SUMMARY: Background rVIII-SingleChain is a novel B-domain truncated recombinant factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand factor. Objectives This phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients < 12 years of age with severe hemophilia A. Patients/Methods Patients could be assigned to prophylaxis or on-demand therapy by the investigator. For patients assigned to prophylaxis, the treatment regimen and dose were based on the bleeding phenotype. For patients receiving on-demand therapy, dosing was guided by World Federation of Hemophilia recommendations. The primary endpoint was treatment success, defined as a rating of 'excellent' or 'good' on the investigator's clinical assessment of hemostatic efficacy for all treated bleeding events. Results The study enrolled 84 patients (0 to < 6 years, n = 35; ≥ 6 to < 12 years, n = 49); 81 were assigned to prophylaxis and three to an on-demand regimen. Patients accumulated a total of 5239 exposure days (EDs), with 65 participants reaching > 50 EDs. In the 347 bleeds treated and evaluated by the investigator, hemostatic efficacy was rated as excellent or good in 96.3%. The median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.00, 2.20), and the median annualized bleeding rate was 3.69 (Q1, Q3: 0.00, 7.20) across all prophylaxis regimens. No participant developed an inhibitor. Conclusions rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study in children < 12 years of age with severe hemophilia A.
OBJECTIVES: To evaluate the psychometric properties of the translated Indonesian version of the Nursing Home Survey on Patient Safety Culture (NHSOPSC-INA).
METHODS: This study was a cross-sectional survey conducted using NHSOPSC-INA. A total of 258 participants from 20 NH in Indonesia were engaged. Participants included NH managers, caregivers, administrative staff, nurses and support staff with at least junior high school education. The SPSS 23.0 was used for descriptive data analysis and internal consistency (Cronbach's alpha) estimation. The AMOS (version 22) was used to perform confirmatory factor analysis (CFA) on the questionnaire's dimensional structure.
RESULTS: The NHSOPSC CFA test originally had 12 dimensions with 42 items and was modified to eight dimensions with 26 items in the Indonesian version. The deleted dimensions were 'Staffing' (4 items), 'Compliance with procedure' (3 items), 'Training and skills' (3 items), 'non-punitive response to mistakes' (4 items) and 'Organisational learning' (2 items). The subsequent analysis revealed an accepted model with 26 NHSOPSC-INA items (root mean square error of approximation = 0.091, comparative fit index = 0.815, Tucker-Lewis index = 0.793, CMIN = 798.488, df = 291, CMIN/Df = 2.74, GFI = 0.782, AGFI = 0.737, p
METHODS: A cross-sectional survey was conducted in 12 private hospitals in Malaysia. A total of 652 (response rate = 61.8%) nurses participated in the study. Data were collected using self-administered questionnaire on nurses' characteristic, adverse events and events reporting, and perceived patient safety.
RESULTS: Patient and family complaints events were the most common adverse events in Malaysian private hospitals as result of increased cost of care (3.24 ± 0.95) and verbal miscommunication (3.52 ± 0.87).
CONCLUSION: Hospital size, accreditation status, teaching status, and nurse ethnicity had a mixed effect on patient safety, perceived adverse events, and events reporting. Policy makers can benefit that errors are related to several human and system related factors. Several system reforms and multidisciplinary efforts were recommended for optimizing health, healthcare and preventing patient harm.
BACKGROUND: Echocardiography is pivotal in the diagnosis of pericardial effusion and tamponade physiology. Ultrasound guidance for pericardiocentesis is currently considered the standard of care. Several approaches have been described recently, which differ mainly on the site of puncture (subxiphoid, apical, or parasternal). Although they share the use of low-frequency probes, there is absence of complete control of needle trajectory and real-time needle visualization. An in-plane and real-time technique has only been described anecdotally.
METHODS AND RESULTS: A retrospective analysis of 11 patients (63% men, mean age: 37.7±21.2 years) presenting with cardiac tamponade admitted to the tertiary-care emergency department and treated with parasternal medial-to-lateral in-plane pericardiocentesis was carried out. The underlying causes of cardiac tamponade were different among the population. All the pericardiocentesis were successfully performed in the emergency department, without complications, relieving the hemodynamic instability. The mean time taken to perform the eight-step procedure was 309±76.4 s, with no procedure-related complications.
CONCLUSION: The parasternal medial-to-lateral in-plane pericardiocentesis is a new technique theoretically free of complications and it enables real-time monitoring of needle trajectory. For the first time, a pericardiocentesis approach with a medial-to-lateral needle trajectory and real-time, in-plane, needle visualization was performed in a tamponade patient population.
METHODS: Seventy-seven medical doctors and eighty nurses answered a self-administered questionnaire designed to capture demographic data and information regarding abbreviation use in medical practice. Comparisons were made between doctors and nurses with regards to frequency and reasons for using abbreviations; from where abbreviations were learned; frequency of encountering abbreviations in medical practice; prevalence of medical errors due to misinterpretation of abbreviations; and their ability to correctly interpret commonly used abbreviations.
RESULTS: The use of abbreviations was highly prevalent among doctors and nurses. Time saving, avoidance of writing sentences in full and convenience, were the main reasons for using abbreviations. Doctors learned abbreviations from fellow doctors while nurses learned from fellow nurses and doctors. More doctors than nurses reported encountering abbreviations. Both groups reported no difficulties in interpreting abbreviations although nurses reported often resorting to guesswork. Both groups felt abbreviations were necessary and an acceptable part of work. Doctors outperformed nurses in correctly interpreting commonly used standard and non-standard abbreviations.
CONCLUSION: The use of standard and non-standard abbreviation in clinical practice by doctors and nurses was highly prevalent. Significant variability in interpretation of abbreviations exists between doctors and nurses.