Natural History of Geographic Atrophy Progression Secondary to Age-Related Macular Degeneration (Geographic Atrophy Progression Study).

PURPOSE The Geographic Atrophy Progression (GAP) study was designed to assess the rate of geographic atrophy (GA) progression and to identify prognostic factors by measuring the enlargement of the atrophic lesions using fundus autofluorescence (FAF) and color fundus photography (CFP). DESIGN Prospective, multicenter, noninterventional natural history study. PARTICIPANTS A total of 603 participants were enrolled in the study; 413 of those had gradable lesion data from FAF or CFP, and 321 had gradable lesion data from both FAF and CFP. METHODS Atrophic lesion areas were measured by FAF and CFP to assess lesion progression over time. Lesion size assessments and best-corrected visual acuity (BCVA) were conducted at screening/baseline (day 0) and at 3 follow-up visits: month 6, month 12, and month 18 (or early exit). MAIN OUTCOME MEASURES The GA lesion progression rate in disease subgroups and mean change from baseline visual acuity. RESULTS Mean (standard error) lesion size changes from baseline, determined by FAF and CFP, respectively, were 0.88 (0.1) and 0.78 (0.1) mm(2) at 6 months, 1.85 (0.1) and 1.57 (0.1) mm(2) at 12 months, and 3.14 (0.4) and 3.17 (0.5) mm(2) at 18 months. The mean change in lesion size from baseline to month 12 was significantly greater in participants who had eyes with multifocal atrophic spots compared with those with unifocal spots (P < 0.001) and those with extrafoveal lesions compared with those with foveal lesions (P = 0.001). The mean (standard deviation) decrease in visual acuity was 6.2 ± 15.6 letters for patients with image data available. Atrophic lesions with a diffuse (mean 0.95 mm(2)) or banded (mean 1.01 mm(2)) FAF pattern grew more rapidly by month 6 compared with those with the "none" (mean, 0.13 mm(2)) and focal (mean, 0.36 mm(2)) FAF patterns. CONCLUSIONS Although differences were observed in mean lesion size measurements using FAF imaging compared with CFP, the measurements were highly correlated with one another. Significant differences were found in lesion progression rates in participants stratified by hyperfluorescence pattern subtype. This large GA natural history study provides a strong foundation for future clinical trials.

Comparison of patients in three different rehabilitation settings after knee or hip arthroplasty: a natural observational, prospective study.

BACKGROUND Patients after primary hip or knee replacement surgery can benefit from postoperative treatment in terms of improvement of independence in ambulation, transfers, range of motion and muscle strength. After discharge from hospital, patients are referred to different treatment destination and modalities: intensive inpatient rehabilitation (IR), cure (medically prescribed stay at a convalescence center), or ambulatory treatment (AT) at home. The purpose of this study was to 1) measure functional health (primary outcome) and function relevant factors in patients with hip or knee arthroplasty and to compare them in relation to three postoperative management strategies: AT, Cure and IR and 2) compare the post-operative changes in patient's health status (between preoperative and the 6 month follow-up) for three rehabilitation settings. METHODS Natural observational, prospective two-center study with follow-up. Sociodemographic data and functional mobility tests, Timed Up and Go (TUG) and Iowa Level of Assistance Scale (ILOAS) of 201 patients were analysed before arthroplasty and at the end of acute hospital stay (mean duration of stay: 9.7 days +/- 3.9). Changes in health state were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and 6 months after arthroplasty. RESULTS Compared to patients referred for IR and Cure, patients referred for AT were significantly younger and less comorbid. Patients admitted to IR had the highest functional disability before arthroplasty. Before rehabilitation, mean TUG was 40.0 s in the IR group, 33.9 s in the Cure group, and 27.5 s in the AT group, and corresponding mean ILOAS was 16.0, 13.0 and 12.2 (50.0 = worst). At the 6 months follow-up, the corresponding effect sizes of the WOMAC global score were 1.32, 1.87, and 1.51 (>0 means improvement). CONCLUSIONS Age, comorbidity and functional disability are associated with referral for intensive inpatient rehabilitation after hip or knee arthroplasty and partly affect health changes after rehabilitation.

Chronic lymphocytic leukemia: A study of the changing patterns of the natural history, clinical factors associated with prognosis, and risk of second cancers

A retrospective cohort study was conducted among 1542 patients diagnosed with CLL between 1970 and 2001 at the M. D. Anderson Cancer Center (MDACC). Changes in clinical characteristics and the impact of CLL on life expectancy were assessed across three decades (1970–2001) and the role of clinical factors on prognosis of CLL were evaluated among patients diagnosed between 1985 and 2001 using Kaplan-Meier and Cox proportional hazards method. Among 1485 CLL patients diagnosed from 1970 to 2001, patients in the recent cohort (1985–2001) were diagnosed at a younger age and an earlier stage compared to the earliest cohort (1970–1984). There was a 44% reduction in mortality among patients diagnosed in 1985–1995 compared to those diagnosed in 1970–1984 after adjusting for age, sex and Rai stage among patients who ever received treatment. There was an overall 11 years (5 years for stage 0) loss of life expectancy among 1485 patients compared with the expected life expectancy based on the age-, sex- and race-matched US general population, with a 43% decrease in the 10-year survival rate. Abnormal cytogenetics was associated with shorter progression-free (PF) survival after adjusting for age, sex, Rai stage and beta-2 microglobulin (beta-2M); whereas, older age, abnormal cytogenetics and a higher beta-2M level were adverse predictors for overall survival. No increased risk of second cancer overall was observed, however, patients who received treatment for CLL had an elevated risk of developing AML and HD. Two out of three patients who developed AML were treated with alkylating agents. In conclusion, CLL patients had improved survival over time. The identification of clinical predictors of PF/overall survival has important clinical significance. Close surveillance of the development of second cancer is critical to improve the quality of life of long-term survivors. ^

Cultural competence in an HIV dedicated dental clinic: Application of the National Standards for Culturally and Linguistically Appropriate Services in Health Care (CLAS)

This dissertation investigated perspectives on cultural competence among African-American women patients, staff, and the administrator of a dental clinic serving people living with HIV/AIDS; and evaluated the role of the National Standards for Culturally and Linguistically Appropriate Services in Health Care (CLAS) in advancing the provision of culturally competent care in the clinic. ^ The study was qualitative with data collection via focus groups and individual interviews with a sample of African-American women patients, and individual interviews with a sample of staff and the clinic administrator. Transcripts were coded and themes identified using the software program ATLAS.ti. A cultural audit template was developed and applied to evaluate cultural competency. ^ Among attitudes and behaviors that contributed to the provision of culturally competent care at the clinic were respect and empathic communication. Formal cultural competency was not featured strongly in the methods by which the staff learned to work with diverse populations. Instead cultural competence among the staff was based on thoughtful hiring practices, natural aptitude and a climate that encouraged learning through informal sharing of experiences. The staff and administrator felt that an African-American dentist would be an asset in improving culturally competent care at the clinic. Previous research and national policy also promote the provider-patient racial/ethnic concordance to improve care. In this study, however, the patients were happy with the care provided regardless of the race/ethnicity of the staff, probably reflecting the well developed cultural competence skills of clinic staff overall. ^ The clinic administrator was unaware of the CLAS standards although the clinic was implicitly operated under their mandates. This occurred because the clinic is supported by federal funding and the CLAS standards were incorporated into the requirements. Incorporation into and monitoring of the CLAS standards in federally funded programs therefore appears to be an effective means for ensuring that they are implemented. ^ This study illustrates that cultural competence, though not universally understood, can be systematically investigated to identify what constitutes appropriate care and the factors that support or inhibit it. Among important elements of culturally competent care are respect and empathic communication. ^

An overview of China's one child policy and health consequences on society

In 1979, China implemented the one child policy to stifle the burden of the massive demographic growth cast on the future economic development and quality of living conditions. At the time, a quarter of the world's population resided in China and occupied only 7 percent of the world's arable land (The World Factbook, 2006). The government set the target total population to about 1.4 billion for the year 2010 and to significantly reduce the natural increase rate. First this overview paper will describe population demographics and economy of China's society. This paper will also investigate what the one child policy entails and how it is implemented. Furthermore, the consequences of the policy in regard to population growth, sex ratio, marital discrepancies, adverse health of mother and child, aging population, and pension coverage will be examined. Finally, future recommendations and an alternative policy will be postulated to increase the effectiveness of the policy and improve its effects on health. ^

A model for use by local public health departments to evaluate pandemic influenza plans

The events of the 1990's and early 2000's demonstrated the need for effective planning and response to natural and man-made disasters. One of those potential natural disasters is pandemic flu. Once defined, the CDC stated that program, or plan, effectiveness is improved through the process of program evaluation. (Centers for Disease Control and Prevention, 1999) Program evaluation should be accomplished not only periodically, but in the course of routine administration of the program. (Centers for Disease Control and Prevention, 1999) Accomplishing this task for a "rare, but significant event" is challenging. (Herbold, John R., PhD., 2008) To address this challenge, the RAND Corporation (under contract to the CDC) developed the "Facilitated Look-Backs" approach that was tested and validated at the state level. (Aledort et al., 2006).^ Nevertheless, no comprehensive and generally applicable pandemic influenza program evaluation tool or model is readily found for use at the local public health department level. This project developed such a model based on the "Facilitated Look-Backs" approach developed by RAND Corporation. (Aledort et al., 2006) Modifications to the RAND model included stakeholder additions, inclusion of all six CDC program evaluation steps, and suggestions for incorporating pandemic flu response plans in seasonal flu management implementation. Feedback on the model was then obtained from three LPHD's—one rural, one suburban, and one urban. These recommendations were incorporated into the final model. Feedback from the sites also supported the assumption that this model promotes the effective and efficient evaluation of both pandemic flu and seasonal flu response by reducing redundant evaluations of pandemic flu plans, seasonal flu plans, and funding requirement accountability. Site feedback also demonstrated that the model is comprehensive and flexible, so it can be adapted and applied to different LPHD needs and settings. It also stimulates evaluation of the major issues associated with pandemic flu planning. ^ The next phase in evaluating this model should be to apply it in a program evaluation of one or more LPHD's seasonal flu response that incorporates pandemic flu response plans.^

Health impacts of extreme weather: Flood fatalities in Texas

Floods are the leading cause of fatalities related to natural disasters in Texas. Texas leads the nation in flash flood fatalities. From 1959 through 2009 there were three times more fatalities in Texas (840) than the following state Pennsylvania (265). Texas also leads the nation in flood-related injuries (7753). Flood fatalities in Texas represent a serious public health problem. This study addresses several objectives of Healthy People 2010 including reducing deaths from motor vehicle accidents (Objective 15-15), reducing nonfatal motor vehicle injuries (Objective 15-17), and reducing drownings (Objective 15-29). The study examined flood fatalities that occurred in Texas between 1959 and 2008. Flood fatality statistics were extracted from three sources: flood fatality databases from the National Climatic Data Center, the Spatial Hazard Event and Loss Database for the United States, and the Texas Department of State Health Services. The data collected for flood fatalities include the date, time, gender, age, location, and type of flood. Inconsistencies among the three databases were identified and discussed. Analysis reveals that most fatalities result from driving into flood water (77%). Spatial analysis indicates that more fatalities occurred in counties containing major urban centers – some of the Flash Flood Alley counties (Bexar, Dallas, Travis, and Tarrant), Harris County (Houston), and Val Verde County (Del Rio). An intervention strategy targeting the behavior of driving into flood water is proposed. The intervention is based on the Health Belief model. The main recommendation of the study is that flood fatalities in Texas can be reduced through a combination of improved hydrometeorological forecasting, educational programs aimed at enhancing the public awareness of flood risk and the seriousness of flood warnings, and timely and appropriate action by local emergency and safety authorities.^

An intervention mapping approach: Identification of human trafficking victims by health professionals

Background. Today modern day slavery is known as human trafficking and is a growing pandemic that is a grave human rights violation. Estimates suggest that 12.3 million people are working under conditions of force, fraud or coercion. Working toward eradication is a worthy effort; it would free millions of humans from slavery, mostly women and children, as well as uphold basic human rights. One tactic to eradicating human trafficking is to increase identification of victims among those likely to encounter victims of human trafficking.^ Purpose. This study aims to develop an intervention that improves certain stakeholders' ability, in the health clinic setting, to appropriately identify and report victims of human trafficking to the National Human Trafficking Resource Center.^ Methods. The Intervention Mapping (IM) process was used by program planners to develop an intervention for health professionals. This methodology is a six step process that guides program planners to develop an intervention. Each step builds on the others through the execution of a needs assessment, and the development of matrices based on performance objectives and determinants of the targeted health behavior. The end product results in an ecological, theoretical, and evidence based intervention.^ Discussion. The IM process served as a useful protocol for program planners to take an ecological approach as well as incorporate theory and evidence into the intervention. Consultation with key informants, the planning group, adopters, implementers, and individuals responsible for institutionalization also contributed to the practicality and feasibility of the intervention. Program planners believe that this intervention fully meets recommendations set forth in the literature.^ Conclusions. The intervention mapping methodology enabled program planners to develop an intervention that is appropriate and acceptable to the implementer and the recipients.^

Policy implications of public health workforce development for disaster preparedness in the United States

Public health efforts were initiated in the United States with legislative actions for enhancing food safety and ensuring pure drinking water. Some additional policy initiatives during the early 20th century helped organize and coordinate relief efforts for victims of natural disasters. By 1950's the federal government expanded its role for providing better health and safety to the communities, and its disaster relief activities became more structured. A rise in terrorism related incidents during the late 1990's prompted new proactive policy directions. The traditional policy and program efforts for rescue, recovery, and relief measures changed focus to include disaster preparedness and countermeasures against terrorism.^ The study took a holistic approach by analyzing all major disaster related policies and programs, in regard to their structure, process, and outcome. Study determined that United States has a strong disaster preparedness agenda and appropriate programs are in place with adequate policy support, and the country is prepared to meet all possible security challenges that may arise in the future. The man-made disaster of September 11th gave a major thrust to improve security and enhance preparedness of the country. These new efforts required large additional funding from the federal government. Most existing preparedness programs at the local and national levels are run with federal funds which is insufficient in some cases. This discrepancy arises from the fact that federal funding for disaster preparedness programs at present are not allocated by the level of risks to individual states or according to the risks that can be assigned to critical infrastructures across the country. However, the increased role of the federal government in public health affairs of the states is unusual, and opposed to the spirit of our constitution where sovereignty is equally divided between the federal government and the states. There is also shortage of manpower in public health to engage in disaster preparedness activities, despite some remarkable progress following the September 11th disaster.^ Study found that there was a significant improvement in knowledge and limited number of studies showed improvement of skills, increase in confidence and improvement in message-mapping. Among healthcare and allied healthcare professionals, short-term training on disaster preparedness increased knowledge and improved personal protective equipment use with some limited improvement in confidence and skills. However, due to the heterogeneity of these studies, the results and interpretation of this systematic review may be interpreted with caution.^

Cross-culture perspectives on fear of HIV disease and AIDS in health care workers

Health care workers have been known to carry into the workplace a variety of judgmental and negative attitudes towards their patients. In no other area of patient care has this issue been more pronounced as in the management of patients with AIDS. Health care workers have refused to treat or manage patients with AIDS and have often treated them more harshly than identically described leukemia patients. Some health care institutions have simply refused to admit patients with AIDS and even recent applicants to medical colleges and schools of nursing have indicated a preference for schools in areas with low prevalence of HIV disease. Since the attitudes of health care workers do have significant consequences on patient management, this study was carried out to determine the differences in clinical practice in Nigeria and the United States of America as it relates to knowledge of a patient's HIV status, determine HIV prevalence and culture in each of the study sites and how they impact on infection control practices, determine the relationship between infection control practices and fear of AIDS, and also determine the predictors of safe infection control practices in each of the study sites.^ The study utilized the 38-item fear of AIDS scale and the measure of infection control questionnaire for its data. Questionnaires were administered to health care workers at the university teaching hospital sites of Houston, Texas and Calabar in Nigeria. Data was analyzed using a chi-square test, and where appropriate, a student t-tests to establish the demographic variables for each country. Factor analysis was done using principal components analysis followed by varimax rotation to simple structure. The subscale scores for each study site were compared using t-tests (separate variance estimates) and utilizing Bonferroni adjustments for number of tests. Finally, correlations were carried out between infection control procedures and fear of AIDS in each study site using Pearson-product moment correlation coefficients.^ The study revealed that there were five dimensions of the fear of AIDS in health care workers, namely fear of loss of control, fear of sex, fear of HIV infection through blood and illness, fear of death and medical interventions and fear of contact with out-groups. Fear of loss of control was the primary area of concern in the Nigerian health care workers whereas fear of HIV infection through blood and illness was the most important area of AIDS related feats in United States health care workers. The study also revealed that infection control precautions and practices in Nigeria were based more on normative and social pressures whereas it was based on knowledge of disease transmission, supervision and employee discipline in the United States, and thus stresses the need for focused educational programs in health care settings that emphasize universal precautions at all times and that are sensitive to the cultural nuances of that particular environment. ^

Natural history of placebo treatment in adults acquiring travelers' diarrhea in Mexico

The natural history of placebo treated travelers' diarrhea and the prognostic factors of recovery from diarrhea were evaluated using 9 groups of placebo treated subjects from 9 clinical trial studies conducted since 1975, for use as a historical control in the future clinical trial of antidiarrheal agents. All of these studies were done by the same group of investigators in one site (Guadalajara, Mexico). The studies are similar in terms of population, measured parameters, microbiologic identification of enteropathogens and definitions of parameters. The studies had two different durations of followup. In some studies, subjects were followed for two days, and in some they were followed for five days.^ Using definitions established by the Infectious Diseases society of America and the Food and Drug Administration, the following efficacy parameters were evaluated: Time to last unformed stool (TLUS), number of unformed stools post-initiation of placebo treatment for five consecutive days of followup, microbiologic cure, and improvement of diarrhea. Among the groups that were followed for five days, the mean TLUS ranged from 59.1 to 83.5 hours. Fifty percent to 78% had diarrhea lasting more than 48 hours and 25% had diarrhea more than five days. The mean number of unformed stools passed on the first day post-initiation of therapy ranged from 3.6 to 5.8 and, for the fifth day ranged from 0.5 to 1.5. By the end of followup, diarrhea improved in 82.6% to 90% of the subjects. Subjects with enterotoxigenic E. coli had 21.6% to 90.0% microbiologic cure; and subjects with shigella species experienced 14.3% to 60.0% microbiologic cure.^ In evaluating the prognostic factors of recovery from diarrhea (primary efficacy parameter in evaluating the efficacy of antidiarrheal agents against travelers' diarrhea). The subjects from five studies were pooled and the Cox proportional hazard model was used to evaluate the predictors of prolonged diarrhea. After adjusting for design characteristics of each trial, fever with a rate ratio (RR) of 0.40, presence of invasive pathogens with a RR of 0.41, presence of severe abdominal pain and cramps with a RR of 0.50, number of watery stools more than five with a RR of 0.60, and presence of non-invasive pathogens with a RR of 0.84 predicted a longer duration of diarrhea. Severe vomiting with a RR of 2.53 predicted a shorter duration of diarrhea. The number of soft stools, presence of fecal leukocytes, presence of nausea, and duration of diarrhea before enrollment were not associated with duration of diarrhea. ^

RUNOFF FROM COAL PILES: EFFECTS ON THE ENVIRONMENT AND THE PUBLIC'S HEALTH

The use of coal for fuel in place of oil and natural gas has been increasing in the United States. Typically, users store their reserves of coal outdoors in large piles and rainfall on the coal creates runoffs which may contain materials hazardous to the environment and the public's health. To study this hazard, rainfall on model coal piles was simulated, using deionized water and four coals of varying sulfur content. The simulated surface runoffs were collected during 9 rainfall simulations spaced 15 days apart. The runoffs were analyzed for 13 standard water quality parameters, extracted with organic solvents and then analyzed with capillary column GC/MS, and the extracts were tested for mutagenicity with the Ames Salmonella microsomal assay and for clastogenicity with Chinese hamster ovary cells.^ The runoffs from the high-sulfur coals and the lignite exhibited extremes of pH (acidity), specific conductance, chemical oxygen demand, and total suspended solids; the low-sulfur coal runoffs did not exhibit these extremes. Without treatment, effluents from these high-sulfur coals and lignite would not comply with federal water quality guidelines.^ Most extracts of the simulated surface runoffs contained at least 10 organic compounds including polycyclic aromatic hydrocarbons, their methyl and ethyl homologs, olefins, paraffins, and some terpenes. The concentrations of these compounds were generally less than 50 (mu)g/l in most extracts.^ Some of the extracts were weakly mutagenic and affected both a DNA-repair proficient and deficient Salmonella strain. The addition of S9 decreased the effect significantly. Extracts of runoffs from the low-sulfur coal were not mutagenic.^ All extracts were clastogenic. Extracts of runoffs from the high-sulfur coals were both clastogenic and cytotoxic; those from the low-sulfur coal and the lignite were less clastogenic and not cytotoxic. Clastogenicity occurred with and without S9 activation. Chromosomal lesions included gaps, breaks and exchanges. These data suggest a relationship between the sulfur content of a coal, its mutagenicity and also its clastogenicity.^ The runoffs from actual coal piles should be investigated for possible genotoxic effects in view of the data presented in this study.^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^