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For decades, all federally funded research involving human subjects has been subject to regulations that require the informed consent of the subject and oversight by the local institution. These regulations last underwent major revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research support, and the institutional environment in which clinical research is conducted. In the intervening years, doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, in terms of time, bureaucracy, and delay, are justified by the level of protection afforded. The Human Research Ethics Group, administered by the Center for Bioethics at the University of Pennsylvania Health System, extensively reviewed the status of existing human subjects protections with the aim of making recommendations to improve and reform the regulations. Here, we present recommendations constituting a consensus of the group members for reform in 3 key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards, and regulatory policy. [ABSTRACT FROM AUTHOR]

Health maintenance organizations (HMOs) are providing an increasing proportion of medical care in the United States. Characteristics of these organizations such as cost containment, incentives to reduce spending by practitioners, and barriers to access for clients raise significant ethical concerns. This paper considers how these features of the HMO withstand ethical scrutiny and what may be done to prevent abuse. Generally, the challenges to the moral integrity of physicians practicing in HMOs are neither intractable nor in all cases unique, although special arrangements may have to be made to ensure that ethical standards are upheld. Independent practice associations pose particular problems. Finally, whether or not an HMO is a for-profit enterprise is a significant consideration. [ABSTRACT FROM AUTHOR]

The registries are databases including information about a treatment or a disease in a definite population. Concerning home artificial nutrition there are registries of patients in different European countries, USA and Japan, collecting data such as the prevalence, indication, follow-up and complications of these treatments. The Spanish group of Home Artificial Nutrition (HAN), NADYA, was established in 1992 with professionals devoted to the practise of artificial nutrition. Since then, one of its wills was the development of the Spanish registry of HAN. This is a voluntary registry accessible through the web page www.nadya-senpe.com. In 2005, this group decided to update the registry according to the Data Protection Law and including other improvements. Thank to the work of all the members of this group we have many data on the practise of HAN in our country. Since 1994, except the years 97-98, the annual registries of patients on home parenteral nutrition and home enteral nutrition have been published periodically, observing an increase in both, the number of patients and collaborating centres, presenting to us the actual practise of HAN in our country. [ABSTRACT FROM AUTHOR]

Ineffective communication is implicated in 80% of medical errors, costing the United States approximately $12 billion annually. Teaching communication skills is a component of nursing curricula linked to improved patient outcomes. Simulation-based experience (SBE) is a strategy for healthcare professionals to learn communication skills. Providing nurses with the ability to practice nurse-nurse, nurse-physician, nurse-patient, and team communication skills in a psychologically safe learning environment provides an opportunity for skill development and meaningful self-reflection. The multiple modalities for SBE support needed communication techniques for skill development and acquisition to improve patient outcomes., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Vertical bone augmentation procedures are increasingly necessary in daily practice. However, it has been reported that vertical ridge augmentation is one of the least predictable techniques in terms of complications. The aim of this systematic review was to evaluate and compare complications in relation to the different procedures used for vertical bone augmentation prior to implant placement. This review was conducted according to PRISMA guidelines. An electronic search was carried out in four databases: The National Library of Medicine (MEDLINE/PubMed); Web of Science; SCOPUS; and Cochrane Central Register of Controlled Trials (CENTRAL). The Newcastle-Ottawa Quality Assessment Scale, the Cochrane Collaboration tool for assessing risk of bias, and The Joanna Briggs Institute Critical Appraisal tool were used to assess the quality of evidence in the studies reviewed. Twenty-five studies with a total of 749 vertically augmented sites were included in the review. Complication rates varied among the different procedures: 51.02% for distraction osteogenesis, 38.01% for bone blocks, and 16.80% for guided bone regeneration. Vertical bone augmentation procedures prior to implant placement are associated with frequent surgical complications and should be approached with caution due to their possible impact on clinical treatment success., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interest., (Copyright © 2023 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Anger is an emotional state that occurs when unexpected things happen to or around oneself and is "an emotional state that varies in intensity from mild irritation to intense fury and rage." It is defined as "a strong feeling of displeasure and usually of antagonism," an emotion characterized by tension and hostility arising from frustration, real or imagined injury by another, or perceived injustice. It can manifest itself in behaviors designed to remove the object of the anger (e.g., determined action) or behaviors designed merely to express the emotion. For the Roman philosopher Seneca anger is not an uncontrollable, impulsive, or instinctive reaction. It is, rather, the cognitive assent that such initial reactions to the offending action or words are in fact unjustified. It is, rather, the cognitive assent that such initial reactions to the offending action or words are in fact unjustified. It seems that the year 2022 was a year when many Americans were plainly angry. "Why is everyone so angry?" the New York Times asked in the article "The Year We Lost It." We believe that Seneca is correct in that anger is unacceptable. Anger is a negative emotion that must be controlled, and Seneca provides us with the tools to avoid and destroy anger. Health care professionals will be more effective, content, and happier if they learn more about Seneca's writings about anger and implement his wisdom on anger from over 2000 years ago., (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)

Background: Home health agencies (HHAs) are often affiliated with hospice agencies and commonly care for patients with serious illness within the Medicare program. HHAs may therefore provide a potential opportunity to facilitate timely referral to hospice when appropriate. Objectives: To determine if patients cared for by HHAs affiliated with hospice agencies experience differential hospice use and care patterns. Design: Nationally representative cohort study. Setting/Subjects: 1431 decedents in the 2002 to 2017 Medicare Current Beneficiary Survey who received home health in the last year of life in the United States. Measurements: Primary independent variable was HHA hospice affiliation. Primary dependent variable was hospice enrollment; secondary dependent variables were hospice live discharge and length of stay. Results: The 27.3% of decedents cared for by a HHA affiliated with a hospice had greater education levels and wealth and were more likely to live in the Midwest and Northeast. In adjusted models, HHA-hospice affiliated decedents had greater odds of enrolling in hospice compared to those cared for by HHAs not affiliated with a hospice, corresponding to a hospice enrollment rate of 51.0% for those cared for by HHAs affiliated with hospices versus 39.7% for HHAs not affiliated ( p  = 0.004). There were no differences in hospice length of stay or live discharge rate by hospice affiliation. Conclusion: Medicare beneficiaries cared for by HHAs affiliated with hospices are more likely to enroll in hospice at the end of life. This has implications for improving hospice access through home health incentives and models of care.

Background: To identify and rank the importance of key determinants of end-of-life (EOL) health care costs, and to understand how the key factors impact different percentiles of the distribution of health care costs., Method: We applied a principled, machine learning-based variable selection algorithm, using Quantile Regression Forests, to identify key determinants for predicting the 10th (low), 50th (median), and 90th (high) quantiles of EOL health care costs, including costs paid for by Medicare, Medicaid, Medicare Health Maintenance Organizations (HMOs), private HMOs, and patient's out-of-pocket expenditures., Results: Our sample included 7 539 Medicare beneficiaries who died between 2002 and 2017. The 10th, 50th, and 90th quantiles of EOL health care cost are $5 244, $35 466, and $87 241, respectively. Regional characteristics, specifically, the EOL-Expenditure Index, a measure for regional variation in Medicare spending driven by physician practice, and the number of total specialists in the hospital referral region were the top 2 influential determinants for predicting the 50th and 90th quantiles of EOL costs but were not determinants of the 10th quantile. Black race and Hispanic ethnicity were associated with lower EOL health care costs among decedents with lower total EOL health care costs but were associated with higher costs among decedents with the highest total EOL health care costs., Conclusions: Factors associated with EOL health care costs varied across different percentiles of the cost distribution. Regional characteristics and decedent race/ethnicity exemplified factors that did not impact EOL costs uniformly across its distribution, suggesting the need to use a "higher-resolution" analysis for examining the association between risk factors and health care costs., (© The Author(s) 2021. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Importance: Use of hospice has been demonstrated to be cost saving to the Medicare program and yet the extent to which hospice saves money across all payers, including whether it shifts costs to families, is unknown., Objective: To estimate the association between hospice use and total health care costs including family out-of-pocket health care spending., Design Setting and Participants: This retrospective cohort study of health care spending in the last 6 months of life used data from the nationally representative Medicare Current Beneficiary Survey (MCBS) between the years 2002 and 2018. Participants were MCBS participants who resided in the community and died between 2002 and 2018., Exposures: Covariate balancing propensity scores were used to compare participants who used hospice (n = 2113) and those who did not (n = 3351), stratified by duration of hospice use., Main Outcomes and Measures: Total health care expenditures were measured across payers (family out-of-pocket, Medicare, Medicare Advantage, Medicaid, private insurance, private health maintenance organizations, Veteran's Administration, and other) and by expenditure type (inpatient care, outpatient care, medical visits, skilled nursing, home health, hospice, durable medical equipment, and prescription drugs)., Results: The study population included 5464 decedents (mean age 78.7 years; 48% female) and 38% enrolled with hospice. Total health care expenditures were lower for those who used hospice compared with propensity score weighted non-hospice control participants for the last 3 days of life ($2813 lower; 95% CI, $2396-$3230); last week of life ($6806 lower; 95% CI, $6261-$7350); last 2 weeks of life ($8785 lower; 95% CI, $7971-$9600); last month of life ($11 747 lower; 95% CI, $10 072-$13 422); and last 3 months of life ($10 908 lower; 95% CI, $7283-$14 533). Family out-of-pocket expenditures were lower for hospice enrollees in the last 3 days of life ($71; 95% CI, $43-$100); last week of life ($216; 95% CI, $175-$256); last 2 weeks of life ($265; 95% CI, $149-$382); and last month of life ($670; 95% CI, $530-$811) compared with those who did not use hospice. Health care savings were associated with reductions in inpatient care., Conclusions and Relevance: In this population-based cohort study of community-dwelling Medicare beneficiaries, hospice enrollment was associated with lower total health care costs for the last 3 days to 3 months of life. Importantly, we found no evidence of cost shifting from Medicare to families related to hospice enrollment. The magnitude of lower out-of-pocket spending to families who enrolled with hospice is meaningful to many Americans, particularly those with lower socioeconomic status., Competing Interests: Conflict of Interest Disclosures: Dr Brody reported grants from National Institutes of Health during the conduct of the study; and is a voluntary unpaid board member of MJHS Hospice and Palliative Care, a nonprofit hospice provider. Dr May reported consulting fees from Icahn School of Medicine at Mount Sinai during the conduct of the study. No other disclosures were reported., (Copyright 2022 Aldridge MD et al. JAMA Health Forum.)

By the end of May 2020, all states in the US have eased their COVID-19 mitigation measures. Different states adopted markedly different policies and timing for reopening. An important question remains in how the relaxation of mitigation measures is related to the number of casualties. To address this question, we compare the actual data to a hypothetical case in which the mitigation measures are left intact using a projection of the data from before mitigation measures were eased. We find that different states have shown significant differences between the actual number of deaths and the projected figures within the present model. We relate these differences to the states different policies and reopening schedules. Our study provides a gauge for the effectiveness of the approaches by different state governments and can serve as a guide for implementing best policies in the future. According to the Pearson correlation coefficients we obtained, the face mask mandate has the strongest correlation with the death count than any other policies we considered., (© 2022. The Author(s).)

Importance: Although geriatric assessment-driven intervention improves patient-centered outcomes, its influence on chemotherapy-related toxic effects remains unknown., Objective: To assess whether specific geriatric assessment-driven intervention (GAIN) can reduce chemotherapy-related toxic effects in older adults with cancer., Design, Setting, and Participants: A randomized clinical trial enrolled 613 participants from a National Cancer Institute-designated cancer center between 2015 and 2019. Patients were 65 years and older with a solid malignant neoplasm, were starting a new chemotherapy regimen, and completed a geriatric assessment. Patients were followed up until chemotherapy completion or 6 months after initiation, whichever occurred first. Data analysis was done by intention-to-treat principle., Interventions: Patients were randomized (2:1) to either the GAIN (intervention) or standard of care (SOC) arm. In the GAIN arm, a geriatrics-trained multidisciplinary team composed of an oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist reviewed geriatric assessment results and implemented interventions based on prespecified thresholds built into the geriatric assessment's domains. In the SOC arm, geriatric assessment results were sent to treating oncologists for consideration., Main Outcomes and Measures: The primary outcome was incidence of grade 3 or higher chemotherapy-related toxic effects (graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0). Secondary outcomes included advance directive completion, emergency department visits, unplanned hospitalizations, average length of stay, unplanned hospital readmissions, chemotherapy dose modifications, and early discontinuation. Overall survival analysis was performed up to 12 months after chemotherapy initiation., Results: Among the 605 eligible participants for analysis, median (range) age was 71 (65-91) years, 357 (59.0%) were women, and 432 (71.4%) had stage IV disease. Cancer types included gastrointestinal (202 [33.4%]), breast (136 [22.5%]), lung (97 [16.0%]), genitourinary (91 [15.0%]), gynecologic (54 [8.9%]), and other (25 [4.1%]). Incidence of grade 3 or higher chemotherapy-related toxic effects was 50.5% (95% CI, 45.6% to 55.4%) in the GAIN arm and 60.6% (95% CI, 53.9% to 67.3%) in the SOC arm, resulting in a significant 10.1% reduction (95% CI, -1.5 to -18.2%; P = .02). A significant absolute increase in advance directive completion of 28.4% with GAIN vs 13.3% with SOC (P < .001) was observed. No significant differences were observed in emergency department visits, unplanned hospitalizations, average length of stay, unplanned readmissions, chemotherapy dose modifications or discontinuations, or overall survival., Conclusions and Relevance: In this randomized clinical trial, integration of multidisciplinary GAIN significantly reduced grade 3 or higher chemotherapy-related toxic effects in older adults with cancer. Implementation of GAIN into oncology clinical practice should be considered among older adults receiving chemotherapy., Trial Registration: ClinicalTrials.gov Identifier: NCT02517034.

Background: In the United States, the percentage of hospitals over 50 beds with palliative care programs has risen substantially from 7% of hospitals in 2001 to 72% in 2017. Yet the dynamic nature of program adoption and closure over time is not known. Objective: To examine the rate of palliative care program adoption and closure and associated hospital and geographic characteristics in a national sample of U.S. hospitals. Design: Adoption and closure rates were calculated for 3696 U.S. hospitals between 2009 and 2017. We used multivariable logistic regression models to examine the association between adoption and closure status and hospital, geographic, and community characteristics. Setting/Subjects: All nonfederal general medical and surgical, cancer, heart, and obstetric or gynecological hospitals, of all sizes, in the United States in operation in both 2009 and 2017. Results: By 2017, 34.9% (812/2327) of the hospitals without palliative care in 2009 had adopted palliative care programs, and 15.0% (205/1369) of the hospitals with programs had closed them. In multivariable models, hospitals in metropolitan areas, nonprofit and public hospitals (compared to for-profit hospitals), and those with residency training approval by the Accreditation Council for Graduate Medical Education were significantly more likely to adopt and significantly less likely to close palliative care programs during the study period. Conclusions: This study indicates that palliative care is not equitably adopted nor sustained by hospitals in the United States. Federal and state interventions may be required to ensure that high-quality care is available to our nation's sickest patients.

State government-mandated social distancing measures have helped to slow the growth of the COVID-19 pandemic in the United States. Many of the current predictive models of the development of COVID-19, especially after mitigation efforts, partially rely on extrapolations from data collected in other countries. Since most states enacted stay-at-home orders towards the end of March, the resulting effects of social distancing should be reflected in the death and infection counts by the end of April. Using the data available through April 25th, we investigate the change in the infection rate due to the mitigation efforts and project death and infection counts through September 2020 for some of the most heavily impacted states: New York, New Jersey, Michigan, Massachusetts, Illinois, and Louisiana. We find that with the current mitigation efforts, five of those six states have reduced their base reproduction number to a value less than one, stopping the exponential growth of the pandemic. We also project different scenarios after the mitigation is relaxed., Competing Interests: The authors have declared that no competing interests exist.

Background/objectives: The Medicare Advantage (MA) program insures a rapidly growing proportion of older adults, and may be more appealing due to lower cost sharing. However, the extent to which older adults are informed of their plan benefits and how plan knowledge has changed over time is unclear. We evaluated temporal trends and characteristics associated with not knowing MA coverage for dental, vision, and nursing home (NH) services., Design: Longitudinal cohort study., Setting: Medicare Current Beneficiary Survey (MCBS), 2010 to 2016., Participants: Adults aged 65 years or older enrolled in MA plans and not in Medicaid., Measurements: Insurance knowledge was determined from separate items asking if individuals had coverage through their MA plan for dental, vision, and NH care. Responses were dichotomized between responding yes/no and not knowing. Demographic, clinical, and functional characteristics were assessed from the MCBS., Results: The proportion of older adults in MA who did not know if their plan covered NH care increased from 38.0% in 2010 to 45.5% in 2016. However, proportions of not knowing dental benefits decreased from 6.4% in 2010 to 3.4% in 2016 and not knowing vision benefits decreased from 8.2% in 2010 to 5.9% in 2016. We found significant associations of race, education, income, region, and disability with knowledge of MA benefits., Conclusions: As enrollment in MA plans has grown, older adults in MA plans increasingly report that they know their plan's vision and dental benefits, although they decreasingly know about NH care. Older adults from racial and ethnic minority groups, with lower levels of education and income and who reside in certain regions or have functional disability, are less likely to know their plan benefits. This may imply decreasing preparedness for future long-term care needs. J Am Geriatr Soc 68:2343-2347, 2020., (© 2020 The American Geriatrics Society.)

Background: Over the past two decades, the number of hospitals with palliative care has increased significantly. Objective: This study analyzes the availability of palliative care in U.S. hospitals and examines the variation by hospital characteristics, community-level socioeconomic demographics, health care markets, and geographic characteristics. Methods: Data were obtained from the American Hospital Association Annual Survey Database for 2017 and supplemented with 2016 for nonresponders, the United States Census Bureau's 2017 American Community Survey, the Dartmouth Atlas of Health Care's 2016 Spending and 2011 Hospital and Physician Capacity datasets, the National Palliative Care Registry™, state-level directories on palliative care, and web-based searches. Multivariable logistic regression and average marginal effects were used to examine predictors of hospital palliative care programs. Results: Seventy-two percent of hospitals with 50 or more beds had palliative care programs. Hospital and geographic characteristics were significantly associated with the presence of palliative care. Most notably, nonprofit hospitals were 24.5 percentage points more likely than for-profit hospitals to have palliative care, and metropolitan areas were 15.4 percentage points more likely than rural areas, controlling for other variables. Conclusion: This study demonstrates that availability of palliative care in U.S. hospitals is determined by where patients live and the type of hospital to which they are admitted. Equitable and reliable availability to quality palliative care must improve across the nation.

As more people live and die in the community despite complex health needs and functional impairment, the need for hospice increases. We found high and increasing penetration of hospice in community-based residential settings, compared with hospice use in private residences and nursing homes.

Study Design: A retrospective cohort study., Objective: To compare the cost of maximum nonoperative therapy (MNT) in patients diagnosed with a herniated lumbar disk undergoing primary (1-3 mo) versus prolonged (4-6 mo) conservative management before microdiscectomy., Summary of Background Data: Patients diagnosed with a herniated lumbar disk often attempt a 3-month trial of conservative management before microdiscectomy. A paucity of data exists characterizing the cost of a subsequent round of nonoperative therapies in patients who fail their initial trial, rather than undergo surgery., Methods: Clinical records from patients diagnosed with a herniated lumbar disk undergoing index microdiscectomy surgery from 2007 to 2017 were gathered from a large insurance database. Records were searchable by International Classification of Diseases diagnosis/procedure codes, Current Procedural Terminology codes, and generic drug codes. Two cohorts were established: patients undergoing primary (1-3 mo) versus prolonged (4-6 mo) courses of conservative management. Nonoperative therapy utilization was documented from initial herniation diagnosis to microdiscectomy surgery. "Utilization" encompassed cost billed to patients, prescriptions written, and quantity of units dispensed., Results: The 3-month MNT cohort included 4587 patients and the 6-month MNT cohort contained 1506 patients. A greater percentage of 6-month cohort patients utilized opioids (P=0.0052), muscle relaxants (P=0.0061), and lumbar steroid injections (P<0.0001). When considering the average amount spent on conservative management, 6-month patients ($1824/patient) spent 1.55 times more than 3-month patients ($1178/patient). The 6-month:3-month average spending ratio was <2.0 for all of the nonoperative therapies except nonsteroidal anti-inflammatory drugs (2.66) and epidural steroid injections (2.25). When normalized by the number of opioid users, the number of opioid medications dispensed was proportionally less in 3-month patients compared with 6-month patients, with a 6-month:3-month ratio of 1.52., Conclusions: The costs associated with a subsequent course of nonoperative therapies for symptomatic lumbar disk herniation seem to be slightly less than that of the primary trial. Assuming a minimal clinical benefit after the initial trial of nonsurgical therapies, the incremental cost-effectiveness ratio of a subsequent trial versus surgery may be unfavorable. Future studies identifying patients likely to benefit from surgery earlier in the treatment course is required., Level of Evidence: Level III.

For the better part of a dozen years and over 3 US presidential terms, heated debates about the ethics of cloning and embryonic stem cell research helped to define the American political landscape. Current lack of public controversy about regulation of human genome editing does not signal that ethical issues about engineering human embryos have been settled. Rather, while genome editing raises old ethical questions about the value of human life, eugenics, and the weight of unintended consequences, it also came into being in a political landscape that vastly differs from the early aughts when bioethics was last a major topic of political controversy., (© 2019 American Medical Association. All Rights Reserved.)

Study Design: Retrospective cohort study., Objective: The purpose of this investigation was to evaluate the regional variations in the use of nonoperative therapies in patients diagnosed with a lumbar intervertebral disc herniation 3 months prior to undergoing microdiscectomy surgery., Summary of Background Data: Regional variations in the management of chronic pain conditions have been previously identified. Patients suffering from a lumbar intervertebral disc herniation are typically treated with a brief course of conservative management prior to attempting microdiscectomy surgery. Whether regional differences exist in the utilization or costs of maximum nonoperative therapy (MNT) remains unknown., Methods: Medical records from patients diagnosed with a lumbar intervertebral disc herniation undergoing 1, 2, or 3-level index microdiscectomy operations between 2007 and 2017 were gathered from the HORTHO insurance database consisting of private/commercially insured and Medicare Advantage beneficiaries. Patient regional designation was divided into Midwest, Northeast, South, and West territories and was derived from the insurance claim location. The utilization of MNT within 3 months after initial lumbar herniation diagnosis in adult patients was analyzed., Results: Our population consisted of 13,106 patients who underwent primary index microdiscectomy surgery. Significant regional variation was identified in the nonoperative therapy failure rate (P<0.0001), with the highest proportion of Midwest patients failing (2.7%). There were statistical differences in the regional distribution of patients utilizing NSAIDs (P<0.0001), muscle relaxants (P <0.0001), lumbar epidural steroid injections (P <0.0001), physical therapy and occupational therapy sessions (P <0.0001), chiropractor treatments (P <0.0001), and emergency department services (P = 0.0049). The total direct cost associated with all MNT prior to microdiscectomy was $13,205,924, with 59.6% from the South, 31.1% from the Midwest, 8.3% from the West, and 1.1% from the Northeast., Conclusion: These findings indicate that regional differences exist in the utilization and costs of MNT of a lumbar intervertebral herniated disc prior to microdiscectomy surgery., Level of Evidence: 3.

Introduction: The long-standing debate on medical complicity in torture has overlooked the complicity of cognitive scientists-psychologists, psychiatrists and neuroscientists-in the practice of torture as a distinct phenomenon. In this paper, we identify the risk of the re-emergence of torture as a practice in the USA, and the complicity of cognitive scientists in these practices., Methods: We review arguments for physician complicity in torture. We argue that these defences fail to defend the complicity of cognitive scientists. We address objections to our account, and then provide recommendations for professional associations in resisting complicity in torture., Results: Arguments for cognitive scientist complicity in torture fail when those actions stem from the same reasons as physician complicity. Cognitive scientist involvement in the torture programme has, from the outset, been focused on the outcomes of interrogation rather than supportive care. Any possibility of a therapeutic relationship between cognitive therapists and detainees is fatally undermined by therapists' complicity with torture., Conclusion: Professional associations ought to strengthen their commitment to refraining from engaging in any aspect of torture. They should also move to protect whistle-blowers against torture programmes who are members of their association. If the political institutions that are supposed to prevent the practice of torture are not strengthened, cognitive scientists should take collective action to compel intelligence agencies to refrain from torture., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Study Design: Retrospective cohort study., Objective: The purpose of this study is to characterize the utilization and costs of MNTs prior to spinal fusion surgery in patients with symptomatic lumbar stenosis or spondylolisthesis., Summary of Background Data: The costs and utilization of long-term maximal nonoperative therapy (MNT) can be substantial, and in the current era of bundled payments, the duration of conservative therapy trials should be reassessed., Methods: A large insurance database was queried for patients with symptomatic lumbar stenosis or spondylolisthesis undergoing index lumbar decompression and fusion procedures between 2007 and 2016. This database consists of 20.9 million covered lives and includes private/commercially insured and Medicare Advantage beneficiaries. Only patients with lumbar stenosis or spondylolisthesis and those continuously active within the insurance system for at least 5 years prior to the index operation were eligible., Results: A total of 4133 out of 497,822 (0.8%) eligible patients underwent 1, 2, or 3-level posterior lumbar instrumented fusion. 20.8% of patients were smokers, 44.5% had type II DM, and 38.2% were obese (body mass index [BMI] >30 kg/m). Patient MNT utilization was as follows: 66.7% used nonsteroidal anti-inflammatory drugs (NSAIDs), 84.4% used opioids, 58.6% used muscle relaxants, 65.5% received lumbar epidural steroid injections (LESI), 66.6% attended 21.1% presented to the emergency department (ED), and 24.9% received chiropractor treatments. The total direct cost associated with all MNT prior to index spinal fusion was $9,000,968; LESI comprised the largest portion of the total cost of MNT ($4,094,646, 45.5%), followed by NSAIDS ($1,624,217, 18.0%) and opioid costs ($1,279,219, 14.2%). At the patient level, when normalized per patient utilizing therapy, an average $4010 was spent on nonoperative treatments prior to index lumbar surgery., Conclusion: Assuming minimal improvement in pain and functional disability after maximum nonoperative therapies, the incremental cost-effectiveness ratio (ICER) for MNTs could be highly unfavorable., Level of Evidence: 3.

Purpose: We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized, phase 4 clinical trial., Materials and Methods: Resource utilization data were prospectively collected and evaluated by cost consequence analysis. Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs. Differences in base case mean costs between the study cohorts for total postoperative ileus related costs (hospital days, study drug, nasogastric tubes, postoperative ileus related concomitant medication and postoperative ileus related readmissions) and total combined costs (postoperative ileus related, laboratory, electrocardiograms, nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission) were evaluated by probabilistic sensitivity analysis using a bootstrap approach., Results: Mean hospital stay was 2.63 days shorter for alvimopan than placebo (mean±SD 8.44±3.05 vs 11.07±8.23 days, p=0.005). Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo, eg total parenteral nutrition 10% vs 25% (p=0.001). Postoperative ileus related health care costs were $2,340 lower for alvimopan and mean total combined costs were decreased by $2,640 per patient for alvimopan vs placebo. Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs (p=0.04) but not total combined costs (p=0.068) was significantly lower for alvimopan than for placebo., Conclusions: In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Most of today's students are skilled in instant messaging, Web browsing, online games, and blogs. These have become part of the social landscape and have changed how we learn and where we learn. The question becomes how to harness the attractiveness and ubiquity of electronic venues toward the goal of teaching neuroscience. At the Rice University Center for Technology in Teaching and Learning, a central focus is the creation of innovative materials that appeal to middle school students. A recent project was undertaken through a Science Education Drug Abuse Partnership Award (R25 DA15063) from the National Institute on Drug Abuse to inform adolescents about the neurobiology of substance abuse and the current research dealing with a class of drugs known as club drugs. Problem-based learning, multimedia pedagogy, and the National Science Content Standards were integrated to produce The Reconstructors, an episodic series available via the World Wide Web at http://reconstructors.rice.edu. A field test of students from five schools assessed the retention of content after "playing" The Reconstructors series titled Nothing to Rave About. Gain scores indicated that middle school students' knowledge about club drugs and the basic neuroscience concepts that explain their effects improved significantly.

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.

Throughout most of the past century, physicians could offer patients no treatments for infections caused by viruses. The experience with treatment of infection by human immunodeficiency virus (HIV) has changed the way healthcare workers deal with viral infections and has triggered a growing rate of discovery and use of antiviral agents, the first fruits of the expanding genomics revolution. HIV treatment also provides an informative paradigm for pharmacogenomics because control of infection and its consequences is limited by the development of viral drug resistance and by host factors. This report summarizes studies published to date on the significance of testing of HIV-1 resistance to antiretroviral drugs. The only Food and Drug Administration-approved kit for HIV drug resistance testing by genotypic sequencing is commercially available through Visible Genetics, Inc. Genotyping sequencing alone is most likely an adequate test to assist in the therapeutic decision-making process for previous regimen failure, for treatment-naïve patients in areas of high prevalence of transmitted resistant virus, and for pregnant women. However, in exceptional cases of highly complex mutation patterns and extensive cross-resistance, it may be useful to obtain a phenotype test, because that result may more easily identify drugs to which virus is least resistant. There are no published clinical trials results on the usefulness of the so-called virtual phenotype over genotypic sequencing alone. Not only has the paradigm of viral pharmacogenomics in the form of HIV genotypic sequencing been useful in treating other viral diseases, but it is also important to the real-life implementation of the growing discipline ofgenomics or molecular medicine. The application of this paradigm to the thousands of potential therapeutic targets that have become available through the various human genome projects will certainly gradually change the landscape of diagnosis and management of many diseases, including cancer.

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it is wise to do so, remains to be seen.

The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

Convinced that armed conflict with the Soviet Union was all but inevitable, that such conflict would involve unconventional atomic, biological, and chemical warfare, and that research with human subjects was essential to respond to the threat, in the early 1950s the U.S. Department of Defense promulgated a policy governing human experimentation based on the Nuremberg Code. Yet the policymaking process focused on the abstract issue of whether human experiments should go forward at all, ignoring the reality of humans subjects research already under way and leaving unanswered ethical questions about how to conduct such research. Documents newly released to the Advisory Committee on Human Radiation Experiments tell the story of the Pentagon policy.

Background: In a previous report of the program of interlaboratory concordancy in the MNIH (Mexican National Institutes of Health) we observed imprecision in nearly half of the analytes assayed by participants B and J., Objectives: 1. To identify possible sources of variation in the analyzers. 2. To take corrective actions and see their effect on precision., Material and Methods: Analyzer B had been operating for 2.5 years and analyzer J for more than ten years (Lab J switched to a new analyzer from a different supplier in the last three months of the study). Both participants submitted their daily results in commercial controls (normal and high). Lab J furnished results for a period of six months (Jul-Sep/92 using the old analyzer, and Oct-Dec using the new one) and Lab B reported five months (it used Jul to change its operating procedure). Lab B assayed 16 analytes (two electrolytes, four enzymes and ten organic analytes) and Lab J 17 (four electrolytes, four enzymes and nine organic). They also agreed to maintain a logbook of any change in calibrators, controls, reagents, analysts, or operating procedures. The information of the first two months was used in a multiple analysis of variance (MANOVA) using the control assays as the dependent variable, and the logbook notations as the independent variables. Precision was expressed as a monthly mean of means of CVs of all analytes., Results: The MANOVA identified two sources of variation in analyzer B: 1) recalibrations (done fortnightly in an effort to improve performance); 2) control flasks. A restriction of calibrations led to an improvement in precision, i.e. from a CV of 5-7% in Aug-Sep to 3-4% in Oct-Dec. In the old analyzer of Lab J, the MANOVA was unable to identify causes of the high imprecision (CVs of 14-19% in Jul-Sep). With the new analyzer, precision improved (CV of 6% in Nov-Dec). Two observations of interest in the new analyzer were: a) a period of familiarization with the apparatus was apparently needed (CV was 11% in Oct); b) imprecision persisted in three analytes (CVs of 11-14% in BUN, calcium, and triglycerides in Nov-Dec). A second MANOVA in this lapse also failed to identify sources of variation for these three analytes., Conclusions: 1. Analyzer B is operating at an acceptable level of precision and can fully participate in our program. 2. The new analyzer of J can participate in the assays of 14 analytes.

Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this level of analysis than about the ethics committee phenomenon itself.

The subject is approached from the standpoint of the debates and events of the "Baby Doe era," from 1982 to 1985. Historic episodes of mass infanticide and practices in other cultures, while often cited as warnings of moral peril, are difficult to apply to the problem of infant euthanasia. Key cases in American courts are reviewed, although no standard pattern of analysis is found to have emerged. The two streams of policy making at the national level, from the Department of Health and Human Services and the Congress, have effectively led back to underlying ethical dilemmas about the proper interpretation of the infant patient's best interests. The conclusion alludes to several issues that neonatal ethics has yet to confront.