[Detection of adverse events in thyroid and parathyroid surgery using trigger tool and Minimum Basic Data Set (MBDS)]. / Detección de eventos adversos en la cirugía tiroidea y paratiroidea utilizando la herramienta trigger y el Conjunto Mínimo de Datos Básicos (CMBD).

OBJECTIVES: To compare the ability of the trigger tool) and the Minimum Basic Data Set (MBDS) in detecting adverse events (AE) in hospitalized surgical patients with thyroid and parathyroid disease. METHODS: A descriptive, cross-sectional observational study, retrospective and cross-sectional study was conducted from May 2014 to April 2015 analysing retrospectively data on of patients submitted to thyroidectomy and parathyroidectomy in order to detect AE through the identification of triggers (an event often associated to an AE) and the MBDS. triggers and AE were located by systematic review of clinical documentation. The MBDS was got from the data base. Once an AE was detected, it was characterized. RESULTS: 203 AE were identified in 251 patients, being the 90.04% detected by trigger tool and 10.34% by MBDS. 126 patients had at least one AE (50.2%). Without the cases in which uncontrolled pain was the only AE, the percentage of patients that suffering AE was 38.65%. 187 AE were considered preventable and 16 AE were considered unpreventable. The trigger tool and the MBDS demonstrated a sensitivity of 91.27 and 13.49%, a specificity of 4.8 and 100%, a positive predictive value of 49,15 and 100%, and a negative predictive value of 35.29 and 53.42%, respectively. The triggers with more predictive power in AE detection were «antiemetic administration¼ and «calcium administration¼. CONCLUSIONS: Trigger tool shows higher sensitivity for detecting AE than the MBDS. All the detected AE were considered low severity and most of them were preventable.

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. / Comparación de la herramienta Trigger con el conjunto mínimo básico de datos (CMBD) para la detección de eventos adversos en cirugía general.

INTRODUCTION: Surgery is a high risk for the occurrence of adverse events (AE). The main objective of this study is to compare the effectiveness of the Trigger tool with the Hospital National Health System registration of Discharges, the minimum basic data set (MBDS), in detecting adverse events in patients admitted to General Surgery and undergoing surgery. MATERIAL AND METHODS: Observational and descriptive retrospective study of patients admitted to general surgery of a tertiary hospital, and undergoing surgery in 2012. The identification of adverse events was made by reviewing the medical records, using an adaptation of "Global Trigger Tool" methodology, as well as the (MBDS) registered on the same patients. Once the AE were identified, they were classified according to damage and to the extent to which these could have been avoided. The area under the curve (ROC) were used to determine the discriminatory power of the tools. The Hanley and Mcneil test was used to compare both tools. RESULTS: AE prevalence was 36.8%. The TT detected 89.9% of all AE, while the MBDS detected 28.48%. The TT provides more information on the nature and characteristics of the AE. The area under the curve was 0.89 for the TT and 0.66 for the MBDS. These differences were statistically significant (P<.001). CONCLUSIONS: The Trigger tool detects three times more adverse events than the MBDS registry. The prevalence of adverse events in General Surgery is higher than that estimated in other studies.

Composite anatomical-clinical-molecular prognostic model in non-small cell lung cancer.

The objective of the present study was to elaborate a survival model that integrates anatomic factors, according to the 2010 seventh edition of the tumour, node and metastasis (TNM) staging system, with clinical and molecular factors. Pathologic TNM descriptors (group A), clinical variables (group B), laboratory parameters (group C) and molecular markers (tissue microarrays; group D) were collected from 512 early-stage nonsmall cell lung cancer (NSCLC) patients with complete resection. A multivariate analysis stepped supervised learning classification algorithm was used. The prognostic performance by groups was: areas under the receiver operating characteristic curve (C-index): 0.67 (group A), 0.65 (Group B), 0.57 (group C) and 0.65 (group D). Considering all variables together selected for each of the four groups (integrated group) the C-index was 0.74 (95% CI 0.70-0.79), with statistically significant differences compared with each isolated group (from p = 0.006 to p < 0.001). Variables with the greatest prognostic discrimination were the presence of another ipsilobar nodule and tumour size > 3 cm, followed by other anatomical and clinical factors, and molecular expressions of phosphorylated mammalian target of rapamycin (phospho-mTOR), Ki67cell proliferation index and phosphorylated acetyl-coenzyme A carboxylase. This study on early-stage NSCLC shows the benefit from integrating pathological TNM, clinical and molecular factors into a composite prognostic model. The model of the integrated group classified patients with significantly higher accuracy compared to the TNM 2010 staging.

Malignancy after liver transplantation: cumulative risk for development.

BACKGROUND: Solid organ recipients are at high risk to develop malignancies due to the complex interactions of several factors, constituting a major cause of late death after transplantation. PATIENTS AND METHODS: We retrospectively reviewed an historic cohort of adult liver recipients from cadaveric donors (multiorgan recipients excluded) performed from 1986-2002 with a minimum follow-up of 36 months. The Kaplan-Meier method was used to assess cumulative risk to develop malignancy and survival analyses. RESULTS: Among the 528 patients undergoing orthotopic liver transplantation (OLT) with a mean follow-up of 2400 days, 98 developed cancer among which 25% were skin malignancies. Sixty-seven patients developed at least 1 noncutaneous malignancy, an overall incidence of 12.7%. Eighteen percent suffered from posttransplant lymphoproliferative disease; 14%, lung cancer; 4%, Kaposi's sarcoma; 7%, genitourinary malignancies; and 17%, oropharyngeal or laryngeal cancer. The cumulative patient risks to develop noncutaneous malignancies at 5, 10, and 15 years posttransplantation were 9% (confidence interval [CI]: 0.06-0.11), 18% (CI: 0.14-0.23), and 25% (CI: 0.18-0.31), respectively. CONCLUSIONS: OLT recipients are at higher risk to develop malignancies after transplantation, reaching a cumulative risk of 25% at 15 years. Long-term surveillance measures and screening programs must be seriously conducted for selected groups.

Control of diabetes and cardiovascular risk factors in patients with type 2 diabetes in primary care. The gap between guidelines and reality in Spain.

To evaluate the level and factors affecting control of diabetes and cardiovascular risk factors in type 2 diabetes (TYPE 2 DM) patients. Multicentre cross-sectional study: a sample of 430 primary care practices across Spain selected 1907 type 2 diabetic patients. The first five consecutive ambulatory patients with TYPE 2 DM were eligible for the inclusion into the survey. Patients were free of known cardiovascular disease (CVD). Control criteria were defined based on 2002 American Diabetes Association (ADA) clinical practice recommendations. A total of 1907 patients (51% women) aged 63 +/- 9 years. Smoking prevalence was 22.6%, 50.6% had levels of A1c < 7%. Mean blood pressure (BP) was 148 +/- 17/86 +/- 10 mmHg. Only 7.8% have achieved the target of BP < 130/80 mmHg. Among the 1180 patients (65%) treated for hypertension, this target was attained in only 4.4% of patients. A measurement for low-density lipoprotein (LDL) cholesterol was available in 1669 patients (88%). Only 5.9% of patients achieved the target of LDL < 100 mg/dl. Among the 638 patients (41.6%) on drug treatment for dyslipidaemia, this target was attained in only 5.6% of patients. Among type 2 diabetic patients in Spain the prevalence of cardiovascular risk factors is high. Control of glycaemia, smoking, BP and LDL are far from optimal despite the widespread use of guidelines for the management of diabetes and CVD. The application of published recommendations needs to be reinforced.

[The Will-Rogers phenomenon. Stage migration in bronchogenic carcinoma after applying certainty criteria]. / El fenómeno Will-Rogers. Migración de estadios en carcinoma broncogénico, tras aplicar criterios de certeza clasificatoria.

OBJECTIVE: To quantify changes in tumor-node-metastasis (TNM) staging (numerical migration) and survival (prognostic migration) that arise when certainty criteria are applied to a patient population with non-small cell lung cancer (NSCLC) treated surgically. METHODS: The population consisted of 1,844 patients with NSCLC who underwent surgery between 1993 and 1996 at hospitals participating in the Bronchogenic Carcinoma Co-operative Group of the Spanish Society of Pneumology and Thoracic Surgery (GCCB-S). For every patient, surgical-pathological TNM staging (p) was based on two classifications: initial staging by each participating GCCB-S center (pTNM-i) and a second classification bearing greater classificatory certainty (pTNM-cc) resulting from the application of stricter criteria. Numerical migration was said to have occurred in cases where the two classifications did not coincide, and the possible prognostic migration under the new staging was then assessed. RESULTS: The results revealed great numerical migration in the pN0 classification (from 1,091 cases to 665). The changes did not result in prognostic migration either for the group as a whole or for pT1-2N0M0 cases. However, for pT3N0M0 cases, median survival increased by 13 months. The difference in three-year survival (S3) for pT3N0M0-i without certainty confirmation [S3 = 0.30 (95%CI 0.18-0.42), n=59] and pT3N0M0-cc [S3=0.54 (95%CI = 0.44-0.64), n = 92] was significant (log-rank, p = 0.035). Such behavior was not observed for pT1-2N0M0. CONCLUSIONS: The numerical migration observed as a result of applying surgical-pathological classificatory certainty criteria is relevant but the prognostic repercussion is scarce, except in cases classified as pT3N0M0, in which a significant positive prognostic migration is observed (the "Will Rogers phenomenon").

Validation of a central review board of staging prior to surgery for non-small-cell lung cancer--impact on prognosis: a multicenter study.

BACKGROUND: In non-small-cell lung cancer (NSCLC), the evaluation of anatomic tumor extension [tumor, node, metastasis (TNM) stage] is indispensable for the exchange of scientific information or determining prognosis. OBJECTIVE: To quantify changes in TNM stages (numerical migration) and survival (prognostic migration) resulting from the application of classificatory certainty criteria to patients with NSCLC who had undergone surgical treatment. METHODS: The study population included 1,844 patients registered by the Bronchogenic Carcinoma Cooperative Group of the Spanish Society of Pneumology and Thoracic Surgery (GCCB-S). For every patient, two evaluations were made of each component of the TNM classification: an initial classification, defined by a local representative, and a confirmed classification resulting from the application of stricter classificatory criteria by the GCCB-S Central Review Board. RESULTS: The results revealed scant numerical migration in the cT category (11.5% of the study population) and a general tendency toward a downstaging. In contrast, the initial cN1 category experienced a complete numerical migration and the initial cN2 category a very large numerical migration (from 200 to 22 cases). In the small group of patients for whom there was a classificatory change in cT (n = 212), the migration for the cT2 category was accompanied by a less favorable prognosis (p = 0.039, log-rank test). However, the migration of this small subset of patients did not affect the general prognosis of the study population for cT2. In cN2, the 3-year survival rate migrated from 0.42 to 0.29. CONCLUSIONS: Numerical migration resulting from the application of stricter classificatory criteria was relevant, but had little, although unfavorable, global prognostic impact.

Impact of mild pulmonary hypertension on mortality and pulmonary artery pressure profile after heart transplantation.

BACKGROUND: Pulmonary hypertension is a risk factor for early mortality after transplantation, but the risk threshold is debated. Also, little is known about the evolution of pulmonary circulation after transplantation. The aim of this study was to determine the influence of current risk pulmonary pressure parameters on early post-operative mortality and to assess the time-related changes in pulmonary pressure after surgery. METHODS: One hundred twelve consecutive transplanted patients were studied retrospectively to determine the influence of trans-pulmonary gradient of >12 mm Hg and pulmonary vascular resistance of >2.5 Wood units, at baseline or after vasodilator test, on early mortality. A multivariate analysis was used to study the hemodynamic parameters associated with early mortality. The pulmonary pressures of all surviving patients were studied for up to 3 years after surgery. RESULTS: Early mortality in the groups with and without pulmonary hypertension were 24.4% and 5.6%, respectively (p =.009). The only variable that was independently associated with early mortality was the pulmonary vascular resistance index (odds ratio = 1.459). Mild pulmonary hypertension disappeared 1 year after heart transplantation. CONCLUSIONS: Mild pulmonary hypertension is a risk factor for early postoperative mortality. The hemodynamic parameter most closely associated with early mortality is pulmonary vascular resistance index. The hemodynamic profile of pulmonary circulation after heart transplantation is partially dependent on the level of pulmonary hypertension before transplantation, at least during the first year after surgery.

Epidemiologic evidence for a new class of compounds associated with toxic oil syndrome.

Toxic oil syndrome appeared in epidemic form in Spain in 1981. Epidemiologic studies have demonstrated that illness was caused by consumption of rapeseed oil that had been denatured with aniline. Chemical analyses of oil specimens conducted in conjunction with epidemiologic studies have established that consumption of specific oils containing fatty acid anilide contaminants was associated with increased risk for disease. New chemical analytic methods identified a family of compounds, the di-fatty acid esters of phenylamino propane-diol, and one of these compounds, the 1,2-di-oleyl ester of 3-(N-phenylamino)-1,2-propanediol (DPAP), has been found to be more strongly associated with disease status than the fatty acid anilides. We found the odds ratio for exposure to DPAP (OR = 26.4, 95% CI = 6.4-76.3) is much higher than the odds ratio for exposure to oleyl anilide (OR = 4.1, 95% CI = 2.2-7.8), implying that exposure to DPAP was a more relevant risk factor for development of toxic oil syndrome than exposure to oleyl anilide. In this paper, we review and present analyses of data from multiple studies of the possible etiologic role of DPAP in toxic oil syndrome. The presence of DPAP in oil collected from affected and unaffected households was a more specific correlate of case relatedness than was the presence of fatty acid anilides, and it was equally sensitive. Moreover, DPAP was found in oil from the only refinery whose oil was clearly associated with illness.

Health status measurement in Toxic Oil Syndrome.

Toxic Oil Syndrome (TOS) is a previously unreported condition which affected more than 20,000 people in Spain in 1981 and whose natural history is unknown. In 1993-94, a stratified random sample of 1400 survivors was drawn to measure their health status through clinical examination and their self-perception of well-being through the Nottingham Health Profile Questionnaire (NHPQ). Two-thirds of the sample population responded; indirect estimates suggest that selection bias was limited. Clear and intermediate signs of neuropathy were found in one-fifth and one-half of the patients, respectively. One-fourth and one-sixth showed some degree of scleroderma and contractures. All conditions were more frequent in women than in men and in age >50 than in younger ages. Although no concurrent control group was included in the study, prevalences of these conditions are well above expectations and are largely attributable to TOS. NHPQ scores increased with age in both sexes up to age 50, after which they reached a plateau (with values around 48 in men and 62 in women). Scores were associated to the occurrence of peripheral neurological changes, contractures, and scleroderma-like conditions. A multivariate analysis indicated age, sex, and severity of neurological conditions as major determinants of the NHPQ scores. This overall pattern of findings is peculiar to TOS and differs from the typical post-disaster nonspecific syndrome.

Toxic oil syndrome mortality: the first 13 years.

BACKGROUND: The toxic oil syndrome (TOS) epidemic that occurred in Spain in the spring of 1981 caused approximately 20000 cases of a new illness. Overall mortality and mortality by cause in this cohort through 1994 are described for the first time in this report. METHODS: We contacted, via mail or telephone, almost every living member of the cohort and family members of those who were known to have died in order to identify all deaths from 1 May 1981 through 31 December 1994. Cause of death data were collected from death certificates and underlying causes of death were coded using the International Classification of Diseases, 9th Revision. RESULTS: We identified 1663 deaths between 1 May 1981 and 31 December 1994 among 19 754 TOS cohort members, for a crude mortality rate of 8.4%. Mortality was highest during 1981, with a standardized mortality ratio (SMR) of 4.92 (95% confidence interval [CI]: 4.39-5.50) compared with the Spanish population as a whole. The highest SMR, (20.41, 95% CI: 15.97-25.71) was seen among women aged 20-39 years during the period from 1 May 1981 through 31 December 1982. Women <40 years old, who were affected by TOS , were at greater risk for death in most time periods than their unaffected peers, while older women and men were not. Over the follow-up period, mortality of the cohort was less than expected when compared with mortality of the general Spanish population, or with mortality of the population of the 14 provinces where the epidemic occurred. We also found that, except for deaths attributed to external causes including TOS and deaths due to pulmonary hypertension, all causes of death were decreased in TOS patients compared to the Spanish population. The most frequent underlying causes of death were TOS, 350 (21.1%); circulatory disorders, 536 (32.3%); and malignancies, 310 (18.7%). CONCLUSIONS: We conclude that while on average people affected by toxic oil syndrome are not at greater risk for death over the 13-year study period than any of the comparison groups, women <40 years old were at greater risk of death.

Toxic oil syndrome: traceback of the toxic oil and evidence for a point source epidemic.

Rapeseed oil denatured with aniline was the vehicle of the causal agent of the toxic oil syndrome (TOS) epidemic that occurred in Spain in 1981. Although the precise aetiologic agent remains unknown, researchers established that increasing concentrations of oleyl anilide and other fatty acid anilides were associated with an increased risk for disease. To examine the hypothesis that 5-litre plastic containers of rapeseed oil associated with TOS, and which contained oleyl anilide had a characteristic shape, we measured fatty acid, sterol and fatty acid anilide levels in oil from containers of different shapes. We identified 1673 bottles of oil that had been collected during the Spanish Government's oil exchange programme and linked these bottles to people with TOS as reported in the official government census of patients with TOS. Although rapeseed oil (identified by the presence of brassicasterol) was found in 798 (47.7%) of the 1673 bottles examined, contamination with fatty acid anilide occurred in only 329 (19.6%) of the 1673 bottles and 319 (97%) of the 329 were oil containers of the shape sold by RAELCA, an oil company in Madrid. The first aniline-denatured oil that RAELCA had purchased to be refined specifically for distribution was refined at the ITH refinery of Seville, and this oil has been most directly associated with the epidemic. Previous work has shown that the only toxic oil linked to a specific refinery was that associated with rapeseed oil from the ITH refinery in Seville, and the epidemic began shortly after this oil was delivered to RAELCA for retail sale. On the basis of these findings, we conclude that oil refined by ITH and distributed by RAELCA was the principal, and probably the only, oil responsible for the TOS epidemic. Information about the history and treatment of this oil may yield important clues towards identifying the aetiologic agent of TOS.