Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery.

INTRODUCTION: Anxiety in children triggered by a scheduled surgical intervention is a major issue due to its frequency and consequences. Preoperative anxiety is associated with increased patient fear and agitation on anesthetic induction. The aim of this study is to compare three preoperative anxiety scales for children undergoing elective outpatient surgery, and to correlate each of these tools with the degree of patient compliance on induction, as assessed by the Induction Compliance Checklist (ICC). METHODS: An observational prospective study was performed on a cohort of children with ages between 2 and 16 years old, scheduled for outpatient surgery. Anxiety was assessed upon arrival to the hospital (M0), during transfer to the surgical unit (M1), and in the operating room during anesthetic induction (M2). Anxiety in the parents (measured with the State-Trait Anxiety Inventory, STAI) and in the children (measured with the Spence Anxiety Scale-Pediatric, SCAS-P, the State-Trait Anxiety Inventory Children, STAIC, and Modified Yale Preoperative Anxiety Scale, m-YPAS) was assessed. Compliance with anesthetic induction was assessed with ICC. RESULTS: The study included 76 patients (72.4% male, median age 7.9 years). Anxiety scores (m-YPAS) increased as the moment of surgery approached, being greater at the entrance to the surgical unit (M0 = 26.1 ± 9.5; M1 = 31.8 ± 18.1; M2 = 33.5 ± 21.1). A strong correlation was found between ICC scale and m-YPAS at M1 (0.738) and M2 timepoints (0.794), but not with the rest of scales at M0. CONCLUSIONS: Standard anxiety assessment scales do not predict the quality of anesthetic induction. m-YPAS scale can detect increasing anxiety in children as they approach the surgical procedure and this correlates strongly with a worse anesthetic induction, defined by higher score on ICC scale.

Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study.

OBJECTIVES: Inadequate bowel cleansing is a major burden for endoscopy units. The aim of this study was to compare two intensive bowel cleansing regimens in patients with previous colonoscopy with inadequate bowel preparation. METHODS: Patients with inadequate cleansing at index colonoscopy were randomized to 4-L split-dose polyethylene-glycol (PEG) regimen vs. 2-L split-dose PEG plus ascorbic acid (PEG+Asc) regimen. All individuals underwent a 3-day low-residue diet and received 10 mg of bisacodyl, the day before colonoscopy. Cleansing was considered to be adequate if the Boston Bowel Preparation Scale scored ≥2 at each colonic segment. A non-inferiority analysis was performed to demonstrate that colonic cleansing with 2-L PEG+Asc was not inferior to 4-l PEG, considering a non-inferiority margin of 10%. RESULTS: Adequate bowel cleansing was significantly higher in patients assigned to 4-L PEG regimen (n=127) vs. those randomized to 2-L PEG+Asc regimen (n=129) by intention-to-treat analysis (81.1 vs. 67.4%, odds ratio (OR) 2.07, 95% confidence interval (CI) (1.163-3.689)) and by per-protocol analysis (86.6 vs. 71.7%, OR: 2.55, 95% CI: (1.316-4.922)). The study was terminated for futility after the interim analysis, because the 95% CI of the difference of proportions was 3.13-24.27% in the intention-to-treat analysis and 3.33-26.47% in the per-protocol analysis, confirming the superiority of 4-L PEG preparation. CONCLUSIONS: After 3-day low-residue diet and oral bisacodyl before colonoscopy, colon cleansing with 4-L split-dose PEG was superior to 2-L split-dose PEG+Asc in patients with previous inadequate cleansing. (EUDRACT: 2013-002506-31, NCT02073552).

Toward a clinical practice guide in pharmacogenomics testing for functional polymorphisms of drug-metabolizing enzymes. Gene/drug pairs and barriers perceived in Spain.

The development of clinical practice recommendations or guidelines for the clinical use of biomarkers is an issue of great importance with regard to adverse drug reactions. The potential of pharmacogenomic biomarkers has been extensively investigated in recent years. However, several barriers to implementing the use of pharmacogenomics testing exist. We conducted a survey among members of the Spanish Societies of Pharmacology and Clinical Pharmacology to obtain information about the perception of such barriers and to compare the perceptions of participants about the relative importance of major gene/drug pairs. Of 11 potential barriers, the highest importance was attributed to lack of institutional support for pharmacogenomics testing, and to the issues related to the lack of guidelines. Of the proposed gene/drug pairs the highest importance was assigned to HLA-B/abacavir, UGT1A1/irinotecan, and CYP2D6/tamoxifen. In this perspective article, we compare the relative importance of 29 gene/drug pairs in the Spanish study with that of the same pairs in the American Society for Clinical Pharmacology and Therapeutics study, and we provide suggestions and areas of focus to develop a guide for clinical practice in pharmacogenomics testing.

Análisis descriptivo de los hallazgos en auditorias de ensayos clínicos (2001–2007) / Descriptive analysis of audit findings in clinical trials (2001–2007)

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Análisis de las reacciones adversas a medicamentos publicadas en ACTAS DERMOSIFILIOGRÁFICAS desde 1997 a 2002 / Analysis of the adverse drug reactions published in ACTAS DERMOSIFILOGRÁFICAS from 1997 to 2002

Introducción. Dado que las reacciones adversas a medicamentos (RAM) cutáneas son las más frecuentes después de las digestivas, se han analizado las comunicadas a ACTAS DERMOSIFILIOGRÁFICAS (ADS) entre 1997 y 2002 para conocer el grado de colaboración de los dermatólogos españoles con el Sistema Español de Farmacovigilancia. Métodos. Se han buscado en ADS, desde enero de 1997 a diciembre de 2002, todas las comunicaciones y artículos relacionados con RAM. Su evaluación se llevó a cabo según los protocolos propuestos por el Sistema Español de Farmacovigilancia (Buenas Prácticas de Farmacovigilancia). Además, se comprobó si habían sido comunicadas al Sistema Español de Farmacovigilancia. Resultados. Reuniones nacionales y territoriales: del total de las 2.220 comunicaciones, en 182 se describen RAM. El eczema, las erupciones y el prurito fueron las manifestaciones más frecuentes y afectaron más a las mujeres que a los varones. Los fármacos relacionados con la reacción fueron los quimioterápicos, antiinfecciosos, inmunomoduladores y antiinflamatorios no esteroideos (AINE). De las 182 RAM halladas, 57 fueron catalogadas como definidas y 49 como probables; hubo 32 RAM graves. De todas las RAM, solamente nueve habían sido comunicadas al Sistema Español de Farmacovigilancia. Artículos: de los 60 artículos relacionados con farmacología clínica, 40 representaron RAM. La manifestación más frecuente fue la erupción, los fármacos implicados los quimioterápicos y antiinfecciosos, y el perfil demográfico semejante al visto antes. Se consideraron graves 15 RAM y sólo cuatro habían sido comunicadas al Sistema Español de Farmacovigilancia. Tan sólo un artículo mencionó haber notificado la RAM al Sistema Español de Farmacovigilancia. Conclusión. Dada la elevada cifra de RAM cutáneas registrada en la base de datos del Sistema Español de Farmacovigilancia (aproximadamente 23.000) y el escaso número de ellas identificadas en ADS, resulta evidente la pobre participación de los dermatólogos españoles con el Sistema Español de Farmacovigilancia. Por otro lado, parece obvio que la mayoría de las RAM cutáneas son comunicadas por otros especialistas (AU)