Effectiveness and safety of oral anticoagulant therapy in a real-world cohort with atrial fibrillation: The SIESTA-A study protocol.

INTRODUCTION: Oral anticoagulants (OACs) are first-line drugs for stroke prevention in patients with atrial fibrillation (AF). The introduction of new lines of therapy with direct oral anticoagulants (DOACs) has led to a decreased use of vitamin K antagonists (VKAs). Comparative analyses of DOACs in clinical trials are scarce and the comparator has mostly been warfarin. Their impact on health outcomes in observational studies has not always been consistent. The aim of this study is to evaluate the effectiveness and safety of DOACs and VKAs in patients with AF using Real-World Data (RWD). METHODS AND ANALYSIS: Population-based retrospective cohort study using RWD from actual practice. Period: January 2012-December 2020. Inclusion criteria: patients with AF who had not taken OACs in the previous 12 months. Exclusion criteria: <40 years, with severe mitral stenosis, or valvular heart disease or aortic and/or mitral valve procedures. Data source: The Andalusian Population Health Database, Spain. Outcome measures: a) Effectiveness: ischaemic stroke, transient ischaemic attack, systemic and pulmonary embolism, and death; b) Safety: gastrointestinal and intracranial haemorrhaging; Independent variables: age, sex, comorbidities, medication and health resource use, CHA2DS2-VASC, HAS-BLED, and analytical tests. Statistical analysis: crude incidence analysis, survival models, Kaplan-Meier, Cox regression analysis adjusted for possible confounding and paired analysis by propensity score matching.

Assessment of pre and postoperative anxiety in patients undergoing ambulatory oral surgery in primary care.

BACKGROUND: To analyze the pre- and postoperative anxiety level in patients undergoing ambulatory oral surgery (AOS) in a primary healthcare center (PHC). MATERIAL AND METHODS: Prospective and descriptive clinical study on 45 patients who underwent AOS procedures in the dental clinic of a public PHC of Spain between April and September 2015. Anxiety analysis was carried out with pre- and postoperative anxiety-state (STAI-S), anxiety-trait (STAI-T) and dental anxiety (MDAS) questionnaires. A descriptive, inferential and binary logistic regression analysis were performed for the variables age, sex, educational level, previous experience of oral treatment, type of oral surgery, degree of third molar impaction, surgical time, intraoperative complications, postoperative complications, and pain score with a visual analogue scale (VAS). RESULTS: The majority were female (57.8%) with a mean age of 33.5±9.6 years. The most frequent procedure was the lower third molar removal (82.2%). The mean pain score on the VAS was 1.6±1.8. The incidence of complications was low (7.8%). There was a statistically significant association between post- and preoperative anxiety (r=0.56, p<0.001) and a correlation between pain score and postoperative anxiety (Rho= -0.35, p=0.02). The likelihood of postoperative anxiety was related to preoperative anxiety (OR=1.3, p=0.03). CONCLUSIONS: AOS in a PHC is safe and should be more encouraged in the public primary care. The emotional impact on users was relatively low, highlighting that the preoperative anxiety levels were higher than the postoperative ones. Psychological factors related to pre- and postoperative anxiety should be considered in the AOS carried out in PC.

Eficacia de la colonografía por tomografía computarizada frente a la colonoscopia como prueba de cribado del cáncer colorrectal / Efficacy of CT colonography versus colonoscopy in screening for colorectal cancer

Objetivo. Determinar la eficacia y efectividad de la colonografía por tomografía computarizada (CTC) frente a la colonoscopia como pruebas de cribado para el cáncer colorrectal (CCR). Material y métodos. Se realizó una revisión sistemática de la literatura científica que incluyó todos los estudios que evaluaran la eficacia de la CTC como prueba de cribado del CCR. Quedaron excluidos aquellos artículos que analizaran la eficacia de otras técnicas de cribado para el CCR o los que utilizaran la CTC como técnica diagnóstica o en poblaciones sintomáticas. De las 213 referencias obtenidas se seleccionaron 9 estudios tras lectura crítica. Resultados. La especificidad demostrada para la CTC en el cribado del CCR fue alta y disminuía con el diámetro del pólipo a detectar. La sensibilidad para la CTC para detectar pólipos de diámetro igual o menor de 6mm resultó ser muy baja y heterogénea, aunque aumentaba para la detección de pólipos de más de 9mm de diámetro. Conclusión. La CTC demostró tener alta especificidad y una sensibilidad muy heterogénea, aunque en la mayoría de los casos no alcanzó los porcentajes de sensibilidad y especificidad logrados por la colonoscopia (AU)

Objective. To determine the efficacy and effectiveness of CT colonography in comparison with those of colonoscopy in screening for colorectal cancer. Material and methods. We systematically reviewed all the studies in the scientific literature that assessed the efficacy of CT colonography in screening for colorectal cancer. We excluded articles that assessed the efficacy of other screening techniques for colorectal cancer and those that used CT colonography in the diagnostic workup of suspected lesions or symptomatic patients. After a critical reading of the 213 references obtained, we selected nine studies. Results. The specificity of CT colonography in screening for colorectal cancer was high, although it decreased with the diameter of the polyp to be detected. The sensitivity of CT colonography in the detection of polyps less than or equal to 6mm in diameter was very low and heterogeneous, although it was higher for polyps greater than 9mm in diameter. Conclusion. CT colonography has high specificity but very heterogeneous sensitivity, although in most cases it was not as sensitive or specific as conventional colonoscopy (AU)

La vitamina K como profilaxis para la enfermedad hemorrágica del recién nacido / Prophylactic Vitamin K for Vitamin K Deficiency Bleeding of the Newborn

Objetivo La administración de vitamina K inmediatamente después del nacimiento ha demostrado un descenso significativo de la incidencia de hemorragias neonatales, pero no existe evidencia suficiente que determine la forma de administración más adecuada. El objetivo de esta revisión es determinar la eficacia de la vitamina K administrada por vía oral frente a la vía intramuscular en la prevención de la enfermedad hemorrágica del recién nacido. Métodos Se realizó una revisión sistematizada de las principales bases de datos (Medline, Embase y Cochrane), entre otras sin limitación por fecha, idioma ni tipo de estudio. Los estudios seleccionados evaluaban la eficacia de la vitamina K. Se excluyeron aquellos estudios realizados en embarazadas, niños pretérmino o en pacientes afectos de alguna enfermedad. La validez de estos estudios fue evaluada mediante herramientas CASPe para revisiones sistemáticas y ensayos clínicos. Resultados Los estudios incluidos fueron cuatro ensayos clínicos y una revisión sistemática. Únicamente dos estudios evaluaron aspectos clínicos en los cuales se observó un descenso en la incidencia de hemorragias en el recién nacido tras la profilaxis con vitamina K por vía intramuscular. Con respecto a la vía oral, diferentes estudios analizaron la eficacia de la vitamina K mediante la determinación de parámetros bioquímicos (factor X, índice y tiempo de protrombina, vitamina K1 en plasma y antígeno de protrombina, entre otros) con resultados poco concluyentes en cuanto a la vía de administración y al número de dosis. Conclusiones(..)(AU)

Background The administration of vitamin K immediately after birth has shown a significant decrease in the incidence of newborn bleeding, but there is not enough evidence to determine the most appropriate method of administration. The objective of this review is to determine the effectiveness of orally administered vitamin K compared to the intramuscular route in the prevention of haemorrhagic disease of newborn (HDN).Methods We conducted a systematic review of the main databases (Medline, Embase and Cochrane, among others) without limitation by date, language or type of study. Selected studies evaluated the efficacy and safety of vitamin K. Excluded were studies in pregnant women in preterm infants or patients with pathology. The validity of these studies was assessed by CASPe tools for systematic reviews and clinical trials. Results Only two studies evaluated clinical aspects. They showed a reduction in the incidence of bleeding in the newborn after intramuscular prophylaxis with vitamin K. With regard to the oral route, different studies examined the effectiveness of vitamin K by determining biochemical parameters (factor X, prothrombin time and index, vitamin K1 in plasma and prothrombin antigen, among others) with inconclusive results regarding the route of administration and the number of doses. Conclusions There is sufficient evidence to support the effectiveness of a single intramuscular dose of vitamin K to prevent the classic form of HDN. With regard to late HDN and oral route, the results are inconclusive because the studies used biochemical indicators of effectiveness, which cannot be correlated with the actual coagulation status of the newborn due to lack of scientific evidence(AU)

[Efficacy of CT colonography versus colonoscopy in screening for colorectal cancer]. / Eficacia de la colonografía por tomografía computarizada frente a la colonoscopia como prueba de cribado del cáncer colorrectal.

OBJECTIVE: To determine the efficacy and effectiveness of CT colonography in comparison with those of colonoscopy in screening for colorectal cancer. MATERIAL AND METHODS: We systematically reviewed all the studies in the scientific literature that assessed the efficacy of CT colonography in screening for colorectal cancer. We excluded articles that assessed the efficacy of other screening techniques for colorectal cancer and those that used CT colonography in the diagnostic workup of suspected lesions or symptomatic patients. After a critical reading of the 213 references obtained, we selected nine studies. RESULTS: The specificity of CT colonography in screening for colorectal cancer was high, although it decreased with the diameter of the polyp to be detected. The sensitivity of CT colonography in the detection of polyps less than or equal to 6mm in diameter was very low and heterogeneous, although it was higher for polyps greater than 9mm in diameter. CONCLUSION: CT colonography has high specificity but very heterogeneous sensitivity, although in most cases it was not as sensitive or specific as conventional colonoscopy.

[Prophylactic vitamin K for vitamin K deficiency bleeding of the newborn]. / La vitamina K como profilaxis para la enfermedad hemorrágica del recién nacido.

BACKGROUND: The administration of vitamin K immediately after birth has shown a significant decrease in the incidence of newborn bleeding, but there is not enough evidence to determine the most appropriate method of administration. The objective of this review is to determine the effectiveness of orally administered vitamin K compared to the intramuscular route in the prevention of hemorrhagic disease of newborn (HDN). METHODS: We conducted a systematic review of the main databases (Medline, Embase and Cochrane, among others) without limitation by date, language or type of study. Selected studies evaluated the efficacy and safety of vitamin K. Excluded were studies in pregnant women in preterm infants or patients with pathology. The validity of these studies was assessed by CASPe tools for systematic reviews and clinical trials. RESULTS: Only two studies evaluated clinical aspects. They showed a reduction in the incidence of bleeding in the newborn after intramuscular prophylaxis with vitamin K. With regard to the oral route, different studies examined the effectiveness of vitamin K by determining biochemical parameters (factor X, prothrombin time and index, vitamin K1 in plasma and prothrombin antigen, among others) with inconclusive results regarding the route of administration and the number of doses. CONCLUSIONS: There is sufficient evidence to support the effectiveness of a single intramuscular dose of vitamin K to prevent the classic form of HDN. With regard to late HDN and oral route, the results are inconclusive because the studies used biochemical indicators of effectiveness, which can not be correlated with the actual coagulation status of the newborn due to lack of scientific evidence.

Disfunción eréctil en pacientes intervenidos de cáncer de próstata. Revisión sistemática de la literatura médica / Erectile dysfunction in patients with prostate cancer who have undergone surgery: Systematic review of literature

Objetivo: Evaluar la aparición de la disfunción eréctil en pacientes con cáncer de próstata sometidos a prostatectomía radical (PR) retropúbica, prostatectomía laparoscópica y/o prostatectomía robótica. Material y métodos: Revisión sistemática de la literatura médica mediante búsqueda bibliográfica (2000–2010) en MedLine, Embase, Cochrane Library, Center for Review Dissemination, ECRI y Hayes. Los términos Mesh fueron «Prostatectomy», «Prostatic neoplasm», «Transuretral resection prostate», «Impotence» y los términos libres fueron «erectile dysfunction» y «prostatectomy». Los estudios incluían pacientes con cáncer de próstata intervenidos para la extirpación de la glándula mediante cirugía abierta (retropúbica), laparoscópica o robótica. Resultados: Se seleccionaron diez estudios observacionales de calidad moderada y 29 series de casos de baja calidad. Los estudios observacionales presentaban los menores porcentajes de disfunción eréctil en pacientes intervenidos mediante cirugía robótica (3–51%). La PR retropúbica (36–91%) y la laparoscópica registraban cifras superiores de aparición de impotencia. Los estudios que comparaban intervenciones, cirugía y radioterapia obtenían con las radiaciones menores índices de disfunción sexual (3–72%). En las series de casos, los menores porcentajes de disfunción eréctil acontecieron en pacientes con cirugía robótica (22%), seguido de cirugía laparoscópica (40%) y de PR retropúbica (41,4%). Conclusiones: Los resultados, aunque deben interpretarse con cautela dada la limitada calidad de los estudios, presentan efectos similares en la evaluación de las diferentes técnicas quirúrgicas, observándose que la cirugía robótica registra los menores porcentajes en relación con la aparición de impotencia sexual (AU)

Objective: To assess erectile dysfunction in patients with prostate cancer undergoing surgery by radical prostatectomy, laparoscopic prostatectomy or robotic prostatectomy. Material and methods: Systematic Review of literature based on a search strategy (2000–10) in MedLine, Embase, Cochrane Library, CRD, ECRI, and Hayes. Mesh terms used were 'Prostatectomy', 'Prostatic Neoplasm', 'Transuretral Resection Prostate', 'Impotence' and as free terms 'erectile dysfunction' and 'prostatectomy'. Studies included patients with prostate cancer underwent by prostatectomy radical with open surgery (retropubic), laparoscopic or robotic surgery. Results: Ten observational studies with moderate quality and 29 case series with low quality were selected. Observational studies showed lower percentages of erectile dysfunction after intervention in the patients underwent robotic surgery (3–51%). Radical surgery (36–91%) and laparoscopic surgery showed higher values of impotence. In the studies that compared surgery versus radiotherapy, the results were better for radiotherapy (3–72% erectile dysfunction). In the case series, lower percentages of erectile dysfunction were shown in patients underwent to robotic surgery (22%), the following was for laparoscopic surgery (40%) and open radical prostatectomy (41.4%). Conclusions: This result should be considered with caution because of the low methodological quality of the studies included. However, the different surgical techniques assessed showed similar effects in the two types of studies included and we found that robotic surgery presented lower percentages of sexual impotence (AU)

[Erectile dysfunction in patients with prostate cancer who have undergone surgery: Systematic review of literature]. / Disfunción eréctil en pacientes intervenidos de cáncer de próstata. Revisión sistemática de la literatura médica.

OBJECTIVE: To assess erectile dysfunction in patients with prostate cancer undergoing surgery by radical prostatectomy, laparoscopic prostatectomy or robotic prostatectomy. MATERIAL AND METHODS: Systematic Review of literature based on a search strategy (2000-10) in MedLine, Embase, Cochrane Library, CRD, ECRI, and Hayes. Mesh terms used were Prostatectomy, "Prostatic Neoplasm, Transuretral Resection Prostate, Impotence and as free terms erectile dysfunction and prostatectomy. Studies included patients with prostate cancer underwent by prostatectomy radical with open surgery (retropubic), laparoscopic or robotic surgery. RESULTS: Ten observational studies with moderate quality and 29 case series with low quality were selected. Observational studies showed lower percentages of erectile dysfunction after intervention in the patients underwent robotic surgery (3-51%). Radical surgery (36-91%) and laparoscopic surgery showed higher values of impotence. In the studies that compared surgery versus radiotherapy, the results were better for radiotherapy (3-72% erectile dysfunction). In the case series, lower percentages of erectile dysfunction were shown in patients underwent to robotic surgery (22%), the following was for laparoscopic surgery (40%) and open radical prostatectomy (41.4%). CONCLUSIONS: This result should be considered with caution because of the low methodological quality of the studies included. However, the different surgical techniques assessed showed similar effects in the two types of studies included and we found that robotic surgery presented lower percentages of sexual impotence.