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Sarah Sorscher, Azza AbuDagga, Sammy Almashat, Michael A Carome, Sidney M Wolfe Health Research Group, Public Citizen, Washington, DC, USA Purpose: The Food and Drug Administration (FDA) permits investigators to withhold active interventions from human subjects randomly assigned to control groups in clinical trials. The scope of this practice in trials for life-threatening diseases is unknown. We assessed the frequency and characteristics of trials providing control group subjects with active interventions versus those providing only placebos to control group subjects in trials supporting FDA approvals of new drugs for nine life-threatening diseases. Materials and methods: We reviewed the FDA’s database of approved drug products and identified all new approvals from 2006 to 2011 for drugs or biological products indicated for asthma, bipolar disorder, chronic obstructive pulmonary disease (COPD), diabetes mellitus, hypertension, osteoporosis, Parkinson’s disease, partial seizures, and schizophrenia. Then, we identified all trials described in FDA medical review documents for these approvals and abstracted information on trial characteristics and the interventions provided to control group subjects. Results: Of 508 included trials, 201 (39.6%) were placebo-only-controlled, meaning subjects in at least one control group did not receive an active intervention, and 307 (60.4%) were active-controlled, meaning subjects in all control groups received an active intervention. The total recorded enrollments in control groups provided with placebos only and in control groups provided with active interventions were 19,361 and 93,093 subjects, respectively. The proportion of placebo-only-controlled trials varied across diseases (P

Application of lower hybrid (LH) current drive in tokamak plasmas can induce both co- and countercurrent directed changes in toroidal rotation, depending on the core q profile. For discharges with q(0)

Joint experiment/theory/modelling research has led to increased confidence in predictions of the pedestal height in ITER. This work was performed as part of a US Department of Energy Joint Research Target in FY11 to identify physics processes that control the H-mode pedestal structure. The study included experiments on C-Mod, DIII-D and NSTX as well as interpretation of experimental data with theory-based modelling codes. This work provides increased confidence in the ability of models for peeling-ballooning stability, bootstrap current, pedestal width and pedestal height scaling to make correct predictions, with some areas needing further work also being identified. A model for pedestal pressure height has made good predictions in existing machines for a range in pressure of a factor of 20. This provides a solid basis for predicting the maximum pedestal pressure height in ITER, which is found to be an extrapolation of a factor of 3 beyond the existing data set. Models were studied for a number of processes that are proposed to play a role in the pedestal ne and Te profiles. These processes include neoclassical transport, paleoclassical transport, electron temperature gradient turbulence and neutral fuelling. All of these processes may be important, with the importance being dependent on the plasma regime. Studies with several electromagnetic gyrokinetic codes show that the gradients in and on top of the pedestal can drive a number of instabilities. © 2013 IAEA, Vienna.

Several seemingly unrelated effects in Alcator C-Mod ohmic L-mode plasmas are shown to be closely connected: non-local heat transport, core toroidal rotation reversals, energy confinement saturation and up/down impurity density asymmetries. These phenomena all abruptly transform at a critical value of the collisionality. At low densities in the linear ohmic confinement regime, with collisionality ν* 0.35 (evaluated inside of the q = 3/2 surface), heat transport exhibits non-local behaviour, core toroidal rotation is directed co-current, edge impurity density profiles are up/down symmetric and a turbulent feature in core density fluctuations with kθ up to 15 cm-1 (kθρs ∼ 1) is present. At high density/collisionality with saturated ohmic confinement, electron thermal transport is diffusive, core rotation is in the counter-current direction, edge impurity density profiles are up/down asymmetric and the high k θ turbulent feature is absent. The rotation reversal stagnation point (just inside of the q = 3/2 surface) coincides with the non-local electron temperature profile inversion radius. All of these observations suggest a possible unification in a model with trapped electron mode prevalence at low collisionality and ion temperature gradient mode domination at high collisionality. © 2013 IAEA, Vienna.

Ohmic energy confinement saturation is found to be closely related to core toroidal rotation reversals in Alcator C-Mod tokamak plasmas. Rotation reversals occur at a critical density, depending on the plasma current and toroidal magnetic field, which coincides with the density separating the linear Ohmic confinement regime from the saturated Ohmic confinement regime. The rotation is directed co-current at low density and abruptly changes direction to counter-current when the energy confinement saturates as the density is increased. Since there is a bifurcation in the direction of the rotation at this critical density, toroidal rotation reversal is a very sensitive indicator in the determination of the regime change. The reversal and confinement saturation results can be unified, since these processes occur in a particular range of the collisionality.

Direction reversals of intrinsic toroidal rotation have been observed in diverted Alcator C-Mod Ohmic L-mode plasmas following electron density ramps. For low density discharges, the core rotation is directed cocurrent, and reverses to countercurrent following an increase in the density above a certain threshold. Such reversals occur together with a decrease in density fluctuations with 2 cm(-1)≤k(θ)≤11 cm(-1) and frequencies above 70 kHz. There is a strong correlation between the reversal density and the density at which the Ohmic L-mode energy confinement changes from the linear to the saturated regime.

The authors' data indicate that the L-mode to H-mode transition in the DIII-D tokamak is associated with the sudden reduction in anomalous, fluctuation-connected transport across the outer midplane of the plasma. In addition to the reduction in edge density and magnetic fluctuations observed at the transition, the edge radial electric field becomes more negative after the transition. They have determined the scaling of the H-mode power threshold with various plasma parameters; the roughly linear increase with plasma density and toroidal field are particularly significant. Control of the ELM frequency and duration by adjusting neutral beam input power has allowed us to produce H-mode plasmas with constant impurity levels and durations up to 5 s. Energy confinement time in ohmic H-mode plasmas and in deuterium H-mode plasmas with deuterium beam injection can exceed saturated ohmic confinement times by at least a factor of two. Energy confinement times above 0.3 s have been achieved in these beam-heated plasmas with plasma currents in the range of 2.0 to 2.5 MA. Local transport studies have shown that electron and ion thermal diffusivities and angular momentum diffusivity are comparable in magnitude and all decrease with increasing plasma current.

Context: Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.Objective: To assess the safety of HBBSs in surgical, stroke, and trauma patients.Data Sources: PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.Study Selection: Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.Data Extraction: Data on death and myocardial infarction (MI) as outcome variables.Results: Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P > or = .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.Conclusion: Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI. [ABSTRACT FROM AUTHOR]

Many U.S. military veterans lack health insurance and are ineligible for care in Veterans Administration health care facilities. Using two recently released national government surveys--the 2004 Current Population Survey and the 2002 National Health Interview Survey--the authors examined how many veterans are uninsured (lacking health insurance coverage and not receiving care from the VA) and whether uninsured veterans have problems in access to care. In 2003, 1.69 million military veterans neither had health insurance nor received ongoing care at Veterans Health Administration (VHA) hospitals or clinics; the number of uninsured veterans increased by 235,159 since 2000. The proportion of nonelderly veterans who were uninsured rose from 9.9 percent in 2000 to 11.9 percent in 2003. An additional 3.90 million members of veterans' households were also uninsured and ineligible for VHA care. Medicare covered virtually all Korean War and World War II veterans, but 681,808 Vietnam-era veterans were uninsured (8.7 percent of the 7.85 million Vietnam-era vets). Among the 8.27 million veterans who served during 'other eras' (including the Persian Gulf War), 12.1 percent (999,548) lacked health coverage. A disturbingly high number of veterans reported problems in obtaining needed medical care. By almost any measure, uninsured veterans had as much trouble getting medical care as other uninsured persons. Thus millions of U.S. veterans and their family members are uninsured and face grave difficulties in gaining access to even the most basic medical care. [ABSTRACT FROM AUTHOR]

THE NUMBER OF nurse-midwife-attended births in U.S. hospitals has jumped tenfold in the last 20 years, rising from just 19,686 in 1975 to 196,977 in 1994. Certified nurse-midwives (CNMs) focus on childbirth as a normal event, emphasizing the educational and psychosocial aspects of care and the judicious use of technological interventions. CNM care appears particularly well suited to help solve two difficult problems in U.S. obstetric care-our country's slow progress in improving the health status of newborns and the excessive use of medical interventions during childbirth. Despite the fact that CNM care has been found to be safe and cost-effective, only a small fraction of those pregnant women who could benefit from CNM care use midwifery services. Lack of consumer awareness is part of the problem, but barriers also exist to accessing CNM services. Sixty-four percent of CNM practices responding to a survey reported practice restrictions, most commonly due to state laws, hospital policies, and inappropriately restrictive physician back-up. One state, Florida, is aggressively promoting the use of CNM care as the standard of practice for healthy pregnant women. [ABSTRACT FROM AUTHOR]

Pemphigus represents a spectrum of potentially life-threatening autoimmune-mediated skin blistering conditions caused by antibody production against desmoglein 1 and 3 (anti-DSG 1 and 3) in keratinocytes. Greater than 50% of pemphigus patients experience relapse, which complicates long-term medical management, including risks associated with re-treatment and complications such as infection and dehydration. This review aims to elucidate mechanisms, risk factors, and medications associated with pemphigus relapse. Mechanisms of relapse include the persistence of auto-reactive B-cell populations post-treatment and CD20- B-cell populations that reactivate after B-cell depletion therapy. Risk factors for relapse include high body surface area (BSA) of pemphigus involvement, high body mass index, high severity according to the Pemphigus Disease Area Index (PDAI) at onset, treatment delay, and high anti-DSG1 and DSG3 titers post-treatment. Targeted B-cell localization is associated with better clinical outcomes, including less frequent relapses. Rituximab is currently the gold standard of treatment for moderate-severe pemphigus and has relapse rates of 11%-44% in selected studies, with a mean time to relapse of 5.8 months to 36 months following treatment. Relapse rates across lymphoma dosing (375 mg/m 2 ) versus rheumatoid arthritis dosing (1 g dosing weekly) was inconsistent; however, more frequent dosing, earlier treatment, and higher cumulative dosing were associated with lower relapse rates. Alternative agents that have clinical efficacy include corticosteroid monotherapy, mycophenolate mofetil, azathioprine, and intravenous immunoglobulin. Future studies should include head-to-head comparators over long follow-up periods to identify the best treatment agents associated with the least relapse risk., (© 2024 The Author(s). The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)

This study underscores the persistent underrepresentation of women in academic dermatology leadership positions by examining the gender composition of editorial boards across top dermatology journals, emphasizing the urgent need for proactive strategies to promote diversity, equity, and inclusion., (©Mindy D Szeto, Torunn E Sivesind, Lori S Kim, Katie A O’Connell, Kathryn A Sprague, Yvonne Nong, Daniel M Strock, Annie L Cao, Jieying Wu, Lauren M Toledo, Sophia M Wolfe, Wyatt Boothby-Shoemaker, Robert P Dellavalle. Originally published in JMIR Dermatology (http://derma.jmir.org), 21.05.2024.)

Nursing professional development (NPD) directors and practitioners are called to lead practice changes. Knowledge of implementation science and diffusion theory equips NPD professionals with the tools necessary for successfully influencing nursing practice. This article analyzes a multisite implementation of the tiered skills acquisition model for clinical orientation and provides NPD directors and practitioners with recommendations for effective implementation strategies that translate beyond clinical orientation to a variety of NPD programs and initiatives. [ J Contin Educ Nurs. 2024;55(3):130-136.] .

Nursing professional development practitioners rely on nurse preceptors to guide the development of nursing staff and students. A lack of experienced preceptors may require individuals who have limited to no experience in precepting to serve in the preceptor role. Nursing professional development practitioners should be prepared to effectively support and develop novice preceptors. This article analyzes the development and implementation of a novel educational resource that assists the novice preceptor in facilitating nursing student clinicals., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Wikipedia is one of the most popular websites and may be a go-to source of health and dermatology education for the general population. Prior research indicates poor skin of color (SOC) photo representation in printed dermatology textbooks and online medical websites, but there has been no such assessment performed to determine whether this discrepancy also exists for Wikipedia., Objective: The aim of this study was to investigate the number and quality of SOC photos included in Wikipedia's skin disease pages and to explore the possible ramifications of these findings., Methods: Photos of skin diseases from Wikipedia's "List of Skin Conditions" were assigned by three independent raters as SOC or non-SOC according to the Fitzpatrick system, and were given a quality rating (1-3) based on sharpness, size/resolution, and lighting/exposure., Results: We identified 421 skin disease Wikipedia pages and 949 images that met our inclusion criteria. Within these pages, 20.7% of images of skin diseases (196 of 949 images) were SOC and 79.3% (753 of 949 images) were non-SOC (P<.001). There was no difference in the average quality for SOC (2.05) and non-SOC (2.03) images (P=.81). However, the photo quality criteria utilized (sharpness, size/resolution, and lighting/exposure) did not capture all aspects of photo quality. Another limitation of this analysis is that the Fitzpatrick skin typing system is prone to subjectivity and was not originally intended to be utilized as a non-self SOC metric., Conclusions: There is SOC underrepresentation in the gross number of SOC images for dermatologic conditions on Wikipedia. Wikipedia pages should be updated to include more SOC photos to mend this divide to ameliorate access to accurate dermatology information for the general public and improve health equity within dermatology., (©William Kim, Sophia M Wolfe, Caterina Zagona-Prizio, Robert P Dellavalle. Originally published in JMIR Dermatology (http://derma.jmir.org), 16.07.2021.)

Objective: In 2018, the Network of the National Libraries of Medicine (NNLM) launched a sponsorship program to support public library staff in completing the Medical Library Association's Consumer Health Information Specialization (CHIS). The objectives of our study were to: (1) determine whether completion of the sponsored specialization improved ability to provide consumer health information; (2) identify new health information services, programming, and outreach activities at public libraries; (3) investigate benefits of the specialization; and (4) determine the impact of sponsorship on obtaining and continuing the specialization., Methods: We used REDCap to administer a 16-question survey in August 2019 to 224 public library staff who were sponsored during the first year of the program. We measured competence in providing consumer health information aligned with the eight Core Competencies for Providing Consumer Health Information Services [1] as well as new activities at public libraries, benefits of the specialization to public library staff, career gains, and the likelihood of continuing the specialization based on funding., Results: More than 80% of 136 participants reported an increase in core consumer health competencies, with a statistically significant improvement in mean competency scores after completing the specialization. Ninety percent of participants have continued their engagement with NNLM, and more than half offered new health information programs and services. While more than half planned to renew the specialization or obtain the Level II specialization, 72% indicated they would not continue without NNLM sponsorship., Conclusions: Findings indicate that NNLM sponsorship of the CHIS specialization was successful in increasing the capacity of public library staff to provide health information to their communities., (Copyright © 2021 Elizabeth Kiscaden, Michele Spatz, Susan Wolfe, MollyKnapp, Erica Lake.)

Despite the strict prohibition against all forms of sexual relations between physicians and their patients, some physicians cross this bright line and abuse their patients sexually. The true extent of sexual abuse of patients by physicians in the U.S. health care system is unknown. An analysis of National Practitioner Data Bank reports of adverse disciplinary actions taken by state medical boards, peer-review sanctions by institutions, and malpractice payments shows that a very small number of physicians have faced "reportable" consequences for this unethical behavior. However, physician self-reported data suggest that the problem occurs at a higher rate. We discuss the factors that can explain why such sexual abuse of patients is a persistent problem in the U.S. health care system. We implore the medical community to begin a candid discussion of this problem and call for an explicit zero-tolerance standard against sexual abuse of patients by physicians. This standard must be coupled with regulatory, institutional, and cultural changes to realize its promise. We propose initial recommendations toward that end.

Objective: The objective of this study was to examine nurse sexual-misconduct-related reports in the National Practitioner Data Bank (NPDB) and to compare them with reports for other types of offenses., Design and Population: We analyzed NPDB's reports of adverse state nursing board licensure actions and malpractice payments for all nurses from January 1, 2003, to June 30, 2016., Results: Overall, 882 nurses had sexual-misconduct-related reports. Most were aged 35-54 (63.2%), male (63.2%), and registered or advanced practice nurses (61.5%). The disciplinary actions noted in the 988 nurse sexual-misconduct-related licensure reports were more frequently serious than those noted in the 207,023 reports for other offenses committed by nurses (90.8% vs. 74.8%, respectively; p < 0.001). Of the 33 nurses with sexual-misconduct-related malpractice-payment reports, 48.5% were not disciplined by any state board of nursing for these offenses. Three-quarters of the victims in the 47 sexual-misconduct-related malpractice-payment reports were female, with "emotional injury only" reported as the severity of injury in 91.5% of these reports., Conclusions: Very few nurses have been reported to the NPDB due to sexual misconduct. We welcome a zero-tolerance standard against sexual misconduct involving patients by all types of health care professionals, including nurses., (© 2018 Public Citizen Foundation. Public Health Nursing Published by Wiley Periodicals, Inc.)

Calibration is a crucial procedure in electron temperature (T e ) inference from a typical electron cyclotron emission (ECE) diagnostic on tokamaks. Although the calibration provides an important multiplying factor for an individual ECE channel, the parameter ΔT e /T e is independent of any calibration. Since an ECE channel measures the cyclotron emission for a particular flux surface, a non-perturbing change in toroidal magnetic field changes the view of that channel. Hence the calibration-free parameter is a measure of T e gradient. B T -jog technique is presented here which employs the parameter and the raw ECE signals for direct measurement of electron temperature gradient scale length.

Objective: The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care., Design/participants/setting: PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions., Results: While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care., Conclusions: SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these differences, are essential elements of adequate informed consent.

Background: Little information exists on U.S. physicians who have been disciplined with licensure or restriction-of-clinical-privileges actions or have had malpractice payments because of sexual misconduct. Our objectives were to: (1) determine the number of these physicians and compare their age groups' distribution with that of the general U.S. physician population; (2) compare the type of disciplinary actions taken against these physicians with actions taken against physicians disciplined for other offenses; (3) compare the characteristics and type of injury among victims of these physicians with those of victims in reports for physicians with other offenses in malpractice-payment reports; and (4) determine the percentages of physicians with clinical-privileges or malpractice-payment reports due to sexual misconduct who were not disciplined by medical boards., Methods and Results: We conducted a cross-sectional analysis of physician reports submitted to the National Practitioner Data Bank (NPDB) from January 1, 2003, through September 30, 2013. A total of 1039 physicians had ≥ 1 sexual-misconduct-related reports. The majority (75.6%) had only licensure reports, and 90.1% were 40 or older. For victims in malpractice-payment reports, 87.4% were female, and "emotional injury only" was the predominant type of injury. We found a higher percentage of serious licensure actions and clinical-privileges revocations in sexual-misconduct-related reports than in reports for other offenses (89.0% vs 68.1%, P = < .001, and 29.3% vs 18.8%, P = .002, respectively). Seventy percent of the physicians with a clinical-privileges or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this problem., Conclusions: A small number of physicians were reported to the NPDB because of sexual misconduct. It is concerning that a majority of the physicians with a clinical-privileges action or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this unethical behavior.

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently., (Project HOPE—The People-to-People Health Foundation, Inc.)

This article demonstrates the application of community psychology practice competencies to health disparities reduction. It begins with a discussion of changes and evolution of the maternal child health field over nearly three decades, then describes implications for community psychology practice and the application of practice competencies.