[Validity and reliability of DASH questionnaire in women who suffer from lymphedema as a side effect of a breast cancer treatment]. / Validez y fiabilidad del cuestionario DASH en mujeres con linfedema secundario a tratamiento de cáncer de mama.

INTRODUCTION: DASH questionnaire was designed to assess upper limb function in musculoskeletal pathologies. The aim of this manuscript is to study the reliability and validity of this questionnaire, to determine if is adequate to use in women with lymphedema due to breast cancer treatment. METHODS: Prospective study in 65 women with lymphedema due to breast cancer treatment was done, in which the reliability of DASH score with internal consistency (Cronbach's alpha) and test-retest reproducibility 15 days' interval (interclass correlation coefficient) and validity by correlation with SF-36v2 and FACT-B+4 (r or Kendall's τ b) scores was investigated. RESULTS: The internal consistency and the test-retest were Cronbach's alpha 0.969 and interclass correlation coefficient 0.861, respectively. There was correlation between the DASH score with the SF-36v2 score, mainly in the areas of physical function, body pain and physical role (r 0.800, 0.738, and 0.682, respectively; p<0.001), and lowest with the emotional and social wellbeing. The DASH score had correlation with FACT-B+4 (0.836; p<0.001) and the subscales the upper limb score (r=0.816; p<0.001), and there was no correlation with the social/familiar subscale (r=0.193; p=0.216). CONCLUSION: The DASH questionnaire is a reliable and valid tool to assess upper limb functionality in Spanish women with breast cancer related lymphedema.

Improving echographic monitoring of hemodynamics in critically ill patients: Validation of right cardiac output measurements through the modified subcostal window.

OBJECTIVE: We aimed to assess the usefulness of using the right ventricle outflow tract (RVOT) velocity-time integral (VTI) for echocardiographic monitoring of cardiac output compared to the gold standard, the VTI along the left ventricle outflow tract (LVOT). DESIGN: Prospective observational study. SETTING: A tertiary intensive care unit. PATIENTS: 100 consecutive patients. INTERVENTIONS: echocardiographic monitoring in critically ill patients. MAIN VARIABLES OF INTEREST: We used intraclass correlation coefficients (ICC) to compare echocardiographic measurements of LVOT VTI through apical window with RVOT VTI through the parasternal and modified subcostal windows and to assess interobserver reproducibility. Preplanned post hoc analyses compared the ICC between ventilated and nonventilated patients. RESULTS: At the time of echocardiography, 44 (44%) patients were mechanically ventilated and 28 (28%) were receiving vasoactive drugs. Good-quality measurements were obtained through the parasternal short-axis and/or apical views in 81 (81%) patients and in 100 (100%) patients through the subcostal window. Consistency with LVOT VTI was moderate for RVOT VTI measured from the modified subcostal view (ICC 0.727; 95%CI: 0.62-0.808) and for RVOT VTI measured from the transthoracic view (0.715; 95%CI: 0.59-0.807). CONCLUSIONS: Measurements of RVOT VTI are moderately consistent with measurements of LVOT VTI. Adding the modified subcostal window allows monitoring RVOT VTI in all the patients of this selected cohort, even those under mechanical ventilation.

[Impact of mammographic breast density on computer-assisted detection (CAD) in a breast imaging department]. / Impacto de la densidad mamaria mamográfica en el funcionamiento de un sistema de detección asistido por ordenador en una unidad de patología mamaria.

OBJECTIVE: To evaluate whether breast density influences the sensitivity of a computer-assisted detection (CAD) system for the detection of breast cancer. MATERIAL AND METHODS: We prospectively studied 8750 digital mammograms with an associated CAD system. We used BI-RADS criteria to classify breast density. We calculated the overall sensitivity of the radiologist and of the CAD system, as well as the sensitivity for each projection and type of finding in relation to the mammographic density of the breast. Finally, we analyzed the interval carcinomas. We used SPSS 11 for all statistical analyses. RESULTS: The overall sensitivity of the CAD system was 88.5% (95% CI: 83.2-92.7%), and the overall sensitivity of the radiologist was 93.5% (95% CI: 84.4%-95.5%). The sensitivity of the craniocaudal view was 81.6% (95% CI: 76.5-90.7%) vs 76.5% (95% CI: 69.3-89.3%) for the mediolateral oblique view. The sensitivity for microcalcifications was 98.6% (95% CI: 96.5-99.7%), and the sensitivity for masses 83.4% (95% CI: 81.2-91.7%). We detected discrepancies smaller than 20% both for microcalcifications present in the four types of densities and for masses with densities 1 and 2. In masses with density 3 the discrepancy was 20.8% and in those with density 4 it was 55%. The CAD system failed to mark only 9.1% (9/94) of the cancers presenting as masses. Half of the interval carcinomas were found in type 4 density and 75% manifested as masses, asymmetries, and distortions. The CAD system had marked 35.7% of the carcinomas. CONCLUSIONS: The craniocaudal view was more sensitive, although this difference was not statistically significant. The sensitivity of CAD was high for microcalcifications in all four density types; however, CAD's sensitivity for masses was low in density types 3 and 4. The CAD system only failed to mark 9.1% of the cancers presenting as masses but was not sensitive for the other two radiological findings included in this marking. Half of the interval carcinomas occurred in type 4 densities and 35.7% had been marked by the CAD system.

[Effect of Helicobacter pylori eradication on patients with functional dyspepsia]. / Efecto del tratamiento erradicador para Helicobacter pylori en pacientes con dispepsia funcional.

OBJECTIVE: This study evaluated Helicobacter pylori eradication therapy in terms of symptomatic response in patients with functional dyspepsia. On the other hand, we analyzed the importance of histologic findings as a predictor of treatment response. In particular, we studied whether antral gastritis (which is associated with peptic ulcer) may predict a greater symptomatic response to Helicobacter pylori eradication in functional dyspepsia. PATIENTS AND METHODS: This prospective, randomized, single-center trial included 48 patients with functional dyspepsia and Helicobacter pylori infection (27 women and 21 men, mean age 37 +/- 13.5 years). Twenty-seven patients received a 10-day course of rabeprazole, amoxicillin, and clarithromycin (eradication group), followed by 20 mg of rabeprazole for 3 months. Twenty-one patients received 20 mg of rabeprazole for 3 months (control group). Patients were followed up over a 1-year period. All patients completed the Dyspepsia-Related Health Scale Questionnaire, which studies four dimensions: pain intensity, pain disability, non-pain symptoms, and satisfaction with dyspepsia-related health. RESULTS: There was significant symptomatic improvement (p < 0.002) after 6 and 12 months, which was similar with both treatments. In the multivariate analyses, eradication therapy and less severe symptoms before treatment were the only independent factors. The symptomatic response to Helicobacter pylori eradication after 6 months was significantly greater as compared to control therapy (p = 0.01) in patients with antral gastritis and in the non-pain symptoms dimension of the questionnaire. CONCLUSIONS: Both treatments proved to be clinically beneficial in patients with functional dyspepsia. We observed a tendency to greater symptomatic benefit with Helicobacter pylori eradication therapy when compared to control treatment in patients with functional dyspepsia and in a population with a high prevalence of this infection. There is a tendency to symptomatic benefit with Helicobacter pylori eradication therapy in patients with antral gastritis.

[Best result of digoxin dosing in the aged by taking into account that both the elimination as well as the volume of distribution of the drug decrease when the kidney function deteriorates]. / Mejor resultado del ajuste de la dosis de digoxina en ancianos si se tiene en cuenta que tanto la eliminación como el volumen de distribución del fármaco disminuyen cuando se reduce la función renal.

PURPOSE: To evaluate three methods for digoxin dose adjustment in aged patients. METHODS: We determined the plasma digoxin levels that would be attained in 87 old patients with doses adjusted to the kidney function by means of three separate procedures. RESULTS: Age: 79.0 "6.3 years of age; creatinin clearance (Clc): 0.70" 0.23 ml/Kg of lean body weight and minute. Only the methods that adjust both the digoxin clearance and the volume of distribution to the Clc achieve the independence between the digoxinemia and the kidney function. The best of them, by calculating the elimination constant (K) and the volume of distribution (V) as linear functions of the Clc, so that K ranges between 0.173 and 0.462 days-1 and V between 4 and 10 l/Kg of lean body weight when the Clc varies from 0 to 110 ml/minute, achieve digoxinemia figures between 0.8 y 2.0 ng/ml and above 2.0 ng/ml in the 81.6% and 0.0% of the patients (95% confidence intervals (95% CI): 72.2% to 88.4 and 0.0% to 4.6%), respectively; with a precision and a bias of 0.43 and -0.06 ng/ml (95% CI: 0.38 to 0.48 and -0.16 to 0.03 ng/ml), respectively. CONCLUSION: The described method would lead to good results if digoxin has not been prescribed in order to control the cardiac frequency in the setting of auricular fibrilation.

Pharmacoeconomic assessment of propofol 2% used for prolonged sedation.

OBJECTIVE: To demonstrate that the use of propofol 2% is comparable to propofol 1% in effectiveness and in the wake-up time used for prolonged sedation. DESIGN: Open-label, case cohort study with a cohort of historical controls, phase IV clinical trial. SETTING: Medical and surgical intensive care unit (ICU) in a community hospital. PATIENTS: Fifty-one consecutive patients (medical, surgical, and trauma) admitted to our ICU requiring mechanical ventilation for >24 hrs. METHODS: All patients received propofol 2% (1-6 mg.kg-1.hr-1, starting with the lowest dose) and morphine chloride (0.5 mg.kg-1.24 hrs-1). A 4-5 level of sedation (Ramsay scale) was recommended. When weaning was indicated clinically, sedation and analgesia were interrupted abruptly, mechanical ventilation was discontinued, and the patient was connected to a T-bridge. OUTCOME MEASUREMENTS: Inability to attain the desired level of sedation with the highest dose rate of proposal, and hypertriglyceridemia >500 mg/dL, were considered therapeutic failure. The time between discontinuation of mechanical ventilation and extubation was measured. Those variables, as well as different items related to ICU cost, were compared between the study group and two historical groups sedated with propofol 1% and midazolam. RESULTS: The duration of sedation was 122.4 +/- 89.2 (sd) hrs for the propofol 2% group. The frequency of hypertriglyceridemia was 3.9% and 20.4% for the propofol 2% and the propofol 1% groups, respectively (p =.016). Therapeutic failure rates were 19.6% and 33.4% for the propofol 2% and propofol 1% groups, respectively (p =.127). The lower frequency of hypertriglyceridemia was associated with a higher number of patients reaching weaning. Weaning time was similar in the two propofol groups, 32.3 hrs ($1,744) for the propofol 2% group vs. 97.9 hrs ($5,287) for the midazolam group. Cost of sedation was $2.68 per hour for the midazolam group and $7.69 per hour for the propofol group. There was a favorable cost-benefit ratio for the propofol group, attributable to the shorter weaning time, although benefit was less than expected because higher doses of propofol 2% than propofol 1% were required during the first 48 hrs (p <.05). CONCLUSIONS: The new propofol 2% preparation is an effective sedative agent and is safe because of the low frequency of associated hypertriglyceridemia. The shorter weaning time associated with the use of propofol 2% as compared with midazolam compensates for its elevated cost. The economic benefit of propofol 2% is less than expected because higher doses of propofol 2% than propofol 1% are required over the first 48 hrs.

[Predictive capacity of 3 methods for estimating the maintenance dose of digoxin in elderly patients]. / Capacidad predictiva de tres métodos de cálculo de la dosis de mantenimiento de digoxina en ancianos.

PURPOSE: To evaluate three methods for digoxin dose adjustment in aged patients. METHODS: We determined the plasma digoxin levels that would be attained in 47 consecutive old patients with doses adjusted to the creatinin clearance (Clc) by means of three mathematical functions. RESULTS: Age: 79.1 +/- 6.1 years of age; Clc: 0.77 +/- 0.24 mL/kg of lean body weight and minute. Once the dose has been fitted to the digoxin pharmacokinetic parameters described in the bibliography, the drug levels would oscillate between 0.8 and 2.0 ng/mL in 85.1% of the patients, with a 95% confidence interval (95% CI) from 72.3% to 92.6%; in 0.0% of the patients the levels would be greater than 2 ng/mL (95% IC: 0.0% to 7.6%). The precision and the bias would be 0.40 ng/mL (95% IC: 0.33 to 0.46 ng/mL) and--0.08 ng/m (95% IC: -0.19 to 0.04 ng/mL), respectively. The drug level would not be associated with the Clc (coefficient of Clc in the regression line: -0.0003; P > 0.9). The results would be worse with the others two mathematical functions. CONCLUSION: The first of the above adjustment methods would lead to good results if digoxin has not been prescriped in order to control the cardiac frequency in the setting of auricular fibrillation.

[Extrapyramidal toxicity caused by metoclopramide and clebopride: study of voluntary notifications of adverse effects to the Spanish Drug Surveillance System]. / Toxicidad extrapiramidal a metoclopramida y a cleboprida: estudio de las notificaciones voluntarias de reacciones adversas al Sistema Español de Farmacovigilancia.

OBJECTIVE: To clarify if there is any basis for the hypothesis that Clebopride leads to more extrapyramidal reactions than Metoclopramide. DESIGN: Observational, longitudinal, retrospective and comparative study of two series of cases. SETTING: The entire Spanish healthcare system. PATIENTS: Those notified to the Spanish Drug watch system as possibly having suffered an adverse reaction to Metoclopramide (n = 98) or Clebopride (n = 123) between 1/1/1990 and 10/6/1997. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 84.3% of suspected adverse reactions to Clebopride and 51.6% of those to Metoclopramide had a non-hospital precedence (P < 0.001). In 48.0% of suspected adverse reactions to Metoclopramide and 72.4% of those to Clebopride, there was extrapyramidal toxicity (P = 0.021). CONCLUSIONS: There is a basis for the hypothesis that Clebopride causes more extrapyramidal reactions than Metoclopramide. It was reasonable to realize a study based on this hypothesis.

[Ambulatory therapeutic noncompliance of the aged treated with digoxin]. / Incumplimiento terapéutico ambulatorio en ancianos tratados con digoxina.

OBJECTIVE: To quantify the percentage of out-patient doses (OPD) of Digoxin taken by elderly people in treatment. DESIGN: An observational, longitudinal and retrospective study. SETTING: Out-patient clinics at a geriatric hospital. PATIENTS: 67 patients were treated orally with Digoxin: 39 women; age 79 +/- 6; ideal weight, 55.7 Kg +/- 7.1; plasma creatinine, 1.3 +/- 0.9 mg/dl; in-hospital dose 3247.6 +/- 1309.4 ng/Kg; out-patient dose, 3205.7 +/- 1359.9 ng/Kg. They had two consecutive Digoxinemias, one in and one out of hospital, with an interval of 1 to 18 months between them. MEASUREMENTS AND MAIN RESULTS: Therapeutic compliance was calculated by comparing the Digoxinemia/dose relationship per Kg of the ideal in-hospital weight against the non-hospital one. 37.3% of the patients ingested 80 to 110% of the OPD (95% CI, 26.7%-49.3%). The 36 patients on a constant dosage took 74.3% +/- 34.1% of the OPD, whereas the 31 not on a daily dose took 87.7% +/- 25.3% (P < 0.07). CONCLUSIONS: Non-compliance is common and hard to detect clinically. Therefore, it is dangerous to adjust the dose of non-compliant patients only on the basis of Digoxinemias or effects of the medicine, or on the doctor's view about compliance.

Prolonged sedation of critically ill patients with midazolam or propofol: impact on weaning and costs.

OBJECTIVE: To compare the effectiveness of sedation, the time required for weaning, and the costs of prolonged sedation of critically ill mechanically ventilated patients with midazolam and propofol. DESIGN: Open-label, randomized, prospective, phase IV clinical trial. SETTING: Medical and surgical intensive care unit (ICU) in a community hospital. PATIENTS: All ICU admissions (medical, surgical and trauma) requiring mechanical ventilation for > 24 hrs. A total of 108 patients were included in the study. INTERVENTIONS: Patients were randomized to receive midazolam or propofol. The dose range allowed for each drug was 0.1 to 0.5 mg/kg/hr for midazolam and 1 to 6 mg/kg/hr for propofol. The lowest dose that achieved an adequate patient-ventilator synchrony was infused. All patients received 0.5 mg/kg/24 hrs of morphine chloride. MEASUREMENTS AND MAIN RESULTS: The level of sedation was quantified by the Ramsay scale every 2 hrs until weaning from mechanical ventilation was started. If sedation could not be achieved by infusing the highest dose of midazolam or propofol, the case was recorded as a therapeutic failure. In the propofol group, serum triglycerides were determined every 72 hrs. Concentrations of > 500 mg/dL were also recorded as a therapeutic failure. When the patient was ready for weaning according to defined criteria, sedation was interrupted abruptly and the time from interruption of sedation to the first T-bridge trial and to extubation was measured. Cost analysis was performed based on the cost of intensive care in our unit ($54/hr). In the midazolam group (n = 54), 15 (27.8%) patients died; 11 (20.4%) patients had therapeutic failure; and 28 (51.8%) patients were subjected to a T-bridge trial. In the propofol group (n = 54), these proportions were 11 (20.4%), 18 (33.4% [including seven due to inadequate sedation, and 11 due to hypertriglyceridemia]), and 25 (46.2%), respectively. None of these values was significantly different between the two groups. Duration of sedation was 141.7 +/- 89.4 (SD) hrs and 139.7 +/- 84.7 hrs (p = NS), and cost (US dollars) attributed to sedation was $378 +/- 342 and $1,047 +/- 794 (p = .0001) for the midazolam and propofol groups, respectively. In the midazolam group, time from discontinuation of the drug infusion to extubation was 97.9 +/- 54.6 hrs (48.9 +/- 47.2 hrs to the first disconnection, and 49.0 +/- 23.7 hrs to extubation). In the propofol group, time from discontinuation of the drug infusion to extubation was 34.8 +/- 29.4 hrs (4.0 +/- 3.9 hrs to the first disconnection, and 30.8 +/- 29.2 hrs to extubation). The difference between the two groups in the weaning time was 63.1 +/- 12.5 (SEM) hrs (p < .0001). Cost per patient in the midazolam group (including ICU therapy and sedation with midazolam) was $10,828 +/- 5,734. Cost per patient in the propofol group was $9,466 +/- 5,820, $1,362 less than in the midazolam group. CONCLUSIONS: In our population of critically ill patients sedated with midazolam or propofol over prolonged periods, midazolam and propofol were equally effective as sedative agents. However, despite remarkable differences in the cost of sedation with these two agents, the economic profile is more favorable for propofol than for midazolam due to a shorter weaning time associated with propofol administration.