Search

The COVID-19 pandemic has been a catalyst for the implementation of decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) in the field while curtailing in-person interactions and putting significant demands on health care resources. DHTs offer improvements in real-time data acquisition remotely while maintaining privacy and security. Here, we describe the implications of technologies, including edge computing, zero-trust environments, and federated computing in DCTs enabled by DHTs. Taken together, these technologies—in the setting of policy and regulation that enable their use while protecting the users—extend the scope and accelerate the pace of clinical research.

Chethan Sarabu,1,2 Sandra Steyaert,1 Nirav R Shah1– 3 1Sharecare Inc., Atlanta, GA, USA; 2Stanford Medicine, Palo Alto, CA, USA; 3Clinical Excellence Research Center, Stanford, CA, USACorrespondence: Chethan SarabuSharecare Inc., 255 East Paces Ferry Road NE, GA, Atlanta, 30305, USATel +1 315-794-2354Email chethan.sarabu@gmail.com

Environmental allergies cause significant morbidity across a wide range of demographic groups. This morbidity could be mitigated through individualized predictive models capable of guiding personalized preventive measures. We developed a predictive model by integrating smartphone sensor data with symptom diaries maintained by patients. The machine learning model was found to be highly predictive, with an accuracy of 0.801. Such models based on real-world data can guide clinical care for patients and providers, reduce the economic burden of uncontrolled allergies, and set the stage for subsequent research pursuing allergy prediction and prevention. Moreover, this study offers proof-of-principle regarding the feasibility of building clinically useful predictive models from “messy,” participant derived real-world data.

Pediatric practice increasingly involves providing care for children with medical complexity. Telehealth offers a strategy for providers and health care systems to improve care for these patients and their families. However, lack of awareness related to the unintended negative consequences of telehealth on vulnerable populations--coupled with failure to intentional design best practices for telehealth initiatives--implies that these novel technologies may worsen health disparities in the long run. This article reviews the positive and negative implications of telehealth. In addition, to achieve optimal implementation of telehealth, it discusses 10 considerations to promote optimal care of children using these technologies.

BACKGROUND: Programs addressing social determinants of health for high-utilizing patients are gaining interest among health systems as an avenue to promote health and decrease utilization. OBJECTIVE: To evaluate impacts of a social needs screening and navigation program for adult predicted high utilizers on total medical visit utilization. DESIGN: A prospective, quasi-experimental study using an intent-to-treat propensity-weighted difference-in-differences approach. Stratified analyses assessed intervention effects among three low–socioeconomic status sub-samples: patients in low-income areas, in low-education areas, and with Medicaid insurance. PARTICIPANTS: Predicted high utilizers—patients predicted to be in the highest 1% for total utilization in a large integrated health system. INTERVENTION: A telephonic social needs screening and navigation program. MAIN MEASURES: Primary difference-in-difference analyses compared total visit count utilization, including outpatient, emergency department (ED), and inpatient utilization, between the intervention and control groups at both in-network and out-of-network facilities. Prevalence of social needs among sample patients and their connection rates to social needs resources are also described. KEY RESULTS: The study included 34,225 patients (7107 intervention, 27,118 control). Most (53%) patients screened reported social needs, but only a minority (10%) of those with a need were able to connect with resources to address these needs. Primary analysis found total utilization visits decreased 2.2% (95% CI − 4.5%, 0.1%; p = 0.058) in the intervention group. Stratified analyses showed decreases in total utilization for all low–socioeconomic status subgroups receiving the intervention compared with controls: − 7.0% (95% CI − 11.9%, − 1.9%; p = 0.008) in the low-income area group, − 11.5% (− 17.6%, 5.0%; p

This retrospective cohort study compared blood pressure (BP) control (BP

Objectives Pneumonia severity tools were primarily developed in cohorts of hospitalized patients, limiting their applicability to the emergency department (ED). We describe current community ED admission practices and examine the accuracy of the CURB-65 to predict 30-day mortality for patients, either discharged or admitted with community-acquired pneumonia (CAP). Methods A retrospective, observational study of adult CAP encounters in 14 community EDs within an integrated healthcare system. We calculated CURB-65 scores for all encounters and described the use of hospitalization, stratified by each score (0–5). We then used each score as a cutoff to calculate sensitivity, specificity, positive predictive value, negative predictive value (NPV), positive likelihood ratios, and negative likelihood ratios for predicting 30-day mortality. Results The sample included 21,183 ED encounters for CAP (7,952 discharged and 13,231 admitted). The C-statistic describing the accuracy of CURB-65 for predicting 30-day mortality in the full sample was 0.761 (95% confidence interval [CI], 0.747–0.774). The C-statistic was 0.864 (95% CI, 0.821–0.906) among patients discharged from the ED compared with 0.689 (95% CI, 0.672–0.705) among patients who were admitted. Among all ED encounters a CURB-65 threshold of ≥1 was 92.8% sensitive and 38.0% specific for predicting mortality, with a 99.9% NPV. Among all encounters, 62.5% were admitted, including 36.2% of those at lowest risk (CURB-65 = 0). Conclusions CURB-65 had very good accuracy for predicting 30-day mortality among patients discharged from the ED. This severity tool may help ED providers risk stratify patients to assist with disposition decisions and identify unwarranted variation in patient care.

Armed with just the rules of the game, Google's AlphaZero mastered chess after 9 hours of training. The program showed an awesome new kind of intelligence, creativity, beauty, and perhaps even play...

BACKGROUND: High-cost patients are a frequent focus of improvement projects based on primary care and other settings. Efforts to characterize high-cost, high-need patients are needed to inform care planning, but such efforts often rely on a priori assumptions, masking underlying complexities of a heterogenous population. OBJECTIVE: To define recognizable subgroups of patients among high-cost adults based on clinical conditions, and describe their survival and future spending. DESIGN: Retrospective observational cohort study. PARTICIPANTS: Within a large integrated delivery system with 2.7 million adult members, we selected the top 1% of continuously enrolled adults with respect to total healthcare expenditures during 2010. MAIN MEASURES: We used latent class analysis to identify clusters of alike patients based on 53 hierarchical condition categories. Prognosis as measured by healthcare spending and survival was assessed through 2014 for the resulting classes of patients. RESULTS: Among 21,183 high-cost adults, seven clinically distinctive subgroups of patients emerged. Classes included end-stage renal disease (12% of high-cost population), cardiopulmonary conditions (17%), diabetes with multiple comorbidities (8%), acute illness superimposed on chronic conditions (11%), conditions requiring highly specialized care (14%), neurologic and catastrophic conditions (5%), and patients with few comorbidities (the largest class, 33%). Over 4 years of follow-up, 6566 (31%) patients died, and survival in the classes ranged from 43 to 88%. Spending regressed to the mean in all classes except the ESRD and diabetes with multiple comorbidities groups. CONCLUSIONS: Data-driven characterization of high-cost adults yielded clinically intuitive classes that were associated with survival and reflected markedly different healthcare needs. Relatively few high-cost patients remain persistently high cost over 4 years. Our results suggest that high-cost patients, while not a monolithic group, can be segmented into few subgroups. These subgroups may be the focus of future work to understand appropriateness of care and design interventions accordingly. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-018-4626-0) contains supplementary material, which is available to authorized users.

Context While hospitals remain important centers of gravity in the health system, services are increasingly being delivered through ambulatory care. This shift to ambulatory care is giving rise to new delivery structures, such as retail clinics and urgent care centers, as well as reinventing existing ambulatory care capacity, as seen with the patient-centered medical home model and the movement toward team-based care. To protect the public's interests, oversight of ambulatory care services must keep pace with these rapid changes. With this purpose, in January 2013 the New York Public Health and Health Planning Council undertook a redesign of the regulatory framework for the state's ambulatory care services. This article describes the principles undergirding the framework as well as the regulatory recommendations themselves.

The New York State Department of Health (DOH) has a long history of biomedical research, public health policy and program development, peer-reviewed scholarship, and teaching. Its evolution as an academic health department advanced significantly when the University at Albany and DOH formed the School of Public Health Sciences in 1985 to further develop these functions while formally training the next generation of public health workers. The School, renamed in 1990 as the School of Public Health (SPH), was initially located within the DOH with its staff as the founding faculty. The curriculum was heavily influenced by public health practice imperatives. The SPH has evolved to have an independent campus and full-time academic faculty, but the DOH remains closely linked. The relationship is governed by a memorandum of understanding that commits both partners to provide substantial and continuing resources to the SPH. The SPH brings value to the DOH's mission to improve the health of the state's citizens by providing an academic focus to problems faced in health department practice settings. The opportunity to teach and be involved in an academic environment increases the DOH's ability to recruit, retain, and improve the skill level of its professional and scientific staff and thereby improve its ability to assess health problems and to design and evaluate public health programs. The SPH also provides training and support to county health departments and nongovernment organizations, which further the DOH's mission, through continuing education programs and an online MPH degree program. International exchanges including those with China, Vietnam, and the Republic of Georgia have enriched the academic environment. Challenges include maintaining sufficient full-time faculty members, the need for the SPH to take on broader public health issues than those applicable to New York, and the shrinkage of the DOH's workforce and departure of many senior scientists who served as faculty.

A freestanding, 911-receiving emergency department was implemented at Bellevue Hospital Center during the recovery efforts after Hurricane Sandy to compensate for the increased volume experienced at nearby hospitals. Because inpatient services at several hospitals remained closed for months, emergency volume increased significantly. Thus, in collaboration with the New York State Department of Health and other partners, the Health and Hospitals Corporation and Bellevue Hospital Center opened a freestanding emergency department without on-site inpatient care. The successful operation of this facility hinged on key partnerships with emergency medical services and nearby hospitals. Also essential was the establishment of an emergency critical care ward and a system to monitor emergency department utilization at affected hospitals. The results of this experience, we believe, can provide a model for future efforts to rebuild emergency care capacity after a natural disaster such as Hurricane Sandy. (Disaster Med Public Health Preparedness. 2014;0:1-4)

The role of social determinants of health, and the business case for addressing them, is clear when it comes to homelessness and housing. New York State is undertaking an experiment that uses Medicaid funds for supportive housing for high-risk, homeless Medicaid recipients.

In patients aged ≥80 years without previous coronary artery disease, peripheral vascular disease, or cerebrovascular disease, no evidence has shown a benefit from statin therapy. We examined the prevalence of statin use in patients aged ≥80 years for the indication of primary prevention. We reviewed the comprehensive electronic health records at the Geisinger Health System in Pennsylvania for all patients aged >55 years with ≥1 primary care encounter from January 24, 2004 and December 31, 2009. The records were scrutinized for the use of a statin, active medical diagnoses, and laboratory values. Patients without a previous diagnosis of coronary artery disease, peripheral vascular disease, or cerebrovascular disease were considered to have a primary prevention indication for statin therapy. The prevalence of statin use was examined, and a multivariate analysis was conducted to determine the predictors of use. A total of 89,086 patients were included in the analysis, with 22,646 patients aged ≥80 years. Of all the patients, 26% were prescribed a statin, of whom, 71% (n = 16,687) received it for primary prevention. Of the 14,604 patients aged ≥80 years with a primary prevention indication, 3,145 (22%) received a statin. A plot of 5-year age cohorts from 55 to >90 years demonstrated an n-shaped relation between age and statin use for primary prevention (18%, 23%, 27%, 29%, 28%, 26%, 21%, and 12%, p

In 1988, the New York State Health Commissioner was confronted with hospital-level data demonstrating very large, multiple-year, interhospital variations in short-term mortality and complications for cardiac surgery. The concern with the extent to which these differences were due to variations in patients' pre-surgical severity of illness versus hospitals' quality of care led to the development of clinical registries for cardiac surgery in 1989 and for percutaneous coronary interventions in 1992 in New York. In 1990, the Department of Health released hospitals' risk-adjusted cardiac surgery mortality rates for the first time, and shortly thereafter, similar data were released for hospitals and physicians for percutaneous coronary interventions, cardiac valve surgery, and pediatric cardiac surgery (only hospital data). This practice is still ongoing. The purpose of this communication is to relate the history of this initiative, including changes or purported changes that have occurred since the public release of cardiac data. These changes include decreases in risk-adjusted mortality, cessation of cardiac surgery in New York by low-volume and high-mortality surgeons, out-of-state referral or avoidance of cardiac surgery/angioplasty for high-risk patients, alteration of contracting choices by insurance companies, and modifications in market share of cardiac hospitals. Evidence related to these impacts is reviewed and critiqued. This communication also includes a summary of numerous studies that used New York's cardiac registries to examine a variety of policy issues regarding the choice and use of cardiac procedures, the comparative effectiveness of competing treatment options, and the examination of the relationship among processes, structures, and outcomes of cardiac care.

J Clin Hypertens (Greenwich). 2012; 14:407–414. ©2012 Wiley Periodicals, Inc. Important questions concerning the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) remain unanswered, including whether they are equally effective in reducing clinical end points and in which populations. An incident cohort of adult patients 18 years and older prescribed an ACE inhibitor or ARB between 2001 and 2008 was identified from Geisinger Clinic, a large community-based set of medical practices that uses a common electronic health record. Propensity score matching was used to balance the groups on baseline factors. The authors examined differences in mortality and new-onset coronary disease, chronic kidney disease, stroke, and diabetes for different patient subgroups based on sex and age. A total of 25,035 hypertensive patients newly prescribed an ACE inhibitor or ARB were identified. No differences were found in risk of death, coronary disease, chronic kidney disease, or stroke between those prescribed ACE inhibitors and those prescribed ARBs. Patients prescribed ARBs had a greater rate of new-onset diabetes (hazard ratio [HR], 1.28; confidence interval [CI], 1.08–1.52), and this was especially true for women (HR, 1.93; CI, 1.22–3.07). Within a large medical-practice based population, there was no evidence of differential effectiveness between ACE inhibitors and ARBs for most outcomes, with diabetes being the notable exception.

Quantitative risk (QR) formulas have been developed for multiple conditions but are not routinely used in clinical practice. Tests were made of the feasibility of an automated clinical care process for using QR in routine primary care. Several modifications were made to the Framingham Risk Score (FRS) and it was applied to routine care in three areas: (1) for risk-stratification, (2) patient education about care options, and (3) guidance on optimizing choice of care options. Evidence-based methods were used to convert the smoking status variable from a binary- to a continuous-scale format and to add variables for alcohol use and HbA1c. An automated protocol tested in 2008-2010 was successful for all three applications. At-risk patients (defined according to criteria from the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC]-7 or the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults [adult treatment panel/ATP-III]) were automatically identified during routine encounters. Patient-reported data were obtained (n = 1826) by touchscreen questionnaire and automatically used with electronic health record (EHR) data to calculate risks on 1068 patients who had complete data. Patients were risk-stratified. Higher-risk patients viewed an interactive web-based tool and chose options to modify risk factors. Feasibility was successful for use of the FRS in the interactive web tool.

The role of social determinants of health, and the business case for addressing them, is clear when it comes to homelessness and housing. New York State is undertaking an experiment that uses Medicaid funds for supportive housing for high-risk, homeless Medicaid recipients.

Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low.To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants.A randomized controlled trial, with randomization at the physician level.Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group.CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician.Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening.The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007).The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions.

The concept of the medical home has existed since the 1960s, but has recently become a focus for discussion and innovation in the health care system. The most prominent definitions of the medical home are those presented by the Patient-Centered Primary Care Collaborative, the National Committee for Quality Assurance, and the Commonwealth Fund. These definitions share: adoption of health information technology and decision support systems, modification of clinical practice patterns, and ensuring continuity of care. Each of these components is a complex undertaking, and there is scant evidence to guide assessment of diverse strategies for achieving their integration into a medical home. Without a shared vocabulary and common definitions, policy-makers seeking to encourage the development of medical homes, providers seeking to improve patient care, and payers seeking to develop appropriate systems of reimbursement will face challenges in evaluating and disseminating the medical home model.

Our goal was to examine colorectal cancer (CRC) screening, referral, and follow-up practices in a population of Chinese and Latino immigrant patients. We conducted a nested cohort study within a larger randomized trial in a primary care clinic of a large municipal hospital. Participants were patients born in China and Latin America, new to the clinic and eligible for screening colonoscopy. The main outcome measures were physician referral for screening colonoscopy and patients’ adherence to referral. One hundred and forty-six (146) patients met inclusion criteria; 92 were born in Latin America and 54 in China. Of those born in Latin America, 27% received a referral for screening colonoscopy and 80% adhered to the provider referral. Of those born in China, 24% received a referral for colonoscopy and 92% of those adhered to it. No significant associations were found between patient characteristics, referral for colonoscopy and completion of screening. Rates of CRC screening among Chinese and Latino patients...

Purpose We conducted a systematic review of the literature to summarize the available data on reconstructive surgeries involving pinch reconstruction and elbow extension restoration in people with tetraplegia. Methods English-language and French-language articles and abstracts published between 1966 and February 2007, identified through MEDLINE and EMBASE searches, bibliography review, and expert consultation, were reviewed for original reports of outcomes with pinch reconstruction and elbow extension restoration in tetraplegic patients after a spinal cord injury. Two reviewers independently extracted data on patient characteristics, surgical methods, and patient outcomes. Results Our search identified 765 articles, of which 37 met eligibility criteria (one article contained information on both elbow and pinch procedures). Results from 377 pinch reconstructions in 23 studies and 201 elbow extension restorations in 14 studies were summarized. The mean Medical Research Council score for elbow extension went from 0 to 3.3 after reconstruction. The overall mean postoperative strength measured after surgery for pinch reconstruction was 2 kg. Conclusions More than 500 patients having these procedures experienced a clinically important improvement for both procedures—one restoring elbow extension, and the other, pinch strength. Upper-limb surgeries markedly improved the hand function of people with tetraplegia. Type of study/level of evidence Therapeutic IV.

Evaluation of: Lyytinen H, Pukkala E, Ylikorkala O: Breast cancer risk in postmenopausal women using estrogen-only therapy. Obstet. Gynecol. 108(6), 1354–1360 (2006) [ 1 ]. A cohort study of 84,729 Finnish women over the age of 50 years who used oral or transdermal estradiol for at least 6 months, followed for the incidence of breast cancer using a national cancer registry. The study was conducted to evaluate whether the risk of breast cancer with estrogen-only therapy varies by dose, constituents or route of administration. A total of 2171 women developed breast cancer, with no increased risk observed for less than 5 years of use, and some risk for greater than 5 years of use for both oral and transdermal routes of administration.

Most clinical decisions involve bridging the inferential gap: Clinicians are required to “fill in” where they lack knowledge or where no knowledge yet exists. In this context we consider how the inferential gap is a product, in part, of how knowledge is created, the limits to gaining access to such knowledge, and the variable ways in which knowledge is translated into decisions. We consider how electronic health records (EHRs) will help narrow this gap by accelerating the creation of evidence relevant to everyday practice needs and facilitating real-time use of knowledge in practice.

The controversies surrounding hormone replacement therapy have left many women confused and afraid. Providers have been faced with long-standing assumptions challenged by an abundance of new data in the past few years, with little guidance on how to interpret these findings. The objective of this paper is to provide a framework for understanding breast cancer risk associated with postmenopausal hormone replacement therapy, with a particular focus on how observational studies and randomised trials provide complementary information. This framework considers the data on risks of various hormonal preparations, the profiles of women at risk, and ends with an expert opinion in this context.

Background. With recent improvements in medical and device therapy, the benefit of cardiac transplantation for UNOS Status 2 patients has been questioned. No randomized trial has been performed to compare transplantation versus contemporary medical therapy.Methods. Between January 1996 and December 2003, 203 patients were listed at our institution for heart transplantation as UNOS Status 2. We performed a retrospective review to determine outcomes in these patients.Results. Demographics of this cohort revealed a mean age of 52 years, female sex in 28%, and ischemic etiology in 47%. Eighty-one patients (40%) had an implantable cardiac defib-rillator. A total of 64 patients (32%) had to be upgraded in their UNOS status, with 9 requiring a left ventricular assist device. Of the entire group, 95 (47%) underwent transplantation at a mean time of 303 days, 45 (22%) died while waiting at a mean time of 397 days, and 24 (12%) were removed from the waiting list due to deterioration in medical condition such that transplantation was no longer an option. The remaining patients continue to wait or have been removed from consideration due to improved condition. Survival at 1- and 3-years postlisting was 94% and 87% for patients who received transplants compared to 81% and 57% for patients who did not receive transplants (P < .01).Conclusion. A significant number of patients listed as Status 2 are upgraded in UNOS status or die while on the waiting list. Early and midterm survival is significantly better with transplantation. Identification of variables associated with deterioration may allow for better risk stratification in the future. At this point, transplantation offers the best outcome.

There is a rapidly evolving debate on the indications and appropriate duration of therapy for postmenopausal hormone therapy. The objective of this meta-analysis was to examine the specific relationships of postmenopausal estrogen therapy (ET), postmenopausal combined (estrogen-progestogen) hormone therapy (CHT), and the incidence of breast cancer.We performed computerized searches of MEDLINE and CancerLit through September 2003 and reviewed reference lists of retrieved studies and meta-analyses. We included English-language studies that identified noncontraceptive postmenopausal hormone use; reported on the risks of "current use" of ET and/or CHT and breast cancer incidence; were case-control, cohort, or experimental; and reported either an odds ratio (OR), relative risk (RR), or HR with CIs. Two investigators were involved during all stages of study selection and independently extracted all data selected for inclusion in meta-analyses.Meta-analysis of 13 studies of ET and breast cancer (700,000 women) resulted in an OR of 1.16 (95% confidence limits [CL] 1.06, 1.28), with estimates for less than 5 years use 1.16 (1.02, 1.32) and more than 5 years use 1.20 (1.06, 1.37). Meta-analysis of eight studies of CHT and breast cancer (650,000 women) resulted in an OR of 1.39 (95% CL 1.12, 1.72), with estimates for less than 5 years use 1.35 (1.16, 1.57) and more than 5 years use 1.63 (1.22, 2.18).Data from observational studies support the association of increased but considerably different risks for breast cancer incidence among current users of ET and CHT. These represent the first pooled estimates for ET. CHT estimates correspond to those from randomized trials.

Background The University of Wisconsin (UW) solution is the gold standard for heart preservation but has limitations in terms of both duration and adequacy of protection. Our laboratory has been interested in a more physiologic approach to heart preservation by maintaining the heart at its resting membrane potential (hyperpolarized arrest) with the KATP channel agonist pinacidil. This study compared our extracellular solution (WashU) with the UW intracellular depolarizing solution and quantified the protective effect of pinacidil in both solutions. Methods Thirty-two rabbit hearts received 1 of 4 solutions in a crystalloid-perfused Langendorff apparatus: (1) UW, (2) WashU containing 0.5 mmol/liter pinacidil, (3) UW with 0.5 mmol/liter pinacidil, or (4) WashU without pinacidil. Thirty minutes of perfusion was followed by data acquisition consisting of left ventricular pressure-volume curves generated by inflating an intraventricular balloon. All hearts were placed in cold storage for 8 hours, followed by 1 hour of reperfusion before data acquisition. Results Post-ischemic developed pressure (DP) was better preserved by WashU (76.8% ± 3.8%) than by UW (48.3% ± 2.5%). Diastolic compliance was better preserved by WashU (239.9% ± 77.2%) compared with UW (711.1% ± 193.1%). Removing pinacidil from our solution resulted in decreased DP (46.6% ± 3.2%) and diastolic compliance (688.8% ± 158.2%) Adding pinacidil to UW had a limited effect on DP and compliance. Conclusions Our results support the superiority of the WashU hyperpolarizing solution for heart preservation over UW. Pinacidil was beneficial in maintaining cardiac function and compliance. This benefit was not observed when pinacidil was placed into the UW depolarizing solution.

SummaryEvaluation of the accuracy of ultrasound has yielded heterogeneous results. Our objective was to summarize the evidence on the accuracy of ultrasound compared to venography in asymptomatic patients, taking into account the variation due to threshold differences. Searches of journal table of contents, computer databases (Medline, Embase, Biomed, Cochrane) and conference proceedings were performed. A study was eligible if it prospectively compared ultrasound to venography for the diagnosis of DVT in asymptomatic patients. Data of studies selected for inclusion were extracted independently by two authors. High quality studies with consecutive patient enrollment, blind evaluation of the two techniques, and absence of verification bias are summarized as Level 1, while those not fulfilling one or more of these criteria are considered Level 2. Original study authors were contacted to confirm accuracy and to provide missing data. A pooled estimate of the accuracy of ultrasound was obtained according to the method of Moses and coworkers. This method gives a summary diagnostic odds ratio (DOR). The DOR is a single indicator of test performance. It varies between 0 and infinity and exceeds 1, only when ultrasound is more often positive in patients with DVT relative to those without DVT. Higher DOR indicates better discriminatory test performance. Thirty one studies were rated as potentially unbiased and graded as Level 1.The mean prevalence of DVT as determined by venography was 22%. In Level 1 studies, the odds of positive ultrasound in proximal veins was 379 times higher (95% confidence limits 65, 2,200) and in distal veins 32 times higher (7.5, 135) among patients with DVT than those without. Our results suggest that, particularly for proximal veins, ultrasound is accurate for the diagnosis of DVT in asymptomatic postoperative orthopedic patients. More research is needed in other clinical settings.

Public health surveillance conducted by health departments in the United States has improved in completeness and timeliness owing to electronic laboratory reporting. However, the collection of detailed clinical information about reported cases, which is necessary to confirm the diagnosis, to understand transmission, or to determine disease-related risk factors, is still heavily dependent on manual processes. The increasing prevalence and functionality of electronic health record (EHR) systems in the United States present important opportunities to advance public health surveillance. EHR data have the potential to further increase the breadth, detail, timeliness, and completeness of public health surveillance and thereby provide better data to guide public health interventions. EHRs also provide a unique opportunity to expand the role and vision of current surveillance efforts and to help bridge the gap between public health practice and clinical medicine.

Background In the hierarchy of research designs, the results of randomized, controlled trials are considered to be evidence of the highest grade, whereas observational studies are viewed as having less validity because they reportedly overestimate treatment effects. We used published meta-analyses to identify randomized clinical trials and observational studies that examined the same clinical topics. We then compared the results of the original reports according to the type of research design. Methods A search of the Medline data base for articles published in five major medical journals from 1991 to 1995 identified meta-analyses of randomized, controlled trials and meta-analyses of either cohort or case–control studies that assessed the same intervention. For each of five topics, summary estimates and 95 percent confidence intervals were calculated on the basis of data from the individual randomized, controlled trials and the individual observational studies. Results For the five clinical topics and 99 r...

We have attempted to quantify the most up-to-date estimate of the association between cigarette smoking by the mother and preterm delivery. Studies were selected for inclusion in this review if they were prospective, reported data stratified across at least two levels of maternal smoking, and defined preterm delivery on the basis of gestational age. In a meta-analysis we combined results from multiple studies that reported on preterm delivery and maternal smoking during pregnancy. Pooled odds ratios were computed for various strata of smoking intensity with the Mantel-Haenszel fixed-effects model. Twenty studies met all inclusion criteria and were included in meta-analysis. The pooled point estimate from 20 prospective studies on any maternal smoking versus no maternal smoking was 1.27 (95% confidence interval, 1.21-1.33). Subgroup analyses stratifying maternal smoking on number of cigarettes per day suggest a dose-response relationship at low to moderate levels of smoking, which was not further increased at high levels of smoking. A nonsignificant level of publication bias appears to exist in the smoking-preterm delivery literature. Cigarette smoking is a preventable risk factor that is associated with preterm delivery. Consistent results across many study populations and research designs and evidence of a dose-response relationship support its causal role in preterm delivery.

Chronic pain affects more than 50 million Americans and results in more than 25 million physician visits a year for lower back pain alone.1 The burden is particularly great in the elderly, in whom associated cardiovascular disease is the leading cause of death. Nonselective, nonaspirin, nonsteroidal antiinflammatory agents (NSAIDs) are effective analgesic, antiinflammatory, and antipyretic agents, but associated gastrointestinal toxicity led to the development and widespread use of selective cyclooxygenase (COX)-2 inhibitors. Originally introduced for use in chronic conditions such as osteoarthritis, they are today used to mitigate acute pain in numerous conditions. Their benefit was presumed to be from their selective inhibition of COX 2, which along with COX-1 is responsible for the conversion of arachidonic acid to prostaglandin H2. Adverse events associated with NSAIDs were attributed to their inhibition of COX 1, which downstream would normally result in the production of prostaglandins responsible for maintenance of gastrointestinal integrity.2 More recent investigations, however, have identified that both COX-1 and COX-2 are involved in vascular hemostasis, and selective COX-2 inhibitors can have net prothrombotic effects. COX-2 inhibitors lower levels of prostacyclin, a platelet inhibitor and vasodilator, whereas uninhibited COX-1 action results in continued thromboxane A2 production, which promotes platelet aggregation.3 There is mounting evidence that nonselective NSAIDs, previously thought to be neutral or beneficial for risk of cardiovascular disease, may also confer harm because of each agent’s relative COX-1/COX-2 prothrombotic effects and potential to reduce glomerular filtration, exacerbate congestive heart failure, and raise blood pressure.4 Article p 2906 In this issue of Circulation , Gislason and colleagues5 report on the risk of death and reinfarction associated with the use of both nonselective, nonaspirin NSAIDs and selective COX-2 inhibitors in post–myocardial infarction (MI) patients in Denmark. The advanced database system in Denmark is …

Surgical repair of recurrent postmyocardial infarction septal defect is associated with a high mortality rate. We present 2 patients whose recurrent defects were closed percutaneously using an Amplatzer device.

November 2013, Vol 310, No. 17 > < Previous Article Full content is available to subscribers Subscribe/Learn More Next Article > Viewpoint | November 6, 2013 Managing the Human Toll Caused by Seasonal InfluenzaNew York State�s Mandate to Vaccinate or Mask Arthur Caplan, PhD1; Nirav R. Shah, MD, MPH2 [+] Author Affiliations JAMA. 2013;310(17):1797-1798. doi:10.1001/jama.2013.280633. Text Size: A A A Article References New York State and the nation as a whole experienced one of the worst influenza seasons in a decade during the winter of 2012-2013. In the peak week ending January 19, 2013, New York alone reported more than 5000 cases of laboratory-confirmed influenza, more than 1120 hospitalizations as a result of influenza, and 5 flu-related pediatric deaths. By the season�s end, more than 45 000 cases had been confirmed, more than 9500 people had been hospitalized, and 14 children had died.1

Advances in shared decision making (SDM) have not successfully translated to practice. We describe our experience and lessons learned in translating an SDM process for primary care cardiovascular disease management. The SDM process operationalized recognized SDM elements using workflow modifications, a computerized patient questionnaire, an automated risk calculator to identify at-risk patients, a web-based tool for patients to choose interventions, automated feedback on the personalized benefits of choices, and a web-based tool for providers to view patient risk, patient choice, and expert advice. Although medication was typically the intervention resulting in the greatest risk reduction, the majority of patients preferred dietary and other lifestyle changes. Patients generally favored the opportunity to make and communicate choices. However, providers only viewed patient choice data in 20% of the encounters. Translation of the SDM process was successful for patients and the difference between patient choice and optimal risk reduction points to the importance of engaging in an SDM process. Lack of engagement by providers may be due to “alert fatigue” or to the failure of the SDM process to improve efficiency in the office visit.

The goals of New York's Empire State Stem Cell Board (ESSCB) are to ignite the growth of a thriving stem cell research community within New York, to stimulate the local economy, and to provide support for efforts to discover treatments and cures for debilitating diseases and injuries. Dr. Nirav R. Shah, New York Commissioner of Health and chair of the ESSCB, shares its history and its approach to research.

To the Editor: We thank McMurray and colleagues for their letter. They interpret a statistically significant protective association for valasartan in one trial and no significant association for ramipril in a separate trial as evidence that angiotensin receptor blockers are superior to angiotensin-converting enzyme inhibitors in preventing diabetes. However, the hazard ratios from these trials were actually quite similar (0.86 for valasartan vs 0.91 for ramipril) and cannot be directly compared because of the differences in the designs and populations of the trials. In our paper, we point out that Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), a prior headto-head trial, found a slightly (but not statistically significantly) higher incidence of diabetes for telmisartan vs ramipril (hazard ratio, 1.12, 95% confidence interval, 0.97–1.29). Even though ONTARGET studied patients with vascular disease and our study was in patients with hypertension, the lack of consistency between ONTARGET and our results contributed to our cautious interpretation of the diabetes result (‘‘warrants further investigation’’). Randomized trials provide invaluable evidence for comparative effectiveness but are not available for every important study question in every population of interest. Therefore, well-controlled and cautiously interpreted nonrandomized studies will continue to provide valuable information to patients, clinicians, and policymakers.

Background Obesity is a serious disease that is associated with an increased risk of diabetes, hypertension, heart disease, stroke, and cancer, among other diseases. The United States Centers for Disease Control and Prevention (CDC) estimates a 20% obesity rate in the 50 states, with 12 states having rates of over 30%. Currently, the body mass index (BMI) is most commonly used to determine adiposity. However, BMI presents as an inaccurate obesity classification method that underestimates the epidemic and contributes to failed treatment. In this study, we examine the effectiveness of precise biomarkers and duel-energy x-ray absorptiometry (DXA) to help diagnose and treat obesity. Methodology/Principal Findings A cross-sectional study of adults with BMI, DXA, fasting leptin and insulin results were measured from 1998–2009. Of the participants, 63% were females, 37% were males, 75% white, with a mean age = 51.4 (SD = 14.2). Mean BMI was 27.3 (SD = 5.9) and mean percent body fat was 31.3% (SD = 9.3). BMI characterized 26% of the subjects as obese, while DXA indicated that 64% of them were obese. 39% of the subjects were classified as non-obese by BMI, but were found to be obese by DXA. BMI misclassified 25% men and 48% women. Meanwhile, a strong relationship was demonstrated between increased leptin and increased body fat. Conclusions/Significance Our results demonstrate the prevalence of false-negative BMIs, increased misclassifications in women of advancing age, and the reliability of gender-specific revised BMI cutoffs. BMI underestimates obesity prevalence, especially in women with high leptin levels (>30 ng/mL). Clinicians can use leptin-revised levels to enhance the accuracy of BMI estimates of percentage body fat when DXA is unavailable.

Background/AimsPrimary Care Providers (PCPs) are seeing more complex patients who were previously managed by specialists. PCPs may not have the time or expertise to fully elicit or evaluate all patient complaints, or apply the detailed evidence required to manage these conditions. We describe provider experience with eCVD, a web-based cardiovascular disease (CVD) management system for use in primary care. eCVD incorporated a shared-decision making (SDM) tool linked to a clinical decision support (CDS) tool that, together, were designed to promote the development of preference-sensitive and evidence-based care plans.MethodsPrior to a primary care encounter, patients completed a behavioral risk factor questionnaire to calculate their CVD risk. Patients at elevated risk used the eCVD system, which included an SDM tool that informed patients of their CVD risk, educated them on the types and benefits of risk factor-specific treatment options, and allowed them to select their preferred treatment options. Via an alert embedded in the electronic health record (EHR), the provider could access a CDS tool displaying both tailored, guideline-based recommendations and the patient’s chosen treatment preferences. We tracked use of the CDS and conducted structured interviews with providers to understand their experience with eCVD. Interview domains included: logistics/workflow, mode of presentation, content, patient preferences, and improving efficiency/effectiveness.ResultsThe CDS alert was presented for 118 patients; only 21.2% were opened by providers. Initial review of interview data showed that providers did not open the CDS alert due to time constraints or because it was indistinguishable from other EHR alerts. Providers stated that they believe discussing a patient’s preferences for care is important but difficult to do with complex patients because of the time needed to:review all relevant data;determine additional data needs (e.g., labs);determine the appropriate clinical course of action; andeducate the patient.ConclusionsModels of technology adoption highlight the importance of usefulness and usability of a tool like eCVD. Our data suggest that, while the SDM/CDS content was useful, usability issues remain. Detailed thematic analysis of how the tool was accessed and the functionality it provided will be completed in December 2010.

From time to time, Clinical Medicine & Research expands its coverage to report on meetings of interest to its readership that span the nexus of research and practice. The Annual Meeting of the Health Maintenance Organization Research Network (HMORN) is one such meeting, and beginning last year, Clinical Medicine & Research has reported on selected proceedings from that gathering. The network was formed in 1994 with its goal being to transform health care practice through population-based research to improve the health and health care of broad populations. The HMORN includes 16 research centers based in health care delivery systems with defined health plan populations, electronic medical record systems, and longitudinal data archives. Network research centers and their various collaborative partners conduct health services, epidemiologic, clinical, behavioral, and other types of health research that are based in community care settings and can be translated into effective clinical practice. The HMORN has been meeting annually since 1995; its conferences provide an opportunity for collaboration, information sharing, and exploration of new research areas. The theme for the 2009 conference, “Clinical Effectiveness: Leadership in Comparative Effectiveness and Translational Research”, presented a timely topic that recognized the shifting landscape of health care research funding. Comparative effectiveness research is highly relevant to HMORN, as it represents an important area of current research and a unique strength of the network. The meeting was held from Sunday, April 26 through Wednesday, April 29, 2009 at the Henry Hood Center for Health Research, Danville, Pennsylvania and was hosted by Geisinger Health System. HMORN member attendees included clinician and other health researchers, as well as operational leaders of clinics and health plans. Formal funding support for the conference was received from the Agency for Healthcare Research and Quality (AHRQ), as well as from Geisinger Clinic. Expert panels provided engaging discussion of: (1) federal funding and industry views on comparative effectiveness research, (2) AHRQ’s role in comparative effectiveness research, and (3) system level health care innovation and research. Dr. Gail Wilensky, economist and senior fellow at Project Hope, served as a keynote speaker for the plenary session titled ‘Comparative Effectiveness Research: Federal Funding and Industry Views.’ Scott Smith of AHRQ served as a keynote speaker for the plenary session titled “Comparative Effectiveness in Practice and AHRQ’s Role in Comparative Effectiveness Research.” The agenda also included 2 scientific poster sessions, the annual state of the Network address, and 20 concurrent sessions with oral abstract presentations across a wide range of important topics (comparative effectiveness, behavioral health, pharmaco-epidemiology, regulatory/compliance, genetic epidemiology, diabetes, informatics, health economics, cancer, new issues in human subjects research, lean management practice for research administration, and cardiovascular disease), and a session for junior investigators showcasing their work. More than 140 scientific presentations were featured in oral or poster format. Importantly, there were also more than 25 ancillary sessions on the formal agenda, most of which reflected new or developing partnerships focused on critical topics such as the Cardiovascular Research Network, child health, the Cancer Research Network, mental health, diabetes, Centers for Education and Research on Therapeutics/Developing Evidence to Inform Decisions about Effectiveness (CERT/DEcIDE), obesity, pharmacovigilance, virtual data warehouse, and informatics. Sessions were also held on research support or development topics including increasing participation in cancer clinical trials, designing translational studies in genetic epidemiology, virtual data warehouse training, information on the peer review process at the National Institutes of Health, and a discussion of health literacy and cancer prevention. The 16th Annual HMO Research Network Conference will be held March 21–24, 2010 in Austin, Texas. The topic of the conference will be “Emerging Frontiers in Healthcare Research and Delivery.” The conference hosts will be Scott & White Healthcare and Scott & White Health Plan.

Background Congenital dislocation of the knee is a rare condition for which the treatment is difficult and remains controversial. For severe cases associated with neuromuscular disorders treatment has usually consisted of extensive surgical reconstruction. The purpose of this study is to assess the short-term results of a new method of treatment for this patient population that involves casting and less extensive surgery. Methods We retrospectively reviewed the cases of 8 consecutive patients, 4 girls and 4 boys, with 16 congenitally dislocated knees that had been diagnosed and treated by a single surgeon with a new minimally invasive treatment protocol. Treatment consisted of serial casting followed by a mini-open quadriceps tenotomy. The mean age at presentation was 5.3 weeks (range, 1 to 13 wk). The mean follow-up was 33 months (range, 12 to 72 mo). All knees were graded in terms of function at final follow-up. Results Serial casting alone was effective in achieving correction in 3 knees. The remaining 13 knees had an average of 7 casts (range, 5 to 9 casts) before surgery. Ten knees were treated with a mini-open quadriceps tenotomy alone and 3 with an additional anterior capsulotomy at the time of the initial surgery. Two knees developed recurrent deformities and required additional surgery. Two knees sustained plastic deformation of the proximal tibia during physical therapy that resolved with time. At final follow-up, knee outcome was excellent in 11 (69%) knees, good in 3 (19%) knees, and fair in 2 (12%) knees. Conclusions The results of our study support the use of a less invasive approach for the initial treatment of congenital dislocation of the knee in this patient population. This approach avoids the complications of extensive scarring and stiffness that often accompany the more invasive surgical treatments. Longer follow-up, however, is necessary to see whether reduction and knee range of motion are maintained. Level of evidence Level 4 case series.

African Americans with high blood pressure (BP) can benefit greatly from therapeutic lifestyle changes (TLC) such as diet modification, physical activity, and weight management. However, they and their health care providers face many barriers in modifying health behaviors. A multidisciplinary panel synthesized the scientific data on TLC in African Americans for efficacy in improving BP control, barriers to behavioral change, and strategies to overcome those barriers. Therapeutic lifestyle change interventions should emphasize patient self-management, supported by providers, family, and the community. Interventions should be tailored to an individual's cultural heritage, beliefs, and behavioral norms. Simultaneously targeting multiple factors that impede BP control will maximize the likelihood of success. The panel cited limited progress with integrating the Dietary Approaches to Stop Hypertension (DASH) eating plan into the African American diet as an example of the need for more strategically developed interventions. Culturally sensitive instruments to assess impact will help guide improved provision of TLC in special populations. The challenge of improving BP control in African Americans and delivery of hypertension care requires changes at the health system and public policy levels. At the patient level, culturally sensitive interventions that apply the strategies described and optimize community involvement will advance TLC in African Americans with high BP.

BACKGROUND Between the promise of evidence-based medicine and the reality of inadequate patient outcomes lies patient adherence. Studies of prescription adherence have been hampered by methodologic problems. Most rely on patient self-report of adherence or cross-sectional data of plan-wide prescription fills to estimate patient-level adherence. METHODS We conducted a retrospective cohort study and linked individual patient data for incident prescriptions for antihypertensive medications from electronic health records (EHRs) to claims data obtained from the patient's insurance plan. Clinical data were obtained from the Geisinger Clinic, a 41 site group practice serving central and northeastern Pennsylvania with an EHR in use since 2001. Adherence was defined as a prescription claim generated for the first-fill prescription within 30 days of the prescribing date. RESULTS Of the 3,240 patients written a new, first-time prescription for an antihypertensive medication, 2,685 (83%) generated a corresponding claim within 30 days. Sex, age, therapeutic class, number of other medications prescribed within 10 days of the antihypertensive prescription, number of refills, co-pay, comorbidity score, baseline blood pressure (BP), and change in BP were significantly associated with first-fill rates (P < 0.05). CONCLUSIONS Patients who are older, female, have multiple comorbidities, and/or have relatively lower BPs may be less likely to fill a first prescription for antihypertensive medications and may be potential candidates for interventions to improve adherence to first-fill prescriptions.