What nursing chooses not to know: Practices of epistemic silence/silencing.

Drawing from a keynote panel held at the hybrid 25th International Philosophy of Nursing Conference, this discussion paper examines the question of epistemic silence in nursing from five different perspectives. Contributors include US-based scholar Claire Valderama-Wallace, who meditated on ecosystems of settler colonial logics of nursing; American scholar Lucinda Canty discussed the epistemic silencing of nurses of colour; Canadian scholar Amelie Perron interrogated the use of disobedience and parrhesia in and for nursing; Canada-based scholar Ismalia De Sousa considered what nursing protects in its silences; and Australian scholar Janice Gullick spoke to trans invisibility in nursing.

Pharmacogenomic panel testing provides insight and enhances medication management in people with HIV.

OBJECTIVE: Our study aimed to assess the impact of pharmacogenomic panel testing in people with HIV (PWH). DESIGN: Prospective, observational intervention assessment. METHODS: One hundred PWH were provided a comprehensive pharmacogenomic panel during routine care visits within the HIV specialty clinic of a large academic medical center. The panel determined the presence of specific genetic variants that could predict response or toxicity to commonly prescribed antiretroviral therapy (ART) and non-ART medications. An HIV specialty pharmacist reviewed the results with participants and the care team. The pharmacist (1) recommended clinically actionable interventions based on the participants' current drug therapy, (2) assessed for genetic explanations for prior medication failures, adverse effects, or intolerances, and (3) advised on potential future clinically actionable care interventions based on individual genetic phenotypes. RESULTS: Ninety-six participants (median age 53 years, 74% white, 84% men, 89% viral load <50 copies/ml) completed panel testing, yielding 682 clinically relevant pharmacogenomic results (133 major, 549 mild-moderate). Ninety participants (89 on ART) completed follow-up visits with 65 (72%) receiving clinical recommendations based on current medication profiles. Of the 105 clinical recommendations, 70% advised additional monitoring for efficacy or toxicity, and 10% advised alteration of drug therapy. Panel results offered explanation for prior ART inefficacy in one participant and ART intolerance in 29%. Genetic explanation for non-ART toxicity was seen in 21% of participants, with genetic contributors to inefficacy of non-ART therapy identified in 39% of participants. CONCLUSION: Preliminary data in a small cohort of PWH demonstrates benefit of routine pharmacogenomic panel testing.

Nursing for the Chthulucene: Abolition, affirmation, antifascism.

Critical posthumanism as a philosophical, antifascist nonhierarchical imagination for nursing offers a liberatory passageway forward amidst environmental collapse, an epic pandemic, global authoritarianism, extreme health and wealth disparities, over-reliance on technology and empirics, and unjust societal systems based in whiteness. Drawing upon philosophical and theoretical works from Black and Indigenous scholars, Haraway's idea of the Chthulucene, Deleuze and Guattari's rhizomatic thought, and Kaba's abolitionist organizing among others, we as activist nurse scholars continue the speculative discussion outlined in prior papers. Here we further imagine how we can engage a radical philosophical mission of care for all beings human and non, walking and working alongside the people and communities nurses accompany, connected as we are on this dystopian celestial orb. Discussion is centred on critical analyses of traditional justice framing in nursing, and on the praxis possibilities found within rhizomatic thought, making kin, and just episteme while knitting filaments of nursing theory and history, humming song lyrics from collective memory, and critically dismantling received wisdoms to stumble toward a more emancipatory present future.

The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial.

BACKGROUND: There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. METHODS: We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia (Mini-Mental State Examination score of ≥18) who lived in the community were eligible for inclusion. Patients were centrally randomly assigned (1:1) to receive the JtD intervention plus standard care (JtD group) or standard care only (standard care group). Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL) 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year (QALY) from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825. FINDINGS: Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 (41%) participants were randomly assigned: 241 (50%) to the JtD group and 239 (50%) to the standard care group. Intervention adherence was very good: 165 (68%) of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 (SD 13·0) for the JtD group and 91·9 (SD 14·6) for the control group. Difference in means was 0·9 (95% CI -1·2 to 3·0; p=0·38) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to -£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 (17%) patients in the JtD group and 35 (15%) patients in the standard care group. INTERPRETATION: In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale. FUNDING: UK National Institute of Health Research Health Technology Assessment Programme.

An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.

BACKGROUND: There are few effective interventions for dementia. AIM: To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia. OBJECTIVES: To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants' experiences. DESIGN: A pragmatic two-arm individually randomised trial analysed by intention to treat. PARTICIPANTS: A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part. INTERVENTION: Those randomised to the Journeying through Dementia intervention (n = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group (n = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded. MAIN OUTCOME MEASURES: The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life. RANDOMISATION AND BLINDING: Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded. DATA SOURCES: Outcome measures were administered in participants' homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists. RESULTS: The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm (n = 191) and 91.9 (standard deviation 14.6) in the control arm (n = 197), with a difference in means of 0.9 (95% confidence interval -1.2 to 3.0; p = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener's Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (-0.003, 95% confidence interval -0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of -£202,857 (95% confidence interval -£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention. LIMITATIONS: Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures. CONCLUSIONS: The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format. FUTURE WORK: Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community. TRIAL REGISTRATION: This trial is registered as ISRCTN17993825. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 24. See the NIHR Journals Library website for further project information.

There are few services proven effective for people with mild dementia. We therefore explored the potential benefit of a programme called Journeying through Dementia. The content, devised in partnership with people living with dementia, aims to help affected individuals to live well and participate in life. The programme involves meeting in groups of about eight every week for 12 weeks. Each person also has four face-to-face meetings with a staff member. Carers are invited to 3 of the 12 group meetings to all individual meetings if the participant wanted this involvement. A total of 480 people with dementia and 350 carers from 13 locations in England took part. Just over half of the participants were randomly allocated to the new programme, whereas the others were not. This allowed us to compare the groups. We were interested in whether or not attending the Journeying through Dementia programme improved participants' quality of life. The results showed that it did not. We also measured participants' mood, self-management skills, positive attitudes and ability with daily living skills. Only one measure of positive psychology suggested even a small benefit. There was no difference between groups in the remaining measures. Although some individual participants described being more confident, enjoying social contact, trying new activities, feeling valued and having increased independence, overall, the programme is unlikely to be worth implementing. Certain aspects of the programme are worth implementing.

Patterns of Knowing and Being in the COVIDicene: An Epistemological and Ontological Reckoning for Posthumans.

The crucible of the COVIDicene distills critical issues for nursing knowledge as we navigate our dystopian present while unpacking our oppressive past and reimagining a radical future. Using Barbara Carper's patterns of knowing as a jumping-off point, the authors instigate provocations around traditional disciplinary theorizing for how to value, ground, develop, and position knowledge as nurses. The pandemic has presented nurses with opportunities to shift toward creating a more inclusive and just epistemology. Moving forward, we propose an unfettering of the patterns of knowing, centering emancipatory knowing, ultimately resulting in liberating the patterns from siloization, cocreating justice for praxis.

Nursing With the People: Reimagining Futures for Nursing.

We wish to advance a theory of nursing that intentionally engages in questions of politics and economics, centering equity and justice as a foundation for the provision of nursing care. As health care costs rise and health disparities widen, nurses have a clear imperative to develop alternative health care delivery models unmoored from the conventional employment and profit-driven structures that now disappoint us. This mandate arises from our disciplinary focus that emphasizes social justice as a social and moral good linked to the human services nurses provide. This kind of sociopolitical engagement is not auxiliary to nursing but rather central to our ethos. A health care environment that prioritizes profit over the well-being of people is an anathema to our disciplinary focus which, we believe, should center communities and people. The health care system that has forged nursing in the United States, transforms nursing into a commodity. This reinscribes inequality for those who are unable to access care, contributes to environmental harm through profligate hospital pollution and waste, and exploits nursing staff as workers. Nurses have a history of both upholding oppressive systems that disenfranchise segments of the public, usually poor, often People of Color, and engaging in innovative alternatives to the status quo. We wish to foster revolutionary alternative care delivery models that free us from the neoliberal confines of for-profit health care. Ultimately, we argue, nursing as a discipline and a science cannot neglect our role as whistleblowers and change agents. Nor can we presuppose that our dysfunctional and harmful health care structure in the United States is a foregone conclusion. Health care is constructed, which means it can be reconstructed. If we wish to realize our emancipatory potential as nurses, critically examining our role in upholding oppressive structures is a critical step toward a more robust future of nursing.

Physical Activity and Healthy Aging.

Healthy aging is the ability to maintain independence, purpose, vitality, and quality of life into old age despite unexpected medical conditions, accidents, and unhelpful social determinants of health. Exercise, or physical activity, is an important component of healthy aging, preventing or mitigating falls, pain, sarcopenia, osteoporosis, and cognitive impairment. A well-balanced exercise program includes daily aerobic, strength, balance, and flexibility components. Most older adults do not meet the currently recommended minutes of regular physical activity weekly. Counseling by health care providers may help older adults improve exercise habits, but it is also important to take advantage of community-based exercise opportunities.

The 'SELection End points in Communities of bacTeria' (SELECT) Method: A Novel Experimental Assay to Facilitate Risk Assessment of Selection for Antimicrobial Resistance in the Environment.

BACKGROUND: Antimicrobial resistance (AMR) is one of the most significant health threats to society. A growing body of research demonstrates selection for AMR likely occurs at environmental concentrations of antibiotics. However, no standardized experimental approaches for determining selective concentrations of antimicrobials currently exist, preventing appropriate environmental and human health risk assessment of AMR. OBJECTIVES: We aimed to design a rapid, simple, and cost-effective novel experimental assay to determine selective effect concentrations of antibiotics and to generate the largest experimental data set of selective effect concentrations of antibiotics to date. METHODS: Previously published methods and data were used to validate the assay, which determines the effect concentration based on reduction of bacterial community (wastewater) growth. Risk quotients for test antibiotics were generated to quantify risk. RESULTS: The assay (SELection End points in Communities of bacTeria, or the SELECT method) was used to rapidly determine selective effect concentrations of antibiotics. These were in good agreement with quantitative polymerase chain reaction effect concentrations determined within the same experimental system. The SELECT method predicted no effect concentrations were minimally affected by changes in the assay temperature, growth media, or microbial community used as the inoculum. The predicted no effect concentrations for antibiotics tested ranged from 0.05µg/L for ciprofloxacin to 1,250µg/L for erythromycin. DISCUSSION: The lack of evidence demonstrating environmental selection for AMR, and of associated human health risks, is a primary reason for the lack of action in the mitigation of release of antibiotics into the aquatic environment. We present a novel method that can reliably and rapidly fill this data gap to enable regulation and subsequent mitigation (where required) to lower the risk of selection for, and human exposure to, AMR in aquatic environments. In particular, ciprofloxacin and, to a lesser extent, azithromycin, cefotaxime, and trimethoprim all pose a significant risk for selection of AMR in the environment. https://doi.org/10.1289/EHP6635.

We Have Never Been Nurses: Nursing in the Anthropocene, Undoing the Capitalocene.

As nurses on this pale blue dot, the impending climate crisis requires us to engage with our world and communities differently if we hope to ensure our planetary survival, human and non. Imagining the next 50 years of nursing theory, we advance a posthuman critique of the discipline. In this article, we lay out a posthumanist critique of nursing. We urge nurses to critically engage with the realities that shape our present and future on a deteriorating planet, decentering the primacy of humans as we engage with the world all around and assemble posthuman tools for our analyses.

The case for "structural missingness:" A critical discourse of missed care.

Stimulated by our conversations at the 2018 International Philosophy of Nursing Society Conference and our shared interests, the coauthors present an argument for augmenting the broader discussion of "missed care" with our synthesized concept called structural missingness. We take the problem of missed care to be largely grounded on a particular economic construction of the healthcare system within an era of what some are calling the Capitalocene, capturing the pervasive influence of capitalism on nature, humanity and the world order. Our perspective is that of the United States, however, extrapolations can be made to the social and healthcare systems in other countries. We are concerned with the underlying conditions that structurally reify inequality and ultimately undermine nursing practice. To situate the discussion, we briefly review existing literature on the contextualization of missed care. We understand contemporary circumstances of missed care as a function of the neoliberalization of healthcare, including the idea of nursing as a commodity. From this, we discuss the implications of missed care, which forms the basis of our critique. Synthesizing the term "structural missingness, we locate a moral imperative in the professional and disciplinary commitments of nursing to consider who and what have been left out. This moral imperative for the nursing profession, along with other social and health related professions, underscores our obligation to be involved in uncovering inequities and conceptualizing upstream solutions for structural missingness.

Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care.

INTRODUCTION: Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress. METHODS AND ANALYSIS: The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months' postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months' postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively. ETHICS AND DISSEMINATION: REC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access. TRIAL REGISTRATION NUMBER: ISRCTN17993825.

Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE): a study protocol of a community-based randomised controlled trial with process and economic evaluations of the incredible years infant and toddler parenting programmes, delivered in a proportionate universal model.

INTRODUCTION: Behavioural and mental disorders have become a public health crisis and by 2020 may surpass physical illness as a major cause of disability. Early prevention is key. Two Incredible Years (IY) parent programmes that aim to enhance child well-being and development, IY Infant and IY Toddler, will be delivered and evaluated in a proportionate universal intervention model called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. The main research question is: Does E-SEE Steps enhance child social emotional well-being at 20 months when compared with services as usual? METHODS AND ANALYSIS: E-SEE Steps will be delivered in community settings by Early Years Children's Services and/or Public Health staff across local authorities. Parents of children aged 8 weeks or less, identified by health visitors, children's centre staff or self-referral, are eligible for participation in the trial. The randomisation allocation ratio is 5:1 (intervention to control). All intervention parents will receive an Incredible Years Infant book (universal level), and may be offered the Infant and/or Toddler group-based programme/s-based on parent depression scores on the Patient Health Questionnaire or child social emotional well-being scores on the Ages and Stages Questionnaire: Social Emotional, Second Edition (ASQ:SE-2). Control group parents will receive services as usual. A process and economic evaluation are included. The primary outcome for the study is social emotional well-being, assessed at 20 months, using the ASQ:SE-2. Intention-to-treat and per protocol analyses will be conducted. Clustering and hierarchical effects will be accounted for using linear mixed models. ETHICS AND DISSEMINATION: Ethical approvals have been obtained from the University of York Education Ethics Committee (ref: FC15/03, 10 August 2015) and UK NHS REC 5 (ref: 15/WA/0178, 22 May 2015. The current protocol is Version 9, 26 February 2018. The sponsor of the trial is the University of York. Dissemination of findings will be via peer-reviewed journals, conference presentations and public events. TRIAL REGISTRATION NUMBER: ISRCTN11079129; Pre-results.

Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade.

BACKGROUND: New treatments for hepatitis C (HCV) infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications. MATERIALS AND METHODS: We performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/LED) from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times. RESULTS: Of 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of whom 100 (77.5%) received initial approval, and an additional 17 patients (13.9%) ultimately received approval through the appeals process. Faster approval times were seen in patients with Child-Pugh Class B disease (14.4 vs. 24.7 days, p = 0.048). A higher proportion of patients were initially approved in those with Medicare/Medicaid coverage (92.2% vs. 71.4%, p = 0.002) and those with baseline viral load ≥ 6 million IU/mL (84.1% vs. 62.5%, p = 0.040). Linear regression modeling identified advanced fibrosis, high Model of End Stage Liver Disease (MELD) score, and female gender as significant predictors of shorter decision and approval times. On logistic regression, Medicare/Medicaid coverage (OR 5.96, 95% CI 1.66-21.48) and high viral load (OR 4.52, 95% CI 1.08-19.08) were significant predictors for initial approval. CONCLUSIONS: Early analysis of real-world drug authorization outcomes between October-December 2014 reveals that nearly one in four patients are initially denied access to SOF/LED upon initial prescription, although most patients are eventually approved through appeal, which delays treatment initiation. Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times. More studies are needed to determine factors resulting in higher likelihood of denial and to evaluate approval rates and times after implementation of restrictive prior authorization guidelines.

'It's hard but you've just gotta get on with it'--The experiences of growing-up with a liver transplant.

The successful evolution of paediatric liver transplantation means that increasing numbers of young people survive into adulthood. Non-adherence to medication regimens leading to liver dysfunction, graft loss and patient death are prevalent in this vulnerable group. Insight into young people's experiences of living with a liver transplant (LTx) is vital to improve outcomes and guide future work in this area. Through semi-structured interviews, this study explored the experiences of living with a LTx for 13 young people transplanted as children and adolescents. Interviews were analysed using interpretative phenomenological analysis, revealing that young people felt different from their peers as a result of their LTx. Young people's perceptions of their scar, experiences of illness symptoms and taking medications acted as triggers of differences. This led to an ongoing struggle to be normal when faced with typical activities for young people and to attempts to take back control. Findings support the implementation of routine psychosocial screening to identify additional support needs and the development of a peer mentoring programme to allow young people to gain social support, thus reducing feelings of being different. It is hoped that such initiatives will have positive consequences for quality of life, self-management and adherence to medications.

School-based opportunities for physical activity in West Virginia public schools.

BACKGROUND: Schools have the unique potential to provide numerous opportunities for promoting physical activity. This article describes findings from a statewide survey of opportunities for physical activity in West Virginia (WV) schools. The purpose was to provide baseline data for two of the WV Healthy People 2010 objectives related to schools and youth to identify priorities for action. METHOD: Survey questions were adapted from the 2000 School Health Policies and Programs Study (SHPPS), conducted by CDC. Random stratified sampling across school level and size resulted in a final sample of 296 elementary schools, 146 middle and junior high schools, and 124 high schools (total = 566). The overall response rate was 73%. RESULTS: Eleven percent of elementary, 2% of middle or junior high, and 31% of senior high schools met the SHPP's criterion of providing daily physical education. Ninety-four percent of elementary schools reported offering daily recess. Overall, 42.3% of schools provided student and community access to indoor facilities outside of normal school hours, while 80.7% of schools provided access to outdoor facilities beyond normal school hours. CONCLUSIONS: Survey results are being used to target increased physical education in elementary schools and increased opportunities beyond physical education at all school levels.