OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.
METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.
RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.
CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
Methods: A cross-sectional, questionnaire-based study was conducted among 103 pharmacists from 74 different community pharmacies to assess their knowledge about the use of herbal medicines and its adverse drug reaction reporting by using a pre-validate knowledge questionnaire consisting of 12 questions related to it. The pharmacists' responses were measured at a 3-point Likert scale (Poor=1, Moderate=2, and Good=3) and data was entered in SPSS version 22. The minimum and maximum possible scores for knowledge questionnaires were 12 and 36 respectively. Quantitative data was analyzed by using One Way ANOVA and Paired t-test whereas Chi-square and Fisher exact test were used for qualitative data analysis. A p-value of less than 0.05 was considered statistically significant for all the analyses.
Results: About 92% of the pharmacist had good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting with a mean knowledge score of 32.88±3.16. One-way ANOVA determined a significant difference of employment setting (p<0.043) and years of experience (<0.008) with mean knowledge scores of Pharmacists. Pharmacists' knowledge was significantly associated with their years of experience with the Chi-square test.
Conclusion: Pharmacists exhibit good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting. However, with an increasing trend of herbal medicine use and its adverse drug reaction reporting it recalls the empowerment of experienced pharmacists with training programs in this area for better clinical outcomes.
RESULTS AND DISCUSSION: Given the current lack of evidence on quality and safety improvements and on the cost-benefits associated with the introduction of eHealth applications, there should be a focus on implementing more mature technologies; it is also important that eHealth applications should be evaluated against a comprehensive and rigorous set of measures, ideally at all stages of their application life cycle.
METHODS: In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants.
RESULTS: At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified.
CONCLUSIONS: The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.
METHODS: A cross-sectional study, using the 'Hospital Survey on Patient Safety Culture (HSOPSC)' questionnaire was carried out in 2018 in SGH. Random sampling was used to select a wide range of staff in SGH. A self-administered questionnaire was distributed to 500 hospital staff consisting of doctors, nurses, pharmacist and other clinical and non-clinical staff, conducted from March to April 2018. A total of 407 respondents successfully completed the questionnaire. Therefore, the final response rate for the survey was 81.4%. This study used SPSS 22.0 for Windows and Hospital Data Entry and Analysis Tool that works with Microsoft Excel developed by United States Agency for Healthcare Research and Quality (AHRQ) to perform statistical analysis on the survey data.
RESULTS: Majority of the respondents graded the overall patient safety as acceptable (63.1%) while only 3.4% graded as excellent. The overall patient safety score was 50.1% and most of the scores related to dimensions were lower than the benchmark scores (64.8%). Generally, the mean positive response rate for all the dimensions were lower than composite data of AHRQ, except for "Organizational Learning - Continuous Improvement", which is also the highest positive response rate (80%), higher than AHRQ data (73%). The result showed that SGH has a good opportunity to improve over time as it gains experience and accumulates knowledge. On the other hand, the lowest percentage of positive responses was "Non-punitive response to error" (18%), meaning that most of the staff perceived that they will be punished for medical error.
CONCLUSIONS: The level of patient safety culture in SGH is acceptable and most of the scores related to dimensions were lower than benchmark score. SGH as a learning organisation should also address the issues of staffing, improving handoff and transition and develop a non-punitive culture in response to error.
OBJECTIVE: The study aims to investigate the effect of the hospital nurse shift length and patient-centered care on the perceived quality and safety of nurses in the medical-surgical and multidisciplinary wards in Malaysia.
METHODS: A cross-sectional survey has been conducted on 12 hospitals in Malaysia. Data have been collected via a questionnaire. A stratified sampling has been used. The Hayes macro regression analyses have been used to examine the mediating effects of patient-centered care between the effect of working long shifts on the perceived quality and patient safety.
RESULTS: There is a significant mediation effect of patient-centered care between the effect of shift length on the perceived quality (F = 42.90, P ˂ 0.001) and patient safety (F = 25.12, P ˂ 0.001).
CONCLUSION: Patient-centered care mitigates the effect of the shift length on the care outcomes. The study provides an input for the policymakers that patient-centered care and restructuring duty hours are important to provide high-quality patient care.
METHOD: A descriptive, analytical quantitative with a cross-sectional approach was used in this study. The total of 95 nurses agreed to participate by using random sampling. Data collection using a structured questionnaire and observational form. The statistical model with a chi-square analysis was used in this study.
RESULTS: The result showed a correlation between knowledge and nurse practice with OR 3.257 (1.375-7.715; p=0.012), attitude and nurse practice with OR 4.286 (1.775-10.345; p=0.002) training and nurse practicewith OR value 5.455 (2.233-13.322; p=0.000).
CONCLUSIONS: Local authority in the hospital must apply patient safety standards to reduce injury rates, both nurses and patients. Nurses need to follow the current trend of nursing science focusing on patient safety.
METHODS: Semi-structured interviews were conducted among 31 medical doctors in three Malaysian government hospitals on the implementation of the Total Hospital Information System (THIS) between March and May 2015. A thematic qualitative analysis was performed on the resultant data to deduce the relevant themes.
RESULTS: Five themes emerged as the factors influencing workarounds to the HIS: (a) typing skills, (b) system usability, (c) computer resources, (d) workload, and (e) time.
CONCLUSIONS: This study provided the key factors as to why doctors were involved in workarounds during the implementation of the HIS. It is important to understand these factors in order to help mitigate work practices that can pose a threat to patient safety.
METHOD: A qualitative case study evaluation was conducted at a 620-bed public teaching hospital in Malaysia using interview, observation, and document analysis to investigate the features and functions of alert appropriateness and workflow-related issues in cardiological and dermatological settings. The current state map for medication prescribing process was also modelled to identify problems pertinent to CDS alert appropriateness.
RESULTS: The main findings showed that CDS was not well designed to fit into a clinician's workflow due to influencing factors such as technology (usability, alert content, and alert timing), human (training, perception, knowledge, and skills), organizational (rules and regulations, privacy, and security), and processes (documenting patient information, overriding default option, waste, and delay) impeding the use of CDS with its alert function. We illustrated how alert affect workflow in clinical processes using a Lean tool known as value stream mapping. This study also proposes how CDS alerts should be integrated into clinical workflows to optimize their potential to enhance patient safety.
CONCLUSION: The design and implementation of CDS alerts should be aligned with and incorporate socio-technical factors. Process improvement methods such as Lean can be used to enhance the appropriateness of CDS alerts by identifying inefficient clinical processes that impede the fit of these alerts into clinical workflow.
DESIGN/METHODOLOGY/APPROACH: The authors conducted a gap analysis on recommended practices gathered from the literature and current practices gathered through semi-structured interviews with Malaysian medical personnel. A life cycle approach was adopted covering mercury use: input, storage, handling, accident, waste disposal and governance phases.
FINDINGS: The authors found that there are significant gaps between recommended and current mercury management practices. Analysis indicates improper mercury management as the main contributor to these gaps. The authors found from recommended practices that core components needing improvement include: mercury management action plan, mercury use identification team, purchasing policy, proper guidelines and monitoring systems.
PRACTICAL IMPLICATIONS: This study helps us to understand mercury management practices and suggests essential steps to establish a mercury-free medical facility.
ORIGINALITY/VALUE: This study explored the gaps between recommended and current mercury management practices in a medical facility and contributes to the Minamata Convention on Mercury aspirations.
OBJECTIVES: To evaluate the efficacy and safety of a botanical-based Rosa E pigmentation serum in healthy fair skin female volunteers with wrinkles, skin tone, and pigmentation.
METHODS: This was a single-arm, open label study conducted in healthy Indian females; 18 subjects aged 30-55, having fair Caucasian-like skin with at least 2 dark skin pigments with facial wrinkles diagnosed by dermatologist were selected. Rosa E pigmentation serum was applied twice a day for 84 days. Effect was evaluated by (i) instrumental technique (spectrophotometer® 2600D), (ii) clinically by dermatologist regarding product efficacy (skin tone, antiwrinkle, pigmentation), and (iii) volunteers self-evaluation.
RESULTS: The L* value of spectrophotometer reading represents lightness in the skin pigment. Reduction in the pigment was reported from day 14, with significant reductions observed till day 84 compared with baseline. Significant (P < .0001) skin pigmentation lightening was seen on day 14 (1.11) vastly improving on day 84 (1.94) based on photographic assessments. The significant reduction in skin pigment was 76.85%, Felix von Luschan skin color score was 30.24% (P < .0001) with a 7.38-fold reduction in skin tone and 57% reduction in facial wrinkles at day 84 from baseline.
CONCLUSIONS: Rosa E pigmentation serum was found safe and effective in significant reduction in skin pigments, improvement of skin tone, and antiwrinkle properties instrumentally, clinically, and self-evaluation by volunteers. In these evaluations, best results were seen the longer the Rosa E was used.