UNASSIGNED: The traditional clinical trial data collection process requires a clinical research coordinator who is authorized by the investigators to read from the hospital\'s electronic medical record. Using electronic source data opens a new path to extract patients\' data from electronic health records (EHRs) and transfer them directly to an electronic data capture (EDC) system; this method is often referred to as eSource. eSource technology in a clinical trial data flow can improve data quality without compromising timeliness. At the same time, improved data collection efficiency reduces clinical trial costs.
UNASSIGNED: This study aims to explore how to extract clinical trial-related data from hospital EHR systems, transform the data into a format required by the EDC system, and transfer it into sponsors\' environments, and to evaluate the transferred data sets to validate the availability, completeness, and accuracy of building an eSource dataflow.
UNASSIGNED: A prospective clinical trial study registered on the Drug Clinical Trial Registration and Information Disclosure Platform was selected, and the following data modules were extracted from the structured data of 4 case report forms: demographics, vital signs, local laboratory data, and concomitant medications. The extracted data was mapped and transformed, deidentified, and transferred to the sponsor\'s environment. Data validation was performed based on availability, completeness, and accuracy.
UNASSIGNED: In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to the sponsor\'s environment with 100% transcriptional accuracy, but the availability and completeness of the data could be improved.
UNASSIGNED: Data availability was low due to some required fields in the EDC system not being available directly in the EHR. Some data is also still in an unstructured or paper-based format. The top-level design of the eSource technology and the construction of hospital electronic data standards should help lay a foundation for a full electronic data flow from EHRs to EDC systems in the future.

BACKGROUND: Population viral load (VL), the most comprehensive measure of the HIV transmission potential, cannot be directly measured due to lack of complete sampling of all people with HIV.
OBJECTIVE: A given HIV clinic\'s electronic health record (EHR), a biased sample of this population, may be used to attempt to impute this measure.
METHODS: We simulated a population of 10,000 individuals with VL calibrated to surveillance data with a geometric mean of 4449 copies/mL. We sampled 3 hypothetical EHRs from (A) the source population, (B) those diagnosed, and (C) those retained in care. Our analysis imputed population VL from each EHR using sampling weights followed by Bayesian adjustment. These methods were then tested using EHR data from an HIV clinic in Delaware.
RESULTS: Following weighting, the estimates moved in the direction of the population value with correspondingly wider 95% intervals as follows: clinic A: 4364 (95% interval 1963-11,132) copies/mL; clinic B: 4420 (95% interval 1913-10,199) copies/mL; and clinic C: 242 (95% interval 113-563) copies/mL. Bayesian-adjusted weighting further improved the estimate.
CONCLUSIONS: These findings suggest that methodological adjustments are ineffective for estimating population VL from a single clinic\'s EHR without the resource-intensive elucidation of an informative prior.

BACKGROUND: Patients\' online record access (ORA) enables patients to read and use their health data through online digital solutions. One such solution, patient-accessible electronic health records (PAEHRs) have been implemented in Estonia, Finland, Norway, and Sweden. While accumulated research has pointed to many potential benefits of ORA, its application in mental healthcare (MHC) continues to be contested. The present study aimed to describe MHC users\' overall experiences with national PAEHR services.
METHODS: The study analysed the MHC-part of the NORDeHEALTH 2022 Patient Survey, a large-scale multi-country survey. The survey consisted of 45 questions, including demographic variables and questions related to users\' experiences with ORA. We focused on the questions concerning positive experiences (benefits), negative experiences (errors, omissions, offence), and breaches of security and privacy. Participants were included in this analysis if they reported receiving mental healthcare within the past two years. Descriptive statistics were used to summarise data, and percentages were calculated on available data.
RESULTS: 6,157 respondents were included. In line with previous research, almost half (45%) reported very positive experiences with ORA. A majority in each country also reported improved trust (at least 69%) and communication (at least 71%) with healthcare providers. One-third (29.5%) reported very negative experiences with ORA. In total, half of the respondents (47.9%) found errors and a third (35.5%) found omissions in their medical documentation. One-third (34.8%) of all respondents also reported being offended by the content. When errors or omissions were identified, about half (46.5%) reported that they took no action. There seems to be differences in how patients experience errors, omissions, and missing information between the countries. A small proportion reported instances where family or others demanded access to their records (3.1%), and about one in ten (10.7%) noted that unauthorised individuals had seen their health information.
CONCLUSIONS: Overall, MHC patients reported more positive experiences than negative, but a large portion of respondents reported problems with the content of the PAEHR. Further research on best practice in implementation of ORA in MHC is therefore needed, to ensure that all patients may reap the benefits while limiting potential negative consequences.

UNASSIGNED: In many countries, health care professionals are legally obliged to share information from electronic health records with patients. However, concerns have been raised regarding the sharing of notes with adolescents in mental health care, and health care professionals have called for recommendations to guide this practice.
UNASSIGNED: The aim was to reach a consensus among authors of scientific papers on recommendations for health care professionals\' digital sharing of notes with adolescents in mental health care and to investigate whether staff at child and adolescent specialist mental health care clinics agreed with the recommendations.
UNASSIGNED: A Delphi study was conducted with authors of scientific papers to reach a consensus on recommendations. The process of making the recommendations involved three steps. First, scientific papers meeting the eligibility criteria were identified through a PubMed search where the references were screened. Second, the results from the included papers were coded and transformed into recommendations in an iterative process. Third, the authors of the included papers were asked to provide feedback and consider their agreement with each of the suggested recommendations in two rounds. After the Delphi process, a cross-sectional study was conducted among staff at specialist child and adolescent mental health care clinics to assess whether they agreed with the recommendations that reached a consensus.
UNASSIGNED: Of the 84 invited authors, 27 responded. A consensus was reached on 17 recommendations on areas related to digital sharing of notes with adolescents in mental health care. The recommendations considered how to introduce digital access to notes, write notes, and support health care professionals, and when to withhold notes. Of the 41 staff members at child and adolescent specialist mental health care clinics, 60% or more agreed with the 17 recommendations. No consensus was reached regarding the age at which adolescents should receive digital access to their notes and the timing of digitally sharing notes with parents.
UNASSIGNED: A total of 17 recommendations related to key aspects of health care professionals\' digital sharing of notes with adolescents in mental health care achieved consensus. Health care professionals can use these recommendations to guide their practice of sharing notes with adolescents in mental health care. However, the effects and experiences of following these recommendations should be tested in clinical practice.

BACKGROUND: The National Health Service (NHS) Talking Therapies program treats people with common mental health problems in England according to \"stepped care,\" in which lower-intensity interventions are offered in the first instance, where clinically appropriate. Limited resources and pressure to achieve service standards mean that program providers are exploring all opportunities to evaluate and improve the flow of patients through their service. Existing research has found variation in clinical performance and stepped care implementation across sites and has identified associations between service delivery and patient outcomes. Process mining offers a data-driven approach to analyzing and evaluating health care processes and systems, enabling comparison of presumed models of service delivery and their actual implementation in practice. The value and utility of applying process mining to NHS Talking Therapies data for the analysis of care pathways have not been studied.
OBJECTIVE: A better understanding of systems of service delivery will support improvements and planned program expansion. Therefore, this study aims to demonstrate the value and utility of applying process mining to NHS Talking Therapies care pathways using electronic health records.
METHODS: Routine collection of a wide variety of data regarding activity and patient outcomes underpins the Talking Therapies program. In our study, anonymized individual patient referral records from two sites over a 2-year period were analyzed using process mining to visualize the care pathway process by mapping the care pathway and identifying common pathway routes.
RESULTS: Process mining enabled the identification and visualization of patient flows directly from routinely collected data. These visualizations illustrated waiting periods and identified potential bottlenecks, such as the wait for higher-intensity cognitive behavioral therapy (CBT) at site 1. Furthermore, we observed that patients discharged from treatment waiting lists appeared to experience longer wait durations than those who started treatment. Process mining allowed analysis of treatment pathways, showing that patients commonly experienced treatment routes that involved either low- or high-intensity interventions alone. Of the most common routes, >5 times as many patients experienced direct access to high-intensity treatment rather than stepped care. Overall, 3.32% (site 1: 1507/45,401) and 4.19% (site 2: 527/12,590) of all patients experienced stepped care.
CONCLUSIONS: Our findings demonstrate how process mining can be applied to Talking Therapies care pathways to evaluate pathway performance, explore relationships among performance issues, and highlight systemic issues, such as stepped care being relatively uncommon within a stepped care system. Integration of process mining capability into routine monitoring will enable NHS Talking Therapies service stakeholders to explore such issues from a process perspective. These insights will provide value to services by identifying areas for service improvement, providing evidence for capacity planning decisions, and facilitating better quality analysis into how health systems can affect patient outcomes.

BACKGROUND: The rapidly increasing availability of medical data in electronic health records (EHRs) may contribute to the concept of learning health systems, allowing for better personalized care. Type 2 diabetes mellitus was chosen as the use case in this study.
OBJECTIVE: This study aims to explore the applicability of a recently developed patient similarity-based analytics approach based on EHRs as a candidate data analytical decision support tool.
METHODS: A previously published precision cohort analytics workflow was adapted for the Dutch primary care setting using EHR data from the Nivel Primary Care Database. The workflow consisted of extracting patient data from the Nivel Primary Care Database to retrospectively generate decision points for treatment change, training a similarity model, generating a precision cohort of the most similar patients, and analyzing treatment options. This analysis showed the treatment options that led to a better outcome for the precision cohort in terms of clinical readouts for glycemic control.
RESULTS: Data from 11,490 registered patients diagnosed with type 2 diabetes mellitus were extracted from the database. Treatment-specific filter cohorts of patient groups were generated, and the effect of past treatment choices in these cohorts was assessed separately for glycated hemoglobin and fasting glucose as clinical outcome variables. Precision cohorts were generated for several individual patients from the filter cohorts. Treatment options and outcome analyses were technically well feasible but in general had a lack of statistical power to demonstrate statistical significance for treatment options with better outcomes.
CONCLUSIONS: The precision cohort analytics workflow was successfully adapted for the Dutch primary care setting, proving its potential for use as a learning health system component. Although the approach proved technically well feasible, data size limitations need to be overcome before application for clinical decision support becomes realistically possible.

UNASSIGNED: Semantic interoperability facilitates the exchange of and access to health data that are being documented in electronic health records (EHRs) with various semantic features. The main goals of semantic interoperability development entail patient data availability and use in diverse EHRs without a loss of meaning. Internationally, current initiatives aim to enhance semantic development of EHR data and, consequently, the availability of patient data. Interoperability between health information systems is among the core goals of the European Health Data Space regulation proposal and the World Health Organization\'s Global Strategy on Digital Health 2020-2025.
UNASSIGNED: To achieve integrated health data ecosystems, stakeholders need to overcome challenges of implementing semantic interoperability elements. To research the available scientific evidence on semantic interoperability development, we defined the following research questions: What are the key elements of and approaches for building semantic interoperability integrated in EHRs? What kinds of goals are driving the development? and What kinds of clinical benefits are perceived following this development?
UNASSIGNED: Our research questions focused on key aspects and approaches for semantic interoperability and on possible clinical and semantic benefits of these choices in the context of EHRs. Therefore, we performed a systematic literature review in PubMed by defining our study framework based on previous research.
UNASSIGNED: Our analysis consisted of 14 studies where data models, ontologies, terminologies, classifications, and standards were applied for building interoperability. All articles reported clinical benefits of the selected approach to enhancing semantic interoperability. We identified 3 main categories: increasing the availability of data for clinicians (n=6, 43%), increasing the quality of care (n=4, 29%), and enhancing clinical data use and reuse for varied purposes (n=4, 29%). Regarding semantic development goals, data harmonization and developing semantic interoperability between different EHRs was the largest category (n=8, 57%). Enhancing health data quality through standardization (n=5, 36%) and developing EHR-integrated tools based on interoperable data (n=1, 7%) were the other identified categories. The results were closely coupled with the need to build usable and computable data out of heterogeneous medical information that is accessible through various EHRs and databases (eg, registers).
UNASSIGNED: When heading toward semantic harmonization of clinical data, more experiences and analyses are needed to assess how applicable the chosen solutions are for semantic interoperability of health care data. Instead of promoting a single approach, semantic interoperability should be assessed through several levels of semantic requirements A dual model or multimodel approach is possibly usable to address different semantic interoperability issues during development. The objectives of semantic interoperability are to be achieved in diffuse and disconnected clinical care environments. Therefore, approaches for enhancing clinical data availability should be well prepared, thought out, and justified to meet economically sustainable and long-term outcomes.

OBJECTIVE:  This study explored physicians\' and nurses\' attitudes toward an electronic health record (EHR) system and examined the features and factors that clinicians associated with the implementation of EHR systems.
METHODS:  A self-administered anonymous questionnaire with high reliability and validity was adopted from existing research to gather clinicians\' attitudes toward the EHR system implemented at King Khalid University Hospital, one of the biggest hospitals in Riyadh, Saudi Arabia.
RESULTS:  A total of 438 questionnaire responses were received from the participants; 240 of them were physicians and 198 were nurses. The participants had a mean age of 43.7 years (standard deviation (SD) 17.1), 213 (52.7%) were female and 207 (47.3%) were male. Most participants (424, 96.8%) had one or more years of experience using computers, and a majority (304, 69.4%) had one or more years of experience using EHR systems. Most physicians and nurses (214, 89.5% vs. 174, 87.9%) were satisfied with their hospital\'s EHR system and felt that the system was highly usable and had the potential to improve communication between staff, facilitate easy storage of and access to information and lead to improved health outcomes for patients. The study found positive attitudes among clinicians concerning the quality of training and education around the new system (178, 74.2% of physicians vs. 142, 71.7% of nurses; p > 0.05) and toward leadership during the transition to HER (222, 92.5% vs. 183, 92.4%). On the other hand, a majority of nurses reported that the EHR system took longer to use and increased their workload compared with the previous analogue system (115 (47.9%) vs. 133 (67.2%); p ≤ 0.01 and 46.7% vs. 112 (64.1%)). A large majority of physicians and nurses surveyed (214 (89.2%) vs. 167 (84.3%)) stated that clinicians should be consulted in the design of such systems as a way to maximise the potential benefits of EHR and mitigate extra workload demands.
CONCLUSIONS:  Most clinicians expressed overall satisfaction with the EHR system, but there were some areas of dissatisfaction among the respondents, such as increasing workload and stress among nurses. There is scope for further research to continue to explore physicians\' and nurses\' attitudes toward EHRs and for future experimental studies that examine the impact of EHRs on clinician workloads, patient health outcomes and quality of care.

BACKGROUND: The COVID-19 pandemic added to the decades of evidence that public health institutions are routinely stretched beyond their capacity. Community health workers (CHWs) can be a crucial extension of public health resources to address health inequities, but systems to document CHW efforts are often fragmented and prone to unneeded redundancy, errors, and inefficiency.
OBJECTIVE: We sought to develop a more efficient data collection system for recording the wide range of community-based efforts performed by CHWs.
METHODS: The Communities Organizing to Promote Equity (COPE) project is an initiative to address health disparities across Kansas, in part, through the deployment of CHWs. Our team iteratively designed and refined the features of a novel data collection system for CHWs. Pilot tests with CHWs occurred over several months to ensure that the functionality supported their daily use. Following implementation of the database, procedures were set to sustain the collection of feedback from CHWs, community partners, and organizations with similar systems to continually modify the database to meet the needs of users. A continuous quality improvement process was conducted monthly to evaluate CHW performance; feedback was exchanged at team and individual levels regarding the continuous quality improvement results and opportunities for improvement. Further, a 15-item feedback survey was distributed to all 33 COPE CHWs and supervisors for assessing the feasibility of database features, accessibility, and overall satisfaction.
RESULTS: At launch, the database had 60 active users in 20 counties. Documented client interactions begin with needs assessments (modified versions of the Arizona Self-sufficiency Matrix and PRAPARE [Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences]) and continue with the longitudinal tracking of progress toward goals. A user-specific automated alerts-based dashboard displays clients needing follow-up and upcoming events. The database contains over 55,000 documented encounters across more than 5079 clients. Available resources from over 2500 community organizations have been documented. Survey data indicated that 84% (27/32) of the respondents considered the overall navigation of the database as very easy. The majority of the respondents indicated they were overall very satisfied (14/32, 44%) or satisfied (15/32, 48%) with the database. Open-ended responses indicated the database features, documentation of community organizations and visual confirmation of consent form and data storage on a Health Insurance Portability and Accountability Act-compliant record system, improved client engagement, enrollment processes, and identification of resources.
CONCLUSIONS: Our database extends beyond conventional electronic medical records and provides flexibility for ever-changing needs. The COPE database provides real-world data on CHW accomplishments, thereby improving the uniformity of data collection to enhance monitoring and evaluation. This database can serve as a model for community-based documentation systems and be adapted for use in other community settings.

UNASSIGNED: Clinical decision support systems (CDSSs) embedded in electronic medical records (EMRs), also called electronic health records, have the potential to improve the adoption of clinical guidelines. The University of Alberta Inflammatory Bowel Disease (IBD) Group developed a CDSS for patients with IBD who might be experiencing disease flare and deployed it within a clinical information system in 2 continuous time periods.
UNASSIGNED: This study aims to evaluate the impact of the IBD CDSS on the adherence of health care providers (ie, physicians and nurses) to institutionally agreed clinical management protocols.
UNASSIGNED: A 2-period interrupted time series (ITS) design, comparing adherence to a clinical flare management protocol during outpatient visits before and after the CDSS implementation, was used. Each interruption was initiated with user training and a memo with instructions for use. A group of 7 physicians, 1 nurse practitioner, and 4 nurses were invited to use the CDSS. In total, 31,726 flare encounters were extracted from the clinical information system database, and 9217 of them were manually screened for inclusion. Each data point in the ITS analysis corresponded to 1 month of individual patient encounters, with a total of 18 months of data (9 before and 9 after interruption) for each period. The study was designed in accordance with the Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI) guidelines for health informatics evaluations.
UNASSIGNED: Following manual screening, 623 flare encounters were confirmed and designated for ITS analysis. The CDSS was activated in 198 of 623 encounters, most commonly in cases where the primary visit reason was a suspected IBD flare. In Implementation Period 1, before-and-after analysis demonstrates an increase in documentation of clinical scores from 3.5% to 24.1% (P<.001), with a statistically significant level change in ITS analysis (P=.03). In Implementation Period 2, the before-and-after analysis showed further increases in the ordering of acute disease flare lab tests (47.6% to 65.8%; P<.001), including the biomarker fecal calprotectin (27.9% to 37.3%; P=.03) and stool culture testing (54.6% to 66.9%; P=.005); the latter is a test used to distinguish a flare from an infectious disease. There were no significant slope or level changes in ITS analyses in Implementation Period 2. The overall provider adoption rate was moderate at approximately 25%, with greater adoption by nurse providers (used in 30.5% of flare encounters) compared to physicians (used in 6.7% of flare encounters).
UNASSIGNED: This is one of the first studies to investigate the implementation of a CDSS for IBD, designed with a leading EMR software (Epic Systems), providing initial evidence of an improvement over routine care. Several areas for future research were identified, notably the effect of CDSSs on outcomes and how to design a CDSS with greater utility for physicians. CDSSs for IBD should also be evaluated on a larger scale; this can be facilitated by regional and national centralized EMR systems.