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Protocol Deviations (protocol + deviation)
Selected AbstractsUsing community pharmacies to conduct an HSV-1 prevalence studyPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2002Joseph C. Veltri PharmD Abstract Purpose To describe the effectiveness of community-based pharmacists in conducting a study to measure the baseline prevalence of Herpes simplex virus, type-1 susceptibility to two antiviral medications in subjects with recurrent Herpes labialis Method A cross-sectional study conducted in 47 US community pharmacies. The pharmacist obtained a viral sample from the surface of the lesion, placed the virus-laden swab in a vial of holding medium, and stored it in a refrigerator until shipment to a central laboratory. Results The population that had swabs processed for viral isolation (1795) was predominantly white (90.1%) and female (67.9%) with a mean age of 37.5 years. A total of 1087 (60.3%) swabs were positive for HSV-1. On-site monitoring revealed 219 protocol deviations related to the stage of the lesion (124), not properly dating or signing the consent form (80), and indeterminate age (15). Conclusions This study demonstrates the ability of pharmacists to conduct a large surveillance study in busy community pharmacies. A population of RHL sufferers with active lesions was recruited to study pharmacies during a 5-month period. Pharmacists successfully obtained viral samples from cold sore lesions at a rate comparable to physician-conducted studies. Protocol deviations were generally not serious, and did not compromise the study results or endanger the rights or welfare of participants. Copyright © 2002 John Wiley & Sons, Ltd. [source] "Tower, Am I Cleared to Land?": Problematic Communication in Aviation DiscourseHUMAN COMMUNICATION RESEARCH, Issue 3 2008John W. Howard III This study examined problematic communication in pilot,air traffic controller (ATC) interaction. More than 15 hours of pilot,ATC dialogue were collected by monitoring control tower frequencies at 15 U.S. airports. The transcribed data yielded a total of 34 ATCs, 270 pilots, and 1,799 turns of talk. Analyses revealed that (a) communication problematics manifested in pilot turns more than ATC turns, (b) higher amounts of information led to increased problematic communication in the subsequent turn, and (c) linguistic violations of ATC protocol increased problematic communication in the subsequent turn. Partial support was found for the effect of frequency congestion on problematic communication. No effect was observed for airport size on problematic communication. The discussion addresses the significance of protocol deviations and system constraints for problematic communication. Applications for the findings in pilot,ATC radio interaction are also suggested. Résumé « Tour de contrôle, suis-je autoriséà atterrir? » : Communication à problèmes dans le discours de l,aviation Cette recherche a étudié la communication à problèmes en interaction pilote-contrôleur aérien. Plus de 15 heures de dialogue pilote-contrôleur aérien furent recueillies grâce au suivi des fréquences des tours de contrôle de 15 aéroports des États-Unis. Un total de 34 contrôleurs aériens, 270 pilotes et 1799 tours de parole se retrouvent dans les données retranscrites. Les analyses ont révélé que a) les problèmes de communication se sont manifestés dans les tours de parole des pilotes plutôt que dans les tours de parole des contrôleurs aériens, b) une plus grande quantité d'information menait à plus de communication à problèmes dans le tour de parole subséquent et c) les violations linguistiques du protocole des contrôleurs aérien augmentaient la communication à problèmes au tour de parole subséquent. L,analyse appuie en partie l'effet de l,encombrement des fréquences sur la communication à problèmes. La taille de l'aéroport n,a pas eu d'effet observable sur la communication à problèmes. La discussion aborde l'importance des déviations du protocole et des contraintes de système pour la communication à problèmes. Il est aussi suggéré des applications des résultats aux interactions radio entre pilotes et contrôleurs aériens. Abstract "Tower, darf ich landen?" Problematische Kommunikation im Luftfahrtsdiskurs Diese Studie befasst sich mit der Untersuchung von problematischer Kommunikation zwischen Pilot und Fluglotse. Durch die Beobachtung der Luftüberwachung an 15 U.S.-amerikanischen Flughäfen konnten mehr als 15 Stunden Dialog zwischen Pilot und Fluglotse zusammengetragen werden. Die transkribierten Daten lieferten 34 Fluglotsen, 270 Piloten und 1799 Gesprächsfolgen. Die Auswertung zeigte, dass (a) Kommunikationsprobleme eher auf Seiten der Piloten als der Fluglotsen zu finden waren, (b) eine größere Informationsmenge zu vermehrter problematischer Kommunikation im darauf folgenden Dialogteil führte und c) linguistische Übertretungen des Fluglotsenprotokolls ebenfalls zu vermehrter problematischer Kommunikation beim darauf folgenden Dialogteil führte. Die Flughafengröße hatte keinen Einfluss auf problematische Kommunikation. In der Diskussion wird die Bedeutsamkeit von Protokollabweichungen und Bedingungen des Systems für die problematische Kommunikation erörtert und die Anwendungsmöglichkeiten der Ergebnisse für die Funkinteraktion zwischen Pilot und Fluglotse vorgeschlagen. Resumen "Torre, ¿Está Despejado Para Aterrizar?": La Comunicación Problemática en el Discurso de la Aviación Este estudio examina la comunicación problemática en la interacción entre el piloto y la torre de control de tráfico de aire (ATC). Más de 15 horas de diálogos entre pilotos y ATC fueron coleccionados mediante el monitoreo de las frecuencias de la torre de control de 15 aeropuertos en los Estados Unidos. Los datos transcriptos resultaron en un total de 34 ATC, 270 pilotos, y 1799 turnos de conversación. Los análisis revelaron que (a) la comunicación problemática se manifestaba más en los turnos de los pilotos que en los turnos de los ATC, (b) mayores niveles de información llevaron a un incremento de la comunicación problemática en los turnos subsecuentes, y (c) las violaciones lingüísticas al protocolo del ATC incrementó la comunicación problemática en los turnos subsecuentes. Se encontró apoyo parcial para el efecto de frecuencia de congestión en la comunicación problemática. No se observó efecto alguno entre el tamaño del aeropuerto y la comunicación problemática. En la discusión, se trata la significancia de las desviaciones del protocolo y las constricciones del sistema sobre la comunicación problemática. Las aplicaciones de estos hallazgos en la interacción entre pilotos y la radio del ATC son sugeridas también. ZhaiYao Yo yak [source] Clinical trial: ulcerative colitis maintenance treatment with 5-ASA: a 1-year, randomized multicentre study comparing MMX® with Asacol®ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009C. PRANTERA Summary Background, 5-ASA-MMX® (1.2 g/tablet) is a 5-aminosalicylic acid formulation, designed for once-daily dosing in the treatment of ulcerative colitis. Aim, To evaluate the efficacy and safety of 5-ASA-MMX (2.4 g/day, once daily), compared with Asacol® (2.4 g/day, twice daily) in the maintenance of left-sided UC, through a double-blind, double-dummy, parallel-group, randomized, comparator study. Methods, In all, 331 patients with UC were randomized to receive either 5-ASA-MMX 2.4 g/day, once daily, or Asacol 2.4 g/day, twice daily, for 12 months. All patients were in remission for ,1 month prior to the trial, with ,1 documented relapse in the previous year. The co-primary endpoints of this study were the proportion of patients in clinical, and clinical and endoscopic remission following 12 months' treatment. Results, In the intent-to-treat population, excluding those with major protocol deviations, 68.0 and 65.9% patients in the 5-ASA-MMX and Asacol groups, respectively, were in clinical remission (P = 0.69), and 60.9 and 61.7% of patients, respectively, were in clinical and endoscopic remission (P = 0.89). Diary card data revealed statistically significant treatment differences favouring 5-ASA-MMX. Both treatments were similarly tolerated. Conclusions, Once-daily 5-ASA-MMX is similarly effective with a comparable safety profile to Asacol administered twice daily, for the maintenance treatment of ulcerative colitis. [source] Using community pharmacies to conduct an HSV-1 prevalence studyPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2002Joseph C. Veltri PharmD Abstract Purpose To describe the effectiveness of community-based pharmacists in conducting a study to measure the baseline prevalence of Herpes simplex virus, type-1 susceptibility to two antiviral medications in subjects with recurrent Herpes labialis Method A cross-sectional study conducted in 47 US community pharmacies. The pharmacist obtained a viral sample from the surface of the lesion, placed the virus-laden swab in a vial of holding medium, and stored it in a refrigerator until shipment to a central laboratory. Results The population that had swabs processed for viral isolation (1795) was predominantly white (90.1%) and female (67.9%) with a mean age of 37.5 years. A total of 1087 (60.3%) swabs were positive for HSV-1. On-site monitoring revealed 219 protocol deviations related to the stage of the lesion (124), not properly dating or signing the consent form (80), and indeterminate age (15). Conclusions This study demonstrates the ability of pharmacists to conduct a large surveillance study in busy community pharmacies. A population of RHL sufferers with active lesions was recruited to study pharmacies during a 5-month period. Pharmacists successfully obtained viral samples from cold sore lesions at a rate comparable to physician-conducted studies. Protocol deviations were generally not serious, and did not compromise the study results or endanger the rights or welfare of participants. Copyright © 2002 John Wiley & Sons, Ltd. [source] | ||||||||||