each factor. The study was carried out at four University Hospitals; Alicante, Elche, Torrevieja and Vinalopo Salud of Elche. The inclusion criteria were women aged 18–45 years old who had just delivered a singleton live baby at 38–42 weeks through vaginal delivery. Women who had difficulty speaking and understanding Spanish were excluded. Results: The process generated 5 different possible internal structures in a nested model more consistent with the theory than other internal structures of the MCSRS applied hitherto. All of them had good levels of validation and reliability. Conclusions: This nested model to explain internal structure of MCSRS-E can accommodate different clinical practice scenarios better than the other structures applied to date, and it is a flexible tool which can be used to identify the aspects that should be changed to improve maternal satisfaction and hence maternal health.
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Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2014
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Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2014