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.

Bleeding and antithrombotic therapy during pregnancy in women with poor aPL-related obstetric outcomes: A survey of 1075 cases from EUROAPS registry∗.

BACKGROUND: The combination of low-dose aspirin (LDA) and low-molecular-weight heparin (LMWH) until the end of gestation are the currently the accepted standard of care for the treatment of antiphospholipid-related obstetric disorders. In refractory cases, hydroxychloroquine (HCQ) can be added to this standard of care. OBJECTIVE: To evaluate the haemostatic safety of LDA and LMWH (medium to high prophylactic doses) during pregnancy and the puerperium in women with both full-blown obstetric antiphospholipid syndrome (OAPS) (Sydney criteria) and noncriteria - incomplete - OAPS. STUDY DESIGN: Retrospective/prospective multicentre observational study. Obstetric background, laboratory categories, delivery mode, antithrombotic regimens and bleeding complications were compared. SETTING: A total of 30 tertiary European hospitals. PATIENTS: Mainly, Caucasian/Arian pregnant women were included. Other ethnicities were minimally present. Women were controlled throughout pregnancy and puerperium. MAIN OUTCOME MEASURES: The primary end-point was to evaluate the number of major and minor haemorrhagic complications in this cohort of women. Neuraxial anaesthetic bleeding complications were particularly assessed. Secondly, we aimed to compare local/general bleeding events between groups. RESULTS: We studied 1650 women, of whom 1000 fulfilled the Sydney criteria of the OAPS and 650 did not (noncriteria OAPS). Data on antithrombotic-related complications were available in 1075 cases (65.15%). Overall, 53 (4.93%) women had bleeding complications, with 34 being considered minor (3.16%) and 19 major (1.76%). Neither obstetric complications nor laboratory categories were bleeding-related. Assisted vaginal delivery and caesarean section were related to local haemorrhage. Heparin doses and platelet count were not associated with major bleeding. CONCLUSIONS: LDA and medium to high prophylactic LMWH during pregnancy in women with full-blown OAPS/noncriteria OAPS are safe. A slight increase in bleeding risk was noted in instrumental deliveries. No women who underwent spinal or epidural anaesthesia suffered bleeding complications. No haemorrhage was observed in cases where HCQ was added to standard therapy.

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.

Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from the EUROAPS registry.

OBJECTIVES: To compare clinical features, laboratory data and fetal-maternal outcomes between 1000 women with obstetric APS (OAPS) and 640 with aPL-related obstetric complications not fulfilling Sydney criteria (non-criteria OAPS, NC-OAPS). METHODS: This was a retrospective and prospective multicentre study from the European Registry on Obstetric Antiphospholipid Syndrome. RESULTS: A total of 1650 women with 5251 episodes, 3601 of which were historical and 1650 latest episodes, were included. Altogether, 1000 cases (OAPS group) fulfilled the Sydney classification criteria and 650 (NC-OAPS group) did not. Ten NC-OAPS cases were excluded for presenting thrombosis during follow-up. All cases were classified as category I (triple positivity or double positivity for aPL) or category II (simple positivity). Overall, aPL laboratory categories showed significant differences: 29.20% in OAPS vs 17.96% in NC-OAPS (P < 0.0001) for category I, and 70.8% in OAPS vs 82% in NC-OAPS (P < 0.0001) for category II. Significant differences were observed when current obstetric complications were compared (P < 0.001). However, major differences between groups were not observed in treatment rates, livebirths and thrombotic complications. In the NC-OAPS group, 176/640 (27.5%) did not fulfil Sydney clinical criteria (subgroup A), 175/640 (27.34%) had a low titre and/or non-persistent aPL positivity but did meet the clinical criteria (subgroup B) and 289/640 (45.15%) had a high aPL titre but did not fulfil Sydney clinical criteria (subgroup C). CONCLUSION: Significant clinical and laboratory differences were found between groups. Fetal-maternal outcomes were similar in both groups when treated. These results suggest that we could improve our clinical practice with better understanding of NC-OAPS patients.

Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.

Importance: Daily spontaneous breathing trials (SBTs) are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration of SBT remain controversial. Objective: To evaluate the effect of an SBT consisting of 30 minutes of pressure support ventilation (an approach that is less demanding for patients) vs an SBT consisting of 2 hours of T-piece ventilation (an approach that is more demanding for patients) on rates of successful extubation. Design, Setting, and Participants: Randomized clinical trial conducted from January 2016 to April 2017 among 1153 adults deemed ready for weaning after at least 24 hours of mechanical ventilation at 18 intensive care units in Spain. Follow-up ended in July 2017. Interventions: Patients were randomized to undergo a 2-hour T-piece SBT (n = 578) or a 30-minute SBT with 8-cm H2O pressure support ventilation (n = 557). Main Outcome and Measures: The primary outcome was successful extubation (remaining free of mechanical ventilation 72 hours after first SBT). Secondary outcomes were reintubation among patients extubated after SBT; intensive care unit and hospital lengths of stay; and hospital and 90-day mortality. Results: Among 1153 patients who were randomized (mean age, 62.2 [SD, 15.7] years; 428 [37.1%] women), 1018 (88.3%) completed the trial. Successful extubation occurred in 473 patients (82.3%) in the pressure support ventilation group and 428 patients (74.0%) in the T-piece group (difference, 8.2%; 95% CI, 3.4%-13.0%; P = .001). Among secondary outcomes, for the pressure support ventilation group vs the T-piece group, respectively, reintubation was 11.1% vs 11.9% (difference, -0.8%; 95% CI, -4.8% to 3.1%; P = .63), median intensive care unit length of stay was 9 days vs 10 days (mean difference, -0.3 days; 95% CI, -1.7 to 1.1 days; P = .69), median hospital length of stay was 24 days vs 24 days (mean difference, 1.3 days; 95% CI, -2.2 to 4.9 days; P = .45), hospital mortality was 10.4% vs 14.9% (difference, -4.4%; 95% CI, -8.3% to -0.6%; P = .02), and 90-day mortality was 13.2% vs 17.3% (difference, -4.1% [95% CI, -8.2% to 0.01%; P = .04]; hazard ratio, 0.74 [95% CI, 0.55-0.99]). Conclusions and Relevance: Among patients receiving mechanical ventilation, a spontaneous breathing trial consisting of 30 minutes of pressure support ventilation, compared with 2 hours of T-piece ventilation, led to significantly higher rates of successful extubation. These findings support the use of a shorter, less demanding ventilation strategy for spontaneous breathing trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02620358.

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.

European Surveillance System on Contact Allergies (ESSCA): polysensitization, 2009-2014.

BACKGROUND: Polysensitization, defined as being allergic to three or more haptens from the European baseline series, is considered to reflect increased susceptibility to developing a contact allergy, and is likely to be associated with an impaired quality of life. OBJECTIVES: To evaluate the prevalences of polysensitization across Europe and to analyse factors associated with polysensitization. METHODS: Patch test data collected by the European Surveillance System on Contact Allergies (ESSCA; www.essca-dc.org) in consecutively patch tested patients from January 2009 to December 2014, comprising 11 countries and 57 departments, were retrospectively analysed. RESULTS: A total of 86 416 patients were available for analysis, showing a standardized prevalence of polysensitization of 7.02%, ranging from 12.7% (Austria) to 4.6% (Italy). Allergen pairs with the strongest association are reported for the total population, for South Europe, and for North/Central Europe. Overall, polysensitized patients showed a higher percentage of extreme (+++) positive patch test reactions than oligosensitized patients. Female sex, occupational dermatitis and age > 40 years were risk factors for polysensitization. CONCLUSIONS: The varying prevalences of polysensitization across Europe most likely reflect differences in patient characteristics and referral patterns between departments. Known risk factors for polysensitization are confirmed in a European dermatitis population.

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.

Lower limb function and 10-year survival in population aged 75 years and older.

BACKGROUND: Scientific societies recommend assessing lower limb function in usual clinical practice. The Short Physical Performance Battery (SPPB) is one of the most validated tools to assess this, but its capacity to predict long-term mortality in very old population attending primary care has not been studied. OBJECTIVE: To assess the ability of the SPPB to predict 10-year survival in individuals aged 75 and over. METHODS: Prospective cohort study with a 10-year follow-up. A representative sample of people aged 75 years or older without severe dependence (Barthel Index > 20) treated at a Spanish primary care centre (n = 315). Baseline evaluation included geriatric assessment with most well-known death predictors. The three SPPB subtasks (standing balance, walking speed and chair stand tests) were administered. Kaplan-Meier curves and Cox proportional hazard models were calculated for all-cause mortality. RESULTS: Mean age was 81.9 years (60.6% female). Ten-year survival of elders with SPPB score <7 and ≥7 was 0.23 and 0.37 (P < 0.001), respectively. This difference remained statistically significant in the Cox model adjusted by age, gender, number of drugs prescribed, cognitive status, body mass index and visual sharpness (adjusted hazard ratio = 1.37; 95% confidence interval: 1.01-1.86). Also, walking speed and chair stand subtasks were both individual-independent predictors of 10-year survival. CONCLUSIONS: Our findings indicate that SPPB is an independent predictor of long-term survival. The chair stand subtask could be a predictor as useful as the full performance battery, becoming a good alternative for primary care where the burden of performing all three subtasks could be excessive.

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.

Determinants associated with activation in patients with oral anticoagulant treatment: A cross-sectional study.

AIMS: The terms "patient activation" and "patient empowerment" are used to describe the extent to which individuals are able to manage their own healthcare. Health outcomes and quality of life improve in patients who are more active in health care. The aim of this study was to identify sociodemographic, clinical, sociological and psychological determinants associated with activation in a group of chronically anticoagulated patients. METHODS: Cross-sectional study of patients treated with oral antivitamin-k drugs attended at a specialized outpatient anticoagulant unit between November 2021 and June 2022. The main dependent variable was the level of patient activation according to the 13-item Patient Activation Measure (PAM-13). Simple and multiple linear regression models were conducted to identify the determinants associated with PAM-13 score. RESULTS: A total of 137 patients who met all the inclusion criteria were recruited for the study. The mean age was 59.6 years (SD 13.8; range 22-86) and 60.6% were male. Sixty per cent presented a level IV of activation according to the PAM-13 scale. Mean patient activation score was 73.9 (SD 15.4). The factors independently associated with significantly lower activation were: emergency department visits in the past 12 months, intermediate social risk, anxiety symptoms, stress symptoms and low self-efficacy. CONCLUSIONS: Five determinants were found to be associated with activation. Knowing the factors that modify the level of activation can help to identify subgroups of chronic anticoagulated patients who are less likely to engage in self-management and are therefore candidates for tailored educational interventions.

Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial.

BACKGROUND: In standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH2O pressure-support ventilation (PSV8) without positive end-expiratory pressure (PEEP) is followed by extubation with continuous suctioning; however, these practices might promote derecruitment. Evidence supports the feasibility and safety of extubation without suctioning. Ultrasound can assess lung aeration and respiratory muscles. We hypothesize that weaning aiming to preserve lung volume can yield higher rates of successful extubation. METHODS: This multicenter superiority trial will randomly assign eligible patients to receive either standard weaning [SBT: 30-min PSV8 without PEEP followed by extubation with continuous suctioning] or lung-volume-preservation weaning [SBT: 30-min PSV8 + 5 cmH2O PEEP followed by extubation with positive pressure without suctioning]. We will compare the rates of successful extubation and reintubation, ICU and hospital stays, and ultrasound measurements of the volume of aerated lung (modified lung ultrasound score), diaphragm and intercostal muscle thickness, and thickening fraction before and after successful or failed SBT. Patients will be followed for 90 days after randomization. DISCUSSION: We aim to recruit a large sample of representative patients (N = 1600). Our study cannot elucidate the specific effects of PEEP during SBT and of positive pressure during extubation; the results will show the joint effects derived from the synergy of these two factors. Although universal ultrasound monitoring of lungs, diaphragm, and intercostal muscles throughout weaning is unfeasible, if derecruitment is a major cause of weaning failure, ultrasound may help clinicians decide about extubation in high-risk and borderline patients. TRIAL REGISTRATION: The Research Ethics Committee (CEIm) of the Fundació Unió Catalana d'Hospitals approved the study (CEI 22/67 and 23/26). Registered at ClinicalTrials.gov in August 2023. Identifier: NCT05526053.

Symptomatic gallstone disease: Recurrence patterns and risk factors for relapse after first admission, the RELAPSTONE study.

BACKGROUND: Delayed cholecystectomy in patients with symptomatic gallstone disease is associated with recurrence. Limited data on the recurrence patterns and the factors that determine them are available. OBJECTIVE: We aimed to determine the pattern of relapse in each symptomatic gallstone disease (acute pancreatitis, cholecystitis, cholangitis, symptomatic choledocholithiasis, and biliary colic) and determine the associated factors. METHODS: RELAPSTONE was an international multicenter retrospective cohort study. Patients (n = 3016) from 18 tertiary centers who suffered a first episode of symptomatic gallstone disease from 2018 to 2020 and had not undergone cholecystectomy during admission were included. The main outcome was relapse-free survival. Kaplan-Meier curves were used in the bivariate analysis. Multivariable Cox regression models were used to identify prognostic factors associated with relapses. RESULTS: Mean age was 76.6 [IQR: 59.7-84.1], and 51% were male. The median follow-up was 5.3 months [IQR 2.1-12.4]. Relapse-free survival was 0.79 (95% CI: 0.77-0.80) at 3 months, 0.71 (95% CI: 0.69-0.73) at 6 months, and 0.63 (95% CI: 0.61-0.65) at 12 months. In multivariable analysis, older age (HR = 0.57; 95% CI: 0.49-0.66), sphincterotomy (HR = 0.58, 95% CI: 0.49-0.68) and higher leukocyte count (HR = 0.79; 95% CI: 0.70-0.90) were independently associated with lower risk of relapse, whereas higher levels of alanine aminotransferase (HR = 1.22; 95% CI: 1.02-1.46) and multiple cholelithiasis (HR = 1.19, 95% CI: 1.05-1.34) were associated with higher relapse rates. CONCLUSION: The relapse rate is high and different in each symptomatic gallstone disease. Our independent predictors could be useful for prioritizing patients on the waiting list for cholecystectomies.

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.

Prognostic Value of a New Tool (the 3D/3D+) for Predicting 30-Day Mortality in Emergency Department Patients Aged 75 Years and Older.

The 3D/3D+ multidimensional geriatric assessment tool provides an optimal model of emergency care for patients aged 75 and over who attend the Emergency Department (ED). The baseline, or static, component (3D) stratifies the degree of frailty prior to the acute illness, while the current, or dynamic, component (3D+) assesses the multidimensional impact caused by the acute illness and helps to guide the choice of care facility for patients upon their discharge from the ED. The objective of this study was to evaluate the prognostic value of the 3D/3D+ to predict short- and long-term adverse outcomes in ED patients aged 75 years and older. Multivariable logistic regression models were used to identify the predictors of mortality 30 days after 3D/3D+ assessment. Two hundred and seventy-eight patients (59.7% women) with a median age of 86 years (interquartile range: 83-90) were analyzed. According to the baseline component (3D), 83.1% (95% CI: 78.2-87.3) presented some degree of frailty. The current component (3D+) presented alterations in 60.1% (95% CI: 54.1-65.9). The choice of care facility at ED discharge indicated by the 3D/3D+ was considered appropriate in 96.4% (95% CI: 93.0-98.0). Thirty-day all-cause mortality was 19.4%. Delirium and functional decline were the dimensions on the 3D/3D+ that were independently associated with 30-day mortality. These two dimensions had an area under receiver operating characteristic of 0.80 (95% CI: 0.73-0.86) for predicting 30-day mortality. The 3D/3D+ tool enhances the provision of comprehensive care by ED professionals, guides them in the choice of patients' discharge destination, and has a prognostic validity that serves to establish future therapeutic objectives.

Low complement levels are related to poor obstetric outcomes in women with obstetric antiphospholipid syndrome. The EUROAPS Registry Study Group.

INTRODUCTION: Obstetric antiphospholipid syndrome (OAPS) is an autoimmune disease related to antiphospholipid antibodies (aPL) with primaryinflammatory injury followed by clot cascade activation and thrombus formation. Complement system activation and their participation in aPL-related thrombosis is unclosed. METHODS: We haveanalysed adverse pregnancy outcomes (APO) related to low complement (LC) levels in a cohort of 1048 women fulfilling classification criteria for OAPS. RESULTS: Overall, 223 (21.3%) women presented LC values, during pregnancy. The length of pregnancy was shorter in OAPS women with LC compared to those with normal complement (NC) (median: 33 weeks, interquartile range: [24-38] vs. 35 weeks [27-38]; p = 0.022). Life new-born incidence was higher in patients with NC levels than in those with LC levels (74.4% vs. 67.7%; p = 0.045). Foetal losses were more related to women with triple or double aPL positivity carrying LC than NC values (16.3% vs. 8.0% NC; p = 0.027). Finally, some placental vasculopathies were affected in OAPS patients with LC as late Foetal Growth Restriction (FGR >34 weeks) rise to 7.2% in women with LC vs. 3.2% with NC (p = 0.007). DISCUSSION: Data from our registry indicate that incidence of APO was higher in OAPS women with LC levels and some could be reverted by the correct treatment.

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.

Effects of chronotherapy on blood pressure control in non-dipper patients with refractory hypertension.

BACKGROUND: Refractory arterial hypertension (RAH) is frequently associated to a non-dipping blood pressure (BP) pattern; this profile has been shown to have a worse clinical prognosis. It is a common clinical practice that patients receive anti-hypertensive medication preferentially in the morning. Non-dipping could be related to the timing of anti-hypertensive drug administration. We analysed whether switching anti-hypertensive medication to bedtime could improve BP control in non-dipper patients with RAH. METHODS: Twenty-seven consecutive patients with RAH and non-dipper or riser BP pattern on ambulatory blood pressure (ABP) monitoring were studied before and after 6 weeks of a change in the timing of anti-hypertensive medications. The intervention consisted of shifting all non-diuretic anti-hypertensive drugs from morning to evening, maintaining the same drugs at the same doses. A parallel group of 12 consecutive patients with similar characteristics and no changes in the therapeutic regimen formed the control group. RESULTS: There were 59% women, mean age 65.7 ± 8.4 years. They were treated with 4 ± 0.7 anti-hypertensive drugs, 90% administered in the morning. At baseline, diurnal and nocturnal ABP averaged 141.6 ± 10.6/81.5 ± 9.3 and 141.7 ± 11/78 ± 8.8, respectively. After the drug shift, mean diurnal and nocturnal ABP was 140.5 ± 10.4/80.5 ± 9.6 and 135.7 ± 12.5/73.8 ± 9.3 (P = 0.005 and 0.04 for systolic and diastolic ABP), 15% of the patients restored a normal ABP circadian rhythm. No changes were observed in the control group. CONCLUSION: In non-dipper or riser patients with RAH, changing the timing of anti-hypertensive medication to the evening could improve BP control.