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
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.
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.
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.