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.
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: 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.
METHODS: We conducted an exploratory qualitative study and purposefully selected people with T2D who drove and fasted during the past Ramadan period in 2019. In-depth face-to-face interviews were conducted and transcribed verbatim. Data were analysed thematically using a constant comparative method until saturation was achieved (n = 16).
RESULTS: Two major themes were identified, namely: (1) knowing oneself and (2) voluntary self-restriction. Participants described the importance of understanding how Ramadan fasting affected them and their level of alertness. As such, participants often adjusted their daily activities and tested their blood glucose levels to prevent experiencing hypoglycaemia. Other coping strategies reported include adjusting their medications and driving restrictions or driving in the mornings when they were more alert. Findings from this study shed light on participants' experiences and coping mechanisms while driving during Ramadan.
CONCLUSION: Given the risks and effects of hypoglycaemia among those who fast, there is a need to provide appropriate and focused patient education during Ramadan to people with T2D to ensure they can perform complex activities such as driving safely, especially in Muslim majority countries.
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.
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: We searched the official Web sites and homepages of the responsible leading patient safety agencies of the three countries. We reviewed all publicly available guidelines, regulatory documents, government reports that included policies, guidelines, strategy papers, reports, evaluation programs, as well as scientific articles and gray literature related to the incident reporting system. We used the World Health Organization components of patient safety reporting system as the guidelines for comparison and analyzed the documents using descriptive comparative analysis.
RESULTS: Taiwan had the most incidents reported, followed by Malaysia and Indonesia. Taiwan Patient Safety Reporting (TPR) and the Malaysian Reporting and Learning System had similar attributes and followed the World Health Organization components for incident reporting. We found differences between the Indonesian system and both of TPR and the Malaysian system. Indonesia did not have an external reporting deadline, analysis and learning were conducted at the national level, and there was a lack of transparency and public access to data and reports. All systems need to establish a clear and structured incident reporting evaluation framework if they are to be successful.
CONCLUSIONS: Compared with TPR and Malaysian system, the Indonesian patient safety incident reporting system seemed to be ineffective because it failed to acquire adequate national incident reporting data and lacked transparency; these deficiencies inhibited learning at the national level. We suggest further research on the implementation at the hospital level to see how far national guidelines and policy have been implemented in each country.
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.
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: 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.
METHODS: A questionnaire based on the Joint Commission International Accreditation Standards was electronically sent to 3 institutions each in 10 geographical regions across 9 Asian countries. Questions addressing 45 practices were divided into 3 categories. A five-tier scale with numerical scores was used to evaluate safety practices in each institution. Responses obtained from three institutions in the United States were used to validate the execution rate of each surveyed safety practice.
RESULTS: The institutional response rate was 70.0% (7 Asian regions, 21 institutions). 44 practices (all those surveyed except for the application of wrist tags for identifying patients with fall risks) were validated using the US participants. Overall, the Asian participants reached a consensus on 89% of the safety practices. Comparatively, most Asian participants did not routinely perform three pre-procedural practices in the examination appropriateness topic.
CONCLUSION: Based on the responses from 21 participating Asian institutions, most routinely perform standard practices during radiological examinations except when it comes to examination appropriateness. This study can provide direction for safety policymakers scrutinizing and improving regional standards of care.
ADVANCES IN KNOWLEDGE: This is the first multicenter survey study to elucidate pre-procedural safety practices in radiological examinations in seven Asian regions.