INFECTIOUS DISEASES ARE COMMONLY ENCOUNTERED IN VIRtually all areas of health care, can represent potential major threats to communities and public health, and account for substantial morbidity and mortality. On a global level, infectious diseases such as malaria and tuberculosis remain leading causes of death. Among hospitalized patients, infectious complications such as central line– associated bloodstream infections, ventilator-associated pneumonia, and surgical site infections continue to be important causes of morbidity and increased length of stay. Illness related to infectious diseases also accounts for significant numbers of office and emergency department visits as well as substantial heath care costs and leads to losses in productivity among workers. In addition, the management of infectious diseases continues to be challenging, with major concerns about the emergence of multidrug-resistant pathogens and a significant decline in the production of new antimicrobial agents from both research and industry sources. Immunologic disorders also are increasingly prevalent, with improved detection of common immunologic and allergic conditions; expanded numbers of patients living longer with immune-suppressing disorders such as human immunodeficiency virus (HIV) infection and some cancers; and increasing numbers of patients receiving immunemodulating and immunosuppressing medications, such as patients with connective tissue disorders and recipients of organ, tissue, and stem cell transplants. Many of these disorders can take a devastating toll on physical functioning, quality of life, and emotional well-being. This theme issue of JAMA, devoted to infectious diseases and immunology, includes research reports and other scholarly articles that provide new information to help inform clinicians about these issues. Three clinical trials in this issue provide data on approaches to treatment and prevention of 3 relatively common infectious disease processes. In a noninferiority trial of tuberculosis treatment conducted among 1585 adults with newly diagnosed tuberculosis at 11 sites in Africa, Asia, and Latin America, Lienhardt and colleagues demonstrated that compared with a regimen of 4 separately administered medications, a fixed-dose 4-drug combination formulation satisfied noninferiority criteria in 2 of 3 analyses. The authors suggest that even though the results do not demonstrate full noninferiority, the potential advantages related to administration and adherence using the fixed-dose combination over separate drug formulations may make this a preferred approach, particularly in resource-poor settings. In another noninferiority clinical trial evaluating alternative dosing regimens for human papillomavirus (HPV) vaccination among 903 adolescent girls in Vietnam, Neuzil and colleagues found that the use of 2 alternative HPV vaccine dosing schedules (at 0, 3, and 9 months and at 0, 6, and 12 months) compared with the standard vaccine schedule (0, 2, and 6 months) did not result in inferior antibody concentrations, although the yearly vaccination schedule (0, 12, and 24 months) did not meet prespecified noninferiority criteria. The study, however, only addressed immunogenicity and reactivity and does not provide information on the efficacy of these dosage regimens for preventing cervical cancer. In a clinical trial of hepatitis B vaccination conducted at 33 centers in France, Launay and colleagues compared the safety and immunogenicity of a 4-intramuscular doubledose regimen (40 μg at weeks 0, 4, 8, and 24) and a 4-intradermal low-dose regimen (4 μg at weeks 0, 4, 8, and 24) vs the standard regimen (20 μg at weeks 0, 4, and 24) of recombinant hepatitis B virus (HBV) vaccine among 396 HIV1–infected adults with CD4 cell counts greater than 200/μL and who were HBV seronegative. The investigators report that both the 4 intramuscular double-dose regimen and the 4 intradermal low-dose regimen improved serological response compared with the standard HBV vaccine regimen. The findings also suggest that intradermal administration of this regimen may be more efficient than the standard intramuscular administration in achieving immunogenicity. Three observational studies in this issue report novel information on 3 clinically important and prevalent conditions. In a study of 498 immunocompetent adults with serologic evidence of infection with herpes simplex virus type 2 (HSV-2), Tronstein and colleagues measured the rate of viral shedding using polymerase chain reaction (PCR) detection of HSV-2 DNA from self-collected genital swabs obtained on consecutive days. Among 410 symptomatic persons with a history of genital lesions, HSV was detected on

IN THE APRIL 9, 2008, ISSUE OF JAMA, AN ARTICLE ENtitled “Chemoembolization Combined With Radiofrequency Ablation for Patients With Hepatocellular Carcinoma Larger Than 3 cm: A Randomized Controlled Trial” was published by Dr Cheng and colleagues. We subsequently received information that raised concerns about the integrity of the data and the veracity of the report. We conducted an extensive internal investigation into these concerns, contacted the primary author of the study, and also notified Shandong University, the authors’ institution, expressing our concerns about the conduct of the trial and the integrity of the data. Based on the responses we received from the authors, we continued to have concerns about the validity and integrity of the study, and therefore requested a formal investigation by the authors’ institution. On March 23, 2009, we received a report from Yun Zhang, MD, PhD, Vice President, Shandong University, and Dean, Shandong University School of Medicine. Dean Yun Zhang indicated that “it took a long time to make a complete investigation” because the university “organized a group of experts in the field of hepatology to investigate the article” by Cheng et al and these experts “thoroughly investigated the protocol, ethics, medical records, methods, statistics, results, and conclusions relevant to this article.” In addition, this investigative group carefully studied the comments of the JAMA editors and reviewers and previous versions of the manuscript reporting the results of this study. The report by the dean indicates the following: “Based on these investigations, we have drawn the following conclusions: 1. The protocol and ethics of this study were not submitted to the Academic Committee of Shandong University Qilu Hospital for approval. Dr Cheng wrote and submitted this manuscript during his postdoctoral training in Sweden without informing our institution. 2. This study was not a well designed, randomized and controlled clinical trial despite the fact that chemoembolization and radiofrequency ablation for patients with hepatocellular carcinoma have been performed in Shandong University Qilu Hospital for many years. Therefore, conclusions drawn from this study are not valid. 3. Because of these unscientific behaviors, we suggest that the article by Dr Cheng should be withdrawn from JAMA. We apologize for any negative impacts on JAMA caused by publication of this paper. We have submitted a report on this serious issue to the Academic Committee of Shandong University and will keep you informed of further decisions on Cheng’s mistakes from our university.” Accordingly, based on this report, we hereby retract this article from JAMA and from the medical literature. We appreciate that readers of JAMA brought their concerns about this article to our attention and their patience in allowing us to investigate, and we are grateful to the dean at Shandong University School of Medicine for the thorough and detailed investigation and professional response to our concerns. The cooperation and professional actions of all involved in this inquiry allowed for a complete investigation. This is an example of how maintaining scientific integrity for published articles requires a team effort by readers, journal editors, and the system of academic oversight.

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Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal

RESEARCH STUDIES IN BIOMEDICAL JOURNALS ARE INcreasingly scrutinized, not only for their scientific findings and clinical and public health implications, but also because of concerns related to conflicts of interest of investigators and concerns about misleading reporting of industry-sponsored research. The perception that conflicts of interest or financial concerns may have potentially detrimental effects on medical science has prompted medical journals to critically examine and more vigorously enforce policies for disclosure of potential conflicts and for reporting of relationships with industry. The need for transparency in reporting the financial conflicts of interest of authors and the relationships between investigators and funding sources has never been greater and is essential to help maintain confidence and trust in the scientific integrity of medical research articles. In this editorial, we review and update our policies for authors reporting conflicts of interest and disclosing financial support and other paid contributions for their work, as well as the requirements for reporting of industry-sponsored studies. Much of this information and the rationale for these policies have been described in previous editorials and are detailed in the current JAMA Instructions for Authors. Reporting Financial Conflicts of Interest. All authors of all manuscripts submitted to JAMA (including research reports, reviews, opinion pieces, letters to the editor, and book reviews) are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript. Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted or the paper was written and up to the time of publication. Authors also must report other financial interests that represent potential future financial gain, such as relevant filed or pending patents or patent applications in preparation. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. Authors who are uncertain about what might constitute a potential financial conflict of interest should always err on the side of full disclosure and should contact the editorial office if they have questions or concerns. To report this information, each author is required to sign and submit the following disclosure statement on the JAMA authorship form: “I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed.” Authors may include these disclosures on the JAMA financial disclosure form or should indicate that the disclosures are included in an attachment to the form or in the manuscript. In addition, authors who have no relevant financial interests should provide a statement indicating that they have no financial interests related to the material in the manuscript. Authors will be reminded to report this information at the time they submit their manuscript via our online manuscript submission and review system. For all accepted manuscripts, each author’s disclosures of relevant financial interests or declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Editors are willing to discuss disclosure of specific