A case-control study of medication-associated acute kidney injuries in hospitalized pediatric patients

Acute kidney Injury (AKI) in hospitalized pediatric patients can be a significant event that can result in increased patient morbidity and mortality. The incidence of medication associated AKI is increasing in the pediatric population. Currently, there are no data to quantify the risks of developing AKI for various potentially nephrotoxic medications. The primary objective of this study was to determine the odds of nephrotoxic medication exposure in hospitalized pediatric patients with AKI as defined by the pediatric modified pRIFLE criteria. A retrospective case-control study was performed with patients that developed AKI, as defined by the pediatric pRIFLE criteria, as cases, and patients without AKI as controls that were matched by age category, gender, and disease state. Patients between 1 day and 18 years of age, admitted to a non-intensive care unit at Texas Children's Hospital for at least 3 days, and had at least 2 serum creatinine values drawn were included. Patient data was analyzed with Student's t test, Mann-Whitney U test, Chi square analysis, ANOVA, and conditional logistic regression. ^ Out of 1,660 patients identified for inclusion, 561 (33.8%) patients had AKI, and 357 cases were matched with 357 controls to become pairs. Of the cases, 441 were category 'R', 117 category 'I', 3 patients were category 'F', and no patient died. Cases with AKI were significantly younger than controls (p < 0.05). Significantly longer hospital length of stays, increased hospital costs, and exposure to more nephrotoxic medications for a longer period of time were characteristics of patients with AKI compared to patient without AKI. Patients with AKI had greater odds of exposure to one or more nephrotoxic medication than patients without AKI (OR 1.3, 95% CI 1.1–1.4, p < 0.05). Percent changes in estimated creatinine clearance (eCCl) from baseline were greatest with increased number of nephrotoxic medication exposures. ^ Exposure to potentially nephrotoxic medications may place pediatric patients at greater risk of acute kidney injury. Multiple nephrotoxic medication exposure may confer a greater risk of development of acute kidney injury, and result in increased hospital costs and patient morbidity. Due to the high percentage of patients that were exposed to potentially nephrotoxic medications, monitoring and medication selection strategies may need to be altered to prevent or minimize risk.^

Efficacy of quality criteria to identify potentially harmful information: a cross-sectional survey of complementary and alternative medicine web sites.

BACKGROUND: Many users search the Internet for answers to health questions. Complementary and alternative medicine (CAM) is a particularly common search topic. Because many CAM therapies do not require a clinician's prescription, false or misleading CAM information may be more dangerous than information about traditional therapies. Many quality criteria have been suggested to filter out potentially harmful online health information. However, assessing the accuracy of CAM information is uniquely challenging since CAM is generally not supported by conventional literature. OBJECTIVE: The purpose of this study is to determine whether domain-independent technical quality criteria can identify potentially harmful online CAM content. METHODS: We analyzed 150 Web sites retrieved from a search for the three most popular herbs: ginseng, ginkgo and St. John's wort and their purported uses on the ten most commonly used search engines. The presence of technical quality criteria as well as potentially harmful statements (commissions) and vital information that should have been mentioned (omissions) was recorded. RESULTS: Thirty-eight sites (25%) contained statements that could lead to direct physical harm if acted upon. One hundred forty five sites (97%) had omitted information. We found no relationship between technical quality criteria and potentially harmful information. CONCLUSIONS: Current technical quality criteria do not identify potentially harmful CAM information online. Consumers should be warned to use other means of validation or to trust only known sites. Quality criteria that consider the uniqueness of CAM must be developed and validated.

AN IMPLANTABLE MOSFET DOSIMETER MODIFIED TO ACT AS A FIDUCIAL MARKER

In external beam radiation therapy, it is imperative that the prescribed dose is administered to the correct location and in the correct amount. Though several ex vivo methods of quality assurance are currently employed to achieve this goal, verifying that the correct dose is received within the patient in situ is impossible without the capability of measuring dose inside the patient. Recently, a method of measuring dose delivered within the patient has been developed, an implantable MOSFET dosimeter. This dosimeter is implanted within the patient and records the dose received. Since the dosimeter is implanted in the patient, it could serve a dual function as a fiducial marker for image guided radiation therapy (IGRT) treatment if it could be modified to be visible on x-rays. In this study, modifications to the MOSFET dosimeter were made to increase its visibility for IGRT treatment. To test whether the modifications hindered the dosimeter’s ability to accurately measure and transmit dose information, the energy dependence, angular dependence and wireless read range of the modified dosimeter were measured and compared to unmodified dosimeters. It was found that the modified dosimeter performed as well as the unmodified dosimeter while also being suitable for use as a fiducial marker for IGRT treatment.

The status of genetically modified foods internationally and in the United States

Biotechnology refers to the broad set of techniques that allow genetic manipulation of organisms. The techniques of biotechnology have broad implications for many industries, however it promises the greatest innovations in the production of products regulated by the Food and Drug Administration (FDA). Like many other powerful new technologies, biotechnology may carry risks as well as benefits. Several of its applications have engendered fervent emotional reactions and raised serious ethical concerns, especially internationally. ^ First, in my paper I discuss the historical and technical background of biotechnology. Second, I examine the development of biotechnology in Europe, the citizens' response to genetically modified (“GM”) foods and the governments' response. Third, I examine the regulation of bioengineered products and foods in the United States. ^ In conclusion, there are various problems with the current status of regulation of GM foods in the United States. These are four basic flaws: (1) the Coordinated Framework allows for too much jurisdictional overlap of biotechnological foods, (2) GM foods are considered GRAS and consequently, are placed on the market without pre-market approval, (3) federal mandatory labeling of GM foods cannot occur until the question of whether or not nondisclosure of a genetic engineering production processes is misleading or material information and (4) an independent state-labeling scheme of GM foods will most likely impede interstate commerce. ^

The use of social media to communicate child health information to low-income parents: A formative study

The Internet, and specifically web 2.0 social media applications, offers an innovative method for communicating child health information to low-income parents. The main objective of this study was to use qualitative data to determine the value of using social media to reach low-income parents with child health information. A qualitative formative evaluation employing focus groups was used to determine the value of using social media for dissemination of child health information. Inclusion criteria included: (1) a parent with a child that attends a school in a designated Central Texas school district; and (2) English-speaking. The students who attend these schools are generally economically disadvantaged and are predominately Hispanic. The classic analysis strategy was used for data analysis. Focus group participants (n=19) were female (95%); White (53%), Hispanic (42%) or African American (5%); and received government assistance (63%). Most had access to the Internet (74%) and were likely to have low health literacy (53%). The most preferred source of child health information was the family pediatrician or general practitioner. Many participants were familiar with social media applications and had profiles on popular social networking sites, but used them infrequently. Objections to social media sites as sources of child health information included lack of credibility and parent time. Social media has excellent potential for reaching low-income parents when used as part of a multi-channel communication campaign. Further research should focus on the most effective type and format of messages that can promote behavior change in this population, such as story-telling. ^

Evaluating the Utility of Clinical Criteria for the Identification of Lynch Syndrome among Endometrial Cancer Patients

Background: Lynch Syndrome (LS) is a familial cancer syndrome with a high prevalence of colorectal and endometrial carcinomas among affected family members. Clinical criteria, developed from information obtained from familial colorectal cancer registries, have been generated to identify individuals at elevated risk for having LS. In 2007, the Society of Gynecologic Oncology (SGO) codified criteria to assist in identifying women presenting with gynecologic cancers at elevated risk for having LS. These criteria have not been validated in a population-based setting. Materials and Methods: We retrospectively identified 412, unselected endometrial cancer cases. Clinical and pathologic information were obtained from the electronic medical record, and all tumors were tested for expression of the DNA mismatch repair proteins through immunohistochemistry. Tumors exhibiting loss of MSH2, MSH6 and PMS2 were designated as probable Lynch Syndrome (PLS). For tumors exhibiting immunohistochemical loss of MLH1, we used the PCR-based MLH1 methylation assay to delineate PLS tumors from sporadic tumors. Samples lacking methylation of the MLH1 promoter were also designated as PLS. The sensitivity and specificity for SGO criteria for detecting PLS tumors was calculated. We compared clinical and pathologic features of sporadic tumors and PLS tumors. A simplified cost-effectiveness analysis was also performed comparing the direct costs of utilizing SGO criteria vs. universal tumor testing. Results: In our cohort, 43/408 (10.5%) of endometrial carcinomas were designated as PLS. The sensitivity and specificity of SGO criteria to identify PLS cases were 32.7 and 77%, respectively. Multivariate analysis of clinical and pathologic parameters failed to identify statistically significant differences between sporadic and PLS tumors with the exception of tumors arising from the lower uterine segment. These tumors were more likely to occur in PLS tumors. Cost-effectiveness analysis showed clinical criteria and universal testing strategies cost $6,235.27/PLS case identified and $5,970.38/PLS case identified, respectively. Conclusions: SGO 5-10% criteria successfully identify PLS cases among women who are young or have significant family history of LS related tumors. However, a larger proportion of PLS cases occurring at older ages with less significant family history are not detected by this screening strategy. Compared to SGO clinical criteria, universal tumor testing is a cost effective strategy to identify women presenting with endometrial cancer who are at elevated risk for having LS.

Modified 3+3 design for phase I clinical trials

Phase I clinical trial is mainly designed to determine the maximum tolerated dose (MTD) of a new drug. Optimization of phase I trial design is crucial to minimize the number of enrolled patients exposed to unsafe dose levels and to provide reliable information to the later phases of clinical trials. Although it has been criticized about its inefficient MTD estimation, nowadays the traditional 3+3 method remains dominant in practice due to its simplicity and conservative estimation. There are many new designs that have been proven to generate more credible MTD estimation, such as the Continual Reassessment Method (CRM). Despite its accepted better performance, the CRM design is still not widely used in real trials. There are several factors that contribute to the difficulties of CRM adaption in practice. First, CRM is not widely accepted by the regulatory agencies such as FDA in terms of safety. It is considered to be less conservative and tend to expose more patients above the MTD level than the traditional design. Second, CRM is relatively complex and not intuitive for the clinicians to fully understand. Third, the CRM method take much more time and need statistical experts and computer programs throughout the trial. The current situation is that the clinicians still tend to follow the trial process that they are comfortable with. This situation is not likely to change in the near future. Based on this situation, we have the motivation to improve the accuracy of MTD selection while follow the procedure of the traditional design to maintain simplicity. We found that in 3+3 method, the dose transition and the MTD determination are relatively independent. Thus we proposed to separate the two stages. The dose transition rule remained the same as 3+3 method. After getting the toxicity information from the dose transition stage, we combined the isotonic transformation to ensure the monotonic increasing order before selecting the optimal MTD. To compare the operating characteristics of the proposed isotonic method and the other designs, we carried out 10,000 simulation trials under different dose setting scenarios to compare the design characteristics of the isotonic modified method with standard 3+3 method, CRM, biased coin design (BC) and k-in-a-row design (KIAW). The isotonic modified method improved MTD estimation of the standard 3+3 in 39 out of 40 scenarios. The improvement is much greater when the target is 0.3 other than 0.25. The modified design is also competitive when comparing with other selected methods. A CRM method performed better in general but was not as stable as the isotonic method throughout the different dose settings. The results demonstrated that our proposed isotonic modified method is not only easily conducted using the same procedure as 3+3 but also outperforms the conventional 3+3 design. It can also be applied to determine MTD for any given TTL. These features make the isotonic modified method of practical value in phase I clinical trials.^

Cost-effectiveness of intensified interventions to control healthcare-associated MRSA infections -- A systematic literature review

Methicillin Resistant Staphylococcus aureus healthcare-associated infections (MRSA HAIs) are a major cause of morbidity in hospitalized patients. They pose great economic burden to hospitals caring for these patients. Intensified Interventions aim to control MRSA HAIs. Cost-effectiveness of Intensified Interventions is largely unclear. We performed a review of cost-effectiveness literature on Intensified Interventions , and provide a summary of study findings, the status of economic research in the area, and information that will help decision-makers at regional level and guide future research.^ We conducted literature search using electronic database PubMed, EBSCO, and The Cochrane Library. We limited our search to English articles published after 1999. We reviewed a total of 1,356 titles, and after applying our inclusion and exclusion criteria selected seven articles for our final review. We modified the Economic Evaluation Abstraction Form provided by CDC, and used this form to abstract data from studies.^ Of the seven selected articles two were cohort studies and the remaining five were modeling studies. They were done in various countries, in different study settings, and with different variations of the Intensified Intervention . Overall, six of the seven studies reported that Intensified Interventions were dominant or at least cost-effective in their study setting. This effect persisted on sensitivity testing.^ We identified many gaps in research in this field. The cost-effectiveness research in the field is mostly composed of modeling studies. The studies do not always clearly describe the intervention. The intervention and infection costs and the sources for these costs are not always explicit or are missing. In modeling studies, there is uncertainty associated with some key model inputs, but these inputs are not always identified. The models utilized in the modeling studies are not always tested for internal consistency or validity. Studies usually test the short term cost-effectiveness of Intensified Interventions but not the long results.^ Our study limitation was the inability to adjust for differences in study settings, intervention costs, disease costs, or effectiveness measures. Our study strength is the presentation of a focused literature review of Intensified Interventions in hospital settings. Through this study we provide information that will help decision makers at regional level, help guide future research, and might change clinical care and policies. ^