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.
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.
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.
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.
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.
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: Systematic reviews were undertaken of English-language articles published between 2000 and 2016, identified from MEDLINE using PubMed, EMBASE and Cochrane databases. The strength of available evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Recommendations were developed through consensus using the Delphi technique.
RESULTS: Fourteen axial SpA treatment recommendations were developed based on evidence summaries and consensus. The first 2 recommendations cover non-pharmacological approaches to management. Recommendations 3 to 5 describe the following: the use of non-steroidal anti-inflammatory drugs as first-line symptomatic treatment; the avoidance of long-term corticosteroid use; and the utility of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for peripheral or extra-articular manifestations. Recommendation 6 refers to the indications for biological DMARDs (bDMARDs). Recommendation 7 deals specifically with screening for infections endemic to Asia, prior to use of bDMARDs. Recommendations 7 to 13 cover the role of bDMARDs in the treatment of active axial SpA and include related issues such as continuing therapy and use in special populations. Recommendation 14 deals with the utility of surgical intervention in axial SpA.
CONCLUSION: These recommendations provide up-to-date guidance for treatment of axial SpA to help meet the needs of patients and clinicians in the Asia-Pacific region.
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.
OBJECTIVE: This paper aimed to describe the development process of the COVID-19 Symptom Monitoring System (CoSMoS), which consists of a self-monitoring, algorithm-based Telegram bot and a teleconsultation system. We describe all the essential steps from the clinical perspective and our technical approach in designing, developing, and integrating the system into clinical practice during the COVID-19 pandemic as well as lessons learned from this development process.
METHODS: CoSMoS was developed in three phases: (1) requirement formation to identify clinical problems and to draft the clinical algorithm, (2) development testing iteration using the agile software development method, and (3) integration into clinical practice to design an effective clinical workflow using repeated simulations and role-playing.
RESULTS: We completed the development of CoSMoS in 19 days. In Phase 1 (ie, requirement formation), we identified three main functions: a daily automated reminder system for patients to self-check their symptoms, a safe patient risk assessment to guide patients in clinical decision making, and an active telemonitoring system with real-time phone consultations. The system architecture of CoSMoS involved five components: Telegram instant messaging, a clinician dashboard, system administration (ie, back end), a database, and development and operations infrastructure. The integration of CoSMoS into clinical practice involved the consideration of COVID-19 infectivity and patient safety.
CONCLUSIONS: This study demonstrated that developing a COVID-19 symptom monitoring system within a short time during a pandemic is feasible using the agile development method. Time factors and communication between the technical and clinical teams were the main challenges in the development process. The development process and lessons learned from this study can guide the future development of digital monitoring systems during the next pandemic, especially in developing countries.