Electronic health records to facilitate clinical research

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research

Electronic health records to facilitate clinical research

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research

Electronic health records to facilitate clinical research

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.</p

Unremarkable AI: Fitting Intelligent Decision Support into Critical, Clinical Decision-Making Processes

Clinical decision support tools (DST) promise improved healthcare outcomes by offering data-driven insights. While effective in lab settings, almost all DSTs have failed in practice. Empirical research diagnosed poor contextual fit as the cause. This paper describes the design and field evaluation of a radically new form of DST. It automatically generates slides for clinicians' decision meetings with subtly embedded machine prognostics. This design took inspiration from the notion of "Unremarkable Computing", that by augmenting the users' routines technology/AI can have significant importance for the users yet remain unobtrusive. Our field evaluation suggests clinicians are more likely to encounter and embrace such a DST. Drawing on their responses, we discuss the importance and intricacies of finding the right level of unremarkableness in DST design, and share lessons learned in prototyping critical AI systems as a situated experience

Pragmatic trials

No abstract available

Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder.

BACKGROUND:Only 40-60% of patients with generalized anxiety disorder experience long-lasting improvement with gold standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success might provide specific targets for more individualized interventions, fostering more optimal outcomes and bringing us closer to the goal of "personalized medicine." Research suggests that reward and threat processing (approach/avoidance behavior) and cognitive control may be important for understanding anxiety and comorbid depressive disorders and may have relevance to treatment outcomes. This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder. METHODS/DESIGN:We are conducting a randomized controlled trial involving two 10-week group-based interventions: exposure-based therapy or behavioral activation therapy. These interventions focus on specific and unique aspects of threat and reward processing, respectively. Prior to and after treatment, participants are interviewed and undergo behavioral, biomarker, and neuroimaging assessments, with a focus on approach and avoidance processing and decision-making. Primary analyses will use mixed models to examine whether hypothesized approach, avoidance, and conflict arbitration behaviors and associated neural responses at baseline moderate symptom change with treatment, as assessed using the Generalized Anxiety Disorder-7 item scale. Exploratory analyses will examine additional potential treatment moderators and use data reduction and machine learning methods. DISCUSSION:This protocol provides a framework for how studies may be designed to move the field toward neuroscience-informed and personalized psychosocial treatments. The results of this trial will have implications for approach-avoidance processing in generalized anxiety disorder, relationships between levels of analysis (i.e., behavioral, neural), and predictors of behavioral therapy outcome. TRIAL REGISTRATION:The study was retrospectively registered within 21 days of first participant enrollment in accordance with FDAAA 801 with ClinicalTrials.gov, NCT02807480. Registered on June 21, 2016, before results

Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study

Abstract Background Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. Methods In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Discussion Integration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. Trial Registration The ClinicalTrials.gov registration number is NCT00495794.http://deepblue.lib.umich.edu/bitstream/2027.42/78258/1/1745-6215-11-95.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/2/1745-6215-11-95.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/3/1745-6215-11-95-S1.DOCPeer Reviewe

Spinal manipulation or mobilization for lumbar disc herniation with radiculopathy : a protocol for a systematic review and meta-analysis

Introduction: The purpose of this study is to conduct a systematic review and meta-analysis into the effects of spinal manipulation or mobilization for Lumbar Disc Herniation with Radiculopathy (LDHR). Methods: An electronic database search of titles and abstracts of articles published in English will be conducted in the following databases: PEDro (Physiotherapy Evidence Database), CINAHL (Cumulative Index to Nursing and Allied Health Literature), PubMed, Science Direct, Google Scholar, and The Cochrane Library. The specific search strategies will be dependent on the particular database being searched and hand searches of the reference lists of the included articles will also be performed. Studies will be included if they reported an acceptable comparison group, and also reported at least one of the main clinically relevant outcome measures for LDHR. Two independent reviewers will screen the identified records, and all disagreements will be resolved. The internal and external validities of the included studies will be assessed using the PEDro scale and the External Validity Assessment Tool (EVAT) respectively. The clinical relevance and risk of bias of the studies will be determined using the 5-Criteria developed by the Cochrane Back Review Group and the Cochrane Risk of Bias Assessment Tool respectively. Studies will be pooled into meta-analysis where appropriate using RevMan software and the outcomes will be reported using the PRISMA guidelines. Discussion: This review will summarize the current evidence about the effects of spinal manipulation or mobilization compared with other interventions in the management of individuals with Lumbar Disc Herniation with Radiculopathy (LDHR). A meta-analysis will also be conducted where appropriate in this review to compare the effects of spinal manipulation or mobilization with other interventions with a view to finding out which technique is better in the management of individuals with LDHR. Review Registration: This review has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019131292). Keywords: Spinal manipulation; spinal mobilization; lumbar disc herniation; systematic review; meta-analysi

School-Based Telemedicine Interventions for Asthma: A Systematic Review.

BackgroundSchool health systems are increasingly investing in telemedicine platforms to address acute and chronic illnesses. Asthma, the most common chronic illness in childhood, is of particular interest given its high burden on school absenteeism.ObjectiveConduct a systematic review evaluating impact of school-based telemedicine programs on improving asthma-related outcomes.Data sourcesPubMed, Cochrane CENTRAL, CINAHL, ERIC, PsycINFO, Embase, and Google Scholar.Study eligibility criteriaOriginal research, including quasi-experimental studies, without restriction on the type of telemedicine.ParticipantsSchool-aged pediatric patients with asthma and their families.InterventionsSchool-based telemedicine.Study appraisal and synthesis methodsTwo authors independently screened each abstract, conducted full-text review, assessed study quality, and extracted information. A third author resolved disagreements.ResultsOf 371 articles identified, 7 were included for the review. Outcomes of interest were asthma symptom-free days, asthma symptom frequency, quality of life, health care utilization, school absences, and spirometry. Four of 7 studies reported significant increases in symptom-free days and/or decrease in symptom frequency. Five of 6 reported increases in at least one quality-of-life metric, 2 of 7 reported a decrease in at least 1 health care utilization metric, 1 of 3 showed reductions in school absences, and 1 of 2 reported improvements in spirometry measures.LimitationsVariability in intervention designs and outcome measures make comparisons and quantitative analyses across studies difficult. Only 2 of 7 studies were randomized controlled trials.Conclusions and implications of key findingsHigh-quality evidence supporting the use of school-based telemedicine programs to improve patient outcomes is limited. While available evidence suggests benefit, only 2 comparative trials were identified, and the contribution of telemedicine to these studies' results is unclear