Ethical Issues of Recruitment and Enrollment of Critically Ill and Injured Patients for Research

The ethical issues of recruitment and enrollment of critically ill and injured patients into research studies is central to the conduct of nursing research in critical care settings. Nurse scientists can anticipate and plan for the challenges that arise during the recruitment and enrollment of these vulnerable patients into research studies

Seriously Injured Urban Black Men’s Perceptions of Clinical Research Participation

Purpose: Black men are uniquely vulnerable in American society and our health care system: they bear a disproportionate burden of injury, yet are underrepresented in clinical research. This study aimed to explore the reasons why urban Black men with serious injuries chose to participate in clinical research and their concerns about research participation. Methods: This qualitative study was conducted within the context of a larger study focused on psychological effects of serious injury in urban Black men; 83 Black men with serious injuries were recruited while hospitalized in an urban trauma center. Informed consent was obtained. Semi-structured interviews were conducted in participants’ homes three months after discharge from the hospital and were audiotaped, transcribed, and de-identified. Thematic content analysis was used to identify themes about perceptions of participating in clinical research. Results: The mean age of our sample was 38.2 years, and the mean injury severity score was 10.7 (SD 9.6). The majority (53.2 %) of injuries was due to interpersonal violence, and 47 % were due to unintentional mechanisms. Eight reasons for research participation emerged from the data: human connection, altruism/community, self-improvement, compensation, gaining knowledge, curiosity/interest, low risk, and reciprocity. Conclusions: A major finding was that injured urban Black men participated in clinical research for the opportunity for human and therapeutic connection. Despite some expressions of mistrust, participants were willing to participate for altruistic reasons rooted in community priorities, and as part of their recovery process post-injury

Seriously Injured Urban Black Men’s Perceptions of Clinical Research Participation

Purpose: Black men are uniquely vulnerable in American society and our health care system: they bear a disproportionate burden of injury, yet are underrepresented in clinical research. This study aimed to explore the reasons why urban Black men with serious injuries chose to participate in clinical research and their concerns about research participation. Methods: This qualitative study was conducted within the context of a larger study focused on psychological effects of serious injury in urban Black men; 83 Black men with serious injuries were recruited while hospitalized in an urban trauma center. Informed consent was obtained. Semi-structured interviews were conducted in participants’ homes three months after discharge from the hospital and were audiotaped, transcribed, and de-identified. Thematic content analysis was used to identify themes about perceptions of participating in clinical research. Results: The mean age of our sample was 38.2 years, and the mean injury severity score was 10.7 (SD 9.6). The majority (53.2 %) of injuries was due to interpersonal violence, and 47 % were due to unintentional mechanisms. Eight reasons for research participation emerged from the data: human connection, altruism/community, self-improvement, compensation, gaining knowledge, curiosity/interest, low risk, and reciprocity. Conclusions: A major finding was that injured urban Black men participated in clinical research for the opportunity for human and therapeutic connection. Despite some expressions of mistrust, participants were willing to participate for altruistic reasons rooted in community priorities, and as part of their recovery process post-injury

A concept analysis of analgesic nonadherence for cancer pain in a time of opioid crisis

Background Pain is one of the most common symptoms identified along the cancer trajectory. Among patients with moderate to severe cancer pain, nonadherence to prescribed analgesics may complicate treatment plans and exacerbate pain severity. Nonadherent behaviors are likely due to a number of individual/family, provider, and system level factors and may lead to negative pain-related outcomes. Purpose The purpose of this concept analysis is to clarify the concept of analgesic nonadherence for cancer pain and qualify its utility in the context of the opioid crisis. Method Walker and Avant's (2019) method for concept analysis was used. We integrated empirical evidence, relevant literature, and sociopolitical considerations related to the opioid crisis to provide critical and timely analysis. Data were collected from a search of PubMed, CINAHL, PsycINFO, and Scopus. The search yielded 418 individual records. Empirical articles using quantitative and qualitative methodologies pertaining to analgesic nonadherence for cancer pain in adult outpatient settings, written in English, with an abstract, and published between 2010 and 2018 were considered. Other relevant literature sources were used if additional criteria were met. A total of 33 records were selected for detailed review. Findings Few studies link analgesic nonadherence to patient outcomes highlighting a significant literature gap. Given the available evidence, a definition for analgesic nonadherence is proposed for future use in research, education, practice, and policy settings. Discussion The paucity of empirical data combined with the implications of the opioid crisis and conflicting pain management guidelines create uncertainty about the utility of analgesic nonadherence. The concept of analgesic nonadherence warrants further normative and empirical research to clarify the role of opioids and the meaning of nonadherence in shaping pain-related outcomes within the current sociopolitical environment

Density functional calculations of nanoscale conductance

Density functional calculations for the electronic conductance of single molecules are now common. We examine the methodology from a rigorous point of view, discussing where it can be expected to work, and where it should fail. When molecules are weakly coupled to leads, local and gradient-corrected approximations fail, as the Kohn-Sham levels are misaligned. In the weak bias regime, XC corrections to the current are missed by the standard methodology. For finite bias, a new methodology for performing calculations can be rigorously derived using an extension of time-dependent current density functional theory from the Schroedinger equation to a Master equation.Comment: topical review, 28 pages, updated version with some revision

Genetic Variation in the Proximal Promoter of ABC and SLC Superfamilies: Liver and Kidney Specific Expression and Promoter Activity Predict Variation

Membrane transporters play crucial roles in the cellular uptake and efflux of an array of small molecules including nutrients, environmental toxins, and many clinically used drugs. We hypothesized that common genetic variation in the proximal promoter regions of transporter genes contribute to observed variation in drug response. A total of 579 polymorphisms were identified in the proximal promoters (−250 to +50 bp) and flanking 5′ sequence of 107 transporters in the ATP Binding Cassette (ABC) and Solute Carrier (SLC) superfamilies in 272 DNA samples from ethnically diverse populations. Many transporter promoters contained multiple common polymorphisms. Using a sliding window analysis, we observed that, on average, nucleotide diversity (π) was lowest at approximately 300 bp upstream of the transcription start site, suggesting that this region may harbor important functional elements. The proximal promoters of transporters that were highly expressed in the liver had greater nucleotide diversity than those that were highly expressed in the kidney consistent with greater negative selective pressure on the promoters of kidney transporters. Twenty-one promoters were evaluated for activity using reporter assays. Greater nucleotide diversity was observed in promoters with strong activity compared to promoters with weak activity, suggesting that weak promoters are under more negative selective pressure than promoters with high activity. Collectively, these results suggest that the proximal promoter region of membrane transporters is rich in variation and that variants in these regions may play a role in interindividual variation in drug disposition and response

High-resolution CT phenotypes in pulmonary sarcoidosis: a multinational Delphi consensus study

One view of sarcoidosis is that the term covers many different diseases. However, no classification framework exists for the future exploration of pathogenetic pathways, genetic or trigger predilections, patterns of lung function impairment, or treatment separations, or for the development of diagnostic algorithms or relevant outcome measures. We aimed to establish agreement on high-resolution CT (HRCT) phenotypic separations in sarcoidosis to anchor future CT research through a multinational two-round Delphi consensus process. Delphi participants included members of the Fleischner Society and the World Association of Sarcoidosis and other Granulomatous Disorders, as well as members' nominees. 146 individuals (98 chest physicians, 48 thoracic radiologists) from 28 countries took part, 144 of whom completed both Delphi rounds. After rating of 35 Delphi statements on a five-point Likert scale, consensus was achieved for 22 (63%) statements. There was 97% agreement on the existence of distinct HRCT phenotypes, with seven HRCT phenotypes that were categorised by participants as non-fibrotic or likely to be fibrotic. The international consensus reached in this Delphi exercise justifies the formulation of a CT classification as a basis for the possible definition of separate diseases. Further refinement of phenotypes with rapidly achievable CT studies is now needed to underpin the development of a formal classification of sarcoidosis

The genetic architecture of the human cerebral cortex

The cerebral cortex underlies our complex cognitive capabilities, yet little is known about the specific genetic loci that influence human cortical structure. To identify genetic variants that affect cortical structure, we conducted a genome-wide association meta-analysis of brain magnetic resonance imaging data from 51,665 individuals. We analyzed the surface area and average thickness of the whole cortex and 34 regions with known functional specializations. We identified 199 significant loci and found significant enrichment for loci influencing total surface area within regulatory elements that are active during prenatal cortical development, supporting the radial unit hypothesis. Loci that affect regional surface area cluster near genes in Wnt signaling pathways, which influence progenitor expansion and areal identity. Variation in cortical structure is genetically correlated with cognitive function, Parkinson's disease, insomnia, depression, neuroticism, and attention deficit hyperactivity disorder