Validation of a Reduced Set of High-Performance Triggers for Identifying Patient Safety Incidents with Harm in Primary Care: TriggerPrim Project.

OBJECTIVE: The aim of the study was to construct and validate a reduced set of high-performance triggers for identifying adverse events (AEs) via electronic medical records (EMRs) review in primary care (PC). METHODS: This was a cross-sectional descriptive study for validating a diagnostic test. The study included all 262 PC centers of Madrid region (Spain). Patients were older than 18 years who attended their PC center over the last quarter of 2018. The randomized sample was n = 1797. Main measurements were as follows: ( a ) presence of each of 19 specific computer-identified triggers in the EMR and ( b ) occurrence of an AE. To collect data, EMR review was conducted by 3 doctor-nurse teams. Triggers with statistically significant odds ratios for identifying AEs were selected for the final set after adjusting for age and sex using logistic regression. RESULTS: The sensitivity (SS) and specificity (SP) for the selected triggers were: ≥3 appointments in a week at the PC center (SS = 32.3% [95% confidence interval {CI}, 22.8%-41.8%]; SP = 92.8% [95% CI, 91.6%-94.0%]); hospital admission (SS = 19.4% [95% CI, 11.4%-27.4%]; SP = 97.2% [95% CI, 96.4%-98.0%]); hospital emergency department visit (SS = 31.2% [95% CI, 21.8%-40.6%]; SP = 90.8% [95% CI, 89.4%-92.2%]); major opioids prescription (SS = 2.2% [95% CI, 0.0%-5.2%]; SP = 99.8% [95% CI, 99.6%-100%]); and chronic benzodiazepine treatment in patients 75 years or older (SS = 14.0% [95% CI, 6.9%-21.1%]; SP = 95.5% [95% CI, 94.5%-96.5%]).The following values were obtained in the validation of this trigger set (the occurrence of at least one of these triggers in the EMR): SS = 60.2% (95% CI, 50.2%-70.1%), SP = 80.8% (95% CI, 78.8%-82.6%), positive predictive value = 14.6% (95% CI, 11.0%-18.1%), negative predictive value = 97.4% (95% CI, 96.5%-98.2%), positive likelihood ratio = 3.13 (95% CI, 2.3-4.2), and negative likelihood ratio = 0.49 (95% CI, 0.3-0.7). CONCLUSIONS: The set containing the 5 selected triggers almost triples the efficiency of EMR review in detecting AEs. This suggests that this set is easily implementable and of great utility in risk-management practice.

Is primary care a patient-safe setting? Prevalence, severity, nature, and causes of adverse events: numerous and mostly avoidable.

Knowing the frequency and characteristics of adverse events (AEs) is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of AEs. Research on AEs in a primary care setting has been limited and primarily focuses on specific types of events (medication errors, etc.) or patients. Large studies that search for any kind of AE in all patients are scarce. This study aimed to estimate the prevalence of AEs in the primary care setting and their characteristics. SETTING: all 262 primary health-care centres in the Madrid region (Spain) during the last quarter of 2018. DESIGN: cross-sectional descriptive study. Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N = 2 743 719); a randomized sample stratified by age. MAIN OUTCOMES: age, sex, occurrence of an AE, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety. The SPSS software package (version 26) was used for the statistical analyses. The evaluators reviewed 1797 clinical records. The prevalence of AEs over the study period was 5.0% [95% confidence interval (CI): 4.0%‒6.0%], with higher values in women (5.7%; 95% CI: 4.6%‒6.8%;P = 0.10) and patients over 75 years of age (10.3%; 95% CI: 8.9%‒11.7%; P < 0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (95% CI: 1.28%‒1.94%). Of the detected AEs, 71.3% (95% CI: 62.1%‒80.5%) were avoidable. Additionally, 60.6% (95% CI: 50.7%‒70.5%) were categorized as mild, 31.9% (95% CI: 22.4%‒41.4%) as moderate, and 7.4% (95% CI: 2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6% (95% CI: 68.0%‒85.2%) of cases. The overall incidence of AEs related to medication was 53.2% (95% CI: 50.9%‒55.5%). The most frequent types of AEs were prescription errors (28.7%; 95% CI: 19.5%‒37.9%), followed by drug administration errors by patients (17.0%; 95% CI: 9.4%‒24.6%), and clinical assessment errors (11.7%; 95% CI: 5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%; 95% CI: 71.1%‒90.1%) and tasks (59.7%; 95% CI: 48.0%‒71.4%). A high prevalence of AEs (1 in 66 consultations) was observed, which was slightly higher than that reported in similar studies. About 3 out of 4 such events were considered to be avoidable and 1 out of 13 was severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of AEs. Graphical Abstract.

Experiencia de los Servicios de Cirugía Torácica españoles en el tratamiento del pectus excavatum mediante la técnica de Nuss / Experience with the Nuss technique for the treatment of Pectus Excavatum in Spanish Thoracic Surgery Departments

INTRODUCCIÓN: Aunque la introducción de la técnica de Nuss revolucionó el tratamiento quirúrgico del pectus excavatum, no se ha generalizado su uso en nuestro medio. El objetivo de este estudio es conocer la situacion actual del uso de esta técnica en una selección de Servicios de Cirugía Torácica de España. MÉTODOS: Estudio observacional retrospectivo multicéntrico que analiza los principales aspectos epidemiológicos y resultados clínicos tras 10 años de experiencia empleando técnica de Nuss. RESULTADOS: Entre 2001 y 2010 se intervino a 149 pacientes (media de edad 21,2 años), 74% varones. Los resultados estéticos iniciales fueron excelentes o buenos en el 93,2%, regulares en el 4,1% y malos en el 2,7% de los casos. Un total de 45 pacientes (30,6%) presentaron complicaciones tras la primera intervención. Las más frecuentes fueron la presencia de seroma en las heridas quirúrgicas, desplazamiento de la barra, rotura del estabilizador, neumotórax, hemotórax, infección de la herida, neumonía, pericarditis y un taponamiento pericárdico que requirió la extracción de la barra de urgencia. El dolor postoperatorio fue referido por todos los pacientes y 3 de ellos (2%) requirieron la extracción precoz de la barra por dolor intratable. Tras una media de 39,2 meses, se había retirado la barra a 72 pacientes (49%), con dificultades en la extracción en 5 (7%). Tras un seguimiento medio de 1,6 años se constató buen resultado en 145 pacientes (98,7%). CONCLUSIONES: La técnica de Nuss en adultos ha tenido buenos resultados en los Servicios de Cirugía Torácica españoles aunque no se ha generalizado su utilización. Las posibles complicaciones se han de tener en cuenta, por lo que la indicación debe ser muy bien valorada. La posibilidad de un tratamiento conservador previo es valorado por alguno de los servicios en la actualidad

INTRODUCTION: Up to 93% of patients undergoing abdominal surgery will develop intra-abdominal adhesions with the subsequent morbidity that they represent. Various substances have been tested for the prevention of adhesions with controversial results; the aim of our study is to compare the capability of pirfenidone in adhesion prevention against sodium hyaluronate/carboxymethylcellulose. METHODS: A randomized, prospective, longitudinal experimental study with Winstar rats. They were divided into 3 groups. The subjects underwent an exploratory laparotomy and they had a 4 cm2 cecal abrasion. The first group received saline on the cecal abrasion, and groups 2 and 3 received pirfenidone and sodium hyaluronate/carboxymethylcellulose respectively. All rats were sacrificed on the 21st day after surgery and the presence of adhesions was evaluated with the modified Granat scale. Simple frequency, central tendency and dispersion measures were recorded. For the statistical analysis we used Fisher's test. RESULTS: To evaluate adhesions we used the Granat's modified scale. The control group had a median adhesion formation of 3 (range 0-4). The pirfenidone group had 1.5 (range 0-3), and the sodium hyaluronate/carboxymethylcellulose group had 0 (range 0-1). There was a statistically significant difference to favor sodium hyaluronate/carboxymethylcellulose against saline and pirfenidone (P< 0 .009 and P< .022 respectively). CONCLUSIONS: The use of sodium hyaluronate/carboxymethylcellulose is effective for the prevention of intra-abdominal adhesions. More experimental studies are needed in search for the optimal adhesion prevention drug

Experience with the Nuss technique for the treatment of Pectus Excavatum in Spanish Thoracic Surgery Departments.

INTRODUCTION: Although the Nuss technique revolutionized the surgical treatment of pectus excavatum, its use has not become widespread in our country. The aim of this study was to analyze the current use of this technique in a sample of Thoracic Surgery Departments in Spain. METHODS: Observational rectrospective multicentric study analyzing the main epidemiological aspects and clinical results of ten years experience using the Nuss technique. RESULTS: Between 2001 and 2010 a total of 149 patients were operated on (mean age 21.2 years), 74% male. Initial aesthetic results were excellent or good in 93.2%, mild in 4.1% and bad in 2.7%. After initial surgery there were complications in 45 patients (30.6%). The most frequent were wound seroma, bar displacement, stabilizer break, pneumothorax, haemothorax, wound infection, pneumonia, pericarditis and cardiac tamponade that required urgent bar removal. Postoperative pain appeared in all patients. In 3 cases (2%) it was so intense that it required bar removal. After a mean follow-up of 39.2 months, bar removal had been performed in 72 patients (49%), being difficult in 5 cases (7%). After a 1.6 year follow-up period good results persisted in 145 patients (98.7%). CONCLUSION: Nuss technique in adults has had good results in Spanish Thoracic Surgery Departments, however its use has not been generalized. The risk of complications must be taken into account and its indication must be properly evaluated. The possibility of previous conservative treatment is being analyzed in several departments at present.

Early and mid-term results of lung transplantation with donors 60 years and older.

OBJECTIVES: There are doubts about the age limit for lung donors and the ideal donor has traditionally been considered to be one younger than 55 years. The objective of this study was to compare the outcomes in lung transplantation between organs from donors older and younger than 60 years. METHODS: We performed a retrospective observational study comparing the group of patients receiving organs from donors 60 years or older (Group A) or younger than 60 years (Group B) between January 2007 and December 2011. Postoperative evolution and mortality rates, short-term and mid-term postoperative complications, and global survival rate were evaluated. RESULTS: We analysed a total of 230 lung transplants, of which 53 (23%) involved lungs from donors 60 years of age or older (Group A), and 177 (77%) were from donors younger than 60 years (Group B). Three (5.7%) patients from Group A and 14 patients (7.9%) from Group B died within 30 days (P = 0.58). The percentage of patients free from chronic lung allograft dysfunction at 1-3 years was 95.5, 74.3 and 69.3% for Group A, and 94.5, 84.8 and 73.3% for Group B, respectively (P = 0.47). There were no statistically significant differences between Groups A and B in terms of survival at 3 years, (69.4 vs 68.8%; P = 0.28). CONCLUSIONS: Our results support the idea that lungs from donors aged 60-70 years can be used safely for lung transplantation with comparable results to lungs from younger donors in terms of postoperative mortality and mid-term survival.

Registro Español de Trasplante Pulmonar: primer informe de resultados (2006-2010) / The Spanish Lung Transplant Registry: First Report of Results (2006-2010)

El Registro Español de Trasplante Pulmonar (RETP) inició su actividad en 2006, participando en él todos los equipos de trasplante pulmonar (TP) con un programa activo en España. Este informe presenta por primera vez de forma global la descripción y resultados de los pacientes trasplantados de pulmón en España entre los años 2006 y 2010. La actividad de TP ha ido en progresivo aumento, trasplantándose en este periodo 951 adultos y 31 niños. La media de edad del receptor fue de 48,2 años, siendo 41,7 años en el donante pulmonar. En el TP adulto, la causa más frecuente de trasplante fue el enfisema/EPOC, seguido de la fibrosis pulmonar idiopática, representando ambas más del 60% del total de las indicaciones. La probabilidad de supervivencia tras el TP adulto a uno y 3 años es del 72 y del 60%, respectivamente, si bien en los pacientes que sobreviven al tercer mes postrasplante estas supervivencias son del 89,7 y del 75,2%. Los factores que más claramente inciden en la supervivencia del paciente son la edad del receptor y el diagnóstico que indicó el trasplante. En los trasplantes pediátricos, la fibrosis quística es la principal causa de trasplante (68%), y la supervivencia al año es del 80, y del 70% a los 3 años. Tanto en el trasplante adulto como en el pediátrico, la causa más frecuente de fallecimiento es la infección. Estos datos confirman la consolidación del TP en España como una opción terapéutica para la enfermedad respiratoria crónica avanzada, tanto en niños como en adultos(AU)

The Spanish Lung Transplant Registry (SLTR) began its activities in 2006 with the participation of all the lung transplantation (LT) groups with active programs in Spain. This report presents for the first time an overall description and results of the patients who received lung transplants in Spain from 2006 to 2010. LT activity has grown progressively, and in this time period 951 adults and 31 children underwent lung transplantation. The mean age of the recipients was 48.2, while the mean age among the lung donors was 41.7. In adult LT, the most frequent cause for lung transplantation was emphysema/COPD, followed by idiopathic pulmonary fibrosis, both representing more than 60% the total number of indications. The probability for survival after adult LT to one and three years was 72% and 60%, respectively, although in patients who survived until the third month post-transplantation, these survival rates reached 89.7% and 75.2%. The factors that most clearly influenced patient survival were the age of the recipient and the diagnosis that indicated the transplantation. Among the pediatric transplantations, cystic fibrosis was the main cause for transplantation (68%), with a one-year survival of 80% and a three-year survival of 70%. In adult as well as pediatric transplantations, the most frequent cause of death was infection. These data confirm the consolidated situation of LT in Spain as a therapeutic option for advanced chronic respiratory disease, both in children as well as in adults(AU)

Fluorescence in situ hybridization and immunohistochemistry as diagnostic methods for ALK positive non-small cell lung cancer patients.

BACKGROUND: Anaplastic Lymphoma Kinase (ALK) positivity represents a novel molecular target in a subset of Non-Small Cell Lung Cancers (NSCLC). We explore Fluorescence in situ Hybridization (FISH) and Immunohistochemistry (IHC) as diagnostic methods for ALK positive patients and to describe its prevalence and outcomes in a population of NSCLC patients. METHODS: NSCLC patients previously screened for Epidermal Growth Factor Receptor (EGFR) at our institution were selected. ALK positive patients were identified by FISH and the value of IHC (D5F3) was explored. RESULTS: ninety-nine patients were identified. Median age was 61.5 years (range 35-83), all were caucasians, eighty percent were adenocarcinomas, fifty-one percent were male and thirty-eight percent were current smokers. Seven (7.1%) patients were ALK positive by FISH, thirteen (13.1%) were EGFR mutant, and 65 (65.6%) were negative/Wild Type (WT) for both ALK and EGFR. ALK positivity and EGFR mutations were mutually exclusive. ALK positive patients tend to be younger than EGFR mutated or wt patients. ALK positive patients were predominantly never smokers (71.4%) and adenocarcinoma (71.4%). ALK positive and EGFR mutant patients have a better outcome than negative/WT. All patients with ALK FISH negative tumours were negative for ALK IHC. Out of 6 patients positive for ALK FISH with more tissue available, 5 were positive for ALK IHC and 1 negative. CONCLUSIONS: ALK positive patients represent 7.1% of a population of selected NSCLC. ALK positive patients have different clinical features and a better outcome than EGFR WT and ALK negative patients. IHC is a promising method for detecting ALK positive NSCLC patients.

The Spanish Lung Transplant Registry: first report of results (2006-2010).

The Spanish Lung Transplant Registry (SLTR) began its activities in 2006 with the participation of all the lung transplantation (LT) groups with active programs in Spain. This report presents for the first time an overall description and results of the patients who received lung transplants in Spain from 2006 to 2010. LT activity has grown progressively, and in this time period 951 adults and 31 children underwent lung transplantation. The mean age of the recipients was 48.2, while the mean age among the lung donors was 41.7. In adult LT, the most frequent cause for lung transplantation was emphysema/COPD, followed by idiopathic pulmonary fibrosis, both representing more than 60% the total number of indications. The probability for survival after adult LT to one and three years was 72% and 60%, respectively, although in patients who survived until the third month post-transplantation, these survival rates reached 89.7% and 75.2%. The factors that most clearly influenced patient survival were the age of the recipient and the diagnosis that indicated the transplantation. Among the pediatric transplantations, cystic fibrosis was the main cause for transplantation (68%), with a one-year survival of 80% and a three-year survival of 70%. In adult as well as pediatric transplantations, the most frequent cause of death was infection. These data confirm the consolidated situation of LT in Spain as a therapeutic option for advanced chronic respiratory disease, both in children as well as in adults.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Neumotórax catamenial: recurrencia con la primera dosis de análogos agonistas de Gn-RH / Catamenial pneumotorax: recurrence with the first dosis of agonists analogs of Gn-RH

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Pemetrexed in previously treated non-small-cell lung cancer.

Several decades of chemotherapy trials in non-small-cell lung cancer (NSCLC) have clearly shown a survival benefit for chemotherapy over best supportive care. However, only short-lived responses are attained, with an average of four cycles of chemotherapy, before tumor progression is observed. Second-line chemotherapy has been demonstrated to improve outcome, with docetaxel (Taxotere) as the predominant cytotoxic drug. A recent randomized trial in second-line NSCLC indicated that the novel drug pemetrexed (Alimta) attained the same response, time to progression, and survival as docetaxel. This finding ushers in a new age in second-line treatment that can be further invigorated by the addition of targeted agents. Accumulated evidence indicates that overexpression of epidermal growth factor receptor and HER2/neu, which occurs frequently in NSCLC, leads to the deregulation of PI3K and MAPK, activating Akt and enhancing chemoresistance. Future clinical trials in NSCLC will include tailored and multitargeted therapy and pemetrexed represents a significant step forward in this direction.