A practice-related risk score (PRS): a DOPPS-derived aggregate quality index for haemodialysis facilities

Background. The Dialysis Outcomes and Practice Patterns Study (DOPPS) database was used to develop and validate a practice-related risk score (PRS) based on modifiable practices to help facilities assess potential areas for improving patient care. Methods. Relative risks (RRs) from a multivariable Cox mortality model, based on observational haemodialysis (HD) patient data from DOPPS I (1996-2001, seven countries), were used. The four practices were the percent of patients with Kt/V >= 1.2, haemoglobin >= 11 g/dl (110 g/l), albumin >= 4.0 g/dl (40g/l) and catheter use, and were significantly related to mortality when modelled together. DOPPS II data (2002-2004, 12 countries) were used to evaluate the relationship between PRS and mortality risk using Cox regression. Results. For facilities in DOPPS I and II, changes in PRS over time were significantly correlated with changes in the standardized mortality ratio (SMR). The PRS ranged from 1.0 to 2.1. Overall, the adjusted RR of death was 1.05 per 0.1 points higher PRS (P < 0.0001). For facilities in both DOPPS I and II (N = 119), a 0.2 decrease in PRS was associated with a 0.19 decrease in SMR (P = 0.005). On average, facilities that improved PRS practices showed significantly reduced mortality over the same time frame. Conclusions. The PRS assesses modifiable HD practices that are linked to improved patient survival. Further refinements might lead to improvements in the PRS and will address regional variations in the PRS/mortality relationship

The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali

Abstract Background Evidence suggests that both preventive and curative nutrition interventions are needed to tackle child acute malnutrition (AM) in developing countries. In addition to reducing the incidence of AM, providing preventive interventions may also help increase attendance (and coverage) of AM screening, a major constraint in the community-based management of child acute malnutrition (CMAM) model. There is a paucity of evidence-based strategies to deliver integrated preventive and curative interventions effectively and affordably at scale. The aim of the Innovative Approaches for the Prevention of Childhood Malnutrition (PROMIS) study is to assess the feasibility, quality of implementation, effectiveness and cost-effectiveness of an integrated child malnutrition prevention and treatment intervention package implemented through a community-based platform in Mali and a facility-based platform in Burkina Faso. Methods/Design The PROMIS intervention entails a comprehensive preventive package offered on a monthly basis to caregivers of children, while children are screened for acute malnutrition (AM). The package consists of behavior change communication on essential nutrition and hygiene actions, and monthly preventive doses of small quantity lipid-based nutrient supplements (SQ-LNS) for children aged 6 to 23.9 months. Positive AM cases are referred to treatment services offered by first-line health services according to the CMAM model. The PROMIS intervention will be evaluated using a mixed methods approach. The impact study encompasses two types of study design: i) repeated cross-sectional surveys conducted at baseline and at endline after 24 months of program implementation and ii) a longitudinal study with a monthly follow-up for 18 months. Primary study impact measures include the incidence and endpoint prevalence of AM, AM screening coverage and treatment compliance. A process evaluation will assess the feasibility and quality of implementation of the intervention guided by country specific program impact pathways (PIPs). Cost-effectiveness analysis will assess the economic feasibility of the intervention. Discussion The PROMIS study assesses the effectiveness of an innovative model to integrate prevention and treatment interventions for greater and more sustainable impacts on the incidence and prevalence of AM using a rigorous, theory-based randomized control trial approach. This type of programmatic research is urgently needed to help program implementers, policy makers, and investors prioritize, select and scale-up the best program models to prevent and treat AM and achieve the World Health Assembly goal of reducing childhood wasting to less than 5% globally by the year 2025. Trial registration Clinicaltrials.gov NCT02323815 (registered on December 18, 2014) and NCT02245152 (registered on September 16, 2014

Association between serum ferritin and mortality : findings from the USA, Japan and European Dialysis Outcomes and Practice Patterns Study

Background: The Kidney Disease: Improving Global Outcomes guidelines have cautioned against administering intravenous (IV) iron to hemodialysis patients with high serum ferritin levels due to safety concerns, but prior research has shown that the association between high ferritin and mortality could be attributed to confounding by malnutrition and inflammation. Our goal was to better understand the ferritin-mortality association and relative influence of IV iron and inflammation in the USA, where ferritin levels have recently increased dramatically, and in Europe and Japan, where ferritin levels are lower and anemia management practices differ. Methods: Data from 18 261 patients in Phases 4 and 5 (2009-15) of the international Dialysis Outcomes and Practice Patterns Study, a prospective cohort study, were analyzed. Using Cox regression, we modeled the association between baseline ferritin and 1-year mortality with restricted cubic splines and assessed the impact of potential confounders. Results: Median ferritin levels were 718 ng/mL in the USA, 405 in Europe and 83 in Japan. High ferritin levels were associated with elevated mortality (relative to region-specific medians) in all three regions. The strength of this association was attenuated more by adjustment for malnutrition and inflammation than by IV iron and erythropoiesis-stimulating agent dose in each region. Conclusion: The utility of high ferritin as a biomarker for clinical risk due to excess iron stores may be limited, although caution regarding IV iron dosing to higher upper ferritin targets remains warranted. Research to resolve biomarker criteria for iron dosing, and whether optimal anemia management strategies differ internationally, is still needed

Mortality risk in patients on hemodiafiltration versus hemodialysis : a 'real-world' comparison from the DOPPS

Background. With its convective component, hemodiafiltration (HDF) provides better middle molecule clearance compared with hemodialysis (HD) and is postulated to improve survival. A previous analysis of Dialysis Outcomes and Practice Patterns Study (DOPPS) data in 1998-2001 found lower mortality rates for high replacement fluid volume HDF versus HD. Randomized controlled trials have not shown uniform survival advantage for HDF; in secondary (non-randomized) analyses, better outcomes were observed in patients receiving the highest convection volumes. Methods. In a 'real-world' setting, we analyzed patients on dialysis >90 days from seven European countries in DOPPS Phases 4 and 5 (2009-15). Adjusted Cox regression was used to study HDF (versus HD) and mortality, overall and by replacement fluid volume. Results. Among 8567 eligible patients, 2012 (23%) were on HDF, ranging from 42% in Sweden to 12% in Germany. Median follow-up was 1.5 years during which 1988 patients died. The adjusted mortality hazard ratio (95% confidence interval) was 1.14 (1.00-1.29) for any HDF versus HD and 1.08 (0.92-1.28) for HDF > 20 L replacement fluid volume versus HD. Similar results were found for cardiovascular and infection-related mortality. In an additional analysis aiming to avoid treatment-by-indication bias, we did not observe lower mortality rates in facilities usingmore HDF (versus HD). Conclusions. Our results do not support the notion that HDF provides superior patient survival. Further trials designed to test the effect of high-volume HDF (versus lower volume HDF versus HD) on clinical outcomes are needed to adequately inform clinical practices

Japanese Intellectual Property Law in Translation: Representative Cases and Commentary

Like much of Japanese law, Japanese intellectual property law is often criticized as being inaccessible. This inaccessibility has contributed to the misperception that Japanese case law regarding intellectual property does not exist. Even if it exists, the perception goes, it takes forever to track down and it is nearly irrelevant. This Commentary, in a very modest way, is aimed at debunking the myth that Japanese case law regarding intellectual property is either non-existent or less meaningful than its U.S. counterpart. This Commentary consists of five translations of recent, significant intellectual property cases, as well as commentary regarding the relevance and meaning of each case. In the end, the most important objective of this Commentary is to show in bright letters that Japanese case law on intellectual property does exist and that it has a very rational and rich intellectual grounding. Although the inaccessibility of actual opinions has been hard to refute, in September of 2000 the Japanese Supreme Court added an intellectual property category to its web page, www.courts.go.jp. In one motion, this has drastically reduced, if not totally eliminated, the appearance of inaccessibility. Now, sometimes even on the same day as they are issued--as in the JACCS Case translated below, intellectual property cases are posted on this site in very easy to read, large Japanese print

Open Letter to Director David Kappos of the United States Patent and Trademark Office

I appreciate the opportunity to respond to the Request for Comments on the extent to which small businesses may be harmed by litigation tactics by corporations‟ attempts to enforce trademark rights beyond a reasonable interpretation of the scope of the rights granted to the trademark owner; the best use of Government services to protect trademarks and prevent counterfeiting; and appropriate policy recommendations. The PTO should be commended for considering whether the use of trademark litigation as a form of “bullying” is a problem for the U.S. trademark system. While some consider trademark litigation as a justifiable effort to police marks to avoid acquiescence to infringing uses, our comprehensive study supports another explanation. We have observed that trademark litigation is increasingly used as a bullying tactic, rather than an effort to reduce serious infringing activity. Merriam-Webster’s Collegiate Dictionary defines bullying as treating others “abusively” or “to affect by means of force or coercion.” I urge you to consider the suggestions made herein, including adoption of a “Fame Registry” by the PTO, creation of a federal cause of action for bullying under the Sherman Act, and finally, the recommendation that Congress amend the FTDA to make the test for dilution “actual dilution,” rather than a “likelihood of dilution,” wherein plaintiffs would not be encouraged to obtain fame at any cost

Trademark Extortion Revisited: A Response to Vogel and Schachter

Trademark bullying (a.k.a. trademark extortion) is a very controversial notion in trademark litigation in the United States. There, for sure, is a lot of illegitimate trademark infringement happening. Anecdotally, we also know that trademark holders often overstep in the assertion of their otherwise legitimate rights. For the first time, this article documents how large a problem trademark bullying is and how often it happens. Trademark bullying occurs when there is evidence that a trademark holder asserts a non-famous mark against a non-competing entity on or in connection with goods or services into which the plaintiff has no reasonable expectation of expanding. Trademark bully occurs in at least 5.5% of the reported cases. This is the same rate that plaintiffs recover any money damages. In the reported cases, trademark bullying is as statistically significant and relevant as cases where the plaintiff recovers money damages. Also, 5.5% is a floor. Trademark bullying happens at least 5.5% of the time. As there is no reporting or recording requirement in the United States, trademark bullying, if it happens at all, can only be found if we use deductive reasoning. This article is based on the deductive notion that cases where summary judgment was granted for the defendants are likely to manifest trademark bullying and it is appropriate to label them as such. In trademark bullying cases, the quality of the plaintiff’s claim is declining. This conclusion is supported by regression analysis that indicates that it is accurate to over 99% certainty. That is, plaintiffs are bringing claims that are less and less likely to succeed on the merits if tried. As no data (just suppositions) was provided by Vogel and Schachter, it is difficult to claim they are wrong in their analysis. Of course, Rule 11 and the other potential sanctions do exist. With this study, we now know that no Rule 11 sanctions were ever applied to any trademark bullying case. Further, no data is relied on by the various trade organizations (simply outdated dicta from now ancient cases). The data here is the first attempt to prove or disproved trademark bullying. It is provided in the spirit of an academic inquiry. To me, the data here supports the idea that trademark bullying deserves the scrutiny that would be brought to bear if Congress elected to get involved. Clearly, the existing “safeguards” have been proven here to be anything but safe. If non-practicing entities is a matter worth the time and energy of States and Congress, then trademark bullying is as well as both involve entities which upset natural markets for and with intellectual property. As such, Congress should act. Congress could go a long way in stopping trademark bullying if it amended Section 1117 of the Lanham to make it explicit that trademark infringement defendants as well as plaintiffs should be awarded its attorney’s fees when the opposing party acts egregiously. Attorney’s fees should be liberally awarded in cases where the defendant moves for summary judgment and prevails as these cases are the clearest manifestation of trademark bullying

Protection of Famous Trademarks in Japan and the United States

The concepts of trademark jurisprudence in Japan and the United States differ drastically. This difference is apparent in many aspects of trademark protection in both countries and is most evident in the treatment of famous marks. Although Japan and the United States share elements of trademark law that cause some observers to claim that Japan is legally the fifty-first State, the conceptual differences at the foundation of trademark law in each country are so significant that such a claim seems inaccurate and misleading

The Commodification of Trademarks: Some Final Thoughts on Trademark Dilution

This article is an explication of the trend toward commodification of famous or putatively famous trademarks and the resultant urging that the FTDA be repealed. This article starts with a literature review showing that the vast majority of commentators have been severely critical of the FTDA. This has been ignored by Congress. The article next pursues Congress\u27s blind support of the FTDA and suggests that more thought and analysis from Congress is still required. The article next explains the data regarding FTDA claims. All reported cases from 1996 through 2015 are coded and examined. The conclusion, looking at the data, is that the FTDA cause of action is going away. It has been rarely used in enforcement actions, it is much less likely to be successful than other trademark litigation, and the downward trend of enforcement continues. Finally, the article considers commodification of trademarks and how we are all negatively impacted by it