Framework for Program Evaluation in Public Health, 2) to share the resulting lessons learned, and 3) to assist future evaluators of PSE-change programs with their evaluation design decisions.The field of public health is increasingly implementing initiatives intended to make policies, systems, and environments (PSEs) more supportive of healthy behaviors, even though the evidence for many of these strategies is only emerging. Our objective was 3-fold: 1) to describe evaluations of PSE-change programs in which the evaluators followed the steps of the Centers for Disease Control and Prevention’s (CDC’s) Seven Prevention Research Centers (PRCs) applied CDC’s framework to evaluate their own PSE-change initiatives. The PRCs followed each step of the framework: 1) engage stakeholders, 2) describe program, 3) focus evaluation design, 4) gather credible evidence, 5) justify conclusions, and 6) ensure use and share lessons learned.Evaluation stakeholders represented a range of sectors, including public health departments, partner organizations, and community members. Public health departments were the primary stakeholders for 4 of the 7 evaluations. Four PRCs used logic models to describe the initiatives being evaluated. Their evaluations typically included both process and outcome questions and used mixed methods. Evaluation findings most commonly focused on contextual factors influencing change (process) and the adoption or implementation of PSE-change strategies (outcome). Evaluators shared lessons learned through various channels to reach local stakeholders and broader public health audiences.Framework for Program Evaluation in Public Health is applicable to evaluations of PSE-change initiatives. Using this framework to guide such evaluations builds practice-based evidence for strategies that are increasingly being used to promote healthful behaviors. Physical inactivity, tobacco use, and other unhealthy behaviors increase risk for numerous chronic conditions and are among the leading contributors to morbidity and mortality –3. EfforPSE interventions are challenging to evaluate because they are often complex . PSE intFramework for Program Evaluation in Public Health (The CDC Prevention Research Centers (PRC) program funds a network of universities to conduct prevention research and partner with public health practitioners and local communities to design, implement, and evaluate interventions to prevent disease . The objc Health  to evaluWe invited 37 PRCs funded from 2009 through 2014 to contribute to this study if they had evaluated a PSE initiative. In 2014, seven PRCs provided information about their PSE evaluations in a series of conference calls organized by the 6 steps of the CDC framework. The Emory University PRC received a contract from the Mississippi State Department of Health to evaluate a community-based initiative focused on reducing stroke and cardiovascular disease in the Mississippi Delta . The iniThe Texas A&M University PRC evaluated local health advisory commissions that were established in 4 rural counties, with members appointed by county government. The PRC also evaluated the interventions that the health advisory commissions implemented in their counties to increase access to physical activity .The Tulane University PRC evaluated its Partnership for an Active Community Environment (PACE) project . Tulane The University of Alabama at Birmingham (UAB) PRC supported their local health department in designing, implementing, and evaluating a policy initiative that encouraged convenience and corner store owners in low-income, predominantly African American communities to voluntarily display point-of-sale tobacco warnings.The University of California, Los Angeles (UCLA) PRC evaluated its WORKING Program: Working Out Regularly Keeps Individuals Nurtured and Going . WORKINGThe University of Iowa (UI) PRC for Rural Health received a contract from the Iowa Department of Public Health to assist in evaluating its CDC-funded Community Transformation Grant (CTG) . The IowThe University of North Carolina at Chapel Hill (UNC) PRC received a contract from the North Carolina Division of Public Health to evaluate the impact of the CTG projects on health equity . The CTGThe first step of the CDC framework is to engage stakeholders; stakeholder input helps generate credible, useful findings and can increase the evaluation’s cultural appropriateness . The secEach PRC project and community was unique; however, we found similarities in the types of stakeholders involved . Three PPRCs reported various stakeholder roles in evaluation. Evaluation stakeholders served both as advisors and as collaborative partners. Stakeholder involvement during the early phases of evaluation included providing input about appropriate evaluation participants and effective ways to access them, evaluation questions, data collection tools, and data collection plans. Nearly every PRC reported stakeholder involvement during the design phase. Stakeholder evaluation roles in mid-project focused primarily on data collection; 5 PRCs involved stakeholders directly in data collection. In later stages, PRCs most commonly engaged stakeholders in interpreting results and disseminating evaluation findings. Six participating PRCs reported such stakeholder involvement during the evaluation’s final stages. To communicate with their stakeholders, most PRCs reported holding regular meetings or conference calls.Approaches to developing models for describing a program differed according to whether the PRC was an internal evaluator or external evaluator . The 4 iThe 3 external evaluator PRCs needed to describe a program with which they were unfamiliar. All three reviewed program documents and met with stakeholders to develop an understanding of the program. Two used this information to develop a logic model. The third used a logic model created by the program staff before contracting with the PRC to do an evaluation; the PRC also developed a conceptual framework to guide the evaluation.PRCs and their evaluation stakeholders selected a range of process and outcome evaluation questions; process evaluation questions focused on topics such as context, PSE strategy selection, PSE-change process, and program reach. Outcome evaluation questions covered topics such as adoption and maintenance of PSE changes, community capacity for change, residents’ access to health care, individual behavior change, and impact of changes on health disparities .Five PRCs used evaluation designs that included mixed methods of data collection . Four usPRCs and their evaluation stakeholders selected a range of indicators for their evaluation questions . ProcessThe study PRCs used several data analysis methods and a variety of approaches to summarize and interpret findings: 5 PRCs used mixed data analysis methods, one PRC used quantitative methods exclusively, and one PRC used qualitative methods exclusively . Three PAll PRCs generated findings and recommendations that could be used for program improvement or to inform future initiatives . Five PRThe PRCs employed 4 kinds of strategies to ensure use of the evaluations and share lessons . First, This article describes how 7 PRCs evaluated PSE-change initiatives, focusing on how PRCs carried out each step of the CDC framework. Understanding how best to evaluate PSE initiatives is important, given the significant investment of public health resources in such initiatives –7,26, deEvaluators need to engage a broad diversity of stakeholders to address the complex, multisectoral nature of PSE change. Evaluation stakeholders were from a range of sectors, including public health departments, community organizations, and community members. PRCs most commonly identified the organization responsible for implementing the initiative as the primary intended user . Most PRCs actively engaged with intended users throughout the intervention process, which is one of the most effective ways to ensure that findings will be used.It is appropriate for PSE evaluation outcomes to focus on changes in policies and environments, provided that an established link exists between those structural changes and health outcomes. For example, increasing the unit price of tobacco is known to reduce tobacco use . Therefostructural approach to encompass multiple types of strategies. Using clearer and more consistent definitions of what is meant by PSE or structural change initiatives when designing and describing programs may help evaluators design studies that can tease out the impact of different components or types of interventions and strengthen our knowledge base about such strategies.Furthermore, it is often difficult to differentiate between policy, systems, and environmental approaches; for example, although CDC has referred to PSE change in many of its programs, it has also described policy change as a type of environmental approach . LiebermThree PRCs also assessed the interventions’ impact on capacity and partnerships. Because PSE change is a new focus for many public health practitioners, capacity and partnership building may be an important precursor to intervention planning and implementation. Six PRCs also gathered evidence on contextual factors that may impede or facilitate implementation, evidence that is critical to strengthening PSE interventions.PRCs were often limited in the type of research designs used. Most were cross-sectional, and only one evaluation included a randomized control group with longitudinal follow-up. Such modest designs are understandable given funding constraints and the resource-intensive nature of rigorous evaluation of large-scale, community-based PSE-change initiatives . HoweverThis article provides an overview of multiple evaluations; this format necessarily gives limited detail about any one study and simplifies methodological issues raised by each. Additionally, we found differences in PSE-change initiatives, their level of funding for evaluation, and the PRC’s role as internal or external evaluator. We provided a brief description of each initiative and noted each PRC’s role, but our small sample did not allow us to explore the breadth of these issues or look for relationships between these characteristics and resulting evaluation decisions.Despite these limitations, the experience of these 7 PRCs offers useful lessons for evaluations of PSE-change initiatives. To our knowledge, this is the first article to describe how all 6 steps of the CDC framework can be applied to PSE interventions. Less frequently described steps in this framework may be particularly relevant to PSE initiatives. For example, attention to describing the program may be helpful in evaluations of complex interventions where change is expected to occur incrementally and where attribution to any one intervention is difficult . The fin


Recognizing the imperiled status of biodiversity and its benefit to human well-being, the world's governments committed in 2010 to take effective and urgent action to halt biodiversity loss through the Convention on Biological Diversity's “Aichi Targets”. These targets, and many conservation programs, require monitoring to assess progress toward specific goals. However, comprehensive and easily understood information on biodiversity trends at appropriate spatial scales is often not available to the policy makers, managers, and scientists who require it. We surveyed conservation stakeholders in three geographically diverse regions of critical biodiversity concern  and found high demand for biodiversity indicator information but uneven availability. To begin to address this need, we present a biodiversity “dashboard” – a visualization of biodiversity indicators designed to enable tracking of biodiversity and conservation performance data in a clear, user-friendly format. This builds on previous, more conceptual, indicator work to create an operationalized online interface communicating multiple indicators at multiple spatial scales. We structured this dashboard around the Pressure-State-Response-Benefit framework, selecting four indicators to measure pressure on biodiversity (deforestation rate), state of species (Red List Index), conservation response (protection of key biodiversity areas), and benefits to human populations (freshwater provision). Disaggregating global data, we present dashboard maps and graphics for the three regions surveyed and their component countries. These visualizations provide charts showing regional and national trends and lay the foundation for a web-enabled, interactive biodiversity indicators dashboard. This new tool can help track progress toward the Aichi Targets, support national monitoring and reporting, and inform outcome-based policy-making for the protection of natural resources. Mounting global evidence shows that biodiversity loss is continuing at alarming rates http://dashboarddev.natureserve.org, with steps 3–5 being implemented in an on-going iterative process.To better understand the challenges to effective biodiversity monitoring at national and regional scales, and how finer-scale  data might be integrated into a framework for global monitoring of biodiversity status and trends, we surveyed local conservation experts working in areas of high conservation value on monitoring and capacity needs. Building from the needs identified in those workshops, we then developed the concept for a biodiversity indicators dashboard using indicators derived from global data sets and constructed a dashboard prototype. This is the first operationalized dashboard to date that communicates multiple biodiversity indicators at multiple scales, and directly serves the global need to monitor progress towards Aichi Targets. Full development of the biodiversity indicators dashboard will encompass: (1) identification of appropriate indicators, (2) proof of concept using global data, (3) building the technological infrastructure necessary to host the dashboard, (4) designing the visual interface for multiple platforms (i.e. web and mobile users), and (5) creating systems to support the integration of finer-scale  data. Here, we address in detail steps 1 and 2 of the dashboard design, laying the foundation for a web-based tool freely available to all with an interest in biodiversity conservation. A prototype of the tool is now available to the international conservation community at We considered three geographically diverse areas with exceptional biodiversity value, that confront a high degree threat and that receive significant investment by international conservation agencies  [25], [2We delineated regional boundaries for the Tropical Andes, African Great Lakes and Greater Mekong regions using hydrological basins derived from HydroSHEDS and compiled by the UN-FAO, We conducted seven consultation workshops in the three study regions between September 2011 and August 2012 to (1) better understand the challenges to effective biodiversity monitoring at national and regional scales, (2) identify gaps in current monitoring capacity and potential mechanisms for filling those gaps, and (3) begin to explore mechanisms for integrating local and national monitoring data into future regional and national biodiversity indicators. In total, 260 individuals from 20 countries attended at least one of the workshops, with broad representation from the public, civil-society, and academic sectors. Invitees included those with professional responsibility for National Biodiversity Strategies and Action Plans for monitoring progress towards Aichi Targets, and managers and technical experts responsible for designing and conducting biodiversity monitoring programs at multiple scales.At each workshop, we solicited multiple-choice feedback on two issues: 1) the spatial scales of monitoring that participants required to guide their work ; and 2) the status of monitoring of selected biodiversity indicators for pressure, state, response, and benefits at the national scale, with answer options of “Monitored”, “Limited Monitoring” , “Not Monitored”, or “Unknown”. Of the 260 workshop participants, 132 (51%) submitted answers to these written questionnaires, of which 39% came from the public sector, 45% from civil-society, and 16% from the academic sector. We also recorded and categorized responses to open-ended questions addressing (1) the utility of tracking biodiversity indicators derived from existing global data with a dashboard approach and (2) national challenges in developing sustainable biodiversity monitoring.1P + 0.52P, with 1P the percent of respondents who answered “monitored” and 2P the percent of respondents who answered “limited monitoring”. We used ANOVA to explore differences of monitoring status between regions, and a repeated-measures ANOVA to examine differences in monitoring status among indicators.To identify the preferred scales of monitoring, we tabulated the frequency of the scales that participants indicated were important. To quantify the existing capacity for monitoring in each of the targeted countries, we calculated a score based on the perceived monitoring status for each biodiversity indicator. The score is scaled 0 (not monitored) to 1 (monitored), and equals Responses to the questionnaire indicate a strong demand for reliable information on the state of, and pressures facing, biodiversity. Regarding scales of monitoring, participants were most interested in analyses carried out at the site (82%) and national levels (76%), followed by watershed (71%), sub-national (68%) and regional levels (65%).Our questionnaires revealed significant differences in the degree to which indicators are currently monitored (p<0.001), with hydrologic measures (average score  = 0.40) and species extinction risk (0.57) less frequently monitored than deforestation (0.72) and protected area coverage (0.79) . While tAmong the open-ended questions, a third of survey respondents from all sectors expressed high interest in using the dashboard approach, and employing appropriate subsets of global scale data, as a means to gather and share information to assess biodiversity status and threats, assess and improve conservation impacts, and inform policy, planning, and decision-making. Supporting capacity building, promoting stakeholder participation and dissemination of information were also frequently cited by survey respondents as potential benefits of this effort .Across regions, the challenges to effective monitoring  include To address the challenges to biodiversity monitoring at regional and national scales identified by the survey, we envision the creation of a biodiversity “dashboard” – a visualization of biodiversity indicators designed to enable ongoing tracking of biodiversity status and trends and present biodiversity monitoring and conservation performance information in a clear, user-friendly, and unified format that facilitates iterative adaptive management. Using biodiversity indicators of the type developed by Butchart et al. (2010) Originating as a business performance monitoring tool, dashboard visualizations are an information management and reporting instrument that has seen increasing use in a variety of contexts to communicate complicated information on current status and historical trends to broad audiences Dashboards have been proposed and employed in various biological and resource management contexts. For example, the CITES Trade Data Dashboard If a dashboard is to be useful for decision makers, the indicators chosen must present information critical to influencing the decisions to be made. We used the Pressure-State-Response-Benefit (PSRB) framework to guide selection of indicators, following Sparks et al. 2011 st century to represent current status and provide an initial baseline, or reference point, against which future trends can be assessed. For all but the benefit indicator (freshwater provision), existing data from either previous time steps (i.e. species extinction risk and percent protection of KBAs) or later time steps (i.e. forest cover loss) supporting the tracking of trends.We selected one indicator from each PSRB component, with consideration for the availability of global datasets, the degree to which the indicator contributes to evaluating progress made towards the Aichi Targets, the feasibility of trend estimates, and the likely availability of analogous data generated locally for future integration into the dashboard. The four selected indicators are examples of the types of data the biodiversity indicators dashboard can be used to track. At this stage in development of the dashboard, the chosen indicators are not intended to address causal relationships; however, as additional indicators are added, the PSRB approach will facilitate exploration of causal links between indicators. We selected forest cover loss as the pressure indicator, species extinction risk as the state indicator, protected area coverage of key biodiversity areas (KBAs) as the response indicator, and freshwater provisioning to downstream human populations as the benefit indicator. We used data from the first decade of the 21Global data were disaggregated to provide regional and national indicator values . For eaca. Pressure Indicator: Forest LossThe forest loss indicator is derived from the Global Forest Monitoring Project While, to our knowledge, the GFCL data provide the best globally consistent spatial representation of deforestation to date, the data are limited in that they do not incorporate information on forest gain from restoration, natural regrowth, and plantation. They also do not address finer resolution forest degradation, as some other regional mapping products do b. State Indicator: Species Extinction RiskThe Red List Index (RLI) is a measure of trends in survival probability (the inverse of extinction risk) for sets of species. It is based on the numbers of species within each IUCN Red List category , Extinct in the Wild (EW), Critically Endangered (CR), Endangered (EN), Vulnerable (VU), Near Threatened (NT), Least Concern (LC)) and the changes in these numbers over time resulting from genuine improvement or deterioration in status between assessments For this indicator, we used the first and last comprehensive Red List assessment  for each of three vertebrate groups , following Butchart et al.  c. Response Indicator: Protected Area Coverage of Key Biodiversity AreasFor the Response indicator, we calculated the mean percentage area of key biodiversity areas , and in the Mekong, due to both mammals (1.29×10−3/yr) and amphibians (0.98×10−3/yr). Protection of key biodiversity areas increased in all regions since 1980, with some regional variation in the rate of increase . Nationally, rates of increase in the protection of key biodiversity areas ranged from lows of zero in Burundi, Malawi, Mozambique and Rwanda, and highs of 2.09%, 1.54%, and 1.42% in Lao P.D.R., China, and Cambodia  and D. R. Congo (0.12%/yr), and highest in Kenya (1.2%/yr) . The RedCambodia .As approaches to biodiversity management shift towards data-intensive and science-driven methods Recognizing that national and local indicator data are often limited or non-existent, the survey respondents affirmed the value of deriving indicators from global datasets as an intermediate measure necessary to meet current demand. Moving forward, the respondents noted that it will be necessary to augment and validate globally-derived measures with national and local monitoring results, and doing so will require both cost-effective participatory monitoring protocols that ensure sustainable data collection and well-designed standards that ensure data interoperability . A lack The biodiversity indicators dashboard, as explained here, is designed to address the unmet needs expressed in our survey of biodiversity experts by laying the foundation for better accessibility and interpretability of existing biodiversity trend data within a framework that enhances monitoring capacity and promotes data interoperability and sharing. Many of these indicators are widely used at global scales, but until now have rarely been reported at national scales. While previous studies have demonstrated the utility of biodiversity indicators in monitoring conservation status and trends As a data visualization tool, the biodiversity indicators dashboard is designed so that a quick examination communicates the overall status of biodiversity conservation, important trends and patterns, and previously hidden challenges. For example, the graphics and values for the state indicator, such as those presented in By using data and methods that are globally consistent, the dashboard facilitates direct comparison of baseline and trends across regions and nations in the three continents targeted for this first stage of dashboard developments. Regional patterns are readily evident, such as the higher rate of decline of the Red List Index in the tropical Andes or the enormous importance of fresh water provisioning in the Greater Mekong countries . Stark d2 and 2592 km2 respectively for the deforestation and freshwater provision datasets used here). With regard to protected areas, global datasets tend to omit recently decreed areas and often fail to capture important differences in on-the-ground management. Similarly, the use of global distributions and Red List categories may not adequately reflect the conservation status of a given species in a particular region, and because global distribution data is only available for terrestrial vertebrates, the results do not reflect the status of many other components of biodiversity.To develop the dashboard concept, we used indicators derived from global data to bypass the many obstacles in obtaining consistent and comprehensive regional and national data. While the reporting of these global indicators at the national level provides new and valuable information, there are limitations in using global data to represent national indicators. While advances in remote sensing technology provide an unprecedented opportunity to gain temporally repetitive information The shortcomings of indicators derived from global data can be addressed by integrating nationally and locally derived data into the final dashboard design. Despite the numerous obstacles, data are being generated at a variety of scales deemed useful by survey respondents, both through governmental efforts By serving these data as a web-accessible dashboard, we can put information on status and trends in biodiversity within easy access of users and organizations from all sectors and backgrounds, and facilitate more informed decision-making, enable exploration of patterns among variables, and support the tracking of progress towards conservation goals. The maps presented here and information contained in In agreeing to the Aichi Targets, the nations of the world implicitly committed to developing the data necessary to effectively monitor progress towards meeting biodiversity goals. The challenges in reporting towards those goals are many, but we believe the dashboard approach, as outlined here, provides a valuable framework that can facilitate and advance the type of reporting required by the conservation community. Starting with global indicators and expanding to incorporate additional national and site-scale data identified as important by conservation practitioners on the ground, the biodiversity indicators dashboard can serve as a tool to track progress towards Aichi Targets, support national monitoring and reporting, and inform outcome-based policy-making in the realm of conservation.


Background: Reduction mammoplasty is an often-performed procedure by plastic surgeons and increasingly by general surgeons. The question has been posed in both general surgical literature and plastic surgical literature as to whether this procedure should remain the domain of surgical specialists. Some general surgeons are trained in breast reductions, whereas all plastic surgeons receive training in this procedure. The National Surgical Quality Improvement Project provides a unique opportunity to compare the 2 surgical specialties in an unbiased manner in terms of preoperative comorbidities and 30-day postoperative complications. Methods: The National Surgical Quality Improvement Project database was queried for the years 2005–2012. Patients were identified as having undergone a reduction mammoplasty by Current Procedural Terminology codes. Results were refined to include only females with an International Classification of Diseases, Ninth Revision, code of 611.1 (hypertrophy of breasts). Information was collected regarding age, surgical specialty performing procedure, body mass index, and other preoperative variables. The outcomes utilized were presence of superficial surgical site infection, presence of deep surgical site infection, presence of wound dehiscence, postoperative respiratory compromise, pulmonary embolism, deep vein thrombosis, perioperative transfusion, operative time, reintubation, reoperation, and length of hospital stay. Results: During this time period, there were 6239 reduction mammaplasties performed within the National Surgical Quality Improvement Project database: 339 by general surgery and 5900 by plastic surgery. No statistical differences were detected between the 2 groups with regard to superficial wound infections, deep wound infections, organ space infections, or wound dehiscence. There were no significant differences noted between within groups with regard to systemic postoperative complications. Patients undergoing a procedure by general surgery were more likely to experience a failure of skin flaps, necessitating a return to the operative room (P < .05). Operative time was longer in procedures performed by general surgery (P < .05). Conclusion: Several important differences appear to exist between reduction mammaplasties performed by general surgery and plastic surgery. A focused training in reduction mammoplasty appears to be beneficial to the patient. The limitations of this study include a lack of long-term follow-up with regard to aesthetic outcome, nipple malposition, nipple sensation, and late wound sequelae. Reduction mammoplasty is a commonly performed procedure with the goals of reducing the weight and volume of the breast. The indications for the procedure include both physical and psychological concerns. The chronic weight and pressure placed on brassiere straps cause deep grooves to form in the trapezius muscles, there may be back and chest wall pain, and the inframammary region becomes subject to rashes and maceration. Gigantomastia can be an embarrassing focus of attention for women of all ages, especially if unilateral hypertrophy with asymmetry exists. Moreover, excessively large breast size may hinder women from being able to participate in forms of exercise or other activities of daily functioning, which can lead to future health concerns.1The earliest recorded reduction mammoplasty procedures were documented in the late 1800s with techniques developed by surgeons who were not concerned with the aesthetic outcome.,4While there are some general surgeons who receive training in reduction mammoplasty, oftentimes through an oncoplastic breast fellowship, all plastic surgeons are trained in this procedure. In the past, there have been several studies in the literature comparing the outcomes of reduction mammoplasty between plastic surgeons and general surgeons.3As the number of reduction mammoplasty procedures in the United States increases, the demand for surgeons and their time does as well. According to statistics posted on the Association of American Medical Colleges Web site, the number of plastic surgeons per 100,000 population has decreased from 2.21 to 2.11 from 2006 to 2013.The goal of this study is to determine whether or not reduction mammoplasty has similar outcomes when performed by general surgeons as compared with plastic surgeons. To accomplish this objective, information provided by the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was used. NSQIP began as a program mandated by Congress in 1988 to assess the morbidity and mortality rates of surgical cases in Veteran Affairs hospitals.8Current Procedural Terminology codes, and these results were then refined to include only females with a International Classification of Diseases, Ninth Revision, code of 611.1 (hypertrophy of breasts). The database provided patient information including general demographics, surgical specialty performing the procedure, as well as other preoperative variables. To compare outcomes of the procedures, the variables utilized included presence of superficial surgical site infection, presence of deep surgical site infection, presence of wound dehiscence, postoperative respiratory compromise, pulmonary embolism, deep vein thrombosis, perioperative transfusion, operative time, reintubation, reoperation, and length of hospital stay. Chi-squared and t-test statistical analyses were utilized with a significance level of 5%.Following institutional review board approval, the participant use files from the NSQIP database were analyzed for the years 2005–2012. Patients who had undergone a reduction mammoplasty were identified by P < .05) calculated in the number of patients experiencing a failure of skin flaps, which necessitated a return to the operating room. The mean operative time was longer for general surgeons (186 minutes) than for plastic surgeons (165 minutes), as depicted in During the time period, a total of 6239 reduction mammoplasties were performed and recorded within the NSQIP database, of which 339 were performed by general surgeons and 5900 by plastic surgeons. Analysis of the results indicates that general surgeons take a longer time to perform a reduction mammoplasty and may be prone to an increased rate of complications. During general surgery residency, exposure to procedures outside of the standard curriculum may vary between institutions. In comparison, reduction mammoplasty is a procedure that is required by the plastic surgery resident review committee. One study applied a unique set of quality and efficiency metrics, including a consideration of the learning curve for given procedures, elucidation of factors that influence operative performance, procedure-specific complications, and definitions of acceptable variance ranges from established norms for reduction mammoplasty.Other variables not assessed in the NSQIP database may also lead to greater patient success with a plastic surgeon. Functionally speaking, a decrease in breast mass and volume will achieve the basic goals of a reduction mammoplasty; however, there still remains subjective measures of outcomes including aesthetics as well as nipple and areola sensitivity. With regard to postsurgical breast sensitivity, studies have shown that there exists an inverse relationship between breast size and sensitivity, as well as an improvement in sensitivity after breast reduction.10While most insurance carriers will not reimburse for procedures involving less than 1000 g, studies have shown that reduction mammoplasties involving less than 1000 g offer substantial relief of macromastia-associated symptoms and significant improvement in the patients’ quality of life.12The focused training in reduction mammoplasty that plastic surgeons receive appears to benefit the patient. These results may be further emphasized with the increasing number of patients desiring reduction mammoplasty procedure due to knowledge and availability. The limitations of this study include an inability to monitor patient outcomes past the 30 day postoperative period, relatively low number of procedures performed by general surgery, and absence of variables such as nipple malposition, nipple sensation, aesthetic outcome, and late wound sequelae.


Objective. To report the patient demographics and nonsurgical complementary and alternative medicine treatment used at a Korean medicine hospital for low back pain (LBP) and/or sciatica after surgery. Methods. Medical records of patients who visited a spine-specialized Korean medicine hospital at 2 separate sites for continuous or recurrent LBP or sciatica following back surgery were reviewed. The demographics, MRI and/or CT scans, and treatments were assessed. Results. Of the total 707 patients, 62% were male and the average age was 50.20 years. Ninety percent of patients presented with LBP and 67% with sciatica. Eighty-four percent were diagnosed with herniated nucleus pulposus at time of surgery. Of these patients, 70% had pain recurrence 6 months or later, but 19% experienced no relief or immediate aggravation of pain after surgery. Many patients selected traditional Korean medicine treatment as primary means of postsurgery care (47%). When time to pain recurrence was short or pain persisted after surgery, return of symptoms at the same disc level and side was frequent. Conclusion. An integrative treatment model focusing on Korean medicine and used in conjunction with radiological diagnostics and conventional medicine is currently used as a treatment option for patients with pain after lumbar spine surgery. Although low back pain (LBP) is considered to have a favorable natural prognosis, lumbar spine surgery is still frequently performed. In the US, the prevalence of lumbar fusion surgery has increased 220% from 1990 to 2001 [However, with the increase of surgery cases, the interest in failure rates is also on the rise. A 10- to 22-year follow-up study by Yorimitsu et al. on the outcomes of discectomy for lumbar herniated nucleus pulposus (HNP) reported 74.6% of patients had residual LBP and 12% required reoperation(s) . In KoreOther studies on the results of back surgery reported that adequate pain relief was not achieved in up to 30% of patients receiving a single lumbar segment operation  and thatAs more patients and practitioners are taking an interest in treatment for patients with pain after surgery, discussions continue to further demarcate the somewhat controversial term, failed back surgery syndrome (FBSS). The term FBSS is usually used to describe conditions presenting as recurrent or persisting LBP with or without sciatica after one or more lumbar surgeries , and numBesides the conventional treatments listed above, there are various types of complementary and alternative medicine (CAM) originating in non-Western cultures or not yet accepted in mainstream medicine lacking scientific evidence. The UK National Health Service (NHS) website cites the US National Center for Complementary and Alternative Medicine (NCCAM) and states that when a treatment is used alongside conventional treatments to help a patient deal with a certain health condition, but not as an alternative, this use of treatment is called “complementary medicine” and when a treatment is used instead of conventional treatments with the intention of curing or treating a health condition, the use is called “alternative medicine” . TraditiJaseng Hospital of Korean Medicine is a group of Korean medicine hospitals that specialize in spine disorders and is designated by the Korean Ministry of Health and Welfare as a spine specialty hospital, treating 900,000 cases of spinal disorders  each year. Treatment mainly focuses on HNP and spine-related pain patients prior to developing postsurgery syndrome, and the hospital employs a cohesive overall treatment approach using Korean medicine as the main modality and the imaging technology of conventional medicine and treatment, as needed, for emergency care. This retrospective multicenter study assesses the demographics of the patients who visited Jaseng Hospital of Korean Medicine in Seoul, Korea, and Bucheon Jaseng Hospital of Korean Medicine in Bucheon, Korea, from January to December, 2012, for low back pain or sciatica recurrence after surgery and the treatment received through electronic medical records.Demographic characteristics included patients' sex, age, occupation, and medical history including hypertension/diabetes, site of pain, number of operations, recommendations for repeat surgery, duration of time from surgery to pain recurrence, duration of pain, limited lumbar range of motion (ROM) due to pain, pain intensity , treatments received prior to current hospital visit, primary diagnosis for surgery as reported through patient recollection, mode of onset of pain recurrence, number of MRI/CT scans performed after surgery at study setting, number of MRI/CT scans performed at other clinics or hospitals, number of patients who received inpatient treatment, and average length of hospital stay.The radiological readings of the MRI/CT scans of 288 patients evaluated by two experienced radiologists were used to categorize patients by radiological diagnosis at time of visit, level of HNP at time of spine surgery, method of surgery, and pain recurrence.Lastly, the types and frequency of treatment, number of recipient patients, and average number of treatment sessions per patient were evaluated. The treatment mainly focused on traditional Korean medicine which encompasses herbal medicine, acupuncture, electroacupuncture, pharmacopuncture, bee venom pharmacopuncture, Chuna , and physical therapy.This study was approved by the Institutional Review Board of Jaseng Hospital of Korean Medicine (SIRB2013-18) and adhered to research ethics .A total of 707 patients presented with recurrent LBP or sciatica after lumbar surgery at the two study sites in 2012, and 16% of these patients received an average 21.72 (±11.91) days of inpatient treatment. The average age was 50.20 (±15.15) yrs, and 62% were male.Of the patients who visited the hospital due to LBP or sciatica following lumbar spine surgery, 90% had a chief complaint of LBP and 67% had sciatica (with or without LBP). Of subgroups classified by pain intensity, the majority (40%) had severe pain with an NRS of 7 or higher, and 31% of the total patients showed restricted ROM with pain.Although 70% of patients had pain recurrence at 6 months or later after surgery, 22% were acute patients with pain recurring within a month. The average time to pain recurrence from surgery was 13.93 (±23.24) months.The average number of surgeries was 1.16 (±0.41). Assessments for prior treatments revealed that 47% of patients, which was the highest proportion, made Jaseng Hospital of Korean Medicine their first choice of treatment, and 17% selected other providers of traditional Korean medicine, showing that many patients chose Korean medicine as their primary means of medical care for postsurgery pain. Sixteen percent had received recommendations for repeat surgery prior to their visit to the study site. The most commonly reported diagnosis for surgery was HNP which accounted for 84%.The findings of the MRI/CT scans of 288 patients were recorded by experienced radiologists and assessed and categorized for study means. The vast majority were diagnosed with HNP (77%) and spinal stenosis (18%) through imaging. The most frequently operated disc level was L4/5 (58%). Analyses on correlations between time to pain recurrence after surgery and symptom recurrence at site of surgery and mode of onset of pain recurrence and symptom recurrence at site of surgery found that in cases with shorter periods to pain recurrence and in continuation of pain, same site and same disc level symptom recurrence was more likely to occur.The treatment methods, frequency of treatment sessions, number of recipients, and average number of treatment sessions per patient were analyzed. The main treatment modality was TKM treatment including herbal medicine, acupuncture, electroacupuncture, pharmacopuncture , bee venom pharmacopuncture, Chuna, and Korean medicine physical therapy based on traditional Korean medicine literature  therapy), and a small number of patients received conventional medicine treatment in addition to the main treatment. The records of herbal and conventional medicine intake were recorded in days and other treatments in number of sessions. The norm for outpatient treatment use was 1~2 times per week and that for inpatients was daily. Considering the relative difference in frequency, it can be inferred that inpatients received more intensive treatment in a compact amount of time than outpatients.Most patients visiting Korean medicine hospitals for postsurgery treatment in our study reported chronic conditions and intense pain. Also, a large proportion presented with more severe conditions with low back pain accompanied by sciatica. Furthermore, almost half the patients selected Jaseng Hospital of Korean Medicine or Bucheon Jaseng Hospital of Korean Medicine as their first choice for primary care, suggesting high expectation levels of TKM treatment in Korea. A practical approach using integrative TKM treatment was provided to the patients rather than a single treatment modality, and conventional medicine treatment was utilized as needed. On analysis of the MRI readings of 236 patients, the most frequent site of surgery was L4/L5.McCulloch reported in a radiological research assessing pain recurrence the incidence of recurrence at the same disc level and ipsilateral side after surgery to be between 80% and 90% . Other sThe basic treatments received were acupuncture, herbal medicine, electroacupuncture, and pharmacopuncture. The results show that patients receiving inpatient care were offered more intensive treatment means than outpatients.In an attempt to define the term FBSS, various standards have been suggested; one RCT specified FBSS as long-term continuance of chronic pain conditions , and somAlthough the need for studies on the etiology of FBSS has been well explained and agreed on, only a limited number is currently available. We had initially considered reporting the demographics of a more clearly defined group of patients, but the large variation in previous definitions of FBSS prevented us from reaching a singular conclusion. The subjects included in our study were back surgery patients visiting the hospital for postoperative pain. While subjective pain levels requiring treatment may vary, all subjects visited the hospital for treatment purposes indicating a certain level of discomfort or pain. Therefore, the demographic characteristics of all patients with recurrent pain after surgery were collected and investigated to a broader extent than previous FBSS studies. The main mode of treatment was CAM focusing on TKM, and use of this integrative model of treatment based on TKM which is not yet well-known in the Americas and Europe was investigated and analyzed.Pharmacopuncture is a relatively new form of TKM derived from a mixture of herbal medicine and acupuncture. The physical therapy referred to in our study is a Korean medicine physical therapy administered by Korean medicine doctors (KMDs) based on traditional Korean medicine literature  therapy). Therefore, pharmacopuncture and Korean medicine physical therapy fall under the category of CAM treatment as TKM modalities provided by KMDs. A small number of patients received conventional pharmacological therapy, injections, and nerve blocks through cooperative, integrative treatment with Western medicine doctors. However, the main objective of this study was not to prove the exclusive effects of CAM treatment, but to show the current use of integrative medicine at a CAM-oriented medical facility.To address a few limitations of this study, first, in the process of interviewing the patients, we were dependent on the memory of the patients regarding information of their condition at time of surgery, so the accuracy of information could not be verified. Second, data collection focused on plain symptom listings with no definite differentiation between such chronic pain disorders as complex regional pain syndrome, myofascial pain syndrome, and fibromyalgia. Third, lack of evidence on the effectiveness of the separate modalities in TKM treatment restricted further analysis and interpretation.The preference for CAM for spinal disorder treatment is increasing not only in Korea, but also in many other countries. According to a 2004 survey, 43% of peripheral neuropathy patients used CAM treatment for management of their symptoms, and the main reason for selecting CAM treatment was that many did not achieve adequate pain relief with standard conventional treatment. The most frequent CAM treatment methods used were acupuncture, chiropractic manipulation, herbal remedies, magnetic therapies, and vitamins .The extent of CAM use is largely influenced by the medical system of each country. In Korea, equal licenses and independent practice rights for Korean medicine doctors and conventional medical doctors are guaranteed by the government, which is one of the reasons why Korean medicine could take on a leading role in this integrative treatment model. In this study, patients with recurrent pain after surgery received radiological diagnosis and requested conventional medicine treatments as necessary under the supervision of KMDs with Korean medicine treatment. However this could be deemed highly unusual in other cultural backgrounds.This study showed how an integrative treatment model focused on Korean medicine treatment was used in patients with chronic and severe pain after back surgery. We hope that our study data may further understanding of FBSS patients who select Korean medicine treatment and be used as basic information in establishing an integrative treatment model for spinal disorders.


Silver (AgNPs) and maghemite, i.e., superparamagnetic iron oxide nanoparticles (SPIONs) are promising candidates for new medical applications, which implies the need for strict information regarding their physicochemical characteristics and behavior in a biological environment. The currently developed AgNPs and SPIONs encompass a myriad of sizes and surface coatings, which affect NPs properties and may improve their biocompatibility. This study is aimed to evaluate the effects of surface coating on colloidal stability and behavior of AgNPs and SPIONs in modelled biological environments using dynamic and electrophoretic light scattering techniques, as well as transmission electron microscopy to visualize the behavior of the NP. Three dispersion media were investigated: ultrapure water (UW), biological cell culture medium without addition of protein (BM), and BM supplemented with common serum protein (BMP). The obtained results showed that different coating agents on AgNPs and SPIONs produced different stabilities in the same biological media. The combination of negative charge and high adsorption strength of coating agents proved to be important for achieving good stability of metallic NPs in electrolyte-rich fluids. Most importantly, the presence of proteins provided colloidal stabilization to metallic NPs in biological fluids regardless of their chemical composition, surface structure and surface charge. In addition, an assessment of AgNP and SPION behavior in real biological fluids, rat whole blood (WhBl) and blood plasma (BlPl), revealed that the composition of a biological medium is crucial for the colloidal stability and type of metallic NP transformation. Our results highlight the importance of physicochemical characterization and stability evaluation of metallic NPs in a variety of biological systems including as many NP properties as possible. Functional nanomaterials, including nanoparticles, nanocrystals, and nanoclusters, are promising tools for new medicinal applications, particularly for clinical use in disease diagnosis and treatment –2. HowevIn comparison to the bulk material, the colloidal stability of the nanoparticulate form of metal is usually more complicated. In colloidal systems, there are several possible interactions between the surface atoms of NPs and the molecules present in the media like dissolution, adsorption, binding, and aggregation, all influencing biological impacts by affecting reactive oxygen species generation, cellular uptake and NP biodistribution –18. MetaVarious types of surface coatings have been shown to affect NP properties, particularly to improve their biocompatibility and stability against agglomeration ,33–35. PBecause AgNPs and SPIONs with various coatings are used in many nanotherapeutic and consumer products , it has (BrijAgNP) and Tween 20 (TweenAgNP). The SPIONs were prepared as uncoated γ-Fe2O3 NPs (UNSPIONs), and coated with D-mannose (MANSPIONs) or poly(L-lysine) (PLLSPIONs). Three media for NP dispersion were investigated: ultrapure water (UW), biological cell culture medium without addition of protein (BM), and BM supplemented with common serum protein (BMP). In addition, the behavior of NPs was investigated in real biological fluids: whole blood (WhBl) and blood plasma (BlPl) taken from Wistar rats. Dulbecco’s modified Eagle’s medium (DMEM), as a common cell culture medium for a broad range of mammalian cells, was used as a model biological fluid. Bovine serum albumin (BSA) served as a model serum protein due to its biological relevance and high significance in biomedical applications. Albumin is the most abundant protein in mammalian blood plasma and has outstanding buffering ability  = 375 μM) were added to the BM (in order to prepare BMPs). In order to present results in a transparent way and obtain accurate conclusions from the DLS measurements, size distribution by intensity and volume were used in analyzing the results. Intensity-weighted size distribution is the first order result from a DLS experiment calculated from the scatter intensity of each particle in solution. On the other hand, intensity distributions can be biased towards larger particles since the intensity of particle light scatter varies with the 6th power of particle diameter. In order to avoid overestimations arising from the scattering of larger particles, volume-weighted size distributions are often used. In addition, dH obtained from size distributions by volume was presented so results could be comparable with our previously published studies. It should be noted that the data was sometimes compiled from different synthesis batches of NPs, leading to some discrepancy in the size distributions of the various control samples.The stock solution of BSA in DMEM was freshly prepared for each experiment and then diluted to the desired concentrations. Differently coated metallic NPs were dispersed in BSA solutions to the final concentration of 1 mg·Lk et al. ). Howevef 66 kDa . Thus, t−1 and agitated for 1 h on a digital waving rotator . After incubation, suspensions were diluted 50 times before further analysis. It should be noted that DLS and ELS measurements were impossible in WhBl and BlPl suspensions.For dispersions of NPs in whole blood (WhBl) and blood plasma (BlPl), whole blood and blood plasma were obtained from healthy twelve weeks old male Wistar rats. Animals were killed by narketan/xilapan anesthesia following the whole blood collection by cardiac puncture. The experiment was approved by the Ethics Committee for Animal Studies of the Institute for Medical Research and Occupational Health according to European and Croatian legislation on animal experimentation and International Council for Laboratory Animal Science ethical guidelines for researchers, respectively. Then, different NPs were dispersed in 1 mL of WhBl or BlPl at a final metal concentration of 10 mg·L® coated copper grid and air-drying at room temperature.TEM samples were prepared by depositing a drop of the NPs suspension after 1 h of incubation at room temperature on a Formvar


Brook Baker describes the potential harms to global health from the Trans Pacific Partnership Agreement and its failure to balance the interests of patients and the public with those of industry. The recently negotiated Trans Pacific Partnership Agreement (TPP) contains provisions that would dramatically and negatively impact access to affordable medicines in the United States and elsewhere if it is ratified.Provisions in the Intellectual Property (IP) Chapter of TPP lengthen, broaden, and strengthen patent-related monopolies on medicine and erect new monopoly protections on regulatory data as well. IP Chapter enforcement provisions also mandate injunctions preventing medicines sales, increase damage awards, and expand confiscation of medicines at the border.IP rightholders gain new powers in the Investment Chapter to bring private, IP-related investor-state-dispute-settlement (ISDS) damage claims directly against foreign governments before unreviewable, three-person arbitration panels. Unrestricted IP-investor damage claims deter countries’ willingness to render adverse IP decisions and to adopt IP policy flexibilities designed to increase access to affordable medicines.The Transparency Chapter contains provisions that allow pharmaceutical companies more access to government decisions listing medicines and medical devices for reimbursement.At the very least, these multiple TPP provisions that extend pharmaceutical powers should be scaled back to the minimum consensus standards reached in the 1994 World Trade Organization (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Health advocates should convince the US Congress and opponents in other countries to reject an agreement that could so adversely impact access to medicines.A new Pacific-Rim trade agreement threatens future access to affordable medicines in the United States and abroad. Buried in 6,000-plus pages of text, annexes, and side letters, there are multiple provisions—complex in their articulation, but simple in their effect: they dramatically increase monopoly protections for the transnational originator pharmaceutical industry.With the Trade Promotion Authority, a procedure for accelerating congressional approval of trade agreements, enacted after a brutal and circuitous congressional battle in June , partiesOne of the most contentious chapters in the TPP is the Intellectual Property (IP) Chapter , whose pTPP parties have been negotiating against a backdrop where there has already been global harmonization of minimum standards of protections for pharmaceutical IP rightholders. In 1994, countries adopted the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) [As revealed in earlier leaked drafts of the TPP, the most protective, TRIPS-plus proposals for pharmaceutical rightholders are those put forward by the office of the US Trade Representative (USTR). The USTR touted its IP proposals as being good for US exports, for jobs in its creative industries, and for innovation of new technologies. Although some troubling proposals were removed from the final text, like provisions mandating patents on new forms of existing medicines and prohibitions against patent opposition procedures, the TPP still contains many provisions that restrict TRIPS-compliant policy space to improve the quality of patents and to use flexibilities to bypass patent and other IP monopolies to encourage generic competition and other cost-controlling and research-enhancing measures.The TPP’s IP Chapter contains final provisions that (1) weaken standards of patentability, leading to more patents; (2) extend patent terms to compensate for delays in granting patents or registering marketing approval; (3) adopt new exclusive rights relating to undisclosed registration-related/clinical-trial data; (4) prevent or interfere with the registration of generics where patents are claimed; and (5) enhance patent infringement remedies.In general, weak standards of patentability, the criteria upon which patents are granted, make it easier to get initial patents—the first 20 years of exclusive rights; weak standards also encourage seeking multiple secondary patents that further extend the period of exclusivity. Using weak patent standards, drug companies can obtain “secondary,” 20-year patents on minor variations of an active ingredient, new formulations and dosages, new uses or methods of use (indications), and new processes of synthesis and manufacture. In the pharmaceutical industry, pursuit of secondary patents is positively framed as patent life-cycle management; in the access-to-medicines world it is criticized as manipulative evergreening .The TPP imposes weakened standard of patentability in two ways. First, it defines “obviousness,” the real meat of the inventiveness inquiry, to eliminate countries’ right to require that an invention have a significant technological advantage as assessed by persons “highly” skilled in the relevant arts. Second, the TPP mandates that countries allow patents on new uses or methods or process of use of known medicines, even though research and development costs are significantly lower for a medicine already known to be safe and even though the search for new indications is more a function of routine, plodding investigation than “inventive-step” science . The conThe TPP lengthens pharmaceutical monopolies in other ways. For example, if there is an unreasonable delay in the granting of a patent (within five years of the filing of a patent application or within three years after a request for patent examination) then the patent term must be adjusted to compensate for the delay. In addition, the TPP requires patent terms adjustments to compensate for delays in the marketing approval process. A study from the US on the impact of patent term extensions found that they add an average of 3.6 years to the period of exclusivity and might account for nearly 20% of pharmaceutical sales in the US .The TPP creates additional forms of monopoly protection by requiring countries to adopt data/marketing exclusivity restrictions like those applied in the US . AccordiAn even longer period of data/marketing exclusivity is required for biologics. Although there is no economic evidence justifying longer exclusivity for biologics , the US The Enforcement Section of the IP Chapter strengthens private enforcement of IP rights and imposes greater enforcement obligations on governments. It contains provisions requiring deterrent remedies, compelling the use of the rightholder’s retail price as a measure of damages, mandating injunctive relief, and banning reasonable royalties as an infringement remedy. Several of these proposals exceed US law . TPP govIn the Investment Chapter, IP rights are defined as protected investments, and foreign IP investors are permitted to seek private arbitration through ISDS whenever they feel that their investments have been treated unfairly or inequitably, taken without compensation, or discriminated against. TPP member states can expect an avalanche of IP-related claims from disappointed pharmaceutical companies that think their legitimate expectations of future profits have been thwarted by foreign governments’ IP decisions or policies.The TPP’s Investment Chapter greatly expands the enforcement rights of foreign pharmaceutical companies, creating substantial risks to countries’ ability to set IP-related policy and to render IP decisions. The Investment Chapter unequivocally defines IP rights as “investments.” It prohibits the following: (1) discrimination against foreign IP investors, (2) unfair and inequitable treatment, and (3) indirect expropriation. More pointedly, it allows ISDS claims directly against governments before unreviewable three-person arbitration panels, even when judicial remedies have not been exhausted or when companies have lost on appeal. Foreign investors can bring ISDS claims that domestic investors cannot. Moreover, companies might claim—correctly or not—a lack of fair and equitable treatment that undermines their well-grounded expectations of profit with respect to many health-related regulatory and judicial decisions, including the following: denials or revocations of pharmaceutical patents; granting of compulsory licenses; denials or restrictions on marketing rights; refusals to list excessively priced, IP-protected products for reimbursement; decisions to establish price controls; and required disclosure of clinical trial data. Foreign companies might claim indirect expropriation following changes in regulatory environments, including changes designed to promote public health .The dangers of ISDS IP enforcement are highlighted in a US$500 million arbitration claim brought by Eli Lilly against the government of Canada under the North America Free Trade Agreement because it revoked patents on two medicines that Canada’s highest court had found failed to satisfy well-established standards of patentability in Canada . Canada In the Transparency Chapter Annex addressing transparency and procedural fairness for pharmaceutical products and medical devices, companies are given multiple opportunities to intercede in decisions to list products for reimbursement. These interventions could result in more listings of higher-priced medicines even in the absence of convincing evidence of added therapeutic value.Under the Pharmaceutical Product and Medical Device Transparency Annex, companies will have multiple chances to influence pharmaceutical/medical-device listing decisions, to scrutinize resulting decisions, and to challenge decisions previously rendered. These multiple inputs can result in more listings, higher prices, and higher administrative costs for affected countries. The Transparency Chapter also gives other countries direct opportunities to complain about individual listing decisions, patterns and practices of decisions, and decision-making criteria and processes.Medical professionals, patients, and others concerned with access to medicines and enhanced generic competition might wonder whether there are justifications for a trade agreement that strengthens IP, investment, and regulatory-participation rights for the originator pharmaceutical industry. They might also wonder what alternative provisions should be in the TPP. The historic justification for longer, stronger, and broader IP protections for medicines is quite simple—they give rise to economic power to charge what the market will bear so that companies can earn extra profits that they thereafter invest to invent the next generation of life-enhancing medicines, including those for currently untreated or undertreated conditions . As succIP maximization in the TPP will harm access to more affordable medicines in both the US and its trading partners. Policy space on both sides of the Pacific will be reduced while opportunities for excessive pricing will increase dramatically with predictable adverse consequence for the right to health. Armed with knowledge about the details of the TPP’s anti-access provisions, there is still time for health advocates to convince the US Congress and TPP partners that the TPP’s monopoly-enhancing measures must be rejected.


Regulation of energy homeostasis is fundamental for life. In animal species and humans, the Central Nervous System (CNS) plays a critical role in such regulation by integrating peripheral signals and modulating behavior and the activity of peripheral organs. A precise interplay between CNS and peripheral signals is necessary for the regulation of food intake and energy expenditure in the maintenance of energy balance. Within the CNS, the hypothalamus is a critical center for monitoring, processing and responding to peripheral signals, including hormones such as ghrelin, leptin, and insulin. Once in the brain, peripheral signals regulate neuronal systems involved in the modulation of energy homeostasis. The main hypothalamic neuronal circuit in the regulation of energy metabolism is the melanocortin system. This review will give a summary of the most recent discoveries on the hormonal regulation of the hypothalamic melanocortin system in the control of energy homeostasis. Energy homeostasis is a tightly regulated process and the imbalance between its components, food intake and energy expenditure, causes metabolic dysfunctions including obesity, a major risk factor for comorbidities including type 2 diabetes, hypertension and stroke, and cardiovascular diseases. A major player in the regulation of energy homeostasis is the Central Nervous System (CNS) and specifically the hypothalamus. By monitoring, processing and responding to peripheral signals, such as hormones, the hypothalamus in turn will regulate peripheral organ functions. Within the hypothalamus several neuronal populations have been identified as important players in metabolism regulation. The central melanocortin system consists of three neuronal populations: the pro-opiomelanocortin (POMC)-expressing neurons, the neuropeptide Y (NPY) and agouti-related peptide (AgRP)-co-expressing neurons , α-, β-, and γ-melanocyte stimulating hormone  and β-endorphin, via several post-translational modification processes. Among these peptides, α-MSH is the most well-known anorexigenic peptide which mediates the effects on food intake and energy expenditure through its binding and activation of MCRs  systems have provided stronger evidences on the central role of POMC and NPY/AgRP neurons in the regulation of feeding behavior  neurons of MC4Rs deficient mice induced a reduced obese phenotype  encoded by a single leptin receptor gene (Ob-R) , consisting of an extracellular and an intact cytoplasmic domain, mediates the anorexigenic effect of leptin  mice displayed an obese phenotype while hepatocyte-specific db/db mice are normal  mice showed reduced food intake and improved glucose tolerance   produced by the thyroid gland is converted in target tissues in the active form of thyroid hormone, Triiodothyronine (T3), by a process called 5′ deiodination. Thyroid hormones affect metabolism acting on both food intake and energy expenditure (Vijayan and Mccann, Glucocorticoids are known regulators of energy balance (Nieuwenhuizen and Rutters, The hypothalamic melanocortin system is an integrative center in the regulation of energy balance. Numerous studies have shown that many peripheral signals including hormones can directly influence the activity of the hypothalamic melanocortin system. Besides hormones, other signals including nutrients such as glucose Thorens, , lipids All of these signals have been shown to regulate the melanocortin system via extracellular and intracellular morphological changes that will affect the activity levels of the different component of the system. These changes include synaptic input organization (Pinto et al., In conclusion, further studies on the mechanisms controlling the melanocortin system are crucial to make advancement in our abilities to develop new therapies for the treatment of metabolic disorders.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The California Delivery System Reform Incentive Program (DSRIP) is a pay-for-performance initiative that incentivizes the state's public health care systems to improve quality of care. Health system participants must report on metrics in both inpatient and outpatient settings. To enhance DSRIP participants' capacity to engage in (1) best practices to improve quality of care and (2) reporting of DRSIP-required metrics, the California Association of Public Hospitals and UCSF established the Public Healthcare systems Evidence Network and Innovation eXchange (PHoENIX), with funding from AHRQ. PHoENIX priorities are meeting the HEDIS Medicare PPO 90Using a mixed methods approach and applying the Consolidated Framework for Implementation Research to characterize improvement efforts, we identified barriers and enablers for meeting the performance metrics.Engagement in improvement was high, with all systems implementing quarterly performance measurement and participating in web-based and in-person learning sessions. Barriers include: lack of personnel for data reporting/management; structural barriers, such as fragmented electronic health records, lack of equipment ; competing priorities, such as providing access to care for the newly insured; and a change in the national guideline for cholesterol control. Enablers included: strong leadership, integrated data systems. To date, 82% of the health systems improved their performance on mammography and 53% improved on LDL.Public health systems can collectively engage in performance measurement and improvement; implementation science methods identify barriers and enablers of change which can be applied to real-world improvement efforts.


The objective of this presentation is to introduce the Consolidated Framework for Implementation Research (CFIR), present results of a literature synthesis of studies citing the CFIR, highlight improvements expected in a second version of the framework, and present tools and resources available for researchers using the CFIR that will be available on a newly revamped website.In a series of four interactive virtual panels, we elicited user feedback from implementation research novices and experts on needed CFIR tools. In addition, we searched multiple databases to identify articles that cited the CFIR. Articles were characterized as original research, syntheses, study protocols, or general background references.347 published articles cited the CFIR, with an average of growth rate of four additional articles per week; fifty-one were original research, protocols, or syntheses. Recommendations were extracted from these articles and used to inform updates for CFIR V2. Refinements will include improved clarity in definitions for existing constructs, addition of new constructs, and better framing of the purpose and uses of CFIR. The CFIR website was significantly redesigned with the addition of new tools and resources including: 1) an interview guide creation tool; 2) links to a periodically updated bibliography of articles applying the CFIR; 3) two published quantitative measures related to organizational change mapped to CFIR constructs; 4) in-depth guidance on how to apply the CFIR; and 5) plans for the future. A demonstration of the publically available website will be provided along with the URL.The CFIR brings clarity to commonly studied constructs by suggesting clear and consistent terms and definitions that can be applied across diverse settings, within and outside healthcare. Use of the CFIR is growing. CFIR V2 along with tools, resources, and published applications, will help researchers collectively advance the science of implementation.Department of Veteran Affairs, Health Services Research & Development Quality Enhancement Research Initiative (QUERI) (Grant # RRP 12-494).


Several studies tested whether stressful work mediates the association between socioeconomic position (SEP) and health. Although providing moderate support, evidence is still inconclusive, partly due to a lack of theory-based measures of SEP and work stress, and because of methodological limitations. This contribution aims at overcoming these limitations.We conduct pathway analysis and investigate indirect effects of SEP on mental health via stressful work. Data are derived from the first two waves of the ‘Survey of Health, Ageing and Retirement in Europe’ (SHARE) with information from employed men and women aged 50–64 across 11 European countries (N=2798). SEP is measured according to two alternative measures of occupational position: occupational class (focus on employment relations) and occupational status (focus on prestige). We assess work stress according to the effort-reward imbalance and the demand-control model (wave 1), and we use newly occurring depressive symptoms as health outcome (wave 2).Effort-reward imbalance and, less consistently, low control mediate the effect of occupational class and occupational status on depressive symptoms.Our findings point to two important aspects of work stress  in explaining socioeconomic differences in health. Further, we illustrate the significance of two alternative dimensions of occupational position, occupational class and occupational status. Research has produced solid evidence on social inequalities in health among working populations in modern societies. Overall, these inequalities in morbidity and mortality appear as social gradients across the whole of a society, leaving those in more disadvantaged socioeconomic positions (SEPs) at higher risk of poor physical and mental health.9Yet, empirical support of this hypothesis is inconsistent up to now.In this study we use two measures of occupational position. The first measure is occupational class, as measured by the internationally used Erikson-Goldthorpe-Portocarero (EGP) scheme.The second measure of occupational position is occupational status, as measured by the Standard International Occupational Prestige Scale (SIOPS).Concerning the mediating construct, we measure work stress in terms of two internationally-established theoretical models, the demand-control model17–19In short, using two different occupational classifications and two established models of work stress, this paper investigates if work stress mediates the association between occupational position and elevated risks of depressive symptoms. As both predicting and mediating constructs are based on complementary, equally important aspects of occupational position and of work stress in modern economies, the analysis may provide a more comprehensive case as compared to previous research.Data are obtained from the first two waves of the Survey of Health, Ageing and Retirement in Europe .For the analyses, we use the longitudinal sample of men and women who participated at wave 1 and wave 2 (N=18 742) and conduct additional restrictions: first, we limit the longitudinal sample to those who were employed at both waves (N=4304). This serves the objective of investigating the effects of occupational position and work stress on depressive symptoms at wave 2, and excludes those who are no longer in employment at wave 2 (22% of people who worked at wave 1). Second, because respondents aged 65 or older may have had more favourable working conditions , the sample is additionally restricted to men and women aged 50–64 in wave 1. Third, to reduce the risk of reverse causality, individuals with increased depressive symptoms at wave 1 are not included either. These restrictions result in a final sample with full available data of 1658 men and 1140 women (N=2798).Occupational position: SHARE data include a description of workers’ employment situation with detailed information on respondents’ occupation as classified by the International Classification of Occupation (4-digit ISCO-88 code).Work stress was measured by abbreviated versions of original scales of the demand-control model and the effort-reward imbalance model. Given the constraints of a multidisciplinary approach, the inclusion of the full questionnaires was not possible in SHARE. Thus, items of the two work stress models were selected on the basis of psychometric properties. With regard to the demand-control model, the measurement was restricted to the control dimension, given the evidence that the explanatory contribution of ‘control’ exceeded the contribution of ‘demand’ in several landmark studies.Our measure of mental health is a binary indicator of increased depressive symptoms, as measured by the EURO-D depression scale.26Age, gender and country affiliation were additionally included, mainly as confounders within pathway analyses. An overview of all measures is presented in Following a general description of the sample , average33In the Results section, findings of four pathway models are presented, two for each measure of occupational position (class and status) which, investigate the mediation effects on depressive symptoms either via low control or via effort-reward imbalance. All models were estimated with MPLUSSample characteristics are presented in Turning to In a next step, indirect effects are calculated to answer the main research question. Results are given in The findings of our analyses can be summarised as follows. First, results indicate a gradual association between occupational position and levels of work stress. Moreover, both variables exert independent effects on subsequent depressive symptoms. Second, importantly, we observed an indirect effect of occupational position through work stress on depressive symptoms. This effect is consistent for the occupational class and occupational status, but is more pronounced in the case of effort-reward imbalance.This study adds two new elements to current research testing the mediation hypothesis.Although this study profits from several strengths , we have to consider several limitations. First, the sample is restricted to employed men and women at older ages and, thus, any generalisation of findings do require additional studies based on younger cohorts. More specifically, there is a risk that the observed effects of work stress are biased, for example, because levels of work stress are generally higher in younger age groups where the burden of disease attributable to stressful work may be even higher.27Several cohort studies tested a mediating role of stressful work, most often measured by high demand combined with low control, in associations between different indicators of socioeconomic position and health.Results provide moderate support, but are confined to the absence of theory-based measures of predicting and mediating variables, and the use of nested regressions.By applying pathway modelling, direct and indirect effects of occupational position and stressful work on depressive symptoms, the health outcome, are estimated in a large sample of men and women.We assess occupational position by two theory-based indicators, class and status, and we measure work stress by low control and effort-reward imbalance.Results show that low control and effort-reward imbalance both mediate effects of occupational position on depressive symptoms, and we illustrate the importance of two core constructs of social stratification, occupational status and occupational class.In conclusion, the results of this study offer limited evidence that stressful work mediates the association of occupational position with newly occurring depressive symptoms among older employed men and women in different European countries. If supported by further research, our findings lend support to policies that aim at reducing health inequalities by improving the quality of work among less privileged occupational groups.


In vitro and in vivo findings as well as observations in humans indicate that opioids and their receptors positively or negatively affect viral replication and virus-mediated pathology. The present study reviews recent insights in the role of opioids and their receptors in viral infections and discusses possible therapeutic opportunities. This review supports the emerging concept that opioids and their receptors have both favorable and unfavorable effects on viral disease, depending on the type of virus. Targeting of the opioid system is a potential option for developing effective therapies; however caution is required in relation to the beneficial functions of opioid systems.Opioids and their receptors have received remarkable attention because they have the ability to alter immune function, which affects disease progression.  Opioids are a group of endogenous and exogenous/synthetic compounds that function through activation of opioid receptors  with an affinity for endogenous opioid peptides and include β-endorphin, encephalin, met-enkephalin, nociceptin, and exogenous natural and synthetic opioid agents  cytokine patterns  causes acquired immunodeficiency syndrome (AIDS), a serious cause of death in humans of all ages  and nuclear factor-kappa B (NF-κB)  that target 3′-UTR of HIV transcripts  causes severe liver disorders such as fibrosis, cirrhosis, and cancer -α-mediated intracellular innate immunity  through up-regulation of cytokine signaling 3 and protein inhibition of activated STAT 3 (SOCS-3), which may contribute to HCV infection and persistence in the liver  causes severe respiratory disease and even death in neonates and the elderly  are a worldwide infectious agents causing variety of diseases such as oral and genital lesions, encephalitis, neonatal infections, and tumors  and University Medical Centre Utrecht (R1763). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.