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Purpose The purpose of this study was to evaluate the safety and efficacy of intra-articular injections of autologous peripheral blood stem cells (PBSCs) plus hyaluronic acid (HA) after arthroscopic subchondral drilling into massive chondral defects of the knee joint and to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than HA plus physiotherapy. Methods This is a dual-center randomized controlled trial (RCT). Sixty-nine patients aged 18 to 55 years with International Cartilage Repair Society grade 3 and 4 chondral lesions (size ≥3 cm2) of the knee joint were randomized equally into (1) a control group receiving intra-articular injections of HA plus physiotherapy and (2) an intervention group receiving arthroscopic subchondral drilling into chondral defects and postoperative intra-articular injections of PBSCs plus HA. The coprimary efficacy endpoints were subjective International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS)–pain subdomain measured at month 24. The secondary efficacy endpoints included all other KOOS subdomains, Numeric Rating Scale (NRS), and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores. Results At 24 months, the mean IKDC scores for the control and intervention groups were 48.1 and 65.6, respectively (P Conclusions Arthroscopic marrow stimulation with subchondral drilling into massive chondral defects of the knee joint followed by postoperative intra-articular injections of autologous PBSCs plus HA is safe and showed a significant improvement of clinical and radiologic scores compared with HA plus physiotherapy. Level of Evidence Level I, RCT.

Graphical abstract, Highlights • There may be long-term consequences of delaying procedures in response to COVID-19. • Electronic health record data can help us understand the impact of procedure delay. • Our high-throughput approach identifies procedures impacted by COVID-19. • Impact of procedure delay on patient outcomes are evaluated with retrospective data. • Our results can help hospital systems minimize adverse patient outcomes from delays., Objective During the COVID-19 pandemic, health systems postponed non-essential medical procedures to accommodate surge of critically-ill patients. The long-term consequences of delaying procedures in response to COVID-19 remains unknown. We developed a high-throughput approach to understand the impact of delaying procedures on patient health outcomes using electronic health record (EHR) data. Materials and Methods We used EHR data from Vanderbilt University Medical Center’s (VUMC) Research and Synthetic Derivatives. Elective procedures and non-urgent visits were suspended at VUMC between March 18, 2020 and April 24, 2020. Surgical procedure data from this period were compared to a similar timeframe in 2019. Potential adverse impact of delay in cardiovascular and cancer-related procedures was evaluated using EHR data collected from January 1, 1993 to March 17, 2020. For surgical procedure delay, outcomes included length of hospitalization (days), mortality during hospitalization, and readmission within six months. For screening procedure delay, outcomes included 5-year survival and cancer stage at diagnosis. Results We identified 416 surgical procedures that were negatively impacted during the COVID-19 pandemic compared to the same timeframe in 2019. Using retrospective data, we found 27 significant associations between procedure delay and adverse patient outcomes. Clinician review indicated that 88.9% of the significant associations were plausible and potentially clinically significant. Analytic pipelines for this study are available online. Conclusion Our approach enables health systems to identify medical procedures affected by the COVID-19 pandemic and evaluate the effect of delay, enabling them to communicate effectively with patients and prioritize rescheduling to minimize adverse patient outcomes.

From the start of the coronavirus disease 2019 (COVID-19) pandemic, researchers have looked to electronic health record (EHR) data as a way to study possible risk factors and outcomes. To ensure the validity and accuracy of research using these data, investigators need to be confident that the phenotypes they construct are reliable and accurate, reflecting the healthcare settings from which they are ascertained. We developed a COVID-19 registry at a single academic medical center and used data from March 1 to June 5, 2020 to assess differences in population-level characteristics in pandemic and non-pandemic years respectively. Median EHR length, previously shown to impact phenotype performance in type 2 diabetes, was significantly shorter in the SARS-CoV-2 positive group relative to a 2019 influenza tested group (median 3.1 years vs 8.7; Wilcoxon rank sum P = 1.3e-52). Using three phenotyping methods of increasing complexity (billing codes alone and domain-specific algorithms provided by an EHR vendor and clinical experts), common medical comorbidities were abstracted from COVID-19 EHRs, defined by the presence of a positive laboratory test (positive predictive value 100%, recall 93%). After combining performance data across phenotyping methods, we observed significantly lower false negative rates for those records billed for a comprehensive care visit (p = 4e-11) and those with complete demographics data recorded (p = 7e-5). In an early COVID-19 cohort, we found that phenotyping performance of nine common comorbidities was influenced by median EHR length, consistent with previous studies, as well as by data density, which can be measured using portable metrics including CPT codes. Here we present those challenges and potential solutions to creating deeply phenotyped, acute COVID-19 cohorts.

Background: Integration of momentary contextual and psychosocial factors within self-management feedback may provide more specific, engaging, and personalized targets for problem solving. Methods: Forty-four youth ages 13–19 with type 1 diabetes (T1D) were provided a Bluetooth meter and completed the 30-day protocol. Participants were randomized to “app + meter” or “meter-only” groups. App + meter participants completed mealtime and bedtime assessment each day. Assessments focused on psychosocial and contextual information relevant for self-management. Graphical feedback integrated self-monitored blood glucose (SMBG), insulin, and Bluetooth-transmitted blood glucose data with the psychosocial and contextual data. App + meter participants completed an interview to identify data patterns. Results: The median number of momentary assessments per participant was 80.0 (range 32–120) with 2.60 per day. By 2 weeks participants had an average of 40.77 (SD 12.23) assessments. Dose–response analyses indicated that the number of app assessments submitted were significantly related to higher mean daily SMBG (r = −0.44, P

Summary The transplantation of human embryonic stem cell (hESC)-derived insulin-producing β cells for the treatment of diabetes is finally approaching the clinical stage. However, even with state-of-the-art differentiation protocols, a significant percentage of undefined non-endocrine cell types are still generated. Most importantly, there is the potential for carry-over of non-differentiated cell types that may produce teratomas. We sought to modify hESCs so that their differentiated progeny could be selectively devoid of tumorigenic cells and enriched for cells of the desired phenotype (in this case, β cells). Here we report the generation of a modified hESC line harboring two suicide gene cassettes, whose expression results in cell death in the presence of specific pro-drugs. We show the efficacy of this system at enriching for β cells and eliminating tumorigenic ones both in vitro and in vivo. Our approach is innovative inasmuch as it allows for the preservation of the desired cells while eliminating those with the potential to develop teratomas., Graphical Abstract, Highlights • hESCs were engineered with suicide genes for safety and differentiation efficiency • One cassette is exclusively expressed in teratogenic cells (safety) • Another is selectively excised out in hESC-derived pancreatic β cells (selectivity) • Our strategy allows for hESC-derived tumors to be prevented or ablated in vivo, In this article, Domínguez-Bendala and colleagues present a strategy to modify pluripotent stem cells to allow for the selective destruction of tumorigenic escapees and/or fully developed teratomas, as well as for the specific selection of differentiated insulin-producing β-like cells. Cells engineered in this manner feature a double fail-safe mechanism designed to minimize the risks associated with their clinical transplantation.

Objective The use of evidence-based guidelines can improve the care for asthma patients. We implemented a computerized asthma management system in a pediatric emergency department (ED) to integrate national guidelines. Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system (Bayesian network) combined with an asthma management system embedded in the workflow decreases time to disposition decision. Methods We performed a prospective, randomized controlled trial in an urban, tertiary care pediatric ED. All patients 2–18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system. Patients identified to have an asthma exacerbation were randomized to intervention or control. For intervention patients, asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage, and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets. Control patients received standard asthma management. The primary outcome measure was the time from triage to disposition decision. Results The Bayesian network identified 1339 patients with asthma exacerbations, of which 788 had an asthma diagnosis determined by an ED physician-established reference standard (positive predictive value 69.9%). The median time to disposition decision did not differ among the intervention (228min; IQR=(141, 326)) and control group (223min; IQR=(129, 316)); ( p =0.362). The hospital admission rate was unchanged between intervention (25%) and control groups (26%); ( p =0.867). ED length of stay did not differ among intervention (262min; IQR=(165, 410)) and control group (247min; IQR=(163, 379)); ( p =0.818). Conclusions The control and intervention groups were similar in regards to time to disposition; the computerized management system did not add additional wait time. The time to disposition decision did not change; however the management system integrated several different information systems to support clinicians' communication.

Introduction Pediatric asthma exacerbations account for >1.8 million emergency department (ED) visits annually. Asthma guidelines are intended to guide time-dependent treatment decisions that improve clinical outcomes; however, guideline adherence is inadequate. We examined whether an automatic disease detection system increases clinicians’ use of paper-based guidelines and decreases time to a disposition decision. Methods We evaluated a computerized asthma detection system that triggered NHLBI-adopted, evidence-based practice to improve care in an urban, tertiary care pediatric ED in a 3-month (7/09–9/09) prospective, randomized controlled trial. A probabilistic system screened all ED patients for acute asthma. For intervention patients, the system generated the asthma protocol at triage for intervention patients to guide early treatment initiation, while clinicians followed standard processes for control patients. The primary outcome measures included time to patient disposition. Results The system identified 1100 patients with asthma exacerbations, of which 704 had a final asthma diagnosis determined by a physician-established reference standard. The positive predictive value for the probabilistic system was 65%. The median time to disposition decision did not differ among the intervention (289 min; IQR = (184, 375)) and control group (288 min; IQR = (185, 375)) (p = 0.21). The hospital admission rate was unchanged between intervention (37%) and control groups (35%) (p = 0.545). ED length of stay did not differ among the intervention (331 min; IQR = (226, 581)) and control group (331 min; IQR = (222, 516)) (p = 0.568). Conclusion Despite a high level of support from the ED leadership and staff, a focused education effort, and implementation of an automated disease detection, the use of the paper-based asthma protocol remained low and time to patient disposition did not change.

Background:Nonadherence to diabetes medication is prevalent and costly. MEssaging for Diabetes (MED), a mobile health (mHealth) intervention, identified and addressed user-specific barriers to medication adherence. We assessed whether MED reduced users’ targeted barriers and if barrier reductions were associated with within-participant improvements in adherence or glycemic control (HbA1c).Methods:Adults (N = 80) with type 2 diabetes completed self-report measures identifying barriers to adherence at baseline and monthly for 3 months. At each assessment, 17 barriers were assessed and ranked for each user. Each subsequent month, users received daily text messages addressing their 3 highest ranked barriers. Targeted barriers were different for each participant and could change monthly. Paired t-tests assessed within-participant improvement in targeted barriers each month, and nested regression models assessed if changes in a participant’s barrier scores were associated with improvements in adherence and HbA1c.Results:Participants were 69% non-white and 82% had incomes Conclusions:Iterative, individual tailoring may overcome users’ barriers to adherence. Attrition is a challenge for mHealth interventions among low-income patients.

Adults with type 2 diabetes (T2DM) and low socioeconomic status (SES) have high rates of medication nonadherence, and, in turn, suboptimal glycemic control (hemoglobin A1c [HbA1c]). We tested the initial efficacy of a short message service (SMS) text messaging and interactive voice response (IVR) intervention to promote adherence among this high-risk group. Eighty low SES, diverse adults with T2DM used the MEssaging for Diabetes (MED) SMS/IVR intervention for three months. We used a pre-post single group design to explore adherence changes over three months, and a quasi-experimental design to test the impact of MED on HbA1c among the intervention group relative to a matched, archival control group. Compared to baseline, adherence improved at one (AOR: 3.88, 95% CI: 1.79, 10.86) and at two months (AOR: 3.76, 95% CI: 1.75, 17.44), but not at three months. HbA1c remained stable, with no differences at three months between the intervention group and the control group. MED had a positive, short-term impact on adherence, which did not translate to improvements in HbA1c. Future research should explore the longer-term impact of SMS/IVR interventions on the medication adherence of high risk adults with T2DM.

Objective To examine the financial impact health information exchange (HIE) in emergency departments (EDs). Materials and Methods We studied all ED encounters over a 13-month period in which HIE data were accessed in all major emergency departments Memphis, Tennessee. HIE access encounter records were matched with similar encounter records without HIE access. Outcomes studied were ED-originated hospital admissions, admissions for observation, laboratory testing, head CT, body CT, ankle radiographs, chest radiographs, and echocardiograms. Our estimates employed generalized estimating equations for logistic regression models adjusted for admission type, length of stay, and Charlson co-morbidity index. Marginal probabilities were used to calculate changes in outcome variables and their financial consequences. Results HIE data were accessed in approximately 6.8% of ED visits across 12 EDs studied. In 11 EDs directly accessing HIE data only through a secure Web browser, access was associated with a decrease in hospital admissions (adjusted odds ratio (OR)=0.27; p

We conducted a pilot trial of a new mobile and web-based intervention to improve diabetes adherence. The text messaging system was designed to motivate and remind adolescents about diabetes self-care tasks. Text messages were tailored according to individually-reported barriers to diabetes self-care. A total of 23 adolescents with type 1 diabetes used the system for a period of three months. On average, they received 10 text messages per week (range 8–12). A matched historical control group from the same clinic was used for comparison. After three months, system users rated the content, usability and experiences with the system, which were very favourable. Comparison of the intervention and control groups indicated a significant interaction between group and time. Both groups had similar HbA1c levels at baseline. After three months, the mean HbA1c level in the intervention group was unchanged (8.8%), but the mean level in the control group was significantly higher (9.9%), P = 0.006. The results demonstrate the feasibility of the messaging system, user acceptance and a promising effect on glycaemic control. Integrating this type of messaging system with online educational programming could prove to be beneficial.

The purpose of this study was to develop a measure of psychosocial barriers to adherence in adolescents with type 1 diabetes (T1D) and examine relationships to patient characteristics, adherence, and hemoglobin A1C (A1C).Barriers to diabetes adherence (BDA) items were generated by researchers, clinicians, and patients. Adolescents aged 12-17 with T1D completed the BDA and an adherence measure. Hemoglobin A1C was obtained through medical chart review.Factor analysis from 123 adolescents resulted in a 21-item, five-component solution that accounted for 64.5% of the variance. The components were stress and burnout, time pressure and planning, social support, parental autonomy support, and stigma. The BDA total and subscales were internally consistent. The BDA total and some components were associated with adherence and A1C. The BDA was the only predictor of A1C compared to demographic, clinical, and adherence variables (F 6.17, p.05). Subjects with higher A1C (8.5) showed a higher level of barriers (F 15.20, p.001) and a differential profile of barriers (F 5.75, p.05).The BDA may be useful in research and clinical settings as a compliment to adherence measures and to tailor educational programs. Additional research is necessary to establish test-retest reliability and discriminant validity.

Objective Health information exchange (HIE) systems are being developed across the nation. Understanding approaches taken by existing successful exchanges can help new exchange efforts determine goals and plan implementations. The goal of this study was to explore characteristics of use and users of a successful regional HIE. Design We used a mixed-method analysis, consisting of cross-sectional audit log data, semi-structured interviews, and direct observation in a sample of emergency departments and ambulatory safety net clinics actively using HIE. For each site, we measured overall usage trends, user logon statistics, and data types accessed by users. We also assessed reasons for use and outcomes of use. Results Overall, users accessed HIE for 6.8% of all encounters, with higher rates of access for repeat visits, for patients with comorbidities, for patients known to have data in the exchange, and at sites providing HIE access to both nurses and physicians. Discharge summaries and test reports were the most frequently accessed data in the exchange. Providers consistently noted retrieving additional history, preventing repeat tests, comparing new results to retrieved results, and avoiding hospitalizations as a consequence of HIE access. Conclusion HIE use in emergency departments and ambulatory clinics was focused on patients where missing information was believed to be present in the exchange and was related to factors including the roles of people with access, the setting, and other site-specific issues that impacted the overall breadth of routine system use. These data should form an important foundation as other sites embark upon HIE implementation.

BACKGROUND: Although pediatric electronic prescribing systems are increasingly being used in pediatric care, many of these systems lack the clinical decision-support infrastructure needed to calculate a safe and effective rounded medication dose. This infrastructure is required to facilitate tailoring of established dosing guidance while maintaining the medication's therapeutic intent. OBJECTIVE: The goal of this project was to establish best practices for generating an appropriate medication dose and to create an interoperable rounding knowledge base combining best practices and dose-rounding information. METHODS: We interviewed 19 pediatric health care and pediatric pharmacy experts and conducted a literature review. After using these data to construct initial rounding tolerances, we used a Delphi process to achieve consensus about the rounding tolerance for each commonly prescribed medication. RESULTS: Three categories for medication-rounding philosophy emerged from our literature review: (1) medications for which rounding is used judiciously to retain the intended effect; (2) medications that are rounded with attention to potential unintended effects; and (3) medications that are rarely rounded because of the potential for toxicity. We assigned a small subset of medications to a fourth category—inadequate data—for which there was insufficient information to provide rounding recommendations. For all 102 medications, we were able to arrive at a consensus recommendation for rounding a given calculated dose. CONCLUSIONS: Results of this study provide the pediatric information technology community with a primary set of recommended rounding tolerances for commonly prescribed drugs. The interoperable knowledge base developed here can be integrated with existing and developing electronic prescribing systems, potentially improving prescribing safety and reducing cognitive workload.

e-Prescribing systems with decision support do not routinely communicate an adequate amount of information regarding the prescribers' decision to pharmacists. To address this communication gap in the e-prescribing process, we implemented a system called Show Your Work (SYW) that appends alerts and override comments to e-prescriptions generated by an e-prescribing system. To assess the quantitative impact of this system, we conducted a randomized, double-blinded, controlled study to assess pharmacy callback rates and types, and to uncover any unintended consequences of the annotations. Each day, SYW output across the enterprise was turned ''on'' or ''off'' randomly for all e-prescriptions. A convenience sample of three pharmacies, blinded to SYW status, submitted callback logs each day. These logs were used to calculate the rate of and reason for callbacks. At the conclusion of the study, we surveyed the 50 most frequently used pharmacies in our area to assess the impact of SYW on satisfaction and communication. A total of 202 callbacks had occurred yielding a callback rate of 45 callbacks/1000 prescriptions for SYW ''on'' days and 40 callbacks/1000 prescriptions for ''off'' days (p=0.4). We received 38 surveys (76% response rate) with 33 respondents commenting about SYW. Most respondents agreed (69%) that SYW favorably impacted callbacks-especially with pediatric prescriptions (82%). Comments suggested that SYW increased callbacks where necessary and decreased them in other situations, but did not contribute to unnecessary callbacks. These findings support the continued and potentially expanded use of SYW by e-prescribing systems to enhance communication with pharmacists.

Medication information is one of the most important types of clinical data in electronic medical records. It is critical for healthcare safety and quality, as well as for clinical research that uses electronic medical record data. However, medication data are often recorded in clinical notes as free-text. As such, they are not accessible to other computerized applications that rely on coded data. We describe a new natural language processing system (MedEx), which extracts medication information from clinical notes. MedEx was initially developed using discharge summaries. An evaluation using a data set of 50 discharge summaries showed it performed well on identifying not only drug names (F-measure 93.2%), but also signature information, such as strength, route, and frequency, with F-measures of 94.5%, 93.9%, and 96.0% respectively. We then applied MedEx unchanged to outpatient clinic visit notes. It performed similarly with F-measures over 90% on a set of 25 clinic visit notes.

OBJECTIVE Nephrin, an immunoglobulin-like protein essential for the function of the glomerular podocyte and regulated in diabetic nephropathy, is also expressed in pancreatic β-cells, where its function remains unknown. The aim of this study was to investigate whether diabetes modulates nephrin expression in human pancreatic islets and to explore the role of nephrin in β-cell function. RESEARCH DESIGN AND METHODS Nephrin expression in human pancreas and in MIN6 insulinoma cells was studied by Western blot, PCR, confocal microscopy, subcellular fractionation, and immunogold labeling. Islets from diabetic (n = 5) and nondiabetic (n = 7) patients were compared. Stable transfection and siRNA knockdown in MIN-6 cells/human islets were used to study nephrin function in vitro and in vivo after transplantation in diabetic immunodeficient mice. Live imaging of green fluorescent protein (GFP)-nephrin–transfected cells was used to study nephrin endocytosis. RESULTS Nephrin was found at the plasma membrane and on insulin vesicles. Nephrin expression was decreased in islets from diabetic patients when compared with nondiabetic control subjects. Nephrin transfection in MIN-6 cells/pseudoislets resulted in higher glucose-stimulated insulin release in vitro and in vivo after transplantation into immunodeficient diabetic mice. Nephrin gene silencing abolished stimulated insulin release. Confocal imaging of GFP-nephrin–transfected cells revealed nephrin endocytosis upon glucose stimulation. Actin stabilization prevented nephrin trafficking as well as nephrin-positive effect on insulin release. CONCLUSIONS Our data suggest that nephrin is an active component of insulin vesicle machinery that may affect vesicle-actin interaction and mobilization to the plasma membrane. Development of drugs targeting nephrin may represent a novel approach to treat diabetes.

Amiloride improves mucociliary clearance (MC) by blocking airway epithelial sodium channels (ENaC) and expanding airway surface liquid (ASL). However, the low potency and rapid absorption of amiloride by airway epithelia translated into a short duration of efficacy as an aerosolized therapy for cystic fibrosis (CF) patients. To improve ENaC blocker CF pharmacotherapy, a more potent and durable ENaC blocker tailored for aerosol delivery was synthesized. Parion compound N -(3,5-diamino-6-chloropyrazine-2-carbonyl)- N ′-4-[4-(2,3-dihydroxypropoxy)phenyl]butyl-guanidine methanesulfonate (552-02) was tested for potency and reversibility of ENaC block, epithelial absorption and biotransformation, selectivity, durability of ASL expansion under isotonic and hypertonic conditions in canine and human CF bronchial epithelial cells, and drug dissociation on ENaC in Xenopus oocytes. Short-circuit current assessed compound potency and reversibility, patch-clamp recordings of ENaC current assessed drug off-rate ( k off ), a gravimetric method and confocal microscopy measured mucosal water retention and ASL height, and drug absorption and biotransformation were assessed using liquid chromatography-mass spectrometry. Amiloride and 552-02 were tested in vivo for MC activity in sheep immediately and 4 to 6 h after aerosol dosing. Compared with amiloride, compound 552-02 was 60 to 100-fold more potent, it was 2 to 5-fold less reversible, it was slower at crossing the epithelium, and it exhibited a 170-fold slower k off value. 552-02 exhibited greater ASL expansion over 8 h in vitro, and it was more effective than amiloride at increasing MC immediately and 4 to 6 h after dosing. When combining hypertonic saline and 552-02, a synergistic effect on ASL expansion was measured in canine or CF bronchial epithelia. In summary, the preclinical data support the clinical use of 552-02 +/– hypertonic saline for CF lung disease.

Objective Mobile health (mHealth) interventions may improve diabetes outcomes, but require engagement. Little is known about what factors impede engagement, so the authors examined the relationship between patient factors and engagement in an mHealth medication adherence promotion intervention for low-income adults with type 2 diabetes (T2DM). Materials and Methods Eighty patients with T2DM participated in a 3-month mHealth intervention called MEssaging for Diabetes that leveraged a mobile communications platform. Participants received daily text messages addressing and assessing medication adherence, and weekly interactive automated calls with adherence feedback and questions for problem solving. Longitudinal repeated measures analyses assessed the relationship between participants’ baseline characteristics and the probability of engaging with texts and calls. Results On average, participants responded to 84.0% of texts and participated in 57.1% of calls. Compared to Whites, non-Whites had a 63% decreased relative odds (adjusted odds ratio [AOR] = 0.37, 95% confidence interval [CI], 0.19-0.73) of participating in calls. In addition, lower health literacy was associated with a decreased odds of participating in calls (AOR = 0.67, 95% CI, 0.46-0.99, P = .04), whereas older age ( Pnonlinear = .01) and more depressive symptoms (AOR = 0.62, 95% CI, 0.38-1.02, P = .059) trended toward a decreased odds of responding to texts. Conclusions Racial/ethnic minorities, older adults, and persons with lower health literacy or more depressive symptoms appeared to be the least engaged in a mHealth intervention. To facilitate equitable intervention impact, future research should identify and address factors interfering with mHealth engagement.

Objective Personal health applications have the potential to help patients with chronic disease by improving medication adherence, self-efficacy, and quality of life. The goal of this study was to assess the impact of MyMediHealth (MMH) – a website and a short messaging service (SMS)-based reminder system – on medication adherence and perceived self-efficacy in adolescents with asthma. Methods We conducted a block-randomized controlled study in academic pediatric outpatient settings. There were 98 adolescents enrolled. Subjects who were randomized to use MMH were asked to create a medication schedule and receive SMS reminders at designated medication administration times for 3 weeks. Control subjects received action lists as a part of their usual care. Primary outcome measures included MMH usage patterns and self-reports of system usability, medication adherence, asthma control, self-efficacy, and quality of life. Results Eighty-nine subjects completed the study, of whom 46 were randomized to the intervention arm. Compared to controls, we found improvements in self-reported medication adherence ( P = .011), quality of life ( P = .037), and self-efficacy ( P = .016). Subjects reported high satisfaction with MMH; however, the level of system usage varied widely, with lower use among African American patients. Conclusions MMH was associated with improved medication adherence, perceived quality of life, and self-efficacy. Trial Registration This project was registered under identifier [NCT01730235][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01730235&atom=%2Fjaminfo%2F23%2F3%2F449.atom

To facilitate the future implementation of an electronic prescribing system, this case study modeled prescription management processes in various primary care settings. The Vanderbilt e-prescribing design team conducted initial interviews with clinic managers, physicians and nurses, and then represented the sequences of steps carried out to complete prescriptions in activity diagrams. The diagrams covered outpatient prescribing for patients during a clinic visit and between clinic visits. Practice size, practice setting, and practice specialty type influenced the prescribing processes used. The model developed may be useful to others engaged in building or tailoring an e-prescribing system to meet the specific workflows of various clinic settings.

To the Editor .— Han et al1 describe a retrospective study in which the mortality rate for interfacility transfers into an ICU was compared before and after implementation of a computerized provider order entry (CPOE) system. The authors found that the mortality rate increased from 2.8% (30 deaths of 1394 patient transfers during 13 months) before CPOE implementation to 6.6% (36 deaths of 548 transfers during 5 months) after. The authors conclude that the increased mortality was associated directly with modifications in standard clinical processes, including the following changes: (1) not allowing order communication until the patient was physically present and registered in the admitting system; (2) relocating medication dispensing to a central (rather than a satellite) pharmacy; (3) increasing the physical separation of nursing and physician staff during the time that orders were generated; (4) implementing computerized order entry; and (5) system-wide provider role changes to support the CPOE system. Perhaps the most important lesson from this study is that there exists an intimate association between care-delivery processes and health information technology. Any shift in the methods used to manage patient care (such as implementing and using a CPOE system) is associated with significant changes in clinical workflows, communication among providers, and distribution of responsibilities.2–4 Decades of research in medical informatics have underscored the importance of this observation, a message that was not lost on the authors. In this study, they note that the increased unadjusted mortality may reflect problems with the process of change, including the extremely rapid implementation plan adopted by their organization. The authors describe other major changes in workflow and patient care processes that occurred coincident with the CPOE system implementation. For example, their …

Article-at-a-Glance Background Clinical pathways are often implemented to improve care, yet their effect on quality of care and outcomes is often not evaluated. The Johns Hopkins Children's Center instituted a clinical pathway in early 1996 to improve the care for pediatric sickle cell vaso-occlusive crisis (VOC) and used a retrospective before–after study to describe how quality of care and outcomes changed after introduction of the pathway. Results Physicians used the pathway in 43% of eligible admissions, with use decreasing over time. Patients on the pathway were more likely to receive each of its required elements than those not on the pathway (odds ratios [OR] 1.15–2.49). After pathway implementation, even patients not on the pathway were more likely to receive incentive spirometry than those admitted before pathway availability (OR 1.40). Pathway use was associated with longer length of stay (LOS) and time to oral pain medication, while readmission rates did not change. Discussion Use of a clinical pathway improved quality of care by increasing compliance with specific care elements, with mixed results on outcomes. Pathways may improve care for all patients, including nonpathway-treated patients, by influencing underlying practice patterns. Quality improvement committees must regularly monitor outcomes after pathway implementation to evaluate the need for pathway reinforcement and refinement.

The use of computer-based documentation tools confers many benefits to the delivery of evidence-based health care. We developed Clictate, a structured reporting environment that utilized standard WindowsTM-based data entry constructs and natural language generation. Clictate has been in use for over 3 years by pediatric providers in an ambulatory setting. More than 50% of our providers use Clictate during the patient encounter. This report describes our results to date, and suggests future opportunities for research and development in the area of computer-based documentation.

Background. Clinical pathways for asthma are tools that have the potential to improve compliance with nationally recognized management guidelines, but their effect on patient outcomes has not been documented. Objectives. To determine the effect of an asthma clinical pathway on patients' length of stay, use of nebulized β-agonist therapy while hospitalized, and use of acute care clinics for 2 weeks after discharge. Design/Methods. The study was a randomized, controlled trial. Patients between the ages of 2 and 18 years admitted with an asthma exacerbation and not under the care of an asthma specialist were eligible for the study. Patients were randomized either to a conventional ward (control group) or to a ward using the clinical pathway (intervention group). For 2 weeks after discharge, we collected data to determine whether patients visited a health care provider for worsening asthma. Results. One hundred ten patients (26%) were enrolled. Control and intervention groups had similar demographic and asthma severity profiles. The intervention group had an average length of stay 13 hours shorter than did the control group. In addition, at every dosing interval, the intervention group received less nebulized β-agonist therapy. There were no deaths in either group. Conclusion. A clinical pathway for inpatient asthma decreased the length of stay and β-agonist medication use with no adverse outcomes or increased acute-care encounters through 2 weeks after discharge.

BackgroundThe Internet can be leveraged to provide disease management support, including medication adherence promotion that, when tailored, can effectively improve adherence to medications. The growing adoption of patient portals represents an opportunity to support medication management and adherence more broadly, but virtually no data exist about the real and potential impact of existing portals on these outcomes. ObjectiveWe sought to (1) understand who uses an existing patient portal and reasons for use and nonuse, (2) understand how portal users are using a portal to manage their medications, and (3) explore participants’ ideas for improving portal functionality for medication management and adherence support. MethodsA total of 75 adults with type 2 diabetes participated in a mixed-methods study involving focus groups, a survey, and a medical chart review. We used quantitative data to identify differences between portal users and nonusers, and to test the relationship between the frequency of portal use and glycemic control among users. We used qualitative methods to understand how and why participants use a portal and their ideas for improving its medication management functionality. ResultsOf the enrolled participants, 81% (61/75) attended a focus group and/or completed a survey; portal users were more likely than nonusers to participate in that capacity (Fisher exact test; P=.01). Users were also more likely than nonusers to be Caucasian/white (Fisher exact test; P

Background: Self-report is the most common method of measuring medication adherence but is influenced by recall error and response bias, and it typically does not provide insight into the causes of poor adherence. Ecological momentary assessment (EMA) of health behaviors using mobile phones offers a promising alternative to assessing adherence and collecting related data that can be clinically useful for adherence problem solving. Objective: To determine the feasibility of using EMA via mobile phones to assess adolescent asthma medication adherence and identify contextual characteristics of adherence decision making. Methods: We utilized a descriptive and correlational study design to explore a mobile method of symptom and adherence assessment using an interactive voice response system. Adolescents aged 12-18 years with a diagnosis of asthma and prescribed inhalers were recruited from an academic medical center. A survey including barriers to mobile phone use, the Illness Management Survey, and the Pediatric Asthma Quality of Life Questionnaire were administered at baseline. Quantitative and qualitative assessment of asthma symptoms and adherence were conducted with daily calls to mobile phones for 1 month. The Asthma Control Test (ACT) was administered at 2 study time points: baseline and 1 month after baseline. Results: The sample consisted of 53 adolescents who were primarily African American (34/53, 64%) and female (31/53, 58%) with incomes US$40K/year or lower (29/53, 55%). The majority of adolescents (37/53, 70%) reported that they carried their phones with them everywhere, but only 47% (25/53) were able to use their mobile phone at school. Adolescents responded to an average of 20.1 (SD 8.1) of the 30 daily calls received (67%). Response frequency declined during the last week of the month ( b =-0.29, P

1) describe and determine the feasibility of using cell-phone-based ecological momentary assessment (EMA) to measure blood glucose monitoring and insulin administration in adolescent Type 1 diabetes, 2) relate EMA to traditional self-report and glycemic control, and 3) identify patterns of adherence by time of day and over time using EMA.Adolescents with Type 1 diabetes (n = 96) completed baseline measures of cell phone use and adherence. Glycemic control (measured by levels of HbA1c) was obtained from medical records. A subgroup of adolescents (n = 50) completed 10 days of EMA to assess blood glucose monitoring frequency, timing of glucose monitoring, insulin administration, and insulin dosing. One third of adolescents were not allowed to use their cell phones for diabetes at school. Parental restrictions on cell phone use at home were not prevalent.The EMA response rate (59%) remained stable over the 10-day calling period. Morning time was associated with worse monitoring and insulin administration, accounting for 59-74% of missed self-care tasks. EMA-reported missed glucose checks and missed insulin doses were correlated to traditional self-report data, but not to HbA1c levels. Trajectory analyses identified two subgroups: one with consistently adequate adherence, and one with more variable, and worse, adherence. The latter adherence style showed worse glycemic control.Mobile phones provide a feasible method to measure glucose monitoring and insulin administration in adolescents, given a limited assessment duration. The method provided novel insights regarding patterns of adherence and should be explored in clinical settings for targeting or tailoring interventions.

Oceanview Medical Center (OMC) successfully implemented a home grown, inpatient, computerized physician ordering entry system (CPOE). In early 2004, OMC launched a small pilot group as the need for a similar ordering entry system in ambulatory care was rising. Doctors, nurses, and programmers collaborated to develop an electronic prescription writer for ambulatory clinical setting. The system was named RxWriter and was designed to operate with the OMC electronic medical record system (OMCEMR, also home grown) to support prescription generation, easier communication of patient information, more efficient clinic workflow, automatic medication monitoring, and quality improvement.

Medical errors arise in part from variations in clinical care. Two broad sources of variations in care are: (a) the progressive complexity of health care (providers caring for more patients with multiple and/or chronic medical needs, less time in which to see them, fragmentation and lack of coordination of care) and (b) barriers (internal and external) that practitioners face in adhering to evidence-based treatment guidelines.1–3

Objective: To describe the use of a computer education station placed within a pediatric emergency department. Design: Prospective tracking of computer tutorial use. Setting: A tertiary care pediatric emergency department. Methods: A computer with two 30-minute multimedia computer tutorials was installed in the emergency department. The tutorials were designed for residents to use on a voluntary basis but were available to medical students and allied health professionals as well. Software tracked time, date, duration of use, and the user's path through each tutorial. Data were collected from July 15, 1996, through April 30, 1997. Results: Twenty-eight residents interacted 71 times with the computer during the study. The mean duration of interactions was 22 minutes (SD, 18 minutes; range, 0-75 minutes), but many lasted less than 5 minutes (15 [21%] of 71). Twenty-four (34%) of the interactions led to tutorial completion. Residents were more likely to complete a tutorial during the day shift (22 [40%] of 55) compared with the evening shift (1 [7%] of 14) (P=.02). A third of the interactions were during evenings and weekends. The education station delivered 26.1 hours of instruction in total. Of 32 first-year pediatric and emergency medicine residents, 22 attempted the tutorials; 4 completed both, and 10 completed one. Allied health professionals were responsible for 28% of the total interactions. They were significantly more likely than medical trainees to have brief interactions, but they were no less likely to complete the tutorials (10 [22%] of 46 vs 31 [27%] of 115; P=.44). Conclusions: Pediatric residents are willing to use an educational computer placed in the emergency department. Choice of form and content should take into account the likelihood of short interactions and the demonstrated interest of allied health professionals.

It is currently recommended that venom immunotherapy (VIT) be continued as long as the sensitivity persists (indicated by positive venom skin tests or RAST). In this pilot study, we performed a retrospective survey of the clinical and immunologic effects of stopping VIT. The 82 patients studied had received maintenance VIT for a mean of 14 months and had stopped VIT a mean of 43 months before evaluation. Subsequent "field" stings in 28 patients caused systemic reactions in six cases (22%), which is significantly higher than the 1% to 3% systemic reaction rate in patients who remain on maintenance VIT. The 22% reaction rate is a minimal estimate caused by loss of venom sensitivity in some patients and residual venom-specific IgG antibody levels in others. Reevaluation of venom skin tests and IgG levels was possible in 43 patients. A tenfold decline from before VIT skin test results was observed in 27 patients (63%). Skin tests remained clearly positive in 32/43 (74%), became weakly positive in 9/43 (21%), and 2/43 (5%) became negative. The IgG level declined from typical maintenance levels before stopping VIT (mean 7.2 +/- 1.2 micrograms/ml) to levels typical of untreated patients at the time of retesting (mean 1.95 +/- 0.3 micrograms/ml). Despite the marked fall of IgG antibody, one third of the patients still had levels in the average range observed in patients receiving maintenance VIT. We conclude that there is a substantial risk of anaphylactic sting reaction if VIT is stopped while venom sensitivity persists.