MATERIALS AND METHODS: This qualitative, explanatory case study evaluated PhIS in ambulatory pharmacies in a hospital and a clinic. Data were collected through observations, interviews, and document analysis. We applied the socio-technical interactive analysis (ISTA) framework to investigate the socio-technical interactions of pharmacy information systems that lead to unintended consequences. We then adopted the human-organization-process-technology-fit (HOPT-fit) framework to identify their contributing and dominant factors, misfits, and mitigation measures.
RESULTS: We identified 28 unintended consequences of PhIS, their key contributing factors, and their interrelations with the systems. The primary causes of unintended consequences include system rigidity and complexity, unclear knowledge, understanding, skills, and purpose of using the system, use of hybrid paper and electronic documentation, unclear and confusing transitions, additions and duplication of tasks and roles in the workflow, and time pressure, causing cognitive overload and workarounds. Recommended mitigating mechanisms include human factor principles in system design, data quality improvement for PhIS in terms of effective use of workspace, training, PhIS master data management, and communication by standardizing workarounds.
CONCLUSION: Threats to information quality emerge in PhIS because of its poor design, a failure to coordinate its functions and clinical tasks, and pharmacists' lack of understanding of the system use. Therefore, safe system design, fostering awareness in maintaining the information quality of PhIS and cultivating its safe use in organizations is essential to ensure patient safety. The proposed evaluation approach facilitates the evaluator to identify complex socio-technical interactions and unintended consequences factors, impact, and mitigation mechanisms.
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.
AREAS COVERED: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.
EXPERT OPINION: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.
DESIGN/METHODOLOGY/APPROACH: Using difference in differences model, BIMC Hospitals and Siloam Hospital Bali were compared before and after shift schedule realignment to test the association between shift schedule realignment and patient safety culture.
FINDINGS: Shift schedule realignment was associated with a significant improvement in staffing (coefficient 1.272; 95% CI 0.842 - 1.702; p<0.001), teamwork within units (coefficient 1.689; 95% CI 1.206 - 2.171; p<0.001), teamwork across units (coefficient 1.862; 95% CI 1.415 - 2.308; p<0.001), handoffs and transitions (coefficient 0.999; 95% CI 0.616 - 1.382; p<0.001), frequency of error reported (coefficient 1.037; 95% CI 0.581 - 1.493; p<0.001), feedback and communication about error (coefficient 1.412; 95% CI 0.982 - 1.841; p<0.001) and communication openness (coefficient 1.393; 95% CI 0.968 - 1.818; p<0.001).
PRACTICAL IMPLICATIONS: With positive impact on patient safety culture, shift schedule realignment should be considered as quality improvement initiative. It stretches the compressed workload suffered by staff while maintaining 40 h per week in accordance with applicable laws and regulations.
ORIGINALITY/VALUE: Shift schedule realignment, designed to improve patient safety culture, has never been implemented in any Indonesian private hospital. Other hospital managers might also appreciate knowing about the shift schedule realignment to improve the patient safety culture.
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.
MATERIALS AND METHODS: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient's condition by patient and physician) over a period of 24 weeks.
RESULTS: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study.
DISCUSSION: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.