The design and methodology of a usability protocol for the management of medications by families for aging older adults.

BACKGROUND: Health research apps often do not focus on usability as a design priority. This is problematic when the population of interest is disproportionately underrepresented as users of mobile apps, especially observed with aging older adults (> = 75). Challenges with the adoption of health information technology (HIT) among this group are exacerbated by poor design and user interface/experience (UI/UX) choices. This protocol describes the testing and evaluation process of one HIT app for the family-based collaboration platform InfoSAGE. METHODS: We aim to recruit twenty subjects from both informal family-caregivers and aging older adults to examine the usability of the InfoSAGE mobile medication manager. Participants will be audio and visually recorded, in addition to the use of screen capture recordings, while 'thinking aloud' as they complete eight common use-case scenarios. Multiple independent reviewers will code video and audio recordings for thematic analysis and use problems will be evaluated. Success and failure of each scenario will be determined by completion of sub-events. Time-to-complete analysis will be used to ascertain the learning curve associated with the app. DISCUSSION: Frequently observed problem areas will be used as the basis of further evolution of the app, and will further inform generalized recommendations for the design of HIT apps for research and public use. This study aims to improve the model of development for dual user populations with dissimilar technological literacy to improve retention and use. Results of this study will form the foundation of a design framework for mobile health apps.

Update on Data Reuse in Health Care.

Objective: Reuse of clinical data has broad use in clinical, research, governmental, and business settings. This summary provides an update on the benefits, barriers to use with large clinical databases, policy frameworks that have been formulated, and challenges. Methods: This report highlights some recent publications on the diverse uses of clinical data and some policy initiatives to promote reuse. It also contains the opinions of the author. Results: Although many examples of the benefits of data reuse have been documented, this summary also reviews why the quality of clinical data needs to be the focus of future informatics work. Conclusion: The promise of reusing data outweighs potential risks, but concerns about privacy and the need to modernize our legal framework will be necessary to realize the full benefits of real-world evidence.

Prevalence and Risk Profile Of Unread Messages To Patients In A Patient Web Portal.

BACKGROUND: Excitement around the adoption of electronic communication between physicians and patients is tempered by the possibility of increased clinical and legal risk. If patients do not read messages in a timely fashion, duplicative communication efforts may be required and patient safety may be jeopardized. OBJECTIVE: We sought to assess the prevalence and risk profile of unread messages in a mature patient portal. METHODS: We analyzed six years of messages (2005-2010) from physicians to patients to determine the prevalence and associated characteristics of unread messages in a patient portal. We focused on clinical messages, and excluded announcements. Because some physicians sent clinical messages to groups of patients, we labeled messages sent to more than 5 patients as "outreach" messages and excluded them from general analyses. We performed a chart review of 75 clinical messages to assess for harm. RESULTS: We found that 3% of clinical messages were unread after 21 days. Messages arriving outside of business hours were slightly more likely to go unread (RR 1.15 95% CI 1.11-1.19). Patients who were male (OR 1.14 CI 1.04-1.26) African American (OR 1.69 CI 1.29-2.22) or Hispanic (OR 1.74 CI 1.17-2.59), or in the lowest income group (OR 1.72 CI 1.19-2.49) were more likely to have unread messages. Chart review showed no evidence of harm, but 13% of sampled unread messages were associated with potential delays in care. Incidentally, we found 50% of the physician-initiated outreach messages were unread. CONCLUSIONS: Overall, secure messaging appears a safe form of communication, but systems to notify senders when messages are unread may have value. While most clinical messages were read, many outreach messages were not, providing caution for relying on such systems for information dissemination. Similar to other studies, differences by race and income were observed and require further study.

Reuse of clinical data.

OBJECTIVES: To provide an overview of the benefits of clinical data collected as a by-product of the care process, the potential problems with large aggregations of these data, the policy frameworks that have been formulated, and the major challenges in the coming years. METHODS: This report summarizes some of the major observations from AMIA and IMIA conferences held on this admittedly broad topic from 2006 through 2013. This report also includes many unsupported opinions of the author. RESULTS: The benefits of aggregating larger and larger sets of routinely collected clinical data are well documented and of great societal benefit. These large data sets will probably never answer all possible clinical questions for methodological reasons. Non-traditional sources of health data that are patient-sources will pose new data science challenges. CONCLUSIONS: If we ever hope to have tools that can rapidly provide evidence for daily practice of medicine we need a science of health data perhaps modeled after the science of astronomy.

Trustworthy reuse of health data: a transnational perspective.

BACKGROUND: The widespread adoption of electronic health records (EHRs) is accelerating the collection of sensitive clinical data. The availability of these data raises privacy concerns, yet sharing the data is essential for public health, longitudinal patient care, and clinical research. METHOD: Following previous work in the United States [1,2], the International Medical Informatics Association convened the 2012 European Summit on Trustworthy Reuse of Health Data. Over 100 delegates representing national governments, academia, patient groups, industry, and the European Commission participated. In all, 21 countries were represented. The agenda was designed to solicit a wide range of perspectives on trustworthy reuse of health data from the participants. RESULTS AND CONCLUSIONS: Delegates agreed that the "government" should provide oversight, that the reuse should be "fully regulated," and that the patient should be "fully informed." One important reflection was that doing nothing will have negative implications across the European Union (EU). First, continued fragmented parallel non-standards-based developments in multiple sectors entail a substantial duplication of costs and human effort. Second, a failure to work jointly across the stakeholders on common policy frameworks will forego a crucial opportunity to boost key EU markets (pharmaceuticals, health technology and devices, and eHealth solutions) and counter global competition. Finally, and crucially, the lack of harmonized policy across EU nations for trustworthy reuse of health data risks patient safety. The productive dialog, initiated with multiple stakeholders from government, academia, and industry, will have to continue, in order to address the many remaining issues outlined in this white paper.

Informatics training for clinicians is more important than hardware and software.

OBJECTIVE: The importance of training physicians and nurses in the art, skill and science of clinical informatics has never been greater. What level of training is necessary and sufficient to equip the 21st century healthcare workforce for the transformative opportunity enabled by widespread deployment of EHRs? METHODS: Building on the success of its 10x10 program, AMIA with support from the Robert Wood Johnson foundation took its next step to create the necessary documents to have clinical informatics recognized as a sub-specialty by the American Board of Medical Specialties (ABMS). RESULTS: We defined the core content that had to be mastered and describing how physicians interested in the sub-specialty clinical informatics would be trained. The results of this work have been approved by the board of AMIA and have been published in its journal JAMIA. CONCLUSION: The health challenges of the 21 century require that we rapidly train the clinical workforce in clinical informatics. In addition to buying hardware and software, our health systems need to sponsor this training. Two percent of every Health IT budget should be targeted for clinician education.

Heparanase expression and activity influences chondrogenic and osteogenic processes during endochondral bone formation.

Endochondral bone formation is a highly orchestrated process involving coordination among cell-cell, cell-matrix and growth factor signaling that eventually results in the production of mineralized bone from a cartilage template. Chondrogenic and osteogenic differentiation occur in sequence during this process, and the temporospatial patterning clearly requires the activities of heparin binding growth factors and their receptors. Heparanase (HPSE) plays a role in osteogenesis, but the mechanism by which it does so is incompletely understood. We used a combination of ex vivo and in vitro approaches and a well described HPSE inhibitor, PI-88 to study HPSE in endochondral bone formation. In situ hybridization and immunolocalization with HPSE antibodies revealed that HPSE is expressed in the peri-chondrium, peri-osteum, and at the chondro-osseous junction, all sites of key signaling events and tissue morphogenesis. Transcripts encoding Hpse also were observed in the pre-hypertrophic zone. Addition of PI-88 to metatarsals in organ culture reduced growth and suggested that HPSE activity aids the transition from chondrogenic to osteogenic processes in growth of long bones. To study this, we used high density cultures of ATDC5 pre-chondrogenic cells grown under conditions favoring chondrogenesis or osteogenesis. Under chondrogenic conditions, HPSE/Hpse was expressed at high levels during the mid-culture period, at the onset of terminal chondrogenesis. PI-88 addition reduced chondrogenesis and accelerated osteogenesis, including a dramatic up-regulation of osteocalcin levels. In normal growth medium, addition of PI-88 reduced migration of ATDC-5 cells, suggesting that HPSE facilitates cartilage replacement by bone at the chondro-osseous junction by removing the HS component of proteoglycans, such as perlecan/HSPG2, that otherwise prevent osteogenic cells from remodeling hypertrophic cartilage.

On exemplary scientific conduct regarding submission of manuscripts to biomedical informatics journals.

As the Editors of leading international biomedical informatics journals, the authors report on a recent pattern of improper manuscript submissions to journals in our field. As a guide for future authors, we describe ethical and pragmatic issues related to submitting work for peer-reviewed journal publication. We propose a coordinated approach to the problem that our respective journals will follow. This Editorial is being jointly published in the following journals represented by the authors: Computer Methods and Programs in Biomedicine, International Journal of Medical Informatics, Journal of Biomedical Informatics, Journal of the American Medical Informatics Association, and Methods of Information in Medicine.

[Treatment of exacerbations of chronic obstructive pulmonary disease with pristinamycin]. / Traitement des exacerbations de broncho-pneumopathie chronique obstructive (BPCO) par la pristinamycine.

BACKGROUND: Pristinamycin is a bactericidal antibiotic whose spectrum covers the main respiratory pathogens including S. pneumoniae poorly sensitive to penicillin. It has not yet been evaluated in short course treatment of acute exacerbations of chronic obstructive bronchitis (AECB). METHODS: 476 patients suffering from an AECB were randomised to either a short course of pristinamycin, 3 G daily for 4 days, or conventional treatment with co-amoxiclav (AAC) 2G daily for 8 days. The duration of follow-up was 6 months. RESULTS: The clinical success rate at 21 days was the same in both groups at 87.2% and 87.9%, CI95% [-7.0%, 6.0%], in the protocol population (FEV1<80%). Among the 120 patients in whom a bacterial pathogen was isolated at the time of inclusion a satisfactory bacteriological response was obtained in 84.6% of the PRI patients against 78.2% of the AAC patients. The time to relapse was comparable with a relapse rate of 25% reached in 128 days in the PRI group and 125 days in the AAC group. Treatment related side effects occurred in 9.2% of the PRI group and in 10.6% of the AAC group. CONCLUSION: Pristinamycin 3 G daily for 4 days is as effective and well tolerated as co-amoxiclav 2G daily for 8 days in the treatment of AECB.

Quality of health care: informatics foundations.

OBJECTIVE: To discuss in what ways computer systems can contribute to the quality of healthcare and on which principles of informatics successful systems are based. METHODS: Part of the information was obtained via a literature search and part is based on the knowledge of the authors. RESULTS: The results of the literature search are reported. The answers to the questions whether decision support is useful and which factors determine its success, the foundations of computerized guidelines systems and applications of physician order entry and medical risk management are presented. CONCLUSIONS: Despite many publications concerning diagnostic support systems their use in clinical practice is limited. Reminder systems do appear to have an impact on health outcomes. Standards for guideline models are being developed for effective sharing of guidelines across systems. Electronic patient records and physician order entry systems are useful aids in medical risk management.

Pediatric Cancer CareLink--supporting home management of childhood leukemia.

We conducted a descriptive evaluation of an Internet-based system designed to support home management of childhood leukemia (Pediatric Cancer CareLink). Twenty-five parents of children with ALL and thirty-four clinicians were interviewed to identify functional requirements and to demonstrate the system's potential to improve the experience and outcomes of children with acute lymphoblastic leukemia (ALL). Parental interviews focused on: medication and side effect management in the home; communication with the health care team; and the use of a computer for ALL home management. Results from these interviews provide strong evidence that parents of children with ALL are struggling to manage the complexity of their children's care in the home. Parents revealed an urgent need for tools that would help them to safely organize the medicines that their children receive while on ALL protocols. Forty percent of parents needed to know more about what to expect during their child's therapy and how to be prepared for it. Clinician interviews focused on the clinical impact and workflow issues associated with such a system. Decision support, prescription refill management, and educational and emotional support functions were considered key components. Clinicians were concerned that such a system would increase their already overburdened workload. Conversely, parents believed that access to such a system would eliminate unnecessary phone calls to the care team. Our findings show that parents would embrace collaborative Internet-based tools that would help with the home management of their child's leukemia.

Perlecan: an important component of the cartilage pericellular matrix.

Perlecan (Pln) is a large proteoglycan that can bear HS (heparan sulfate) and chondroitin sulfate glycosaminoglycans. Previous studies have demonstrated that Pln can interact with growth factors and cell surfaces either via its constituent glycosaminoglycan chains or core protein. Herein, we summarize studies demonstrating spatially and temporally regulated expression of Pln mRNA and protein in developing and mature cartilage. Mutations either in the Pln gene or in genes involved in glycosaminoglycan assembly result in severe cartilage phenotypes seen in both human syndromes and mouse model systems. In vitro studies demonstrate that Pln can trigger chondrogenic differentiation of multipotential mouse CH310T1/2 stem cells as well as maintain the phenotype of adult human chondrocytes. Structural mapping indicates that these activities lie entirely within domain I, a region unique to Pln, and that they require glycosaminoglycans. We also discuss data indicating that Pln cooperates with the key chondrogenic growth factor, BMP-2, to promote expression of hypertrophic chondrocyte markers. Collectively, these studies indicate that Pln is an important component of human cartilage and may have useful applications in tissue engineering and cartilage-directed therapeutics.

A web-based rapid prototyping and clinical conversational system that complements electronic patient record system.

Even the most extensive hospital information system cannot support all the complex and ever-changing demands associated with a clinical database, such as providing department or personal data forms, and rating scales. Well-designed clinical dialogue programs may facilitate direct interaction of patients with their medical records. Incorporation of extensive and loosely structured clinical data into an existing medical record system is an essential step towards a comprehensive clinical information system, and can best be achieved when the practitioner and the patient directly enter the contents. We have developed a rapid prototyping and clinical conversational system that complements the electronic medical record system, with its generic data structure and standard communication interfaces based on Web technology. We believe our approach can enhance collaboration between consumer-oriented and provider-oriented information systems.

Dissemination of electronic patient records using primary care referrals as a vector for change.

The Online Medical Record (OMR) is a full-featured shared electronic patient record in use since 1989 at Beth Israel Deaconess Medical Center in Boston. The first practice to use the OMR was a primary care practice. We observed the pattern of voluntary adoption of the OMR and the referral patterns from primary care to specialists. Adoption of the OMR among specialists has accelerated in recent years, in many cases mirroring the referral patterns from primary care to specialists. We hypothesize that referral of patients from primary care providers to specialists exposes these specialists to the benefits the electronic patient record and may promote the use of this technology. We conclude that these referral patterns provide a vector for the dissemination of electronic patient records. The important lesson is that EPR implementation in a health care network should begin with primary care to ensure the most efficient diffusion of this technology throughout the enterprise.

Reinventing patient-centered computing for the twenty-first century.

Despite evidence over the past decade that patients like and will use patient-centered computing systems in managing their health, patients have remained forgotten stakeholders in advances in clinical computing systems. We present a framework for patient empowerment and the technical realization of that framework in an architecture called CareLink. In an evaluation of the initial deployment of CareLink in the support of neonatal intensive care, we have demonstrated a reduction in the length of stay for very-low birthweight infants, and an improvement in family satisfaction with care delivery. With the ubiquitous adoption of the Internet into the general culture, patient-centered computing provides the opportunity to mend broken health care relationships and reconnect patients to the care delivery process. CareLink itself provides functionality to support both clinical care and research, and provides a living laboratory for the further study of patient-centered computing.

ECG Wave-Maven: a self-assessment program for students and clinicians.

Proficiency in the interpretation of electrocardiograms (ECGs) is an essential skill for medical students, house officers, and attending physicians. However, resources to develop and upgrade the necessary high level of "ECG literacy" are limited. A small number of centers have attempted to address this challenge by developing "ECG of the week" internet sites. These resources are difficult to maintain and update, and many of them quickly become stagnant. We present "ECG Wave-Maven," an innovative web-based tutorial that overcomes these obstacles via a direct link to the hospital's extensive and increasing clinical ECG repository. By interfacing our educational tool to live data, we can greatly decrease the time and effort required from the time a practitioner notes an interesting case to its inclusion in the program. Users can opt to encounter the test cases sequentially or randomly, or by reviewing a list of questions or diagnoses, making this not just a quiz, but a basic educational reference. This tool may be useful in meeting the challenge of reducing serious medical errors related to ECG misinterpretation.