Nirav R. Shah

RANDOMIZED, CONTROLLED TRIALS, OBSERVATIONAL STUDIES, AND THE HIERARCHY OF RESEARCH DESIGNS

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 reports evaluated, the average results of the observational studies were remarkably similar to those of the randomized, controlled trials. For example, analysis of 13 randomized, controlled trials of the effectiveness of bacille Calmette-Guérin vaccine in preventing active tuberculosis yielded a relative risk of 0.49 (95 percent confidence interval, 0.34 to 0.70) among vaccinated patients, as compared with an odds ratio of 0.50 (95 percent confidence interval, 0.39 to 0.65) from 10 case-control studies. In addition, the range of the point estimates for the effect of vaccination was wider for the randomized, controlled trials (0.20 to 1.56) than for the observational studies (0.17 to 0.84). CONCLUSIONS The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Housing as health care - New York's boundary-crossing experiment

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.

Uses of Electronic Health Records for Public Health Surveillance to Advance Public Health

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.

Seasonal Pattern of the Acute Mortality Effects of Air Pollution

Abstract Evidence of seasonal variation of acute mortality effects of air pollution is inconsistent. The seasonal patterns of associations between daily mortality and daily mean concentrations of particulate matter 10 µm or less in aerodynamic diameter (PM10), sulfur dioxide (SO2), and nitrogen dioxide (NO2) were examined using 4 yr of data (2001–2004) in Wuhan, China. Four distinct seasons occur in Wuhan, where approximately 4.5 million residents live in the city core area of 201 km2. Air pollution levels are higher and pollution ranges are wider in Wuhan than in most cities. Quasi-likelihood estimation within the context of the generalized additive models (natural spline [NS] models in R) was used to model the natural logarithm of the expected daily death counts as a function of the predictor variables. The estimates of the interaction between seasons and pollution were obtained from the main effects and pollutant season interaction models. It was found that the interactions between three pollutants and cause-specific mortality were statistically significant (P < 0.05). The strongest effects occurred consistently in winter for all-natural, cardiovascular, stroke, and respiratory mortality. Every 10-µg/m3 increase in PM10 daily concentration at lag 0–1 days was associated with an increase in all-natural mortality of 0.69% (95% confidence interval [CI]: 0.44–0.94%) for winter, 0.34% (95% CI: 0.00–0.69%) for spring, 0.45% (95% CI: –0.13 to 1.04%) for summer, and –0.21% (95% CI: –0.54 to 0.12%) for fall. The results show a clear seasonal pattern of acute mortality effects of ambient air pollution and the strongest effects occurred during winter in the study city.

The Wired Patient: Patterns of Electronic Patient Portal Use Among Patients With Cardiac Disease or Diabetes

Background As providers develop an electronic health record–based infrastructure, patients are increasingly using Web portals to access their health information and participate electronically in the health care process. Little is known about how such portals are actually used. Objective In this paper, our goal was to describe the types and patterns of portal users in an integrated delivery system. Methods We analyzed 12 months of data from Web server log files on 2282 patients using a Web-based portal to their electronic health record (EHR). We obtained data for patients with cardiovascular disease and/or diabetes who had a Geisinger Clinic primary care provider and were registered “MyGeisinger” Web portal users. Hierarchical cluster analysis was applied to longitudinal data to profile users based on their frequency, intensity, and consistency of use. User types were characterized by basic demographic data from the EHR. Results We identified eight distinct portal user groups. The two largest groups (41.98%, 948/2258 and 24.84%, 561/2258) logged into the portal infrequently but had markedly different levels of engagement with their medical record. Other distinct groups were characterized by tracking biometric measures (10.54%, 238/2258), sending electronic messages to their provider (9.25%, 209/2258), preparing for an office visit (5.98%, 135/2258), and tracking laboratory results (4.16%, 94/2258). Conclusions There are naturally occurring groups of EHR Web portal users within a population of adult primary care patients with chronic conditions. More than half of the patient cohort exhibited distinct patterns of portal use linked to key features. These patterns of portal access and interaction provide insight into opportunities for electronic patient engagement strategies.

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitor-Based Treatment on Cardiovascular Outcomes in Hypertensive Blacks Versus Whites

BACKGROUND Clinical trial evidence suggests poorer outcomes in blacks compared with whites when treated with an angiotensin-converting enzyme (ACE) inhibitor-based regimen, but this has not been evaluated in clinical practice. OBJECTIVES This study evaluated the comparative effectiveness of an ACE inhibitor-based regimen on a composite outcome of all-cause mortality, stroke, and acute myocardial infarction (AMI) in hypertensive blacks compared with whites. METHODS We conducted a retrospective cohort study of 434,646 patients in a municipal health care system. Four exposure groups (Black-ACE, Black-NoACE, White-ACE, White-NoACE) were created based on race and treatment exposure (ACE or NoACE). Risk of the composite outcome and its components was compared across treatment groups and race using weighted Cox proportional hazard models. RESULTS Our analysis included 59,316 new users of ACE inhibitors, 47% of whom were black. Baseline characteristics were comparable for all groups after inverse probability weighting adjustment. For the composite outcome, the race treatment interaction was significant (p = 0.04); ACE use in blacks was associated with poorer cardiovascular outcomes (ACE vs. NoACE: 8.69% vs. 7.74%; p = 0.05) but not in whites (6.40% vs. 6.74%; p = 0.37). Similarly, the Black-ACE group had higher rates of AMI (0.46% vs. 0.26%; p = 0.04), stroke (2.43% vs. 1.93%; p = 0.05), and congestive heart failure (3.75% vs. 2.25%; p < 0.0001) than the Black-NoACE group. However, the Black-ACE group was no more likely to develop adverse effects than the White-ACE group. CONCLUSIONS ACE inhibitor-based therapy was associated with poorer cardiovascular outcomes in hypertensive blacks but not in whites. These findings confirm clinical trial evidence that hypertensive blacks have poorer outcomes than whites when treated with an ACE inhibitor-based regimen.

Outcomes with Angiotensin-converting Enzyme Inhibitors vs Other Antihypertensive Agents in Hypertensive Blacks

BACKGROUND Angiotensin-converting enzyme inhibitors are used widely in the treatment of patients with hypertension. However, their efficacy in hypertensive blacks when compared with other antihypertensive agents is not well established. METHODS We performed a cohort study of patients using data from a clinical data warehouse of 434,646 patients from New York Citys Health and Hospitals Corporation from January 2004 to December 2009. Patients were divided into the following comparison groups: angiotensin-converting enzyme inhibitors vs calcium channel blockers, angiotensin-converting enzyme inhibitors vs thiazide diuretics, and angiotensin-converting enzyme inhibitors vs β-blockers. The primary outcome was a composite of death, myocardial infarction, and stroke. Secondary outcomes included the individual components and heart failure. RESULTS In the propensity score-matched angiotensin-converting enzyme inhibitors vs calcium channel blocker comparison cohort (4506 blacks in each group), angiotensin-converting enzyme inhibitors were associated with a higher risk of primary outcome (hazard ratio [HR], 1.45; 95% confidence interval [CI], 1.19-1.77; P = .0003), myocardial infarction (HR, 3.40; 95% CI, 1.25-9.22; P = .02), stroke (HR, 1.82; 95% CI, 1.29-2.57; P = .001), and heart failure (HR, 1.77; 95% CI, 1.30-2.42; P = .0003) when compared with calcium channel blockers. For the angiotensin-converting enzyme inhibitors vs thiazide diuretics comparison (5337 blacks in each group), angiotensin-converting enzyme inhibitors were associated with a higher risk of primary outcome (HR, 1.65; 95% CI, 1.33-2.05; P < .0001), death (HR, 1.35; 95% CI, 1.03-1.76; P = .03), myocardial infarction (HR, 4.00; 95% CI, 1.34-11.96; P = .01), stroke (HR, 1.97; 95% CI, 1.34-2.92; P = .001), and heart failure (HR, 3.00; 95% CI, 1.99-4.54; P < .0001). For the angiotensin-converting enzyme inhibitors vs β-blocker comparison, the outcomes between the groups were not significantly different. CONCLUSIONS In a real-world cohort of hypertensive blacks, angiotensin-converting enzyme inhibitors were associated with a higher risk of cardiovascular events when compared with calcium channel blockers or thiazide diuretics.

Liberating data to transform health care: New York's open data experience.

The health community relies on governmental survey, surveillance, and administrative data to track epidemiologic trends, identify risk factors, and study the health care delivery system. Since 2009, a quiet “open data” revolution has occurred. Catalyzed by President Obama’s open government directive, federal, state, and local governments are releasing deidentified data meeting 4 “open” criteria: public accessibility, availability in multiple formats, free of charge, and unlimited use and distribution rights.1 As of February 2014, HealthData.gov, the federal health data repository, has more than 1000 data sets, and Health Data NY, New York’s health data site, has 48 data sets with supporting charts and maps. Data range from health interview surveys to administrative transactions. The implicit logic is that making governmental data readily available will improve government transparency; increase opportunities for research, mobile health application development, and data-driven quality improvement; and make health-related information more accessible. Together, these activities have the potential to improve health care quality, reduce costs, facilitate population health planning and monitoring, and empower health care consumers to make better choices and live healthier lives.

Putting the Health of Communities and Populations First

The poor US performance on key population health measures is a call to action that justifies bold strategies to direct resources toward improvements in support of population health. US investments in health care amount to nearly one-fifth of national expenditures. Yet the United States is less healthy than other countries with a comparable standard of living, with a comparatively lower life expectancy at birth and a comparatively higher infant mortality rate higher than all other industrialized nations. Promising opportunities and actionable steps exist to achieving healthier communities. In this Viewpoint examining possibilities and priorities, we embrace the World Health Organization definition of health as “the state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity”; define the term population health in the sense of “total population health”; discuss actions to improve health in entire geographic regions1; and embrace the vision for a healthy community as a “strong, healthful, and productive society, which cultivates human capital and equal opportunity.”2 Importantly, vital directions are highlighted for continuing to move US public health efforts on the path toward prevention.3 Many are national strategies to guide and facilitate universal and equitable reach. Their implementation requires a strong commitment to leveraging inherent assets of communities, mitigating circumstances of social disadvantage, considering the cultural and historical contexts of diverse communities, and assuring the protection of those that are particularly vulnerable to social and environmental stressors (ie, children, the elderly, and individuals with other conditions).

Managing the Human Toll Caused by Seasonal Influenza: New York State’s Mandate to Vaccinate or Mask

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