JMIR Publications

JMIR Medical Informatics

Clinical informatics, decision support for health professionals, electronic health records, and ehealth infrastructures.

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Journal Description

JMIR Medical Informatics (JMI, ISSN 2291-9694) is a top-rated, tier A journal which focuses on clinical informatics, big data in health and health care, decision support for health professionals, electronic health records, ehealth infrastructures and implementation. It has a focus on applied, translational research, with a broad readership including clinicians, CIOs, engineers, industry and health informatics professionals.

Published by JMIR Publications, publisher of the Journal of Medical Internet Research (JMIR), the leading eHealth/mHealth journal (Impact Factor 2015: 4.532), JMIR Med Inform has a slightly different scope (emphasizing more on applications for clinicians and health professionals rather than consumers/citizens, which is the focus of JMIR), publishes even faster, and also allows papers which are more technical or more formative than what would be published in the Journal of Medical Internet Research.

JMIR Medical Informatics journal features a rapid and thorough peer-review process, professional copyediting, professional production of PDF, XHTML, and XML proofs (ready for deposit in PubMed Central/PubMed). The site is optimized for mobile and iPad use.

JMIR Medical Informatics adheres to the same quality standards as JMIR and all articles published here are also cross-listed in the Table of Contents of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (http://www.jmir.org/issue/current).

 

Recent Articles:

  • EHR and FOCUS. Image sourced and copyright owned by authors.

    Finding Important Terms for Patients in Their Electronic Health Records: A Learning-to-Rank Approach Using Expert Annotations

    Abstract:

    Background: Many health organizations allow patients to access their own electronic health record (EHR) notes through online patient portals as a way to enhance patient-centered care. However, EHR notes are typically long and contain abundant medical jargon that can be difficult for patients to understand. In addition, many medical terms in patients’ notes are not directly related to their health care needs. One way to help patients better comprehend their own notes is to reduce information overload and help them focus on medical terms that matter most to them. Interventions can then be developed by giving them targeted education to improve their EHR comprehension and the quality of care. Objective: We aimed to develop a supervised natural language processing (NLP) system called Finding impOrtant medical Concepts most Useful to patientS (FOCUS) that automatically identifies and ranks medical terms in EHR notes based on their importance to the patients. Methods: First, we built an expert-annotated corpus. For each EHR note, 2 physicians independently identified medical terms important to the patient. Using the physicians’ agreement as the gold standard, we developed and evaluated FOCUS. FOCUS first identifies candidate terms from each EHR note using MetaMap and then ranks the terms using a support vector machine-based learn-to-rank algorithm. We explored rich learning features, including distributed word representation, Unified Medical Language System semantic type, topic features, and features derived from consumer health vocabulary. We compared FOCUS with 2 strong baseline NLP systems. Results: Physicians annotated 90 EHR notes and identified a mean of 9 (SD 5) important terms per note. The Cohen’s kappa annotation agreement was .51. The 10-fold cross-validation results show that FOCUS achieved an area under the receiver operating characteristic curve (AUC-ROC) of 0.940 for ranking candidate terms from EHR notes to identify important terms. When including term identification, the performance of FOCUS for identifying important terms from EHR notes was 0.866 AUC-ROC. Both performance scores significantly exceeded the corresponding baseline system scores (P<.001). Rich learning features contributed to FOCUS’s performance substantially. Conclusions: FOCUS can automatically rank terms from EHR notes based on their importance to patients. It may help develop future interventions that improve quality of care.

  • Creative abstract healthcare, medicine and cardiology tool concept: laptop or notebook computer with medical cardiologic diagnostic test software on screen and stethoscope isolated on white background. Image source: http://m.shutterstock.com/images/245894956. Image Author: Scanrail1. Image purchased by authors.

    A Predictive Model for Medical Events Based on Contextual Embedding of Temporal Sequences

    Abstract:

    Background: Medical concepts are inherently ambiguous and error-prone due to human fallibility, which makes it hard for them to be fully used by classical machine learning methods (eg, for tasks like early stage disease prediction). Objective: Our work was to create a new machine-friendly representation that resembles the semantics of medical concepts. We then developed a sequential predictive model for medical events based on this new representation. Methods: We developed novel contextual embedding techniques to combine different medical events (eg, diagnoses, prescriptions, and labs tests). Each medical event is converted into a numerical vector that resembles its “semantics,” via which the similarity between medical events can be easily measured. We developed simple and effective predictive models based on these vectors to predict novel diagnoses. Results: We evaluated our sequential prediction model (and standard learning methods) in estimating the risk of potential diseases based on our contextual embedding representation. Our model achieved an area under the receiver operating characteristic (ROC) curve (AUC) of 0.79 on chronic systolic heart failure and an average AUC of 0.67 (over the 80 most common diagnoses) using the Medical Information Mart for Intensive Care III (MIMIC-III) dataset. Conclusions: We propose a general early prognosis predictor for 80 different diagnoses. Our method computes numeric representation for each medical event to uncover the potential meaning of those events. Our results demonstrate the efficiency of the proposed method, which will benefit patients and physicians by offering more accurate diagnosis.

  • Word cloud. Image created and copyright owned by authors.

    Consumers’ Use of UMLS Concepts on Social Media: Diabetes-Related Textual Data Analysis in Blog and Social Q&A Sites

    Abstract:

    Background: The widely known terminology gap between health professionals and health consumers hinders effective information seeking for consumers. Objective: The aim of this study was to better understand consumers’ usage of medical concepts by evaluating the coverage of concepts and semantic types of the Unified Medical Language System (UMLS) on diabetes-related postings in 2 types of social media: blogs and social question and answer (Q&A). Methods: We collected 2 types of social media data: (1) a total of 3711 blogs tagged with “diabetes” on Tumblr posted between February and October 2015; and (2) a total of 58,422 questions and associated answers posted between 2009 and 2014 in the diabetes category of Yahoo! Answers. We analyzed the datasets using a widely adopted biomedical text processing framework Apache cTAKES and its extension YTEX. First, we applied the named entity recognition (NER) method implemented in YTEX to identify UMLS concepts in the datasets. We then analyzed the coverage and the popularity of concepts in the UMLS source vocabularies across the 2 datasets (ie, blogs and social Q&A). Further, we conducted a concept-level comparative coverage analysis between SNOMED Clinical Terms (SNOMED CT) and Open-Access Collaborative Consumer Health Vocabulary (OAC CHV)—the top 2 UMLS source vocabularies that have the most coverage on our datasets. We also analyzed the UMLS semantic types that were frequently observed in our datasets. Results: We identified 2415 UMLS concepts from blog postings, 6452 UMLS concepts from social Q&A questions, and 10,378 UMLS concepts from the answers. The medical concepts identified in the blogs can be covered by 56 source vocabularies in the UMLS, while those in questions and answers can be covered by 58 source vocabularies. SNOMED CT was the dominant vocabulary in terms of coverage across all the datasets, ranging from 84.9% to 95.9%. It was followed by OAC CHV (between 73.5% and 80.0%) and Metathesaurus Names (MTH) (between 55.7% and 73.5%). All of the social media datasets shared frequent semantic types such as “Amino Acid, Peptide, or Protein,” “Body Part, Organ, or Organ Component,” and “Disease or Syndrome.” Conclusions: Although the 3 social media datasets vary greatly in size, they exhibited similar conceptual coverage among UMLS source vocabularies and the identified concepts showed similar semantic type distributions. As such, concepts that are both frequently used by consumers and also found in professional vocabularies such as SNOMED CT can be suggested to OAC CHV to improve its coverage.

  • Health care challenges. Image sourced and copyright owned by authors.

    Challenges and Opportunities of Big Data in Health Care: A Systematic Review

    Abstract:

    Background: Big data analytics offers promise in many business sectors, and health care is looking at big data to provide answers to many age-related issues, particularly dementia and chronic disease management. Objective: The purpose of this review was to summarize the challenges faced by big data analytics and the opportunities that big data opens in health care. Methods: A total of 3 searches were performed for publications between January 1, 2010 and January 1, 2016 (PubMed/MEDLINE, CINAHL, and Google Scholar), and an assessment was made on content germane to big data in health care. From the results of the searches in research databases and Google Scholar (N=28), the authors summarized content and identified 9 and 14 themes under the categories Challenges and Opportunities, respectively. We rank-ordered and analyzed the themes based on the frequency of occurrence. Results: The top challenges were issues of data structure, security, data standardization, storage and transfers, and managerial skills such as data governance. The top opportunities revealed were quality improvement, population management and health, early detection of disease, data quality, structure, and accessibility, improved decision making, and cost reduction. Conclusions: Big data analytics has the potential for positive impact and global implications; however, it must overcome some legitimate obstacles.

  • Visual Representations of Physiologic Data. Image sourced and copyright owned by authors.

    A Review of Visual Representations of Physiologic Data

    Abstract:

    Background: Physiological data is derived from electrodes attached directly to patients. Modern patient monitors are capable of sampling data at frequencies in the range of several million bits every hour. Hence the potential for cognitive threat arising from information overload and diminished situational awareness becomes increasingly relevant. A systematic review was conducted to identify novel visual representations of physiologic data that address cognitive, analytic, and monitoring requirements in critical care environments. Objective: The aims of this review were to identify knowledge pertaining to (1) support for conveying event information via tri-event parameters; (2) identification of the use of visual variables across all physiologic representations; (3) aspects of effective design principles and methodology; (4) frequency of expert consultations; (5) support for user engagement and identifying heuristics for future developments. Methods: A review was completed of papers published as of August 2016. Titles were first collected and analyzed using an inclusion criteria. Abstracts resulting from the first pass were then analyzed to produce a final set of full papers. Each full paper was passed through a data extraction form eliciting data for comparative analysis. Results: In total, 39 full papers met all criteria and were selected for full review. Results revealed great diversity in visual representations of physiological data. Visual representations spanned 4 groups including tabular, graph-based, object-based, and metaphoric displays. The metaphoric display was the most popular (n=19), followed by waveform displays typical to the single-sensor-single-indicator paradigm (n=18), and finally object displays (n=9) that utilized spatiotemporal elements to highlight changes in physiologic status. Results obtained from experiments and evaluations suggest specifics related to the optimal use of visual variables, such as color, shape, size, and texture have not been fully understood. Relationships between outcomes and the users’ involvement in the design process also require further investigation. A very limited subset of visual representations (n=3) support interactive functionality for basic analysis, while only one display allows the user to perform analysis including more than one patient. Conclusions: Results from the review suggest positive outcomes when visual representations extend beyond the typical waveform displays; however, there remain numerous challenges. In particular, the challenge of extensibility limits their applicability to certain subsets or locations, challenge of interoperability limits its expressiveness beyond physiologic data, and finally the challenge of instantaneity limits the extent of interactive user engagement.

  • Diabetes. Image Source: https://pixabay.com/en/diabetes-blood-finger-glucose-777002/. Author: Tesaphotography. Copyright: CC0 Public Domain.

    Web-based Real-Time Case Finding for the Population Health Management of Patients With Diabetes Mellitus: A Prospective Validation of the Natural Language...

    Abstract:

    Background: Diabetes case finding based on structured medical records does not fully identify diabetic patients whose medical histories related to diabetes are available in the form of free text. Manual chart reviews have been used but involve high labor costs and long latency. Objective: This study developed and tested a Web-based diabetes case finding algorithm using both structured and unstructured electronic medical records (EMRs). Methods: This study was based on the health information exchange (HIE) EMR database that covers almost all health facilities in the state of Maine, United States. Using narrative clinical notes, a Web-based natural language processing (NLP) case finding algorithm was retrospectively (July 1, 2012, to June 30, 2013) developed with a random subset of HIE-associated facilities, which was then blind tested with the remaining facilities. The NLP-based algorithm was subsequently integrated into the HIE database and validated prospectively (July 1, 2013, to June 30, 2014). Results: Of the 935,891 patients in the prospective cohort, 64,168 diabetes cases were identified using diagnosis codes alone. Our NLP-based case finding algorithm prospectively found an additional 5756 uncodified cases (5756/64,168, 8.97% increase) with a positive predictive value of .90. Of the 21,720 diabetic patients identified by both methods, 6616 patients (6616/21,720, 30.46%) were identified by the NLP-based algorithm before a diabetes diagnosis was noted in the structured EMR (mean time difference = 48 days). Conclusions: The online NLP algorithm was effective in identifying uncodified diabetes cases in real time, leading to a significant improvement in diabetes case finding. The successful integration of the NLP-based case finding algorithm into the Maine HIE database indicates a strong potential for application of this novel method to achieve a more complete ascertainment of diagnoses of diabetes mellitus.

  • Clinical decision support. Image sourced and copyright owned by Authors David F. Lobach et al.

    Increasing Complexity in Rule-Based Clinical Decision Support: The Symptom Assessment and Management Intervention

    Abstract:

    Background: Management of uncontrolled symptoms is an important component of quality cancer care. Clinical guidelines are available for optimal symptom management, but are not often integrated into the front lines of care. The use of clinical decision support (CDS) at the point-of-care is an innovative way to incorporate guideline-based symptom management into routine cancer care. Objective: The objective of this study was to develop and evaluate a rule-based CDS system to enable management of multiple symptoms in lung cancer patients at the point-of-care. Methods: This study was conducted in three phases involving a formative evaluation, a system evaluation, and a contextual evaluation of clinical use. In Phase 1, we conducted iterative usability testing of user interface prototypes with patients and health care providers (HCPs) in two thoracic oncology clinics. In Phase 2, we programmed complex algorithms derived from clinical practice guidelines into a rules engine that used Web services to communicate with the end-user application. Unit testing of algorithms was conducted using a stack-traversal tree-spanning methodology to identify all possible permutations of pathways through each algorithm, to validate accuracy. In Phase 3, we evaluated clinical use of the system among patients and HCPs in the two clinics via observations, structured interviews, and questionnaires. Results: In Phase 1, 13 patients and 5 HCPs engaged in two rounds of formative testing, and suggested improvements leading to revisions until overall usability scores met a priori benchmarks. In Phase 2, symptom management algorithms contained between 29 and 1425 decision nodes, resulting in 19 to 3194 unique pathways per algorithm. Unit testing required 240 person-hours, and integration testing required 40 person-hours. In Phase 3, both patients and HCPs found the system usable and acceptable, and offered suggestions for improvements. Conclusions: A rule-based CDS system for complex symptom management was systematically developed and tested. The complexity of the algorithms required extensive development and innovative testing. The Web service-based approach allowed remote access to CDS knowledge, and could enable scaling and sharing of this knowledge to accelerate availability, and reduce duplication of effort. Patients and HCPs found the system to be usable and useful.

  • Data protection. Image source:https://pixabay.com/en/castle-chain-security-979597/. Author: bykst. images
Copyright:CC0 Public Domain.

    It’s Time for Innovation in the Health Insurance Portability and Accountability Act (HIPAA)

    Abstract:

    Whether it is the result of a tragic news story, a thoughtful commentary, or a segment on the entertainment networks, patient privacy rights are never far from the top of our minds. The Privacy and Security Rules contained in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) represent a concerted effort to protect the privacy and security of the volumes of patient data generated by the health care system. However, the last twenty years has seen innovations and advancements in health information technology that were unimaginable at that time. It is time for innovation to the Privacy and Security Rules. We offer a common and relatable scenario as proof that certain Privacy and Security Rules can tie the hands of educators and innovators and need to be transformed.

  • Evaluating the Economic Impact of Smart Care Platforms: Qualitative and Quantitative Results of a Case Study. Image created and copyright owned by authors.

    Evaluating the Economic Impact of Smart Care Platforms: Qualitative and Quantitative Results of a Case Study

    Abstract:

    Background: In response to the increasing pressure of the societal challenge because of a graying society, a gulf of new Information and Communication Technology (ICT) supported care services (eCare) can now be noticed. Their common goal is to increase the quality of care while decreasing its costs. Smart Care Platforms (SCPs), installed in the homes of care-dependent people, foster the interoperability of these services and offer a set of eCare services that are complementary on one platform. These eCare services could not only result in more quality care for care receivers, but they also offer opportunities to care providers to optimize their processes. Objective: The objective of the study was to identify and describe the expected added values and impacts of integrating SCPs in current home care delivery processes for all actors. In addition, the potential economic impact of SCP deployment is quantified from the perspective of home care organizations. Methods: Semistructured and informal interviews and focus groups and cocreation workshops with service providers, managers of home care organizations, and formal and informal care providers led to the identification of added values of SCP integration. In a second step, process breakdown analyses of home care provisioning allowed defining the operational impact for home care organization. Impacts on 2 different process steps of providing home care were quantified. After modeling the investment, an economic evaluation compared the business as usual (BAU) scenario versus the integrated SCP scenario. Results: The added value of SCP integration for all actors involved in home care was identified. Most impacts were qualitative such as increase in peace of mind, better quality of care, strengthened involvement in care provisioning, and more transparent care communication. For home care organizations, integrating SCPs could lead to a decrease of 38% of the current annual expenses for two administrative process steps namely, care rescheduling and the billing for care provisioning. Conclusions: Although integrating SCP in home care processes could affect both the quality of life of the care receiver and informal care giver, only scarce and weak evidence was found that supports this assumption. In contrast, there exists evidence that indicates the lack of the impact on quality of life of the care receiver while it increases the cost of care provisioning. However, our cost-benefit quantification model shows that integrating SCPs in home care provisioning could lead to a considerable decrease of costs for care administrative tasks. Because of this cost decreasing impact, we believe that the integration of SCPs will be driven by home care organizations instead of the care receivers themselves.

  • Physician dictating notes in NLP-NLP Condition. Image sourced and copyright owned by authors: David Kaufman; Barbara Sheehan; Peter Stetson; Ashish Bhatt; Adele Field; Chirag Patel; James M. Maisel. 



Copyright Notice: (c) 2016 David R. Kaufman, Barbara Sheehan, Peter Stetson, Ashish R. Bhatt, Adele I. Field, Chirag Patel, James M. Maisel.

    Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study

    Abstract:

    Background: The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)–enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user’s experience. Objective: The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. Methods: This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods (“protocols”) of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. Results: A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. Conclusions: In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience.

  • Blood Glucose Level. Image Source: http://www.pixnio.com/science/medical-science/check-blood-glucose-level. Author:Amanda Mills, USCDCP. License: public domain (CC0).

    Evaluating the Effect of Web-Based Iranian Diabetic Personal Health Record App on Self-Care Status and Clinical Indicators: Randomized Controlled Trial

    Abstract:

    Background: There are 4 main types of chronic or noncommunicable diseases. Of these, diabetes is one of the major therapeutic concerns globally. Moreover, Iran is among the countries with the highest incidence of diabetic patients. Furthermore, library-based studies by researchers have shown that thus far no study has been carried out to evaluate the relationship between Web-based diabetic personal health records (DPHR) and self-care indicators in Iran. Objective: The objective of this study is to examine the effect of Web-based DPHR on self-care status of diabetic patients in an intervention group as compared with a control group. Methods: The effect of DPHR on self-care was assessed by using a randomized controlled trial (RCT) protocol for a 2-arm parallel group with a 1:1 allocation ratio. During a 4-month trial period, the control group benefited from the routine care; the intervention group additionally had access to the Web-based DPHR app besides routine care. During the trial, 2 time points at baseline and postintervention were used to evaluate the impact of the DPHR app. A sample size of 72 people was randomly and equally assigned to both the control and intervention groups. The primary outcome measure was the self-care status of the participants. Results: Test results showed that the self-care status in the intervention group in comparison with the control group had a significant difference. In addition, the dimensions of self-care, including normal values, changes trend, the last measured value, and the last time measured values had a significant difference while other dimensions had no significant difference. Furthermore, we found no correlation between Web-based DPHR system and covariates, including scores of weight, glycated hemoglobin (HbA1c), serum creatinine, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, and planned visit adherence, as well as the change trend of mean for blood glucose and blood pressure. Conclusions: We found that as a result of the Web-based DPHR app, the self-care scores in the intervention group were significantly higher than those of the control group. In total, we found no correlation between the Web-based DPHR app and covariates, including planned visit adherence, HbA1c, serum creatinine, HDL, LDL, total cholesterol, weight, and the change trend of mean for blood glucose and blood pressure. ClinicalTrial: Iranian Registry of Clinical Trials (IRCT): 2013082914522N1; http://www.irct.ir/searchresult.php?id= 14522&number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau)

  • human-group-silhouette-personal. Image source:https://pixabay.com/en/human-group-silhouette-personal-276760/. Author: Geralt. License: CC0 Public Domain. Image modified by authors.

    Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data

    Abstract:

    Background: Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. Objectives: The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Methods: Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. Results: In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (P<.001) when compared with the lowest incidence in the 20-29 years-old group. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (P<.001). Adverse event diversity increased at an average rate of 77% for each age group (older than 30 years) until reaching the 60-69 years-old group, which had a diversity level of 54.7 different types of adverse events per trial arm. The 70-100 years-old group showed the highest diversity level of 55.5 events per trial arm, which is approximately 3.44 times more than the 20-29 years-old group (P<.001). We also observe that adverse events display strong age-related patterns among different categories. Conclusion: The results show that there is a significant adverse event variance at the population level between different age groups in clinical trials. The data suggest that age-associated adverse events should be considered in planning, monitoring, and regulating clinical trials.

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  • Design, Implementation and Evaluation of Self-describing Diabetes Medical Records

    Date Submitted: Oct 21, 2016

    Open Peer Review Period: Oct 23, 2016 - Dec 18, 2016

    Background: Each patient’s medical record consists of data specific to that patient and is therefore an appropriate source to adapt educational information content. Objective: This study aimed to de...

    Background: Each patient’s medical record consists of data specific to that patient and is therefore an appropriate source to adapt educational information content. Objective: This study aimed to design and implement an information provision system based on the medical records of diabetic patients and to investigate the attitudes of users towards using this product. Methods: The study was organized into three phases: need analysis, design and implementation, and final evaluation. The aim of the need analysis phase was to investigate the questioning behavior of the patient in the real-world context. The design and implementation phase consisted of four stages: determining the minimum dataset for diabetes medical records, collecting and validating content, designing and implementing a diabetes electronic medical record system, and data entry. Evaluating the final system was done based on the constructs of the Technology Acceptance Model (TAM) in the two dimensions of perceived usefulness and perceived ease of use. A semi-structured interview was used for this purpose. Results: Three main categories were extracted for the patient’s perceived usefulness of the system: raising the self-awareness and knowledge of patients, improving their self-care, and improving doctor-patient interaction. Both patients and physicians perceived the personalized sense of information as a unique feature of the application and believed that this feature could have a positive effect on the patient's motivation for learning and using information in practice. Specialists believed that providing personal feedback on the patient’s lab test results along with general explanations encourages the patients to read the content more precisely. Moreover, accessing medical records and helpful notes was a new and useful experience for the patients. Conclusions: One of the key perceived benefits of providing tailored information in the context of medical records was raising patient awareness and knowledge. The results obtained from field observations and interviews has shown that patients were ready to accept the system and had a positive attitude when it was put into practice. The findings related to user attitude can be used as a guideline to design the next phase of the research (i.e., investigation of system effectiveness on patient outcomes).

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