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Direct-to-consumer (DTC) genetic testing has raised questions about the accuracy of the test results, which may raise potential novel liability issues. This chapter examines potential liability exposures relating to DTC genetic testing in two main contexts. The first is potential liability for the DTC provider itself for erroneous results. Key issues in such cases will be the validity and effect of the representations and disclosures that the DTC company provides, which often informs the consumer that the results should not be relied on for medical care, disclaim any liability for any harms that may result from such reliance, and require any disputes to be resolved by mandatary arbitration. The second potential type of case is against health care providers who are presented with DTC results by their patients. Providers will often be put in a “damned if they do, damned if they don’t” predicament by such results, as both ignoring or relying on the DTC test results could create potential liabilities in certain situations. While providers can usually protect themselves by requiring validation of the DTC results by an independent laboratory, time and economic constraints may make this infeasible in some cases.
The study investigates sex differences in the prevalence of undernutrition in sub-Saharan Africa. Undernutrition was defined by Z-scores using the CDC-2000 growth charts. Some 128 Demographic and Health Surveys (DHS) were analysed, totalling 700,114 children under-five. The results revealed a higher susceptibility of boys to undernutrition. Male-to-female ratios of prevalence averaged 1.18 for stunting (height-for-age Z-score <−2.0); 1.01 for wasting (weight-for-height Z-score <−2.0); 1.05 for underweight (weight-for-age Z-score <−2.0); and 1.29 for concurrent wasting and stunting (weight-for-height and height-for-age Z-scores <−2.0). Sex ratios of prevalence varied with age for stunting and concurrent wasting and stunting, with higher values for children age 0–23 months and lower values for children age 24–59 months. Sex ratios of prevalence tended to increase with declining level of mortality for stunting, underweight and concurrent wasting and stunting, but remained stable for wasting. Comparisons were made with other anthropometric reference sets (NCHS-1977 and WHO-2006), and the results were found to differ somewhat from those obtained with CDC-2000. Possible rationales for these patterns are discussed.
Antisociality across adolescence and young adulthood puts individuals at high risk of developing a variety of problems. Prior research has linked antisociality to autonomic nervous system and endocrinological functioning. However, there is large heterogeneity in antisocial behaviors, and these neurobiological measures are rarely studied conjointly, limited to small specific studies with narrow age ranges, and yield mixed findings due to the type of behavior examined.
We harmonized data from 1489 participants (9–27 years, 67% male), from six heterogeneous samples. In the resulting dataset, we tested relations between distinct dimensions of antisociality and heart rate, pre-ejection period (PEP), respiratory sinus arrhythmia, respiration rate, skin conductance levels, testosterone, basal cortisol, and the cortisol awakening response (CAR), and test the role of age throughout adolescence and young adulthood.
Three dimensions of antisociality were uncovered: ‘callous-unemotional (CU)/manipulative traits’, ‘intentional aggression/conduct’, and ‘reactivity/impulsivity/irritability’. Shorter PEPs and higher testosterone were related to CU/manipulative traits, and a higher CAR is related to both CU/manipulative traits and intentional aggression/conduct. These effects were stable across age.
Across a heterogeneous sample and consistent across development, the CAR may be a valuable measure to link to CU/manipulative traits and intentional aggression, while sympathetic arousal and testosterone are additionally valuable to understand CU/manipulative traits. Together, these findings deepen our understanding of the fundamental mechanisms underlying different components of antisociality. Finally, we illustrate the potential of using current statistical techniques for combining multiple datasets to draw robust conclusions about biobehavioral associations.
Studying phenotypic and genetic characteristics of age at onset (AAO) and polarity at onset (PAO) in bipolar disorder can provide new insights into disease pathology and facilitate the development of screening tools.
To examine the genetic architecture of AAO and PAO and their association with bipolar disorder disease characteristics.
Genome-wide association studies (GWASs) and polygenic score (PGS) analyses of AAO (n = 12 977) and PAO (n = 6773) were conducted in patients with bipolar disorder from 34 cohorts and a replication sample (n = 2237). The association of onset with disease characteristics was investigated in two of these cohorts.
Earlier AAO was associated with a higher probability of psychotic symptoms, suicidality, lower educational attainment, not living together and fewer episodes. Depressive onset correlated with suicidality and manic onset correlated with delusions and manic episodes. Systematic differences in AAO between cohorts and continents of origin were observed. This was also reflected in single-nucleotide variant-based heritability estimates, with higher heritabilities for stricter onset definitions. Increased PGS for autism spectrum disorder (β = −0.34 years, s.e. = 0.08), major depression (β = −0.34 years, s.e. = 0.08), schizophrenia (β = −0.39 years, s.e. = 0.08), and educational attainment (β = −0.31 years, s.e. = 0.08) were associated with an earlier AAO. The AAO GWAS identified one significant locus, but this finding did not replicate. Neither GWAS nor PGS analyses yielded significant associations with PAO.
AAO and PAO are associated with indicators of bipolar disorder severity. Individuals with an earlier onset show an increased polygenic liability for a broad spectrum of psychiatric traits. Systematic differences in AAO across cohorts, continents and phenotype definitions introduce significant heterogeneity, affecting analyses.
The coronavirus disease 2019 (COVID-19) pandemic has resulted in shortages of personal protective equipment (PPE), underscoring the urgent need for simple, efficient, and inexpensive methods to decontaminate masks and respirators exposed to severe acute respiratory coronavirus virus 2 (SARS-CoV-2). We hypothesized that methylene blue (MB) photochemical treatment, which has various clinical applications, could decontaminate PPE contaminated with coronavirus.
The 2 arms of the study included (1) PPE inoculation with coronaviruses followed by MB with light (MBL) decontamination treatment and (2) PPE treatment with MBL for 5 cycles of decontamination to determine maintenance of PPE performance.
MBL treatment was used to inactivate coronaviruses on 3 N95 filtering facepiece respirator (FFR) and 2 medical mask models. We inoculated FFR and medical mask materials with 3 coronaviruses, including SARS-CoV-2, and we treated them with 10 µM MB and exposed them to 50,000 lux of white light or 12,500 lux of red light for 30 minutes. In parallel, integrity was assessed after 5 cycles of decontamination using multiple US and international test methods, and the process was compared with the FDA-authorized vaporized hydrogen peroxide plus ozone (VHP+O3) decontamination method.
Overall, MBL robustly and consistently inactivated all 3 coronaviruses with 99.8% to >99.9% virus inactivation across all FFRs and medical masks tested. FFR and medical mask integrity was maintained after 5 cycles of MBL treatment, whereas 1 FFR model failed after 5 cycles of VHP+O3.
MBL treatment decontaminated respirators and masks by inactivating 3 tested coronaviruses without compromising integrity through 5 cycles of decontamination. MBL decontamination is effective, is low cost, and does not require specialized equipment, making it applicable in low- to high-resource settings.
We surveyed infectious disease specialists about early COVID-19 vaccination preparedness. Almost all respondents’ institutions rated their facility’s preparedness plan as either excellent or adequate. Vaccine hesitancy and concern about adverse reactions were the most common anticipated barriers to COVID-19 vaccination. Only 60% believed currently that COVID-19 vaccination should be mandatory.
In recent years, a variety of efforts have been made in political science to enable, encourage, or require scholars to be more open and explicit about the bases of their empirical claims and, in turn, make those claims more readily evaluable by others. While qualitative scholars have long taken an interest in making their research open, reflexive, and systematic, the recent push for overarching transparency norms and requirements has provoked serious concern within qualitative research communities and raised fundamental questions about the meaning, value, costs, and intellectual relevance of transparency for qualitative inquiry. In this Perspectives Reflection, we crystallize the central findings of a three-year deliberative process—the Qualitative Transparency Deliberations (QTD)—involving hundreds of political scientists in a broad discussion of these issues. Following an overview of the process and the key insights that emerged, we present summaries of the QTD Working Groups’ final reports. Drawing on a series of public, online conversations that unfolded at www.qualtd.net, the reports unpack transparency’s promise, practicalities, risks, and limitations in relation to different qualitative methodologies, forms of evidence, and research contexts. Taken as a whole, these reports—the full versions of which can be found in the Supplementary Materials—offer practical guidance to scholars designing and implementing qualitative research, and to editors, reviewers, and funders seeking to develop criteria of evaluation that are appropriate—as understood by relevant research communities—to the forms of inquiry being assessed. We dedicate this Reflection to the memory of our coauthor and QTD working group leader Kendra Koivu.1
Achieving gender equality fundamentally requires a transfer of power from men to women. Yet data on men's support for women's empowerment (WE) remains scant and limited by reliance on self-report methodologies. Here, we examine men's support for WE as a sexual conflict trait, both via direct surveys (n = 590) and indirectly by asking men's wives (n = 317) to speculate on their husband's views. Data come from a semi-urban community in Mwanza, Tanzania. Consistent with reduced resource competition and increased exposure to relatively egalitarian gender norms, higher socioeconomic status predicted greater support for WE. However, potential demographic indicators of sexual conflict (high fertility, polygyny, large spousal age gap) were largely unrelated to men's support for WE. Contrasting self- and wife-reported measures suggests that men frequently exaggerate their support for women in self-reported attitudes. Discrepancies were especially pronounced among men claiming the highest support for WE, but smallest among men who held a professional occupation and whose wife participated in wage labour, indicating that these factors predict genuine support for WE. We discuss the implications of these results for our understanding of both individual variation and patriarchal gender norms, emphasising the benefits of greater exchange between the evolutionary human sciences and global health research on these themes.
Background: Contamination of the near-patient hospital environment including work surfaces and equipment, contributes to skin colonization and subsequent invasive bacterial infections in hospitalized neonates. In resource-limited settings, cleaning of the neonatal ward environment and equipment is seldom standardized and infrequently audited. Methods: A baseline multimodal assessment of surface and equipment cleaning was performed in a 30-bed high-care neonatal ward in Cape Town, South Africa, October 7–9, 2019. Adequacy of routine cleaning was evaluated using ATP bioluminescence assays, fluorescent ultraviolet (UV) markers, and quantitative bacterial surface cultures. For flat surfaces (eg, tables, incubators, trolleys), a 10×10-cm template was used to standardize the swab inoculum; for small equipment and devices with complex surfaces (eg, humidifiers, suction apparatus, stethoscopes), a standard swabbing protocol was developed for each item. Swabs in liquid transport medium were processed in the laboratory by vortexing for 30 seconds, plating onto blood and MacConkey agars, and incubating at 37°C for 48 hours. Manual counting of bacterial colony forming units was performed, followed by conventional biochemical testing and/or VITEK automated identification. Results: Of 100 swabs (58 from surfaces and 42 from equipment), 11 yielded growth of known neonatal pathogens (Enterobacteriaceae, A. baumannii, P. aeruginosa, S. aureus, S. agalactiae, and enterococci), 36 isolated potential neonatal pathogens (mostly coagulase-negative staphylococci). In addition, 4 grew environmental organisms and 49 showed no growth. The highest aerobic colony counts (ACCs) were obtained from swabs of suction tubing, milk kitchen surfaces, humidifiers, and sinks; the median ACC from swabs with any bacterial growth (n = 51) was 3 (IQR, 1–22). Only 40% of the 100 surface and equipment swabs had ATP values <200 relative light units (RLU) threshold for cleanliness. Median ATP values were 301 (IQ range, 179–732) RLUs for surface swabs versus 230 (IQ range, 78–699) RLUs for equipment swabs (P = .233). Of the 100 fluorescent UV markers placed on near-patient surfaces and high-touch equipment, only 23% had been removed after 2 staff shift changes (24 hours later). Surfaces had a higher proportion of UV marker removal than equipment (19 of 58 [32.8%] vs 4 of 42 [9.5%]; P = .008). Conclusions: Environmental cleaning of this neonatal ward was suboptimal, especially for equipment. Improvement of environmental cleaning practices is an important intervention for neonatal infection prevention in resource-limited settings. Future studies should evaluate the impact of staff training, environmental cleaning tools and repeated audit with feedback, on the adequacy of cleaning in neonatal wards.
Funding: Funding: for the laboratory work was provided by The Society for Healthcare Epidemiology of America (SHEA) International Ambassador Alumni Research Award and a South African Medical Research Council Self-initiated Research (SIR) Grant to Angela Dramowski, who is supported by a NIH Fogarty Emerging Global Leader Award K43 TW010682.
Background: Nosocomial influenza infections can be caused by direct patient-to-patient transmission, as well as bidirectionally between patient and healthcare workers (HCWs). Lapses in infection control practices (droplet precautions), and HCWs who come to work despite influenza-like illness (ILI, ie, “presenteeism”) can potentiate transmission. Cocirculation of >1 strain of influenza may complicate efforts to track infections. We describe a multidisciplinary response that helped control a late winter nosocomial influenza outbreak at a time when both influenza A/H3 and A/H1(2009) were prevalent in the community. Methods: Infection control practitioners detected a potential cluster of influenza A/H3 cases on an adult general medicine unit during the middle of March. The patients were spread out in nonadjacent rooms in a 30-bed unit, which suggested a possible common shared source. Further investigation revealed other potential clusters. Hospital incident command (HIC) was deployed to assess and respond to the outbreak; the incident commander was the chief medical officer (CMO) and the hospital epidemiologist was the subject matter expert. Other HIC roles were manned by nursing leadership, hospital administration, employee health, and the clinical laboratory. The group met at least daily (teleconference on weekends) until the extent of the outbreak was known and no new cases were identified. Results: A multipronged approach was used to control the outbreak. HCWs who reported to work with ILI symptoms were referred to employee health, tested with a PCR-based influenza screening panel, and sent home. Inpatients with ILI symptoms were tested with a comprehensive respiratory virus panel that could distinguish influenza A/H1(2009) from A/H3. Inpatients who were newly positive for influenza were evaluated to determine whether they were epidemiologically linked to an existing cluster, represented a new case of nosocomial acquisition, or were presumed to be community-acquired. The outbreak involved separate clusters caused by A/H3 and A/H1(2009) that affected 40 patients on 9 clinical units. Conclusions: A key component of the response was implementation of a local “mask rule”: all physicians, nurses, other employees, students, and visitors were required to wear surgical masks on affected floors regardless of their vaccination status. In addition, the hospital IT team developed a dynamic spreadsheet that listed information about all nosocomial cases (location, date of onset, etc), as well as ILI call-ins for HCWs. A password-protected version was posted on the hospital intranet and facilitated cohorting of infected patients. Additionally, it allowed timely discontinuation of the local mask rule on specific units, once 2 incubation periods concluded without new cases.
The inclusion of students with autism spectrum disorder (ASD) is increasing, but there have been no longitudinal studies of included students in Australia. Interview data reported in this study concern primary school children with ASD enrolled in mainstream classes in South Australia and New South Wales, Australia. In order to examine perceived facilitators and barriers to inclusion, parents, teachers, and principals were asked to comment on the facilitators and barriers to inclusion relevant to each child. Data are reported about 60 students, comprising a total of 305 parent interviews, 208 teacher interviews, and 227 principal interviews collected at 6-monthly intervals over 3.5 years. The most commonly mentioned facilitator was teacher practices. The most commonly mentioned barrier was intrinsic student factors. Other factors not directly controllable by school staff, such as resource limitations, were also commonly identified by principals and teachers. Parents were more likely to mention school- or teacher-related barriers. Many of the current findings were consistent with previous studies but some differences were noted, including limited reporting of sensory issues and bullying as barriers. There was little change in the pattern of facilitators and barriers identified by respondents over time. A number of implications for practice and directions for future research are discussed.
Participant-driven research (PDR) is a burgeoning domain of research innovation, often facilitated by mobile technologies (mHealth). Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.
Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.
For most of the twentieth century, Ireland had a system of residential institutions – known as Industrial Schools – for children. These institutions were funded and overseen by the Irish state, and run by the religious orders of the Catholic Church. Though the institutions were intended to provide children with vocational education for industrial employment and to respond to perceived problems of poverty and anti-social behaviour, in reality children were incarcerated in these residential institutions and physically, emotionally, and sexually abused. This chapter traces how Irish culture has galvanised official state responses to this history, and how contemporary narrative practices and technologies, in particular digital humanities, can facilitate greater understanding of Ireland’s difficult past.
Hypoxemic patients often desaturate further with movement and transport. While inhaled epoprostenol does not improve mortality, improving oxygenation allows for transport of severely hypoxemic patients to tertiary care centers with a related improvement in mortality rates. Extracorporeal membrane oxygenation (ECMO) use is increasing in frequency for patients with refractory hypoxemia, and with increasing regionalization of care, safe transport of hypoxemic patients only becomes more important. In this series, four cases are presented of young patients with severe hypoxemic respiratory failure from Legionnaires’ disease transported on inhaled epoprostenol to ECMO centers for consideration of cannulation. With continued climate changes, Legionella and other pathogens are likely to be a continued threat. As such, optimizing oxygenation to allow for transport should continue to be a priority for critical care transport (CCT) services.
To characterize nontuberculous mycobacteria (NTM) associated with case clusters at 3 medical facilities.
Retrospective cohort study using molecular typing of patient and water isolates.
Veterans Affairs Medical Centers (VAMCs).
Isolation and identification of NTM from clinical and water samples using culture, MALDI-TOF, and gene population sequencing to determine species and genetic relatedness. Clinical data were abstracted from electronic health records.
An identical strain of Mycobacterium conceptionense was isolated from 41 patients at VA Medical Centers (VAMCs A, B, and D), and from VAMC A’s ICU ice machine. Isolates were initially identified as other NTM species within the M. fortuitum clade. Sequencing analyses revealed that they were identical M. conceptionense strains. Overall, 7 patients (17%) met the criteria for pulmonary or nonpulmonary infection with NTM, and 13 of 41 (32%) were treated with effective antimicrobials regardless of infection or colonization status. Separately, a M. mucogenicum patient strain from VAMC A matched a strain isolated from a VAMC B ICU ice machine. VAMC C, in a different state, had a 4-patient cluster with Mycobacterium porcinum. Strains were identical to those isolated from sink-water samples at this facility.
NTM from hospital water systems are found in hospitalized patients, often during workup for other infections, making attribution of NTM infection problematic. Variable NTM identification methods and changing taxonomy create challenges for epidemiologic investigation and linkage to environmental sources.
Infective endocarditis is a microbial infection of the endothelial surface of the heart, predominantly the heart valves, that is associated with high mortality and morbidity. Few contemporary data exist regarding affected children in our context.
Aims and Objectives:
We aimed to describe the profile and treatment outcomes of infant and childhood endocarditis at our facilities.
This is a retrospective analysis of infants and children with endocarditis at two public sector hospitals in the Western Cape Province of South Africa over a 5-year period. Patients with “definite” and “possible” endocarditis according to Modified Duke Criteria were included in the review.
Forty-nine patients were identified for inclusion; 29 had congenital heart disease as a predisposing condition; 64% of patients met “definite” and 36% “possible” criteria. The in-hospital mortality rate was 20%; 53% of patients underwent surgery with a post-operative mortality rate of 7.7%. The median interval from diagnosis to surgery was 20 days (interquartile range, 9–47 days). Valve replacement occurred in 28% and valve repair in 58%. There was a significant reduction in valvular dysfunction in patients undergoing surgery and only a marginal improvement in patients treated medically. Overall, 43% of patients had some degree of residual valvular dysfunction.
Endocarditis is a serious disease with a high in-hospital mortality and presents challenges in making an accurate diagnosis. Despite a significant reduction in valvular dysfunction, a portion of patients had residual valvular dysfunction. Early surgery is associated with a lower mortality rate, but a higher rate of valve replacement compared with delayed surgery.