Comparative Assessment of Two Strategies for Interpreting Tumor Markers in Ascitic Effusions.

BACKGROUND/AIM: There are two strategies for the interpretation of tumor markers (TM) in fluid effusions: i) high cut-off and ii) fluid/serum ratio (F/S) and low cut-off. The objective of this study is to compare these two strategies and to determine whether diagnostic accuracy improves by the identification of possible false positives using Adenosine deaminase (ADA), C reactive protein (CRP) and % of polymorphonuclear cells (%PN). PATIENTS AND METHODS: We studied 157 ascitic fluids, 74 of which were malignant. ADA, CRP and %PN were determined in ascitic fluid, and Carcinoembryonic antigen (CEA), Cancer antigen 72-4 (CA72-4), Cancer antigen CA19-9 and Cancer antigen 15-3 (CA15-3) in both fluid and serum. RESULTS: The strategy of high cut-off showed 59.5% sensitivity at 100% specificity. The F/S strategy showed 75.7% sensitivity at 95.2% specificity. Subclassifying cases with ADA, CRP and %PN negative showed 67.5% sensitivity at 100% specificity for high cut-off and for the F/S strategy was 81.7% sensitivity at 98.7% specificity. CONCLUSION: The strategy of F/S with negative ADA, CRP and %PN allow the best interpretation for TM in the ascitic fluid.

Reliability and Diagnostic Accuracy of a New Vaginal Dynamometer to Measure Pelvic Floor Muscle Strength.

AIMS: Assess the intrarater and interrater reliabilities and diagnostic accuracy of a new vaginal dynamometer to measure pelvic floor muscle (PFM) strength in incontinent and continent women. METHODS: A test-retest reliability study including 152 female patients. EXCLUSION CRITERIA: history of urge urinary incontinence, prolapse of pelvic organ, pregnancy, previous urogynecological surgery, severe vaginal atrophy, or neurological conditions. The examination comprised digital assessment using the modified Oxford scale (MOS) and dynamometry measurements with a new prototype hand-held dynamometer. The MOS score ranges from 0 to 5: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; 5, strong. Examinations were performed by a physiatrist, a physiotherapist and a midwife. The rest period between each rater measurement was 5 minutes. Assessment of intrarater and interrater reliability was calculated with the intraclass correlation coefficient. RESULTS: One hundred twenty-two incontinent women and 30 continent women were included. Scores between 0 and 2 in MOS were recorded in 72% of incontinent women versus 20% in continent patients (P < 0.001). Intrarater reliability of the dynamometer was 0.942 (95% confidence interval [CI], 0.920-0.958) and the interrater reliability was 0.937 (95% CI, 0.913-0.954). The analysis of variance analysis showed significant differences in PFM strength across digital assessment categories. The post-hoc analysis showed statistical differences between adjacent categories of MOS 1-2 and 2-3. The diagnostic accuracy showed an area under the curve of 0.82 (95% C,: 0.75-0.89), 0.87 (95% CI, 0.81-0.92), and 0.83 (95% CI, 0.77-0.90) for the physiatrist, midwife, and physiotherapist, respectively. CONCLUSIONS: The results obtained show a good reliability and validity of this new vaginal dynamometer to quantify PFM strength.

Diagnostic Accuracy of CYFRA21-1 in the Differential Diagnosis of Pleural Effusions.

BACKGROUND/AIM: Approximately 20% of pleural effusions are associated with cancer; about 50% require invasive procedures to perform diagnosis. Determination of the concentration of soluble cytokeratin 19-fragments (CYFRA21-1) may help identify patients with malignant effusions. However, pathologies other than cancer can increase its concentration. The identification of these possible false positives with routine tests CRP, ADA, % polymorphonuclear cells (PN) may improve diagnostic accuracy. This study aimed to determine the diagnostic accuracy of CYFRA21-1 in the detection of malignant pleural effusions and the possible false positives. MATERIALS AND METHODS: Analysis of CYFRA21-1, adenosine deaminase (ADA), C-reactive protein (CRP), and the percentage of polymorphonuclear leukocytes (PN%) in the fluid from 643 consecutive undiagnosed pleural effusions was performed. RESULTS: CYFRA21-1 showed 38.7% sensitivity and 97.3% specificity at 175 ng/ml cut-off. Effusions not suspicious of a false-positive showed 39.0% sensitivity and 98.2% specificity, while effusions suspicious of false positive showed lower sensitivity (36.4%) and specificity (95.0%). CONCLUSION: The diagnostic accuracy of CYFRA21-1 in pleural effusions can be improved by classification according to the possibility of false positives.

Inter-rater reliability of the digital palpation of pelvic floor muscle by the modified oxford grading scale in continent and incontinent women / Fiabilidad inter evaluador de la palpación digital de los músculos del suelo pélvico utilizando la escala modificada de Oxford graduada en mujeres continentes e incontinentes

Objective: The first choice treatment in stress urinary incontinence (SUI) is rehabilitation of the pelvic floor in order to improve muscle strength. However, no entirely reliable instruments for quantifying pelvic floor muscle (PFM) strength are currently available. Our aim was to test the inter-rater reliability of the Modified Oxford Scale (MOS) used as the gold standard for measuring PFM strength. Methods: Test-retest reliability study. One hundred and twenty-two women with SUI and thirty continent women were recruited. Patients were excluded if they had a history consistent with pelvic organ prolapse, pregnancy, previous urogynaecological surgery, or neurological conditions. Bidigital palpation quantified by the MOS was carried out by three independent examiners. Each subject answered a two-part questionnaire: demographic and clinical characteristics and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The Cohen’s Kappa index with quadratic (Kw) weighting was used to assess the inter-rater agreement. Results: 122 incontinent and 30 continent women were included. MOS ranged between 0 and 2 in 72.2% incontinent and 19.5% of continent women. The degree of agreement was substantial in the group of incontinent women (Kw between 0.73 and 0.81) and moderate in the group of continent women (Kw between 0.55 and 0.72). Conclusions: Our results suggest that the inter-observer reliability of MOS is improbable, especially in continent women

Objetivo: El tratamiento de primera elección en la incontinencia urinaria de esfuerzo es la rehabilitación del suelo pélvico con el fin de mejorar la fuerza muscular. Sin embargo, actualmente no se dispone de instrumentos totalmente fiables para cuantificar la fuerza de la musculatura del suelo pélvico. Nuestro objetivo fue determinar la fiabilidad interobservador de la Escala de Oxford Modificada (MOS) utilizada como el patrón oro para medir la fuerza. Métodos: Estudio de fiabilidad test-retest. Se reclutaron ciento veintidós mujeres con Incontinencia Urinaria de Esfuerzo y treinta mujeres continentes. Las pacientes fueron excluidas si presentaban: prolapso de órganos pélvicos, embarazo, cirugía uroginecológica previa, o enfermedades neurológicas. La palpación bidigital cuantificada con la Escala de Oxford Modificada fue realizada por tres examinadores independientes. Cada sujeto respondió a un cuestionario en dos partes: características demográficas y clínicas y el International Consultation on Incontinence Questionnaire-Forma abreviada (ICIQ-SF). Se utilizó el índice de Kappa de Cohen con ponderación cuadrática (Kw) para evaluar el acuerdo entre evaluadores. Resultados: El MOS osciló entre 0 y 2 en el 72,2% de incontinentes y el 19,5% de las mujeres continentes. El grado de concordancia fue considerable en el grupo de mujeres incontinentes (Kw entre 0,73 y 0,81) y moderado en el grupo de mujeres continentes (Kw entre 0,55 y 0,72). Conclusión: Nuestros resultados sugieren que la fiabilidad interobservador de la MOS es mejorable, especialmente en las mujeres continentes

Inter-rater reliability of the digital palpation of pelvic floor muscle by the modified Oxford Grading Scale in continent and incontinent women. / Fiabilidad inter evaluador de la palpación digital de los músculos del suelo pélvico utilizando la escala modificada de Oxford graduada en mujeres continentes e incontinentes.

OBJECTIVE: The first choice treatment in stress urinary incontinence (SUI) is rehabilitation of the pelvic floor in order to improve muscle strength. However, no entirely reliable instruments for quantifying pelvic floor muscle (PFM) strength are currently available. Our aim was to test the inter-rater reliability of the Modified Oxford Scale (MOS) used as the gold standard for measuring PFM strength. METHODS: Test-retest reliability study. One hundred and twenty-two women with SUI and thirty continent women were recruited. Patients were excluded if they had a history consistent with pelvic organ prolapse, pregnancy, previous urogynaecological surgery, or neurological conditions. Bidigital palpation quantified by the MOS was carried out by three independent examiners. Each subject answered a two-part questionnaire: demographic and clinical characteristics and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The Cohen's Kappa index with quadratic (Kw) weighting was used to assess the inter-rater agreement. RESULTS: 122 incontinent and 30 continent women were included. MOS ranged between 0 and 2 in 72.2% incontinent and 19.5% of continent women. The degree of agreement was substantial in the group of incontinent women (Kw between 0.73 and 0.81) and moderate in the group of continent women (Kw between 0.55 and 0.72). CONCLUSIONS: Our results suggest that the inter-observer reliability of MOS is improbable, especially in continent women.

OBJETIVO: El tratamiento de primera elección en la incontinencia urinaria de esfuerzo es la rehabilitación del suelo pélvico con el fin de mejorar la fuerza muscular. Sin embargo, actualmente no se dispone de instrumentos totalmente fiables para cuantificar la fuerza de la musculatura del suelo pélvico. Nuestro objetivo fue determinar la fiabilidad interobservador de la Escala de Oxford Modificada (MOS) utilizada como el patrón oro para medir la fuerza. MÉTODOS: Estudio de fiabilidad test-retest. Se reclutaron ciento veintidós mujeres con Incontinencia Urinaria de Esfuerzo y treinta mujeres continentes. Las pacientes fueron excluidas si presentaban: prolapso de órganos pélvicos, embarazo, cirugía uroginecológica previa, o enfermedades neurológicas. La palpación bidigital cuantificada con la Escala de Oxford Modificada fue realizada por tres examinadores independientes. Cada sujeto respondió a un cuestionario en dos partes: características demográficas y clínicas y el International Consultation on Incontinence Questionnaire-Forma abreviada (ICIQ-SF). Se utilizó el índice de Kappa de Cohen con ponderación cuadrática (Kw) para evaluar el acuerdo entre evaluadores. RESULTADOS: El MOS osciló entre 0 y 2 en el 72,2% de incontinentes y el 19,5% de las mujeres continentes. El grado de concordancia fue considerable en el grupo de mujeres incontinentes (Kw entre 0,73 y 0,81) y moderado en el grupo de mujeres continentes (Kw entre 0,55 y 0,72).CONCLUSIÓN: Nuestros resultados sugieren que la fiabilidad interobservador de la MOS es mejorable, especialmente en las mujeres continentes.

Sound isolation and music on the comfort of mechanically ventilated critical patients.

OBJECTIVES: To assess the effect of sound isolation versus music on the comfort of mechanically ventilated patients admitted to the intensive care unit (ICU) as a combined measurement of the hypnotic level, the level of sedation and the alteration of behaviour because of pain. INTRODUCTION: Patients admitted to the ICU who require mechanical ventilation are surrounded by an ambient noise level ranging from 60 to 90 dB, well above the 40 dB recommended by the World Health Organization (WHO). METHODS: This was a randomized crossover clinical trial. Group A: sound isolation (1 h) followed by music (1 h); Group B: music (1 h) followed by sound isolation (1 h). Interventions were administered using noise-cancelling headphones. The hypnotic level, the level of sedation and the alteration of behaviour because of pain was assessed using the bispectral index (BIS), the Ramsay scale and the behavioural pain scale (BPS), respectively. Statistical analysis of correlated data was performed using a generalized estimating equations (GEE) model. RESULTS: Of 130 patients assessed for eligibility, 82 were randomized to Groups A (n = 40) or B (n = 42). Mean age was 69 years (SD = 14), and 77·3% were men. A decrease of 4-5 points out of 100 during sound isolation and music therapy was recorded in BIS in both groups; the differences were not statistically significant compared with baseline scores. Likewise, no differences were observed in the scores obtained in the Ramsay scale and BPS. CONCLUSIONS: Sound isolation and music intervention did not modify the comfort or physiological variables of mechanically ventilated critical patients from their respective baseline values. RELEVANCE TO CLINICAL PRACTICE: Music and sound isolation are potential strategies that could be used in nursing care to provide comfort to critical patients. Further studies should be undertaken to define the role of these new approaches and determine which groups of patients can benefit most from music or sound isolation.

Causas de no consecución del objetivo terapéutico del colesterol de las lipoproteínas de baja densidad en pacientes de alto y muy alto riesgo vascular controlados en Unidades de Lípidos y Riesgo Vascular. Estudio EROMOT / Causes of failure to achieve the low density lipoprotein cholesterol therapeutic target in patients with high and very high vascular risk controlled in Lipid and Vascular Risk Units. EROMOT study

Objetivos: Determinar el grado de consecución del objetivo terapéutico del colesterol de las lipoproteínas de baja densidad (cLDL) en pacientes de alto y muy alto riesgo vascular atendidos en las unidades de lípidos, así como las causas de no consecución. Pacientes y método: Estudio observacional retrospectivo multicéntrico. Se incluyó a los pacientes mayores de 18 años con alto o muy alto riesgo vascular, según los criterios de la Guía europea de prevención cardiovascular de 2012, remitidos de forma consecutiva a las unidades de lípidos entre enero y junio del 2012 y con seguimiento a los 2 años de la primera visita. Resultados: Se incluyó a 243 pacientes procedentes de 16 unidades de lípidos. La edad media fue de 52,2 años (DE 13,7) con un 62,6% de varones. Un 40,3% eran de muy alto riesgo. En la primera visita seguían tratamiento hipolipidemiante el 86,8% (en combinación 25,1%) y en la segunda visita el 95,0% (en combinación 47,3%) (p<0,001). El 28% (IC del 95%: 22,4-34,1) alcanzó el objetivo terapéutico. Sobre las causas de no consecución, el 24,6% de ellas estaban relacionadas con el medicamento (10,3% máxima dosis tolerada y 10,9% por aparición de efectos adversos), el 43,4% con el médico (19,4% por inercia, 13,7% por considerar que ya ha llegado al objetivo) y con el paciente el 46,9%, destacando el incumplimiento terapéutico (31,4%). Conclusiones: Se consiguieron los objetivos de cLDL en cerca de un tercio de los pacientes. La baja adherencia del paciente, seguida de la inercia médica, son las causas más frecuentes que pueden explicar estos resultados (AU)

Objectives: Determination of the level of achievement of the low density lipoprotein cholesterol (LDL-C) therapeutic target in patients with high and very high vascular risk treated in Lipid Units, as well as the causes of non-achievement. Patients and method: Multicentre retrospective observational study that included patients over 18 years with high and very high vascular risk, according to the criteria of the 2012 European Guidelines on Cardiovascular Disease Prevention, referred consecutively to Lipid Units between January and June 2012 and with follow-up two years after the first visit. Results: The study included a total of 243 patients from 16 lipid units. The mean age was 52.2 years (SD 13.7), of whom 62.6% were males, and 40.3% of them were very high risk. At the first visit, 86.8% (25.1% in combination) and 95.0% (47.3% in combination) in the second visit (P<.001) were treated with lipid-lowering treatment. The therapeutic target was achieved by 28% (95 CI: 22.4-34.1). As regards the causes of non-achievement, 24.6% were related to the medication (10.3% maximum tolerated dose and 10.9% due to the appearance of adverse effects), 43.4% due to the physician (19.4% by inertia, 13.7% considering that target already reached), and 46.9% due to the patient, highlighting the therapeutic non-compliance (31,4%). Conclusions: LDL-C targets were achieved in about one-third of patients. The low adherence of the patient, followed by medical inertia are the most frequent causes that can explain these results (AU)

Causes of failure to achieve the low density lipoprotein cholesterol therapeutic target in patients with high and very high vascular risk controlled in Lipid and Vascular Risk Units. EROMOT study. / Causas de no consecución del objetivo terapéutico del colesterol de las lipoproteínas de baja densidad en pacientes de alto y muy alto riesgo vascular controlados en Unidades de Lípidos y Riesgo Vascular. Estudio EROMOT.

OBJECTIVES: Determination of the level of achievement of the low density lipoprotein cholesterol (LDL-C) therapeutic target in patients with high and very high vascular risk treated in Lipid Units, as well as the causes of non-achievement. PATIENTS AND METHOD: Multicentre retrospective observational study that included patients over 18 years with high and very high vascular risk, according to the criteria of the 2012 European Guidelines on Cardiovascular Disease Prevention, referred consecutively to Lipid Units between January and June 2012 and with follow-up two years after the first visit. RESULTS: The study included a total of 243 patients from 16 lipid units. The mean age was 52.2 years (SD 13.7), of whom 62.6% were males, and 40.3% of them were very high risk. At the first visit, 86.8% (25.1% in combination) and 95.0% (47.3% in combination) in the second visit (P<.001) were treated with lipid-lowering treatment. The therapeutic target was achieved by 28% (95 CI: 22.4-34.1). As regards the causes of non-achievement, 24.6% were related to the medication (10.3% maximum tolerated dose and 10.9% due to the appearance of adverse effects), 43.4% due to the physician (19.4% by inertia, 13.7% considering that target already reached), and 46.9% due to the patient, highlighting the therapeutic non-compliance (31,4%). CONCLUSIONS: LDL-C targets were achieved in about one-third of patients. The low adherence of the patient, followed by medical inertia are the most frequent causes that can explain these results.

Evaluation of two strategies for the interpretation of tumour markers in pleural effusions.

BACKGROUND: Pleural effusions present a diagnostic challenge. Approximately 20% are associated with cancer and some 50% require invasive procedures to perform diagnosis. Determination of tumour markers may help to identify patients with malignant effusions. Two strategies are used to obtain high specificity in the differential diagnosis of malignant pleural effusions: a) high cut-off, and b) fluid/serum (F/S) ratio and low cut-off. The aim of this study is to compare these two strategies and to establish whether the identification of possible false positives using benign biomarkers - ADA, CRP and % of polymorphonuclear cells - improves diagnostic accuracy. METHODS: We studied 402 pleural effusions, 122 of them malignant. Benign biomarkers were determined in pleural fluid, and CEA, CA72-4, CA19-9 and CA15-3 in pleural fluid and serum. RESULTS: Establishing a cut-off value for each TM for a specificity of 100%, a joint sensitivity of 66.5% was obtained. With the F/S strategy and low cut-off points, sensitivity was 77% and specificity 98.2%, Subclassifying cases with negative benign biomarkers, both strategies achieved a specificity of 100%; sensitivity was 69.9% for single determination and 80.6% for F/S ratio. CONCLUSIONS: The best interpretation of TM in the differential diagnosis of malignant pleural effusions is obtained using the F/S ratio in the group with negative benign biomarkers.

Intra-rater reliability and diagnostic accuracy of a new vaginal dynamometer to measure pelvic floor muscle strength in women with urinary incontinence.

AIMS: The first choice treatment in urinary incontinence (UI) is rehabilitation of the pelvic floor in order to improve muscle strength. However, no entirely reliable instruments for quantifying pelvic floor muscle (PFM) strength are currently available. Our aim was to test the intra-rater reliability and diagnostic accuracy of a new vaginal dynamometer for measuring PFM strength. METHODS: Test-retest reliability study. One hundred and four women with stress urinary incontinence (SUI) were recruited. Patients were excluded if they had a history consistent with urge urinary incontinence or pelvic organ prolapse, pregnancy, previous urogynecological surgery, severe vaginal atrophy, or neurological conditions. The examination comprised digital palpation quantified by the modified Oxford scale and by two consecutive dynamometry measurements obtained using a new prototype dynamometer. This instrument comprises a speculum in which an inductive displacement sensor (LVDTSM210.10.2.KTmodel, Schreiber) is attached to a spring of known stiffness constant (k). The intraclass correlation coefficient (ICC) was calculated to assess intra-rater reliability. Diagnostic accuracy was assessed using Receiver Operating Characteristics (ROC) curves analysis. RESULTS: Of the 104 subjects included, 59.6% presented scores between 0-2 on the Oxford scale. Intra-rater reliability was 0.98 (95%CI: 0.97-0.99). In the Bland & Altman plot, the distribution of disagreements was similar in the lowest and the highest strength values. The diagnostic accuracy of the dynamometer with regard to digital palpation showed an area under the curve of 0.85 (95%CI: 0.77-0.93). CONCLUSIONS: Our results suggest that this new vaginal dynamometer is a reliable and valid instrument for quantifying PFM strength. Neurourol. Urodynam. 36:333-337, 2017. © 2015 Wiley Periodicals, Inc.

The efficacy of a supervised exercise training programme on readmission rates in patients with myocardial ischemia: results from a randomised controlled trial.

BACKGROUND: The results of research into the outcomes of physical rehabilitation and its relationship with post-myocardial ischaemia survival and readmissions are inconclusive. Our primary aim was to evaluate the efficacy of a supervised exercise training programme in terms of decreasing hospital cardiac readmission in patients with myocardial ischaemia. METHODS: We conducted a randomised controlled trial including patients with myocardial ischaemia. Eligible patients were assigned to a control group receiving standard care or to an intervention group that took part in a supervised exercise training programme. The follow-up period was 12 months after hospital discharge. RESULTS: Of 478 patients assessed for eligibility, 86 were randomised to the control group ( n = 44) or the intervention group ( n = 42). Cardiac readmission rates were 14% versus 5% ( p = 0.268) in the control and intervention groups, respectively, and all-cause readmission rates were 23% versus 15% ( p = 0.34). There were no deaths in either group. More control patients were treated in the emergency services (50% vs. 24%; p = 0.015). In terms of health-related quality of life, patients in the intervention group presented with significant increases in functional capacity and mobility. More intervention patients returned to work (77.3% vs. 36.0%; p = 0.005). CONCLUSIONS: The supervised physical exercise programme was effective at reducing the number of emergency room visits and at increasing the percentage of patients who returned to work. It also improved patients' exercise capacity and increased their health-related quality of life. Although the results were promising, the programme was not associated with a significant reduction in cardiac and all-cause readmission rates.

Diagnostic Accuracy and Impact on Management of Ultrasonography-Guided Fine-Needle Aspiration to Detect Axillary Metastasis in Breast Cancer Patients: A Prospective Study.

BACKGROUND: The axillary nodal status is essential to determine the stage of disease at diagnosis. Our aim was to prospectively assess the diagnostic accuracy of ultrasonography-guided fine-needle aspiration (US-FNA) for the detection of metastasis in axillary lymph nodes in patients with breast cancer (BC) and its impact on the therapeutic decision. MATERIALS AND METHODS: Ultrasonography (US) was performed in 407 axillae of 396 patients who subsequently underwent surgery. US-FNA was conducted when lymph nodes were detected by US. Axillary dissection (AD) was performed when US-FNA was positive for metastasis. Patients with negative US-FNA and breast tumors of 30 mm in size were candidates for selective sentinel lymph node biopsy (SLNB). The anatomopathological results of AD or SLNB were used as reference tests. RESULTS: Lymph nodes were detected by US in 207 (50.8%) axillae. Of these, US-FNA was performed on 180 (86.9%). 94 axillae (52.2%) were positive for carcinoma and 79 women received AD. US-FNA had 77.5% sensitivity, 100% specificity, 100% positive predictive value, 69.3% negative predictive value, and 85.1% diagnostic accuracy. US-FNA avoided SLNB in 18.1% of patients who underwent AD. CONCLUSIONS: Axillary US-FNA is an accurate technique in the staging of patients with BC. It allows reducing the number of SLNB and, when positive, offers a fast and useful tool.

Diagnostic Accuracy of Tumor Markers CYFRA21-1 and CA125 in the Differential Diagnosis of Ascites.

BACKGROUND: The usefulness of tumor markers in the differential diagnosis of cancer in patients with ascites remains a matter of controversy. Few studies have reported the measurement of cancer antigen 125 (CA125) and cytokeratin 19 soluble fragments (CYFRA21-1) in ascitic fluid. The aim of the present study was to evaluate the diagnostic accuracy of these tumor markers in the detection of malignant ascites. MATERIALS AND METHODS: We analyzed CA125 and CYFRA21-1 from 143 consecutive undiagnosed patients with ascitis. RESULTS: Use of CA125 gave a sensitivity of 39.7% and a specificity of 98.8%, and CYFRA21-1 a sensitivity of 50.0% and a specificity of 97.6% in differential diagnosis of malignant ascites. For combined use of CA125 plus CYFRA21-1, sensitivity was 65.5% and specificity 96.5%. In patients with negative cytology, these two tumor markers had a sensitivity of 50% and a specificity of 96.5%. CONCLUSION: The determination of tumor markers in ascitic fluid could be useful for the diagnostic assessment of patients with ascites.

Clinical utility of determining tumor markers in patients with signs and symptoms of cancer.

BACKGROUND: Diagnosing patients with signs or symptoms suggestive of cancer is difficult. Serum tumor markers (TM) may be useful, but it is known that a range of pathologies other than cancer can increase their concentrations and so TM data must be interpreted with caution. The aim of this study is to determine the diagnostic accuracy of TMs in patients with signs or symptoms of cancer. METHODS: We prospectively studied 234 patients seen at rapid diagnostic units who presented signs or symptoms suggestive of cancer. Ninety patients had wasting syndrome, 74 had pulmonary symptoms and 70 other presentations. CYFRA21-1, CEA, CA19-9, total bilirubin and creatinine were determined. The final diagnosis was obtained after 6 months' follow-up. Patients were classified according to the absence (group A) or presence (group B) of abnormal bilirubin or creatinine. RESULTS: Of the 234 patients studied, 103 (44.0%) had tumors diagnosed. Cut-off points for each TM were calculated for a specificity of 100%. For the total group, the values were CYFRA21-1, 15 µg/L, CEA, 43.8 µg/L and CA19-9, 7428 KU/L, with an overall sensitivity of 46.6%. For group A (n=142), the following cut-off points were established: CYFRA21-1, 7.8 µg/L, CEA, 13.8 µg/L and CA19-9, 101 KU/L, obtaining a sensitivity of 68.6%. For group B (n=92), the values were the same as for the whole group, and a sensitivity of 42.4% was achieved. CONCLUSIONS: We conclude that TMs can aid diagnosis in these patients with signs or symptoms suggestive of cancer. Their sensitivity can be improved by using different cut-off points in the presence and absence of renal and hepatic dysfunction.

Randomized clinical trial to evaluate the effect of a supervised exercise training program on readmissions in patients with myocardial ischemia: a study protocol.

BACKGROUND: In recent decades, several studies have assessed the value of cardiac rehabilitation as secondary prevention and have reported substantial reductions in readmissions. However, conclusive evidence is scarce. The present study aims to evaluate the efficacy of a supervised exercise training program for improving percentages of hospital readmission for cardiac causes in patients with myocardial ischemia in the first year after a cardiac event. The effect on all-cause readmission, all-cause mortality, functional capacity, quality of life and adherence to regular exercise is also discussed. METHODS/DESIGN: This study will be conducted as a randomized controlled trial. Eligible patients will be randomly assigned to a control group receiving standard care or to an intervention group which, in addition to standard care, will take part in a supervised exercise training program consisting of three hours a week (spread over three alternate days) of supervised exercise training for 10 weeks. Both groups will perform an exercise stress test and a blood test during the first and third month after hospital discharge. The follow-up period will be 12 months after hospital discharge. The primary outcome measures will be the percentage of patients readmitted, total number of readmissions and length of hospitalization for cardiac disease during the first year after hospital discharge, and time to first hospital admission for cardiac disease. DISCUSSION: A representative group of hospitalized patients after myocardial ischemia will be studied in order to provide comprehensive data on the potential impact of a supervised exercise training program on hospital readmission rates. TRIAL REGISTRATION: Current Controlled Trials ISRCTN57634424.

A prognostic score based on clinical factors and biomarkers for advanced non-small cell lung cancer.

AIMS: The objective of the present study is to determine the prognostic value of clinical variables and biomarkers in patients with advanced stages of NSCLC and establish a prognostic classification of these patients. METHODS: For 135 patients with advanced NSCLC we determined their clinical variables and their levels of CEA, CA 125, CYFRA 21-1, albumin, LDH, erythrosedimentation and leukocytes. RESULTS: Multivariate analysis identified PS (ECOG) >1, metastases, no anti-neoplastic treatment, CA 125 >35 U/mL, CYFRA 21-1 >3.3 ng/mL and leukocytes >10'000/µL, as independent prognostic factors for survival. Patients were classified into 3 groups according to the number of adverse prognostic factors (APF). One point was assigned for each APF, except for chemotherapy treatment. Patients with 0-1 APF represented our reference group: patients with 2-3 APF had HR=2.7 (95% CI: 1.5-4.6), while patients with 4-5 APF had HR=8.8 (95% CI: 4.6-16.8). This "score" maintained the differences between risk groups both in patients who received antineoplastic treatment and in those who did not. CONCLUSION: The application of a score that includes clinical data and biomarkers may improve the prognostic classification of NSCLC patients.

Diagnostic accuracy of tumour markers in serous effusions: a validation study.

The utility of tumour markers (TM) in the differential diagnosis of cancer in serous effusion (fluid effusion (FE)) has been the subject of controversy. The aim of this study was to prospectively validate our previous study and to assess whether the addition of adenosine deaminase (ADA), C-reactive protein (CRP) or percentage of polymorphonuclear cells (%PN) allows the identification of false positives. In this study, carcinoembryonic antigen, cancer antigen 15-3, cancer antigen 19-9, ADA, CRP and %PN in FE were determined in 347 patients with 391 effusions. Effusions were considered as malignant effusion when at least one TM in serum exceeded the cutoff and the ratio FE/S was higher than 1.2. Also, cases with values of ADA, CRP and %PN above the established cutoffs in serous effusion were considered as potential false positives. The combined sensitivity and specificity of the three TM was 76.2 % (95 % confidence intervals (CI) 67.8-83.3 %) and 97.0 % (95 % CI 94.1-98.7), respectively. Subanalysis of the 318 cases with previous criteria and negative ADA, CRP and %PN obtained sensitivities of 78.4 % (95 % CI 69.4-85.6) and a specificity of 100 % (95 % CI 98.2-100). The results obtained validate our previous study and are improved with the addition of ADA, CRP and %PN. TM in serous effusions and serum could be useful for the diagnostic assessment of patients with serous effusions.

Determination of the biological variation of S100ß and lactate dehydrogenase in disease-free patients with malignant melanoma.

BACKGROUND: Biological variation is important for determining analytical goals and for establishing the magnitude of change between two consecutive measurements. The aim of this study was to determine the biological variation for S100ß and lactate dehydrogenase in patients diagnosed with malignant melanoma but without evidence of disease recurrence. METHODS: The biological variation of S100ß and lactate dehydrogenase was estimated from a mean of four consecutive measurements in 32 patients diagnosed with malignant melanoma but without evidence of disease recurrence, 3 months after tumor resection or 4 months after finishing adjuvant treatment. The mean sampling interval was 3 months. RESULTS: Mean concentrations of S100ß and lactate dehydrogenase were 0.0557 µg/L and 6.3 µkat/L, respectively. Between-run analytical variation was 3.5% at 0.181 µg/L for S100ß and 3.5% at 2.83 µkat/L for lactate dehydrogenase. Biological variations obtained for S100ß and lactate dehydrogenase were 14.2% and 8.2%, respectively. The analytical goals (defined as 50% of biological variation) were 7.1% for S100ß and 4.1% for lactate dehydrogenase. CONCLUSIONS: The estimation of biological variation allows us to calculate analytical goals and reference change values. These are necessary tools for the correct interpretation of serial measurements in patient follow-up.

The changing pattern of non-small cell lung cancer between the 90 and 2000 decades.

BACKGROUND: In Europe, approximately 381,500 patients are diagnosed with non-small cell lung cancer (NSCLC) every year. The aim of this study is to analyse the changes in diagnosis, treatment and evolution during the last two decades, using data from a hospital registry. MATERIAL AND METHODS: Patients diagnosed with NSCLC at the Corporació Sanitària Parc Taulí-Sabadell (Catalonia, Spain) during the periods 1990-1997 (n=748) and 2003-2005 (n=311) were included. The hospital tumour registry was used for prospective data collection. RESULTS: Our series shows a significant increase in women diagnosed with NSCLC (6% vs 10.3%; p 0.01) in the latter period; the incidence of adenocarcinomas increased by 20% (31% vs 51.1%), whereas that of squamous cell carcinomas fell (51.3% vs 32.5%; p<0.001). The proportion of patients receiving active treatment also increased significantly, from 56.6% to 76.5% (p<0.001). Disease stage at diagnosis and the number of patients treated by radical surgical resection remained unchanged. Among the favourable independent prognostic factors for survival were: gender (women), age less than 70 years old, Karnofsky index ≥70%, early stage at diagnosis, treatment with chemotherapy, and being diagnosed in the latter period 2003-2005 (HR 0.67). Over this 10-year period, absolute gain in mean survival in our series was 115 days. CONCLUSIONS: The absolute gain in mean survival in NSCLC patients in the period studied was 3.8 months, with a 6.75% increase in 5-year survival. Hospital registry data may help the correct assessment of epidemiological changes and the real effectiveness of treatments, which are sometimes overestimated in clinical trials.