Marisa Baré

Transrectal ultrasound-guided prostate biopsy: is antibiotic prophylaxis necessary?

The aim of this study was to assess infectious complications in transrectal ultrasound-guided prostate biopsy (TRUSPB), comparing two groups of patients: one group with antibiotic prophylaxis and the other without prophylaxis. A total of 1,018 TRUSPBs were performed from April 1996 to July 2003. No antibiotic prophylaxis was given in the first 614; the remaining 404 procedures were performed under antibiotic prophylaxis. Biopsy complications were assessed at outpatient urologist visits after the procedure in the 212 first biopsies and by telephone interview in the remaining 806. A total of 78 infectious complications were found. Major infectious complications (n=41) were septic shock (n=3), sepsis (n=3), Fournier gangrene (n=1), urinary tract infection (n=2), and fever requiring hospital admission (n=32). Minor infectious complications were fever that did not require admission (n=29), prostatitis (n=6), and epididymitis (n=2). Infectious complications occurred in 63 of 614 (10.3%) procedures without antibiotic prophylaxis and in 15 of 404 (3.7%) of those with antibiotic prophylaxis (P=0.0001). Of the 41 major infectious complications, 31 (75.6%) occurred in procedures without antibiotic prophylaxis (n=583) versus ten (24.4%) in those with prophylaxis (n=394) (P=0.0410). In conclusion, transrectal ultrasound-guided biopsy of the prostate has a statistically significant higher risk of infectious complications when performed without antibiotic prophylaxis.

Responsiveness and Clinically Important Differences for the VF-14 Index, SF-36, and Visual Acuity in Patients Undergoing Cataract Surgery

OBJECTIVE To assess visual acuity (VA) and 2 questionnaires of health-related quality of life--the Visual Function 14 (VF-14) index and the Medical Outcomes Study Short Form 36 Health Survey (SF-36)--as instruments for capturing clinically important changes after cataract surgery. DESIGN Prospective, observational study. PARTICIPANTS Four thousand three hundred fifty-six consecutive patients attending ophthalmologic clinics in 17 hospitals in preparation for cataract surgery were recruited. METHODS Clinical data were collected in the visit before the intervention and 6 weeks after surgery by ophthalmologists. Patients completed the questionnaires before surgery and 3 months after surgery. MAIN OUTCOME MEASURES The VF-14 and SF-36 questionnaire results obtained before surgery and 3 months after the procedure and VA before the procedure and 6 weeks afterward. RESULTS Positive mean changes in VA (+0.47) and VF-14 results (+24.03) indicated significant improvements after cataract surgery that were not reflected in changes in SF-36 domains (from 1.86 to 5.62). Responsiveness parameters demonstrated large changes in VA and VF-14 scores but not in SF-36 domains. The minimal clinically important differences (MCID) after surgery were 0.41 for VA and 15.57 for VF-14 results; the minimal detectable change (MDC) for VF-14 was 10.81. CONCLUSIONS Visual acuity and VF-14 scores, but not SF-36 scores, are appropriate instruments for capturing clinically important changes after cataract surgery. The MCID and MDC values obtained herein, although not absolute thresholds, may aid in the interpretation of changes in VA and VF-14 scores.

Tumor phenotype and breast density in distinct categories of interval cancer: results of population-based mammography screening in Spain

IntroductionInterval cancers are tumors arising after a negative screening episode and before the next screening invitation. They can be classified into true interval cancers, false-negatives, minimal-sign cancers, and occult tumors based on mammographic findings in screening and diagnostic mammograms. This study aimed to describe tumor-related characteristics and the association of breast density and tumor phenotype within four interval cancer categories.MethodsWe included 2,245 invasive tumors (1,297 screening-detected and 948 interval cancers) diagnosed from 2000 to 2009 among 645,764 women aged 45 to 69 who underwent biennial screening in Spain. Interval cancers were classified by a semi-informed retrospective review into true interval cancers (n = 455), false-negatives (n = 224), minimal-sign (n = 166), and occult tumors (n = 103). Breast density was evaluated using Boyd’s scale and was conflated into: <25%; 25 to 50%; 50 to 75%; >75%. Tumor-related information was obtained from cancer registries and clinical records. Tumor phenotype was defined as follows: luminal A: ER+/HER2- or PR+/HER2-; luminal B: ER+/HER2+ or PR+/HER2+; HER2: ER-/PR-/HER2+; triple-negative: ER-/PR-/HER2-. The association of tumor phenotype and breast density was assessed using a multinomial logistic regression model. Adjusted odds ratios (OR) and 95% confidence intervals (95% CI) were calculated. All statistical tests were two-sided.ResultsForty-eight percent of interval cancers were true interval cancers and 23.6% false-negatives. True interval cancers were associated with HER2 and triple-negative phenotypes (OR = 1.91 (95% CI:1.22-2.96), OR = 2.07 (95% CI:1.42-3.01), respectively) and extremely dense breasts (>75%) (OR = 1.67 (95% CI:1.08-2.56)). However, among true interval cancers a higher proportion of triple-negative tumors was observed in predominantly fatty breasts (<25%) than in denser breasts (28.7%, 21.4%, 11.3% and 14.3%, respectively; <0.001). False-negatives and occult tumors had similar phenotypic characteristics to screening-detected cancers, extreme breast density being strongly associated with occult tumors (OR = 6.23 (95% CI:2.65-14.66)). Minimal-sign cancers were biologically close to true interval cancers but showed no association with breast density.ConclusionsOur findings revealed that both the distribution of tumor phenotype and breast density play specific and independent roles in each category of interval cancer. Further research is needed to understand the biological basis of the overrepresentation of triple-negative phenotype among predominantly fatty breasts in true interval cancers.

Hipovitaminosis D asociada a exposición solar insuficiente en la población mayor de 64 años

BACKGROUND AND OBJECTIVE To identify the factors related to hypovitaminosis D in the population over 64 years of age without known risk factors of hypovitaminosis D. SUBJECTS AND METHOD It was a cross-sectional population study in individuals over 64 year-old attending basic healthcare areas in our hospitals area of reference. A survey was conducted to assess various items (functional capacity, exposure to sun, walks, eating habits). Blood samples taken from each participant were analyzed. RESULTS A total of 239 individuals -mean age (standard deviation): 72 (5.4) years- were evaluated. 95% of the participants scored > 90 on the Barthel index. Mean serum 25-hydroxyvitamin D3 -25(OH)D3- concentration was 17 (7.5) ng/ml and intact parathormone was 60 (26 pg/ml). The prevalence of hypovitaminosis D was 87%, including 70.3% with insufficiency (25(OH)D3 between 11 and 25 ng/ml) and 16.7% with deficiency (25(OH)D3 < or = 10 ng/ml). The intake of vitamin D and calcium were below recommended levels. The principal source of vitamin D was oily fish. Participants with deficiency scored lower on the Barthel index, had a higher mean age, lived in flats, had less exposure to sun, and used to walk less in sun-hours. Higher levels of alkaline phosphatase and intact parathormone were found in participants with deficiency. The variables independently and significantly associated with vitamin D deficiency were a Barthel score < or = 90, scant exposure to sun and living in a flat. CONCLUSIONS There is a high prevalence of hypovitaminosis D in the population aged over 64 years in our area, which is associated with lower functional capacity, scant exposure to sun and living in flats.

Effect of false-positive results on reattendance at breast cancer screening programmes in Spain.

BACKGROUND Mammography is the only breast screening method, we are aware of today, which is able to reduce mortality from breast cancer. Nevertheless, this procedure carries an inherent risk of false-positive screening mammogram. The association between these results and reattendance at the next scheduled screening mammogram is controversial. The aim of this study was to examine the effect of a false-positive screening mammogram and womens characteristics on reattendance in eight regional population-based breast cancer screening programmes in Spain. METHODS This study included 1 383 032 women aged 44-67 years who were initially screened for breast cancer between 1990 and 2004. To investigate factors associated with reattendance, logistic regression models were used. RESULTS The mean age of women at first screening was 53.6 years (SD = 6.1 years). Of 120 800 women with a false-positive screening mammogram, 78.3% returned for a subsequent screening mammogram compared with 81.9% of those with a negative result (P < 0.001). Multivariate analysis showed that women with a false-positive result at first screening mammogram were less likely to reattend (OR = 0.71; 95% CI 0.70-0.73) and that the likelihood was lower in those who had undergone invasive additional tests (OR = 0.56; 95% CI 0.53-0.59). CONCLUSION A false-positive screening mammogram in the first screening negatively affected attendance at the subsequent screening. The results of this study could be useful to improve the screening process and to increase womens compliance.

Validity of Newly Developed Appropriateness Criteria for Cataract Surgery

OBJECTIVE The introduction of phacoemulsification in the early 1990s significantly changed the treatment of cataract. It is possible that appropriateness criteria for cataract extraction developed before the widespread adoption of phacoemulsification no longer is as accurate or valid as possible. The objective of this study was to validate newly developed explicit appropriateness criteria. DESIGN Prospective, observational cohort study. PARTICIPANTS Consecutive patients with a diagnosis of cataract who were on waiting lists to undergo cataract extraction by phacoemulsification were recruited. METHODS Newly developed explicit appropriateness criteria for cataract extraction, following Research and Development methodology, were applied in this study conducted in 17 public teaching hospitals. Data necessary to classify the appropriateness of the intervention, including demographic and clinical data and that related to the surgery and complications, were recorded by previously trained ophthalmologists in all centers before the intervention and at the 6-week visit afterward. MAIN OUTCOME MEASURES Subjects completed 2 questionnaires that measure health-related quality of life--the Short Form 36 and the Visual Function Index 14 (VF-14)--before the procedure and 3 months afterward. Also, visual acuity was recorded by ophthalmologists previous to the intervention and at 6 weeks after. RESULTS Five thousand two hundred fifty-seven cases were included in the study. At 3 months after cataract extraction, 4335 (82.5%) patients had responded to the questionnaires. Patients whose procedures were classified as necessary or appropriate by the new appropriateness criteria had greater improvements in visual acuity and VF-14 scores than those undergoing procedures classified as inappropriate. These differences seemed to be clinically relevant by measures such as the minimal clinically important difference and minimal detectable change. Complications rates were similar among all appropriateness categories, except for complications occurring in the peri-intervention period. CONCLUSIONS These results suggest a direct relationship between the newly developed explicit appropriateness criteria for cataract extraction and outcomes, as measured by clinical evaluation and health-related quality-of-life instruments. The results support the use of these criteria for clinical evaluation or the development of clinical guidelines.

Importance of appropriateness of empiric antibiotic therapy on clinical outcomes in intra-abdominal infections

OBJECTIVES The objective of this study is to describe the frequency of inappropriate empirical antibiotic therapy in secondary intra-abdominal infection and to identify the possible relationship between inappropriateness and some clinical outcomes. METHODS A retrospective descriptive multicenter study was conducted using hospital secondary databases developed at two university hospitals located in northeast Spain. Participants were patients 18 years of age or older who were diagnosed with community-acquired intra-abdominal infections between January 1, 1998, and December 31, 2000, identified through computerized patient records using ICD-9 codes. Appropriateness of empirical treatment was defined according to the recommendations of the literature. The clinical outcome of each patient was classified as one of the following: (i) resolved with initial therapy, (ii) required second-line antibiotics, (iii) required re-operation, or (iv) in-hospital death. The Fishers exact test or the Chi-squared test for categorical variables and the t-test or Mann-Whitney test for continuous variables were used for comparing groups. Conditional logistic and linear regression analyses were also applied. RESULTS Of 376 cases, 51 cases (13.6 percent, 95 percent confidence interval, 10-17 percent) received inappropriate empirical antibiotic therapy according to the scientific literature. Inappropriate initial empirical treatment was significantly associated with the need for a second line of antibiotics (p < .001), although not with re-operation, mortality, or length of hospitalization. CONCLUSIONS Approximately 14 percent of the patients received inappropriate empirical antibiotic treatment. Worse clinical outcomes consistently were observed in the group of patients receiving inappropriate empirical treatment. The appropriateness of antibiotic treatment for a given infection, in light of the availability of clearly defined clinical guidelines is an easily evaluated aspect of the quality of care.

The IRYSS-COPD appropriateness study: objectives, methodology, and description of the prospective cohort

BackgroundPatients with chronic obstructive pulmonary disease (COPD) often experience exacerbations of the disease that require hospitalization. Current guidelines offer little guidance for identifying patients whose clinical situation is appropriate for admission to the hospital, and properly developed and validated severity scores for COPD exacerbations are lacking. To address these important gaps in clinical care, we created the IRYSS-COPD Appropriateness Study.Methods/DesignThe RAND/UCLA Appropriateness Methodology was used to identify appropriate and inappropriate scenarios for hospital admission for patients experiencing COPD exacerbations. These scenarios were then applied to a prospective cohort of patients attending the emergency departments (ED) of 16 participating hospitals. Information was recorded during the time the patient was evaluated in the ED, at the time a decision was made to admit the patient to the hospital or discharge home, and during follow-up after admission or discharge home. While complete data were generally available at the time of ED admission, data were often missing at the time of decision making. Predefined assumptions were used to impute much of the missing data.DiscussionThe IRYSS-COPD Appropriateness Study will validate the appropriateness criteria developed by the RAND/UCLA Appropriateness Methodology and thus better delineate the requirements for admission or discharge of patients experiencing exacerbations of COPD. The study will also provide a better understanding of the determinants of outcomes of COPD exacerbations, and evaluate the equity and variability in access and outcomes in these patients.

In-hospital mortality after stomach cancer surgery in Spain and relationship with hospital volume of interventions

BackgroundThere is no consensus about the possible relation between in-hospital mortality in surgery for gastric cancer and the hospital annual volume of interventions. The objectives were to identify factors associated to greater in-hospital mortality for surgery in gastric cancer and to analyze the possible independent relation between hospital annual volume and in-hospital mortality.MethodsWe performed a retrospective cohort study of all patients discharged after surgery for stomach cancer during 2001–2002 in four regions of Spain using the Minimum Basic Data Set for Hospital Discharges. The overall and specific in-hospital mortality rates were estimated according to patient and hospital characteristics. We adjusted a logistic regression model in order to calculate the in-hospital mortality according to hospital volume.ResultsThere were 3241 discharges in 144 hospitals. In-hospital mortality was 10.3% (95% CI 9.3–11.4). A statistically significant relation was observed among age, type of admission, volume, and mortality, as well as diverse secondary diagnoses or the type of intervention. Hospital annual volume was associated to Charlson score, type of admission, region, length of stay and number of secondary diagnoses registered at discharge. In the adjusted model, increased age and urgent admission were associated to increased in-hospital mortality. Likewise, partial gastrectomy (Billroth I and II) and simple excision of lymphatic structure were associated with a lower probability of in-hospital mortality. No independent association was found between hospital volume and in-hospital mortalityConclusionDespite the limitations of our study, our results corroborate the existence of patient, clinical, and intervention factors associated to greater hospital mortality, although we found no clear association between the volume of cases treated at a centre and hospital mortality.

Two-week dual vs. one-week triple therapy for cure of Helicobacter pylori infection in primary care: a multicentre, randomized trial

: One‐week triple therapy has been suggested to be superior to two‐week omeprazole‐clarithromycin therapy for the cure of Helicobacter pylori infection. However, direct comparisons of the two treatments are scarce.