Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial.

BACKGROUND: Postoperative pulmonary complications (PPC) are the most frequent postoperative complications, with an estimated prevalence in elective surgery ranging from 20% in observational cohort studies to 40% in randomized clinical trials. However, the prevalence of PPCs in patients undergoing emergency abdominal surgery is not well defined. Lung-protective ventilation aims to minimize ventilator-induced lung injury and reduce PPCs. The open lung approach (OLA), which combines recruitment manoeuvres (RM) and positive end-expiratory pressure (PEEP) titration, aims to minimize areas of atelectasis and the development of PPCs; however, there is no conclusive evidence in the literature that OLA can prevent PPCs. The purpose of this study is to compare an individualized perioperative OLA with conventional standardized lung-protective ventilation in patients undergoing emergency abdominal surgery with clinical signs of intraoperative lung collapse. METHODS: Randomized international clinical trial to compare an individualized perioperative OLA (RM plus individualized PEEP and individualized postoperative respiratory support) with conventional lung-protective ventilation (standard PEEP of 5 cmH2O and conventional postoperative oxygen therapy) in patients undergoing emergency abdominal surgery with clinical signs of lung collapse. Patients will be randomised to open-label parallel groups. The primary outcome is any severe PPC during the first 7 postoperative days, including: acute respiratory failure, pneumothorax, weaning failure, acute respiratory distress syndrome, and pulmonary infection. The estimated sample size is 732 patients (366 per group). The final sample size will be readjusted during the interim analysis. DISCUSSION: The Individualized Perioperative Open-lung Ventilatory Strategy in emergency abdominal laparotomy (iPROVE-EAL) is the first multicentre, randomized, controlled trial to investigate whether an individualized perioperative approach prevents PPCs in patients undergoing emergency surgery.

[Effectiveness of thromboprophylaxis with low molecular weight heparin in critically ill patients with COVID-19. An observational prospective, multicenter study]. / Eficacia de la tromboprofilaxis con heparina de bajo peso molecular en pacientes críticos con COVID-19: estudio observacional, prospectivo y multicéntrico.

Introduction: COVID-19 induces coagulopathy associated with an increase of thromboembolic events. Due to the lack of agreement on recommendations for thromboprophylactic management, the aim of this study was to study the dosages of LMWH used in critically ill COVID-19 patients assessing the effect on their outcome. Metohds: We evaluated data of the Reg-COVID19. According to LMWH dose two groups were analyzed: prophylaxis and treatment. Primary outcome was the relationship of LMWH dosage with mortality. Secondary outcomes included the incidence of thrombotic and bleeding events, length of ICU stay, invasive mechanical ventilation, and thrombotic and inflammatory parameters. Results: Data of 720 patients were analyzed, 258 in the prophylaxis group and 462 in the treatment group. C Reactive Protein, invasive mechanical ventilation, tocilizumab and corticosteroid treatments were related with the choice of LMWH dose. Hemorrhagic events (66/720, 9.2%) and thrombotic complications (69/720, 9.6%) were similar in both groups (P=.819 and P=.265), as was the time course of the thrombotic events, earlier than hemorrhagic ones (9 [3-18] and 12 [6-19] days respectively). Mortality was lower in prophylaxis group (25.2% versus 35.1%), but once an inverse probability weighting model was applied, we found no effect of LMWH dose. Conclusion: We found no benefit or harm with the administration of therapeutic or prophylactic LMWH dose in COVID19 critically ill patients. With a similar rate of hemorrhagic or thrombotic events, the LMWH dose had no influence on mortality. More studies are needed to determine the optimal thromboprophylaxis protocol for critically ill patients.

Effectiveness of thromboprophylaxis with low molecular weight heparin in critically ill patients with COVID-19. An observational prospective, multicenter study.

INTRODUCTION: COVID-19 induces coagulopathy associated with an increase of thromboembolic events. Due to the lack of agreement on recommendations for thromboprophylactic management, the aim of this study was to study the dosages of LMWH used in critically ill COVID-19 patients assessing the effect on their outcome. METHODS: We evaluated data of the Reg-COVID19. According to LMWH dose two groups were analyzed: prophylaxis and treatment. Primary outcome was the relationship of LMWH dosage with mortality. Secondary outcomes included the incidence of thrombotic and bleeding events, length of ICU stay, invasive mechanical ventilation, and thrombotic and inflammatory parameters. RESULTS: Data of 720 patients were analyzed, 258 in the prophylaxis group and 462 in the treatment group. C Reactive Protein, invasive mechanical ventilation, tocilizumab and corticosteroid treatments were related with the choice of LMWH dose. Hemorrhagic events (66/720, 9.2%) and thrombotic complications (69/720, 9.6%) were similar in both groups (p = .819 and p = .265), as was the time course of the thrombotic events, earlier than hemorrhagic ones (9 [3-18] and 12 [6-19] days respectively). Mortality was lower in prophylaxis group (25.2% versus 35.1%), but once an inverse probability weighting model was applied, we found no effect of LMWH dose. CONCLUSION: We found no benefit or harm with the administration of therapeutic or prophylactic LMWH dose in COVID19 critically ill patients. With a similar rate of hemorrhagic or thrombotic events, the LMWH dose had no influence on mortality. More studies are needed to determine the optimal thromboprophylaxis protocol for critically ill patients.

Adherence to oral anticoagulants in patients with atrial fibrillation-a population-based retrospective cohort study linking health information systems in the Valencia region, Spain: a study protocol.

INTRODUCTION: Adherence to oral anticoagulation (OAC) treatment, vitamin K antagonists or new oral anticoagulants, is an essential element for effectiveness. Information on adherence to OAC in atrial fibrillation (AF) and the impact of adherence on clinical outcomes using real-world data barely exists. We aim to describe the patterns of adherence to OAC over time in patients with AF, estimate the associated factors and their impact on clinical events, and assess the same issues with conventional measures of primary and secondary adherence-proportion of days covered (PDC) and persistence-in routine clinical practice. METHODS AND ANALYSIS: This is a population-based retrospective cohort study including all patients with AF treated with OAC from 2010 to date in Valencia, Spain; data will be obtained from diverse electronic records of the Valencia Health Agency. PRIMARY OUTCOME MEASURE: adherence trajectories. SECONDARY OUTCOMES: (1) primary non-adherence; (2) secondary adherence: (a) PDC, (b) persistence. Clinical outcomes: hospitalisation for haemorrhagic or thromboembolic events and death during follow-up. ANALYSIS: (1) description of baseline characteristics, adherence patterns (trajectory models or latent class growth analysis models) and conventional adherence measures; (2) logistic or Cox multivariate regression models, to assess the associations between adherence measures and the covariates, and logistic multinomial regression models, to identify characteristics associated with each trajectory; (3) Cox proportional hazard models, to assess the relationship between adherence and clinical outcomes, with propensity score adjustment applied to further control for potential confounders; (4) to estimate the importance of different healthcare levels in the variations of adherence, logistic or Cox multilevel regression models. ETHICS AND DISSEMINATION: This study has been approved by the corresponding Clinical Research Ethics Committee. We plan to disseminate the project's findings through peer-reviewed publications and presentations at relevant health conferences. Policy reports will also be prepared in order to promote the translation of our findings into policy and clinical practice.

Chronic comorbidity and outcomes of hospital care: length of stay, mortality, and readmission at 30 and 365 days.

This article evaluates the behavior of an adaptation of the Charlson Index (CHI) applied to administrative databases to measure the relationship between chronic comorbidity and the hospital care outcomes of length of stay (LOS), in-hospital mortality, and emergency readmissions at 30 and 365 days. These outcomes were analyzed in 106,673 hospitalization episodes whose records are registered in a minimum basic data set maintained by the public health authorities of the community of Valencia, Spain. The highest comorbidity measured by the CHI was associated with greater LOS and in-hospital mortality and increased readmission at 30 and 365 days. The rate of readmissions at 1 year dropped, however, in the group with the greatest comorbidity, probably owing to an increase in mortality after hospitalization. While comorbidity does appear to increase the risk of adverse outcomes in general and mortality and readmission specifically, the second outcome is only possible if the first has not occurred. For this reason, information and selection biases derived from administrative databases, or from the CHI itself, should be taken into account when using and interpreting the index.

Inter-hospital variations in caesarean sections. A risk adjusted comparison in the Valencia public hospitals.

BACKGROUND: The aim of this study was to describe the variability in caesarean rates in the public hospitals in the Valencia Region, Spain, and to analyse the association between caesarean sections and clinical and extra-clinical factors. METHODS: Analysis of data contained in the Minimum Basic Data Set (MBDS) compiled for all births in 11 public hospitals in Valencia during 1994-1995 (n=36 819). Bivariate and multivariate analyses were used to evaluate the association between caesarean section rates and specific risk factors. The multivariate model was used to construct predictions about caesarean rates for each hospital, for comparison with rates observed. RESULTS: Caesarean rates were 17.6% (inter-hospital range: 14.7% to 25.0%), with ample variability between hospitals in the diagnosis of maternal-fetal risk factors (particularly dystocia and fetal distress), and the indication for caesarean in the presence of these factors. Multivariate analysis showed that maternal-fetal risk factors correlated strongly with caesarean section, although extra-clinical factors, such as the day of the week, also correlated positively. After adjusting for the risk factors, the inter-hospital variation in caesarean rates persisted. CONCLUSIONS: Although certain limitations (imprecision of some diagnoses and information biases in the MBDS) make it impossible to establish unequivocal conclusions, results show a high degree of variability among hospitals when opting for caesarean section. This variability cannot be justified by differences in obstetric risks.

[Variations in the use of hospital resources in treating patients with chronic obstructive pulmonary disease]. / Variabilidaad en la utilización de recursos hospitalarios en pacientes con enfermedad pulmonar obstructiva crónica (EPOC),

AIM: To analyze factors associated with the length of stay and pharmaceuticals expense for patients admitted with chronic obstructive pulmonary disease (COPD) and to evaluate whether treatment by different physicians means greater or less use of hospital resources. METHODS: We retrospectively studied a cohort of 1033 COPD patients admitted to the Hospital de Mataró, Catalonia, Spain, during the years 1996 through 1998 in order to analyze factors associated with length of stay and pharmaceuticals use. We used the Minimum Basic Data Set, laboratory databases, and pharmacy single-dose database. We also analyzed the differences among patients treated by different physicians and developed multiple linear regression models to evaluate differences in treatment between one physician and another. RESULTS: The length of stay increased with patient age, the number of times admitted, the presence of atrial fibrillation or respiratory insufficiency, ventilatory alterations, chronicity, a forced expiratory volume in 1 second less than 50% of predicted, and treatment by certain physicians. Medication costs showed a similar pattern. Although the characteristics of patients treated by different physicians were quite homogeneous, the median length of stay varied from 9 to 11 days depending on the physician, while the median cost for medication varied from;43.62 to;54.39 (from $41.07 to $51.21). After removing the effects of several covariables by multiple regression analysis, an effect of physician persisted. CONCLUSIONS: Significant differences in length of hospital stay and consumption of pharmaceuticals are related to attending physician and continue to have an important effect after controlling for the differences in the severity of patient status.

[Abstruse comparisons in abstracts of clinical trials in Spanish medical journals]. / Comparaciones abstrusas en los resúmenes de ensayos clínicos en revistas médicas españolas.

BACKGROUND: To describe the frequency of abstracts of clinical trials whose information does not allow to assess the clinical relevance of the comparisons made. METHOD: Review of 64 trials published in the journals Atención Primaria and Medicina Clínica. Abstracts were defined as quantitative or qualitative abtruse when it was not possible to identify the numerical values used in the comparison or when scales were included without specifying their range and clinical implications, respectively. RESULTS: 43.7% of abstracts were deemed quantitively abstruse, and 75% of 8 including scales were deemed qualitatively abstruse. CONCLUSIONS: Abstracts of clinical trials should present results in a way that makes it possible to evaluate

[Factors associated with emergency hospital readmission in digestive and hepatobiliary diseases]. / Factores asociados al reingreso hospitalario urgente en enfermedades digestivas y hepatobiliares.

OBJECTIVE: To describe the epidemiological characteristics of emergency readmissions due to digestive and hepatobiliary diseases within the hospitals of the Valencian Health Service (VHS), Spain, and to examine their relationship with defined variables related to patients or to previous periods of hospitalization. PATIENTS AND METHODS: Out of the 212,947 episodes of patient hospitalization included in the Uniform Hospital Discharge Data Set of the VHS, excluding those persons under 16 years of age, those who had died in hospital or were discharged due to being transferred to another hospital and also excluding the two hospitals whose record were of poor quality, 18,075 patients were chosen whose principal diagnosis on first admission was one of a digestive or hepatobiliary disease. After a descriptive analysis the relationship was explored between risk of readmission and the variables of age, gender, hospital funding, whether the environment is a rural or urban one, the hospital itself, the diagnostic group, comorbidity, type of admission, length of stay, presence of surgical procedure, discharge criteria and service using an independent Cox Proportional Hazards analysis for each variable and a second Cox analysis adjusted for selected variables. RESULTS: 16.9% of those patients discharged for digestive disorders are re-admitted within a year. The risk of readmission is associated with age, comorbidity, male sex and chronic diseases and, with respect to the previous episode of hospitalization, it is associated with emergency admission, longer period of hospitalization, non-surgical discharge and admission to certain hospitals. CONCLUSION: The risk of emergency readmission is associated with defined variables relating to patient or previous episodes of hospitalization connected with a more serious condition. The risk adjustment carried out could be used in order to identify high-risk cases which could then be paid special attention in order to delay or prevent readmission and as an indirect indicator for use in monitoring the quality of hospital care.

[Do chronic diseases prevent intra-hospital mortality? Paradoxes and biases in information about hospital morbidity]. / Previenen las enfermedades crónicas la mortalidad intrahospitalaria? Paradojas y sesgos en la información sobre morbilidad hospitalaria.

OBJECTIVE: Previous studies have demonstrated how the incomplete codification of the secondary diagnostics can bias the estimation of the risk of in-hospital death based on clinical-administrative databases. The objective of this study is to measure the trend of the association between in-hospital mortality and the secondary diagnostics register in the Minimum Basic Data Set (MBDS) of the Valencian Community. METHODS: The 14,161 admissions of persons over the age of 64 were extracted from the MBDS (years 1993-94) for: stroke (S), bacterial pneumonia (BN), myocardial infarction (MI) and congestive heart failure (CHF). The relation was measured between the availability of some additional diagnostics (selected to dispose of a group of heterogeneous chronic and acute processes), and the risk of in-hospital death, relative risk (RR) and adjusted odds ratios (aOR) were calculated per age, gender, length of stay and number of diagnoses. RESULTS: Many of the conditions are associated with a reduced risk of death such as the diabetes mellitus (Mortality for stroke, RR: 0.58; aOR: 0.53), old myocardial infarction (mortality for myocardial infarction, RR: 0.40; aOR: 0.35) or hypertension (mortality for stroke, RR: 0.54; aOR: 0.49): this also occurs in angina, coronary atherosclerosis, aortic and mitral valve disease, atrial fibrillation, chronic obstructive pulmonary disease and urinary tract infection. CONCLUSIONS: Although there maybe other explanations, such as the existence of a bias in the hospital selection, the explanation which is most in agreement with the findings is the presence of an information bias in the MBDS due to the tendency to register less information about chronic antecedents of the persons who die.

[Automated analysis of the quality of the minimum set of basic data. Implications for risk-adjusting systems]. / Análisis automatizado de la calidad del conjunto mínimo de datos básicos. Implicaciones para los sistemas de ajuste de riesgos.

SETTING: Together with the age of the patient, the main diagnosis, secondary diagnosis (comorbility and complications) and the procedures performed are the critical variables for risk-adjusting. Therefore, its correct incorporation to CMBD is of great importance. However, several studies, especially in the United States, but also in Spain, have made evident the existence of important problems of quality in these data, difficulties for its improvement and the limitations which this has to assess the quality or the efficiency of hospitals. The objective of this study is to approach the quality of administrative and clinical collected in the CMBD of the Valencian Health Service (VHS) using an automatized process of analysis of data from the same CMBD, and discuss the implications for its management, as well as possible improvement strategies. MATERIAL AND METHOD: An automatized analysis of the quality of CMBD 1994 of the VHS (20 hospitals, 241,341 admissions) was performed, using indicators of valid fulfilling of field values, relationship between fields of the same episode, relationship between variables in different episodes and volume and specificity of clinical information. RESULTS: The analysed CMBD contains few errors in management variables, with the exception of residence, but it shows important problems of volume and specificity of clinical information, as well as a high variability in its fulfilling and quality in different hospitals. CONCLUSIONS: The quality of the clinical data of CMBD may be biased in its use with management aims or when assessing quality, as well as in epidemiological studies, evaluation of technology or use of services.

[Declaring conflict of interest in scientific publications. Time for the spotlights and stenographers in the backroom of research financed by the industry?]. / La declaración del conflicto de intereses en las publicaciones científicas. Tiempo para las luces y los taquígrafos en la trastienda de la investigación financiada por la industria?

The term conflict of interests is applied to those situations in which the research validity and integrity may be influenced by a secondary interest, typically an economic benefit, but also an ideological, personal or professional interest. In this work we describe some ways of conflict of interests--particularly those related with the publication of clinical and epidemiological research supported by the industry--and the regulation of this problem from medical journals, including references to the situation in Spain. The conflict of interest is not synonymous of scientific fraud neither malpraxis in research, but in the medical literature there exists enough evidence to consider it as an important source of biases. The usual form of facing the conflict of interests is to make it public, so that readers can judge its importance. The editorial policies of the Spanish journals are, in general, far from giving importance to this problem, an aspect which could favor an attitude of the investigators, to maintain funding or to obtain new contracts, unnecessarily subordinated to the interests of the companies.

[The quality assessment from the minimum basic hospital discharge data set]. / Evaluación de calidad a partir del conjunto mínimo de datos básicos al alta hospitalaria.

INTRODUCTION: Risk adjustment is essential before comparing patient outcomes across hospitals. With this aim several risk adjustment systems have been developed, including the well-known diagnosis related groups. MATERIAL AND METHODS: Narrative review on risk assessment framework from administrative databases, including data quality and system pitfalls. RESULTS: The risk adjustment systems developed for cost-control aims to group different patient typologies in relation to the predicted use of resources with the aim to develop incentives to cost-reduction; the systems developed for measuring effectiveness have the objective to assess the health care quality. Both systems are useful for clinical, management and health public uses, but they have several pitfalls and their results should be interpreted cautiously. CONCLUSIONS: Managers and physicians should consider the risk adjustment systems as a valuable resource for decision-making and reducing uncertainty, but not as the scientific referee of hospital quality or hospital efficiency.

[Senior citizen health conditions and hospitalization on geriatric, general and surgical floors, a population study conducted in Toledo]. / Estado de salud de las personas ancianas y hospitalización en servicios geriátricos, médicos y quirúrgicos. Estudio poblacional en Toledo.

BACKGROUND: The health condition and some clinical aspects configure a group of senior citizens in need of further care who could benefit from specialized geriatric care, although no consensus exists as to how to identify these patients. The aim of this study is to describe the profile of those patients over 64 years of age who are hospitalized in a geriatric unit and to compare this profile to the senior citizens hospitalized in general medical and surgical units. METHOD: A cohort representative of the population over age 64 in the Judicial District of Toledo (n = 3214) was studied over an eighteen-month period for the purpose of identifying the income and length of stays at the public hospitals in the health care district in question. The health condition-related variables were gathered by means of personal interviews, and the income and the different aspects thereof by way of hospital admissions department data. RESULTS: A total of 410 individuals were admitted (12.8%), 168 patients (30.7%) in geriatrics, 204 (37.3%) in medical units and 174 (32.0%) in surgical units. In geriatrics, the average age was significantly higher (age 77.4), there being no differences in the average length of stay (12.8 days; CI 95%) 10.6-14.0), 44 patients (8.1%) having died, 26 (59.1%) hospitalized in geriatrics. More females, younger patients having minor vision and hearing impairments were admitted to the surgical units. In geriatrics, as compared to the medical units, more patients over 80 years of age, living in senior citizen living facilities, having no spouse, moderate-to-severe functional dependence, impaired cognitive function, depression, poor quality of life and scanty social resources. CONCLUSIONS: No differences were found to exist between the health conditions of those over age 64 who were hospitalized in non-surgical and surgical units. In geriatrics, as compared to the other groups of units, the patients were older, in worse condition, had a higher death rate and similar average length of stay.

[Factors associated with the use and adaptation of hospitalization in people over than 64 years of age]. / Factores asociados con el uso y adecuación de la hospitalización en personas mayores de 64 años.

BACKGROUND: Some social, medical or functional aspects are associated with a greater use of health care resources, although this does not necessarily imply an inappropriate usage of the same. The aim of this research is that of ascertaining the influence of health condition on hospital stays and inappropriate stays among the population over 64 years of age. METHODS: A cohort representative of the population over age 64 in the Judicial District of Toledo (n = 3214) whose health condition had been previously evaluated was studied over an eighteen-month period identifying the income and length of stays at the public hospitals, the appropriateness of which was evaluated by the Appropriateness Evaluation Protocol. Associations analyzed were those of the cohort socio-demographic characteristics, health condition-related variables and morbidity with frequency and hospitalization rates and with inappropriate stays and admissions. RESULTS: During the 18 months of study 410 individuals were hospitalized, who generated 546 admissions (frequency rate = 17.0 admissions/100 rooms) and 7015 stay days (hospitalization rate = 218.3 stays/100 rooms), 18.9% of the admissions and 49.9% of the stays were evaluated as inappropriate. Hospitalization was associated with a worse health condition, institutionalization, male sex, certain pathologies and previous health services usage. Patients characteristics were not associated with the percentage of inappropriate stays. 97.5% of inappropriate stays were attributed to hospital scheduling problems and physicians' practices. CONCLUSIONS: Socio-demographic factors, morbidity, health condition and previous health service usage are shown as good hospitalization predictors for senior citizens, but these factors are not related to inappropriate hospitalization usage.

Caesarean section on request: a comparison of obstetricians' attitudes in eight European countries.

OBJECTIVE: To explore the attitudes of obstetricians to perform a caesarean section on maternal request in the absence of medical indication. DESIGN: Cluster sampling cross-sectional survey. SETTING: Neonatal Intensive Care Unit (NICU) associated maternity units in eight European countries. POPULATION: Obstetricians with at least 6 months clinical experience. METHODS: NICU-associated maternity units were chosen by census in Luxembourg, Netherlands and Sweden and by geographically stratified random sampling in France, Germany, Italy, Spain and UK. An anonymous, self-administered questionnaire was used for data collection. MAIN OUTCOME MEASURES: Obstetricians' willingness to perform a caesarean section on maternal request. RESULTS: One hundred and five units and 1,530 obstetricians participated in the study (response rates of 70 and 77%, respectively). Compliance with a hypothetical woman's request for elective caesarean section simply because it was 'her choice' was lowest in Spain (15%), France (19%) and Netherlands (22%); highest in Germany (75%) and UK (79%) and intermediate in the remaining countries. Using weighted multivariate logistic regression, country of practice (P<0.001), fear of litigation (P= 0.004) and working in a university-affiliated hospital (P= 0.001) were associated with physicians' likelihood to agree to patient's request. The subset of female doctors with children was less likely to agree (OR 0.29, 95% CI 0.20-0.42). CONCLUSIONS: The differences in obstetricians' attitudes are not founded on concrete medical evidence. Cultural factors, legal liability and variables linked to the specific perinatal care organisation of the various countries play a role. Greater emphasis should be placed on understanding the motivation, values and fears underlying a woman's request for elective caesarean delivery.