Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial

OBJECTIVE: This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. MATERIALS AND METHODS: Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated. RESULTS: A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups: 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta: 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05). CONCLUSION: Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine.

Mejora de la calidad en el consentimiento informado / Enhancement of informed consent quality / Melhora da qualidade no consentimento informado

Objetivo: Aplicar un círculo de mejora al consentimiento informado para la transfusión de hemoderivados. Pacientes y Método: Durante 10 meses se incluyeron 577 pacientes intervenidos en el Hospital General Reina Sofía de Murcia. Seleccionamos 6 criterios relacionados con el cumplimiento de la normativa sobre transfusiones. Tras el análisis de calidad, se aplicaron medidas correctoras y se reevaluaron los criterios. Los datos se compararon con los estándares en ambos periodos y entre periodos. En la primera evaluación se obtuvo un pobre cumplimiento de los criterios. Basándonos en el análisis de factores asociados al incumplimiento y la priorización resultante del diagrama de Pareto, el plan de intervención se dividió en actividad docente y modificaciones organizativas. Resultados: Todos los criterios estaban por debajo del estándar (p<0,001). En la segunda evaluación el cumplimiento de todos los criterios mejoró significativamente respecto de la primera; aun así los resultados continúan, también significativamente, por debajo de los estándares establecidos. Conclusiones: El cumplimiento de los 6 criterios era mínimo al inicio del estudio; las medidas correctoras fueron adecuadas, puesto que mejoraron todos ellos en la segunda evaluación, pero es necesario insistir en estas medidas ya que continuamos por debajo del estándar establecido.

Aim: To apply an enhancement circle for informed consent for transfusion of blood derivatives. Patients and Method: During 10 months 577 intervened patients were included in General Hospital Reina Sofia of Murcia, Spain. Six criteria were selected related to compliance with transfusion norms. After quality analysis, corrected measures were taken and the criteria were re evaluated. Data were compared with standards in both periods and between periods. In the first evaluation a poor compliance to criteria was observed. Based on the analysis of factors associated to lack of compliance and the resulting priorization from Pareto’s diagram, the intervention plan was divided in teaching activity and management modifications. Results: all criteria were under the standard (p<0.001). In the second evaluation, compliance for all criteria was significantly enhance with respect to the first; but nevertheless, results continue, also significantly, under established standards. Conclusions: Compliance to the six criteria was minimum at the beginning of the study; corrected measures were adequate, since they enhance all of them in the second evaluation, but it is necessary to insist in these measures since we continue under the established standard.

Objetivo: Aplicar um círculo de melhora ao consentimento informado para a transfusão de hemoderivados. Pacientes e Método: Durante 10 meses foram incluídos 577 pacientes internados no Hospital General Reina Sofía de Murcia. Selecionamos 6 critérios relacionados com o cumprimento da norma sobre transfusões. Após a análise de qualidade, foram aplicadas medidas corretoras e se reavaliaram os critérios. Os dados foram comparados com os padrões em ambos periodos e entre periodos. Na primeira avaliação se obteve um pobre cumprimento dos critérios. Baseando-nos na análise de fatores associados ao incumprimento e a priorização resultante do diagrama de Pareto, o plano de intervenção se dividiu em atividade docente e modificações organizativas. Resultados: Todos os critérios estavam abaixo do padrão (p<0,001). Na segunda avaliação o cumprimento de todos os critérios melhorou significativamente com respeito à primeira; ainda assim os resultados continuam, também significativamente, abaixo dos padrões estabelecidos. Conclusões: O cumprimento dos 6 critérios era mínimo ao início do estudo; as medidas corretoras foram adequadas, posto que melhoraram todos eles na segunda avaliação, porém é necessário insistir nestas medidas já que continuamos abaixo do padrão estabelecido.

Melhoria da proteção radiológica mediante um ciclo de avaliação interna da qualidade / Enhancement of radiological protection through an internal quality assessment cycle

OBJETIVO: Determinar o nível de qualidade da proteção radiológica para os pacientes durante a realização de exames radiológicos e avaliar a efetividade de uma intervenção dirigida a melhorar a qualidade. MATERIAIS E MÉTODOS: Realizou-se um ciclo de melhoria em um serviço de radiologia da Administração Geral de Saúde do Algarve, Portugal. Utilizando seis critérios de qualidade, foram efetivadas uma avaliação, uma intervenção focada nos critérios mais problemáticos (durante oito meses) e uma reavaliação. As amostras foram aleatórias (n = 60), possibilitando a inferência sobre as estimativas pontuais e intervalos de confiança do cumprimento de cada critério, assim como o cálculo da significância estatística da melhoria identificada, através do teste Z. RESULTADOS: Na avaliação inicial, todos os critérios de qualidade apresentaram falhas. Após a intervenção, a melhoria relativa mínima foi de 33% em cinco dos seis critérios, sendo significativa (p < 0,05) em dois deles. A frequência absoluta de não conformidades diminuiu de 38 (primeira avaliação) para 21 (segunda avaliação), que corresponde a uma melhoria de 44,7%. CONCLUSÃO: O início do ciclo de avaliação institucional revelou uma margem de melhoria que antes parecia incipiente, porém, a intervenção implementada foi efetiva para estimular boas práticas e aumentar o nível de proteção radiológica para os pacientes.

OBJECTIVE: To determine the level of quality in radiation protection of patients during radiological examination, evaluating the effectiveness of an intervention aimed at enhancing the quality of such a protection. MATERIALS AND METHODS: A quality improvement cycle was implemented in a radiology service of the Regional Health Administration, in Algarve, Portugal. Based on six quality criteria, an initial evaluation was performed and followed by an intervention focused on the most problematic points (over an eight-month period) and a subsequent quality reassessment. A random sampling (n = 60) has allowed the authors to infer the point estimates and confidence intervals for each criterion, as well as calculating the statistical significance of the results by means of the Z-test. RESULTS: Initially, deficiencies were observed in relation to all the quality criteria. After the intervention, a minimum relative improvement of 33% was observed in five of the six criteria, with statistical significance (p < 0.05) in two of them. The absolute frequency of non-compliance decreased from 38 (first evaluation) to 21 (second evaluation), corresponding to a 44.7% improvement. CONCLUSION: The first institutional evaluation cycle showed a seemingly incipient improvement margin. However, the implemented intervention was effective in stimulating good practices and improving the level of radiological protection of patients.

Clinical image quality evaluation for panoramic radiography in Korean dental clinics

PURPOSE: The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. MATERIALS AND METHODS: Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. RESULTS: A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. CONCLUSION: Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively.