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.
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, 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.
Methods: The drug classification systems of the United States, the United Kingdom, Japan, Singapore, Malaysia, the Philippines, and Canada were selected to study alongside Thailand's system. The regulatory review was conducted through each country's drug regulatory agency website and available published research. Complementary interviews with drug regulatory authorities were conducted when written documentation was unclear and had limited access. Fifty-two common drugs were selected to compare their actual classifications across the different countries.
Results: All selected countries classified drugs into two major groups: prescription drugs and non-prescription drugs. The studied countries further sub-classified non-prescription drugs into 1-4 categories. Principles of drug classification criteria among countries are similar; they comprised of three themes: disease characteristics, drug safety profile, and other drug characteristics. Actual drug classification of antibiotics, dyslipidemia treatments, and hypertension treatments in Thailand are notedly different from other countries. Furthermore, 77.4% of drugs studied in Thailand fall into the behind-the-counter (dangerous) drug category, which varied from antihistamines to antibiotics, dyslipidemia treatments, and vaccines.
Conclusion: Thailand's drug classification criteria are comparable with other nations; however, there is a need to review drug classification statuses as many drugs have been classified into improper drug categories.
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 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.
METHODS: A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach.
RESULTS: Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified.
CONCLUSIONS: Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.
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.
DESIGN/METHODOLOGY/APPROACH: This study applied stratified random sampling to collect data from 15 different hospitals in Peninsular Malaysia. The self-administered survey questionnaires were distributed among 673 hospital staff (i.e. doctors, nurses, pharmacists, and medical laboratory technologists) to obtain 335 useful responses with a 49.47 per cent valid response rate. The research data were analysed based on confirmatory factor analysis and structural equation modelling by using AMOS version 23 software.
FINDINGS: The research findings indicated that LSS and workforce management have a significant impact on quality performance of the Malaysian hospitals, whereas senior management commitment was found to have an insignificant relationship with quality performance. The research findings indicate that senior management commitment has no direct significant relationship with quality performance, but it has an indirect significant relationship with quality performance through the mediating effects of LSS and workforce management.
RESEARCH LIMITATIONS/IMPLICATIONS: This research focussed solely on healthcare organisations in Malaysia and thus the results might not be applicable for other countries as well as other service organisations.
ORIGINALITY/VALUE: This research provides theoretical, methodological, and practical contributions for the LSS approach and the research findings are expected to provide guidelines to enhance the level of quality performance in healthcare organisations in Malaysia as well as other countries.
MATERIALS AND METHODS: A search of relevant literature from 2014 to 2016 concerning targeted therapies in RA was conducted. The RA Update Working Group evaluated the evidence and proposed updated recommendations using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach, to describe the quality of evidence and strength of recommendations. Recommendations were finalized through consensus using the Delphi technique.
RESULTS: This update provides 16 RA treatment recommendations based on current best evidence and expert clinical opinion. Recommendations 1-3 deal with the use of conventional synthetic disease-modifying antirheumatic drugs. The next three recommendations (4-6) cover the need for screening and management of infections and comorbid conditions prior to starting targeted therapy, while the following seven recommendations focus on use of these agents. We address choice of targeted therapy, switch, tapering and discontinuation. The last three recommendations elaborate on targeted therapy for RA in special situations such as pregnancy, cancer, and major surgery.
CONCLUSION: Rheumatoid arthritis remains a significant health problem in the Asia-Pacific region. Patients with RA can benefit from the availability of effective targeted therapies, and these updated recommendations provide clinicians with guidance on their use.
METHODS: We did a network meta-analysis based on a systematic review of randomised controlled trials comparing fibrinolytic drugs in patients with STEMI. Several databases were searched from inception up to Feb 28, 2017. We included only randomised controlled trials that compared fibrinolytic agents as a reperfusion therapy in adult patients with STEMI, whether given alone or in combination with adjunctive antithrombotic therapy, against other fibrinolytic agents, a placebo, or no treatment. Only trials investigating agents with an approved indication of reperfusion therapy in STEMI (streptokinase, tenecteplase, alteplase, and reteplase) were included. The primary efficacy outcome was all-cause mortality within 30-35 days and the primary safety outcome was major bleeding. This study is registered with PROSPERO (CRD42016042131).
FINDINGS: A total of 40 eligible studies involving 128 071 patients treated with 12 different fibrinolytic regimens were assessed. Compared with accelerated infusion of alteplase with parenteral anticoagulants as background therapy, streptokinase and non-accelerated infusion of alteplase were significantly associated with an increased risk of all-cause mortality (risk ratio [RR] 1·14 [95% CI 1·05-1·24] for streptokinase plus parenteral anticoagulants; RR 1·26 [1·10-1·45] for non-accelerated alteplase plus parenteral anticoagulants). No significant difference in mortality risk was recorded between accelerated infusion of alteplase, tenecteplase, and reteplase with parenteral anticoagulants as background therapy. For major bleeding, a tenecteplase-based regimen tended to be associated with lower risk of bleeding compared with other regimens (RR 0·79 [95% CI 0·63-1·00]). The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy increased the risk of major bleeding by 1·27-8·82-times compared with accelerated infusion alteplase plus parenteral anticoagulants (RR 1·47 [95% CI 1·10-1·98] for tenecteplase plus parenteral anticoagulants plus glycoprotein inhibitors; RR 1·88 [1·24-2·86] for reteplase plus parenteral anticoagulants plus glycoprotein inhibitors).
INTERPRETATION: Significant differences exist among various fibrinolytic regimens as reperfusion therapy in STEMI and alteplase (accelerated infusion), tenecteplase, and reteplase should be considered over streptokinase and non-accelerated infusion of alteplase. The addition of glycoprotein IIb or IIIa inhibitors to fibrinolytic therapy should be discouraged.
FUNDING: None.