We are happy to announce the metamorphosis of the Southern Med Review (SMR) into the Journal of Pharmaceutical Policy and Practice[1-3]. As an open access journal published by BioMed Central [4-7], Journal of Pharmaceutical Policy and Practice (JoPPP) will reach a greater number of readers. Open access will lead to a wider readership, higher downloads, higher citations, and a higher Impact Factor [7-9]. Articles are archived in PubMed Central, and other freely accessible full-text repositories which also extends the access by readership. While rejoicing the start of an exciting new phase, it seems appropriate to review where we have come from and where are we heading with this new Journal. The first issue (Vol 1 Issue 1) of SMR was published on 23rd Dec 2008 [1,2]. Since its beginning, nine issues have been published which include a total of 70 articles. Issues covered have included medicines access (governance, development and pharmaceutical systems, pharmacoeconomics, medicine pricing policies, patents and TRIPS, and affordability) as well as medicines use (socio behavioural aspects of medicine use, pharmacoepidemiology, pharmacovigilance, drug utilization studies, pharmacy practice issues and concerns) [1]. The main aim of SMR was to promote pharmaceutical policy research from low and middle income countries - a job which the journal did well. SMR provided opportunity and support to emerging researchers with 30 to 40% of the contributors being first time authors [1]. The journal also published studies on the pharmaceutical situation of countries where little or no pharmaceutical literature is available e.g. Slovenia, Macedonia and Afghanistan [10-12]. SMR was commended by the World Health Organisation (WHO) and its policy impact was evident from published studies which were instrumental in changes in the medicines pricing policies of Vietnam and Thailand [13]. Now the journal is entering a new phase and is renamed the Journal of Pharmaceutical Policy and Practice (JoPPP) [3]. This change in title reflects a broadening in the remit of the Journal. As alluded to above, each word in the title of the new journal has been carefully selected and we have taken the opportunity to outline what these words mean to us and how we see them relating to the scope of JoPPP. SMR was an internationally focussed journal with a wide geographic and socioeconomic flavour; although most of the research centred on the developing world [1,2]. Academics residing in both the developed and the developing world generated interesting policy and practice related work; more often policy than practice! We expect that this will continue under the JoPPP flagship. However, in line with the broadening remit we expect to receive more pharmaceutical policy related work from those in high-income countries. The word Pharmaceutical was also chosen with care; to be intentionally broad and to differentiate from Pharmacy per se. The term pharmacy encompasses the physical structure of the community or hospital pharmacy and the practices within that. However, pharmacies are only one component of a larger complex health system which influences global access to, and use of, medicines. The term pharmaceutical encompasses pharmacy but is broader in that it involves wider aspects of medicines access and use including: technology, the pharmaceutical industry, other health professionals that influence use such as doctors and nurse prescribers and so forth. Pharmaceutical policy includes such areas as national pharmaceutical policy, pharmacoeconomics [14], regulatory affairs, pharmaceutical industry inspection; to name just a few examples. There do however remain many unanswered questions in the field of pharmaceutical policy. From a practice viewpoint, international policy has been churned out of government departments in high income countries; particularly in the commonwealth [15]. However, there is little understanding of the degree to which these policies are being adhered to and a global systematic review of international medicines policies at the level of the health system as a whole is yet to be undertaken. These are considerable tasks and country and/or continent level reviews of the status of pharmaceutical policy and practices would be useful. Defining what “Pharmaceutical Policy” is globally, and its scope as a concept and instrument for change across a range of country contexts, will be a sensible first step to doing this. Finally, adding the word ‘practice’ to the JoPPP title warrants consideration. There are a number of contexts that encompass pharmaceutical practice and we will be particularly interested in the studies related to community pharmacy setting. This could range from the papers discussing policies and their impact on pharmaceutical practice. Also, the interest would be in medicines compliance, concordance, rationale use of medicines, medicines use among minorities and the disadvantaged groups as well those in the disaster or conflict zones. We believe pharmaceutical policy is encompassing and directing activities which are related to access to medicines and their use. We look forward to receiving more of these papers as JoPPP continues to grow and morph. We encourage our readers to keep their contributions rolling in!
Journal of Women's HealthVol. 29, No. 4 CommentaryFree AccessSex and Gender Disparities in the COVID-19 PandemicJewel Gausman and Ana LangerJewel GausmanWomen & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.Search for more papers by this author and Ana LangerAddress correspondence to: Ana Langer, MD, Women & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 651 Huntington Avenue, FXB Building 6th Floor Office 643B, Boston, MA 02115 E-mail Address: [email protected]Women & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.Search for more papers by this authorPublished Online:17 Apr 2020https://doi.org/10.1089/jwh.2020.8472AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail In the case of the ongoing COVID-19 pandemic, sex-disaggregated data suggest that fewer women are dying from the disease than men.1 However, taking this observation at face value oversimplifies the biological, behavioral, and social and systemic factors that may cause differences to emerge with regard to how women and men experience both the disease and its consequences. As governments react with swift and severe measures in their ongoing fight to control the pandemic's spread, it is important to understand how these actions may disproportionately increase the risks for women both directly and indirectly with regard to sex and gender.Pregnant women are often among the most vulnerable groups during public health emergencies. In some cases, pregnant women face increased biological susceptibility to adverse health outcomes, as in the case of some respiratory infections. With other emergent coronaviruses, such as those responsible for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS), pregnant women who became infected were found to be more likely than nonpregnant women to experience severe complications.2 It is still too early to tell whether this will be the case with COVID-19.In the ongoing pandemic, other factors may have a ripple effect that put women at increased risk even if the disease itself does not. As made clear during the 2014 Ebola outbreak, the consequences of large-scale infectious disease outbreaks on uninfected pregnant women can be dire. Routine prenatal care appointments, if not interrupted or discontinued, may put women at increased risk of exposure to the virus. Overwhelmed hospitals struggling to function with staff and supply shortages may not be able to provide the high quality of care that all pregnant women and their newborns deserve, let alone respond to emergency obstetric complications. Furthermore, there is also a risk that life-saving treatments or vaccines will be denied to pregnant women over concern for fetal safety or a lack of data.3,4The fear of infection, concern for the well-being of friends and loved ones, uncertainty, disruption, and social isolation that have become part and parcel of daily life for many around the world will undoubtedly have profound effects on mental health on the population at large, but being pregnant during a global pandemic is likely to be even more frightening for many women. Although containment strategies, such as those that require women to deliver without a companion present, including partners and doulas, that have already been put into place in some cities in the United States,5 or those that separate newborns from their mothers immediately after birth if the mother is infected with COVID-196 may be clinically important to reduce transmission, they may also have profound short- and long-term mental health implications for women. Among women who have young children, previous research in Ethiopia, India, and Vietnam found that women who experience family-related stressful life events, such as illness or death within the household and financial uncertainty, are more likely to experience episodes of severe mental distress.7 With the ongoing need to social distance, family and community networks may struggle and pregnant and postpartum women may feel even more vulnerable and isolated over a lack of social support.The adverse effects of the pandemic in relation to women's reproductive health are not limited to pregnancy or motherhood. As movement restrictions are put into place, supply chains are disrupted, and businesses are shuttered, some women may be at increased risk of unintended pregnancy should it become difficult to obtain their regular contraceptive method or emergency contraceptives, if needed. Furthermore, some states within the United States have begun to impose restrictions on certain medical procedures that they deem to be elective, including abortion, suggesting they must be delayed until after the pandemic is over.8 Spikes in domestic violence during times of crisis are another area of grave concern for women's health, and as governments continue to put into place more extreme measures to enforce social distancing, for some women, more time at home may mean more time spent with an abusive partner. Fewer social interactions may also mean less accountability for perpetrators and fewer opportunities for others to intervene.Gender-related factors may also increase the impact of the COVID-19 pandemic on women globally. Women constitute a disproportionately high percentage of caregivers in both the formal and informal sectors.9 A large proportion of frontline health care professionals (nurses, community health workers, health technicians, etc.) is women who face a higher risk of infection, morbidity, and death as a result of their profession.9 At the same time, women more frequently serve as the primary caregivers within a household, which may further increase their risk of exposure. In the United States, 65% of unpaid family caregivers are estimated to be women and 80% of them care for someone aged 50 years or older.10 Outside of their caregiving role, women are overrepresented in the informal employment sector. In low-and middle-income countries, two-thirds of women who work do so as part of the informal economy with limited access to health care for themselves and their families.9 Containment and mitigation policies that limit women's ability to perform their duties without offering effective alternatives, such as closing of daycare facilities for their children or not providing paid sick leave, may result in unnecessary exposure to disease and increased family vulnerability.It is urgent that we adopt a gender lens to study the pandemic and its effects, including the policies and actions that are put into place at the global, country, and local levels. This may be especially important in disadvantaged populations and resource-poor communities, where women are especially vulnerable. The public health community must ensure that existing health and social services meant to support women in the face of their unique needs do not disappear in lieu of the all-encompassing focus on stopping the pandemic. Furthermore, we argue that special attention needs to be paid to ensure that informal caregivers are supported, informed, and protected. To avoid making existing gender disparities larger as a result of the pandemic, a special body at the U.S. Centers of Disease Control and Prevention is urgently needed to track sex disaggregated data and analyze policies related to COVID-19 using a gender lens.Author Disclosure StatementNo competing financial interests exist.Funding InformationNo funding was received for this article.References1. Cai H. Sex difference and smoking predisposition in patients with COVID-19. Lancet Respir Med 2020;pii: S2213-2600(20)30117-X. Medline, Google Scholar2. Favre G, Pomar L, Musso D, Baud D. 2019-nCoV epidemic: What about pregnancies? Lancet 2020;395:e40. Crossref, Medline, Google Scholar3. Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus disease 2019 (COVID-19) and pregnancy: What obstetricians need to know. Am J Obstet Gynecol 2020;pii: S0002-9378(20)30197-6. Medline, Google Scholar4. Weigel G. Novel coronavirus "COVID-19": Special considerations for pregnant women. Available at: https://www.kff.org/womens-health-policy/issue-brief/novel-coronavirus-covid-19-special-considerations-for-pregnant-women/?utm_source=Global+Health+NOW+Main+List Accessed March 17, 2020. Google Scholar5. Caron C, Syckle KV. Laboring alone: Some hospitals bar partners because of virus fears. The New York Times. 2020. Google Scholar6. American College of Obstetricians and Gynecologists. Practice advisory: Novel coronavirus 2019 (COVID-19). Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Novel-Coronavirus2019?IsMobileSet=false Accessed March 13, 2020. Google Scholar7. Gausman J, Austin SB, Subramanian S, Langer A. Adversity, social capital, and mental distress among mothers of small children: A cross-sectional study in three low and middle-income countries. PLoS One 2020;15:e0228435. Crossref, Medline, Google Scholar8. Tavernise S. Texas and Ohio include abortion as medical procedures that must be delayed. The New York Times. 2020. Google Scholar9. Langer A, Meleis A, Knaul FM, et al. Women and health: The key for sustainable development. Lancet 2015;386:1165–1210. Crossref, Medline, Google Scholar10. Feinberg L, Reinhard SC, Houser A, Choula R. Valuing the invaluable: 2011 update, the growing contributions and costs of family caregiving. Washington, DC: AARP Public Policy Institute, 2011:32. 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E. and April 2021 | Journal of Women's Health, Vol. 30, No. and of and in March 2021 | Medicine, Vol. No. impact of COVID-19 on the mental health of and Science & Medicine, Vol. of and with in April 2021 | Vol. 12, No. health and well-being of staff during the coronavirus disease 2019 4 and in an March 2021 | Journal of Vol. of Gender in the and of Coronavirus Disease 2019 An of Health and and March 2021 | Journal of Women's Health, Vol. 30, No. of the COVID-19 pandemic on and Vol. of COVID-19 and of and Public Health, Vol. No. cross-sectional study of the of and with perceptions of to March 2021 | Open, Vol. 11, No. research and social of health: at the of of impact on and of Clinical Medicine, Vol. 17, No. differences in responses to SARS-CoV-2 in patients with January 2021 | Reports, Vol. No. and to COVID-19 in and January 2021 | Policy and Practice, Vol. impact of COVID-19 among and of November | & Health, Vol. 26, No. in case and mortality of coronavirus disease 2019 (COVID-19) among states in the United November | of Medicine, Vol. No. and pandemic risk and fear among September 2021 | Health and Behavioral Medicine, Vol. No. June 2021 | Vol. No. of and with of Coronavirus Related September 2021 | Vol. a January 2021 | Cadernos de Saúde Vol. No. and Among Vol. of Psychological Distress and Factors among During the COVID-19 Pandemic at in March 2021 | Disease and Vol. and on During the COVID-19 Pandemic in of Social Media October 2021 | Journal of Medical Research, Vol. 23, No. and and attitudes, and practices toward COVID-19 among birth of and Health Vol. 10, No. the of in COVID-19 October | Health Vol. No. in the of COVID-19 and political Vol. services in times of in of quality care for pregnant women and their October | Health Care for Women Vol. No. social support in the face of the December | Journal of & Vol. 12, No. with fear and during the COVID-19 pandemic in October | and Health, Vol. 16, No. and of People from by December | Journal of in Health, and Education, Vol. 10, No. is in gender and age for COVID-19 A December | Journal of and Vol. No. of SARS-CoV-2 Among Nursing and in September | Journal of Medicine, Vol. No. role of in the severity of learned from Vol. on gender disparities in the impact of the U.S. COVID-19 Research, Vol. Gender Women's Health and October | Frontiers in Global Women's Health, Vol. and the risk to and women during Journal of Vol. No. With Disparities in COVID-19 Outcomes in an Health Care October | JAMA Network Open, Vol. No. in the time of in August | Vol. 17, No. de la en en por September | Vol. No. de la COVID-19 en la de September | Vol. No. Perspectives to Health Research and Prevention During the COVID-19 | and Health Vol. 24, No. and Disease Disparities in the United in Vol. No. for a to | Global Public Health, Vol. No. and of in September | Vol. 11, No. and What is the Vol. No. we in Covid-19 women and men Vol. in of COVID-19: Insights a Vol. No. will The need to for the research on and the role of and and Vol. Impact and Factors During the of the Coronavirus (COVID-19) Pandemic Among the Population in June | Frontiers in Psychology, Vol. and of and the in SARS-CoV-2 to the in May | International Journal of Sciences, Vol. No. Coronavirus Disease 2019 the of August | Vol. Gender of to in January | Vol. Social of Vol. of of and Digital Vol. this Gausman and Ana and Gender Disparities in the COVID-19 of Women's in April 17,
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. 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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
The Journal of Alternative and Complementary MedicineVol. 26, No. 5 CommentariesPublic Health Approach of Ayurveda and Yoga for COVID-19 ProphylaxisGirish Tillu, Sarika Chaturvedi, Arvind Chopra, and Bhushan PatwardhanGirish TilluAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.Search for more papers by this author, Sarika ChaturvediDr. D.Y. Patil Vidyapeeth (DPU), Pune, India.Search for more papers by this author, Arvind ChopraCenter for Rheumatic Diseases, Pune, India.Search for more papers by this author, and Bhushan PatwardhanAddress correspondence to: Bhushan Patwardhan, AYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India E-mail Address: [email protected]AYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.Search for more papers by this authorPublished Online:11 May 2020https://doi.org/10.1089/acm.2020.0129AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byDNA metabarcoding uncovers fungal communities in Zingiberis RhizomaChinese Herbal Medicines, Vol. 6"We are adapting to it because it is within us": The co‐becoming of COVID‐19 in Malawi20 December 2023 | World Medical & Health Policy, Vol. 5COVID-19 Cases and Comorbidities: Complementary and Alternative Medicinal Systems (CAM) for Integrated Management of the PandemicJournal of Herbal Medicine, Vol. 42Traditional Formulations for Managing COVID-19: A Systematic Review Rudra B. 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Mills14 July 2020 | The Journal of Alternative and Complementary Medicine, Vol. 26, No. 7AYUSH for COVID-19 managementJournal of Ayurveda and Integrative Medicine, Vol. 11, No. 2Indians vs.COVID-19: The scenario of mental healthSensors International, Vol. 1Preventive strategies to combat infections–a review of traditional practices and Ayurveda concepts1 January 2020 | International Journal of Complementary and Alternative Medicine, Vol. 13, No. 3COVID-19: A new horizon for ayurvedaAYUHOM, Vol. 7, No. 2Ayurveda: The promising shelter for the mankind in the wake of COVID-19 pandemicJournal of Ayurveda Case Reports, Vol. 3, No. 1Epidemic containment measures in Unani medicine and their contemporary relevanceJournal of Indian System of Medicine, Vol. 8, No. 2COVID 19 in ayurvedic perspectiveInternational Journal of Health & Allied Sciences, Vol. 9, No. 5 Volume 26Issue 5May 2020 InformationCopyright 2020, Mary Ann Liebert, Inc., publishersTo cite this article:Girish Tillu, Sarika Chaturvedi, Arvind Chopra, and Bhushan Patwardhan.Public Health Approach of Ayurveda and Yoga for COVID-19 Prophylaxis.The Journal of Alternative and Complementary Medicine.May 2020.360-364.http://doi.org/10.1089/acm.2020.0129Published in Volume: 26 Issue 5: May 11, 2020Online Ahead of Print:April 20, 2020 TopicsCOVID-19Yoga PDF download
The credibility of industry-sponsored clinical research has suffered in recent years, undercut by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest.1Bruyere O. Kanis J.A. Ibar-Abadie M.E. et al.The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Rest of Ethics and Excellent in Science (GREES).Osteopor Int. 2010; 21: 713-722Crossref PubMed Scopus (9) Google Scholar, 2Pyke S. Julious S.A. Day S. et al.The potential for bias in reporting of industry-sponsored clinical trials.Pharm Stats. 2011; 10: 74-79Crossref PubMed Scopus (14) Google Scholar In response, many pharmaceutical companies have integrated best practices and recommendations from groups such as the International Committee of Medical Journal Editors (ICMJE), the Good Publication Practice guidelines, the Committee on Publication Ethics, the EQUATOR (Enhancing the QUAlity and Transparency Of health Resources) Network, and the Medical Publishing Insights and Practices (MPIP) initiative into their internal policies and standard operating procedures.3Strahlman E. Rockhold F. Freeman A. Public disclosure of clinical research.Lancet. 2009; 373: 1319-1320Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar, 4PhRMA Principles on Conduct of Clinical Trials: Communication of Clinical Trial Results.http://www.phrma.org/sites/default/files/105/042009_clinical_trial_principles_final.pdfGoogle Scholar, 5AmgenAmgen Guidelines for Publications.http://www.amgen.com/about/amgen_guidelines_for_publications.htmlGoogle Scholar, 6AstraZenecaTransparency of Trial Information.http://www.astrazeneca.com/Responsibility/Research-ethics/Clinical-trials/Transparency-of-trial-informationGoogle Scholar, 7GlaxoSmithKlineReports and publications, Public policies, Disclosure of Clinical Trial Information.http://www.gsk.com/reportsandpublications-policies.htmGoogle Scholar, 8Johnson & JohnsonTransparency in Our Business Activities.http://www.jnj.com/connect/about-jnj/our-citizenship/transparency-in-our-business-activities/transparency+in+our+business+activitiesGoogle Scholar, 9MerckMerck Guidelines for Publication of Clinical Trials and Related Works.http://www.merck.com/research/discovery-and-development/clinical-development/Merck-Guidelines-for-Publication-of-Clinical-Trials-and-Related-Works.pdfGoogle Scholar, 10PfizerConducting Ethical Research – Registration, Disclosure, and Authorship.http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship.jspGoogle Scholar However, a credibility gap remains: some observers, including some journal editors and academic reviewers, maintain a persistent negative view of industry-sponsored studies.11Angell M. Industry-sponsored clinical research: a broken system.JAMA. 2008; 300: 1069-1071Crossref PubMed Scopus (187) Google Scholar Given industry's pivotal role in the development of new therapies, further improvements in research conduct and disclosure are needed across the industry-investigator-editor enterprise to restore confidence in industry-sponsored biomedical research. In 2008, the MPIP was founded by members of the pharmaceutical industry and the International Society for Medical Publication Professionals to elevate trust, transparency, and integrity in publishing industry–sponsored studies through education and creation of a discussion forum among industry research sponsors and biomedical journals.12Clark J. Gonzalez J. Mansi B. et al.Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative.Int J Clin Pract. 2010; 64: 1028-1033Crossref PubMed Scopus (8) Google Scholar, 13www.mpip-initiative.orgGoogle Scholar In 2010, the MPIP convened a roundtable of 23 journal editors and industry representatives (see the “Acknowledgments” section for a list of MPIP participants) to characterize the persistent and perceived credibility gap in industry-sponsored research and identify approaches to resolve it. Attendees agreed that there have been important improvements in the conduct and reporting of industry-sponsored studies during the past 5 years, but several opportunities remain for additional improvement. Attendees reached consensus on a top 10 list of recommendations (Table), intended to serve as a call to action for all stakeholders—authors, journal editors, research sponsors, and others—to enhance the quality and transparency of industry-sponsored clinical research reporting. Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source.TABLETop 10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research 1Ensure clinical studies and publications address clinically important questions2Make public all results, including negative or unfavorable ones, in a timely fashion, while avoiding redundancy3Improve understanding and disclosure of authors' potential conflicts of interest4Educate authors on how to develop quality manuscripts and meet journal expectations5Improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship6Report adverse event data more transparently and in a more clinically meaningful manner7Provide access to more complete protocol information8Transparently report statistical methods used in analysis9Ensure authors can access complete study data, know how to do so, and can attest to this10Support the sharing of prior reviews from other journals Open table in a new tab Many perceive a mismatch between the research hypotheses of some industry-sponsored studies and the needs of the public and practicing clinicians to improve patient health. The best way to elevate the credibility of industry-sponsored clinical research is to ensure that such research is designed to answer important clinical and scientific questions while respecting regulatory requirements that may influence certain aspects of study design. Credibility is compromised when clinical research is intended for marketing purposes rather than advancing scientific and medical knowledge. Sponsors could enhance transparency and credibility by better explaining to journals,14Clark S. Horton R. Putting research into context – revisited.Lancet. 2010; 376: 10-11Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar the biomedical community, and the public the decision-making process underlying the research endeavor. For example, sponsors could be more transparent in describing how external input and involvement from the academic community were obtained to inform study design (eg, by acknowledging participants in protocol development, advisory boards, and other roles). Many industry sponsors have committed to disclosing the results of all clinical studies through recognized trial registries. Complete and transparent disclosure is required by law in many regions, fulfills the ethical obligation to trial participants, and is critical to the advancement of science. The ability to cross-reference trial registries, results databases, and all related publications informs the scientific community whether studies are completed or are under way and discourages selective reporting. Several recent articles have highlighted that there is a persistent need for better disclosure of clinical trial results, irrespective of study sponsorship.15Lehman R. Loder E. Missing clinical trial data.BMJ. 2012; 344: d8158Crossref PubMed Scopus (43) Google Scholar, 16Prayle A.P. Hurley M.N. Smyth A.R. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.BMJ. 2011; 344: d7373Crossref Scopus (215) Google Scholar, 17Ross J.S. Tse T. Zarin D.A. et al.Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis.BMJ. 2011; 344: d7292Crossref Scopus (285) Google Scholar Whereas results from well-designed studies that are negative, confirmatory, inconclusive, or less immediately relevant to practicing clinicians can be particularly challenging to publish, these manuscripts can contribute toward the progress of science, may open the door for future research, and can prevent redundancy. Sponsors and authors should strive to disseminate them in appropriate venues, provided the data are put in context and the study limitations are clearly stated. This may require editors and publishers to explore and implement novel publication approaches well suited to these sorts of reports. Some possible approaches could include journals dedicated to these studies (perhaps in open-access format), abridged article formats more suitable to them, and/or specific reviewing mechanisms focused on scientific validity as opposed to “impact.” Many of these potential solutions are currently being explored and developed by journals and publishers.12Clark J. Gonzalez J. Mansi B. et al.Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative.Int J Clin Pract. 2010; 64: 1028-1033Crossref PubMed Scopus (8) Google Scholar Finally, sponsors and authors should avoid redundant or duplicate publications. As part of this effort, sponsors could support editors' educational efforts to combat plagiarism.18Fighting plagiarism [editorial].Lancet. 2008; 371: 2146Google Scholar Recent advances by academia, journals, and organizations such as the Institute of Medicine and ICMJE have improved processes for disclosing authors' potential conflicts of interest. Consensus among journal editors remains elusive on some specifics, such as the time frame for the reporting period and minimum amounts for financial reporting. These debates notwithstanding, however, editors and sponsors should support the use of the updated ICMJE Conflict of Interest Reporting Form19ICMJEUniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest.www.icmje.org/ethical_4conflicts.htmlGoogle Scholar and continue dialogue regarding its improvement. Furthermore, the same conflict of interest reporting standards should be applied uniformly to all authors, regardless of the source of research funding.20Lanier W.L. Bidirectional conflicts of interest involving industry and medical journals: who will champion integrity?.Mayo Clinic Proc. 2009; 84: 771-775Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar To further enhance disclosure transparency and reduce the administrative burden on authors, all parties should also explore the feasibility of developing a centralized, publicly accessible disclosure database.21Steinbrook R. Online disclosure of physician-industry relationships.N Engl J Med. 2009; 360: 325-327Crossref PubMed Scopus (30) Google Scholar Specific issues that need to be addressed include responsibility for quality control and maintenance, privacy/public data access issues, data ownership, and database funding. If these issues could be resolved, a digital database would provide an efficient and effective means of promoting transparent reporting. Ineffective or inappropriate reporting can diminish the value and credibility of clinical research. Authors who are well versed in study design, conduct, and analysis may lack formal writing training or knowledge of reporting guidelines such as the Consolidated Standards of Reporting Trials (CONSORT) requirements.22CONSORTThe CONSORT statement.www.consort-statement.org/consort-statementGoogle Scholar The experiences of editors and industry publication professionals suggest there is a large “information gap” in this regard, particularly related to authors' knowledge of key aspects of authorship that directly affect the quality and credibility of submitted manuscripts. Journals and research sponsors should collaborate to educate researchers and other groups who conduct or contribute to publication development, whether they work in industry, academia, or other venues. Best practice guides should be widely disseminated to industry and academic authors. For example, the MPIP's Authors' Submission Toolkit23Chipperfield L. Citrome L. Clark J. et al.Authors' Submission Toolkit: a practical guide to getting your research published.Curr Med Res Opin. 2010; 26: 1967-1982Crossref PubMed Scopus (45) Google Scholar can help authors navigate the manuscript development and submission process, and EQUATOR's author resource library can provide guidance on research reporting.24EQUATORResources for authors of research reports.www.equator-network.org/resource-centre/authors-of-research-reports/authors-of-research-reportsGoogle Scholar On the basis of author and editor feedback, additional materials or educational programs may be needed to supplement existing guidelines; editors and industry representatives should collaborate to identify specific areas of unmet need and develop educational resources to address them. Finally, editors have an additional opportunity and responsibility to expand their academic educational efforts and drive education within and among journals to encourage the harmonization of editorial policies and reviewer standards in line with evolving best practices. Research sponsors have improved their credibility significantly by incorporating into their policies and standard practices5AmgenAmgen Guidelines for Publications.http://www.amgen.com/about/amgen_guidelines_for_publications.htmlGoogle Scholar, 6AstraZenecaTransparency of Trial Information.http://www.astrazeneca.com/Responsibility/Research-ethics/Clinical-trials/Transparency-of-trial-informationGoogle Scholar, 7GlaxoSmithKlineReports and publications, Public policies, Disclosure of Clinical Trial Information.http://www.gsk.com/reportsandpublications-policies.htmGoogle Scholar, 8Johnson & JohnsonTransparency in Our Business Activities.http://www.jnj.com/connect/about-jnj/our-citizenship/transparency-in-our-business-activities/transparency+in+our+business+activitiesGoogle Scholar, 9MerckMerck Guidelines for Publication of Clinical Trials and Related Works.http://www.merck.com/research/discovery-and-development/clinical-development/Merck-Guidelines-for-Publication-of-Clinical-Trials-and-Related-Works.pdfGoogle Scholar, 10PfizerConducting Ethical Research – Registration, Disclosure, and Authorship.http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship.jspGoogle Scholar definitions of authorship and contributorship developed by ICMJE, the American Medical Writers Association, the European Medical Writers Association, and other professional bodies. Importantly, these definitions explicitly recognize the positive role that professional writers can play in manuscript development, provided they are appropriately acknowledged as authors or contributors (in accordance with ICMJE guidelines) and their names, affiliations, and potential conflicts of interest are disclosed.25Norris R. Bowman A. Fagan J.M. et al.International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer.Curr Med Res Opin. 2007; 23: 1837-1840Crossref PubMed Scopus (24) Google Scholar All parties must continue to work toward zero tolerance of ghostwriting (defined as failure to acknowledge individuals who helped write the paper) and guest authorship (defined as inclusion of individuals as authors who do not qualify because they do no meet ICMJE or journal criteria for authorship). Sponsors should ensure that employees' contributions are fully disclosed, using the same standards for employees and nonemployees. Such disclosure should be done without applying quotas of the maximum number of industry-employed authors or prespecified ratios of industry-employed to independent authors that would inappropriately exclude individuals who qualify for authorship or acknowledgment. For their part, journals need to eliminate any biases against manuscripts that have industry authors. Finally, sponsors, academic institutions, and editors should reinforce collaboratively the unacceptability of ghostwriting and guest authorship. There is an unmet need for better and more uniform reporting of adverse events. Although “no clinically significant adverse events” and “no unexpected adverse events” are common shorthand in journal articles, such phrases lack clinical relevance, particularly regarding rare adverse events that may be important for agents used over a long period in large populations. Editors, sponsors, and clinicians would benefit from consensus on more uniform reporting guidelines that clearly specify the type and format of adverse event data provided in the manuscript and/or supplemental material.26Ionnidis J.P.A. Evans S.J.W. Gøtzsche P.C. et al.Better reporting of harms in randomized trials: an extension of the CONSORT statement.Ann Intern Med. 2004; 141: 781-788Crossref PubMed Scopus (1103) Google Scholar In addition, journals may need to revisit their manuscript length policies if they wish this information to be present in the main document. Finally, editors and sponsors must educate authors on the need to balance the strength of adverse event claims vs the features and limitations of trial design appropriately. In a study that is not powered to assess rare adverse events, it is more appropriate to qualify the findings (eg, “additional severe adverse events were not detected in this short, small trial”) than to make broad statements that could mislead readers (eg, “generally safe and well tolerated”). Some journals request submission of a clinical study protocol to validate methods and end points used in submitted manuscripts, screen for analysis or reporting errors, confirm that the manuscript matches the protocol, and verify that any protocol amendments do not affect study conduct or integrity inappropriately.27Chan A.W. Bias, spin and misreporting: time for full access to trial protocols and results.PLoS Med. 2008; 5: e230Crossref PubMed Scopus (117) Google Scholar In addition, several journals post online complete protocols or excerpts together with the published manuscript to provide greater transparency and additional context to readers. Journals should describe their protocol submission requirements and publication policies in their instructions for authors and apply them irrespective of study sponsorship. Public dissemination of protocols by journals raises several practical issues that require further discussion. To foster development of effective policies on protocol disclosure, sponsors should engage with journals on the appropriate format and organization and the extent and legitimacy of redactions to protect proprietary intellectual property or other concerns. In addition, because study protocols are frequently amended as research progresses, disclosure of different versions in multiple public venues may create confusion and redundancy. Stakeholders should explore whether a single repository is feasible and meets the objective of transparency. Most journals assess statistical methods as a routine part of the peer review process, often relying on established reporting guidelines such as CONSORT.22CONSORTThe CONSORT statement.www.consort-statement.org/consort-statementGoogle Scholar Sponsors should ensure that authors provide adequate information about the chosen methods based on the prespecified study design and parameters, and how they were applied to the final data set. To enhance credibility, authors need to adhere to existing reporting standards, and editors have a responsibility to uniformly enforce these requirements at their journals. The issue of statistical analysis credibility warrants further discussion among editors, authors, and research sponsors to explore how journals can develop policies that raise standards for all clinical publications, independent of the financial support or authorship. Singling out industry-sponsored trials for additional statistical validation28Fontanarosa P.B. Flanagin A. DeAngelis C.D. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies.JAMA. 2005; 294: 110-111Crossref PubMed Scopus (116) Google Scholar unfairly implies that these studies' analyses are inherently deficient and deserve heightened scrutiny. The credibility of industry-sponsored research is threatened when authors cannot explain or defend key details of study design and analysis or verify access to raw data. Sponsors' letters of agreements with authors should clearly define authors' data access rights and expectations and their responsibility to understand and attest to them if required by journals. Industry sponsors need internal policies and procedures that facilitate data access for investigators and authors, and journals should unambiguously state their submission and publication policies on data access. Journals and sponsors should consider that data access needs may also differ, on study For example, the of data access and feasible for all authors may not be the same for a study as for a The MPIP's Authors' Submission authors, when a manuscript to to explore the of a of the prior manuscript and to that have been L. Citrome L. Clark J. et al.Authors' Submission Toolkit: a practical guide to getting your research published.Curr Med Res Opin. 2010; 26: 1967-1982Crossref PubMed Scopus (45) Google Scholar Although the practice is not uniformly at this some journals encourage the sharing of prior reviews on the that it transparency, and the quality of Given that there is no consensus among editors on whether to prior this should be by journals. journals that prior reviews must their policies clearly and their peer on how best to use them, and authors must be about how journals prior reviews into their decision-making These top 10 recommendations several opportunities to enhance the transparency and credibility of industry-sponsored clinical research. Sponsors must continue to best practice guidelines, them into their policies and and work with other and medical companies and professional organizations to ensure uniform should also drive author education efforts by guidelines and Editors must ensure their policies are transparent, well and uniformly applied irrespective of author or study sponsorship, and should their and role in promoting best practices.
Academia and Clinic18 August 2009Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA StatementFREEDavid Moher, PhD, Alessandro Liberati, MD, DrPH, Jennifer Tetzlaff, BSc, and Douglas G. Altman, DSc, the PRISMA Group*David Moher, PhDFrom Ottawa Methods Centre, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Università di Modena e Reggio Emilia, Modena, Italy; Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy; and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.Search for more papers by this author, Alessandro Liberati, MD, DrPHFrom Ottawa Methods Centre, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Università di Modena e Reggio Emilia, Modena, Italy; Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy; and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.Search for more papers by this author, Jennifer Tetzlaff, BScFrom Ottawa Methods Centre, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Università di Modena e Reggio Emilia, Modena, Italy; Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy; and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.Search for more papers by this author, and Douglas G. Altman, DScFrom Ottawa Methods Centre, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Università di Modena e Reggio Emilia, Modena, Italy; Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy; and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.Search for more papers by this author, the PRISMA Group*Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-151-4-200908180-00135 SectionsSupplemental MaterialAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Editor's Note: In order to encourage dissemination of the PRISMA Statement, this article is freely accessible on the Annals of Internal Medicine Web site (www.annals.org) and will be also published in PLOS Medicine, BMJ, Journal of Clinical Epidemiology, and Open Medicine. The authors jointly hold the copyright of this article. For details on further use, see the PRISMA Web site (www.prisma-statement.org).Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field (1, 2), and they are often used as a starting point for developing clinical practice guidelines. Granting agencies may require a systematic review to ensure there is justification for further research (3), and some health care journals are moving in this direction (4). As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews.Several early studies evaluated the quality of review reports. In 1987, Mulrow examined 50 review articles published in four leading medical journals in 1985 and 1986 and found that none met all eight explicit scientific criteria, such as a quality assessment of included studies (5). In 1987, Sacks and colleagues (6) evaluated the adequacy of reporting of 83 meta-analyses on 23 characteristics in six domains. Reporting was generally poor; between one and 14 characteristics were adequately reported (mean = 7.7; standard deviation = 2.7). A 1996 update of this study found little improvement (7).In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized, controlled trials (8). In this article, we summarize a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews (Box 1).Box 1. Conceptual Issues in the Evolution From QUOROM to PRISMA Download figure Download PowerPoint TerminologyThe terminology used to describe a systematic review and meta-analysis has evolved over time. One reason for changing the name from QUOROM to PRISMA was the desire to encompass both systematic reviews and meta-analyses. We have adopted the definitions used by the Cochrane Collaboration (9). A systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies.Developing the PRISMA StatementA three-day meeting was held in Ottawa, Ontario, Canada, in June 2005 with 29 participants, including review authors, methodologists, clinicians, medical editors, and a consumer. The objective of the Ottawa meeting was to revise and expand the QUOROM checklist and flow diagram, as needed.The executive committee completed the following tasks, prior to the meeting: a systematic review of studies examining the quality of reporting of systematic reviews, and a comprehensive literature search to identify methodological and other articles that might inform the meeting, especially in relation to modifying checklist items. An international survey of review authors, consumers, and groups commissioning or using systematic reviews and meta-analyses was completed, including the International Network of Agencies for Health Technology Assessment (INAHTA) and the Guidelines International Network (GIN). The survey aimed to ascertain views of QUOROM, including the merits of the existing checklist items. The results of these activities were presented during the meeting and are summarized on the PRISMA Web site (www.prisma-statement.org).Only items deemed essential were retained or added to the checklist. Some additional items are nevertheless desirable, and review authors should include these, if relevant (10). For example, it is useful to indicate whether the systematic review is an update (11) of a previous review, and to describe any changes in procedures from those described in the original protocol.Shortly after the meeting a draft of the PRISMA checklist was circulated to the group, including those invited to the meeting but unable to attend. A disposition file was created containing comments and revisions from each respondent, and the checklist was subsequently revised 11 times. The group approved the checklist, flow diagram, and this summary paper.Although no direct evidence was found to support retaining or adding some items, evidence from other domains was believed to be relevant. For example, Item 5 asks authors to provide registration information about the systematic review, including a registration number, if available. Although systematic review registration is not yet widely available (12, 13), the participating journals of the International Committee of Medical Journal Editors (ICMJE) (14) now require all clinical trials to be registered in an effort to increase transparency and accountability (15). Those aspects are also likely to benefit systematic reviewers, possibly reducing the risk of an excessive number of reviews addressing the same question (16, 17) and providing greater transparency when updating systematic reviews.The PRISMA StatementThe PRISMA Statement consists of a 27-item checklist (Table 1; see also Table S1, for a downloadable Word template for researchers to re-use) and a four-phase flow diagram (Figure 1; see also Figure S1, for a downloadable Word template for researchers to re-use). The aim of the PRISMA Statement is to help authors improve the reporting of systematic reviews and meta-analyses. We have focused on randomized trials, but PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions. PRISMA may also be useful for critical appraisal of published systematic reviews. However, the PRISMA checklist is not a quality assessment instrument to gauge the quality of a systematic review.Table 1. Checklist of Items to Include When Reporting a Systematic Review or Meta-AnalysisFigure 1. Flow of information through the different phases of a systematic review. Download figure Download PowerPoint From QUOROM to PRISMAThe new PRISMA checklist differs in several respects from the QUOROM checklist, and the substantive specific changes are highlighted in Table 2. Generally, the PRISMA checklist “decouples” several items present in the QUOROM checklist and, where applicable, several checklist items are linked to improve consistency across the systematic review report.Table 2. Substantive Specific Changes Between the QUOROM Checklist and the PRISMA ChecklistThe flow diagram has also been modified. Before including studies and providing reasons for excluding others, the review team must first search the literature. This search results in records. Once these records have been screened and eligibility criteria applied, a smaller number of articles will remain. The number of included articles might be smaller (or larger) than the number of studies, because articles may report on multiple studies and results from a particular study may be published in several articles. To capture this information, the PRISMA flow diagram now requests information on these phases of the review process.EndorsementThe PRISMA Statement should replace the QUOROM Statement for those journals that have endorsed QUOROM. We hope that other journals will support PRISMA; they can do so by registering on the PRISMA Web site. To underscore to authors, and others, the importance of transparent reporting of systematic reviews, we encourage supporting journals to reference the PRISMA Statement and include the PRISMA Web address in their instructions to authors. We also invite editorial organizations to consider endorsing PRISMA and encourage authors to adhere to its principles.The PRISMA Explanation and Elaboration PaperIn addition to the PRISMA Statement, a supporting Explanation and Elaboration document has been produced (18) following the style used for other reporting guidelines (19–21). The process of completing this document included developing a large database of exemplars to highlight how best to report each checklist item, and identifying a comprehensive evidence base to support the inclusion of each checklist item. The Explanation and Elaboration document was completed after several face-to-face meetings and numerous iterations among several meeting participants, after which it was shared with the whole group for additional revisions and final approval. Finally, the group formed a dissemination subcommittee to help disseminate and implement PRISMA.DiscussionThe quality of reporting of systematic reviews is still not optimal (22–27). In a recent review of 300 systematic reviews, few authors reported assessing possible publication bias (22), even though there is overwhelming evidence both for its existence (28) and its impact on the results of systematic reviews (29). Even when the possibility of publication bias is assessed, there is no guarantee that systematic reviewers have assessed or interpreted it appropriately (30). Although the absence of reporting such an assessment does not necessarily indicate that it was not done, reporting an assessment of possible publication bias is likely to be a marker of the thoroughness of the conduct of the systematic review.Several approaches have been developed to conduct systematic reviews on a broader array of questions. For example, systematic reviews are now conducted to investigate cost-effectiveness (31), diagnostic (32) or prognostic questions (33), genetic associations (34), and policy making (35). The general concepts and topics covered by PRISMA are all relevant to any systematic review, not just those whose objective is to summarize the benefits and harms of a health care intervention. However, some modifications of the checklist items or flow diagram will be necessary in particular circumstances. For example, assessing the risk of bias is a key concept, but the items used to assess this in a diagnostic review are likely to focus on issues such as the spectrum of patients and the verification of disease status, which differ from reviews of interventions. The flow diagram will also need adjustments when reporting individual patient data meta-analysis (36).We have developed an explanatory document (18) to increase the usefulness of PRISMA. For each checklist item, this document contains an example of good reporting, a rationale for its inclusion, and supporting evidence, including references, whenever possible. We believe this document will also serve as a useful resource for those teaching systematic review methodology. We encourage journals to include reference to the explanatory document in their Instructions to Authors.Like any evidence-based endeavor, PRISMA is a living document. To this end we invite readers to comment on the revised version, particularly the new checklist and flow diagram, through the PRISMA Web site. We will use such information to inform PRISMA's continued development.References1. Oxman AD, Cook DJ, Guyatt GH. Users' guides to the medical literature. VI. How to use an overview. Evidence-Based Medicine Working Group. JAMA. 1994;272:1367-71. [PMID: 7933399] CrossrefMedlineGoogle Scholar2. Swingler GH, Volmink J, Ioannidis JP. Number of published systematic reviews and global burden of disease: database analysis. BMJ. 2003;327:1083-4. [PMID: 14604930] CrossrefMedlineGoogle Scholar3. Canadian Institutes of Health Research. Randomized controlled trials registration/application checklist. December 2006. Accessed at www.cihr-irsc.gc.ca/e/documents/rct_reg_e.pdf on 19 May 2009. Google Scholar4. Young C, Horton R. Putting clinical trials into context. Lancet. 2005;366:107-8. [PMID: 16005318] CrossrefMedlineGoogle Scholar5. Mulrow CD. 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[PMID: CrossrefMedlineGoogle In to A Article, and Disclosure From Ottawa Methods Centre, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Università di Modena e Reggio Emilia, Modena, Italy; Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy; and Centre for Statistics in Medicine, University of Oxford, Oxford, United The following to the PRISMA Altman, DSc, Centre for Statistics in Medicine United PhD, University Hospital MD, Health Research & Health PLoS Medicine United PhD, Hospital of Ontario, A. & Research and PhD, PLoS Medicine the of United PhD, Cochrane Centre United and of and MD, of Medicine, Clinical Epidemiology and University Ontario, PhD, Università di Modena e Reggio and Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario J. PhD, University of United MD, PhD, of Medicine, Clinical Epidemiology and University Ontario, PhD, of Health MD, of and Medicine, University of MD, PhD, Medical United MD, The Cochrane Centre PhD, Ottawa Hospital Research Institute Ontario, MD, of Medicine, Clinical Epidemiology and University Ontario, PhD, United MD, University of MD, PhD, Systematic Reviews United and for Health and University of the and Alessandro Liberati, MD, Università di Modena e Reggio and Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario MD, Centre for the of the of Health PhD, The United MD, Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Moher, PhD, Ottawa Methods Centre, Ottawa Hospital Research Institute Ontario, MD, Annals of Internal Medicine for Medical MD, Health Research Centre Health and Technology Assessment Ontario, Canada; at the of the first meeting of the group, Ontario, MD, University of Hospital of Ontario, PhD, Health International G. MD, PhD, Evidence-Based Jennifer Tetzlaff, BSc, Ottawa Methods Centre, Ottawa Hospital Research Institute Ontario, The Cochrane Cochrane Collaboration United at the of the first meeting of the group, United and MD, Institute of University of Ottawa Ontario, PRISMA was by the Canadian Institutes of Health Università di Modena e Reggio Emilia, Italy; Research Clinical Evidence The Cochrane Collaboration; and Liberati is in through of the of University and Altman is by Research Moher is by a University of Ottawa Research of the any in the or of the PRISMA no a role in the Moher, PhD, Ottawa Methods Centre, Ottawa Hospital Research Institute, The Ottawa Ottawa, Canada; Moher and Ottawa Methods Centre, Ottawa Hospital Research Institute, The Ottawa Ottawa, Università di Modena e Reggio and Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Centre for Statistics in Medicine, University of Oxford, United of the PRISMA is in the PRISMA Statement for Reporting Systematic Reviews and of Studies Health Explanation and Elaboration Alessandro Liberati Douglas G. Altman Jennifer
Position Papers1 July 1995Economic Analysis of Health Care Technology: A Report on PrinciplesTask Force on Principles for Economic Analysis of Health Care Technology*Task Force on Principles for Economic Analysis of Health Care Technology*Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-123-1-199507010-00011 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail PreambleAlthough economic outcomes research is an evolving field in health services research, there are correct and incorrect ways to conduct and report on economic outcomes studies. Research practices that help to minimize real or perceived bias will increase the quality and usefulness of such studies for those who sponsor, publish, and use them. Because of public concerns about the potential for bias in the design, analysis, and reporting of economic analyses of health care technology, we formed a task force to develop principles to enhance the credibility of these studies. The Task Force on Principles for Economic Analysis of ...References1. Henry D. Economic analysis as an aid to subsidization decisions: the development of Australian guidelines for pharmaceuticals. PharmacoEconomics. 1992; 1:54-67. Google Scholar2. Detsky A. Guidelines for economic analysis of pharmaceutical products: a draft document for Ontario and Canada. PharmacoEconomics. 1993; 3:354-61. Google Scholar3. Udvarhelyi IS, Colditz GA, Rai A, Epstein AM. Cost-effectiveness and cost–benefit analyses in the medical literature. Are the methods being used correctly? Ann Intern Med. 1992; 116:238-44. Google Scholar4. Luce BR, Simpson K. Methods of cost effectiveness analysis: areas of consensus and debate. Clin Ther. 1995; 17:263-80. Google Scholar5. Drummond M, Brandt A, Luce B, Rovira J. Standardizing methodologies for economic evaluation in health care. Practice, problems, and potential. Int J Technol Assess Health Care. 1993; 9:26-36. Google Scholar6. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317:141-5. Google Scholar7. Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. JAMA. 1993; 269:2282-6. Google Scholar8. Angell M, Relman AS. Ethical imperialism? Fraud in biomedical research: a time for congressional restraint (Editorial). N Engl J Med. 1988; 318:1462-3. Google Scholar9. Engler RL, Covell JW, Friedman PJ, Kitcher PS, Peters RM. Misrepresentation and responsibility in medical research. N Engl J Med. 1987; 317:1383-9. Google Scholar10. Chalmers TC, Frank CS, Reitman D. Minimizing the three stages of publication bias. JAMA. 1990; 263:1392-5. Google Scholar11. Sharp DW. What can and should be done to reduce publication bias? The perspective of an editor. JAMA. 1990; 263:1390-1. Google Scholar12. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA. 1990; 263:1385-9. Google Scholar13. Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990; 263:1405-8. Google Scholar14. Schafer A. The ethics of the randomized clinical trial. N Engl J Med. 1982; 307:719-24. Google Scholar15. U.S. Public Health Service Panel on Cost-Effectiveness in Health and Medicine, Washington, D.C.: U.S. Public Health Service 1995. Google Scholar16. American Federation for Clinical Research National Council. American Federation for Clinical Research guidelines for avoiding conflict of interest. Clin Res. 1990; 38:239-40. Google Scholar17. Donaldson MS, Capron AM, eds. Patient Outcomes Research Teams: Managing Conflict of Interest. Washington, D.C.: National Academy Pr; 1991. Google Scholar18. American College of Physicians Ethics Manual. Part II: Research, other ethical issues. Recommended reading. Ad Hoc Committee on Medical Ethics, American College of Physicians. Ann Intern Med. 1984; 101:263-74. Google Scholar19. Institute of Medicine. The Responsible Conduct of Research in the Health Sciences: Report of a Study by a Committee on the Responsible Conduct of Research, Institute of Medicine, Division of Health Sciences Policy. Washington, D.C.: National Academy Pr; 1989. Google Scholar20. Korenman SG, Shipp AC. Teaching the Responsible Conduct of Research through a Case Study Approach: A Handbook for Instructors. Washington, D.C.: Association of American Medical Colleges; 1994; 191-5. Google Scholar21. Association of Academic Health Centers. Conflicts of Interest in Institutional Decision-Making: Task Force on Science Policy. Washington, D.C.: Association of Academic Health Centers; 1994. Google Scholar22. AFCR guidelines for the responsible conduct of research. Clin Res. 1989; 37:510-1. Google Scholar23. Harvard guidelines for investigators in scientific research. Clin Res. 1989; 37:192-3. Google Scholar24. Donaldson MS, Capron AM. Patient Outcome Research Teams: Managing Conflicts of Interest. Washington, D.C.: National Academy Pr; 1991. Google Scholar25. Hillman AL, Eisenberg JM, Pauly MV, Bloom BS, Glick H, Kinosian B, et al. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med. 1991; 324:1362-5. Google Scholar26. Drummond MF. Economic evaluation of pharmaceuticals: science or marketing? Pharmacoeconomics. 1992; 1:8-13. Google Scholar27. Freeman R. Health economics and strategic planning in pharmaceutical companies. Journal of Research in Pharmaceutical Economics. 1992; (In press). Google Scholar28. The Zitter Group. The HMO Outcomes Study. San Francisco: Center for Outcomes Information; 1991. Google Scholar29. Asch D. Opportunity and motive: conflicts of interest in industry-sponsored research. LDI Health Policy and Research Quarterly. 1981; 1:3. Google Scholar30. Kassirer JP, Angell M. The journal's policy on cost-effectiveness analyses (Editorial). N Engl J Med. 1994; 331:669-70. Google Scholar31. Hillman AL, Kim M. Decision-making in health care: discounting of life years revisited. PharmacoEconomics. 1994; 1995; 7:198-205. Google Scholar Author, Article, and Disclosure InformationAffiliations: Disclosure: The public announcement (at the time of a presentation or publication) of the evaluation and interpretation of the results of a study. Disclosure includes discussion of sources of possible bias, potential conflict of interest, relevant constraints imposed on investigators in their conduct or reporting of the study, the nature and amount of support received by the investigators, and other pertinent information necessary for full evaluation of the report.Corresponding Author: Alan L. Hillman, MD, MBA, Leonard Davis Institute of Health Economics, Center for Health Policy, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104-6218.Disclaimer: Some of the views expressed in this report do not necessarily reflect those of all individual members of the Task Force or their affiliated organizations. Individual members did not officially represent the affiliated organizations. 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No AccessDirections in Development - General1 Feb 2013Government-Sponsored Health Insurance in IndiaAre You Covered?Authors/Editors: Gerard La Forgia and Somil NagpalGerard La Forgia and Somil Nagpalhttps://doi.org/10.1596/978-0-8213-9618-6AboutView ChaptersPDF (4.8 MB)Other FormatsePUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookTwitterLinked In Abstract:This book presents research findings on India?s major central and state government-sponsored health insurance schemes (GSHISs). The analysis centers on the GSHISs launched since 2007. These schemes targeted poor populations, aiming to provide financial protection against catastrophic health shocks, defined in terms of inpatient care. Focus is on two lines of inquiry. The first involves institutional and ?operational? opportunities and challenges regarding schemes? design features, governance arrangements, financial flows, cost-containment mechanisms, underlying stakeholder incentives, information asymmetries, and potential for impact on financial protection and on access to care and use by targeted beneficiaries. The second entails ?big picture? questions on the future configuration of India?s health financing and delivery systems that have surfaced, due in part to the appearance of a new wave of GSHISs. In addition to gains in population coverage, reaching about 185 million low-income beneficiaries by 2010, the new crop of schemes introduced a demand-side approach to public financing while embracing several innovation features, at least for the Indian context. These include: defined entitlements, separation of purchasing from financing, patient choice of providers, impressive use of information and communication technology and engagement with the private sector in the areas of insurance, administration and provision. Strong political interest in the schemes is also evident, especially at the state level and is a driver of increased public expenditures for health. The schemes face a number of operational challenges that have emerged during implementation and are examined in the book. They will need to strengthen institutional and governance arrangements, purchasing and contracting capacities, monitoring systems, and cost containment mechanisms. They need to use their financial leverage to improve the quality of network providers. Beneficiaries also appear to have insufficient information on enrolment, benefits and providers. The book recommends a series of corrective measures to address these shortcomings. The book outlines a ?pragmatic pathway? toward achieving universal coverage that takes as a starting point the current configuration of health financing and delivery arrangements in India, recent trends in government health financing as well as innovations and lessons from the recent GSHISs analyzed in this book. The book concludes with a review of issues for further research. 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Evidence from the National Health Insurance System in IndonesiaApplied Health Economics and Health Policy, Vol.18, No.118 September 2019When state-funded health insurance schemes fail to provide financial protection: An in-depth exploration of the experiences of patients from urban slums of Chhattisgarh, IndiaGlobal Public Health, Vol.15, No.213 August 2019Breaking the Stigma of Health InsuranceManagement and Labour Studies, Vol.45, No.118 December 2019Utilisation and financial protection for hospital care under publicly funded health insurance in three states in Southern IndiaBMC Health Services Research, Vol.19, No.127 December 2019Challenges constraining availability and affordability of insulin in Bengaluru region (Karnataka, India): evidence from a mixed-methods studyJournal of Pharmaceutical Policy and Practice, Vol.12, No.117 October 2019Bibliography26 November 2019Understanding public health insurance in India: A design perspectiveThe International Journal of Health Planning and Management, Vol.34, No.423 July 2019Program design, implementation and performance: the case of social health insurance in IndiaHealth Economics, Policy and Law, Vol.14, No.427 July 2018Family Caregivers' Experiences with Dying and Bereavement of Individuals with Motor Neuron Disease in IndiaJournal of Social Work in End-of-Life & Palliative Care, Vol.15, No.2-32 August 2019The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana and the path to universal health coverage in India: Overcoming the challenges of stewardship and governancePLOS Medicine, Vol.16, No.37 March 2019Assessing health reform: studying tool appropriateness & critical capacitiesPolicy and Society, Vol.38, No.125 March 2019Impact of Publicly Financed Health Insurance Scheme (Rashtriya Swasthya Bima Yojana) from Equity and Efficiency PerspectivesVikalpa: The Journal for Decision Makers, Vol.43, No.429 October 2018Effectiveness of government strategies for financial protection against costs of hospitalization Care in 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December 2016Health Insurance and Children in Low- and Middle-Income Countries: A ReviewSSRN Electronic JournalSubsidized health insurance coverage of people in the informal sector and vulnerable population groups: trends in institutional design in AsiaInternational Journal for Equity in Health, Vol.15, No.14 October 2016Confronting Health Inequalities in the BRICS: Political Institutions, Foreign Policy Aspirations and State-civil Societal RelationshipsGlobal Policy, Vol.7, No.410 June 2016Occupational Differences in the Awareness and Perception of Health Insurance of Workers Employed in Urban Informal Sector of PunjabJournal of Health Management, Vol.18, No.330 September 2016An Implementation Research Approach to Evaluating Health Insurance Programs: Insights from IndiaInternational Journal of Health Policy and Management, Vol.5, No.526 March 2016Uncovering Coverage: Utilisation of the Universal Health Insurance Scheme, Chhattisgarh by Women in Slums of RaipurIndian Journal of Gender 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Participation in India's Health Insurance Scheme for the PoorPLoS ONE, Vol.8, No.621 June 2013The Welfare Implications of Patent Protection, Pricing, and Licensing in the Indian Oral Anti-Diabetic Drug MarketSSRN Electronic Journal View Published: August 2012ISBN: 978-0-8213-9618-6e-ISBN: 978-0-8213-9619-3 Copyright & Permissions Related TopicsHealth Nutrition and PopulationPoverty ReductionSocial Protections and Labor KeywordsSOCIAL INSURANCEFINANCIAL PROTECTIONHEALTH FINANCINGHEALTH PROVISIONUNIVERSAL HEALTH COVERAGEHEALTH COVERAGETARGETING OF THE POORPUBLIC-PRIVATE PARTNERSHIPSHEALTH INSURANCE PDF DownloadLoading ...
No AccessWorld Bank Technical Papers12 Aug 2013Medicinal plantsAn expanding role in developmentAuthors/Editors: Jitendra P. Srivastava, John Lambert, Noel VietmeyerJitendra P. Srivastava, John Lambert, Noel Vietmeyerhttps://doi.org/10.1596/0-8213-3613-4SectionsAboutPDF (0.2 MB) ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookTwitterLinked In Abstract:Medicinal plants are commonly used in treating and preventing specific ailments and diseases and are considered to play a beneficial role in health care. Despite their importance, medicinal plants are seldom handled within an organized, regulated sector, most are still exploited with little or no regard to the future. The paper outlines the importance and usage of medicinal plants in health care, national conservation activities in selected countries, and in World Bank development projects. The final section focuses on developing country strategy needs for implementing policies covering medicinal plant conservation, cultivation, processing and marketing. Medicinal plants are viewed as a possible bridge between sustainable economic development, affordable health care and conservation of vital biodiversity. 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HBK (Piperaceae)African Journal of Pharmacy and Pharmacology, Vol.9, No.218 June 2015Microbiological profiling and the demonstration of in vitro anti-bacterial traits of the major oral herbal medicines used in Dhaka MetropolisSpringerPlus, Vol.3, No.115 December 2014Plant Diversity in Addressing Food, Nutrition and Medicinal Needs4 April 2014Study of some biological activities of aqueous extract of ginger (Zingiber officinale)Egyptian Pharmaceutical Journal, Vol.13, No.2Antimicrobial activity of Calotropis procera Ait. (Asclepiadaceae) and isolation of four flavonoid glycosides as the active constituentsWorld Journal of Microbiology and Biotechnology, Vol.29, No.717 February 2013Antibacterial and antifungal potential of some medicinal plants against certain phytopathogenic micro-organismsArchives Of Phytopathology And Plant Protection, Vol.46, No.9Anthelmintic and antimicrobial activity of methanolic and aqueous extracts of Euphorbia helioscopia L.Tropical Animal Health and Production, Vol.45, No.312 October 2012Scutellaria: Biotechnology, Phytochemistry and Its Potential as a Commercial Medicinal Crop8 August 2012Medicine from the Wild: An Overview of the Use and Trade of Animal Products in Traditional Medicines19 September 2012DNA-Based Authentication of TCM-Plants: Current Progress and Future Perspectives29 November 2012Studies on Ethno-Medicine, Vol.7, No.2Evaluation of in-vitro antibacterial activity and anti-inflammatory activity for different extracts of Rauvolfia tetraphylla L. root barkAsian Pacific Journal of Tropical Biomedicine, Vol.2, No.10Antimicrobial effect of edible plant extract on the growth of some foodborne bacteria including pathogensNutrafoods, Vol.11, No.316 November 2012Antifungal activity of Coriaria nepalensis essential oil by disrupting ergosterol biosynthesis and membrane integrity against CandidaYeast, Vol.28, No.813 July 2011Antibacterial Activity of Argemone mexicana Seeds Extract Against Staphylococcus aureus and Escherichia coliJournal of Biologically Active Products from Nature, Vol.1, No.5-6Antidiarrhoea and toxicological evaluation of the leaf extract of Dissotis rotundifolia triana (Melastomataceae)BMC Complementary and Alternative Medicine, Vol.10, No.117 November 2010Indigenous Medicine and Primary Health Care: The Importance of Lay Knowledge and Use of Medicinal Plants in Rural South AfricaHuman Ecology, Vol.37, No.121 January 2009Medicinal biotechnology in the genus scutellariaIn Vitro Cellular & Developmental Biology - Plant, Vol.43, No.46 July 2007Sustainable Wild Collection of Medicinal and Aromatic PlantsManaging, Manipulating and Manuevering Biology in the Early 21st Century: Reflections on Discursive Practice, Empirical Events and Power in Pursuit of Bio-CommerceSSRN Electronic JournalIn vitro conservation and propagation of medicinal plantsBiodiversity, Vol.5, No.2Conservation, Trade, Sustainability and Exploitation of Medicinal Plant SpeciesIn Vitro Approaches to the Conservation and Development of Medicinal Plant Species View Published: April 1996ISBN: 978-0-8213-3613-7 Copyright & Permissions Related RegionsAfricaSouth AsiaEast Asia & PacificRelated CountriesIndiaRelated TopicsAgricultureRural DevelopmentHealth Nutrition and PopulationEnvironment KeywordsMEDICINAL PLANTSHEALTH CARECULTIVATIONMARKETINGPROCESSINGECONOMIC DEVELOPMENTRESOURCES CONSERVATIONRESOURCES EXPLOITATIONBIOLOGICAL DIVERSITYBIOLOGYCONSERVATIONDEGRADED FORESTSFORESTFOREST SECTORISSUESMEDICINAL PLANTSNATURAL RESOURCESROADSTREE PDF DownloadLoading ...
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