Effect of goal-directed haemodynamic therapy guided by non-invasive monitoring on perioperative complications in elderly hip fracture patients within an enhanced recovery pathway.

BACKGROUND: Goal-directed haemodynamic therapy (GDHT) has been shown to reduce morbidity and mortality in high-risk surgical patients. However, there is little evidence of its efficacy in patients undergoing hip fracture surgery. This study aims to evaluate the effect of GDHT guided by non-invasive haemodynamic monitoring on perioperative complications in patients undergoing hip fracture surgery. METHODS: Patients > 64 years undergoing hip fracture surgery within an enhanced recovery pathway (ERP) were enrolled in this single-centre, non-randomized, intervention study with a historical control group and 12-month follow-up. Exclusion criteria were patients with pathological fractures, traffic-related fractures and refractures. Control group (CG) patients received standard care treatment. Intervention group (IG) patients received a GDHT protocol based on achieving an optimal stroke volume, in addition to a systolic blood pressure > 90 mmHg and an individualized cardiac index. No changes were made between groups in the ERP during the study period. Primary outcome was percentage of patients who developed intraoperative haemodynamic instability. Secondary outcomes were intraoperative arrhythmias, postoperative complications (cardiovascular, respiratory, infectious and renal complications), administered fluids, vasopressor requirements, perioperative transfusion, length of hospital stay, readmission and 1-year survival. RESULTS: In total, 551 patients (CG=272; IG=279) were included. Intraoperative haemodynamic instability was lower in the IG (37.5% vs 28.0%; p=0.017). GDHT patients had fewer postoperative cardiovascular (18.8% vs 7.2%; p < 0.001), respiratory (15.1% vs 3.6%; p<0.001) and infectious complications (21% vs 3.9%; p<0.001) but not renal (12.1% vs 33.7%; p<0.001). IG patients had less vasopressor requirements (25.5% vs 39.7%; p<0.001) and received less fluids [2.600 ml (IQR 1700 to 2700) vs 850 ml (IQR 750 to 1050); p=0.001] than control group. Fewer patients required transfusion in GDHT group (73.5% vs 44.4%; p<0.001). For IG patients, median length of hospital stay was shorter [11 days (IQR 8 to 16) vs 8 days; (IQR 6 to 11) p < 0.001] and 1-year survival higher [73.4% (95%CI 67.7 to 78.3 vs 83.8% (95%CI 78.8 to 87.7) p<0.003]. CONCLUSIONS: The use of GDHT decreases intraoperative complications and postoperative cardiovascular, respiratory and infectious but not postoperative renal complications. This strategy was associated with a shorter hospital stay and increased 1-year survival. TRIAL REGISTRATION: ClinicalTrials.gov NCT02479321 .

Compound Endoscopic Morphological Features for Identifying Non-Pedunculated Lesions ≥20 mm with Intramucosal Neoplasia.

BACKGROUND: The major limitation of piecemeal endoscopic mucosal resection (EMR) is the inaccurate histological assessment of the resected specimen, especially in cases of submucosal invasion. OBJECTIVE: To classify non-pedunculated lesions ≥20 mm based on endoscopic morphological features, in order to identify those that present intramucosal neoplasia (includes low-grade neoplasia and high-grade neoplasia) and are suitable for piecemeal EMR. DESIGN: A post-hoc analysis from an observational prospective multicentre study conducted by 58 endoscopists at 17 academic and community hospitals was performed. Unbiased conditional inference trees (CTREE) were fitted to analyse the association between intramucosal neoplasia and the lesions' endoscopic characteristics. RESULT: 542 lesions from 517 patients were included in the analysis. Intramucosal neoplasia was present in 484 of 542 (89.3%) lesions. A conditional inference tree including all lesions' characteristics assessed with white light imaging and narrow-band imaging (NBI) found that ulceration, pseudodepressed type and sessile morphology changed the accuracy for predicting intramucosal neoplasia. In ulcerated lesions, the probability of intramucosal neoplasia was 25% (95%CI: 8.3-52.6%; p < 0.001). In non-ulcerated lesions, its probability in lateral spreading lesions (LST) non-granular (NG) pseudodepressed-type lesions rose to 64.0% (95%CI: 42.6-81.3%; p < 0.001). Sessile morphology also raised the probability of intramucosal neoplasia to 86.3% (95%CI: 80.2-90.7%; p < 0.001). In the remaining 319 (58.9%) non-ulcerated lesions that were of the LST-granular (G) homogeneous type, LST-G nodular-mixed type, and LST-NG flat elevated morphology, the probability of intramucosal neoplasia was 96.2% (95%CI: 93.5-97.8%; p < 0.001). CONCLUSION: Non-ulcerated LST-G type and LST-NG flat elevated lesions are the most common non-pedunculated lesions ≥20 mm and are associated with a high probability of intramucosal neoplasia. This means that they are good candidates for piecemeal EMR. In the remaining lesions, further diagnostic techniques like magnification or diagnostic +/- therapeutic endoscopic submucosal dissection should be considered.

Tumour Markers in the Differential Diagnosis of Patients With Isolated Involuntary Weight Loss.

BACKGROUND/AIM: Paraneoplastic syndrome symptoms include isolated involuntary weight loss (IIWL). The differential diagnosis of cancer from other diseases may require a significant number of tests. Tumour markers (TMs) can be used for the diagnosis and stratification of patients according to cancer risk. PATIENTS AND METHODS: This study included 606 patients (48% females) seen at the rapid diagnostic unit for IIWL. We determined the levels of TMs carcinoembryonic antigen, carbohydrate antigen 19-9, soluble fragments of cytokeratin 19, carbohydrate antigen 15-3, carbohydrate antigen 125, neuron specific enolase, alpha-fetoprotein, prostatic specific antigen using the multiparametric analyser COBAS 601. Two cut-off points were established, the upper reference limit described by the manufacturer and a high cut-off point suggested by Molina et al., to stratify patients according to cancer risk. RESULTS: Patients were classified according to TM levels as follows: I) all TMs below the upper reference limit; II) highest number of TMs between the two cut-offs; III) at least one TM above the higher cut-off. The odds ratio for malignancy was 4.3 for group II and 248 for group III. These results indicate that when at least one TM is above the higher cut-off, neoplasia is highly probable. CONCLUSION: TM determination allowed to establish cancer risk in patients with IIWL.

Etiologies and 12-month mortality in patients with isolated involuntary weight loss at a rapid diagnostic unit.

BACKGROUND: Numerous studies on involuntary weight loss (IWL) have been published since the 1980s, although most of them have included small samples of patients with specific symptoms. The aim of the present study was to determine the causes, demographic and clinical characteristics and mortality at 12 months in patients attended at a rapid diagnostic unit (RDU) for isolated IWL. METHODS: A single-center retrospective observational study including all patients presenting to the RDU for isolated IWL between 2005 and 2013. The following data were recorded: demographic and clinical variables, results of complementary tests (blood tests, x-rays, computed tomography scan and digestive endoscopy), main diagnosis and vital status at 12 months. RESULTS: Seven hundred and ninety-one patients met the criteria for IWL. Mean age was 67.9 years (SD 4.7), 50.4% were male and mean weight loss was 8.3 kg (SD 4.7). The cause for IWL was malignant disease in 23.6% of patients, non-malignant organic disease in 44.5%, psychiatric disorder in 29.0% and unknown in 3.2%. Overall mortality at 12 months was 18.6% (95%CI: 16.1-21.6). The mortality rate was highest in the group with malignancy (61.1%; 95%CI: 54.2-68.2). CONCLUSIONS: Almost a quarter of all patients attended at the RDU for IWL were diagnosed with cancer. Mortality at 12 months was higher in this group than in the other three. Malignancy should therefore be ruled out during the first visit for patients attended for IWL.

Factors contributing to satisfaction with care in cancer outpatients.

OBJECTIVES: To evaluate satisfaction with care (SC) in cancer patients treated at a Spanish day hospital, to identify determinants of SC, and to assess the association between SC and quality of life (QL). METHODS: Cross-sectional study in which 119 patients undergoing outpatient chemotherapy completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Cancer Outpatient Satisfaction with Care questionnaire for chemotherapy (OUT-PATSAT35 CT), and an item on loyalty. Bivariate correlations between each subscale of the OUT-PATSAT35 CT and overall satisfaction, and between the subscales of OUT-PATSAT35 CT and QLQ-C30, were calculated. Multiple linear regression models were used to analyze determinants of patients' SC. RESULTS: Mean age was 62.5 years (SD 11.7), and 54.6% of the sample were female. Mean scores for SC were > 75 out of 100 on all OUT-PATSAT35 CT subscales, except environment. Overall satisfaction was higher than satisfaction in any subscale, and all patients would choose the same day hospital again. Correlation with overall satisfaction was moderate but statistically significant for all subscales. Patients treated for tumor recurrence and those undergoing palliative treatment manifested significantly lower overall satisfaction. Correlation between the EORTC QLQ-C30 and the OUT-PATSAT35 CT was not statistically significant, although patients with better health status reported higher satisfaction in several subscales. CONCLUSION: Patient-reported SC and loyalty towards the day hospital were high. Disease evolution and aim of treatment were determinants of overall satisfaction. The correlation between SC and QL was unclear. Some areas for improving care were noted.

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.

Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps.

BACKGROUND & AIMS: T1 colorectal polyps with at least 1 risk factor for metastasis to lymph node should be treated surgically and are considered endoscopically unresectable. Optical analysis, based on the Narrow-Band Imaging International Colorectal Endoscopic (NICE) classification system, is used to identify neoplasias with invasion of the submucosa that require endoscopic treatment. We assessed the accuracy of the NICE classification, along with other morphologic characteristics, in identifying invasive polyps that are endoscopically unresectable (have at least 1 risk factor for metastasis to lymph node). METHODS: We performed a multicenter, prospective study of data collected by 58 endoscopists, from 1634 consecutive patients (examining 2123 lesions) at 17 university and community hospitals in Spain from July 2014 through June 2016. All consecutive lesions >10 mm assessed with narrow-band imaging were included. The primary end point was the accuracy of the NICE classification for identifying lesions with deep invasion, using findings from histology analysis as the reference standard. Conditional inference trees were fitted for the analysis of diagnostic accuracy. RESULTS: Of the 2123 lesions analyzed, 89 (4.2%) had features of deep invasion and 91 (4.3%) were endoscopically unresectable. The NICE classification system identified lesions with deep invasion with 58.4% sensitivity (95% CI, 47.5-68.8), 96.4% specificity (95% CI, 95.5-97.2), a positive-predictive value of 41.6% (95% CI, 32.9-50.8), and a negative-predictive value of 98.1% (95% CI, 97.5-98.7). A conditional inference tree that included all variables found the NICE classification to most accurately identify lesions with deep invasion (P < .001). However, pedunculated morphology (P < .007), ulceration (P = .026), depressed areas (P < .001), or nodular mixed type (P < .001) affected accuracy of identification. Results were comparable for identifying lesions that were endoscopically unresectable. CONCLUSIONS: In an analysis of 2123 colon lesions >10 mm, we found the NICE classification and morphologic features identify those with deep lesions with >96% specificity-even in non-expert hands and without magnification. ClinicalTrials.gov number NCT02328066.

Multimodal treatment for smoking cessation with varenicline in alcoholic, methadone-maintained, and psychotic patients: A one-year follow-up.

INTRODUCTION: Numerous studies have evaluated the efficacy and safety of varenicline for smoking cessation in smokers in the general population and, to a lesser extent, among the psychiatric population. However, few studies have evaluated varenicline in patients with other addictions. The present study was conducted to assess outcomes of a multimodal treatment for smoking cessation intervention with varenicline in a sample of alcohol and substance use disorders and patients with psychotic disorders. METHODS: This was a prospective, multicenter study. The patient sample comprised alcoholics in remission, methadone-maintained patients, and patients with psychotic disorders, all of whom wanted to stop smoking. All participants received multimodal treatment for smoking cessation therapy (psychological therapy plus varenicline). Smoking abstinence and changes in the psychopathological state of patients were assessed at predefined time points during a 12-month follow-up. The probability of tobacco abstinence after one year of treatment was computed using Kaplan-Meier life tables. RESULTS: The probability of abstinence at one year was 0.225 (95% CI: 0.1430-0.319). By group, the probabilities were as follows: patients with psychotic disorders 0.254 (95% CI: 0.118-0.415); alcoholics 0.237 (95% CI: 0.098-0.409); and methadone-maintained patients 0.177 (95% CI: 0.065-0.335). Patients with previous quit attempts had a higher probability of achieving abstinence at one year (p<0.01). CONCLUSIONS: The results of this study support the use of multimodal treatment with varenicline in patients with alcohol addiction in remission, patients on methadone maintenance, and patients with stable psychotic disorders. Previous smoking cessation attempts were predictive of smoking cessation success in these patients.

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.

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.

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.

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.