Thomas W. Concannon

A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes Research

Despite widespread agreement that stakeholder engagement is needed in patient-centered outcomes research (PCOR), no taxonomy exists to guide researchers and policy makers on how to address this need. We followed an iterative process, including several stages of stakeholder review, to address three questions: (1) Who are the stakeholders in PCOR? (2) What roles and responsibilities can stakeholders have in PCOR? (3) How can researchers start engaging stakeholders? We introduce a flexible taxonomy called the 7Ps of Stakeholder Engagement and Six Stages of Research for identifying stakeholders and developing engagement strategies across the full spectrum of research activities. The path toward engagement will not be uniform across every research program, but this taxonomy offers a common starting point and a flexible approach.

A Systematic Review of Stakeholder Engagement in Comparative Effectiveness and Patient-Centered Outcomes Research

ABSTRACTOBJECTIVESWe conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research.METHODS AND RESULTSWe worked with stakeholders before, during and after the review was conducted to: define the primary and key research questions; conduct the literature search; screen titles, abstracts and articles; abstract data from the articles; and analyze the data. The literature search yielded 2,062 abstracts. The review was conducted on 70 articles that reported on stakeholder engagement in individual research projects or programs.FINDINGSReports of stakeholder engagement are highly variable in content and quality. We found frequent engagement with patients, modestly frequent engagement with clinicians, and infrequent engagement with stakeholders in other key decision-making groups across the healthcare system. Stakeholder engagement was more common in earlier (prioritization) than in later (implementation and dissemination) stages of research. The roles and activities of stakeholders were highly variable across research and program reports.RECOMMENDATIONSTo improve on the quality and content of reporting, we developed a 7-Item Stakeholder Engagement Reporting Questionnaire. We recommend three directions for future research: 1) descriptive research on stakeholder-engagement in research; 2) evaluative research on the impact of stakeholder engagement on the relevance, transparency and adoption of research; and 3) development and validation of tools that can be used to support stakeholder engagement in future work.

Geographic access to burn center hospitals.

CONTEXT The delivery of burn care is a resource-intensive endeavor that requires specialized personnel and equipment. The optimal geographic distribution of burn centers has long been debated; however, the current distribution of centers relative to geographic area and population is unknown. OBJECTIVE To estimate the proportion of the US population living within 1 and 2 hours by rotary air transport (helicopter) or ground transport of a burn care facility. DESIGN AND SETTING A cross-sectional analysis of geographic access to US burn centers utilizing the 2000 US census, road and speed limit data, the Atlas and Database of Air Medical Services database, and the 2008 American Burn Association Directory. MAIN OUTCOME MEASURE The proportion of state, regional, and national population living within 1 and 2 hours by air transport or ground transport of a burn care facility. RESULTS In 2008, there were 128 self-reported burn centers in the United States including 51 American Burn Association-verified centers. An estimated 25.1% and 46.3% of the US population live within 1 and 2 hours by ground transport, respectively, of a verified burn center. By air, 53.9% and 79.0% of the population live within 1 and 2 hours, respectively, of a verified center. There was significant regional variation in access to verified burn centers by both ground and rotary air transport. The greatest proportion of the population with access was highest in the northeast region and lowest in the southern United States. CONCLUSION Nearly 80% of the US population lives within 2 hours by ground or rotary air transport of a verified burn center; however, there is both state and regional variation in geographic access to these centers.

Epidemiology of clostridium difficile Colitis in Hospitalized Patients with Inflammatory Bowel Diseases

PURPOSE: A notable increase in-hospital admissions for Clostridium difficile colitis has occurred in the United States. In this paper we evaluate changes in the epidemiology of Clostridium difficile colitis in a subset of hospitalized patients with inflammatory bowel diseases. METHODS: A retrospective cohort analysis was conducted for all inflammatory bowel disease patients with Clostridium difficile colitis in the Nationwide Inpatient Sample, a 20 percent stratified random sample of national hospital discharge abstracts from 1993 through 2003. Using standard diagnostic codes, we identified yearly admissions for Clostridium difficile, other bacterial infections, and parasitic infections in inflammatory bowel disease patients. Next, we calculated prevalence, case fatality, and operative mortality for inflammatory bowel disease patients diagnosed with Clostridium difficile. RESULTS: We found that the prevalence of Clostridium difficile rose significantly in patients with ulcerative colitis and in those Crohns disease patients with some component of large bowel involvement but not in patients with Crohns disease limited to the small bowel alone. During the study period, case fatality also rose significantly in patients with ulcerative colitis and Clostridium difficile but not in patients with Crohns disease and Clostridium difficile. Operative mortality for ulcerative colitis patients with Clostridium difficile reached 25.7 percent. CONCLUSIONS: The prevalence and case fatality of patients with inflammatory bowel disease and Clostridium difficile rose significantly during the study period. Changes in Clostridium difficile epidemiology were particularly noteworthy for those patients with ulcerative colitis, who experienced elevated rates of hospitalization and case fatality.

A Percutaneous Coronary Intervention Lab in Every Hospital

Background— In 2001, 1176 US hospitals were capable of performing primary percutaneous coronary intervention (PCI), and 79% of the population lived within 60-minute ground transport of these hospitals. We compared these estimates with data from 2006 to explore how hospital PCI capability and population access have changed over time. Methods and Results— We estimated the proportion of the population 18 years of age or older, living in 2006 within a 60-minute drive of a PCI-capable hospital, and we compared our estimate with a previously published report on 2001 data. Over the 5-year period, the number of PCI-capable hospitals grew from 1176 to 1695 hospitals, a relative increase of 44%; access to the procedure grew from 79.0% to 79.9% of the population, a relative increase of 1%. Conclusions— Our data indicate a large increase in the number of hospitals capable of performing PCI from 2001 to 2006, but this increase was not associated with an appreciable change in the proportion of the population with access to the procedure. In the future, more attention is needed on changes in PCI capacity over time and on the effects of these changes on outcomes of interest such as service utilization, expenditures, patient outcomes, and population health.

Comparative Effectiveness of ST-Segment–Elevation Myocardial Infarction Regionalization Strategies

Background—Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy in the treatment of ST-segment–elevation myocardial infarction. Yet, most US hospitals are not equipped for PCI, and fibrinolytic therapy is still widely used. This study evaluated the comparative effectiveness of ST-segment–elevation myocardial infarction regionalization strategies to increase the use of PCI against standard emergency transport and care. Methods and Results—We estimated incremental treatment costs and quality-adjusted life expectancies of 2000 patients with ST-segment–elevation myocardial infarction who received PCI or fibrinolytic therapy in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy with 12 hospital-based strategies of building new PCI laboratories or extending the hours of existing laboratories and 1 emergency medical services–based strategy of transporting all patients with ST-segment–elevation myocardial infarction to existing PCI-capable hospitals. The base case resulted in 609 (95% CI, 569–647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years saved and were cost-effective under a variety of conditions. An emergency medical services–based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options. Conclusion—Our results suggest that new construction and staffing of PCI laboratories may not be warranted if an emergency medical services strategy is both available and feasible.

Elapsed Time in Emergency Medical Services for Patients With Cardiac Complaints Are Some Patients at Greater Risk for Delay

Background—In patients with a major cardiac event, the first priority is to minimize time to treatment. For many patients, first contact with the health system is through emergency medical services (EMS). We set out to identify patient-level and neighborhood-level factors that were associated with elapsed time in EMS. Methods and Results—A retrospective cohort study was conducted in 10 municipalities in Dallas County, Tex, from January 1 through December 31, 2004. The data set included 5887 patients with suspected cardiac-related symptoms. The region was served by 29 hospitals and 98 EMS depots. Multivariate models included measures of distance traveled, time of day, day of week, and patient and neighborhood characteristics. The main outcomes were elapsed time in EMS (continuous; in minutes) and delay in EMS (dichotomous; >15 minutes beyond median elapsed time). We found positive associations between patient characteristics and both average elapsed time and delay in EMS care. Variation in average elapsed time was not large enough to be clinically meaningful. However, approximately 11% (n=647) of patients were delayed ≥15 minutes. Women were more likely to be delayed (adjusted odds ratio, 1.52; 95% confidence interval, 1.32 to 1.74), and this association did not change after adjusting for other characteristics, including neighborhood socioeconomic composition. Conclusions—Compared with otherwise similar men, women have 50% greater odds of being delayed in the EMS setting. The determinants of delay should be a special focus of EMS studies in which time to treatment is a priority.

Evidence of systematic duplication by new percutaneous coronary intervention programs.

Background—Evidence suggests that recent and projected future investments in percutaneous coronary intervention (PCI) programs at US hospitals fail to increase access to timely reperfusion for patients with ST-segment elevation myocardial infarction. Methods and Results—We set out to estimate the annual number and costs of new PCI programs in US hospitals from 2004 to 2008 and identify the characteristics of hospitals, neighborhoods, and states where new PCI programs have been introduced. We estimated a discrete-time hazard model to measure the influence of these characteristics on the decision of a hospital to introduce a new PCI program. In 2008, 1739 US hospitals were capable of performing PCI, a relative increase of 16.5% (251 hospitals) over 2004. The percentage of the US population with projected access to timely PCI grew by 1.8%. New PCI programs were more likely to be introduced in areas that already had a PCI program with more competition for market share, near populations with higher rates of private insurance, in states that had weak or no regulation of new cardiac catheterization laboratories, and in wealthier and larger hospitals. Conclusions—Our data show that new PCI programs were systematically duplicative of existing programs and did not help patients gain access to timely PCI. The total cost of recent US investments in new PCI programs is large and of questionable value for patients.

Elapsed Time in Emergency Medical Services for Patients With Cardiac ComplaintsCLINICAL PERSPECTIVE

Background—In patients with a major cardiac event, the first priority is to minimize time to treatment. For many patients, first contact with the health system is through emergency medical services (EMS). We set out to identify patient-level and neighborhood-level factors that were associated with elapsed time in EMS. Methods and Results—A retrospective cohort study was conducted in 10 municipalities in Dallas County, Tex, from January 1 through December 31, 2004. The data set included 5887 patients with suspected cardiac-related symptoms. The region was served by 29 hospitals and 98 EMS depots. Multivariate models included measures of distance traveled, time of day, day of week, and patient and neighborhood characteristics. The main outcomes were elapsed time in EMS (continuous; in minutes) and delay in EMS (dichotomous; >15 minutes beyond median elapsed time). We found positive associations between patient characteristics and both average elapsed time and delay in EMS care. Variation in average elapsed time was not large enough to be clinically meaningful. However, approximately 11% (n=647) of patients were delayed ≥15 minutes. Women were more likely to be delayed (adjusted odds ratio, 1.52; 95% confidence interval, 1.32 to 1.74), and this association did not change after adjusting for other characteristics, including neighborhood socioeconomic composition. Conclusions—Compared with otherwise similar men, women have 50% greater odds of being delayed in the EMS setting. The determinants of delay should be a special focus of EMS studies in which time to treatment is a priority.

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.