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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.

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]

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.)

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 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.

Objective: To characterize the mixed-longitudinal craniofacial growth of untreated, white, Class III subjects 6 to 16 years of age., Materials and Methods: Serial cephalograms of 19 females and 23 males with Class III malocclusion were evaluated at three time points (6-8, 10-12, and 14-16 years of age). A similar number of Class I controls were randomly selected and matched for age and sex. The cephalograms were traced and digitized, and 20 variables were evaluated. Growth patterns were quantified, and class and sex differences were evaluated using multi-level analyses., Results: In comparison with Class I subjects, Class III subjects had significantly (P ≤ .05) larger mandibular plane angles, gonial angles, mandibular ramus heights, mandibular corpus lengths, and SNB angles, with differences that were maintained between 6 and 16 years of age. Maxillary lengths and ANB angles were significantly smaller and remained smaller in Class III subjects than in Class I subjects. Lower face height, maxillary-mandibular differential, and mandibular body length were also significantly larger and increased significantly more between 6 and 16 years of age in Class III subjects. The WITS appraisal was significantly smaller in Class III subjects and decreased significantly more over time. Most linear measures showed significant sex differences favoring males; the angular measures and anteroposterior (AP) maxillomandibular relationships showed no sex differences., Conclusions: The AP maxillomandibular relationship of Class III subjects worsens over time. AP discrepancies are primarily due to excessive mandibular growth, which produces a protrusive, hyperdivergent phenotype. The AP discrepancies of males are larger than those of females, with differences increasing over time.

We conducted a cross-sectional study of all exhibit booths for the 24 pharmaceutical companies at the 2002 American Psychiatric Association (APA) convention. We collected and categorized one of each item distributed by the companies at each booth. A total of 268 items were collected from 24 companies (median=8). The most common categories of items were "reprints or pamphlets" (37%) and "noneducational gifts" (27%), including music CDs and invitations to dinners and museums. There were a total of 16 violations of the APA's own exhibit rules: eight companies had one violation and two companies had four violations. Four companies engaged in FDA-prohibited off-label promotion; one also violated the APA code. Over half of all companies (54%) were in violation of either APA rules or FDA regulations. The APA's voluntary code has failed to adequately reduce inappropriate promotional activity at the annual APA meeting.

A high resolution submillimeter interferometer system for measurement of electron densities in the 10(14)-cm(-3)

The present data disagree with earlier suggestions that thrombin's effect on platelets is to cause a decrease in intracellular cyclic 3',5'-adenosine monophosphate. Washed human platelets or platelet-rich plasma were incubated at 37 degrees C with human thrombin. After centrifugation, the supernates were assayed for nucleotides and calcium released. The platelet pellets, and in some experiments the supernates as well, were assayed by radioimmunoassay for intracellular cyclic AMP. In the washed platelet system, increasing doses of thrombin to 0.5 U/cc induced increasing release of nucleotides and calcium. This was accompanied by an average twofold increase in intracellular cyclic AMP levels. Prostaglandin E(1), which inhibited 30-50% of release, induced a four- to fivefold increase in cyclic AMP levels that was additive to the cyclic AMP-stimulatory effect of thrombin. Theophylline, which inhibited only 20-40% of nucleotide release, was synergistic with thrombin in the intracellular accumulation of cyclic AMP. The time-course of cyclic AMP accumulation in response to thrombin was slower than thrombin-induced nucleotide release. Similar findings were made in the platelet-rich plasma system where thrombin stimulation of nucleotide release also resulted in a marked accumulation of intracellular cyclic AMP. Thrombin did not appear to stimulate the release of intracellular cyclic AMP. The mechanism underlying these observations was not apparent. The thrombin had no measurable inhibitory effect on platelet phosphodiesterase activity in either intact washed cells or the platelet homogenate supernates. Furthermore, thrombin inhibited, rather than stimulated, platelet adenyl cyclase activity in both intact washed cells and washed platelet particulate fractions. Of note, however, was the finding that thrombin did not completely inhibit the adenyl cyclase activity of prostaglandin-stimulated cells. Further work is needed to clarify the significance of this observation.Nonetheless, the accumulation of intracellular cyclic AMP in response to thrombin observed in the present study suggests that the antagonistic actions of various agents on the platelet release reaction, thought to underlie platelet function, may depend upon a mechanism more intricate than a straightforward mediation through directly opposite effects on platelet cyclic AMP.