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Evidence-based guidelines for implementation and measurement of antibiotic stewardship interventions in inpatient populations including long-term care were prepared by a multidisciplinary expert panel of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. The panel included clinicians and investigators representing internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties. These recommendations address the best approaches for antibiotic stewardship programs to influence the optimal use of antibiotics.

Evidence-based guidelines for implementation and measurement of antibiotic stewardship interventions in inpatient populations including long-term care were prepared by a multidisciplinary expert panel of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. The panel included clinicians and investigators representing internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties. These recommendations address the best approaches for antibiotic stewardship programs to influence the optimal use of antibiotics.

To meet ethical and scientific obligations, authors should submit timely, high-quality manuscripts. Authors, however, can encounter ethical (e.g., authorship designation) and practical (e.g., time and resource limitations) challenges during manuscript preparation. Could professional medical writers-not ghostwriters-help authors address these challenges? This essay summarizes evidence countering three myths that may have hindered authors from considering the use of professional medical writers. Authors with sufficient time, writing expertise, and reporting guideline knowledge may meet their obligations without writing assistance. Unfortunately, not all authors are in this position. Decisions about writing support should be based on evidence, not myths.

Purpose of review The increasing rate of ventilator-associated pneumonia (VAP) caused by multidrug-resistant pathogens warrants the development of new treatment strategies. Carefully engineered delivery systems are undergoing evaluation to test the hypothesis that aerosolized administration of antibiotics will provide high local concentrations and fast clearance, which in turn may improve efficacy and decrease the risk of microbial resistance. Recent findings Recent studies indicate that aerosolized delivery systems for specially formulated antibiotics yield high local concentrations with rapid clearance and low systemic exposure. Preliminary clinical studies reveal that aerosolized delivery of antibiotics is well tolerated and active, when combined with intravenous antibiotics. No single aerosolized antibiotic is likely to provide broad-spectrum activity against both Gram-negative and Gram-positive bacteria. Summary Large multicenter trials are needed to determine whether preliminary findings will translate to improved clinical activity and decreased microbial resistance in VAP patients, and to optimize the use of aerosolized antibiotics.

If patients knew that most results from clinical research were not shared as completely or as quickly as they should be, how many patients would volunteer for research studies?If patients knew this...

We quantified surgical site infections (SSIs) after preoperative screening/selective decolonization before elective total joint arthroplasty (TJA) with 2-year follow-up and 2 controls. Concurrent controls (n = 2284) were patients of surgeons not participating in screening/decolonization. Preintervention controls (n = 741) were patients of participating surgeons who underwent TJA the previous year. Staphylococcus aureus nasal carriers (321/1285 [25%]) used intranasal mupirocin and chlorhexidine baths as outpatients. Staphylococcal SSIs occurred in no intervention patients (0/321) and 19 concurrent controls. If all SSIs occurred in carriers and 25% of controls were carriers, staphylococcal SSI rate would have been 3.3% in controls (19/571; P = .001). Overall SSI rate decreased from 2.7% (20/741) in preintervention controls to 1.2% (17/1440) in intervention patients (P = .009). Preoperative screening/selective decolonization was associated with fewer SSIs after elective TJA.

Substantial confusion exists about the role of medical writers and editors (hereafter, medical communicators) in medical publication. Much of the confusion is due to the failure to recognize the difference between terms. Ghostwriting is unethical, whereas professional medical communication refers to legitimate writing and editing services provided by individuals who comply with ethical guidelines. The purpose of this article is to shed light on this subject by reviewing relevant guidelines and by providing practical tips for authors interested in collaborating with medical communicators. Specifically, this article addresses a series of questions, such as what to expect from medical communicators, how to evaluate them, and how to collaborate ethically and efficiently with them. To ensure that the process is ethical, authors should begin collaborating with the medical communicator early in the process, continue doing so throughout manuscript development, and control manuscript content. In addition, authors should disclose substantial contributions and funding sources of the medical communicator and all other individuals not meeting authorship criteria. To ensure that the process is efficient, authors should delegate time-consuming technical writing and editing tasks to the medical communicator.

Dear Editor, We thank Dr. Schofferman and colleagues for warning readers about the many perils of ghost and guest authorship [1]. The exact prevalence of these unethical practices is difficult to determine partly because of the use of different definitions and lack of well-designed studies. Schofferman et al. are to be commended for selecting standard definitions and for citing serial surveys suggesting that the prevalence has declined over time. Unfortunately, ghosting and other unethical authorship practices have not disappeared. As members of the Global Alliance of Publication Professionals (GAPP; www.gappteam.org), we appreciate their recognition of professional medical writers as “legitimate participants in scientific papers provided their role is transparent.” We wish to expand on their commentary by adding recent references that may provide insight about how to exorcise the ghosts from published medical information. Schofferman et al. referred to authorship guidelines from the International Committee of Medical Journal Editors (ICJME) [2], which are used by more than 500 medical journals, including Pain Medicine . As noted …

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem—they are a research problem. To enhance trust in industry-sponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices.

Objective.To evaluate the economic impact of ventilator-associated pneumonia (VAP) on length of stay and hospital costs.Design.Retrospective matched cohort study.Setting.Premier database of hospitals in the United States.Patients.Eligible patients were admitted to intensive care units (ICUs), received mechanical ventilation for ≥2 calendar-days, and were discharged between October 1, 2008, and December 31, 2009.Methods.VAP was defined by International Classification of Diseases, Ninth Revision (ICD-9), code 997.31 and ventilation charges for ≥2 calendar-days. We matched patients with VAP to patients without VAP by propensity score on the basis of demographics, administrative data, and severity of illness. Cost was based on provider perspective and procedural cost accounting methods.Results.Of 88,689 eligible patients, 2,238 (2.5%) had VAP; the incidence rate was 1.27 per 1,000 ventilation-days. In the matched cohort, patients with VAP (n = 2,144) had longer mean durations of mechanical ventilation (21.8 vs 10.3 days), ICU stay (20.5 vs 11.6 days), and hospitalization (32.6 vs 19.5 days; all P< .0001) than patients without VAP (n = 2,144). Mean hospitalization costs were $99,598 for patients with VAP and $59,770 for patients without VAP (P< .0001), resulting in an absolute difference of $39,828. Patients with VAP had a lower in-hospital mortality rate than patients without VAP (482/2,144 [22.5%] vs 630/2,144 [29.4%]; PConclusions.Our findings suggest that VAP continues to occur as defined by the new specific ICD-9 code and is associated with a statistically significant resource utilization burden, which underscores the need for cost-effective interventions to minimize the occurrence of this complication.Infect Control Hosp Epidemiol 2012;33(3):250-256

We quantified surgical site infections (SSIs) after preoperative screening/selective decolonization before elective total joint arthroplasty (TJA) with 2-year follow-up and 2 controls. Concurrent controls (n = 2284) were patients of surgeons not participating in screening/decolonization. Preintervention controls (n = 741) were patients of participating surgeons who underwent TJA the previous year. Staphylococcus aureus nasal carriers (321/1285 [25%]) used intranasal mupirocin and chlorhexidine baths as outpatients. Staphylococcal SSIs occurred in no intervention patients (0/321) and 19 concurrent controls. If all SSIs occurred in carriers and 25% of controls were carriers, staphylococcal SSI rate would have been 3.3% in controls (19/571; P = .001). Overall SSI rate decreased from 2.7% (20/741) in preintervention controls to 1.2% (17/1440) in intervention patients (P = .009). Preoperative screening/selective decolonization was associated with fewer SSIs after elective TJA.

The principles of writing and publishing scientific papers are outlined. Scientific writing can be both professionally and financially rewarding, but many pharmacists hesitate to write for publication. A primary obstacle is not knowing how to begin. Thoughtful planning is the first and most important step. Before writing a word, the writer should identify the main message, audience, target journal, resource materials, type of manuscript, and authorship. The sections of a paper reporting original research include the title, abstract, introduction, methods, results, discussion, conclusion, references, and tables and figures. Some of these elements also appear in review papers and columns. In general, information given in one section should not duplicate information in another. The writer typically drafts the methods section first, followed by the results, the discussion, and the introduction. Along with intellectual responsibility for the paper, an author must assume various ethical responsibilities, such as ensuring that it contains no plagiarism, that all sources of funding have been acknowledged, and that the paper has not been simultaneously submitted to other journals. To enhance the likelihood of publication, the writer should edit the manuscript carefully and follow the target journal's instructions to contributors. Once the writer has submitted a paper, it must pass the muster of editors and, for peer-reviewed journals, outside experts. Several revisions may be requested before final acceptance. Pharmacists who adhere to the established pattern for writing and submitting scientific papers have the best chance of seeing their work in print.

T o the Editors: We read with interest Roper and Korenstein’s article entitled Industry Collaboration and Primary Guest Authorship of High-Impact Randomized Clinical Trials: A Cross-Sectional Study, which appears to show a decrease in the prevalence of guest authorship compared with previous studies. As leaders of the Global Alliance of Publication Professionals – GAPP (www.gappteam.org), we have been, and continue to be, strong and vocal critics of inappropriate authorship. However, we are wary about how comparable this study is with the others cited by the authors. Roper and Korenstein open their article by defining guest authorship as Battribution of research article authorship to investigators not meeting standard authorship criteria,^ yet fail to use standard authorship criteria in their study. They also suggest their guest authorship criteria are conservative and may underestimate the true prevalence of guest authorship. We disagree, as Roper and Korenstein focus only on the first part of the second International Committee of Medical Journal Editors (ICMJE) criterion. By limiting their definition of authorship to Bdrafting the work^ and ignoring Bor revising it critically for important intellectual content^, they lower the bar to guest author status and inflate prevalence estimates over apparently similar studies. We also disagree that the initial writing of the manuscript is Bgenerally^ viewed as the responsibility of the primary author(s). There is no such guidance in the ICMJE criteria, though we acknowledge that there are a few journals that specify this in their individual instructions for authors. The ICMJE authorship criteria are viewed bymany as flawed, but they are widely accepted by journals and publishers. It would be helpful they were applied consistently in studies such as these. In the interests of full disclosure, all members of GAPP have provided or do provide ethical medical writing services to academic, biotechnology, or pharmaceutical clients, and all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices. Jackie Marchington, PhD, CMPP, Director of Operations, Caudex, UK, on behalf of the Global Alliance of Publication Professionals (www.gappteam.org).

Linezolid is an attractive alternative for orthopedic infections because of oral bioavailability and activity against methicillin-resistant staphylococci and vancomycin-resistant enterococci. To determine efficacy and safety, we prospectively monitored 51 consecutive adults who were not vancomycin candidates and who received linezolid for 53 Gram-positive orthopedic infections, usually chronic osteomyelitis (n = 25) or prosthetic joint infection (n = 23). Pathogens were usually Staphylococcus aureus (n = 27) or coagulase-negative staphylococci (n = 19); 38 were methicillin resistant. After remission, 17 infections required long-term suppression, usually because of retained hardware. Clinical and microbiologic failure occurred in only one patient. The most common adverse events were thrombocytopenia (n = 5) and anemia (n = 5), necessitating treatment discontinuation in 3 patients. One patient developed reversible optic and irreversible peripheral neuropathy after 24 months of linezolid. Linezolid, with surgery, may be a reasonable alternative for Gram-positive orthopedic infections. We recommend weekly hematologic monitoring, and, if therapy lasts >2 months, periodic ophthalmologic monitoring.

To the Editor:—Fugh-Berman1 described the unethical practice of soliciting an author for a review prepared by an undisclosed writer. We agree with Tierney and Gerrity's2 characterization of the problem as failure to disclose the original author(s) and pertinent financial relationships. We also applaud the World Association of Medical Editors (WAME) for recommending that journal editors expand their Information for Authors to indicate that medical writers can be legitimate contributors to manuscripts and to encourage disclosure of their roles and affiliations.3 Put into practice, this recommendation empowers biomedical communicators to become part of the solution. We believe biomedical communicators are in an ideal position to help solve the problem. More than 5,000 biomedical communicators belong to the American Medical Writers Association (AMWA), an educational organization founded in 1940 to promote excellence in biomedical communication and to recommend principles of conduct for its members. The first principle in AMWA's Code of Ethics4 states, “Biomedical communicators should recognize and observe statutes and regulations pertaining to the materials they write, edit, or otherwise develop.” Principle 4 states, in part, “[Biomedical communicators] should refuse … assignments that require unethical or questionable practices.” AMWA's recently adopted position statement recommends acknowledgment of substantial contributions to scientific publications with disclosure of pertinent relationships.5 Biomedical communicators who contribute substantially to manuscripts should join the author-writer team at the inception of the project. Under these circumstances, biomedical communicators can encourage authors to adhere to ethical standards while following a logical process—beginning with identifying the main message to be conveyed, targeting the audience, and determining the most appropriate journal for conveying the message. One of us (C.W.H.) recently conducted a pilot survey to identify practices of biomedical communicators who contribute substantially to manuscripts submitted to biomedical journals. Seventy-three of 221 eligible advertisers in AMWA's freelance directory (33%) participated. More than half indicated that they followed guidelines from AMWA4,5 (59%) and the International Committee of Medical Journal Editors6 (ICMJE) (56%) and encouraged authors and other contributors to follow guidelines from AMWA (56%) and the ICMJE (54%). We plan to expand this survey to assess the experience of more biomedical communicators, the frequency of practices such as those described by Fugh-Berman,1 and the impact of AMWA's ongoing educational campaign on that frequency. We encourage authors, editors, and writers to continue working together to eliminate unethical practices in the writing of scientific manuscripts. Sincerely

Background to the debate: Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer., In a debate Peter Gøtzsche argues that ghostwriting in medical literature is scientific misconduct, Jerome Kassirer says more evidence is needed, and Karen Woolley and colleagues propose an explicit role for professional medical writers.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are capable of inducing a variety of renal function abnormalities, particularly in high-risk patients with decreased renal blood perfusion who depend on prostaglandin synthesis to maintain normal renal function. Fluid retention is the most common NSAID-related renal complication, occurring to some degree in virtually all exposed individuals; however, clinically detectable edema occurs in less than 5% of patients and is readily reversible on discontinuation of the NSAID. Other electrolyte complications, notably hyperkalemia, are seen infrequently and occur in specific at-risk patients. The next most worrisome complication is acute deterioration of renal function, which occurs in high-risk patients and is also reversible. Nephrotic syndrome with interstitial nephritis is a rare problem of NSAID use and is reversible. Papillary necrosis is the only permanent complication of NSAIDs and is very rare. Altogether, these renal function abnormalities, with the exception of mild fluid retention, are clinically detectable in approximately 1% of exposed patients. Given the number of patients who take NSAIDs on a prescription or over-the-counter basis, the absolute number of at-risk patients is relatively large. Consequently, an appreciation for the risk factors and pathophysiology of NSAID-induced renal function abnormalities is required for optimal use of these drugs.

Widescale implementation of prospective payment systems as a means of reimbursing hospitals on the basis of diagnosis-related group designation has important implications with respect to the selection of drug therapy. Instead of analyzing costs on a departmental basis, pharmacists need to identify the impact of optimal drug therapy on overall profitability. Clinically evident deep venous thrombosis and pulmonary embolism occur in approximately 3.5% and 1.8% of patients undergoing general surgery. Treatment of these complications consumes hospital resources, but the hospital absorbs the cost of treatment under the prospective payment system. Effective prophylactic measures increase profitability by preventing complications and minimizing the proportion of outliers due to increased length of stay. In selecting prophylactic measures, this impact on overall profitability is as important as acquisition cost. For example, in comparison with no prophylaxis, dihydroergotamine-heparin reduces the frequency of deep venous thrombosis in patients undergoing general surgery by 61.5% and heparin alone reduces it by 31.2%. The relative effect of this combination on postoperative complications and resultant savings in terms of treating them compensates for differences in acquisition costs between these measures.

In animals, Corynebacterium parvum lowers the rate of drug metabolism and enhances the pharmacologic effect of drugs requiring hepatic microsomal enzyme activity for elimination. A pilot study was conducted to assess this drug interaction in patients given clinical protocol doses of C. parvum. In individual patients, C. parvum did not reduce microsomal drug metabolism as measured by antipyrine half-life. Conversely, antipyrine elimination appeared to be enhanced in 10 of 14 patients. Results from this small heterogenous patient group are not definitive, and further studies are needed to determine the clinical significance of the effects of nonspecific immunotherapy on drug metabolism.