Validation of a score to identify inpatients at risk of a drug-related problem during a 4-year period.

OBJECTIVE: Drug-related problems (DRP) produce high morbidity and mortality. It is therefore essential to identify patients at higher risk of these events. This study aimed to validate a DRP risk score in a large number of inpatients. MATERIAL AND METHODS: Validation of a previously designed score to identify inpatients at risk of experiencing at least one DRP in a tertiary university hospital from 2010 to 2013. DRP were detected by a pharmacy warning system integrated in the electronic medical record. The score included the following variables associated with a higher risk of DRP: prescription of a higher number of drugs, greater comorbidity, advanced age, specific ATC groups and certain major diagnostic categories. RESULTS: The study included a total of 52,987 admissions; of these, at least one DRP occurred in 14.9%. After validation of the score (period range, 2010-2013: 0.746-0.764), the area under the curve (AUC) was 0.751 (95% CI: 0.745-0.756). CONCLUSIONS: This value is higher than those reported in other studies describing validation of risk scores. The score showed good capacity to identify those patients at higher risk of DRP in a much larger sample of inpatients than previously described in the literature. This tool allows optimization of drug therapy monitoring in admitted patients.

Joint ultrasound baseline abnormalities predict a specific long-term clinical outcome in systemic lupus erythematosus patients.

Objective To describe long-term clinical and serological outcome in all systemic lupus erythematosus (SLE) domains in SLE patients with hand arthralgia (HA) and joint ultrasound (JUS) inflammatory abnormalities, and to compare them with asymptomatic SLE patients with normal JUS. Methods SLE patients with HA who presented JUS inflammatory abnormalities ('cases') and SLE patients without HA who did not exhibit JUS abnormalities at baseline ('controls') were included. All SLE clinical and serological domain involvement data were collected. End follow-up clinical activity and damage scores (systemic lupus erythematosus disease activity index (SLEDAI), Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR)) were recorded. JUS inflammatory abnormalities were defined based on the Proceedings of the Seventh International Consensus Conference on Outcome Measures in Rheumatology Clinical Trials (OMERACT-7) definitions. Statistical analyses were carried out to compare 'cases' and 'controls'. Results A total of 35 patients were recruited. The 'cases', n = 18/35, had a higher incidence of musculoskeletal involvement (arthralgia and/or arthritis) through the follow-up period (38.9% vs 0%, p = 0.008) and received more hydroxychloroquine (61.1% vs 25.0%, p = 0.034) and methotrexate (27.8% vs 0%, p = 0.046) compared to 'controls', n = 17/35. Other comparisons did not reveal any statistical differences. Conclusions We found SLE patients with arthralgia who presented JUS inflammatory abnormalities received more hydroxychloroquine and methotrexate, mainly due to persistent musculoskeletal involvement over time. JUS appears to be a useful technique for predicting worse musculoskeletal outcome in SLE patients.

Computerized pharmacy surveillance and alert system for drug-related problems.

WHAT IS KNOWN AND OBJECTIVE: Because of the impact of drug-related problems (DRPs) on morbidity and mortality, there is a need for computerized strategies to increase drug safety. The detection and identification of the causes of potential DRPs can be facilitated by the incorporation of a pharmacy warning system (PWS) in the computerized prescriber order entry (CPOE) and its application in the routine validation of inpatient drug therapy. A limited number of studies have evaluated a clinical decision support system to monitor drug treatment. Most of these applications have utilized a small range of drugs with alerts and/or types of alert. The objective of this study was to describe the implementation of a PWS integrated in the electronic medical record (EMR). METHODS: The PWS was developed in 2003-2004. Pharmacological information to generate drug alerts was entered on demographic data, drug dosage, laboratory tests related to the prescribed drug and drug combinations (interactions, duplications and necessary combinations). The PWS was applied in the prescription reviews conducted in patients admitted to the hospital in 2012. RESULTS AND DISCUSSION: Information on 83% of the drugs included in the pharmacopeia was introduced into the PWS, allowing detection of 2808 potential DRPs, representing 79·1% of all potential DRPs detected during the study period. Twenty per cent of PWS DRPs were clinically relevant, requiring pharmacist intervention. WHAT IS NEW AND CONCLUSION: The PWS detected most potential DRPs, thus increasing inpatient safety. The detection ability of the PWS was higher than that reported for other tools described in the literature.

Do surgical expectations change depending on first time surgery or reoperation? A prospective cohort study in lumbar spine surgery.

PURPOSE: To assess whether patients undergoing lumbar spine surgery for the first time (Group 1) had different expectations from those undergoing lumbar spine surgery for a failed previous procedure (Group 2). METHODS: A prospective study that included 77 patients. A set of self-reported questionnaires was pre-operatively administered including VAS, Oswestry Disability Index (ODI), Zung Depression Scale and the NASS lumbar spine questionnaire (expectations scale). RESULTS: Fifty-six patients in Group 1 and 21 patients in Group 2. Both groups had high expectations with regard to the surgical procedure (n.s.). Depressed patients, despite being more disabled than non-depressed according to ODI (p 0.001), had similar expectations than non-depressed patients (n.s.). CONCLUSION: Patients' expectations remained very high despite having had a failed previous surgery for the same procedure.

An ergonomic study of single-port versus multi-port laparoscopic mesh insertion for ventral hernia repair.

PURPOSE: To assess the mental effort and physical discomfort of placement of a prosthetic mesh into the abdominal cavity with single-incision laparoscopic surgery (SILS) or multi-port laparoscopic access for incisional ventral hernia repair. METHODS: A total of 10 surgeons with previous experience in conventional laparoscopic surgery performed four surgical tasks through a multi-port laparoscopic access and a SILS access in a porcine model during a first 4-hour working session and a second 2-hour working session. These tasks included (a) introduction of a prosthetic mesh for abdominal wall surgery, (b) manipulation of the mesh inside the abdomen, (c) manipulation of the laparoscopic instruments and (d) mesh insertion to the intraperitoneal abdominal wall and fixation with tackers. The level of mental effort was assessed with the Subjective Mental Effort Questionnaire (SMEQ) and physical discomfort with the Local Experienced Discomfort Scale (LED). RESULTS: Seventy percent were men, with a mean age of 45 years and a mean of 18 years of experience in practicing surgery. The SMEQ questionnaire showed a median physical effort of 24.4 (range 9-36.1) points for the multi-port laparoscopic access and 107.4 (range 74.7-128.4) for SILS (p < 0.01). Statistically significant differences between multi-port laparoscopic surgery and SILS were consistently demonstrated in all tasks as well as in both the 4-hour and 2-hour working sessions. The median (interquartile range) score of the LED scale was 12.5 (2-34.5) for tasks during multi-port laparoscopic surgery and 53.5 (29-89.2) for SILS (p < 0.001). All individual tasks were associated with a significantly higher physical effort for SILS than for conventional laparoscopic access, which were also independent of being performed during the 4-hour or 2-hour working periods. CONCLUSIONS: Placement and manipulation of a prosthetic mesh for incisional ventral hernia repair is more difficult with SILS than using multi-port laparoscopic access, independently of previous experience with standard laparoscopic techniques. This greater difficulty was observed both in terms of mental effort and physical discomfort. More experimental and clinical studies are needed to define specific training aspects and clinical advantages of incisional ventral hernia repair through SILS.

Determinants of mortality in cancer patients with unscheduled admission to the Intensive Care Unit: A prospective multicenter study.

OBJECTIVES: To analyze clinical features associated to mortality in oncological patients with unplanned admission to the Intensive Care Unit (ICU), and to determine whether such risk factors differ between patients with solid tumors and those with hematological malignancies. DESIGN: An observational study was carried out. SETTING: A total of 123 Intensive Care Units across Spain. PATIENTS: All cancer patients with unscheduled admission due to acute illness related to the background oncological disease. INTERVENTIONS: None. MAIN VARIABLES: Demographic parameters, severity scores and clinical condition were assessed, and mortality was analyzed. Multivariate binary logistic regression analysis was performed. RESULTS: A total of 482 patients were included: solid cancer (n=311) and hematological malignancy (n=171). Multivariate regression analysis showed the factors independently associated to ICU mortality to be the APACHE II score (OR 1.102; 95% CI 1.064-1.143), medical admission (OR 3.587; 95% CI 1.327-9.701), lung cancer (OR 2.98; 95% CI 1.48-5.99) and mechanical ventilation after the first 24h of ICU stay (OR 2.27; 95% CI 1.09-4.73), whereas no need for mechanical ventilation was identified as a protective factor (OR 0.15; 95% CI 0.09-0.28). In solid cancer patients, the APACHE II score, medical admission, antibiotics in the previous 48h and lung cancer were identified as independent mortality indicators, while no need for mechanical ventilation was identified as a protective factor. In the multivariate analysis, the APACHE II score and mechanical ventilation after 24h of ICU stay were independently associated to mortality in hematological cancer patients, while no need for mechanical ventilation was identified as a protective factor. Neutropenia was not identified as an independent mortality predictor in either the total cohort or in the two subgroups. CONCLUSIONS: The risk factors associated to mortality did not differ significantly between patients with solid cancers and those with hematological malignancies. Delayed intubation in patients requiring mechanical ventilation might be associated to ICU mortality.

Postoperative serum Vascular Endothelial Growth Factor is an independent prognostic factor of disease free survival and overall survival in patients with non metastatic colon cancer.

BACKGROUND: Angiogenesis is essential for tumor growth and formation of metastasis. VEGF is the most potent agiogenic citokine. The aim was to investigate the predictive value of postoperative VEGF serum concentration in patients undergoing surgery for colon cancer. METHODS: Consecutive patients with colon cancer undergoing surgery with curative intent were included. VEGF was measured in serum at 48 h and postoperative day 4. Cox proportional hazards model was used to estimate its contribution with prognosis. RESULTS: A total of 94 patients were included. On multivariate analysis VEGF on postoperative day 4 (HR: 1.05; p = 0.011) was independent prognostic factor of decreased DFS and OS. Five-year DFS (57.7% vs. 85%; p = 0.001) and OS (93% vs. 72%; p = 0.005) were significantly lower in patients with postoperative serum VEGF greater than 370 pg/dl. CONCLUSION: Postoperative VEGF serum concentration was an independent predictor of recurrence. These results must be verified in a prospective independent testing cohort.

Prognostic impact of CD133 expression in Endometrial Cancer Patients.

To assess the impact of CD133 expression on the prognosis of endometrioid endometrial carcinoma (EEC). We retrospectively assessed CD133 expression in tissue microarray of 116 surgically treated FIGO I-III EEC. Tumors with ≥10% of CD133-expressing cells were considered CD133-positive (CD133+). On the basis of CD133 expression, clinical and pathological parameters, progression-free survival (PFS) and overall survival (OS) were evaluated. Of the EEC studied 85.2% showed CD133-expressing cells. Only 61% (n = 66) of EEC presented ≥10% of CD133 expressing cells and were considered CD133+. The mean OS for CD133+ tumour patients was 161 months (95% CI, 154-168) as compared with 146 months (95% CI, 123-160) for those with CD133- tumors (p = 0.012). The mean PFS for CD133+ tumour was 159 months (95% CI, 149-168) as compared with 147 months (95% CI, 132-161) in those with a CD133-tumour (p = 0.014). CD133+ tumours were less likely to have vascular invasion (p = 0.010) and more likely to be well differentiated (p = 0.034). C133+ tumours predicted favorable OS and PFS of EEC patients, with a Hazard Ratio 4.731 (95% CI, 1.251-17.89; p = 0.022). CD133+ tumor status correlates with favorable prognosis of EEC. Our findings are in agreement with studies addressing brain and colorectal tumours.

[Lung cancer at a university hospital: epidemiological and histological characteristics of a recent and a historical series]. / Características del cáncer de pulmón en un hospital universitario. Cambios epidemiológicos e histológicos en relación con una serie histórica.

OBJECTIVE: To describe the clinical, histological, and epidemiological characteristics of patients diagnosed with lung cancer in our hospital over a period of 5 years and compare them with those of historical cases treated at the same hospital. PATIENTS AND METHODS: The cases of patients diagnosed with lung cancer from January 1998 through December 2002 were studied retrospectively and compared with data published for the period from 1978 through March 1981. RESULTS: A total of 678 patients (89% men, mean age 67 years) were studied. Fifty-six percent of the men and 38% of the women were smokers (P<.001). The most common histological types were squamous cell carcinoma (33%) and adenocarcinoma (30%): squamous carcinoma in men (36%) and adenocarcinoma in women (56%). Metastasis was present in 42% of the patients with non-small cell lung cancer and in 55% of those with small cell lung cancer. In patients with a history of neoplastic disease, laryngeal tumors were most common in patients with squamous carcinoma whereas bladder tumors were the most frequent in patients with adenocarcinoma. The ratio of men to women was lower in the recent series than in the historical one. The percentage of squamous carcinoma was lower and that of adenocarcinoma higher (P<.001). The percentage of patients diagnosed with regional involvement was greater in the recent series (P<.001). CONCLUSIONS: Squamous cell carcinoma continues to be the most frequent histological type. Male sex and smoking are associated with squamous carcinoma and female sex is associated with adenocarcinoma. Epidemiological and histological patterns have changed, possibly in relation to changes in smoking habits.

Stickler syndrome. Epidemiology of retinal detachment.

OBJECTIVE: A review was performed on all patients with Stickler syndrome that had been treated in our Centre since it was diagnosed, in order to evaluate the risk of suffering a retinal detachment (RD). METHODS: A total of 14 patients, diagnosed by clinical criteria, were included. The following variables were evaluated: age, gender, ocular background, follow-up, initial and final visual acuity (VA), optical prescription, prophylactic treatment, surgery and techniques performed. The risk age to suffer a RD, as well as cataracts, was determined by using the Kaplan-Meier survival curve analysis. RESULTS: From a total of 5 men and 9 women, the median initial VA was 0.35, which was the same as the final VA. The median optical prescription was -9.5 D myopia. The median of follow-up was 7 years. Ocular background was 4 RD cases and 2 Lasik surgeries. The operations performed were 8 RD, 12 cataract, 2 glaucoma, 2 macular hole, and one endotropia. The median age of RD was 20 years and cataract 34 years. As regards surgical tecnique, 4 scleral buckle cases, and 4 scleral buckle+pars plana vitrectomy cases were formed. The prophylactic treatments performed were: one scleral buckle case, 4 endolaser photocoagulation, and one cryotherapy. Two of which presented with RD. CONCLUSION: In the series presented, retinal detachment in Stickler syndrome mainly occurs in the second decade of life, with cataracts mainly developing in the fourth decade.

Postoperative intra-abdominal infection and colorectal cancer recurrence: a prospective matched cohort study of inflammatory and angiogenic responses as mechanisms involved in this association.

BACKGROUND: Anastomotic leakage is associated with higher rates of recurrence after surgery for colorectal cancer. However, the mechanisms responsible are unknown. The aim was to investigate the inflammatory and angiogenic responses in patients undergoing surgery for colorectal cancer who had postoperative intra-abdominal infection, and to compare the results with patients without complications. METHODS: Consecutive patients undergoing surgery for colorectal cancer with curative intent were included. Patients who had an anastomotic leak or intra-abdominal abscess were included in the infection group and matched with patients who had an uncomplicated postoperative course. IL-6 and VEGF were measured in serum and peritoneal fluid. RESULTS: Serum concentration of IL-6 was higher in the infection group (n = 30) compared with the control group (n = 30) on day 4 (infection: 42.3 [27.6-1473.2] versus control: 0.6 [0.6-17.1] pg/ml; p = 0.008). IL-6 in peritoneal fluid was higher in the infection group at 48 h and day 4 (infection: 1000.2 [995.4-1574.0] versus control: 90.3 [35.2.6-106.1] pg/ml; p = 0.001). Serum VEGF was higher in the infection group on day 4 (infection: 1128.6 [427.3-10000.0] versus control: 438.3 [214.1-677.6] pg/ml; p = 0.001). Peritoneal VEGF concentration was higher in the infection group at 48 h and day 4 (infection: 10000.0 [2563.0-10000.0] versus control: 477.8 [313.5-814.4] pg/ml; p = 0.001). Two-year recurrence rate was higher in patients with infection (infection: 30% versus control: 4%; p = 0.001). CONCLUSIONS: Intra-abdominal infection increases IL-6 and VEGF after surgery for colorectal cancer. Amplification of inflammation and angiogenesis might be one of the mechanisms responsible for the higher recurrence rate observed in patients with anastomotic leakage or intra-abdominal abscess.

Perfusion SPECT, SISCOM and PET (18)F-FDG in the assessment of drug- refractory epilepsy patients candidates for epilepsy surgery.

AIMS: Brain perfusion SPECT (ictal-interictal), SPECT images and subtraction ictal SPECT coregistered to MRI (SISCOM) and (18)F-FDG-PET (interictal), play an important role in the pre-surgical diagnosis of patients with medically refractory epilepsy. This study aimed to establish: the reproducibility of visual ictal-interictal SPECT and SISCOM analysis altogether with the capacity of SPECT, SISCOM and PET to determine the epileptogenic zone. MATERIAL AND METHODS: (99m)Tc-HMPAO SPECT ictal-interictal and SISCOM (Analyze 7.0) were performed on 47 refractory epilepsy patients (24 F, 19-60 yrs). In 13 patients, SISCOM was also performed using a new program (Focus DET). Ictal-interictal SPECT and SISCOM images were analysed independently by two nuclear medicine physicians (observer 1 and 2). Kappa concordance coefficient was used to evaluate the reproducibility. In sixteen patients, SPECT, SISCOM and PET findings were compared with the resected area during the surgery, and surgical outcome using Engel scale or with the stereo EEG-(SEEG). RESULTS: The ictal-interictal SPECT interobserver agreement was 91%, Kappa index 0.86, SISCOM (Analyze 7.0) interobserver agreement percentage was 82%, Kappa index 0.80, Analyze 7.0 showed a higher inconclusive results than visual SPECT analysis. SISCOM FocusDET interobserver agreement was 92%, Kappa index 0.87, with lower inconclusive results than Analyze 7.0. SPECT, SISCOM and PET combined findings identified 87% seizure onset zone: 79% temporal, 26% parieto-temporal and 7% frontal. CONCLUSIONS: Ictal-interictal SPECT and SISCOM showed a high reproducibility in this sample of patients with drug-refractory epilepsy. SPECT,SISCOM and PET combined findings improved detection of epileptogenic zone in comparison with the individual assessment.

[Interobserver agreement in the visual and semi-quantitative analysis of the 123I-FP-CIT SPECT images in the diagnosis of Parkinsonian syndrome]. / Concordancia interobservador en el análisis visual y semicuantitativo de las imágenes SPECT (123)I-FP-CIT en el diagnóstico del síndrome parkinsoniano.

AIMS: Using (123)I-FP-CIT SPECT images makes it possible to identify presynaptic deterioration of the dopaminergic pathway by studying the dopamine transporter (DAT). A correct analysis of the SPECT images contributes to an adequate interpretation and diagnosis of movement disorders. Aims: 1. To compare visual and semiquantitative analysis of (123)I-FP-CIT SPECT images in patients with movement disorders. 2. To evaluate interobserver agreement in visual and semiquantitative analysis. 3. To obtain a cut-off in the semiquantitative analysis to discriminate primary Parkinsonism Syndrome (PS) from non-primary PS. METHODS: A (123)I-FP-CIT SPECT was performed in 32 patients with movement disorders suggestive of primary PS. Visual and semiquantitative images analyses were performed independently by two nuclear medicine physicians. Visual analysis was based on the visual interpretation. Semiquantitative analysis was calculated as specific uptake (caudate, putamen and striatum) versus non-specific uptake (occipital). Sensitivity, specificity, PPV, and NPV were calculated. Data were compared using ANOVA test followed by Bonferroni post-hoc test. Interobserver agreement of the visual and semiquantitative analysis was assessed by intraclass correlation coefficient and Kappa statistics, respectively. ROC curve was generated with semiquantitative data. RESULTS: Visual analysis showed 86% sensitivity and 100-88% specificity for the differential diagnosis of primary PS from non-primary PS. Semiquantitative analysis showed a gradual hypo-uptake proportional to the disease severity obtained in the visual analysis. Semiquantitative analysis did not provide any additional information to the visual analysis. Intraclass correlation coefficient and Kappa statistics showed 0.92 and 0.80 values, respectively. The Cut-off value to differentiate primary PS from non-primary PS was 1.9 on the putamen index.

Effect of subcentimeter nonpositive resection margin on hepatic recurrence in patients undergoing hepatectomy for colorectal liver metastases. Evidences from 663 liver resections.

OBJECTIVE: To elucidate if a nonpositive <1-cm resection margin has any effect on hepatic recurrence in patients undergoing liver resection for colorectal liver metastases. PATIENTS AND METHODS: Six hundred and nine patients underwent 663 liver resections. Patients with positive margin were excluded from the analysis. Two groups were studied: group A, <1-cm resection margin and group B, > or =1-cm resection margin. RESULTS: A total of 545 liver resections in 523 patients were carried out with nonpositive resection margins. With a median follow-up of 25 months, the 5-year cumulative hepatic recurrence reached 54% in group A (n = 206) and 41% in group B (n = 339). Factors associated with hepatic recurrence were synchronic metastases (P = 0.0015), bilobar (P < 0.001), two or more metastases (P < 0.001), margin <1 cm (P = 0.0123) and extrahepatic disease (P = 0.0037). A strong correlation between resection margin and number of metastases was confirmed (P < 0.001). At multivariate analysis only two factors were independent predictors of hepatic recurrence: multinodular disease in the liver specimen [> or =4 metastases hazard ratio (HR) = 3.45; 95% confidence interval (CI): 2.2-5.38; P < 0.001] and extrahepatic disease at hepatectomy (HR = 1.58; 95% CI: 1.58-3.32). CONCLUSION: Subcentimeter nonpositive resection margins do not directly influence hepatic recurrence in patients undergoing hepatectomy for colorectal liver metastases.