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Perspectives5 February 2002Medical Professionalism in the New Millennium: A Physician CharterFREEProject of the ABIM Foundation, ACP–ASIM Foundation, and European Federation of Internal Medicine*Project of the ABIM Foundation, ACP–ASIM Foundation, and European Federation of Internal Medicine*Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-136-3-200202050-00012 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail To our readers: I write briefly to introduce the Medical Professionalism Project and its principal product, the Charter on Medical Professionalism. The charter appears in print for the first time in this issue of Annals and simultaneously in The Lancet. I hope that we will look back upon its publication as a watershed event in medicine. Everyone who is involved with health care should read the charter and ponder its meaning.The charter is the product of several years of work by leaders in the ABIM Foundation, the ACP–ASIM Foundation, and the European Federation of Internal Medicine. The charter consists of a brief introduction and rationale, three principles, and 10 commitments. The introduction contains the following premise: Changes in the health care delivery systems in countries throughout the industrialized world threaten the values of professionalism. The document conveys this message with chilling brevity. The authors apparently feel no need to defend this premise, perhaps because they believe that it is a universally held truth. The authors go further, stating that the conditions of medical practice are tempting physicians to abandon their commitment to the primacy of patient welfare. These are very strong words. Whether they are strictly true for the profession as a whole is almost beside the point. Each physician must decide if the circumstances of practice are threatening his or her adherence to the values that the medical profession has held dear for many millennia.Three Fundamental Principles set the stage for the heart of the charter, a set of commitments. One of the three principles, the principle of primacy of patient welfare, dates from ancient times. Another, the principle of patient autonomy, has a more recent history. Only in the later part of the past century have people begun to view the physician as an advisor, often one of many, to an autonomous patient. According to this view, the center of patient care is not in the physician's office or the hospital. It is where people live their lives, in the home and the workplace. There, patients make the daily choices that determine their health. The principle of social justice is the last of the three principles. It calls upon the profession to promote a fair distribution of health care resources.There is reason to expect that physicians from every point on the globe will read the charter. Does this document represent the traditions of medicine in cultures other than those in the West, where the authors of the charter have practiced medicine? We hope that readers everywhere will engage in dialogue about the charter, and we offer our pages as a place for that dialogue to take place. If the traditions of medical practice throughout the world are not congruent with one another, at least we may make progress toward understanding how physicians in different cultures understand their commitments to patients and the public.Many physicians will recognize in the principles and commitments of the charter the ethical underpinning of their professional relationships, individually with their patients and collectively with the public. For them, the challenge will be to live by these precepts and to resist efforts to impose a corporate mentality on a profession of service to others. Forces that are largely beyond our control have brought us to circumstances that require a restatement of professional responsibility. The responsibility for acting on these principles and commitments lies squarely on our shoulders.–Harold C. Sox, MD, EditorPhysicians today are experiencing frustration as changes in the health care delivery systems in virtually all industrialized countries threaten the very nature and values of medical professionalism. Meetings among the European Federation of Internal Medicine, the American College of Physicians–American Society of Internal Medicine (ACP–ASIM), and the American Board of Internal Medicine (ABIM) have confirmed that physician views on professionalism are similar in quite diverse systems of health care delivery. We share the view that medicine's commitment to the patient is being challenged by external forces of change within our societies.Recently, voices from many countries have begun calling for a renewed sense of professionalism, one that is activist in reforming health care systems. Responding to this challenge, the European Federation of Internal Medicine, the ACP–ASIM Foundation, and the ABIM Foundation combined efforts to launch the Medical Professionalism Project (www.professionalism.org) in late 1999. These three organizations designated members to develop a “charter” to encompass a set of principles to which all medical professionals can and should aspire. The charter supports physicians' efforts to ensure that the health care systems and the physicians working within them remain committed both to patient welfare and to the basic tenets of social justice. Moreover, the charter is intended to be applicable to different cultures and political systems.PreambleProfessionalism is the basis of medicine's contract with society. It demands placing the interests of patients above those of the physician, setting and maintaining standards of competence and integrity, and providing expert advice to society on matters of health. The principles and responsibilities of medical professionalism must be clearly understood by both the profession and society. Essential to this contract is public trust in physicians, which depends on the integrity of both individual physicians and the whole profession.At present, the medical profession is confronted by an explosion of technology, changing market forces, problems in health care delivery, bioterrorism, and globalization. As a result, physicians find it increasingly difficult to meet their responsibilities to patients and society. In these circumstances, reaffirming the fundamental and universal principles and values of medical professionalism, which remain ideals to be pursued by all physicians, becomes all the more important.The medical profession everywhere is embedded in diverse cultures and national traditions, but its members share the role of healer, which has roots extending back to Hippocrates. Indeed, the medical profession must contend with complicated political, legal, and market forces. Moreover, there are wide variations in medical delivery and practice through which any general principles may be expressed in both complex and subtle ways. Despite these differences, common themes emerge and form the basis of this charter in the form of three fundamental principles and as a set of definitive professional responsibilities.Fundamental PrinciplesPrinciple of primacy of patient welfare. This principle is based on a dedication to serving the interest of the patient. Altruism contributes to the trust that is central to the physician–patient relationship. Market forces, societal pressures, and administrative exigencies must not compromise this principle.Principle of patient autonomy. Physicians must have respect for patient autonomy. Physicians must be honest with their patients and empower them to make informed decisions about their treatment. Patients' decisions about their care must be paramount, as long as those decisions are in keeping with ethical practice and do not lead to demands for inappropriate care.Principle of social justice. The medical profession must promote justice in the health care system, including the fair distribution of health care resources. Physicians should work actively to eliminate discrimination in health care, whether based on race, gender, socioeconomic status, ethnicity, religion, or any other social category.A Set of Professional ResponsibilitiesCommitment to professional competence. Physicians must be committed to lifelong learning and be responsible for maintaining the medical knowledge and clinical and team skills necessary for the provision of quality care. More broadly, the profession as a whole must strive to see that all of its members are competent and must ensure that appropriate mechanisms are available for physicians to accomplish this goal.Commitment to honesty with patients. Physicians must ensure that patients are completely and honestly informed before the patient has consented to treatment and after treatment has occurred. This expectation does not mean that patients should be involved in every minute decision about medical care; rather, they must be empowered to decide on the course of therapy. Physicians should also acknowledge that in health care, medical errors that injure patients do sometimes occur. Whenever patients are injured as a consequence of medical care, patients should be informed promptly because failure to do so seriously compromises patient and societal trust. Reporting and analyzing medical mistakes provide the basis for appropriate prevention and improvement strategies and for appropriate compensation to injured parties.Commitment to patient confidentiality. Earning the trust and confidence of patients requires that appropriate confidentiality safeguards be applied to disclosure of patient information. This commitment extends to discussions with persons acting on a patient's behalf when obtaining the patient's own consent is not feasible. Fulfilling the commitment to confidentiality is more pressing now than ever before, given the widespread use of electronic information systems for compiling patient data and an increasing availability of genetic information. Physicians recognize, however, that their commitment to patient confidentiality must occasionally yield to overriding considerations in the public interest (for example, when patients endanger others).Commitment to maintaining appropriate relations with patients. Given the inherent vulnerability and dependency of patients, certain relationships between physicians and patients must be avoided. In particular, physicians should never exploit patients for any sexual advantage, personal financial gain, or other private purpose.Commitment to improving quality of care. Physicians must be dedicated to continuous improvement in the quality of health care. This commitment entails not only maintaining clinical competence but also working collaboratively with other professionals to reduce medical error, increase patient safety, minimize overuse of health care resources, and optimize the outcomes of care. Physicians must actively participate in the development of better measures of quality of care and the application of quality measures to assess routinely the performance of all individuals, institutions, and systems responsible for health care delivery. Physicians, both individually and through their professional associations, must take responsibility for assisting in the creation and implementation of mechanisms designed to encourage continuous improvement in the quality of care.Commitment to improving access to care. Medical professionalism demands that the objective of all health care systems be the availability of a uniform and adequate standard of care. Physicians must individually and collectively strive to reduce barriers to equitable health care. Within each system, the physician should work to eliminate barriers to access based on education, laws, finances, geography, and social discrimination. A commitment to equity entails the promotion of public health and preventive medicine, as well as public advocacy on the part of each physician, without concern for the self-interest of the physician or the profession.Commitment to a just distribution of finite resources. While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician's professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures. The provision of unnecessary services not only exposes one's patients to avoidable harm and expense but also diminishes the resources available for others.Commitment to scientific knowledge. Much of medicine's contract with society is based on the integrity and appropriate use of scientific knowledge and technology. Physicians have a duty to uphold scientific standards, to promote research, and to create new knowledge and ensure its appropriate use. The profession is responsible for the integrity of this knowledge, which is based on scientific evidence and physician experience.Commitment to maintaining trust by managing conflicts of interest. Medical professionals and their organizations have many opportunities to compromise their professional responsibilities by pursuing private gain or personal advantage. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. Physicians have an obligation to recognize, disclose to the general public, and deal with conflicts of interest that arise in the course of their professional duties and activities. Relationships between industry and opinion leaders should be disclosed, especially when the latter determine the criteria for conducting and reporting clinical trials, writing editorials or therapeutic guidelines, or serving as editors of scientific journals.Commitment to professional responsibilities. As members of a profession, physicians are expected to work collaboratively to maximize patient care, be respectful of one another, and participate in the processes of self-regulation, including remediation and discipline of members who have failed to meet professional standards. The profession should also define and organize the educational and standard-setting process for current and future members. Physicians have both individual and collective obligations to participate in these processes. These obligations include engaging in internal assessment and accepting external scrutiny of all aspects of their professional performance.SummaryThe practice of medicine in the modern era is beset with unprecedented challenges in virtually all cultures and societies. These challenges center on increasing disparities among the legitimate needs of patients, the available resources to meet those needs, the increasing dependence on market forces to transform health care systems, and the temptation for physicians to forsake their traditional commitment to the primacy of patients' interests. To maintain the fidelity of medicine's social contract during this turbulent time, we believe that physicians must reaffirm their active dedication to the principles of professionalism, which entails not only their personal commitment to the welfare of their patients but also collective efforts to improve the health care system for the welfare of society. This Charter on Medical Professionalism is intended to encourage such dedication and to promote an action agenda for the profession of medicine that is universal in scope and purpose. Comments0 CommentsSign In to Submit A Comment Dr.Tanu Pramanik PhD(Social Psychology) Principal,Dr.Jogenananda Pramanik MD Executive Dean, Careers Abroad Institute School of Medicine, Mandeville, Jamaica.WI. Principal, Careers Abroad Institute School of Medicine,Hatfield, Mandeville, Manchester, Jamaica, WI.,16 October 2017 Humanise health care- A major concern workdwide The practice of medicine in the modern era is beset with unprecedented challenges in virtually all cultures and societies(1).We applauded current initiative to review and humanise health care.In the recent past,we responded to the editorial in British Medical Journal, emphasising impact of behavioural science curriculum in medical education.We are painfully concerned that most of our medical students are unfortunate that they did not get an opportunity to learn about behavioural science as a part of their curriculum during their medical school training program. They were never been exposed to the local community for a supervised health screening program with a mission to develop doctor-patient relationship and professional communication skills in real life scenarioRef: 1.Medical Professionalism in the New Millennium: A Physician Charter.Impact of behavioural science curriculum in medical education 2016; 355 doi: https://doi.org/10.1136/bmj.i6262 (Published 13 December 2016)Cite this as: BMJ 2016;355:i6262Re: Humanising healthcare Author, Article, and Disclosure InformationAffiliations: Corresponding Author: Linda Blank, ABIM Foundation, 510 Walnut Street, Suite 1700, Philadelphia, PA 19106-3699; e-mail, [email protected]org.*This charter was written by the members of the Medical Professionalism Project: ABIM Foundation: Troy Brennan, MD, JD (Project Chair), Brigham and Women's Hospital, Boston, Massachusetts; Linda Blank (Project Staff), ABIM Foundation, Philadelphia, Pennsylvania; Jordan Cohen, MD, Association of American Medical Colleges, Washington, DC; Harry Kimball, MD, American Board of Internal Medicine, Philadelphia, Pennsylvania; and Neil Smelser, PhD, University of California, Berkeley, California. ACP–ASIM Foundation: Robert Copeland, MD, Southern Cardiopulmonary Associates, LaGrange, Georgia; Risa Lavizzo-Mourey, MD, MBA, Robert Wood Johnson Foundation, Princeton, New Jersey; and Walter McDonald, MD, American College of Physicians–American Society of Internal Medicine, Philadelphia, Pennsylvania. European Federation of Internal Medicine: Gunilla Brenning, MD, University Hospital, Uppsala, Sweden; Christopher Davidson, MD, FRCP, FESC, Royal Sussex County Hospital, Brighton, United Kingdom; Philippe Jaeger, MB, MD, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Alberto Malliani, MD, Università di Milano, Milan, Italy; Hein Muller, MD, PhD, Ziekenhuis Gooi-Noord, Rijksstraatweg, the Netherlands; Daniel Sereni, MD, Hôpital Saint-Louis, Paris, France; and Eugene Sutorius, JD, Faculteit der Rechts Geleerdheid, Amsterdam, the Netherlands. Special Consultants: Richard Cruess, MD, and Sylvia Cruess, MD, McGill University, Montreal, Canada; and Jaime Merino, MD, Universidad Miguel Hernández, San Juan de Alicante, Spain. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCharter on Medical Professionalism: Putting the Charter into Practice Sadeq A. Quraishi and Ayesha N. Khalid Charter on Medical Professionalism: Putting the Charter into Practice Neil J. Smelser Charter on Medical Professionalism: Putting the Charter into Practice Charles M. Haskell Charter on Medical Professionalism: Putting the Charter into Practice Neil J. Smelser Charter on Medical Professionalism: Putting the Charter into Practice Donatella Lippi , GianFranco Gensini , and Andrea A. Conti Charter on Medical Professionalism: Putting the Charter into Practice Neil J. Smelser Charter on Medical Professionalism: Putting the Charter into Practice Jerome C. Arnett Jr. Charter on Medical Professionalism: Putting the Charter into Practice Sylvia L. Cruess and Richard L. Cruess Charter on Medical Professionalism: Putting the Charter into Practice Robert Feldman Charter on Medical Professionalism: Putting the Charter into Practice Walter J. McDonald Charter on Medical Professionalism: Putting the Charter into Practice Steven A. Wartman Charter on Medical Professionalism: Putting the Charter into Practice Jordan J. Cohen Charter on Medical Professionalism: Putting the Charter into Practice Yevgeniya Nusinovich Charter on Medical Professionalism: Putting the Charter into Practice Risa Lavizzo-Mourey Charter on Medical Professionalism: Putting the Charter into Practice Richard L. Cruess and Sylvia L. Cruess Charter on Medical Professionalism: Putting the Charter into Practice Christopher J. Lyons Professionalism and the Medical Student Nancy R. Angoff Providing High-Value, Cost-Conscious Care Christine K. Cassel Providing High-Value, Cost-Conscious Care Steven E. Weinberger Can the Practice of Retainer Medicine Improve Primary Care? Martin T. Donohoe Metrics Cited byA scoping review on the relationship between mental wellbeing and medical professionalismEmergency physician professionalism versus wellness: A conceptual modelSystem Citizenship: Re-Envisioning the Physician Role as Part of the Sixth Wave of ProfessionalismRECALMIN IV. Evolución de la actividad de las unidades de medicina interna del Sistema Nacional de Salud (2008-2021)RECALMIN IV. Evolution in the activity of internal medicine units of the National Health System (2008–2021)Should a patient’s socioeconomic status count in decisions about treatment in medical care? A longitudinal study of Norwegian doctorsValidity and reliability of the Professionalism Assessment Scale in Turkish medical studentsRelevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials“It really puts me in a bind”, professionalism dilemmas reported by Chinese residentsShared Decision MakingLos fundamentos del profesionalismo en medicinaImplementation of an Online Reporting System to Identify Unprofessional Behaviors and Mistreatment Directed at Trainees at an Academic Medical CenterNational Health Policy Leadership Program for General InternistsProfessionalism in dentistry: deconstructing common terminologyMedical in the Program during the a study about and the development of new and a of the for patient assessment of medical professionalism a setting how of medical professional are The of a a study on in beyond integrity and curriculum on informed toward persons with of or A into medical professionalism among medical students and new physicians in a of a based clinical program to reduce professional and social a in of the on Medical of Professionalism: A on on the of Physician care in a clinical and informed Professionalism in Medical and Medical of in of current and for the de las en de la de Physician to the of Health and with for medical school after in A and in Policy for of the A me do change and the different of a to Health for Health in the and ethical systems for but to The of Medical the and among of a Cancer the Relationships between the and and or to Care views and of professionalism mental health services patients and of at the of by of and The of A to Professional and to Clinical Practice and and Medical and Society Each A on Medical Society and is A the Role in a Leadership The de de and of medical professionalism for and de do a de of the of and in of a Medical School in Medicine of to Medical in Clinical A Professionalism in the of Clinical Care in Medical More Academic A by and Unprofessional on for Health Care and of the of Health for the and health patient and as an in Medical and and of role of social in the relationship between physician and professionalism of of Unprofessional by Physicians and Practice of in a based on clinical role of medical students training in respect for patient and a of the Care a and of for among medical and in medical a study of its with professionalism are the of Care and of Health for in Health a of Health Medical Society for Medicine Principles for the of Medicine in of Medical Professionalism among Medical in of a of in clinical learning on Medical Board as a for of Professionalism in Medical care needs of persons with and their A scoping of of Professional professionalism and a of from to of healthcare leaders in with physicians an of in Medical of in Medical a Medical students American Association and American College of on Professionalism

Editorials21 September 2004Clinical Trial Registration: A Statement from the International Committee of Medical Journal EditorsFREECatherine De Angelis, MD, MPH, Jeffrey M. Drazen, MD, Frank A. Frizelle, MBChB, MMedSc, FRACS, Charlotte Haug, MD, PhD, MSc, John Hoey, MD, Richard Horton, FRCP, Sheldon Kotzin, MLS, Christine Laine, MD, MPH, Ana Marusic, MD, PhD, A. John P.M. Overbeke, MD, PhD, Torben V. Schroeder, MD, DMSc, Harold C. Sox, MD, and Martin B. Van Der Weyden, MDCatherine De Angelis, MD, MPH, Jeffrey M. Drazen, MD, Frank A. Frizelle, MBChB, MMedSc, FRACS, Charlotte Haug, MD, PhD, MSc, John Hoey, MD, Richard Horton, FRCP, Sheldon Kotzin, MLS, Christine Laine, MD, MPH, Ana Marusic, MD, PhD, A. John P.M. Overbeke, MD, PhD, Torben V. Schroeder, MD, DMSc, Harold C. Sox, MD, and Martin B. Van Der Weyden, MDAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-141-6-200409210-00109 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Altruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants. In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product.Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making. Researchers (and journal editors) are generally most enthusiastic about the publication of trials that show either a large effect of a new treatment (positive trials) or equivalence of two approaches to treatment (noninferiority trials). Researchers (and journals) typically are less excited about trials that show that a new treatment is inferior to standard treatment (negative trials) and even less interested in trials that are neither clearly positive nor clearly negative, since inconclusive trials will not in themselves change practice. Irrespective of their scientific interest, trial results that place financial interests at risk are particularly likely to remain unpublished and hidden from public view. The interests of the sponsor or authors notwithstanding, anyone should be able to learn of any trial's existence and its important characteristics.The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice. Rather than a single trial, it is usually a body of evidence, consisting of many studies, that changes medical practice. When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy. If all trials are registered in a public repository at their inception, every trial's existence is part of the public record and the many stakeholders in clinical research can explore the full range of clinical evidence. We are far from this ideal at present, since trial registration is largely voluntary, registry data sets and public access to them vary, and registries contain only a small proportion of trials. In this editorial, published simultaneously in all member journals, the International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal.The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment prior to this date, the ICMJE member journals will require registration by September 13, 2005, before considering the trial for publication. We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies. For this purpose, the ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (for example, phase I trials), would be exempt.The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable. An acceptable registry must include at minimum the following information: a unique identifying number, a statement of the intervention (or interventions) and comparison (or comparisons) studied, a statement of the study hypothesis, definitions of the primary and secondary outcome measures, eligibility criteria, key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last follow-up, planned or actual date of closure to data entry, and date trial data considered complete), target number of subjects, funding source, and contact information for the principal investigator. To our knowledge, at present, only www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets these requirements; there may be other registries, now or in the future, that meet all these requirements.Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials. Research sponsors may argue that public registration of clinical trials will result in unnecessary bureaucratic delays and destroy their competitive edge by allowing competitors full access to their research plans. We argue that enhanced public confidence in the research enterprise will compensate for the costs of full disclosure. Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance this goal.Catherine De Angelis, MD, MPH, Editor-in-Chief, Journal of the American Medical AssociationJeffrey M. Drazen, MD, Editor-in-Chief, The New England Journal of MedicineProfessor Frank A. Frizelle, MBChB, MMedSc, FRACS, Editor, The New Zealand Medical JournalCharlotte Haug, MD, PhD, MSc, Editor-in-Chief, Norwegian Medical JournalJohn Hoey, MD, Editor, Canadian Medical Association JournalRichard Horton, FRCP, Editor, The LancetSheldon Kotzin, MLS, Executive Editor, MEDLINE; National Library of MedicineChristine Laine, MD, MPH, Senior Deputy Editor, Annals of Internal MedicineAna Marusic, MD, PhD, Editor, Croatian Medical JournalA. John P.M. Overbeke, MD, PhD, Executive Editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine)Torben V. Schroeder, MD, DMSc, Editor, Journal of the Danish Medical AssociationHarold C. Sox, MD, Editor, Annals of Internal MedicineMartin B. Van Der Weyden, MD, Editor, The Medical Journal of AustraliaCatherine De Angelis, MD, MPHEditor-in-Chief, Journal of the American Medical AssociationJeffrey M. Drazen, MDEditor-in-Chief, The New England Journal of MedicineProfessor Frank A. Frizelle, MBChB, MMedSc, FRACSEditor, The New Zealand Medical JournalCharlotte Haug, MD, PhD, MScEditor-in-Chief, Norwegian Medical JournalJohn Hoey, MDEditor, Canadian Medical Association JournalRichard Horton, FRCPEditor, The LancetSheldon Kotzin, MLSExecutive Editor, MEDLINE; National Library of MedicineChristine Laine, MD, MPHSenior Deputy Editor, Annals of Internal MedicineAna Marusic, MD, PhDEditor, Croatian Medical JournalA. John P.M. Overbeke, MD, PhDFrom Executive Editor, Nederlands Tijdschrift voor Geneeskunde.Torben V. Schroeder, MD, DMScEditor, Journal of the Danish Medical AssociationHarold C. Sox, MDEditor, Annals of Internal MedicineMartin B. Van Der Weyden, MDEditor, The Medical Journal of Australia Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAuthors: Catherine De Angelis, MD, MPH; Jeffrey M. Drazen, MD; Frank A. Frizelle, MBChB, MMedSc, FRACS; Charlotte Haug, MD, PhD, MSc; John Hoey, MD; Richard Horton, FRCP; Sheldon Kotzin, MLS; Christine Laine, MD, MPH; Ana Marusic, MD, PhD; A. John P.M. Overbeke, MD, PhD; Torben V. Schroeder, MD, DMSc; Harold C. Sox, MD; Martin B. Van Der Weyden, MDAffiliations: Corresponding Author: Customer Service, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoRegistration of Clinical Trials Alain Braillon , Gérard Dubois , and Michel Slama Registration of Clinical Trials Christine Laine and Harold C. Sox International Committee of Medical Journal Editors' Definition of a Clinical Trial Christine Laine Metrics Cited byHas the degree of outcome reporting bias in surgical randomized trials changed? 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Bledsoe, MD, for the ACP Ethics, Professionalism and Human Rights Committee*A Risk-Based Paradigm of Biomarkers in Clinical TrialsInteresting TimesThe enforcement of mandatory disclosure rulesAn observational analysis of discontinuation and non-publication of osteoarthritis trialsDifferences between protocols for randomized controlled trials and systematic reviewsA mapping of 115,000 randomized trials revealed a mismatch between research effort and health needs in non–high-income regionsPublication of Randomized Clinical Trials in Pediatric ResearchOpen season: positive changes for increased transparency in the biomedical literatureKeeping a watchful eye on the food giants and cleansing the temple of nutritional medicine and epidemiologyThe Role and Importance of Clinical Trial Registries and Results DatabasesClinical trial registry use in anaesthesiology systematic reviewsData Escrow and Clinical Trial TransparencyHarlan M. Krumholz, MD, SM and Jeanie Kim, JDPublication Rates of Abstracts Presented at the Society of General Internal Medicine Annual MeetingPhase-II trials in osteosarcoma recurrences: A systematic review of past experienceOn Fishing for Significance and Statistician's Degree of Freedom in the Era of Big Molecular DataThe method of systematic review for clinical guidelinesA metadata schema for data objects in clinical researchRandomized trials in top dermatological journals, 2009-13Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reportingApplication of an automated natural language processing (NLP) workflow to enable federated search of external biomedical content in drug discovery and developmentCONSORT and clinical trial reporting: room for improvementDeveloping timely insights into comparative effectiveness research with a text-mining pipelineThe Changing Geography of Clinical Research: A Critical Analysis of Its DriversManaging the incidence of selective reporting bias: a survey of Cochrane review groupsConsiderations from the risk of bias perspective for updating Cochrane reviewsRegistration status and outcome reporting of trials published in core headache medicine journalsPeer reviewDo surgery journals insist on reporting by CONSORT and PRISMA? A follow-up survey of 'instructions to authors'Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological studyStandardization of Patient Outcomes Reporting in Percutaneous NephrolithotomyDesign and execution of clinical trials in orthopaedic surgeryMaking Prospective Registration of Observational Research a RealityReplication and the Manufacture of Scientific Inferences: A Formal ApproachElectromagnetic fields for treating osteoarthritisHow Psychiatry Journals Support the Unbiased Translation of Clinical Research. A Cross-Sectional Study of Editorial PoliciesIntegrated disease management interventions for patients with chronic obstructive pulmonary diseaseEuropean Union Clinical Trials Register: on the way to more transparency of clinical trial dataPRAISE (Prospective Randomized Amlodipine Survival Evaluation) and Criticism ∗What If We Were Texas Sharpshooters? Predictor Reporting Bias in Regression AnalysisLearning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study)Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical dataOpen-access clinical trial registries: the Italian scenarioPublishing Results of Clinical Trials and Reviewing Papers for PublicationTrial registration in Latin America and the Caribbean's: study of randomized trials published in 2010Normative arguments and new solutions for the unbiased registration and publication of clinical trialsThe Growth of Clinical Trials and Systematic Reviews in Informing Dermatological Patient CareAmerican College of Physicians Ethics Manual Sixth EditionLois Snyder, JD, for the American College of Physicians Ethics, Professionalism, and Human Rights Committee*The Role and Importance of Clinical Trial Registries and Results DatabasesRegistration and Reporting Guidelines for Clinical TrialsDisclosure of Investigators' Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research TransparencyWalking the talk: the need for a trial registry for development interventionsLimited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseasesIntegrated disease management interventions for patients with chronic obstructive pulmonary diseaseRegistration of epidemiological studies: benefits and risksWorldwide Clinical Interventional Studies on Leading Causes of Death: A Descriptive AnalysisWorldwide Behavioral Research on Major Global Causes of MortalityZur Ethik einer restriktiven Regulierung der StudienregistrierungReporting of noninferiority trials was incomplete in trial registriesEarly phase drugs and biologicals clinical trials on worldwide leading causes of death: a descriptive analysisBest Practice in Systematic Reviews: The Importance of Protocols and RegistrationBotulinum toxin injection for tennis elbowObstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trialsInfluence of trial registration on reporting quality of randomized trials: Study from highest ranked journalsRCT of urethral versus suprapubic catheterizationCONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized TrialsKenneth F. Schulz, PhD, MBA, Douglas G. Altman, DSc, and David Moher, PhD, for the CONSORT Group*Implementing registries and results databases of clinical trials: is there a side effect?Can Clinical Trial Results Databases and Manuscripts Coexist?ReferencesClinical Trial Overview and Enrollment«Conflict of Interest» oder Interesse am Konflikt? Vom Umgang mit Erkenntnis und Interesse in der MedizinPrimary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS)Missing a critical piece of the pie: simple document search strategies inadequate for systematic reviewsTrials, tricks and transparency: How disclosure rules affect clinical knowledgeJournal of Foot and Ankle Research, one year onOutcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label UseBidirectional Conflicts of Interest Involving Industry and Medical Journals: Who Will Champion Integrity?The Role of Conflict of Interest in Reporting of Scientific InformationPharmaceutical Product Liabilities: A Review of Current Status and Future TrendsSubmission of clinical studies to ethics committees or clinical trials registers: the authors' point of viewAssessment of registration quality of trials sponsored by ChinaGuidelines, Consensus Conferences and Overviews (Meta-analysis)Developing a Research GroupThe Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian TrialsWar, enmity, and statistical tablesEndorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'War, Enmity, and Statistical TablesPoor Reporting of Scientific Leadership Information in Clinical Trial RegistersDo we learn the right things from clinical trials?A perspective on risks that impede development of drugs to modify the course of Alzheimer's disease: Can they be reduced?Do trialists endorse clinical trial registration? Survey of a Pubmed sampleReview of new regulations for the conduct of clinical trials of investigational medicinal productsRegistro dos ensaios clínicosPaliperidone: quo vadis?Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial designPeer review policies and theCanadian Journal of Anesthesia: an update for authors and readersReported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000–2005Clinical research design and reporting: always room for improvement!Quality assessment of randomized controlled trials in the treatment of hepatocellular carcinomaNew regulatory rules for clinical trials in the United States and the European Union: Key points and comparisonsThe Editor as umpire: clinical trial registration and dispute resolutionQuality of Trials in a Systematic Review of Powered Toothbrushes: Suggestions for Future Clinical TrialsThe need to register clinical trials in orthodonticsClinical trial data: to disclose or not to disclose?International Committee of Medical Journal Editors' Definition of a Clinical TrialChristine Laine, MD, MPH, Senior Deputy EditorIs This Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors*Catherine D. De Angelis, MD, MPH, Jeffrey M. Drazen, MD, Frank A. Frizelle, MB, ChB, MMedSc, FRACS, Charlotte Haug, MD, PhD, MSc, John Hoey, MD, Richard Horton, FRCP, Sheldon Kotzin, MLS, Christine Laine, MD, MPH, Ana Marusic, MD, PhD, A. John P.M. Overbeke, MD, PhD, Torben V. Schroeder, MD, DMSc, Harold C. Sox, MD, and Martin B. Van Der Weyden, MDAnnals 2004–2005: A Peek Back and a Look ForwardThe EditorsRegistration of Clinical TrialsAlain Braillon, MD, Gérard Dubois, MD, and Michel Slama, MDRegistro (de ensayos clínicos) sin fronteras 21 September 2004Volume 141, Issue 6Page: 477-478KeywordsClinical trial reportingClinical trialsHealth careHeartInformation storage and retrievalLibrariesPharmacokineticsResearch ethicsToxicityTreatment guidelines ePublished: 21 September 2004 Issue Published: 21 September 2004 PDF downloadLoading ...

This is the fourth in a series of papers describing the burden of cardiovascular disease (CVD) within Europe.1–3 CVD remains the most common cause of death worldwide, with the 2013 Global Burden of Disease (GBD) study estimating that CVD caused 17.3 million deaths globally. It accounted for 31.5% of all deaths and 45% of all non-communicable disease deaths, more than twice that caused by cancer, as well as more than all communicable, maternal, neonatal and nutritional disorders combined. The 2013 GBD also reported that CVD caused a greater number of deaths and was responsible for a greater percentage of all deaths than in 1990 when 12.3 million deaths were attributed to CVD, corresponding to 25.9% of total deaths.4 Previous publications in this series have reported that despite the decreases in CVD mortality in Europe more than 4 million people die from CVD across the continent every year, with more than 1.4 million dying prematurely, before the age of 75 years.1–3 In this article we present an updated overview of the burden of CVD in Europe, including new statistics for mortality, morbidity, and treatment. Where possible we provide statistics for all CVD and for coronary heart disease (CHD) and stroke in particular. All data included here are updated from previous publications and we present prevalence statistics for the first time. This series of publications describing the current burden and distribution of CVD and CHD in Europe has been based on the European Cardiovascular Disease Statistics 2012 report,5 the fourth in a series of Europe-wide compendia, which was published jointly by the European Heart Network and the European Society of Cardiology. Throughout this article, we present statistics from a number of data sources chosen with consideration of data quality, date of most recent update, and coverage of the European region. Rather than collected data from individual countries we utilized major data sources which make their statistics publically available. Specifically, we aimed to obtain data for as many European countries as possible from as recently as possible. In order to present data on CVD throughout Europe, with a particular focus on the two most common forms of CVD: CHD and stroke, we identified international sources that collect and report comparable data for a number of countries. Commonly, such sources are updated through routine and administrative data collections and provide an overview of the burden and distribution of CVD in Europe through the mortality, morbidity, and treatment associated with CVD across the continent. However, these data sources generally rely on individual countries to provide the data they collate, this means that in some cases the data that we obtain from a central source, in order to be consistent and comparable between countries and across Europe, may not be as up to date as could be obtained from some individual countries’ own databases. In this article, we define Europe as the 53 member states of the World Health Organization (WHO) European region. There were no ‘ideal’ data sources that provided complete, up-to-date, high-quality, and representative information for all 53 countries for any topic in this overview and comparability and quality of the data varies by topic. We also present data for EU-15 countries, those in the European Union (EU) prior to the accession of 10 candidate countries on 1 May 2004: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, UK, and the EU-28 countries which include these 15 countries and the 13 additional countries which have subsequently joined the EU: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia. Mortality data come from the WHO Mortality Database using the most recent (25 November 2015) update of age- and cause-specific mortality data, and age-specific population data, by country.6 All analyses, interpretations, and conclusions are those of the authors, not the WHO, which is responsible only for the provision of the original information. The WHO database collates data reported by national authorities based on their civil registration systems and contains data for 52 of 53 European countries, with no data available for Andorra. Age-standardized rates can only be calculated where data on the absolute number of an outcome and the population are available in comparable age-specific aggregates. Where rates are presented for the ‘most recent year’, this relates to the most recent data for which both mortality and population data were available. Mortality data for Turkmenistan, for example, are now available for 2013, but the most recent population data come from 1998, hence rates for this country are from the earlier year. For one country (Monaco), although mortality data were available, no population data were. These could not, therefore, be used in the presentation of age-standardized death rates (ASDRs) but were included in the calculations for total number of deaths and premature deaths in Europe. In order to calculate rates, population data from the same database were applied to these mortality data and were standardized using the 2013 European Standard Population (ESP). The 2013 ESP was developed by the European Commission for the EU27 + European Free Trade Association countries as an update to the 1976 ESP, to reflect the current age structure of the present European population.7 On average, when using the same data, CHD ASDRs for European countries calculated using the 2013 ESP are around twice as large as those calculated using the previous (1976) ESP.8 This means that although comparisons can be made within this study between countries in which ASDRs have been calculated using the same 2016 ESP, comparisons cannot be made to other studies, including earlier papers from this series, which have used the 1976 ESP to calculate standardized rates. WHO mortality and population data are relatively up to date, with the most recent data for only 11 of the 52 countries dating from 2010 or before; however, data from five countries were not available for any years more recent than 2005: Albania (2004), San Marino (2005), Tajikistan (2004), Turkmenistan (1998), and Uzbekistan (2005). Mortality rates are presented for CVD and CHD for all ages and for those under the ages of 65 and 75 years separately; deaths before these ages are often described as premature or preventable. Morbidity data come from the WHO9 and the European Social Survey.10 Disability-adjusted life years (DALYs) are available for the entire WHO European Region from the WHO’s Health Statistics and Information Systems11 and allow for a comparison of disease burden between both countries and conditions. One DALY is equivalent to 1 year of healthy life lost and is a composite measure of years of life lost due to death from a condition and years lived with disability due to a condition. The WHO has calculated DALYs for all conditions and all countries using estimates that draw on the methods used by the GBD project.9 Prevalence data come from the European Social Survey.10 This is a European Commission-funded cross-sectional survey that is repeated every 2 years with face-to-face data collection. Using random probability methods, samples are drawn from each participating country and aim to be representative of all people aged 15 and over in that country. Data are only available for selected countries that participated in the 2014 survey. The question relating to CVD prevalence was included in 2014 in the ‘health inequalities’ module and asked people to recall if they had had any health problems listed on a showcard in the last 12 months; with heart or circulation problems as an option. Hospital discharge data come from the WHO European Region’s Health for All Database.12 Data are sourced from the national registries of each country and provide an indication of the burden of CVD on health services within European countries. In addition to discharge data, the average length of stay in hospitals (ALOS) is often regarded as a good indicator of health service efficiency. The Organization for Economic Co-operation and Development (OECD) presents the ALOS as the mean number of days that patients spend in hospital.13 ALOS is generally measured by dividing the total number of days stayed by all patients during a year by cause-specific admissions or discharges. The data cover all inpatient cases with the exception of the Netherlands where data refer to curative acute care only, resulting in an under estimation. The OECD also presents 30-day case-fatality rate as a percentage of people aged 45 and over who die within 30 days following admission to hospital for acute myocardial infarction (AMI) and ischaemic stroke (IS), which represents around 85% of all cerebrovascular disease cases. The OECD presents case fatality through ‘admission-based’ and ‘patient-based’ data.13 Admission-based data refer to deaths occurring in the same hospital as the initial admission. Rates based on patient data refer to a death occurring in the same hospital, a different hospital, or out of hospital. This indicator is more robust because it captures fatalities more comprehensively. More countries can report the same-hospital ‘admission-based’ measure, with ‘patient-based’ data requiring a unique patient identifier and linked data which are not currently available in all countries. Admissions resulting in a transfer were excluded for some countries. This exclusion generally increases the case-fatality rate compared with those countries which do not exclude these transfers.13 Using the latest available data, CVD causes more than 4 million deaths each year across Europe, accounting for 45% of all deaths. CHD and cerebrovascular disease were the most common causes of CVD deaths, accounting for 1.8 million and 1.0 million deaths, respectively. The number of deaths from CVD is higher in women (2.2 million) than men (1.8 million), with CVD accounting for 49% of all deaths in women and 40% of all deaths in men. With similar numbers of men and women dying from CHD, these sex differences arise from a greater number of women dying from cerebrovascular disease and ‘other cardiovascular diseases’ (Table1, Figure1). Proportion of all deaths due to major causes in Europe, latest available year, among men (A) and women (B). Note: No data are available for Andorra. Source: WHO Mortality Database. Number and percentage of deaths from CVDs in Europe—latest available yeara Latest available years for each country are the same as those presented in Table2, except for: Albania (2009), Lithuania (2013), Monaco (1987), Slovakia (2014), Tajikistan (2005), and Turkmenistan (2013). No data are available for Andorra. Source: WHO Mortality Database. Although more than three-fifths of all CVD deaths occur in those over the age of 75 years, 1.4 million people under the age of 75 and just under 700 000 under the age of 65 die from CVD in Europe each year. More men (0.9 million) than women (0.5 million) die from CVD before the age of 75, however due to the greater number of total premature deaths in men CVD accounts for a similar proportion of deaths before 75 years in both sexes. The observed sex differences in number of deaths are greater at younger ages, with more than twice as many men than women dying from CVD under the age of 65. The greatest differences between the sexes in number of premature deaths are found for CHD, despite similar numbers of CHD deaths for all ages in men and women (Table1). Large differences in the burden of CVD between countries in the European Region remain. Of the 3.8 million total deaths in the EU-15 countries, 33% of these were caused by CVD (1.3 million), compared with 38% of deaths in the EU-28 countries (1.9 million) and 54% of deaths in non-EU member countries (2.1 million). In countries of the EU-15, ASDRs for CVD in men, calculated using the 2013 ESP (ESP13), ranged from 275.2/100 000 men in to 000 in and women from 000 women in to 000 in In the additional countries to the EU-15 ASDRs ranged from 000 men in to 000 men in and in women from 000 women in to 000 in of the to those which had data from 2010 or had the of rates. CVD ASDRs for men in these countries ranged from 000 in to 000 in For CVD ASDRs in non-EU countries ranged from 000 in to 000 in All countries for which data from 2010 were not available were from the ASDRs from CVD and CHD by country and sex 000 rate for most recent year of data and percentage in rates over 10 years Rates are not available for Monaco due to population No mortality data are available for Andorra. Age-standardized to the 2013 European Standard not available. in rates for is over 11 years due to data for the year 10 years Source: WHO Mortality Database. in rates were found for premature In the EU-15, of deaths under the age of 75 years were from CVD million with ASDRs for this age in men from 000 men in to 000 in and in women from 000 women in to 000 in In the of deaths under the age of 75 years were from CVD million with ASDRs from additional countries to the EU-15 from 000 men in to 000 men in and from 000 women in to 000 women in In non-EU countries, of deaths under the age of 75 (1.3 million were from CVD, with ASDRs countries which had data from 2010 or from 000 men in to 000 in For women CVD ASDRs in non-EU countries ranged from 000 women in to 000 in the of CVD mortality rates under 65 years similar but at rates ASDRs calculated for the most recent year to those for 10 years as a percentage of the earlier year, most of the countries in the European decreases in ASDRs for CVD and CHD from The were which reported an in CHD ASDRs over 10 years for both sexes and the Czech that a in CHD Although other countries reported increases in rates for both CVD and CHD these were within countries recent data, latest available year of data was before such as The decreases in ASDRs over 10 years between countries. In the EU-15, decreases the latest year in CVD ASDRs in men ranged from in to in and in women from in to in In the decreases in CVD from additional countries to the EU-15 ranged from in Slovakia to in and in women from in Slovakia to in the Czech In non-EU countries, CVD decreases ranged from in to in and in women from in to in a of the observed decreases in CVD, a number of countries now a greater number of deaths from than from CVD despite accounting for than the number of deaths than CVD in Europe as a to the most recent data more men die from than CVD in 12 countries and in two countries for All of these countries are in Europe as by the GBD with of the 12 countries from the This from CVD to as the most common cause of death for men was first in in 1998, with the only other country to it before the year There were two countries in which more than CVD for both with this occurring in the same year in and years in countries in which CVD as the most common cause of death also now have higher of to CVD deaths, that of an burden of mortality compared with CVD mortality this The year the higher absolute number of deaths from CVD to by of to CVD deaths, by sex and European country. Note: and same year and similar are only included for countries in which the number of deaths from is greater than the number of deaths from CVD for women as well as and Data for all other countries, those a are for men Source: WHO Mortality Database. European countries where the number of deaths the number of deaths from CVD for men and women Disability-adjusted life years are a composite measure of years of life lost due to death from a condition and years lived with disability due to a condition. One DALY is equivalent to 1 year of healthy life rates of WHO estimates for the number of DALYs to CVD in 2012 for European countries were in the with only five countries CVD DALYs population of more than and countries had DALYs attributed to CVD of and More DALYs were attributed to CVD and CHD in men than women in all countries, with Tajikistan the only country in which women greater DALYs due to CVD than men. No country reported more DALYs for women than men for however this not for stroke, with similar number of countries higher DALYs for each of the sexes DALYs population for all cardiovascular coronary heart disease and stroke, WHO European Region Source: World Health Health Statistics and Information DALYs population by cause and WHO European Region 2012 Source: World Health Health Statistics and Information prevalence of people heart or circulation problems in the last 12 in the European Social for all countries was the same for both sexes at There were five countries in which more than of men reported heart or circulation the Netherlands and This was the case for women in and countries reported a prevalence for men, and the Czech and for the Czech and of population heart or circulation problems in the last 12 by country and sex Note: to for for Source: European Social Data Data Social Data and of data for of population heart or circulation problems in the last 12 by country and sex 2014 Note: to for for Source: European Social Data Data Social Data and of data for The WHO collates data on rates of hospital for CVD, CHD, and The rates of were in available year with hospital for CVD 000 this a from The of countries had an in rates from the year For CHD, the was with around of countries an in rates and the other a For stroke, of the 52 countries increases in rates. It be that the data are not therefore, in rates over and differences between countries could be due to differences and in population age Hospital for CVD, CHD, and cerebrovascular disease 000 by to latest year to Cardiovascular disease data and to CHD and cerebrovascular disease data countries from Source: World Health Organization for Europe. European Health for All Database.12 had the case standardized to the 2010 OECD population aged for both and measured through and Although were greater than for all countries and both disease countries not provide data and one country not present any data The case fatalities for were found in and and the was found in two other countries had an case fatality for and and were the only countries to have case fatality for and all reported case fatalities On average, case fatality was for than However, countries had case fatalities that were greater for than the Netherlands, UK, Spain, Finland, Germany, and rates and stroke, latest year, by country rate the percentage of people aged 45 and over who die within 30 days following admission to hospital for a acute condition. rates have been standardized to the 2010 OECD population Admission-based rates refer to death occurring in the same hospital as the initial admission. rates refer to death occurring in the same hospital as the initial a different hospital, or out of hospital. average for and Admissions resulting in a transfer are Source: OECD Health Statistics OECD European countries the average length of stay (ALOS) following was with the ALOS found in and with Slovakia the only other country to report an ALOS than days ALOS following was in Germany, the only country to report an ALOS of more than 10 days and were the only other countries to report ALOS of than days length of hospital stay following latest year, by country length of stay (ALOS) the mean number of days the patients spend in hospital. cases. Data cover all inpatient cases with the exception of the admission cases are not all inpatient cases. Source: OECD Health Statistics Mortality statistics that CVD remains the most common cause of death in Europe, accounting for 45% of all 49% of deaths among women and 40% among men. More than 4 million people die from CVD across Europe every year, with 1.4 million of these deaths before the age of 75 There remains of across Europe in the burden of CVD mortality and the in rates of death from these In this article we that with the higher rates found in Europe, as in the member countries, on average, a burden from CVD mortality, with EU-15 countries that have been of the the on average the In addition the 12 countries in which the mortality burden from CVD such that the number of deaths from CVD is than that from in men, with the two countries in which this has in are all found in Europe. Although death rates for all countries were age-standardized for and across it be that these rates are only standardized for the age structure of the population and do not other of these For example, and other of population structure may between countries and across the years of data presented but these are not accounted for when using the The burden of CVD in Europe is not to mortality and this is the first in this series of papers that we present data on DALYs and presented here as population rates, were higher in European however, as these rates are not standardized for age or some differences may be due to different population between countries. The European Social data from on they have heart or circulation problems and large in prevalence between countries. It be that prevalence estimates can be to recall and higher prevalence may also be an indication of more and of these conditions in the such that it not for CVD, which may cause a large burden to countries. In although the European Social to report they have these problems in the 12 it may not for who have CVD which provide a more measure of those who have from heart or circulation or who are it may report that they do not currently such In as is no measure of the problems in the 12 or this cannot be used as a measure of With such prevalence and data from a central the survey the data we have rates an burden of CVD in health systems despite mortality rates. between countries in rates of discharge may be a of health service and as well as CVD It is by not only the quality of care provided in hospitals but also differences in hospital average length of and of condition on number of can to including to acute of and health for and can differences between countries in length of stay following CVD In addition to the of the these are also to reflect differences in and In order to ALOS many countries have a number of including of in hospital methods, and for hospitals to the of care across treatment and The average length of stay (ALOS) in hospitals is often regarded as a good indicator of health as in a burden on the health service of that country. However, although a has been found between average hospital and ALOS following an ALOS could also cause on health that of may only or In a such as can have a on patients and they may not be for discharge at if no have In addition to the of the data described in the and the of this article is that it to be a data on CVD in Europe, to provide an overview of the burden of CVD across the continent. It therefore, some of the in CVD that are presented throughout In as the study not have to the data on many we are not to present on the of all the statistics we present In where we do report data and using or age-standardized population rates, we cannot for and other of population This latest update on the of CVD within Europe presents new on the in CVD described through mortality, morbidity, and treatment throughout Europe. This for more in and countries and the of data to make comparisons on mortality and between countries, in order that can be to In particular and prevalence data across Europe are in comparison to mortality statistics and these with data on the burden of CVD, CVD conditions that are currently not identified by health services or within national be to and those in is available at European Heart and from the Heart is by an of

When I took over the editorial office of the European Heart Journal in the autumn of 2002 the flow of papers was mainly handled manually, and online submission did not even exist. Today more papers are read on the website of the journal than on paper, and an efficient electronic platform distributes manuscripts for review around the world in a few seconds. The use of the internet had a tremendous impact on the review process and the speed of publication. This is not the end of the electronic revolution. Let me give you one example. Even today, most papers are published several months (and, in the case of a cumbersome review, sometimes a year) after submission, thus hampering progress especially in rapidly evolving fields. Furthermore, debates on important published study results usually take place at meetings or webcasts organized several months after publication. Writing a letter to the editor is another possible way of commenting on published results, but few people read these letters besides the correspondent and the authors of the paper involved. It seems therefore likely that, in the future, authors may want to discuss their work with colleagues on a website, similar to Facebook, which could become a kind of electronic journal club allowing discussions among researchers shortly after publication. Other electronic revolutions are pending, and journals, medical societies, and industry will have to take advantage of these opportunities. A departing editor is usually allowed to give some reflections. These 6 years of editorship have been both challenging and very stimulating. I started the job without any experience. In his last editorial the famous editor of the BMJ, Richard Smith, wrote: ‘One day you're a professor of cardiology, the next—without any training and often little support—you're the editor of a million pound journal: it wouldn't be possible the other way around’. This is exactly what happened to me. I learned a lot during my editorship. Not only from the submitted research itself but also from the people who performed it and the ‘circumstances’ in which it was carried out. What has become very clear to me, and I fully realize that this is stating the obvious, is that the selection of the best papers and thus the scientific value of a journal is critically dependent on the peer-review process. This process, rightly called ‘sacred’ by Richard Smith, is far from perfect, sometimes biased, and often much delayed, upsetting authors (and editors). Yet I strongly believe it is the best available system and that there is no alternative. Putting papers on a (public) website without peer-review will undermine the credibility of research. Good reviewers are able to detect fraud or subtle duplicate publications (as I sometimes witnessed during my editorship). I also believe that all papers should undergo a careful statistical review before being accepted. Using inappropriate statistical analyses is a kind of hidden (intentional or unintentional) fraud. Reflecting on the European Heart Journal, I am pleased with what has been achieved over the last 6 years (see Table). Although it has never been our intention to ‘beat’ the AHA and ACC journals, it is fair to say that ESC leaders and editors of ESC journals are a bit frustrated that the best papers always go first to the USA, including those authored by Europeans. European authors should not be criticized for this as authors always try to get their papers published in the best journals. The bottom line is that it is up to the ESC and the editors of the ESC journals to make their journals better and more attractive to authors. This process will require a lot of effort (and money). With the support of the ESC and the publisher, Oxford Journals, the European Heart Journal has come a long way and has now become a major player in the field of clinical cardiology, and we are very pleased to have contributed to this progress. *There are an additional 5000 institutions with access to the Journal. *There are an additional 5000 institutions with access to the Journal. Running this journal would never have been possible without the invaluable help of my deputy editors: Stefan Janssens, Frank Rademakers, Johan Vanhaecke, and, for a few years, also George Sutherland, and of all the associate editors at the university of Leuven. Special thanks go to Ann Belmans for excellent and very tough statistical reviews (sometimes at the despair of the authors), and to Inge Hödl, Anita Meuris, and Roos Struyven for running the editorial office. Tom Lüscher and his team will take over the journal. They have already received all the new submissions since 1 October 2008. Tom Lüscher has vast experience with handling cardiovascular research papers as an associate editor of Circulation. I am sure new important initiatives will be taken by him. I am convinced that I leave the journal in the best of hands.

Published research in English-language journals are increasingly required to carry a statement that the study has been approved and monitored by an Institutional Review Board in conformance with 45 CFR 46 standards if the study was conducted in the United States. Alternative language attesting conformity with the Helsinki Declaration is often included when the research was conducted in Europe or elsewhere. The Helsinki Declaration was created by the World Medical Association in 1964 (ten years before the Belmont Report) and has been amended several times. The Helsinki Declaration differs from its American version in several respects, the most significant of which is that it was developed by and for physicians. The term "patient" appears in many places where we would expect to see "subject." It is stated in several places that physicians must either conduct or have supervisory control of the research. The dual role of the physician-researcher is acknowledged, but it is made clear that the role of healer takes precedence over that of scientist. In the United States, the federal government developed and enforces regulations on researcher; in the rest of the world, the profession, or a significant part of it, took the initiative in defining and promoting good research practice, and governments in many countries have worked to harmonize their standards along these lines. The Helsinki Declaration is based less on key philosophical principles and more on prescriptive statements. Although there is significant overlap between the Belmont and the Helsinki guidelines, the latter extends much further into research design and publication. Elements in a research protocol, use of placebos, and obligation to enroll trials in public registries (to ensure that negative findings are not buried), and requirements to share findings with the research and professional communities are included in the Helsinki Declaration. As a practical matter, these are often part of the work of American IRBs, but not always as a formal requirement. Reflecting the socialist nature of many European counties, there is a requirement that provision be made for patients to be made whole regardless of the outcomes of the trial or if they happened to have been randomized to a control group that did not enjoy the benefits of a successful experimental intervention.

BACKGROUND: One of the most consistent findings from clinical and health services research is the failure to translate research into practice and policy. As a result of these evidence-practice and policy gaps, patients fail to benefit optimally from advances in healthcare and are exposed to unnecessary risks of iatrogenic harms, and healthcare systems are exposed to unnecessary expenditure resulting in significant opportunity costs. Over the last decade, there has been increasing international policy and research attention on how to reduce the evidence-practice and policy gap. In this paper, we summarise the current concepts and evidence to guide knowledge translation activities, defined as T2 research (the translation of new clinical knowledge into improved health). We structure the article around five key questions: what should be transferred; to whom should research knowledge be transferred; by whom should research knowledge be transferred; how should research knowledge be transferred; and, with what effect should research knowledge be transferred? DISCUSSION: We suggest that the basic unit of knowledge translation should usually be up-to-date systematic reviews or other syntheses of research findings. Knowledge translators need to identify the key messages for different target audiences and to fashion these in language and knowledge translation products that are easily assimilated by different audiences. The relative importance of knowledge translation to different target audiences will vary by the type of research and appropriate endpoints of knowledge translation may vary across different stakeholder groups. There are a large number of planned knowledge translation models, derived from different disciplinary, contextual (i.e., setting), and target audience viewpoints. Most of these suggest that planned knowledge translation for healthcare professionals and consumers is more likely to be successful if the choice of knowledge translation strategy is informed by an assessment of the likely barriers and facilitators. Although our evidence on the likely effectiveness of different strategies to overcome specific barriers remains incomplete, there is a range of informative systematic reviews of interventions aimed at healthcare professionals and consumers (i.e., patients, family members, and informal carers) and of factors important to research use by policy makers. SUMMARY: There is a substantial (if incomplete) evidence base to guide choice of knowledge translation activities targeting healthcare professionals and consumers. The evidence base on the effects of different knowledge translation approaches targeting healthcare policy makers and senior managers is much weaker but there are a profusion of innovative approaches that warrant further evaluation.

BACKGROUND: It is widely acknowledged that there is a global divide on health care and health research known as the 10/90 divide. METHODS: A retrospective survey of articles published in the BMJ, Lancet, NEJM, Annals of Internal Medicine & JAMA in a calendar year to examine the contribution of the developing world to medical literature. We categorized countries into four regions: UK, USA, Other Euro-American countries (OEAC) and (RoW). OEAC were European countries other than the UK but including Australia, New Zealand and Canada. RoW comprised all other countries. RESULTS: The average contribution of the RoW to the research literature in the five journals was 6.5%. In the two British journals 7.6% of the articles were from the RoW; in the three American journals 4.8% of articles were from RoW. The highest proportion of papers from the RoW was in the Lancet (12%). An analysis of the authorship of 151 articles from RoW showed that 104 (68.9%) involved authorship with developed countries in Europe or North America. There were 15 original papers in these journals with data from RoW but without any authors from RoW. CONCLUSIONS: There is a marked under-representation of countries in high-impact general medical journals. The ethical implications of this inequity and ways of reducing it are discussed.

BACKGROUND: This study aims to review the literature regarding the barriers to sampling, recruitment, participation, and retention of members of socioeconomically disadvantaged groups in health research and strategies for increasing the amount of health research conducted with socially disadvantaged groups. METHODS: A systematic review with narrative synthesis was conducted. Searches of electronic databases Medline, PsychInfo, EMBASE, Social Science Index via Web of Knowledge and CINHAL were conducted for English language articles published up to May 2013. Qualitative and quantitative studies as well as literature reviews were included. Articles were included if they reported attempts to increase disadvantaged group participation in research, or the barriers to research with disadvantaged groups. Groups of interest were those described as socially, culturally or financially disadvantaged compared to the majority of society. Eligible articles were categorised according to five phases of research: 1) sampling, 2) recruitment and gaining consent, 3) data collection and measurement, 4) intervention delivery and uptake, and 5) retention and attrition. RESULTS: In total, 116 papers from 115 studies met inclusion criteria and 31 previous literature reviews were included. A comprehensive summation of the major barriers to working with various disadvantaged groups is provided, along with proposed strategies for addressing each of the identified types of barriers. Most studies of strategies to address the barriers were of a descriptive nature and only nine studies reported the results of randomised trials. CONCLUSIONS: To tackle the challenges of research with socially disadvantaged groups, and increase their representation in health and medical research, researchers and research institutions need to acknowledge extended timeframes, plan for higher resourcing costs and operate via community partnerships.

The main aim of the trial was to determine whether drug treatment of mild hypertension (phase V diastolic pressure 90-109 mm Hg) reduced the rates of stroke, of death due to hypertension, and of coronary events in men and women aged 35-64 years. Subsidiary aims were: to compare the course of blood pressure in two groups, one taking bendrofluazide and one taking propranolol, and to compare the incidence of suspected adverse reactions to these two drugs. The study was single blind and based almost entirely in general practices; 17 354 patients were recruited, and 85 572 patient years of observation have accrued. Patients were randomly allocated at entry to take bendrofluazide or propranolol or placebo tablets. The primary results were as follows. The stroke rate was reduced on active treatment: 60 strokes occurred in the treated group and 109 in the placebo group, giving rates of 1.4 and 2.6 per 1000 patient years of observation respectively (p less than 0.01 on sequential analysis). Treatment made no difference, however, to the overall rates of coronary events: 222 events occurred on active treatment and 234 in the placebo group (5.2 and 5.5 per 1000 patient years respectively). The incidence of all cardiovascular events was reduced on active treatment: 286 events occurred in the treated group and 352 in the placebo group, giving rates of 6.7 and 8.2 per 1000 patient years respectively (p less than 0.05 on sequential analysis). For mortality from all causes treatment made no difference to the rates. There were 248 deaths in the treated group and 253 in the placebo group (rates 5.8 and 5.9 per 1000 patient years respectively). Several post hoc analyses of subgroup results were also performed but they require very cautious interpretation. The all cause mortality was reduced in men on active treatment (157 deaths versus 181 in the placebo group; 7.1 and 8.2 per 1000 patient years respectively) but increased in women on active treatment (91 deaths versus 72; 4.4 and 3.5 per 1000 patient years respectively). The difference between the sexes in their response to treatment was significant (p = 0.05). Comparison of the two active drugs showed that the reduction in stroke rate on bendrofluazide was greater than that on propranolol (p = 0.002). The stroke rate was reduced in both smokers and non-smokers taking bendrofluazide but only in non-smokers taking propranolol. This difference between the responses to the two drugs was significant (p = 0.03).(ABSTRACT TRUNCATED AT 400 WORDS)

The Clinical Practice Research Datalink (CPRD) is an ongoing primary care database of anonymised medical records from general practitioners, with coverage of over 11.3 million patients from 674 practices in the UK. With 4.4 million active (alive, currently registered) patients meeting quality criteria, approximately 6.9% of the UK population are included and patients are broadly representative of the UK general population in terms of age, sex and ethnicity. General practitioners are the gatekeepers of primary care and specialist referrals in the UK. The CPRD primary care database is therefore a rich source of health data for research, including data on demographics, symptoms, tests, diagnoses, therapies, health-related behaviours and referrals to secondary care. For over half of patients, linkage with datasets from secondary care, disease-specific cohorts and mortality records enhance the range of data available for research. The CPRD is very widely used internationally for epidemiological research and has been used to produce over 1000 research studies, published in peer-reviewed journals across a broad range of health outcomes. However, researchers must be aware of the complexity of routinely collected electronic health records, including ways to manage variable completeness, misclassification and development of disease definitions for research.

The European Hernia Society (EHS) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS. They are evidence-based and, when necessary, a consensus was reached among all members. The Guidelines have been reviewed by a Steering Committee. Before finalisation, feedback from different national hernia societies was obtained. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) instrument was used by the Cochrane Association to validate the Guidelines. The Guidelines can be used to adjust local protocols, for training purposes and quality control. They will be revised in 2012 in order to keep them updated. In between revisions, it is the intention of the Working Group to provide every year, during the EHS annual congress, a short update of new high-level evidence (randomised controlled trials [RCTs] and meta-analyses). Developing guidelines leads to questions that remain to be answered by specific research. Therefore, we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment. In addition, a short summary, specifically for the general practitioner, is given. In order to increase the practical use of the Guidelines by consultants and residents, more details on the most important surgical techniques, local infiltration anaesthesia and a patient information sheet is provided. The most important challenge now will be the implementation of the Guidelines in daily surgical practice. This remains an important task for the EHS. The establishment of an EHS school for teaching inguinal hernia repair surgical techniques, including tips and tricks from experts to overcome the learning curve (especially in endoscopic repair), will be the next step. Working together on this project was a great learning experience, and it was worthwhile and fun. Cultural differences between members were easily overcome by educating each other, respecting different views and always coming back to the principles of evidence-based medicine. The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

Graves' orbitopathy (GO) is the main extrathyroidal manifestation of Graves' disease (GD). Choice of treatment should be based on the assessment of clinical activity and severity of GO. Early referral to specialized centers is fundamental for most patients with GO. Risk factors include smoking, thyroid dysfunction, high serum level of thyrotropin receptor antibodies, radioactive iodine (RAI) treatment, and hypercholesterolemia. In mild and active GO, control of risk factors, local treatments, and selenium (selenium-deficient areas) are usually sufficient; if RAI treatment is selected to manage GD, low-dose oral prednisone prophylaxis is needed, especially if risk factors coexist. For both active moderate-to-severe and sight-threatening GO, antithyroid drugs are preferred when managing Graves' hyperthyroidism. In moderate-to-severe and active GO i.v. glucocorticoids are more effective and better tolerated than oral glucocorticoids. Based on current evidence and efficacy/safety profile, costs and reimbursement, drug availability, long-term effectiveness, and patient choice after extensive counseling, a combination of i.v. methylprednisolone and mycophenolate sodium is recommended as first-line treatment. A cumulative dose of 4.5 g of i.v. methylprednisolone in 12 weekly infusions is the optimal regimen. Alternatively, higher cumulative doses not exceeding 8 g can be used as monotherapy in most severe cases and constant/inconstant diplopia. Second-line treatments for moderate-to-severe and active GO include (a) the second course of i.v. methylprednisolone (7.5 g) subsequent to careful ophthalmic and biochemical evaluation, (b) oral prednisone/prednisolone combined with either cyclosporine or azathioprine; (c) orbital radiotherapy combined with oral or i.v. glucocorticoids, (d) teprotumumab; (e) rituximab and (f) tocilizumab. Sight-threatening GO is treated with several high single doses of i.v. methylprednisolone per week and, if unresponsive, with urgent orbital decompression. Rehabilitative surgery (orbital decompression, squint, and eyelid surgery) is indicated for inactive residual GO manifestations.

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years (DALYs) in Europe, and is also increasingly common in developing countries.1 In the European Union, the economic cost of CVD represents annually E192 billion1 in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. These guidelines deal with the management of dyslipidaemias as an essential and integral part of CVD prevention. Prevention and treatment of dyslipidaemias should always be considered within the broader framework of CVD prevention, which is addressed in guidelines of the Joint European Societies’ Task forces on CVD prevention in clinical practice.2 – 5 The latest version of these guidelines was published in 20075; an update will become available in 2012. These Joint ESC/European Atherosclerosis Society (EAS) guidelines on the management of dyslipidaemias are complementary to the guidelines on CVD prevention in clinical practice and address not only physicians [e.g. general practitioners (GPs) and cardiologists] interested in CVD prevention, but also specialists from lipid clinics or metabolic units who are dealing with dyslipidaemias that are more difficult to classify and treat.

Cancer initiates from the transformation of normal living cells into malignant cells via a multistage event that usually advances from a pre-cancerous phase to a malignant tumour. Anti-metastatic drugs or anti-neoplastic drugs prevent and regulate the growth of onco cells. Based on the mode of drugs, the universally anticancer drugs market is categorized into cytotoxic,

BACKGROUND: Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery. METHODS: In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. RESULTS: Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. CONCLUSIONS: In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).

BACKGROUND: The Danish National Patient Registry (DNPR) is one of the world's oldest nationwide hospital registries and is used extensively for research. Many studies have validated algorithms for identifying health events in the DNPR, but the reports are fragmented and no overview exists. OBJECTIVES: To review the content, data quality, and research potential of the DNPR. METHODS: We examined the setting, history, aims, content, and classification systems of the DNPR. We searched PubMed and the Danish Medical Journal to create a bibliography of validation studies. We included also studies that were referenced in retrieved papers or known to us beforehand. Methodological considerations related to DNPR data were reviewed. RESULTS: During 1977-2012, the DNPR registered 8,085,603 persons, accounting for 7,268,857 inpatient, 5,953,405 outpatient, and 5,097,300 emergency department contacts. The DNPR provides nationwide longitudinal registration of detailed administrative and clinical data. It has recorded information on all patients discharged from Danish nonpsychiatric hospitals since 1977 and on psychiatric inpatients and emergency department and outpatient specialty clinic contacts since 1995. For each patient contact, one primary and optional secondary diagnoses are recorded according to the International Classification of Diseases. The DNPR provides a data source to identify diseases, examinations, certain in-hospital medical treatments, and surgical procedures. Long-term temporal trends in hospitalization and treatment rates can be studied. The positive predictive values of diseases and treatments vary widely (<15%-100%). The DNPR data are linkable at the patient level with data from other Danish administrative registries, clinical registries, randomized controlled trials, population surveys, and epidemiologic field studies - enabling researchers to reconstruct individual life and health trajectories for an entire population. CONCLUSION: The DNPR is a valuable tool for epidemiological research. However, both its strengths and limitations must be considered when interpreting research results, and continuous validation of its clinical data is essential.