Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network / Compartir los datos de los estudios: Una nueva iniciativa editorial del Comité Internacional de Editores de Revistas Médicas. Implicaciones para la red europea de editores cardiovasculares

Abstract: The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Resumen: El Comite internacional de editores de revistas medicas (CIERM) propone recomendaciones para mejorar los standares editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones abarcan desde requerimeintos ténicos uniformados a temas editoriales mas complejos y evasivos, como los aspectos bioéticos relacionados con el proceso científico. Recientemente se han propuesto algunas iniciativas editoriales, como el registro de los ensayos clinicos, la declaración de los conflictos de interés y los nuevos criterios para autoría (que destacan la responsabilidad de los autores sobre el estudio). El año pasado se presentó una nueva iniciativa editorial para resaltar la importancia de compartir los datos generados en los estudios clinicos. En este artículo se discute esta nueva iniciativa editorial, con la idea de difundir su conocimiento entre los lectores, investigadores, autores y editores de la red de editores de revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network / Compartilhamento de dados: Nova Iniciativa Editorial do Comitê Internacional de Editores de Revistas Médicas. Implicações para a Rede de Editores

Abstract The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.

Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.

Políticas de conflictos de intereses y requisitos para su declaración en las revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología / Conflict of interest policies and disclosure requirements among european society of cardiology national cardiovascular journals

Las revistas biomédicas utilizan la declaración de posibles conflictos de intereses para garantizar la credibilidad y la transparencia del proceso científico. Sin embargo, las revistas no abordan la declaración de conflictos de intereses de manera sistemática ni uniforme. Recientes esfuerzos editoriales conjuntos han abierto el camino a la aplicación de herramientas uniformes para la declaración de conflictos de intereses. En este artículo se presenta una visión integral sobre cuestiones clásicas relacionadas con los conflictos de intereses desde un punto de vista editorial. Además, a partir de los datos de un estudio transversal basado en el empleo de un cuestionario estandarizado, se comentan nuevas apreciaciones sobre las políticas y los actuales procedimientos editoriales relativos a los conflictos de intereses en las diversas revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.

Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardized questionnaire, are discussed.

Retention of chest compression performance of medical students.

Background and objectives: Chest compression (CC) performance is one of the most important parts in saving the lives of victims with cardiac arrest. The primary objective was to determine the retention of CC performance among last-year medical students (externs). Methods: All externs were recorded for their CC performance at the end of their BLS (BLS not yet defined) workshop by the use of a CPR training manikin. The retention of BLS performance was evaluated by CC score (CCS) which is the percentages of correct CC during their internal medicine rotation. Detailed errors of chest compression performance including rate of compression, compression to ventilation ratio, incomplete release, too little, too much, and wrong hand position were also recorded. Results: 223 externs had baseline data for a chest compression score (CCS1) and 118 with follow-up data (CCS2). The interval between CCS1 and CCS2 was 198 (range 119-266) days. CCS during the training course (CCS1) and CCS during the test (CCS2) were 89 (range 84-94) and 81 (range 68- 89) respectively. CCS2 was significantly lower than CCS1 (p < 0.001). The percentages of externs who passed 80% decreased from 90.5% to 51.4% (p <0.001). The independent predictors for a high CCS2 included male gender, grade point average, experience in CPR observation or participation - especially recent experience. The area of errors in CC included compression rate, compression: ventilation ratio, too little and too deep compressions. Conclusion: CC performance significantly decreases after CPR training. Assessment of predictors for retention of CC performance and the area of errors may help to strengthen the CPR training program in the future.

Accuracy of visual assessment in the detection and quantification of myocardial scar by delayed enhancement magnetic resonance imaging.

BACKGROUND: Delayed-enhancement magnetic resonance imaging (DE-MRI) is now a standard for the detection of myocardial scar and viability. Standard analysis needs expensive software. OBJECTIVE: To determine the accuracy of visual assessment in the detection and quantification of myocardial scar by DE-MRI technique. MATERIAL AND METHOD: The authors enrolled 32 patients with coronary artery disease (CAD) as documented by coronary angiography (CAG) and left ventricular dysfunction. All patients underwent cardiac magnetic resonance imaging for the assessment of global and regional myocardial function and DE-MRI. The presence and amount of scar in each myocardial segment was assessed by standard method. Visual assessment was performed by two methods: 1) visual drawing of the boundary of the hyperenhancement region and calculation of percentages of scar in an individual segment; 2) visual estimation of grading of hyperenhancement area from 0 (no scar) to 4 (> 75% scar). The agreement for scar detection and correlation of scar quantification for individual segments were evaluated. RESULTS: Thirty-one of 32 patients in the present study had myocardial scar. One thousand four hundred and thirty two myocardial segments were analyzed. Visual detection of myocardial scar has an excellent level of agreement with standard method of scar (Kappa = 0.963 and 0.952, p<0.001 for visual method I and II). Visual method I and II has an accuracy of 98.2% and 97.6% respectively in the detection of myocardial scar compared to standard method. Percentages of myocardial scar in each myocardial segment by visual method I correlate very well with standard method (Intraclass Correlation Coefficient = 0.885). Visual grading of amount of myocardial scar also has an excellent correlation with standard method (Spearman rank correlation coefficient = 0.934). CONCLUSION: Visual assessment of myocardial scar is accurate for the detection and quantification of scar.

Acute coronary syndrome in 1366 patients at Siriraj Hospital: clinical characteristics, management and in-hospital outcomes.

OBJECTIVE: To characterize the baseline characteristics, management and in-hospital outcomes of all patients admitted with acute coronary syndrome (ACS). MATERIAL AND METHOD: The present study is a prospective, observational study of all consecutive patients admitted with ACS. From August 1, 2002 through October 31, 2005, data from 1366 ACS patients were collected. RESULTS: The patients were classified according to the final discharge diagnosis as ST-segment elevation myocardial infarction (STEMI, 33.5%), non-ST-segment elevation myocardial infarction (NSTEMI, 47%) and unstable angina (UA, 19.5%). Approximately half of the patients were older than 65 years old. The STEMI patients were significantly younger and had a higher percentage of men than the NSTE-ACS patients. There was a very high prevalence of diabetes, hypertension and dyslipidemia in the patients. Only 60% of the STEMI patients received reperfusion therapy. Of these, primary percutaneous coronary intervention (PCI) was performed more frequently (35%) than thrombolytic therapy (24%). There were substantial delays in time to treatment. Median door to needle and door to balloon time were 135 and 130 minutes respectively. Half of the NSTEMI and UA patients underwent coronary angiography and about one-third had PCI or coronary artery bypass grafting in the same hospital admission. In-hospital mortality rate was high: STEMI 19%, NSTEMI 16% and UA 4%. CONCLUSION: The present study provides invaluable information regarding the spectrum of ACS in our country. Overall in-hospital mortality was higher than that reported from international registries. The present findings represent a significant opportunity for quality improvement in the care of patients with ACS and the implementation of preventive strategies for patients with and at risk for coronary artery disease.

Primary percutaneous transluminal coronary intervention compared with intravenous thrombolysis in patients with ST segment elevation myocardial infarction.

BACKGROUND: Primary percutaneous transluminal coronary intervention (PCI) and thrombolytic therapy (TT) are alternative means of achieving reperfusion in patients with acute ST segment elevation myocardial infarction (STEMI). OBJECTIVE: To compare the outcomes between both reperfusion strategies. The authors sought to compare in-hospital outcomes after PCI or TT for patients with acute STEMI. MATERIAL AND METHOD: From August 2002 through June 2004, data from all patients who received reperfusion therapy for acute STEMI were collected prospectively. The decision regarding type of reperfusion strategy was at the attending cardiologist's discretion. The patient's data on demographics, procedures, medications, and in-hospital outcomes were analyzed. RESULTS: From August 2002 through June 2004, 234 patients were admitted to the authors' institute with the diagnosis of acute STEMI. Of the 146 patients who received reperfusion therapy, 91 were treated with primary PCI and 55 received intravenous TT as the reperfusion modality. In the TT group, 51 (93%) patients received streptokinase and 11 (21.6%) underwent rescue angioplasty. The two groups had similar baseline characteristics. Both patient groups had frequent presence of diabetes (PCI 44.2% vs. TT 39.6%, p = 0. 6). Cardiogenic shock on admission was present in 11% of the PCI patients and 7.3% of the TT patients (p = ns). In-hospital mortality was not significantly different in the two groups (PCI 14.3% vs. TT 10. 9%, p = 0.56). In the TT group, there was a trend toward a higher rate of major bleeding (PCI 6.6% vs. TT 16.4%, p = 0.06) and stroke (PCI 2.2% vs. TT 7.3%, p = 0.13) complications without statistical significance. CONCLUSION: The present findings suggest that both PCI and TT are comparable alternative methods of reperfusion among STEMI patients in terms of in-hospital mortality. In certain subgroups that are at increased risk of bleeding or stroke, primary PCI may be the preferred treatment strategy.

The association of apolipoprotein B and low density lipoprotein with cardiovascular risk factors in the Thai population.

BACKGROUND: Although direct and calculated low density lipoprotein cholesterol (LDL-cholesterol) has been widely used as an important predictor for cardiovascular risk, many studies have shown that apolipoprotein B (apo B) may be a more important lipoprotein marker. MATERIAL AND METHOD: We performed a cross-sectional study on 191 volunteers who were Shinawatra employees during their annual physical check up. The following cardiovascular risk factors were recorded or measured: direct and calculated LDL, apo B, gender age, total cholesterol, triglyceride, HDL-cholesterol (HDL), calculated LDL, fasting plasma glucose (FPG), systolic and diastolic blood pressure, smoking status, body mass index (BMI), waist circumference, and waist-hip ratio (WHR). Apo B, direct LDL and calculated LDL levels were tested for their associations with other potential cardiovascular risk factors. RESULTS: There were a total of 76 men and 115 women with an average age of 28.8 +/- 5.4 years. Male gender, cigarette smoking, high cholesterol, high triglyceride, high fasting plasma glucose, hypertension, high WHR and high BMI were associated with increased apo B level. Only male gender and high cholesterol were associated with increased calculated and direct LDL level. The association of direct and calculated LDL-cholesterol level with cardiovascular risk factors appears to be similar. CONCLUSION: We demonstrated that apo B level correlates more with other cardiovascular risk factors compared to direct and calculated LDL-cholesterol. The clinical relevance of this finding needs to be explored in large-scale studies.

Identification of known mutation in LDL receptor gene underlying severe FH phenotype in Thai patient: A case report.

Objective: Familial hypercholesterolemia (FH) is associated with atherosclerosis coronary artery disease (CAD). The aim of this study is to identify a mutation in the LDL receptor gene that underlined the FH phenotype in a female patient and her family. Methods: The LDL receptor gene was screened by Polymerase Chain Reaction-Single Strand Conformation Polymorphism (PCR-SSCP), direct DNA sequencing and was subsequently confirmed by PCR-RFLP. Results: The screening of the entire LDL receptor gene revealed a 5’ donor splice site mutation of the first base of intron 3, i.e., 313+1G T mutation in one allele. This mutation was previously reported in a Danish patient with severe hypercholesterolemia. Conclusions: This case report illustrates the use of DNA diagnosis of a female heterozygous FH case and her family members, which is more accurate than clinical diagnosis especially when clinical phenotype is variable or when the individual who is at high risk is still a normolipidemic at his/ her young age. DNA diagnosis is now used as a tool to find or diagnose FH. Accurate and/or early diagnosis is important for prevention and treatment of FH patients in order to avoid the development of CAD in these patients.

Sudden cardiac death in athlete : A case report and review of literature.

A 21 year old man was successfully resuscitated from sudden cardiac arrest during sports training. Cardiac investigations revealed that he had pre-excitation syndrome. He was scheduled to cardiac electro physiologic study and radiofrequency ablation. The bypass tract was located at left posteroseptal site, the procedure was successful. The detailed history and investigations are reported, as well as review of the literatures.

An abnormal systemic and regional hypercoagulable state in patients with mitral stenosis.

Mitral stenosis still remains a major problem in Southeast Asia including Thailand. It contributes to the morbidity and mortality related to thromboembolism which was associated with the left atrial thrombus. However, the pathogenesis of left atrial thrombus in these patients is not completely understood. Therefore, the objective of this study was to investigate the coagulation and platelet activity including the function of the endocardium in the left atrium and peripheral circulation in patients with mitral stenosis who were free of left atrial thrombus and to compare those hematologic markers activity in the peripheral venous blood between the patients with mitral stenosis and the control. Thirty-six patients with moderate to severe mitral stenosis were included in the study. Most of the patients were in functional class II and 50 per cent had atrial fibrillation. Blood was obtained from the femoral vein, femoral artery, pulmonary artery and left atrium of these patients before heparin was administered to determine the value of various hematologic markers. In the control group, blood for determining the hematologic markers was collected only from the antecubital vein. The results of this study demonstrated that the levels of prothrombin activation fragment 1+2 (F1+2), thrombin-antithrombin III complex (TAT) and Beta-thromboglobulin (beta-TG) in the left atrium of the patients with mitral stenosis were significantly higher than those in the femoral vein and femoral artery, whereas the level of thrombomodulin was significantly lower in the left atrium compared with the femoral artery and vein. When comparing with the control group, the levels of TAT, plasminogen activator inhibitors-1 (PAI-1) from the peripheral vein were significantly higher and the level of thrombomodulin was also significantly lower in the patients with mitral stenosis. In conclusion, the present study demonstrated an abnormal hypercoagulable state of the left atrium and systemic circulation related to the abnormalities of coagulation, platelets and the endocardium which may cause the formation of left atrial thrombus in patients with mitral stenosis.

A randomized clinical trial of the efficacy of radiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrial fibrillation.

The limited efficacy and proarrhythmic risks of antiarrhythmia agents have resulted in alternative therapeutic approaches. Radiofrequency ablation has been reported to be an effective treatment of patients with atrial fibrillation. However, there is no randomized clinical trial comparing drug and radiofrequency ablation. The authors randomized 30 patients with chronic atrial fibrillation refractory to medication into amiodarone and radiofrequency ablation. The primary objective of this study was to compare the efficacy of amiodarone and radiofrequency ablation in the maintenance of sinus rhythm at 1 year after randomization. Pulmonary vein isolation and linear ablation of right atrium was the technique used for radiofrequency ablation. There were no significant differences in baseline patient characteristics between the 2 groups. The results of this study showed that the probability of free from atrial fibrillation was better in the radiofrequency ablation group compared to amiodarone (78.6% in the ablation group and 40% in the amiodarone group, p = 0.018). Radiofrequency ablation results in a significant reduction in symptoms relating to atrial fibrillation and a significant improvement in quality of life, whereas amiodarone had no significant effect on symptoms and quality of life. There was an ischemic stroke as a major complication related to radiofrequency ablation. Amiodarone was associated with adverse effects in 46.7 per cent of patients and needed discontinuation in 1 patient. In conclusion, radiofrequency ablation is an effective alternative treatment in patients with atrial fibrillation refractory to medication.

Radiofrequency catheter ablation of ventricular tachycardia from right ventricular outflow tract.

From January 1996 to May 2002, 61 patients with ventricular tachycardia from right ventricular outflow tract were referred to Siriraj hospital. All patients underwent clinical examination, Doppler echocardiography and electrophysiologic study. Mapping of ventricular tachycardia was performed by activation mapping and pacemapping. There were 44 females and 17 males with an average age of 41.7 +/- 9.9 years. Presenting symptoms were palpitation (95.1%), presyncope (39.3%), and syncope (26.2%). Six patients were found to have underlying cardiac disease. Radiofrequency catheter ablation was successful in 56 patients (91.8%). There were no major complications. Seven patients (12.5%) had recurrent ventricular tachycardia. Five of them were successfully reablated. The authors concluded that radiofrequency ablation is an effective treatment in patients with ventricular tachycardia from right ventricular outflow tract.

Accuracy of magnetic resonance imaging in the diagnosis of coronary artery disease.

BACKGROUND: Coronary magnetic resonance angiography is a noninvasive method to visualize coronary arteries. The objective of this study was to determine the accuracy of coronary magnetic resonance imaging in the detection of coronary artery stenosis. METHOD: The authors studied 61 patients who were scheduled for their first diagnostic X-ray coronary angiography. Magnetic resonance imaging of the coronary arteries under free-breathing was performed prior to the catheterization schedule. The results were compared. RESULTS: Forty-one out of 61 patients (67.2%) had significant coronary stenosis of at least one major coronary artery. Sixteen (26.2%) had triple vessel disease. A total of 391 of 427 segments had interpretable image quality (91.6%). The diagnostic accuracy of the left main artery, left anterior descending artery, left circumflex artery, and right coronary artery was 96.7 per cent, 90 per cent, 80 per cent and 85.2 per cent respectively. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of the detection of any significant coronary disease were 97.6 per cent, 75 per cent, 91.2 per cent, 90.9 per cent and 92.3 per cent respectively. CONCLUSIONS: Coronary magnetic resonance imaging is an accurate non-invasive imaging technique in the detection of coronary artery stenosis.