Search

The epidemic of intentional injury continues to be a leading cause of premature death in America. The ravages of violence are particularly devastating within the minority community. With this position paper from the Surgical Section of the National Medical Association (the country's oldest and largest organization of minority physicians), a group of trauma surgeons and surgical intensivists resolve to focus on underused violence prevention opportunities and to extend their spheres of influence beyond the walls of their institutions and emphasize violence prevention activities. ( JAMA . 1995;273:1788-1789)

IN A RESEARCH career that began in 1919 and continued for nearly 6 decades at Johns Hopkins University School of Medicine in Baltimore, Md, Psychobiologist Curt P. Richter, PhD (1894-1988), observed more than 20000 animals, often for their entire lifespans. He kept— and saved—meticulous records on every one, from rodents to humans, creating a mountain of logbooks, charts, and graphs. An investigator with encyclopedic interests, Richter, who died in 1988: • found that rats deprived of salt, protein, fat, and other nutrients developed specific hungers for the missing substances; • localized the hypothalamus as the site of the biological clock; • charted the natural history of the grasp reflex from cradle to grave; • documented the impact of domestication on wild rats; • tied alterations in biological rhythms to psychiatric illness; • and anticipated modern chaos theory as applied to medical illness. While Richter published more than 375 scientific papers

Paper patch myringoplasties are commonly performed in children at the time of ventilation tube removal, yet no series documenting their efficacy appears in the otolaryngology literature. Over an 18-month period at the Children's Hospital of Philadelphia (Pa), 163 ventilation tube removals were performed on 131 children aged 1 to 18 years. In 95 of these ears, a paper patch myringoplasty was performed after tube removal. No significant difference (87% vs 85%) in the overall healing rate at 6 months was shown between these two groups. An analysis of the variables potentially affecting outcome revealed that healing following simple tube removal was influenced by the frequency of tube placement and by tube size. Paper patch myringoplasty significantly improved outcome (93% vs 61%) in ears with more than three previous tube placements.

A bioethicist argues that two journal articles about quality of life-adjusted years research oversimplifies the issue and do not take into consideration people's abilities to adapt to disability and disease. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

ing a study that followed up 4383 men for 28 years, Orsted found that stepwise increases in PSA levels predicted a 3to 57-fold increased risk of prostate cancer and a 2to 16-fold increased risk of prostate cancer mortality. The absolute 10-year risk of prostate cancer was 35% to 80% in those with PSA levels above 10 ng/mL, but only 0.6% to 1.5% in men with levels less than 1 ng/mL. “Based on the results of our study, it would seem reasonable to perform a baseline PSA measurement in asymptomatic men 45 to 50 years of age if these men wish to be assessed for risk of prostate cancer,” said Orsted. Those with a higher baseline PSA level—2 to 4 ng/mL—might be rescreened every 2 to 4 years, and those with a PSA of less than 2 ng/mL should consider screening every 10 years, he said. Examination for prostate cancer is warranted in men with PSA values greater than 4 ng/ mL. Orsted’s findings were presented at the European Multidisciplinary Cancer Conference and Congress of the European Society for Medical Oncology (ECCO-ESMO) in September and were published online in European Urology on November 12 (http://www.scienced i r ec t . com/ sc i ence / a r t i c l e /p i i /S0302283811012401). While the task force’s recommendation may “sensitize the medical community and the lay public that screening is not a slam dunk,” Stephenson faulted the USPSTF for failing to acknowledge that there are benefits to PSA screening in addition to the harms. Instead of adopting “a rather extreme position that no one should be screened,” he said, “the most honest position [for the task force] to take is that men should be informed about the risks and benefits and make an informed decision about screening.” That’spreciselywhattheUSPSTFhopes to achieve with its recommendation. “I would be shocked” if physicians abruptly stop ordering PSA tests, said LeFevre. “There are doctors who didn’t think this was a good test but they didn’t feel they had a choice not to offer it.” In his practice, LeFevre will stop bringing up the PSA test with patients. But if they ask, “I will inform them of what we know and don’t know, and if they still want it, I’ll order the test,” he said. What LeFevre does hope will disappear are the communityand employer-based PSA screenings that are done without a discussion of the risks. “Men should be screened only by choice and with the necessary information,” said LeFevre. “If we have no other impact than to eliminate screening in people who don’t know it or who don’t know what the potential risks and benefits are, that would be a big shift in the right direction.”

Nooneneedsa reminderof the cost to taxpayers andconsumers forhealth careeachyear, bothhere in theUnitedStates and abroad.Legislators and taxpayers arealso concernedabout the returnon investment inhealth care research, andwhether this investment is furtheringorevenhindering theeffort toachieve 3objectives that are frequently in conflictwith eachother: improving quality, access, and cost-effectiveness. Muchevidencehasaccumulatedover the last coupleofdecades that the timebetweenaccumulationof evidence that an intervention or therapy does or does not work and its incorporation or removal from practice is measured in years if not decades. Simply implementing what we knowworks and desisting from what we know does not would have an enormous impact on health and health care. Investigators, clinicians, administrators, andgovernment agencies have learned that the translationofevidencetopolicyandpractice is far from simple and never assured. A new field of inquiry, implementation science, has developed that recognizes and addresses the multitude of gaps that impede evidence-based interventions fromproducingoptimal health outcomes. These knowledge and practice gaps include: • “Research-to-program”gaps,whichexistwhen researchevidence is not adequately or appropriately considered and integrated in the development of health outcomes. • “Research-to-policy” gaps, which exist when research evidence is not adequately or appropriately considered and integrated in the development of health policy. Implementation science is the study ofmethods to promote the integrationof research findingsandevidence intohealth care policy and practice. It seeks to understand the behavior of health careprofessionals andother stakeholders as a keyvariable in the sustainable uptake, adoption, and implementation of evidence-based practice. It also examines system issues for barriers to implementation and new methods to overcome these. A newer component of this science is starting to focusondeimplementation, thediscontinuanceof things proven not to be effective or safe. JAMAPediatricswill devote an entire issue in spring 2015 to implementation science research in childhealth, both in the United States and abroad, in high-resource aswell as lowand middle-resource countries.Aspediatric carebecomes increasingly focusedonchildren, adolescents, andyoungadultswith chronic illness, who account for the largest part of our health care expenditures, our hospital beds, and our specialty care, implementation research for these children and adolescents is of particular interest. Research on how to implement evidence-based practice is needed at all levels of care: the intensivecareunit, theemergencydepartment, thewards, theclinic, the home, and sites in the community including schools and neighborhoods. Implementationcanbe inall forms: frompractice to policy. We are interested in rigorous studies that test hypotheses about methods to close these gaps, to translate research in those stepsbetweenefficacy trials andpopulationhealth.This will include randomized clinical trials including cluster randomizedclinical trials,adaptiveresearchdesigns,carefullyconducted time series analyses, longitudinal studies, interrupted time series, andqualitative research.Weare interested aswell in cost-effectiveness analyses and systematic reviews on themost effective strategies to changeprofessional behavior; create informed, activated consumers; and guide the behavior of administrators and health care organizations and policy makers. Manuscripts submitted before October 2014 will have the bestchanceofacceptance.Fulldetailsonsubmissionandauthor guidelines are available at http://archpedi.jamanetwork.com.

To coincide with the American Diabetes Association Scientific Sessions in June 2014, JAMA will publish a theme issue on diabetes research. Our goals are to inform readers about the latest research in both type 1 and type 2 diabetes and to provide useful reviews of the current state of basic and clinical science underlying diabetes treatments. The World Health Organization estimates that 350 million people worldwide have diabetes.1 The international obesity epidemic has certainly accelerated the need to better understand the epidemiology, identification, and treatment of diabetes. We invitemanuscripts that address the identification and management of this complex chronic disease. We are especially interested in clinical trials of prevention, treatment, and delivery of care for people with diabetes. Care requirements and treatment goals for diabetes vary by age, and we welcome studies of patient populations of any and all ages, from children to the elderly. We recognize that diabetes is a global health problem, and we encourage submission of manuscripts that address aspects of diabetes thatmay be unique to a specific regional population, such as Asia or Africa. For example, a recent study indicated that approximately 114 million individuals in China have type 2 diabetes and an additional 493 million have prediabetes.2 A recent meta-analysis estimated a 5.7% prevalence rate of diabetes associated with impaired glucose tolerance among adults in sub-Saharan Africa.3 Bothof these studieshighlight theburdenofnoncommunicable diseases, especially diabetes, which is among the most common,withmore than 80%of the 3.4million annual deaths from diabetes occurring in lowand middle-income countries.4 We encourage authors to submit reports of original research, review articles, and Viewpoints for consideration for this theme issue. We are particularly interested in reports of randomized clinical trials that represent advances in the treatment of diabetes and interventions aimed at prevention. Authors who are interested in submitting a manuscript for the diabetes theme issue should indicate this in the cover letter accompanying their manuscript submission. Manuscripts received before January 15, 2014, will have the best chance of consideration for the theme issue. Exceptions may be granted for late-breaking randomized clinical trials to be presented at the American Diabetes Association Scientific Sessions. In these cases, we recommend that authors contact us as early as possible to discuss the trial and to allow coordination of timing of publication with the scientific presentation. We also welcome questions about this theme issue. Authors should consult the JAMA Instructions for Authors for guidelines on manuscript preparation and submission.5 Highquality manuscripts submitted to JAMA that are not of sufficiently high priority for publication in JAMA may be referred to another journal in The JAMA Network. We look forward to receivingyourmanuscripts for the2014 diabetes theme issue of JAMA.

TRAUMATIC BRAIN INJURY (TBI) IS AMONG THE MOST SEvere outcomes associated with violence. In the United States, TBI is a contributing factor to 30.5% of all injury-related deaths. The fourth leading cause of TBI (after falls, “struck by/against,” and motor vehicle crashes) is assault, which accounted for 15 341 hospitalizations and 5813 deaths in the years 2002 through 2006. In this issue of JAMA, Zafonte et al report the results of a randomized trial of citicoline, a widely used pharmacotherapy for the treatment of patients with TBI. In this trial, 9.3% of the study participants were injured in assaults. Zafonte et al found that citicoline treatment did not result in improvement of cognitive or functional status, and as acknowledged in an accompanying editorial by Ruff and Riechers, there are no specific, evidence-based therapies for patients with complicated mild or moderate TBI resulting from assault or any other mechanism. Randomized trials of interventions for the treatment and rehabilitation of patients with TBI are clearly needed, even if the interventions turn out to be ineffective. The value of “negative” studies is to expose critical gaps in knowledge and redirect attention to promising alternatives. To further promote the scientific evaluation of promising interventions for the causes of violence and human rights abuses and the clinical management of their related health effects, including TBI, we invite manuscripts for another JAMA theme issue on violence and human rights, to be published on August 7, 2013. Authors may submit manuscripts addressing any topic related to violence, war, civil conflict, or human rights abuses. Randomized controlled trials of preventive, therapeutic, or rehabilitative interventions are of primary interest, but we will also consider reports of observational studies and systematic reviews that address new and important findings in the fields of violence and human rights, as well as scholarly Viewpoints. Manuscripts received by March 15, 2013, will have the best chance of consideration for publication in this theme issue. Submitted manuscripts will undergo JAMA’s usual rigorous editorial evaluation and peer review. Please follow JAMA’s instructions for authors for manuscript preparation and submission. We look forward to receiving manuscripts and inquiries about prospective articles for this theme issue.

THE US Food and Drug Administration (FDA) has released a draft "concept paper" on guidelines for pharmaceutical company support of scientific or educational programs. The FDA has been requesting comments on the proposed guidelines from industry, medical educators, and other interested parties. According to Dennis K. Wentz, MD, director of the American Medical Association's (AMA) Division of Continuing Medical Education and chair of the Ad Hoc Task Force on Industry-Continuing Medical Education (CME) Provider Collaboration—which includes representatives from the AMA, the Accreditation Council for Continuing Medical Education (ACCME), the pharmaceutical industry, and now observers from the FDA—the task force met last month and will meet again next week (December 12) to discuss the FDA's draft concept paper. It also will examine a proposal, by the pharmaceutical industry's Fred W. Lyons, Jr, to create a self-regulating system. Similar to ACCME, AMA The proposed FDA guidelines are not very different from the

PEDIATRICS HAS TRADITIONALLY BEEN DEFINED BY ACUTE illnesses, but with the aid of public health measures, modern medications, vaccines, and product safety advances, acute illnesses are more preventable and treatable than ever. The major challenge for health care professionals who care for infants, children, and young adults and for those who will treat them as they age into adulthood has become the management of chronic diseases. Chronic illnesses in children include a wide range of maladies. Some, such as obesity, malnutrition, and cardiovascular disease, begin in childhood and can continue into adulthood. Others, such as congenital heart disease, are very different from adult-onset disease and require different management. Illnesses such as sickle cell disease and certain cancers that manifest in childhood have had gradual advances in treatment, and these diseases and others, such as neonatal prematurity, present new challenges as children live longer. While all children require general pediatric care (attention to immunization, proper nutrition, development, etc), some problems, such as cancer, congenital heart disease, and autism, are treated primarily by subspecialists. Others, such as cerebral palsy, require the teamwork of multiple disciplines. The prevalence of chronic conditions in childhood varies depending on the condition and how it is defined in terms of severity and functional impact. The Maternal and Child Health Bureau proposed an encompassing view of chronic illness, defining children with special health care needs as “those children who have or are at increased risk for a chronic physical, developmental, behavioral or emotional condition and who also require health care-related services of a type or amount beyond that required by children generally.” In 2001, an estimated 12.8% or 9.3 million US children younger than 18 years had special health care needs. Prevalence was higher in boys, older children, and those from low-income families. A national survey in 20022003 found similar results. The leading chronic health conditions causing activity limitation in children differed by age and sex, but included speech problems, asthma, mental retardation, learning disability, and attention-deficit/ hyperactivity disorder. The impact of chronic diseases in childhood is enormous, whether measured economically or in terms of mortality and morbidity. Children with special health care needs accounted for 42.1% of total medical care costs for US children in 2000. In 2003, 5 of the 10 leading causes of death in childhood were chronic diseases: malignant neoplasms; congenital malformations, deformations, and chromosomal abnormalities; diseases of the heart; chronic lower respiratory tract diseases; and cerebrovascular diseases. Chronic conditions resulted in 66 million restricted-activity days and 27 million days lost from school. The impact on families of having a child with a chronic illness should not be overlooked. Having a child with poor health has been associated with higher rates of marital stress, divorce, and paternal unemployment, and one fifth of families report financial problems caused by their child’s health care needs. Because the burden of chronic diseases on children, their families, and the health care systems throughout the world is sogreat, JAMAwilldevoteanissuetochronicdiseasesof infants, children, and young adults in June 2007. Research in the realm of chronic diseases of children has the potential to influence notonlyhealth inchildhoodbuthealthandwell-beingthroughout the child’s life and, as such, is of utmost importance. We wish to increase awareness of the variety of chronic diseases that can afflict children, encourage research on treatment and outcomes, and promote attention at the health policy level for patients who cannot advocate for themselves. Because the development and impact of chronic conditions are influenced by genetics, behavior, and environment, we encourage studies that consider the multidimensionality of these disorders and their management. Authors are invited to submit manuscripts on topics related to chronic diseases in infants, children, and young adults. High-quality original research, especially randomized clinical trials, systematic reviews, and commentaries, are welcome. Manuscripts received by January 8, 2007, will have the best chance of consideration for this theme issue. Please consult the JAMA Instructions for Authors for guidelines on manuscript preparation and submission.

To the Editor. —The recent US Food and Drug Administration (FDA) initiative in the area of industry support of scientific and educational activities led to the release of a draft "concept paper" (DCP) in late October 1991. 1-3 The stated objective of this initiative was to define more clearly a category of drug company—supported scientific and educational activity that is not subject to the rules governing advertising and labeling. This clarification is deemed essential so as not to chill industry support of nonpromotional, educational, and scientific programs. Food and Drug Administration officials have stated that the agency's policy is to avoid undue intrusion into continuing medical education and scientific exchange. The DCP describes this category as "independent scientific and educational activity" and identifies four criteria: independence, objectivity, balance, and scientific rigor, which distinguish it from promotional activity. A number of specific "factors" are listed for each criterion, which would serve

T he aging of the world’s population has profound implications for medical care and health care systems. According to the United Nations, the number of people worldwide aged 60 years or older will increase from 1 in 10 currently to 1 in 5 by 2050. In some developed countries, that proportion will increase from 1 in 5 to 1 in 2 in 2050. The population 80 years or older is projected to increase from 11% of those older than 60 years now to 19% by 2050, and the number of centenarians is expected to increase 15-fold to 2.2 million. The rate of aging of the population is greatest in developing nations, a growing challenge for nations with few health care resources. By 2050, the ratio of people 65 years or older to those aged 15 to 64 years will double in developed nations and triple in developing nations. This demographic revolution will fundamentally affect both health care and society. As one example of the dramatic social and economic effects expected from this trend, the United Nations will hold the Second World Assembly on Ageing in April 2002. According to Nitin Desai, United Nations Under-Secretary-General for Economic and Social Affairs, “. . . Ageing is not a separate issue from social integration, gender advancement, economic stability or issues of poverty. It has developed a connection with many global agendas and will play, increasingly, a prominent role in the way society interacts with economic and social welfare institutions, family and community life and the roles of women. . . . Societies must respond to the extraordinary potential and range of variability in individual ageing, and seize the opportunity to rethink our notion of limits and recognize the farreaching benefits societies stand to gain from the continuing contributions of their older citizens.” The United States faces specific problems related to aging. The Congressional Budget Office estimates that Medicare spending will double in the next decade under existing laws (without a drug benefit), costing an estimated $3.3 trillion over the next decade—while 44 million people remain uninsured. The high cost of drugs for elderly patients is on the national agenda, with proposals for some drug benefits for the poorest individuals, even while some Medicare managed care organizations are discontinuing drug benefits. A federal study found that more than 90% of US nursing homes have too few workers to take proper care of patients but because of the cost involved, the federal government does not plan to set minimum staffing levels. The aging population will put further demands on this already stressed system. These demographic and societal trends have major and far-reaching implications for clinical care, medical research, and health care policy. Given the importance of these issues for physicians, JAMA and several of the Archives Journals will publish theme issues on aging in November 2002. We invite authors to submit manuscripts reporting original research, including randomized controlled trials and high-quality observational research; systematic reviews; and special communications and scholarly commentaries addressing aging issues. Topics may include interventions that prevent disease, reduce disability, or extend functional years, as well as interventions to improve the afflictions more frequent in older age: Alzheimer disease and other dementias, osteoporosis, frailty, mobility limitations, incontinence, cardiovascular disease, stroke, diabetes, and cancer. Other appropriate topics include providing high-quality care for older adults regardless of race/ethnicity, sex, or ability to pay, and care for persons nearing the end of life. Authors are advised to consult the JAMA Instructions for Authors for guidelines on manuscript submission and preparation. Manuscripts received before June 1, 2002, will have the best chance of acceptance for the November 13, 2002, JAMA theme issue.

FOR THE SECOND TIME THIS DECADE, JAMA WILL PUBlish a theme issue devoted to the topic of diabetes mellitus. While some progress has been made in understanding and managing diabetes since the May 15, 2002, theme issue, the epidemic continues, as does JAMA’s strong interest in this problem. In 2000 the worldwide prevalence of diabetes was estimated to be 2.8% and is projected to reach 4.4% by 2030. In 2005, the total prevalence of diabetes among all ages for those born in the United States was 20.8 million individuals (7% of the population), and an estimated 30% of the cases were undiagnosed. The estimated lifetime risk of developing diabetes for individuals in the United States is 32.8% for men and 38.5% for women. By virtue of the disease process and its associated complications, individuals with diabetes have substantial reductions in life expectancy and quality of life. Research to help counteract these outcomes in patients with diabetes has resulted in a number of new and advanced therapies, including novel antidiabetes medications, surgical interventions, islet cell transplantation, hematopoietic stem cell transplantation, and gene therapy. Because of the continued challenges of diabetes and its associated comorbidities, JAMA will devote an entire issue to this topic in April 2009. This theme issue will be in conjunction with all 9 of our Archives family of specialty journals, which also will devote some or all of their April issues to this topic. We invite authors to submit manuscripts reporting original research (original contributions, preliminary reports, and research letters), systematic reviews, special communications, and commentaries on any topic related to diabetes and its comorbidities. We also welcome articles addressing the economic implications, policy aspects, and ethical considerations relative to diabetes. Special consideration will be given to randomized trials of new therapies and to research reports addressing the management of diabetes, including glycemic monitoring and new technologies for diabetes care; genetic aspects and prevention; islet cell/pancreatic transplantation and related effects of diabetes on cardiovascular and oncologic disorders. Manuscripts received by November 1, 2008, will have the best chance of consideration for publication in the diabetes theme issue of JAMA. High-quality articles also may be published in other issues of JAMA or if not suitable for JAMA, may be referred (with the authors’ permission) for consideration for publication in one of our Archives specialty journals. Please consult the instructions for authors for preparing and submitting manuscripts. We look forward to receiving your manuscripts for our theme issue devoted to this increasingly important global health problem.