Center for Outcomes Research

Brussels, Belgium

Center for Outcomes Research

Brussels, Belgium
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News Article | April 17, 2017

A patchwork of state laws creates a labyrinth that can make it confusing to navigate incapacitated patients' medical wishes. Without clear national standards, the problem may worsen as the nation's 75 million baby boomers continue to age, according to medical ethics research published Wednesday in the New England Journal of Medicine. "Decisions about withdrawing or withholding life-sustaining care are incredibly emotional and challenging," said Erin Sullivan DeMartino, MD, a pulmonary and critical care medicine physician at Mayo Clinic in Minnesota who led the study as part of a fellowship with the University of Chicago's MacLean Center for Clinical Medical Ethics. "But when there is ambiguity about who is responsible for decision-making, it adds much more stress to that moment." Fewer than 30 percent of Americans have "advance directives" or legal documents outlining their treatment preferences that can also grant someone power to make medical decisions on their behalf. The documents are often used when a patient is unconscious, incapacitated or unable to speak for himself and can dictate how to treat - or not treat -- anything from a minor illness to a life-threatening injury. On average, 40 percent of hospitalized adults can't make their own medical decisions. In some intensive care units, that figure skyrockets to 90 percent. "We have medical technology we didn't have 50 years ago, so we have a whole group of people who - transiently or sometimes permanently -- can't communicate with us and can't participate in their own life-and-death decisions," DeMartino said. For patients without advance directives, most states have laws dictating that medical decisions fall to someone else -- typically a spouse, parent, or child. But the legal surrogate may not always be someone who understands the patient's specific values and wishes. That presents both ethical and health care policy problems, researchers said. DeMartino and her team reviewed laws in 50 states and the District of Columbia to compile what's thought to be the first comprehensive analysis of the country's medical decision-making statutes. Their examination revealed a complex, conflicting and often confusing system that poses barriers to "safeguarding of patients' choices in their most vulnerable moments," according to the study. The inconsistencies spanned topics that are both basic and complex. For example, 30 states require "alternate decision makers" to demonstrate an ability to engage in complex medical decisions, but none explain how to assess that ability. Only thirty-five states have what researchers call a "surrogacy ladder" establishing a hierarchy for who gets to make medical decisions in the absence of a durable power of attorney for health care, but these vary widely in regards what sorts of decisions a surrogate can actually make. In addition, some states included countless details for what constitutes an appropriate decision-maker, listing everything from frequency of someone's contact with a patient to their availability to meet with clinicians in person, to their familiarity with a patient's values and religious beliefs. Other states don't mention anything aside from requiring decision makers to be an adult. (The states even had conflicting definitions of "adult.") While it's unclear whether this variation in statutes impacts clinical care, the research team said one thing is certain: disputes about medical treatment are happening on a regular basis inside hospitals and hospice programs and there's no national standard or benchmark to guide families or physicians. "One important message from this study is that, in the absence of a clearly identified spokesperson, the decision-making process for incapacitated patients may vary widely depending on where they live," said Daniel B. Kramer, MD, MPH, a cardiac electrophysiologist at the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and Beth Israel Deaconess Medical Center in Boston, who was the study's senior author. "The next steps will be to study how this variability plays out in practice, and whether specific kinds of treatment decisions, such as withdrawing life-sustaining therapy or mental health interventions, actually turn out differently in different states due to the way these laws are written." Four of the paper's nine authors are affiliated with UChicago's MacLean Center, which pioneered the formal study of clinical medical ethics in the early 1980s. The center runs the world's largest clinical medical ethics fellowship for health care providers. "This study continues the MacLean Center's longstanding mission of examining critical issues in clinical medicine through research and training," said Mark Siegler, MD, MACP, an internist at the University of Chicago who directs the MacLean Center. "As medical ethicists - and practicing health care providers -- we wanted to provide a comprehensive resource to help guide patients, families, and other health care providers who are trying to resolve complicated ethical dilemmas." In addition to DeMartino, Kramer and Siegler, other authors of Who Decides When A Patient Can't? Statues On Alternate Decision Makers include: David M. Dudzinski, MD, JD, from Massachusetts General Hospital; Cavan K. Doyle, JD, LLM, of the MacLean Center for Clinical Medical Ethics at the University of Chicago; Beau P. Sperry, of Mayo Clinic; Sarah E. Gregory of the Beazley Institute for Health Law and Policy at Loyola University Chicago; Daniel P. Sulmasy, MD, PhD, of the Pellegrino Center for Clinical Bioethics and Kennedy Institute of Ethics at Georgetown

Seriola A.,Research Group Reproduction and Genetics REGE | Spits C.,Research Group Reproduction and Genetics REGE | Simard J.P.,The Hospital for Sick Children | Hilven P.,Research Group Reproduction and Genetics REGE | And 5 more authors.
Human Molecular Genetics | Year: 2011

Huntington's disease (HD) and myotonic dystrophy (DM1) are caused by trinucleotide repeat expansions. The repeats show different instability patterns according to the disorder, cell type and developmental stage. Here we studied the behavior of these repeats in DM1- and HD-derived human embryonic stem cells (hESCs) before and after differentiation, and its relationship to the DNA mismatch repair (MMR). The relatively small (CAG)44 HD expansion was stable in undifferentiated and differentiated HD hESCs. In contrast, the DM1 repeat showed instability from the earliest passages onwards in DM1 hESCs with (CTG)250 or (CTG)1800. Upon differentiation the DM1 repeat was stabilized. MMR genes, including hMSH2, hMSH3 and hMSH6 were assessed at the transcript and protein levels in differentiated cells. The coincidence of differentiation-induced down-regulated MMR expression with reduced instability of the long expanded repeats in hESCs is consistent with a known requirement of MMR proteins for repeat instability in transgenic mice. This is the first demonstration of a correlation between altered repeat instability of an endogenous DM1 locus and natural MMR down-regulation, in contrast to the commonly used murine knock-down systems. © The Author 2010. Published by Oxford University Press. All rights reserved.

Kim W.R.,Minneapolis Medical Research Foundation | Kim W.R.,Mayo Medical School | Smith J.M.,Minneapolis Medical Research Foundation | Smith J.M.,University of Washington | And 7 more authors.
American Journal of Transplantation | Year: 2014

Liver transplant in the US remains a successful life-saving procedure for patients with irreversible liver disease. In 2012, 6256 adult liver transplants were performed, and more than 65,000 people were living with a transplanted liver. The number of adults who registered on the liver transplant waiting list decreased for the first time since 2002; 10,143 candidates were added, compared with 10,359 in 2011. However, the median waiting time for active wait-listed adult candidates increased, as did the number of candidates removed from the list because they were too sick to undergo transplant. The overall deceased donor transplant rate decreased to 42.3 per 100 patient-years, and varied geographically from 18.9 to 228.0 per 100 patient-years. Graft survival continues to improve, especially for donation after circulatory death livers. The number of new active pediatric candidates added to the waiting list also decreased. Almost 75% of pediatric candidates listed in 2009 underwent transplant within 3 years; the 2012 rate of deceased donor transplants among active pediatric wait-listed candidates was 136 per 100 patient-years. Graft survival for deceased donor pediatric transplants was 92.8% at 30 days. Medicare paid for some or all of the care for more than 30% of liver transplants in 2010.

News Article | December 26, 2016

BOSTON - The Affordable Care Act (ACA) instituted financial penalties against hospitals with high rates of readmissions for Medicare patients with certain health conditions. A new analysis led by researchers at Beth Israel Deaconess Medical Center (BIDMC), Harvard T.H. Chan School of Public Health and Massachusetts General Hospital has found that the penalties levied under the law's Hospital Readmissions Reduction Program were associated with reduced readmissions rates and that the poorest performing hospitals achieved the greatest reductions. The research appears online in The Annals of Internal Medicine on December 27, 2016. The Hospital Readmissions Reduction Program was enacted into law in 2010 and implemented in 2012 in response to the high numbers of patients who were readmitted within 30 days of their initial discharge from the hospital after treatment for several common conditions -- including heart failure, pneumonia and acute myocardial infarction (heart attack). While some readmissions may be unavoidable, there was evidence of wide variation in hospitals' readmission rates before the ACA, suggesting that patients admitted to certain hospitals were more likely to experience readmissions compared to other hospitals. "Hospital readmissions represent a significant portion of potentially preventable medical expenditures, and they can take a physical and emotional toll on patients and their families," said co-senior author Robert W. Yeh, MD, MBA, Director of the Smith Center for Outcomes Research in Cardiology at BIDMC and Associate Professor of Medicine at Harvard Medical School. "The Affordable Care Act sought to introduce financial incentives to motivate hospitals, especially the poorest performing ones, to reduce their readmission rates, and only the data could tell us if and how well it worked." "We know that the national hospital readmission rate has been declining since passage of the Affordable Care Act, and our team wanted to assess whether this improvement was driven by the best-performing hospitals alone, or if all groups improved," said first author Jason H. Wasfy, MD, MPhil, who is Director of Quality and Analytics at the Massachusetts General Hospital Heart Center and Instructor in Medicine at Harvard Medical School. The researchers examined Medicare fee-for-service hospitalization data from more than 2,800 hospitals across the country between 2000 and 2013. Based on 30-day readmission rates after initial hospitalization for acute myocardial infarction, congestive heart failure or pneumonia, the researchers categorized hospitals into one of four groups based on the penalties they had incurred under the Hospital Readmissions Reduction Program: highest performance (0% penalty), average performance (greater than 0% but less than 0.5% penalty), low performance (equal to or greater than 0.5% but less than 0.99% penalty), and lowest performance (equal to or greater than 0.99% penalty). "We analyzed data from more than 15 million Medicare discharges," said co-senior author Francesca Dominici, PhD, Professor of Biostatistics and Senior Associate Dean for Research at Harvard T.H. Chan School of Public Health. "We implemented Bayesian hierarchical models to estimate readmission rates for each hospital, accounting for differences in each hospital's patient population. We then used pre-post analysis methods to assess whether there were accelerated reductions in readmission rates within each group after the passage of the reform. It turned out that all groups of hospitals improved to some degree. Notably, we found that it was the hospitals that were the lowest performers before passage of the Affordable Care Act that went on to improve the most after being penalized financially." "For every 10,000 patients discharged per year, the worst performing hospitals - which were penalized the most - avoided 95 readmissions they would have had if they'd continued along their current trajectory before the implementation of the law," added Dominici. "It's a testament to the fact that hospitals do respond to financial penalties, in particular when these penalties are also tied to publicly reported performance goals." "Paying hospitals not just for what they do, but for how well they do - that's still a relatively new way of reimbursing hospitals, and it looks to be effective," Yeh added. This work was funded, in part, by grants from the National Institutes of Health (P01 CA 134294, R01 GM111339, R01 ES024332 and K23 HL 118138-01), as well as support from the Massachusetts General Hospital Cardiology Division's Hassenfeld Scholars Program. Co-authors also include Corwin Matthew Zigler, PhD, Christine Choirat, PhD and Yun Wang, PhD, all of the Department of Biostatistics at the Harvard T.H. Chan School of Public Health. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .

Jolly S.E.,Cleveland Clinic | Burrows N.R.,Centers for Disease Control and Prevention | Chen S.-C.,Chronic Disease Research Group | Li S.,Chronic Disease Research Group | And 3 more authors.
Clinical Journal of the American Society of Nephrology | Year: 2011

Background and objectives Chronic kidney disease (CKD) is prevalent in minority populations and racial/ ethnic differences in survival are incompletely understood. Design, setting, participants, & measurements Secondary analysis of Kidney Early Evaluation Program participants from 2000 through 2008 with CKD, not on dialysis, and without previous kidney transplant was performed. Self-reported race/ethnicity was categorized into five groups: non-Hispanic white, African American, Asian, American Indian/Alaska Native, and Hispanic. CKD was defined as a urinary albumin to creatinine ratio of ≥30 mg/g among participants with an estimated GFR (eGFR) ≥60 ml/min per 1.73 m 2 or an eGFR of <60 ml/min per 1.73 m 2. The outcome was all-cause mortality. Covariates used were age, sex, obesity, diabetes, hypertension, albuminuria, baseline eGFR, heart attack, stroke, smoking, family history, education, health insurance, geographic region, and year screened. Results 19,205 participants had prevalent CKD; 55% (n = 10,560) were White, 27% (n = 5237) were African American, 9% (n = 1638) were Hispanic, 5% (n = 951) were Asian, and 4% (n = 813) were American Indian/ Alaska Native. There were 1043 deaths (5.4%). African Americans had a similar risk of death compared with Whites (adjusted Hazard Ratio (AHR) 1.07, 95% CI 0.90 to 1.27). Hispanics (AHR 0.66, 95% CI 0.50 to 0.94) and Asians (AHR 0.63, 95% CI 0.41 to 0.97) had a lower mortality risk compared with Whites. In contrast, American Indians/Alaska Natives had a higher risk of death compared with Whites (AHR 1.41, 95% CI 1.08 to 1.84). Conclusions Significant differences in mortality among some minority groups were found among persons with CKD detected by community-based screening. © 2011 by the American Society of Nephrology.

Belva F.,Center for Medical Genetics | De Schrijver F.,Center for Medical Genetics | Tournaye H.,Center for Reproductive Medicine | Liebaers I.,Center for Medical Genetics | And 4 more authors.
Human Reproduction | Year: 2011

Background: Safety concerns have been expressed regarding the use of immature non-ejaculated spermatozoa for ICSI. Therefore, adverse health outcomes, birth parameters, major anomaly rates and chromosomal aberrations in children born after ICSI using testicular and epididymal sperm were investigated. Methods: Questionnaire data and Results: of physical examinations of 530 children born after ICSI with testicular sperm and of 194 children born after ICSI with epididymal sperm were compared with data on 2516 ICSI children born using ejaculated sperm. Results: Birth parameters, stillborn rates, prematurity rates and rates of low birthweight and very low birthweight were comparable between the non-ejaculated and the ejaculated sperm groups. The perinatal death rate was higher for twins but not for singletons in the non-ejaculated sperm group in comparison to the control cohort of children born using ejaculated sperm. A non-significant increase in major anomalies was reported in the non-ejaculated sperm group in comparison to the ejaculated sperm group. No more anomalies were observed in pre- and post-natal karyotypes from viable pregnancies established using non-ejaculated sperm versus ejaculated sperm.CONCLUSIONOverall neonatal health in terms of birth parameters, major anomalies and chromosomal aberrations in our large cohort of children born by the use of non-ejaculated sperm seems reassuring in comparison to the outcome of children born after the use of ejaculated sperm. © 2011 The Author.

Van Saen D.,Vrije Universiteit Brussel | Goossens E.,Vrije Universiteit Brussel | Haentjens P.,Center for Outcomes Research | Baert Y.,Vrije Universiteit Brussel | And 2 more authors.
Reproductive BioMedicine Online | Year: 2013

In a previous study, meiotic activity was observed in human intratesticular xenografts from peripubertal patients. However, full spermatogenesis could not be established. The present study aimed to evaluate whether the administration of recombinant human FSH could improve the spermatogonial survival and the establishment of full spermatogenesis in intratesticular human xenografts. Human testicular tissue was obtained from six boys (aged 2.5-12.5 years). The testicular biopsy was fragmented and one fragment of 1.5-3.0 mm3 was transplanted to the testis of immunodeficient nude mice. Transplanted mice were assigned to different experimental groups to enable evaluation of the effects of FSH administration and freezing. The structural integrity of the seminiferous tubules, the spermatogonial survival and the presence of differentiated cells were evaluated by histology and immunohistochemistry. Freezing or administration of FSH did not influence tubule integrity and germ cell survival in human xenografts. Meiotic germ cells were observed in the xenografts. More tubules containing only Sertoli cells were observed in frozen-thawed grafts, and more tubules with meiotic cells were present in fresh grafts. There was no clear influence of FSH treatment on meiotic differentiation. Administration of FSH did not improve the establishment of full spermatogenesis after intratesticular tissue grafting. © 2012, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Jurkovitz C.T.,Center for Outcomes Research | Elliott D.,Center for Outcomes Research | Li S.,Chronic Disease Research Group | Saab G.,University of Washington | And 4 more authors.
American Journal of Kidney Diseases | Year: 2012

Background: Chronic kidney disease (CKD) is a well-known risk factor for cardiovascular mortality, but little is known about the association between physician utilization and cardiovascular disease risk-factor control in patients with CKD. We used 2005-2010 data from the National Kidney Foundation's Kidney Early Evaluation Program (KEEP) to examine this association at first and subsequent screenings. Methods: Control of risk factors was defined as control of blood pressure, glycemia, and cholesterol levels. We used multinomial logistic regression to examine the association between participant characteristics and seeing a nephrologist after adjusting for kidney function and paired t tests or McNemar tests to compare characteristics at first and second screenings. Results: Of 90,009 participants, 61.3% had a primary care physician only, 2.9% had seen a nephrologist, and 15.3% had seen another specialist. The presence of 3 risk factors (hypertension, diabetes, and hypercholesterolemia) increased from 26.8% in participants with CKD stages 1-2 to 31.9% in those with stages 4-5. Target levels of all risk factors were achieved in 7.2% of participants without a physician, 8.3% of those with a primary care physician only, 9.9% of those with a nephrologist, and 10.3% of those with another specialist. Of up to 7,025 participants who met at least one criterion for nephrology consultation at first screening, only 12.3% reported seeing a nephrologist. Insurance coverage was associated strongly with seeing a nephrologist. Of participants who met criteria for nephrology consultation, 406 (5.8%) returned for a second screening, of whom 19.7% saw a nephrologist. The percentage of participants with all risk factors controlled was higher at the second screening (20.9% vs 13.3%). Conclusion: Control of cardiovascular risk factors is poor in the KEEP population. The percentage of participants seeing a nephrologist is low, although better after the first screening. Identifying communication barriers between nephrologists and primary care physicians may be a new focus for KEEP. © 2012 National Kidney Foundation, Inc.

Vo A.A.,Cedars Sinai Medical Center | Petrozzino J.,Compara Biomedical | Petrozzino J.,University of Vermont | Yeung K.,Cedars Sinai Medical Center | And 6 more authors.
Transplantation | Year: 2013

Background. Transplantation rates are very low for the broadly sensitized patient (panel reactive antibody [PRA]980%; HS). Here, we examine the efficacy, outcomes, and cost-effectiveness of desensitization using high-dose intravenous immunoglobulin (IVIG) and rituximab to improve transplantation rates in HS patients. Methods. From July 2006 to December 2011, 207 HS (56 living donors/151 deceased donors) patients (donor-specific antibody positive, PRA980%) were desensitized using IVIG and rituximab. After desensitization, responsive patients proceeded to transplantation with an acceptable crossmatch. Cost and outcomes of desensitization were compared with dialysis. Results. Of the 207 treated patients, 146 (71%) were transplanted. At 48 months, patient and graft survival by KaplanYMeier were 95% and 87.5%, respectively. The total 3-year cost for patients treated in the desensitization arm was $219,914 per patient compared with $238,667 per patient treated in the dialysis arm. Thus, each patient treated with desensitization is estimated to save the U.S. healthcare system $18,753 in 2011 USD. Overall, estimated patient survival at the end of 3 years was 96.6% for patients in the desensitization arm of the model (based on Cedars-Sinai survival rate) compared with 79.0% for an age, end-stage renal disease etiology, and PRA matched group of patients remaining on dialysis during the study period. Conclusions. We conclude that desensitization with IVIG+rituximab is clinically and cost-effective, with both financial savings and an estimated 17.6%greater probability of 3-year survival associated with desensitization versus dialysis alone. However, the benefits of desensitization and transplantation are limited by organ availability and allocation policies. © 2013 Lippincott Williams & Wilkins.

Zimmerman R.F.,Maine Medical Center | Ezeanuna P.U.,Maine Medical Center | Kane J.C.,Maine Medical Center | Cleland C.D.,Maine Medical Center | And 3 more authors.
Kidney International | Year: 2011

Acute kidney injury, a common complication of cardiac surgery with cardiopulmonary bypass, is associated with increased morbidity and mortality. Ischemic preconditioning at a remote site mitigates ischemia-reperfusion injury and may prevent acute kidney injury after cardiac surgery, thus providing clinical benefit. To further study this, we enrolled 120 adult patients undergoing elective cardiac surgery for whom cardiopulmonary bypass was anticipated in a randomized, single-blind, and controlled pilot trial. Patients were stratified for the type of surgery and equally assigned to a control group or to receive remote ischemic preconditioning by an automated thigh tourniquet consisting of three 5-min intervals of lower extremity ischemia separated by 5-min intervals of reperfusion. The primary end point was acute kidney injury defined as an elevation of serum creatinine of 0.3 mg/dl or 50% within 48 h after surgery. Fifty-nine patients in each group were analyzed on an intention-to-treat basis. Acute kidney injury occurred in 12 remote ischemic preconditioned and 28 control patients, reflecting an absolute risk reduction of 0.27 and a significantly reduced relative risk due to preconditioning of 0.43. Hence, remote ischemic preconditioning prevents acute kidney injury in patients undergoing cardiopulmonary bypass-assisted cardiac surgery. © 2011 International Society of Nephrology.

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