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Interest in the use of animal models of human disease has been increasing both within pharmaceutical companies and regulatory authorities, as evidenced by several recent publications and inclusion of recommendations for the use of these models in regulatory guidances. While the use of conventional or healthy animal models will continue to be a central component of safety evaluation, there are certain instances in which the use of animal models is critical for the understanding of potential risk for a diseased population. This review article provides highlights of the use of animal models of disease and provides examples of recent uses of animal models in the elucidation of safety considerations for humans, focusing on instances in which the models have been utilized in regulatory filings.

OBJECTIVE To conduct a systematic review of studies reporting prevalence rates of depression in women living in low-income circumstances in developed countries. METHODS The published and unpublished literature was searched for studies reporting prevalence of depression in women with low income in developed countries. Searches, data extraction, and methodological appraisal were conducted twice independently. To perform the analysis, the meta and metafor packages in R, a random effect model to account for both between and within studies' variances, and the restricted maximum likelihood method for estimation were used. RESULTS One-hundred sixty-four studies, involving 218,035 participants, were located through the search process. The point prevalence of depression among women in low-income circumstances using self-report instruments in 134 studies was 37.4% (95% CI, 34.0%-40.7%). Additionally, the point prevalence according to depression diagnosis in 25 studies was 22.9% (95% CI, 17.8%-28.5%). CONCLUSIONS The high rate of depression among women living in low-income circumstances is of serious public health concern. POLICY IMPLICATIONS Women living in low-income circumstances should receive screening and referral/treatment in not only medical service settings, but also in social service settings serving women receiving welfare benefits.

In patients with gastroesophageal reflux disease (GERD) and erosive esophagitis, treatment with proton pump inhibitors (PPIs) is highly effective. However, in some patients, especially those with nonerosive reflux disease or atypical GERD symptoms, acid-suppressive therapy with PPIs is not as successful. Alginates are medications that work through an alternative mechanism by displacing the postprandial gastric acid pocket. This study performed a systematic review and meta-analysis to examine the benefit of alginate-containing compounds in the treatment of patients with symptoms of GERD. PubMed/MEDLINE, Embase, and the Cochrane library electronic databases were searched through October 2015 for randomized controlled trials comparing alginate-containing compounds to placebo, antacids, histamine-2 receptor antagonists (H2RAs), or PPIs for the treatment of GERD symptoms. Additional studies were identified through a bibliography review. Non-English studies and those with pediatric patients were excluded. Meta-analyses were performed using random-effect models to calculate odds ratios (OR). Heterogeneity between studies was estimated using the I2 statistic. Analyses were stratified by type of comparator. The search strategy yielded 665 studies and 15 (2.3%) met inclusion criteria. Fourteen were included in the meta-analysis (N = 2095 subjects). Alginate-based therapies increased the odds of resolution of GERD symptoms when compared to placebo or antacids (OR: 4.42; 95% CI 2.45–7.97) with a moderate degree of heterogeneity between studies (I2 = 71%, P = .001). Compared to PPIs or H2RAs, alginates appear less effective but the pooled estimate was not statistically significant (OR: 0.58; 95% CI 0.27–1.22). Alginates are more effective than placebo or antacids for treating GERD symptoms.

Anesthesia information management systems (AIMS) are sophisticated hardware and software technology solutions that can provide electronic feedback to anesthesia providers. This feedback can be tailored to provide clinical decision support (CDS) to aid clinicians with patient care processes, documentation compliance, and resource utilization. We conducted a systematic review of peer-reviewed articles on near real-time and point-of-care CDS within AIMS using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies were identified by searches of the electronic databases Medline and EMBASE. Two reviewers screened studies based on title, abstract, and full text. Studies that were similar in intervention and desired outcome were grouped into CDS categories. Three reviewers graded the evidence within each category. The final analysis included 25 articles on CDS as implemented within AIMS. CDS categories included perioperative antibiotic prophylaxis, post-operative nausea and vomiting prophylaxis, vital sign monitors and alarms, glucose management, blood pressure management, ventilator management, clinical documentation, and resource utilization. Of these categories, the reviewers graded perioperative antibiotic prophylaxis and clinical documentation as having strong evidence per the peer reviewed literature. There is strong evidence for the inclusion of near real-time and point-of-care CDS in AIMS to enhance compliance with perioperative antibiotic prophylaxis and clinical documentation. Additional research is needed in many other areas of AIMS-based CDS.

Malnutrition in the critically ill or injured child is associated with increased morbidities and mortality in the pediatric intensive care unit (PICU), whether present upon admission or acquired during the PICU stay. Particular subpopulations such as those with congenital heart disease or severe thermal injury are at highest risk for malnutrition which can worsen with illness progression. A growing body of evidence suggests the presence of a positive association between nutrition support during critical illness and patient outcomes. Enteral nutrition (EN), the preferred route of nutrient delivery, may be a crucial component of care provided in the PICU which modifies the response to critical illness or injury, resulting in improved outcomes. Numerous challenges exist in the delivery of the EN goal in critically ill children. These include accurate assessment of nutrient requirements, hemodynamic instability, feeding intolerance, feeding interruptions, and the lack of a standardized approach to nutrition support. This article describes the current state of the science and challenges related to EN prescription and delivery in the critically ill child. Suggestions for improving EN practice are then presented, in addition to a platform for further research inquiry.

In patients with gastroesophageal reflux disease (GERD) and erosive esophagitis, treatment with proton pump inhibitors (PPIs) is highly effective. However, in some patients, especially those with non-erosive reflux disease or atypical GERD symptoms, acid suppressive therapy with PPIs is not as successful. Alginates are medications that work through an alternative mechanism by displacing the post-prandial gastric acid pocket. We performed a systematic review and meta-analysis to examine the benefit of alginate-containing compounds in the treatment of patients with symptoms of GERD.PubMed/MEDLINE, Embase and the Cochrane library electronic databases were searched through October 2015 for randomized controlled trials comparing alginate-containing compounds to placebo, antacids, histamine-2 receptor antagonists (H2RAs) or PPIs for the treatment of GERD symptoms. Additional studies were identified through bibliography review. Non-English studies and those with pediatric patients were excluded. Meta-analyses were performed using random-effects models to calculate odds ratios (OR). Heterogeneity between studies was estimated using the I2 statistic. Analyses were stratified by type of comparator. The search strategy yielded 665 studies and 15 (2.3%) met inclusion criteria. Fourteen were included in the meta-analysis (N = 2095 subjects). Alginate-based therapies increased the odds of resolution of GERD symptoms when compared to placebo or antacids (OR: 4.42; 95% CI 2.45-7.97) with a moderate degree of heterogeneity between studies (I2 = 71%, P = .001). Compared to PPIs or H2RAs, alginates appear less effective but the pooled estimate was not statistically significant (OR: 0.58; 95% CI 0.27-1.22). Alginates are more effective than placebo or antacids for treating GERD symptoms.

This cross-sectional correlation study examined use of health-promoting (HP) behaviors and self-efficacy for engaging in HP behaviors. Participants reported higher HP behavior scores for health responsibility, interpersonal relationships, and spiritual growth, and lower scores for physical activity/exercise, nutrition, and stress management. Low physical activity, stress management, and nutrition scores suggest nurses can implement strategies that encourage use of these HP behaviors and enhance self-efficacy.

The US federal government has enacted legislation for a federal incentive program for health care providers and hospitals to implement electronic health records. The primary goal of the Meaningful Use (MU) program is to drive adoption of electronic health records nationwide and set the stage to monitor and guide efforts to improve population health and outcomes. The MU program provides incentives for the adoption and use of electronic health record technology and, in some cases, penalties for hospitals or providers not using the technology. The MU program is administrated by the Department of Health and Human Services and is divided into 3 stages that include specific reporting and compliance metrics. The rationale is that increased use of electronic health records will improve the process of delivering care at the individual level by improving the communication and allow for tracking population health and quality improvement metrics at a national level in the long run. The goal of this narrative review is to describe the MU program as it applies to anesthesiologists in the United States. This narrative review will discuss how anesthesiologists can meet the eligible provider reporting criteria of MU by applying anesthesia information management systems (AIMS) in various contexts in the United States. Subsequently, AIMS will be described in the context of MU criteria. This narrative literature review also will evaluate the evidence supporting the electronic health record technology in the operating room, including AIMS, independent of certification requirements for the electronic health record technology under MU in the United States.

Importance The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. Objective To provide new and updated evidence-based recommendations for the prevention of SSI. Evidence Review A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. Findings Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. Conclusions and Relevance This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.