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Serious and continuing research noncompliance and integrity violations undermine the quality of research and trust in science. When researchers engage in these behaviors, institutional officials (IOs) often develop corrective action plans. Ideally, such plans address the root causes so noncompliance or research integrity violations discontinue. The aim of this study was to identify what IOs perceive as causes and action plan activities typically prescribed. We conducted semi-structured in-depth interviews with 47 IOs at research institutions across the U.S. including: institutional review board and institutional animal care and use committee chairs and directors, chief research officers, research compliance and integrity officers, and institutional conflicts of interest chairs and directors. The most common root causes identified were: 1) lack of knowledge or training, 2) failure to provide research team supervision, and 3) researcher attitudes toward compliance. The most common action plan activities include: 1) retraining in compliance or research integrity, 2) follow-up and hands-on involvement with the researcher, and 3) mandated oversight or mentoring. Because the most commonly identified action plan activities fail to adequately address the majority of root causes, our findings suggest a need for IOs to rethink existing approaches to action plan development to more effectively target root causes.

Background: Effective leadership and management practices contribute to responsible, high-quality research and the well-being of team members. We describe the development and initial validation of a measure assessing principal investigators' leadership and management practices and a measure of research team practices., Methods: Using a cross-sectional survey design, 570 postdoctoral researchers funded by the National Institutes of Health reported on the perceived behaviors of their principal investigator (PI) and the research team. The PI leadership and management items factored into two dimensions: fostering relationships and directing research., Results: Correlations of these new scales with existing, validated measures of ethical leadership and general leader behavior provided evidence of convergent validity. Providing evidence for criterion-related validity, scores on the new measures predicted lab climate for research ethics, self-reported productivity, and job satisfaction. Research team practices provided additional predictive value beyond leadership and management behaviors., Conclusions: This study provides construct validity evidence for the new Leadership and Management in Science (LAMPS) Measure and the Research Team Practices (RTP) Measure. Qualitative responses to an open-ended item reinforced the importance of relationships and directive supervision for a positive environment. These measures can be useful tools for future research or may be useful for PIs seeking feedback about their practices.

Introduction: Research has provided novel insights into how light stimulates circadian rhythms through specialised retinal ganglion cells to the suprachiasmatic nucleus. In addition, there has been a revolution in light-emitting diode (LED) technology, leading to tunable LED light sources and lighting systems, enabling 24-hour dynamic light scenarios with bright blue-enriched short wavelength light during the day and dim evening light, stimulating the circadian system. These dynamic LED lighting systems are now being implemented at hospitals without adequate understanding of how it may affect the health and well-being of patients and staff., Methods and Analysis: An optimised dynamic LED lighting scenario is investigated at a newly built psychiatric hospital in Copenhagen. In the 12 months baseline period, a standard lighting scenario with dynamic colour temperature and fixed light intensity is investigated. In the following 12-month intervention period, a new DEL scenario is investigated, having dynamic colour temperature as well as dynamic light intensity with a higher daytime and lower evening-time melanopic daylight equivalent illuminance. This setting is furthermore adjusted for geographical orientation to compensate for differences in sunlight access in wintertime. The study uses a quasiexperimental design comparing patients admitted in the two study periods. Prior to each of the study periods, daylight and the contribution from the LED-lighting scenarios was measured. Patient sociodemographic and mental health data will be retrieved retrospectively from electronic medical records and by questionnaires administered in the two periods, evaluating lighting, noise, sleep quality and quality of life. Primary outcome is the proportion of patients receiving pro re nata medications. Secondary outcomes are the length of stay, sleep onset latency, sleep quality and quality of life., Ethics and Dissemination: No ethical issues are expected. The results will be disseminated through peer-reviewed international journal, lectures, posters and interviews., Trial Registration Number: NCT05868291., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Clinical trials for upcoming disease-modifying therapies of spinocerebellar ataxias (SCA), a group of rare movement disorders, lack endpoints sensitive to early disease progression, when therapeutics will be most effective. In addition, regulatory agencies emphasize the importance of biological outcomes., Objectives: READISCA, a transatlantic clinical trial readiness consortium, investigated whether advanced multimodal magnetic resonance imaging (MRI) detects pathology progression over 6 months in preataxic and early ataxic carriers of SCA mutations., Methods: A total of 44 participants (10 SCA1, 25 SCA3, and 9 controls) prospectively underwent 3-T MR scanning at baseline and a median [interquartile range] follow-up of 6.2 [5.9-6.7] months; 44% of SCA participants were preataxic. Blinded analyses of annual changes in structural, diffusion MRI, MR spectroscopy, and the Scale for Assessment and Rating of Ataxia (SARA) were compared between groups using nonparametric testing. Sample sizes were estimated for 6-month interventional trials with 50% to 100% treatment effect size, leveraging existing large cohort data (186 SCA1, 272 SCA3) for the SARA estimate., Results: Rate of change in microstructural integrity (decrease in fractional anisotropy, increase in diffusivities) in the middle cerebellar peduncle, corona radiata, and superior longitudinal fasciculus significantly differed in SCAs from controls (P < 0.005), with high effect sizes (Cohen's d = 1-2) and moderate-to-high responsiveness (|standardized response mean| = 0.6-0.9) in SCAs. SARA scores did not change, and their rate of change did not differ between groups., Conclusions: Diffusion MRI is sensitive to disease progression at very early-stage SCA1 and SCA3 and may provide a >5-fold reduction in sample sizes relative to SARA as endpoint for 6-month-long trials. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society., (© 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)

Cognitive and Behavioural Therapy for Insomnia (CBT-I) is the gold standard treatment for chronic insomnia, with one crucial step being the restriction of time spent in bed. This restriction often intensifies early afternoon sleepiness, leading to a natural gateway for a short recuperative nap, which might foster adherence to CBT-I over time. In practice, mental health professionals providing CBT-I lack consensus on whether or not to tolerate short naps during the CBT-I period for requesting patients. In this pilot study, we examined the effects of authorised napping on CBT-I efficiency in patients with insomnia (a napping group was compared with a matched non-napping group, n = 108). We report that napping enhanced early afternoon alertness and importantly did not affect CBT-I-mediated improvements in the Insomnia Severity Index and Beck Depression Inventory-2 and in self-reported sleep efficiency, latency, and wake after sleep onset (assessed by the sleep diaries). Further investigations using objective methods of sleep assessments are now needed to confirm that napping behaviour does not compromise the improvements enabled by CBT-I and may even strengthen adherence to the treatment., (© 2024 The Author(s). Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Combativeness is a social illness. We are surrounded by culture wars over abortion, vaccine mandates, transgender care, how we die, and even how we define death. The problem is not that we disagree, but how we disagree: too often, with anger, aggression, and a sense of urgency to win against the other. Bioethicists have the knowledge and skills needed to model constructive disagreement and respectful calls for change. Bioethicists may have increased awareness that everyone suffers from unconscious self-serving biases-we are all imperfect. They are trained to recognize competing values and to engage in processes of balancing values in social contexts. Clinical ethicists are additionally trained in mediation, which involves acknowledging goodwill, listening deeply, apologizing when needed, and seeking common ground. In short, bioethicists have many of the tools needed to be healers of a culture afflicted with combativeness., (© 2024 The Hastings Center.)

Youth prefer to be involved in treatment decisions, yet youth participation is minimally present in decisions like stem cell transplant (SCT) that require frequent medications and social isolation to be successful in curing cancer and chronic illness. The purpose of our study is to identify the barriers and facilitators to youth decision-making involvement in the youth-parent interaction when referred for treatment with SCT. We report qualitative findings from our theory-driven mixed-methods study. We thematically analyzed our field notes of youth and parent observations and audio-recordings during SCT consultations and semi-structured interviews. Data were collected from 10 youth, 8 to 16 (median 12) years of age, and their parents ( n = 20). Three themes emerged: (a) Reluctant unless motivated, (b) Uncertain but capable, and (c) Limited unless supported. Our findings emphasize the critical role parents may take in facilitating youth involvement in decisions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication or this article.

Objective: We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats., Results: Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects., (© 2024. The Author(s).)

Objective: To identify perceived benefits, problems, facilitators, and barriers to adolescent online patient portal use., Study Design: Qualitative, semi-structured interviews with dyads of parents and adolescents with or without chronic illness. The study team purposively sampled for racial and ethnic minorities and fathers. Three team members then performed thematic analysis of the transcripts, with subsequent dyadic analysis of themes represented by related parents and adolescents., Results: We performed 102 interviews with 51 dyads of parents and adolescents (26 with chronic illness, 25 without chronic illness). Nearly all participants believed that adolescents should be permitted portal access. We identified 4 themes related to portal benefits: improves adolescent's knowledge of health; supports medical self-management and autonomy; strengthens communication and relationships; and supports parental influence. We identified 4 themes related to portal problems: misunderstanding or confusion; emotional distress; strain on relationships; and irresponsible use of portal. Facilitators of portal use included severity of illness, adolescent's curiosity, and ease of technology use. Barriers included lack of awareness or interest, complexity of information, and access difficulties. Twenty adolescents (39%) did not know they could access the portal, and 23 (45%) lacked interest in portals. Parents and adolescents seldom used the portal as a collaborative tool, and instead were engaging with the portal independently., Conclusion: Parents and adolescents perceive several benefits and problems with portal use, but many adolescents lack interest in using portals. Adolescent portals represent an underutilized resource to engage adolescents in their care., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The association between the administration of sodium-glucose cotransporter 2 inhibitors (SGLT2is) during acute kidney injury (AKI) and the incidence of major adverse kidney events (MAKEs) is not known., Methods: This retrospective cohort study included patients with AKI and compared the outcomes for those who were treated with SGLT2is during hospitalization and those without SGLT2i treatment. The associations of SGLT2i use with MAKEs at 10 and 30-90 days, each individual MAKE component, and the pre-specified patient subgroups were analyzed., Results: From 2021 to 2023, 374 patients were included in the study-316 without SGLT2i use and 58 with SGLT2i use. Patients who were treated with SGLT2is were older; had a greater prevalence of diabetes, hypertension, chronic heart failure, and chronic kidney disease; required hemodialysis less often; and presented stage 3 AKI less frequently than those who were not treated with SGLT2is. Logistic regression analysis with nearest-neighbor matching revealed that SGLT2i use was not associated with the risk of MAKE10 (OR 1.08 [0.45-2.56]) or with MAKE30-90 (OR 0.76 [0.42-1.36]). For death, the stepwise approach demonstrated that SGLT2i use was associated with a reduced risk (OR 0.08; 0.01-0.64), and no effect was found for kidney replacement therapy (KRT). The subgroups of patients who experienced a reduction in the risk of MAKEs in patients with AKI treated with SGLT2is were those older than 61 years, those with an eGFR >81, and those without a history of hypertension or DM ( p ≤ 0.05 for all)., Conclusion: The use of SGLT2is during AKI had no effect on short- or medium-term MAKEs, but some subgroups of patients may have experienced benefits from SGLT2i treatment., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Alcantar-Vallin, Zaragoza, Díaz-Villavicencio, Hernandez-Morales, Camacho-Guerrero, Perez-Venegas, Carmona-Morales, Oseguera-Gonzalez, Murguia-Soto, Chávez-Alonso, Arredondo-Dubois, Orozco-Chan, Gómez-Fregoso, Rodríguez-García, Navarro-Blackaller, Medina-González, Martínez Gallardo-González, Abundis-Mora, Vega-Vega, García-García and Chávez-Iñiguez.)

Background : A person's cultural background shapes how they interpret and navigate problems. Given that large numbers of international researchers work and train in the U.S. we sought to better understand how researchers use the decision-making strategy of seeking help to navigate ethical and professional challenges. Methods : Participants ( N  = 300) were researchers working or training in the U.S. who were born in East Asia (EA) or born in the U.S. They completed a screening survey; then a subset completed think-aloud interviews ( n  = 66) focused on how they would respond to three hypothetical research scenarios. Results : Thematic analysis of the transcripts showed that seeking help was a commonly endorsed strategy, with some nuances between groups. Themes included seeking help in the form of getting advice, seeking someone to help solve the problem, and gathering information. Endorsement of the seeking help strategy frequently depended on participants' relationships; desiring to seek help from people they trusted. Notably, EA participants tended to prefer seeking help in ways that avoided reputational harm to others. Conclusion : A better understanding of how researchers from different cultural backgrounds use decision-making strategies can inform how to make educational programs more inclusive and comprehensive to more effectively develop researchers' ethical and professional decision-making skills.

Background: Major depressive disorder (MDD) is a debilitating condition that affects more than 300 million people worldwide. Current treatments are based on a trial-and-error approach, and reliable biomarkers are needed for more informed and personalized treatment solutions. One of the potential biomarkers, gamma-frequency (30-80 Hz) brainwaves, are hypothesized to originate from the excitatory-inhibitory interaction between the pyramidal cells and interneurons. The imbalance between this interaction is described as a crucial pathological mechanism in neuropsychiatric conditions, including MDD, and the modulation of this pathological interaction has been investigated as a potential target. Previous studies attempted to induce gamma activity in the brain using rhythmic light and sound stimuli (GENUS - Gamma Entrainment Using Sensory stimuli) that resulted in neuroprotective effects in Alzheimer's disease (AD) patients and animal models. Here, we investigate the antidepressant, cognitive, and electrophysiological effects of the novel light therapy approach using 40 Hz masked flickering light for patients diagnosed with MDD., Methods and Design: Sixty patients with a current diagnosis of a major depressive episode will be enrolled in a randomized, double-blinded, placebo-controlled trial. The active treatment group will receive 40 Hz masked flickering light stimulation while the control group will receive continuous light matched in color temperature and brightness. Patients in both groups will get daily light treatment in their own homes and will attend four follow-up visits to assess the symptoms of depression, including depression severity measured by Hamilton Depression Rating Scale (HAM-D 17 ), cognitive function, quality of life and sleep, and electroencephalographic changes. The primary endpoint is the mean change from baseline to week 6 in depression severity (HAM-D 6 subscale) between the groups.

Background: Apolipoprotein L1 (ApoL1) variants G1 and G2 are associated with a higher risk of kidney disease. ApoL1 risk variants are predominantly seen in individuals with sub-Saharan African ancestry. In most transplant centers, potential organ donors are being selectively genetically tested for ApoL1 risk variants. Transplant programs have highly variable ApoL1 testing practices and need guidance on essential ApoL1 clinical policy questions., Methods: We conducted a Delphi consensus panel focused on ApoL1 clinical policy questions, including who gets tested, who decides whether testing occurs, how test results are shared, who receives test results, and how test results are used. A total of 27 panelists across seven stakeholder groups participated: living kidney donors ( n =4), deceased donor family members ( n =3), recipients of a deceased donor kidney ( n =4), recipients of a living donor kidney ( n =4), nephrologists ( n =4), transplant surgeons ( n =4), and genetic counselors ( n =4). Nineteen panelists (70%) identified as Black. The Delphi panel process involved two rounds of educational webinars and three rounds of surveys administered to panelists, who were asked to indicate whether they support, could live with, or oppose each policy option., Results: The panel reached consensus on one or more acceptable policy options for each clinical policy question; panelists supported 18 policy options and opposed 15. Key elements of consensus include the following: ask potential donors about African ancestry rather than race; make testing decisions only after discussion with donors; encourage disclosure of test results to blood relatives and organ recipients but do not require it; use test results to inform decision making, but never for unilateral decisions by transplant programs., Conclusions: The panel generally supported policy options involving discussion and shared decision making among patients, donors, and family stakeholders. There was general opposition to unilateral decision making and prohibiting donation altogether., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology.)

Insomnia: DEFINITIONS, EPIDEMIOLOGY AND CHANGES WITH AGE. Chronic insomnia is a disorder defined as a subjective complaint relating to the quality and/or quantity of sleep associated with daytime impact, and which must be present 3 nights per week for a period of at least 3 months. This is a common sleep problem in the general population and represents a significant proportion of reasons for consultation in the general practice. It requires early identification at all ages of life to allow the establishment of adequate care, which will have the benefit of both improving the quality of life of these patients in the short term and preventing the consequences of chronic insomnia., Competing Interests: J. M. Dubois déclare n’avoir aucun lien d’intérêts. A. Rouen déclare avoir été pris en charge, à l’occasion de déplacements pour congrès, par Asten. D. Léger déclare avoir participé à des interventions ponctuelles pour Idorsia, BioSerenity, Vanda Pharma, iSommeil, Sanofi et avoir été pris en charge, à l’occasion de déplacements pour congrès, par Linde, SOS Oxygène et VitalAire.