Blockchain Papers

Maximilian Unfried

In an era marked by scientific stagnation, Decentralized Science (DeSci) challenges the inefficiencies of traditional funding and publishing systems. DeSci employs blockchain technology to address the misalignment of incentives in academic research, emphasizing transparency, rapid funding, and open-source principles. Centralized institutions have been linked to a deceleration of progress, which is acutely felt in the field of longevity science-a critical discipline as aging is the #1 risk factor for most diseases. DeSci proposes a transformative model where decentralized autonomous organizations (DAOs) facilitate community-driven funding, promoting high-risk, high-reward research. DeSci, particularly within longevity research, could catalyze a paradigm shift towards an equitable, efficient, and progressive scientific future.

Adugna Negussie, Abay Sisay, Agumas Shibabaw, Edosa Kebede · 9 authors

No abstract is available for this record.

Authors unavailable

No abstract is available for this record.

Catherine R. Lucey, Karen E. Hauer, Patricia O’Sullivan, Ann Poncelet · 6 authors

Medical Education Program Highlights In 2016, the University of California, San Francisco (UCSF) School of Medicine launched the Bridges Curriculum, developed to ensure that graduates are prepared to tackle the most complex problems of 21st-century patients and communities. The curriculum has an enduring focus on providing evidence-based, compassionate care while leveraging emerging skills in systems science and new methods of discovery. The Bridges Curriculum seeks to instill the 4 UCSF physician habits of mind: inquiry, continuous improvement, adaptive leadership, and social justice. To teach these habits of mind, the curriculum has an inquiry thread focusing on deep exploration into a scholarly area. Each step advances the learner, first to a sophisticated consumer of biomedical science, then to a producer of new knowledge. Continuous improvement skills are instilled through the clinical microsystem clerkship (CMC), a longitudinal clinical skills curriculum integrating skills in direct patient care, health systems improvement, and interprofessional collaboration. The CMC engages students in systems improvement work directly affecting the quality and safety of care. During the core clerkship phase, we offer a series of clinical immersion experiences (CIExes) electives, which provide opportunities for deeper exploration of a specialty or subspecialty. Trained and dedicated faculty “coaches” support students’ progression. The coaching program is designed to provide academic guidance for students and support professional/personal development throughout the curriculum. Curriculum Curriculum description The Bridges Curriculum is a 4-year, 3-phase curriculum: Foundations 1 (F1) is the preclerkship phase, including foundational sciences coursework and early, robust instruction and practice of health systems sciences (CMC). Foundations 2 (F2) starts in December, year 2, with six 8-week blocks for 8 core clerkships and 8 weeks of CIExes. Career launch starts in March of year 3, including a longitudinal ambulatory subinternship, dedicated time for completing scholarly projects, and advanced clinical training preparing students for their chosen career paths. Other curricular characteristics: Early, robust instruction and practice of health systems science (CMC) Incorporation of a dedicated coaching program, integrated with the CMC during the preclerkship phase, embedded in a longitudinal curriculum in assessment, reflection, coaching, and health (ARCH) across all 3 phases Deliberate instruction with dedicated time in concepts and application of inquiry in scientific domains Intentional incorporation of elements of social justice into all curricular aspects, including a planned required rotation demonstrating these principles in the community-engaged context Collaborative integration of foundational science content into clerkships Curriculum changes since 2010 The rollout of the Bridges Curriculum will be complete in May 2020, a significant evolution of our curricular content and pedagogy. Structural changes within the 4-year timeline include: A shortened preclerkship phase (ends December, year 2) Earlier start of clerkship phase (January, year 2) Longitudinal structure of the family and community medicine clerkship Shift in placement of USMLE Step 1 examination to after core clerkships (January, year 3) Earlier start of postclerkship phase (March, year 4) Over the coming year, we will also adjust delivery of foundational science content. Class size changes since 2010 In AY 2019–2020, UCSF became the sponsoring institution for the San Joaquin Valley Program in Medical Education (SJV PRIME), serving central California communities. The class size increased by 6 students for the first academic year’s entering class and will subsequently rise to 12. These students have been incorporated into class structures with minimal change required in structure or function, primarily because their clerkship and postclerkship phases take place at UCSF Fresno, where they had been placed previously for clerkships while managed by a different institution. Assessment Medical education program objectives are based on ACGME domains of competence, with the addition of interprofessional collaboration as a separate domain. See Supplemental Digital Appendix 1—Program Objectives and Assessment Methods——at https://links.lww.com/ACADMED/A959. Assessment changes since 2010 UCSF has implemented programmatic assessment in the F1 phase of the curriculum and is in the process of implementing programmatic assessment in core clerkships, F2. Implementation of programmatic assessment aims to support students’ learning across the curriculum and ensure achievement of expected competence. The assessment system emphasizes students’ development of reflection, learning, and planning skills in close coordination with their coaches throughout the 4-year curriculum. Students and coaches have ready access to performance data in an individual electronic student dashboard containing visual displays of student progress compared with expected benchmarks and class averages. The dashboard includes score reports from summative assessments and students’ reflections and learning goals. In the core clerkships, the school eliminated tiered (honors) grades in January 2019. This decision was made after a multiyear effort to explore and address concerns about accuracy, fairness, and equity of clerkship grades and the impact of grading on students’ learning and well-being. Clerkships are now graded Pass/Fail, with a new requirement for 2 weekly work-based assessments for formative feedback, completed collaboratively by a faculty/resident supervisor working with the student. Parallel curriculum or tracks UCSF has 5 parallel tracks: Joint Medical Program is a 5-year integrated MS–MD program for 16 students who begin their education at UC Berkeley and transfer to the UCSF campus for clerkships and senior year. Program in Medical Education for the Urban Underserved is a 5-year track accepting 12 students annually. Students take a year off to pursue a master’s degree in a field enhancing their leadership ability in the care of vulnerable populations. SJV PRIME is a 4-year track recruiting 12 students from the Central Valley of California committed to addressing health care disparities in this underserved area. Students participate in their preclerkship years at UCSF in San Francisco, then relocate to Fresno to complete clinical studies. The Medical Scientist Training Program is the UCSF MD–PhD program, accepting 12 students yearly into a T32 and institutionally supported combined program. The Oral Maxillofacial Surgery (OMFS) program accepts 4 students with DDS degrees into an integrated MD–OMFS residency program. Pedagogy The core curriculum and 5 parallel tracks use these pedagogical approaches: Case-based learning Clinical experience: ambulatory Clinical experience: inpatient Discussion: large group (> 12) Discussion: small group (≤ 12) Laboratory Lecture Peer teaching Preceptorship Problem-based learning Changes in pedagogy since 2010 Our work since 2010 has been in identifying the balance between instructional strategies and content to best help learners with cognitive integration, particularly in the content-dense, preclerkship phase. Clinical experiences Clinical sites represent the spectrum of communities for which we provide care, including urban and rural, primary and tertiary/quaternary, ambulatory, and inpatient sites. Required longitudinal experiences The Bridges Curriculum has numerous longitudinal experiences: Longitudinal small groups to support learning for each key element in the preclerkship phase Longitudinal delivery of the family and community medicine core clerkship 3 longitudinal integrated clerkships Longitudinal, ambulatory experience during the postclerkship phase (specialty practice ambulatory subinternship) A longitudinal curriculum (ARCH) delivered at key touchpoints across all 3 phases Clinical experience first encounter Students first enter the clinical environment in the third week of the preclerkship phase, during the CMC. This experience starts with a focus on health systems and systems improvement, gradually introducing patient care skills. Required and elective community-based rotations All core clerkship rotations have community-based sites; many clinical electives are also offered at community-based sites. The San Francisco Veterans Affairs Health System is a key affiliate, and over 75% of students rotate there at some point during medical school. Challenges in designing and implementing clinical experiences for medical students The primary limitation on students’ clinical experiences comes from increased demands placed on limited clinical sites by learners from other domestic and international institutions, and across the health care training spectrum. Curricular Governance The faculty committee with primary curricular responsibility is the Committee on Curriculum and Educational Policy (CCEP), a standing committee of, and deriving its authority from, the Council of the Faculty. The CCEP accomplishes its work through a group of subcommittees: an executive committee, subcommittees focused on operations during the 3 phases, Mapping and Integration Committee, and Student Governance Committee. Each committee has LCME standards of primary responsibility and meets monthly. The executive committee is responsible for operational management of and reporting on CQI through reviewing operations reports and program evaluation data. Decentralized curricular governance None of our governance is managed at the department level. Clerkship directors and staff are funded through a centrally managed budget for curriculum leadership. Education Staff The Medical Education Unit oversees the continuum of medical education, under the vice dean for education and associate dean for medical education (ADME). The ADME oversees all staff, including the medical student programs. The structure includes a central office under the chief of staff, which oversees accreditation, financing, staff engagement, affiliations, communications, and overall strategic support. The ADME oversees educational technology, data and analytics services, and simulation and anatomy centers. Medical student programs are organized under the associate deans for admissions, students, curriculum, and assessment. Student services provides daily support for students and career advising. The Assessment, Curriculum, and Evaluation Unit oversees curriculum support and clinical phase coordination. It also supports required scholarly activities (inquiry curriculum), student coaching program, and CQI of the curriculum under the director of program evaluation. Medical education leadership The dean provides overall leadership for the School of Medicine. Reporting to the dean is the executive vice dean and vice dean for education, responsible for the medical education continuum. There are 6 associate deans reporting to the vice dean for education: Associate dean for medical education: Responsible for staff, program development and support, communications, physical space, technology, finance Associate dean for admissions: Responsible for admissions process, student scholarships, financial aid Associate dean for students: Responsible for the medical student experience and assisting students and faculty with issues with student activities, supports, career planning, professional development Associate dean for curriculum: Responsible for the medical student curriculum, including foundational sciences, clinical and systems sciences, the inquiry curriculum, and curriculum governance and CQI Associate dean for competency assessment and professional standards: Responsible for student assessment, including competencies and milestones, and the MSPE; also oversees the coaching program, which provides nonevaluative longitudinal student support Department of Medical Education Medical education staff support the medical education continuum: outreach and postbaccalaureate preparation for medical school, admissions, medical student curriculum, GME, continuous professional development, educational technology, and simulation and anatomy-based instruction. Central staff also support multiple student support services. The Office of Medical Education includes the Center for Faculty Educators (CFE), which houses our Academy of Medical Education (AME), faculty develop programs, and educational research. The center includes faculty directors of the academy and of faculty development and educational research. Faculty Development and Support in Education Professional development for faculty as educators The CFE hosts the AME and an award-winning faculty development program, recipient of an ASPIRE to Excellence Award. Faculty can view online orientation resources for the Bridges Curriculum and coaches receive tailored faculty development. We are initiating workplace-based faculty development through the Learning and Caring Ecosystem program. Faculty can participate in “Teach for UCSF” certificates in general, clinical, simulation, interprofessional, quality improvement and patient safety, and equity and inclusion teaching as well as educational leadership. Education-focused faculty can apply to the longitudinal Teaching Scholars Program and advance to master’s and doctoral degrees in health professions education through external partners. Role of teaching in promotion and tenure Faculty must demonstrate quality teaching. Peer observation of teaching can be submitted as data for promotion and tenure application. Clinical educators must show engagement in creative activity and/or dissemination of educational scholarship and/or substantial educational leadership and can be promoted through the University of California “clinical X” series. Educators can embed a teaching portfolio into their CV. Academy for Medical Educators Since 2000, the AME has supported the educators who carryout and advance UCSF’s education mission through community, diversity, advocacy, service, and innovation. The AME currently has 163 members from medicine, dentistry, nursing, and pharmacy, selected by a rigorous application process. Programs include education grants, endowed chairs (24), teaching awards, quarterly meetings/workshops, an education showcase, teacher observation program, and UCSF-wide initiatives to address diversity/equity/inclusion, wellness, learning climate, and education finance. Regional Medical Campuses Directors of both campuses are ex officio members of the CCEP, which oversees educational programming. See Table 1—Regional Medical Campuses.Table 1: Regional Medical CampusesEducational experiences across sites Directors of each program meet quarterly with main campus associate education deans to review curriculum, assessment, student experience, and progress. Each regional campus submits an annual report to the CCEP demonstrating equivalency in student satisfaction, outcomes, and competency. Memorandums of understanding between main and regional campuses are reevaluated and renewed every 5 years.

Gary Gaddis

In 2000, the first Academic Emergency Medicine consensus conference was convened. The topic, “Errors in Emergency Medicine,” was interposed between two well-known Institute of Medicine (IOM) reports of direct relevance: To Err is Human: Building a Safer Health System1 (1999) and Crossing the Quality Chasm: A New Health System for the 21st Century2 (2001). This foreshadowed the great degree of relevance and timeliness that would characterize future consensus conferences, each of which has as its primary goal the development of a research agenda that will guide the science of the topic at hand. This year, Academic Emergency Medicine convened its 11th consensus conference, “Beyond Regionalization: Integrated Networks of Emergency Care,” in conjunction with the annual meeting of the Society for Academic Emergency Medicine in Phoenix, Arizona. The proceedings will appear in the December issue of this journal. In this fashion, another timely research agenda will be developed, refined, and disseminated. These consensus conferences have not occurred in a vacuum. They have, to a demonstrable degree, had their intended effect of stimulating research. This month’s issue of the journal is the first to be devoted primarily to dissemination of research and concepts that have grown from prior consensus conferences. There is every reason to believe that a new and useful tradition has been established. The topics of the prior AEM consensus conferences have been: 2000: Errors in Emergency Medicine 2001: The Unraveling Safety Net 2002: Assuring Quality 2003: Disparities in Emergency Care 2004: Emergency Medicine Information Technology 2005: Ethical Conduct of Resuscitation Research 2006: The Science of Surge 2007: Knowledge Translation in Emergency Medicine: Establishing a Research Agenda and Guide Map for Evidence Uptake 2008: The Science of Simulation in Health Care: Defining and Developing Clinical Expertise 2009: Public Health in the Emergency Department: Surveillance, Screening, and Intervention 2010: Beyond Regionalization: Integrated Networks of Emergency Care A number of the consensus conferences have received significant financial support from Canadian, American federal, other public, and various private sources. Focusing on the conferences of 2007, 2008, and 2009 is illustrative. The 2007 conference received financial support from the Agency for Healthcare Research and Quality (AHRQ), and among the featured speakers who took time from their busy schedules to join us in Chicago was Carolyn Clancy, the director of the AHRQ since 2003. Support also came from the National Center for Research Resources, an organization promoting the Clinical and Translational Science Awards program within the United States National Institutes of Health, and the Knowledge Translation Workshops and Symposia Grant Program of the Canadian Institutes of Health.3 The 2008 conference received primary financial support from AHRQ, the Josiah Macy, Jr. Foundation, MedEdPORTAL (an electronic publication of the American Association of Medical Colleges), and the Risk Management Foundation of the Harvard Medical Institutions. Over 30 other medical organizations and academic departments nationwide provided smaller degrees of support. In addition, unrestricted educational grants were received from major manufacturers of medical simulator hardware and software.4 The 2009 conference was primarily supported by a grant from AHRQ and the National Institute on Drug Abuse of the National Institutes of Health, with secondary support from the National Institute of Mental Health; the National Institute on Alcohol Abuse and Alcoholism; the Substance Abuse and Mental Health Services Administration (SAMHSA); “Join Together” of the Boston University School of Public Health; and the Departments of Emergency Medicine of Boston University, Brown University, Emory University, George Washington University, Johns Hopkins University, the University of Maryland, the University of Michigan, and Yale University. This conference featured participation from Dr. Richard Denisco from the National Institute on Drug Abuse, Dr. Ralph Hingson from the National Institute on Alcohol Abuse and Alcoholism, Dr. Amy Goldstein from the National Institute of Mental Health, Dr. James Heffelfinger from the Centers for Disease Control and Prevention, Dr. Richard Saitz from Boston University, and Dr. Jack Stein, director of SAMHSA’s Center for Substance Abuse Treatment.5 Given the significant and continuing financial support of the agencies and foundations that have supported our consensus conferences, it seems prudent to provide them with proof that their efforts have been followed by meaningful responses to the numerous calls for research contained within the consensus conference summary statements and proceedings. In other words, this issue of our journal can be thought of as the first installment of a series of “itemized receipts” that will document how the financial support provided to enable the consensus conferences has been worthwhile. The first several consensus conferences did not enjoy such external financial support, but as the size and scope of the sessions grew, so did the need for funding. Our journal will continue to present these annual consensus conferences into the foreseeable future, and they will require the expenditure of significant resources of time and finances. To be able to document, from the pages of our own journal, that prior consensus conferences have had the desired effect of stimulating relevant research may increase the likelihood that the organizers of future conferences can continue to achieve similar external financial support. Looking forward, it is hoped that an even greater number of research efforts will be inspired by our consensus conferences and that much of that research will appear in our journal. It must be noted that not all of this month’s articles were submitted by authors who had the express intent that they appear in this special consensus conference follow-up issue. The Associate Editors and Senior Associate Editors, as well as Kathleen Seal, our Technical Editor, have referred a number of manuscripts submitted to the journal, but not submitted specifically for appearance in this issue, to the attention of the consensus conference guest editors group. In other words, our work group had to “prime the pump” somewhat. It is hoped that this will not be necessary in the future and that a greater number of manuscripts will be submitted with the goal that they appear in the consensus conference follow-up proceedings. A suggestion going forward relates to the probability that the research agendas set forth at a given consensus conference may eventually become “dated.” Toward that end, it is possible that future consensus conference follow-up issues might only accept manuscripts inspired by consensus conferences of the past 3 to 5 years. This issue contains a total of 15 manuscripts, with the following representation: 2002: one manuscript 2003: two manuscripts 2004: two manuscripts 2005: zero manuscripts 2006: two manuscripts 2007: three manuscripts 2008: one manuscripts 2009: four manuscripts I would be remiss not to thank several people without whom this edition of the journal would not have been possible. The Guest Assistant Editors, who functioned most capably as decision editors, included Gail D’Onofrio, Nicole Deiorio, Lynne Richardson, and Terri Schmidt. I am indebted to them for their efforts. It would be misleading to state that this process evolved exactly as first envisioned, and I must also thank these Guest Assistant Editors for their patience with the evolving processes. David Cone gave me the opportunity to more truly understand the extreme degree of knowledge and organization he brings to his role as Editor-in-Chief. Finally, but most importantly, I thank Kathleen Seal for her most capable guidance and patience. I have learned to an even greater degree than before what a valuable resource she is to our journal.

Michael A. Weber

Academic physicians are under attack in the United States. Federal and state politicians, the lay media, some regulatory agencies, medical journals, and even medical schools have voiced strong concerns over the relationships between academic physicians and the pharmaceutical and device industries. These industries have been accused of corrupting medical research, education, and practice; and so, by extension, academic physicians who participate in these activities have become a focus of unfriendly attention. In their clamor, critics have not been reluctant to use the pejorative and misleading term conflict of interest in describing these academic-industry relationships. Physicians are notoriously slow to react, but in the end a group of academics from diverse medical specialties met at Harvard in late July to conduct the inaugural public meeting of a new organization: The Association of Clinical Researchers and Educators (obviously now known as ACRE). And, in the interests of transparency, let me immediately state that not only do I participate in research and educational services supported by industry, but that I was one of the founders of ACRE and took part actively at the Harvard meeting. Why in the United States—and throughout much of the world, for that matter—have academic physicians and industry forged their collaborations? In reality, a large part of medical research and education in contemporary times is based on this relationship. Dr Jeffrey Flier, Dean of Harvard Medical School, acknowledged at the ACRE meeting that his school’s mission to promote medical education and research requires interaction with industry.1 Most of the major advances in recent decades in conditions such as cancer and heart disease, and their incorporation into medical practice, have resulted from this partnering between academia and industry. Academic physicians are uniquely qualified to identify unmet medical needs and, working collaboratively with industry colleagues, to devise and conduct the types of basic research and clinical trials that lead to therapeutic breakthroughs. It is not difficult to understand why our critics have come to question this relationship, including legitimate concerns about preserving the independence of academic physicians. But one of the dominant motivations for this negativity comes from the costs—admittedly, often quite high—of new developments in patient care. Government agencies with limited budgets and commercial health plans with financial obligations to investors understandably look with dismay as relatively more costly tests, procedures, and therapies are developed and made available by industry and its academic advisors. From the perspective of health plan operators, the situation only gets worse when academic physicians teach their practicing colleagues about the attributes of these new developments. ACRE’s first meeting, which played to a packed house in the Bornstein Amphitheater at the Brigham and Women’s Hospital, attracted a wide range of speakers. There were representatives of medical societies, including such disciplines as diabetes, lymphoma, myeloma, and hypertension. As well, there were representatives of patient advocacy groups passionately committed to preserving the productive academia-industry collaboration needed to address unmet needs across a broad range of serious illnesses. An important insight came from a nationally recognized medical ethicist, Lance Stell, who is a professor of philosophy and Director of the Medical Humanities Program at Davidson College. “Conflict of interest” in the medical context has a clear meaning. Specifically, it occurs when practitioners accept personal rewards (such as fees, grants, awards, or recognition) in return for actions that could violate their professional obligations. In essence, to accuse a clinician of conflict of interest would require empirical proof that, in return for a reward, an action was taken that resulted in diminished care or even harm to patients. Clearly, such occurrences are extraordinarily rare in the conduct of medical research and education activities. There are words that are more accurate and less emotive than “conflict,” and we are starting to see a preference for such terms as duality, concordance, or alignment of interests. It is ironical that another speaker at the ACRE meeting discussed how certain actions in the medical setting, which perhaps really do represent true conflicts of interest, go without criticism. For instance, some commercial health plans offer practitioners direct monetary rewards for switching their patients from more expensive to less expensive drugs, or, possibly, for reducing their use of tests, referrals, and therapies so as to minimize the insurers’ outlays. Much of the information received by practicing clinicians comes from events that are funded, directly or indirectly, by industry. Partly, this is by default. After all, who else has both the responsibility as well as the resources to provide ongoing education in the clinical sciences? Inevitably this type of sponsorship has been criticized on the grounds that industry is not providing support out of altruistic principles, but rather is more intent on marketing its products. Apart from unrestricted grants that industry can provide to medical schools or hospitals to support educational ventures of their own choosing, there are two main types of industry-supported education. The first of these comes under the heading of promotional activities, and the second is labeled as continuing medical education, or CME. Each of these has its share of critics. Promotional education programs can take place in hospitals, medical offices, or at outside venues such as restaurants and are designed to provide information directly about a company’s product. These types of activities are regulated by such agencies as the Food and Drug Administration. In the case of a pharmaceutical agent, the information presented must be balanced, providing information about risks as well as benefits, and must conform largely to what is stated about the drug in its approved product label. Claiming a desire to comply with these rules, many pharmaceutical companies have tightly scripted the content of these presentations, typically demanding that presenters faithfully use a company-provided slide set without allowing them the option to add, delete, or make any other changes. This requirement obviously creates fundamental problems for academic physicians invited to present at such events. After all, how can well-regarded experts stake their reputations, not to mention the reputations of their academic institutions, on material that has been created by unknown persons at the behest of a pharmaceutical company? Not surprisingly, some major medical schools have now instructed their faculty members not to give such lectures unless they have meaningful control over the content. For community practitioners who attend such events, this is an unfortunate development, for it deprives them of beneficial teaching interactions with true medical leaders. Some observers believe that industry lawyers, in imposing this censorship, have overreacted to regulatory requirements, and there is even a suspicion that these rules—rather too conveniently—enable companies to focus more directly on their marketing messages. Rescuing this situation and re-creating collegial educational experiences in the community will require negotiations between industry and academia and, in all likelihood, regulatory agencies as well. CME is a very demanding proposition. On the one hand, industry has a compelling obligation to facilitate high-quality educational opportunities and updates for the users of its products. But, at the same time, CME rules demand that industry has a “hands off” involvement in such events, merely serving as a provider of grants. The contents of CME programs usually are created by academic faculty and are subjected to peer review (similar to an article submitted to a journal) to ensure their objectivity. Even so, some critics still claim that industry can exert a bias on this process simply by selecting which types of programs they will support. But while it is true that pharmaceutical companies are more likely to support CME activities within their areas of medical interest, industry now goes to considerable pains to ensure that its grant decision processes are kept entirely separate from marketing activities. The opponents of industry support for CME activities still claim that, despite the firewalls, industry is still rewarded for its support of CME activities by increased sales of its products. Even if this were true, it is a not unreasonable proposition that if well-balanced data, presented in an unbiased fashion, affects the subsequent utilization of drugs or devices, this will very likely be to the benefit of patients. From the perspective of academic clinicians, rigorously conducted CME events in which they are free to select the content and ideas represent ideal opportunities to enhance practitioner knowledge and patient care. Attempts by legislators (and others who regard medical education as a health–care cost driver) to prevent or limit industry support of CME could have the effect of diminishing the quality of medical practice. Again, it is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research. Many medical societies, particularly small specialty organizations, depend on industry support. The operating costs of societies, as well as the cost of meetings, publications, patient education and other professional activities cannot be fully funded by member subscriptions. Support from industry is often essential and comes in the form of corporate memberships, sponsorship of CME or other activities at scientific meetings, exhibit fees, and journal advertising. This support has been criticized by the media as indicative of excess industry influence on professional activities. And, indeed, it might be appropriate for societies to consider whether funding from industry and income from members should be directed selectively to purposes relevant to those funding sources. It is worth noting that the mistrust between the provider of health services and the worlds of academia and industry became a major public issue in Great Britain about 4 years ago. In fact, a committee of Parliament issued a report expressing concern at the failure of the academic community and the health service to work more closely with the pharmaceutical industry to minimize inappropriate or suboptimal use of drugs in clinical practice.2 Subsequently, in a high-profile report issued early this year, the Royal College of Physicians (which represents a broad range of medical specialists) stated that the interests of patients and their clinicians are best served by close cooperation between academia, industry, and the health services.3 It is unfortunate that we have lagged behind on this side of the Atlantic. Indeed, one of the most telling statements made at the Harvard meeting came from Massachusetts State Representative Michael Rodrigues, who helped lead the opposition in the legislature to a now-enacted law that dramatically curtails interactions between physicians and industry in that state. It was particularly discouraging to hear from this representative that he and his colleagues lost their opportunity to block the legislation when local physician leaders gave up the fight and decided to remain silent. The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its initial goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry. This will be no easy task, for so many negative items have already appeared in the media regarding the alleged manipulation of physicians by industry, usually with only weak rebuttals by academic or industry leaders. Indeed, one of ACRE’s main responsibilities will be to develop a public voice that gets heard and quoted when such issues arise. There already has been one such success: Dr Thomas Stossel, one of ACRE’s leaders and the chair of the Harvard meeting, was invited to testify at a high-profile US Senate hearing on CME in late July. Another of ACRE’s main tasks will be to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. This, again, will take considerable thought and discussion. As Dean Flier pointed out, we still need to figure out how best to “strike a wise balance” and create “manageable tension” in optimizing productive interactions between academics and industry. From the perspective of the many of us involved in cardiovascular medicine, it is easy to see the dramatic improvements in patient care that have resulted from the academic-industry partnership in recent years. Major clinical events and mortality have been sharply reduced in such areas as hypertension, lipid disorders, diabetes, heart failure, acute coronary syndromes and chronic kidney disease by this collaboration. ACRE’s members, in common with most physicians, no longer find it acceptable to let others unilaterally set up the rules by which we are expected to function in performing these vital tasks. It is long overdue that we take responsibility for our professional activites in research, education, and practice. More information about ACRE can be found on its Web site: http://www.acreonline.org The site also has information about how to become a member.

Imelda Bates, Kathryn Maitland

In this issue of Clinical Infectious Diseases, Petti and colleagues [1] highlight the need for increased investment in laboratory services to avoid compromising patient care. Health care professionals are waking up to the realization that the development of new drugs and treatment strategies has far outstripped the ability of health care systems to deliver them to individuals who need them. The decision has been made by leading global health care funders that cost should not be a deterrent to providing effective treatment, even in the poorest countries. As a result, there are major drives to rapidly increase availability of antiretroviral drugs and antimalarial combination therapies. A similar and potentially stronger argument for prioritizing effectiveness over cost pertains to the provision of accurate frontline diagnostic services. Yet, as Petti and colleagues [1] illustrate, there is widespread use of “empiricism without laboratory support for diagnosing disease” in sub-Saharan Africa, which would not be tolerated in resource-plenty countries. What can be done to redress the imbalance and bring investments in diagnostics to a level that will support cost-effective deployment of available treatment regimens in sub-Saharan Africa? Let us consider how this might be achieved by exploring opportunities within the major areas of concern discussed by Petti et al. [1]: clinical misdiagnosis, inadequate health care infrastructure, and laboratory capability and diagnostic accuracy. Almost none of these opportunities can be realized by laboratory services in isolation; they depend on close partnerships between technical and clinical professionals and local and national health care managers. For many common infections in sub-Saharan Africa, including severe and nonsevere malaria and septicemia, clinical diagnosis is not adequately sensitive or specific. Because malarial and bacterial infections share similar presenting features, syndromic management [2] results in overtreatment of both conditions, increasing the expense and threatening the longevity of the limited repertoire of inexpensive antimicrobials. Often, frontline medical personnel have to make immediate clinical decisions on the basis of a limited number of diagnostic tests. Equally important are the refinement of this initial diagnosis and the targeting of therapies over the ensuing hours and days, which is greatly facilitated by good diagnostic facilities; thus, the laboratory is the most important determinant in this process. Ideally, rapid and accurate diagnostic testing would be available at the first consultation, to enable personnel to make the correct diagnosis and to avoid the waste of resources and increased ill health associated with incorrect initial diagnoses. In some cases, such diagnostic tools are available but are not in routine use, because they are considered to be too expensive or because they have not been adequately evaluated in real-life situations. Such tools include rapid dipstick malaria tests, anemia and HIV tests, and fingerprick hemoglobinometric tests. Much more investment is needed to evaluate and adapt existing tools and to develop new diagnostic approaches for common conditions. This is likely to be most effectively achieved through partnerships between researchers, policy makers, and commercial companies that are similar to the programs that have been used for drug development (e.g., Medicines for Malaria Venture). The availability of such diagnostic tools is not likely to greatly impact clinical care unless their use is underpinned by evidence-based guidelines that are implemented, supervised, audited, and embedded within local practice. The process of producing guidelines is based on the synthesis of published evidence from diverse sources and then adaptation to suit local circumstances, and it needs to involve collaboration between clinicians and laboratory professionals. A proposal to simplify the complex process of guideline development has been proposed recently by Raine et al. [3]. Laboratory services are one of the most neglected areas of health care provision in sub-Saharan Africa and are disproportionately affected by the staff shortages, poor communications, inadequate equipment, low morale, and lack of training that impinge on all those involved in delivering health care in poorer African countries. The reforms currently underway in the health care sector in many sub-Saharan African countries and the consequent decentralization of planning and financing could be used as an opportunity for laboratory services to move up on the priority list of essential services. This will only happen if laboratories represent themselves on key decision-making bodies, rather than being represented by other sections of health care services, such as pharmacy. Within top-level management, the voice of clinicians is generally much more powerful than that of laboratory professionals. Clinicians therefore have a responsibility to support and advocate for their technical colleagues in the laboratory service, to ensure that they are involved in decisions affecting the laboratory at all levels, and to promote, facilitate, and demand high-quality and responsive laboratory support for effective patient care. The fact that a test was done by a senior technician or that it was performed on a sophisticated piece of equipment in no way guarantees the accuracy of the results. Establishing, maintaining, and demonstrating the accuracy of diagnostic tests is a major challenge for most laboratories in sub-Saharan Africa. To do this, they need to have the skills and resources to institute regular internal quality checks for each test, reliable documentation processes, and access to an external reference center that is itself linked to and accredited by international quality-assessment networks. Laboratories must be able to show that they perform well in such an external quality-assessment scheme before clinicians can be confident that the results of tests they request will be accurate. The complexity and cost of setting up and maintaining such a quality-assurance system means that only a very few laboratories, almost exclusively those that are tertiary or privately owned, can provide evidence that their results are accurate. There are a few examples of innovative local schemes for simple external quality checks on key laboratory tests—for instance, sending blood samples, malaria slides, or sputum smears for tuberculosis diagnosis to neighboring laboratories and then meeting regularly to compare results and to reflect on any discrepancies. In addition, there are particularly good examples of local quality-assurance systems designed to evaluate testing in tuberculosis control programs that could be expanded to include the malaria test (another microscopy-based test) and further extended to other essential laboratory investigations, such as hemoglobin and transfusion-related tests. Even these local schemes require a high degree of motivation and organization by the laboratory staff, as well as support from clinicians and regional or national health care managers. Qualityassurance networks are one of the areas in which nongovernmental organizations and the private sector could play a much greater role, particularly in places where governmental health care systems are ineffective or dysfunctional. Outsourcing external quality assessment to such agencies would bring many mutual benefits, especially because many of the public-sector laboratory staff also work in the private sector. The current international focus on rapidly widening the access to antiretrovirals can be perceived as either a threat to or an opportunity for laboratory services in sub-Saharan Africa. It is a potential threat because strong vertical programs concerned with HIV care and management focus on the HIV-related aspects of laboratory services, thereby fragmenting the service and diverting scarce resources, particularly human resources, away from important non-HIV tests, such as those for malaria, anemia, and tuberculosis. On the other hand, if laboratory aspects of HIV programs are able to integrate into and strengthen existing systems, they will provide a unique opportunity to build the capacity of long-neglected laboratory services in sub-Saharan Africa. It is very surprising that the article by Petti et al. [1], which is wholly concerned with the provision of laboratory services in sub-Saharan Africa, does not include an African author. Is this indicative of the dearth of indigenous laboratory advocates in sub-Saharan Africa? As treatment costs for common conditions increase in poorer countries, the balance must shift away from syndromic management toward achievement of specific diagnoses. Laboratory services will have an increasingly important role to play in improving the quality and effectiveness of patient care, but, to do this, laboratories and their advocates need to be given a much louder voice on the international health care stage. Potential conflicts of interest. I.B. and K.M.: no conflicts.

David S. Jones

In the early 1970s physicians engaged in fierce debates over the most appropriate method of evaluating the efficacy of coronary artery bypass grafting (CABG). With millions of patients and billions of dollars at stake, CABG sparked fierce controversy. Skeptics demanded that randomized controlled trials (RCTs) be performed, while enthusiasts argued that they already had visual proof of CABG's efficacy. When RCTs appeared, they did not settle the controversy. Participants simply reasserted their preconceptions, defending a trial's strengths or exploiting its flaws. The debate centered on standards of knowledge for the evaluation of therapeutic efficacy. Specifically, cardiologists and cardiac surgeons struggled to assess the relevance of different measures of therapeutic success: physiological or clinical, visual or statistical. Many factors contributed to participants' decisions, including disciplinary affiliation, traditions of research, personal experience with angiography, and assessments of the history of cardiac therapeutics. Physicians had to decide whether angiography provided a meaningful representation of the disease and its treatment or whether demonstrations of therapeutic success could come only from long-term statistical evaluation of mortality data.