Prognostic Factors Associated with Resectable Adenocarcinoma of the Head of the PancreasA retrospective study of patients with surgically resectable adenocarcinoma of the pancreatic head was undertaken to determine which prognostic factors are independently associated with improved survival. Thirty-four men and 41 women (mean age, 61.9 years) had resection for adenocarcinoma of the pancreatic head between 1980 and 1997 at Rush-Presbyterian-St. Luke's Medical Center. Surgical resections included 15 total pancreatectomies, 43 pyloric-preserving procedures, and 17 standard Whipple procedures. Thirty-six patients received adjuvant radiation and/or chemotherapy. Overall median survival was 13 months, with a 5-year survival of 17 per cent. Thirty-day surgical mortality was 1.3 per cent. Significant factors that negatively influenced survival using univariate Kaplan-Meier analysis were: positive resection margin (P = 0.01), intraoperative blood transfusion (P = 0.01), and lymph node metastases (P = 0.01). Presenting signs and symptoms, patient demographics, operative procedure, tumor size, histologic differentiation, and adjuvant therapy did not have a significant impact on survival. Using multivariate Cox regression analysis, the only significant independent factors improving survival were the absence of intraoperative blood transfusion (P = 0.02) and a negative resection margin (P = 0.04). Performing pancreaticoduodenectomy for adenocarcinoma of the head of the pancreas with negative microscopic margins of resection and without intraoperative transfusion significantly improves survival.
The science of <scp>Learning Health Systems</scp>: Foundations for a new journalIn recent years, health systems across the United States and around the world have faced persistent challenges including the underutilization of necessary care, the overutilization of inappropriate care, rising costs, disparities in access to care, patient safety concerns, outdated public health infrastructures, and an oft-cited 17-year latency between bench and bedside.1, 2 This well-documented state of the health of individuals and populations generates an imperative to improve human health, worldwide, through system-level innovations to address what are increasingly recognized as system-level problems. A proliferation of knowledge about “what works” in health care, availability of ever more powerful and affordable information technology, increasingly routine digital documentation of health care delivery, and accumulating understanding of how to inculcate behavior that promotes health, among other factors, combine to place these system-level innovations within reach. A second imperative thus challenges us to capitalize on these opportunities. System-level improvement requires a broad and diverse intellectual community. The necessary transdisciplinary community will be composed of scholars with expertise in social, political, technical, and clinical fields, along with many others who bring critical experience from practice. It follows that a third imperative is to form this community and provide it with a gathering place for its evolving scientific ideas and insights. A vision for Learning Health Systems (LHSs) has emerged in response to these imperatives. Since it was initially conceived by the National Academy of Medicine (formerly, the Institute of Medicine) in 2007,3 the LHS has evolved from an intriguing idea to a nascent reality. The concept of the LHS is perhaps best understood by examining each of its component words. Learning refers to the capability for continuous improvement through the collection and analysis of data, creating new knowledge, and the application of the new knowledge to influence practice. Health is both an end-goal of universally recognized benefit to humanity and a domain of human endeavor seeking to achieve that end. A system consists of component parts acting in unison to achieve goals not attainable by any subset of the components. Integrating these terms, health systems become learning health systems when they acquire the ability to continuously, routinely, and efficiently study and improve themselves. Learning Health Systems can exist at any level of scale: a single organization, organizations within an identified geographic or jurisdictional region, a network of organizations, an entire nation, groups of nations, or the entire world. To the extent that the infrastructures supporting continuous learning are compatible across distinct systems, there is potential to form systems at higher levels of scale through composition of systems at lower levels. Learning Health Systems, at varying levels of scale, are appearing across the United States, framed by federal policy affirming the LHS as the pinnacle goal for the next decade.4 At the organizational level, institutions such as Intermountain Health Care,5 Kaiser Permanente,6 and as described in this journal,7 Johns Hopkins University has established the LHS as a goal and have made significant progress toward achieving the characteristics described above. Networks of institutions seeking to achieve significant aspects of LHS capability abound in the United States, including networks funded through PCORI,8 which are focused on comparative effectiveness research across disease types, disease-focused initiatives such as CancerLinQ,9 and statewide efforts such as the Michigan Surgical Quality Collaborative.10 National programs aligned with the LHS include the Precision Medicine Initiative of the National Institutes of Health,11 and EvGen from the Food and Drug Administration.12 These efforts are broadly supported by a series of 18 reports from the US Institute of Medicine dating to 2007,13 and by endorsement of a consensus set of LHS Core Values by 105 organizations spanning the health spectrum.14 Similar trends are in evidence around the world. The TRANSFoRm project, funded by the European Commission, addressed fundamental problems in developing infrastructure to support continuous learning.15 TRANSFoRm gave rise to the first “LHS in Europe” meeting in 2015. The European Institute for Innovation through Health Data, described in this journal,16 reflects the growing LHS movement across the continent. In the United Kingdom, the work of the Farr Institute17 closely aligns with the LHS. In Asia, a collaboration between the nation of Taiwan and the Tohoku region of Japan is growing infrastructure for an LHS.18 Perhaps of greatest importance is a widely shared vision that achievement of an LHS is an asymptotic goal that will never be fully achieved. The LHS will be shaped and reshaped by new health problems, evolving policies, innovation in health delivery, and behavior, with much of this innovation stimulated by the LHS itself. Moreover, realizing an LHS requires attention to an unprecedented range of deep scientific problems that may require entire new methods and modes of thinking, approaching the status of a new science. The system as a whole—not just the digital infrastructure, but also networks of people and institutions—will have to be understood not just as users of a technological infrastructure, but also as parts of the information system itself.19 Moreover, it fails to recognize that, as the scale of the LHS increases, its characteristics approach those of an ultra–large-scale system20 that exhibits unique characteristics, behaves in ways fundamentally different from systems at smaller scale, and requires new approaches to system conception, design, implementation, orchestration, evolution, certification, and governance. These four requirements suggest the range of disciplines—spanning the behavioral, social, information, computing, and mathematical sciences as well as engineering—required to carry out the needed research and development. Transcendent research challenges—for example, achieving a scalable infrastructure to support continuous learning—may require new methods and new modes of thinking that evolve naturally from the admixture of these disciplines. The vision of a different science, and perhaps even a new science, is the foundation for this new journal. This journal seeks to be a virtual space for gathering the diverse community increasingly focused on this science. We, the editors, welcome articles that report research relating to cyber-social systems as applied to health. The scope of this science is very broad, but its domain can be generally described in relation to the four key functional characteristics of an LHS, as listed just above. The range of methods applicable to investigations within this journal's scope is similarly wide, drawing from a complete spectrum of basic disciplines. It follows that achieving an LHS of ultra-large scale will likewise require new forms of collaboration at ultra-large scale. The editors welcome articles of several different types, exemplified by this first issue of the journal: Commentaries express views or expert opinions of community members on topics of pertinence and importance. This issue features a commentary by Dipak Kalra and colleagues on the new European Institute.16 Research Reports describe original data-driven investigations to design or model, formulate or develop, enable or facilitate, implement, assess, or evaluate LHSs. This issue includes two research reports: an article by Richard Tannen22 and colleagues introducing statistical methods for drawing potentially causal conclusions from observational data; and an article by Stephanie Morain and colleagues that draws insights from interview data on how health systems transition to learning systems.23 Technical Reports are similar to research reports but describe models or architectures underlying any aspect of an LHS. This issue features a report by Christel Daniel and colleagues addressing the technical methods required to achieve cross-border interoperability.24 Experience Reports describe the development of functioning learning systems within health settings at any level of scale, and experiences in working across levels of scale. This issue includes an experience report from Peter Pronovost and colleagues reporting on the journey of Johns Hopkins Medical Center toward becoming an LHS.7 Consistent with the global interest in the LHS is a distinct international character to this journal. We are proud to have 10 nations represented on our Editorial Board and that the authors of the articles in this first issue represent 6 different nations. We hope that this journal will itself become part of the cyber-social infrastructure of the LHS. We invite all who share the vision of the LHS to use this journal to share their insightful viewpoints, new knowledge, and important experiences.