New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics.

BACKGROUND: Sputum-based testing is a barrier to increasing access to molecular diagnostics for tuberculosis (TB). Many people with TB are unable to produce sputum, and sputum processing increases assay complexity and cost. Tongue swabs are emerging as an alternative to sputum, but performance limits are uncertain. METHODS: From June 2022 to July 2023, we enrolled 397 consecutive adults with cough >2 weeks at 2 health centers in Kampala, Uganda. We collected demographic and clinical information, sputum for TB testing (Xpert MTB/RIF Ultra and 2 liquid cultures), and tongue swabs for same-day quantitative polymerase chain reaction (qPCR) testing. We evaluated tongue swab qPCR diagnostic accuracy versus sputum TB test results, quantified TB targets per swab, assessed the impact of serial swabbing, and compared 2 swab types (Copan FLOQSWAB and Steripack spun polyester). RESULTS: Among 397 participants, 43.1% were female, median age was 33 years, 23.5% were diagnosed with human immunodeficiency virus, and 32.0% had confirmed TB. Sputum Xpert Ultra and tongue swab qPCR results were concordant for 98.2% (95% confidence interval [CI]: 96.2-99.1) of participants. Tongue swab qPCR sensitivity was 92.6% (95% CI: 86.5 to 96.0) and specificity was 99.1% (95% CI: 96.9 to 99.8) versus microbiological reference standard. A single tongue swab recovered a 7-log range of TB copies, with a decreasing recovery trend among 4 serial swabs. Swab types performed equivalently. CONCLUSIONS: Tongue swabs are a promising alternative to sputum for molecular diagnosis of TB, with sensitivity approaching sputum-based molecular tests. Our results provide valuable insights for developing successful tongue swab-based TB diagnostics.

Measuring sustainability of opioid agonist therapy programs in the context of transition from global fund support.

BACKGROUND: Programmatic and financial sustainability of health responses dependent on donor funding has risen as a major concern. In the HIV field in particular, it generated a number of instruments and assessments on sustainability and processes related to donor transition planning. The authors aimed to develop an instrument specific to opioid agonist therapy (OAT) programs as they were addressed only marginally by the HIV-specific assessments. METHODS: The development of the OAT sustainability instrument used desk review of existing HIV sustainability concepts and tools, an International Advisory Board, and piloting to validate the instrument. RESULTS: The new OAT sustainability instrument is comprised of the three parts: the conceptual framework, methodological guidelines and a practical implementation tool for assessing the degree of OAT sustainability at the country level. It measures sustainability in the three broad areas for sustainability measuring-Policy & Governance; Finance & Resources; and Services. The selection of indicators and their composites for the three sustainability areas extensively used the United Nations and World Health Organization's guidance on health system building blocks, on care and HIV and viral hepatitis prevention among people using opioids and for opioid dependence, and the definition of access to health framed by the United Nations Convent on Economic, Social and Cultural Rights. The instrument's methodological guidelines require the engagement of a national consultant to conduct desk review, key informant interviews and focus groups for measuring discrete milestones and adding qualitative information for interpretation of the data, progress and opportunities. The guidelines advise engaging a country-specific multi-stakeholder advisory group for planning, validation and follow-up of the assessment. The pilot of the instrument in 3 countries in 2020 validated it and required minor adjustments in the instrument. By mid-2023, the instrument has been successfully applied in 5 countries. CONCLUSIONS: The developed instrument enables a comprehensive review of the resilience of OAT programs and their ability to scale up and to inform a roadmap for improved sustainability. While developed in the context of Eastern Europe and Central Asia, it has been reviewed by a global advisory panel and could be easily adapted outside this regional context.

Sustainability of opioid agonist therapy programmes in Belarus, the Republic of Moldova, Tajikistan and Ukraine in the context of transition from Global Fund support during 2020-2023.

BACKGROUND: Most national programmes of opioid agonist therapy (OAT) in Eastern Europe and Central Asia are at a critical juncture for building their sustainability due to decreasing support from the Global Fund and other international HIV funders. Therefore, it is timely to identify the status, trends, opportunities and risk factors of OAT preparedness in the face of donor transition. METHODS: The study assessed the OAT sustainability progress in 4 countries: Belarus, the Republic of Moldova, Tajikistan and Ukraine. The study used a comparative country case study design with qualitative methods and two data points in 2020 and 2022-2023. In total, 363 sources were reviewed and used, 83 interviews with key informants and 13 focus groups were conducted with clients, using a joint methodology and a defined Framework with three dimensions: 'Policy & Governance'; 'Finance & Resources'; and, 'Services'. RESULTS: All four countries have made improvements to increase OAT sustainability, though it varied. In 2022, Ukraine had a substantial degree of sustainability, followed by Belarus and Moldova with a moderate degree, while Tajikistan's sustainability was at moderate-to-high risk. No country achieved a high degree of OAT sustainability in any of the three dimensions measured. However, a high degree of sustainability was reported for at least one indicator in Belarus, Moldova and Ukraine: 'Medicines'; 'Financial resources'; 'Evidence and information systems'; 'Service Accessibility'; or, 'Service integration & quality'. On average, the greatest improvement between 2020 and 2022 was seen for 'Availability & coverage'; 'Financial resources'; 'Service quality & integration'; and, 'Service accessibility'. The highest risks across the countries, notably in Belarus and Tajikistan, were recorded for the indicator, 'Availability and coverage'. Of concern is that the least progress, or even a decline, was found in 'Human resources'. CONCLUSIONS: OAT sustainability in the 4 analysed countries remains at risk, despite progress in all countries. Managing HIV donor transition can have positive effects in addressing financial sustainability, especially inspired by Ukraine's continued progress despite economic contraction and Russia's invasion. More attention is needed to non-financial aspects of OAT sustainability in donor transition planning. The directions that could have multifaceted positive influence for OAT long-term resilience and scale up for impact on drug problems include decentralisation outside of health settings and broader drug treatment financial and management transformation, together with drug policy reforms. Thus far, viable solutions for sustainability of OAT in conflict areas appear unlikely. Building OAT resilience should remain high on the agenda of national stakeholders, technical partners and donors.

An analysis of time conceptualisations and good care in an acute hospital setting.

This study articulates the relationship between conceptualisations of time and the accounts of good care in an acute setting. Neoliberal healthcare services, with their focus on efficiencies, predominantly calculate quality care based on time-on-the-clock workforce management planning systems. However, the ways staff conceptualise and then relate to diverse meanings of time have implications for good care and for staff morale. This phenomenological study was undertaken in acute medical-surgical wards, investigating the contextual, temporal nature of care embedded in human relations. The study interviews involved 17 participants: 11 staff, 3 previous patients and 3 family members. Data were analysed iteratively to surface the phenomenality of temporality and good care. The following constituents of the data set are explored that together illustrate the relationship between the conceptualisations of time and the accounts of good care in an acute setting: patient time as a relational journey; patient time, sovereign time and time ethics and time, teamwork and flow. The findings are clinically significant because they offer a contrasting narrative about the relationship between time and care quality. The experiences of giving and receiving good care are indivisible from how temporality is experienced and the social relations within which care is embedded. Healthcare staff experience temporality differently from patients and families, a point that healthcare participants in this study appeared to comprehend and accommodate. For all parties involved in providing care or being the recipient of care, however, the capacity to be present was valued as a humanising ethic of care. Our study reinforces the importance of not creating presumptive binaries about which temporal structures are more or less humanising-there is a place for a fast-paced tempo, which can be experienced as being in the flow of human relations with one's team and on behalf of patients.

Macrolide and Nonmacrolide Resistance with Mass Azithromycin Distribution.

BACKGROUND: Mass distribution of azithromycin to preschool children twice yearly for 2 years has been shown to reduce childhood mortality in sub-Saharan Africa but at the cost of amplifying macrolide resistance. The effects on the gut resistome, a reservoir of antimicrobial resistance genes in the body, of twice-yearly administration of azithromycin for a longer period are unclear. METHODS: We investigated the gut resistome of children after they received twice-yearly distributions of azithromycin for 4 years. In the Niger site of the MORDOR trial, we enrolled 30 villages in a concurrent trial in which they were randomly assigned to receive mass distribution of either azithromycin or placebo, offered to all children 1 to 59 months of age every 6 months for 4 years. Rectal swabs were collected at baseline, 36 months, and 48 months for analysis of the participants' gut resistome. The primary outcome was the ratio of macrolide-resistance determinants in the azithromycin group to those in the placebo group at 48 months. RESULTS: Over the entire 48-month period, the mean (±SD) coverage was 86.6±12% in the villages that received placebo and 83.2±16.4% in the villages that received azithromycin. A total of 3232 samples were collected during the entire trial period; of the samples obtained at the 48-month monitoring visit, 546 samples from 15 villages that received placebo and 504 from 14 villages that received azithromycin were analyzed. Determinants of macrolide resistance were higher in the azithromycin group than in the placebo group: 7.4 times as high (95% confidence interval [CI], 4.0 to 16.7) at 36 months and 7.5 times as high (95% CI, 3.8 to 23.1) at 48 months. Continued mass azithromycin distributions also selected for determinants of nonmacrolide resistance, including resistance to beta-lactam antibiotics, an antibiotic class prescribed frequently in this region of Africa. CONCLUSIONS: Among villages assigned to receive mass distributions of azithromycin or placebo twice yearly for 4 years, antibiotic resistance was more common in the villages that received azithromycin than in those that received placebo. This trial showed that mass azithromycin distributions may propagate antibiotic resistance. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT02047981.).

Good death disrupted: Nurses' moral emotions navigating clinical and public health ethics during the first wave of COVID-19 pandemic.

AIM: To explore the moral emotions that frontline nurses navigated in endeavouring to ensure a 'good death' for hospital patients and care home residents during the first wave of the COVID-19 pandemic. BACKGROUND: Under normal circumstances, frontline staff are focused on clinical ethics, which foreground what is best for individuals and families. Public health crises such as a pandemic require staff to adapt rapidly to focus on what benefits communities, at times compromising individual well-being and autonomy. Visitor restrictions when people were dying provided vivid exemplars of this ethical shift and the moral emotions nurses encountered with the requirement to implement this change. METHODS: Twenty-nine interviews were conducted with nurses in direct clinical care roles. Data were analysed thematically informed by the theoretical concepts of a good death and moral emotions. RESULTS: The data set highlighted that moral emotions such as sympathy, empathy, distress and guilt were integral to the decisions participants described in striving for a good palliative experience. Four themes were identified in the data analysis: nurses as gatekeepers; ethical tensions and rule bending; nurses as proxy family members; separation and sacrifice. CONCLUSIONS: Participants reflected on morally compromising situations and highlighted agency through emotionally satisfying workarounds and collegial deliberations that enabled them to believe that they were party to painful but morally justifiable decisions. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Nurses are required to implement national policy changes that may disrupt notions of best practice and therefore be experienced as a moral wrong. In navigating the moral emotions accompanying this shift, nurses benefit from compassionate leadership and ethics education to support team cohesion enabling nurses to prevail. PUBLIC CONTRIBUTION: Twenty-nine frontline registered nurses participated in the qualitative interviews that inform this study. REPORTING METHOD: The study adhered to the Consolidated Criteria for Reporting Qualitative Research checklist.

A Heideggerian analysis of good care in an acute hospital setting: Insights from healthcare workers, patients and families.

This study articulates the relational constituents of good care beyond techno-rational competence. Neoliberal healthcare means that notions of care are readily commodified and reduced to quantifiable assessments and checklists. This novel research investigated accounts of good care provided by nursing, medical, allied and auxiliary staff. The Heideggerian phenomenological study was undertaken in acute medical-surgical wards, investigating the contextual, communicative nature of care. The study involved interviews with 17 participants: 3 previous patients, 3 family members and 11 staff. Data were analysed iteratively, dwelling with stories and writing and rewriting to surface the phenomenality of good care. The data set highlighted the following essential constituents: authentic care: caring encompassing solicitude (fürsorge); impromptu care: caring beyond role category; sustained care: caring beyond specialist parameters; attuned care: caring encompassing family and culture; and insightful care: caring beyond assessment and diagnosis. The findings are clinically significant because they indicate the importance of nurse leaders and educators harnessing the potential capacity of all healthcare workers to participate in good care. Healthcare workers reported that participating in or witnessing good care was uplifting and added meaning to their work, contributing to a sense of shared humanity.

Value pluralism about sexual intimacy in residential care.

BACKGROUND: The existing literature on sexuality and intimacy in residential care tends to focus on either the question of rights, or the value of autonomy. Where the literature does reference values other than autonomy, such values are considered in the context of being a guide to whether or not a resident is autonomous, rather than being important values in their own right. OBJECTIVE: This paper draws on qualitative data gathered as part of a larger study in order to inform practice on how care workers respond to intimacy issues that arise with residents with dementia and to inform a general ethics of sex and sexuality, demonstrating that an approach which permits value pluralism can be appropriate in certain contexts. RESEARCH DESIGN: The qualitative data referred to in this paper was gathered from semi-structured interviews undertaken as part of a larger mixed-method research project. The interview text was analysed using Thorne's methodological approach, interpretive description. PARTICIPANTS AND RESEARCH CONTEXT: The qualitative arm of the project consisted of semi-structured interviews conducted between October 2018 and October 2019 with participants (staff, residents and family members) recruited from 35 residential care homes in Aotearoa New Zealand. ETHICAL CONSIDERATIONS: Participation was informed, voluntary and written consent was gained before interviews. The project was approved by the Massey University Human Ethics Committee (Northern), number NOR 18/25. FINDINGS: Analysis of the scenarios presented in this paper shows that decision-making around sexual intimacy involving people with dementia in a residential care setting is complex and requires recognizing and weighing the different values that may be a in play. CONCLUSION: A focus on safety and consent to the exclusion of other values which matter morally in this context is a mistake which prevents care workers from providing appropriately person-centred care to residents, as policies which focus on the goal of care allow space for critical examination of issues which are likely to be highly context-sensitive.

Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa.

BACKGROUND: The MORDOR I trial (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) showed that in Niger, mass administration of azithromycin twice a year for 2 years resulted in 18% lower postneonatal childhood mortality than administration of placebo. Whether this benefit could increase with each administration or wane owing to antibiotic resistance was unknown. METHODS: In the Niger component of the MORDOR I trial, we randomly assigned 594 communities to four twice-yearly distributions of either azithromycin or placebo to children 1 to 59 months of age. In MORDOR II, all these communities received two additional open-label azithromycin distributions. All-cause mortality was assessed twice yearly by census workers who were unaware of participants' original assignments. RESULTS: In the MORDOR II trial, the mean (±SD) azithromycin coverage was 91.3±7.2% in the communities that received twice-yearly azithromycin for the first time (i.e., had received placebo for 2 years in MORDOR I) and 92.0±6.6% in communities that received azithromycin for the third year (i.e., had received azithromycin for 2 years in MORDOR I). In MORDOR II, mortality was 24.0 per 1000 person-years (95% confidence interval [CI], 22.1 to 26.3) in communities that had originally received placebo in the first year and 23.3 per 1000 person-years (95% CI, 21.4 to 25.5) in those that had originally received azithromycin in the first year, with no significant difference between groups (P = 0.55). In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007). In communities that had originally received azithromycin and continued receiving it for an additional year, the difference in mortality between the third year and the first 2 years was not significant (-3.6%; 95% CI, -12.3 to 4.5; P = 0.50). CONCLUSIONS: We found no evidence that the effect of mass administration of azithromycin on childhood mortality in Niger waned in the third year of treatment. Childhood mortality decreased when communities that had originally received placebo received azithromycin. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02047981.).

Culture clash: responses to sexual diversity in residential aged care.

This paper explores attitudes of staff, residents and family members towards sexually diverse persons based on data from the first national study of its kind in Aotearoa New Zealand. The study was a two-arm mixed-method cross-sectional study using a concurrent triangulation design. The quantitative arm included the results of 433 staff surveys related to knowledge, attitudes, behaviours and beliefs about sexuality, intimacy and ageing. The qualitative arm included interviews with 77 participants including staff, residents and family members. This paper focuses only on sexual diversity. A generational cultural effect was noted among all respondents; younger participants expressed the most open and accepting views of diversity. Residents were aware that they mostly held the views of their generation; nonetheless they also looked to staff to set the tone. Staff held varying views and felt that residents would be less accepting; some staff felt the issue of intimate relationships was not something they were willing to discuss at intake. Facilities will want to establish policies about sexuality and intimacy and communicate those policies and practices to staff, residents and family members. Facilities may also wish to consider specific educational events about sexual diversity for residents.

Gut Resistome of Preschool Children After Prolonged Mass Azithromycin Distribution: A Cluster-randomized Trial.

We evaluated the gut resistome of children from communities treated with 10 twice-yearly azithromycin distributions. Although the macrolide resistance remained higher in the azithromycin arm, the selection of non-macrolide resistance observed at earlier time points did not persist. Longitudinal resistance monitoring should be a critical component of mass distribution programs. CLINICAL TRIALS REGISTRATION: NCT02047981.

Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa.

BACKGROUND: We hypothesized that mass distribution of a broad-spectrum antibiotic agent to preschool children would reduce mortality in areas of sub-Saharan Africa that are currently far from meeting the Sustainable Development Goals of the United Nations. METHODS: In this cluster-randomized trial, we assigned communities in Malawi, Niger, and Tanzania to four twice-yearly mass distributions of either oral azithromycin (approximately 20 mg per kilogram of body weight) or placebo. Children 1 to 59 months of age were identified in twice-yearly censuses and were offered participation in the trial. Vital status was determined at subsequent censuses. The primary outcome was aggregate all-cause mortality; country-specific rates were assessed in prespecified subgroup analyses. RESULTS: A total of 1533 communities underwent randomization, 190,238 children were identified in the census at baseline, and 323,302 person-years were monitored. The mean (±SD) azithromycin and placebo coverage over the four twice-yearly distributions was 90.4±10.4%. The overall annual mortality rate was 14.6 deaths per 1000 person-years in communities that received azithromycin (9.1 in Malawi, 22.5 in Niger, and 5.4 in Tanzania) and 16.5 deaths per 1000 person-years in communities that received placebo (9.6 in Malawi, 27.5 in Niger, and 5.5 in Tanzania). Mortality was 13.5% lower overall (95% confidence interval [CI], 6.7 to 19.8) in communities that received azithromycin than in communities that received placebo (P<0.001); the rate was 5.7% lower in Malawi (95% CI, -9.7 to 18.9), 18.1% lower in Niger (95% CI, 10.0 to 25.5), and 3.4% lower in Tanzania (95% CI, -21.2 to 23.0). Children in the age group of 1 to 5 months had the greatest effect from azithromycin (24.9% lower mortality than that with placebo; 95% CI, 10.6 to 37.0). Serious adverse events occurring within a week after administration of the trial drug or placebo were uncommon, and the rate did not differ significantly between the groups. Evaluation of selection for antibiotic resistance is ongoing. CONCLUSIONS: Among postneonatal, preschool children in sub-Saharan Africa, childhood mortality was lower in communities randomly assigned to mass distribution of azithromycin than in those assigned to placebo, with the largest effect seen in Niger. Any implementation of a policy of mass distribution would need to strongly consider the potential effect of such a strategy on antibiotic resistance. (Funded by the Bill and Melinda Gates Foundation; MORDOR ClinicalTrials.gov number, NCT02047981 .).

Intimacy for older adults in long-term care: a need, a right, a privilege-or a kind of care?

BACKGROUND: To investigate attitudes of staff, residents and family members in long-term care towards sex and intimacy among older adults, specifically the extent to which they conceptualise sex and intimacy as a need, a right, a privilege or as a component of overall well-being. METHODS: The present study was a part of a two-arm mixed-methods cross-sectional study using a concurrent triangulation design. A validated survey tool was developed; 433 staff surveys were collected from 35 facilities across the country. Interviews were conducted with 75 staff, residents and family members. RESULTS: It was common for staff, residents and family members to talk about intimacy and sexuality in terms of rights and needs. As well as using the language of needs and rights, it was common for participants to use terms related to well-being, such as fun, happiness or being miserable. One participant in particular (a staff member) described receiving intimate touch as a 'kind of care'-a particularly useful way of framing the conversation. CONCLUSION: While staff, residents and family frequently used the familiar language of needs and rights to discuss access to intimate touch, they also used the language of well-being and care. Reframing the conversation in this way serves a useful purpose: it shifts the focus from simply meeting minimum obligations to a salutogenic approach-one that focuses on caring for the whole person in order to improve overall well-being and quality of life.

Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial.

Importance: Azithromycin has been hypothesized to have activity against SARS-CoV-2. Objective: To determine whether oral azithromycin in outpatients with SARS-CoV-2 infection leads to absence of self-reported COVID-19 symptoms at day 14. Design, Setting, and Participants: Randomized clinical trial of azithromycin vs matching placebo conducted from May 2020 through March 2021. Outpatients from the US were enrolled remotely via internet-based surveys and followed up for 21 days. Eligible participants had a positive SARS-CoV-2 diagnostic test result (nucleic acid amplification or antigen) within 7 days prior to enrollment, were aged 18 years or older, and were not hospitalized at the time of enrollment. Among 604 individuals screened, 297 were ineligible, 44 refused participation, and 263 were enrolled. Participants, investigators, and study staff were masked to treatment randomization. Interventions: Participants were randomized in a 2:1 fashion to a single oral 1.2-g dose of azithromycin (n = 171) or matching placebo (n = 92). Main Outcomes and Measures: The primary outcome was absence of self-reported COVID-19 symptoms at day 14. There were 23 secondary clinical end points, including all-cause hospitalization at day 21. Results: Among 263 participants who were randomized (median age, 43 years; 174 [66%] women; 57% non-Hispanic White and 29% Latinx/Hispanic), 76% completed the trial. The trial was terminated by the data and safety monitoring committee for futility after the interim analysis. At day 14, there was no significant difference in proportion of participants who were symptom free (azithromycin: 50%; placebo: 50%; prevalence difference, 0%; 95% CI, -14% to 15%; P > .99). Of 23 prespecified secondary clinical end points, 18 showed no significant difference. By day 21, 5 participants in the azithromycin group had been hospitalized compared with 0 in the placebo group (prevalence difference, 4%; 95% CI, -1% to 9%; P = .16). Conclusions and Relevance: Among outpatients with SARS-CoV-2 infection, treatment with a single dose of azithromycin compared with placebo did not result in greater likelihood of being symptom free at day 14. These findings do not support the routine use of azithromycin for outpatient SARS-CoV-2 infection. Trial Registration: ClinicalTrials.gov Identifier: NCT04332107.

Iatrogenic loneliness and loss of intimacy in residential care.

BACKGROUND: There is an international trend for frail older adults to move to residential care homes, rather than ageing at home. Residential facilities typically espouse a person-centred philosophy, yet evidence points to restrictive policies and surveillance resulting in increased loneliness and diminished opportunities for intimacy and sexual expression. Residents may experience what has been termed social death, rather than perceive they are related to by others as socially alive. AIM: To consider how the loss of intimacy and sexuality in residents' lives contributes to iatrogenic loneliness experienced in residential care, and the importance of considering these issues together. RESEARCH DESIGN: The study utilised a constructionist methodology, investigating the meanings associated with intimacy, loneliness, and ageing. PARTICIPANTS AND RESEARCH CONTEXT: Qualitative data used in this study are drawn from a larger dataset of a mixed-methods study. Interviews were completed as follows: staff, 21 individual interviews, and two groups with a total of 13 additional people; residents, 26 interviews with 28 people; and family members, 12 interviews with 13 people. FINDINGS: Five key themes were identified in the data analysis: loneliness and relational identity, loneliness and functional relationships, loneliness and disrupted intimacy, loneliness and liminality, and loneliness and the built environment. ETHICAL CONSIDERATIONS: The study was approved by a University Human Ethics Committee. Participation was voluntary. Consent was gained and confidentiality upheld. DISCUSSION: Residents' expression of intimacy and sexuality can be compromised through paternalism, ageism, restrictive policies, care-rationing and functional care, alienating residents from sustaining and developing significant relationships. Attitudes and cultural beliefs of staff and family members about ageing and intimacy, compounded by architectural design, may intensify loneliness. CONCLUSIONS: Nurses have a pivotal role in ensuring policies and practice enhance social citizenship.

Biannual azithromycin distribution and child mortality among malnourished children: A subgroup analysis of the MORDOR cluster-randomized trial in Niger.

BACKGROUND: Biannual azithromycin distribution has been shown to reduce child mortality as well as increase antimicrobial resistance. Targeting distributions to vulnerable subgroups such as malnourished children is one approach to reaching those at the highest risk of mortality while limiting selection for resistance. The objective of this analysis was to assess whether the effect of azithromycin on mortality differs by nutritional status. METHODS AND FINDINGS: A large simple trial randomized communities in Niger to receive biannual distributions of azithromycin or placebo to children 1-59 months old over a 2-year timeframe. In exploratory subgroup analyses, the effect of azithromycin distribution on child mortality was assessed for underweight subgroups using weight-for-age Z-score (WAZ) thresholds of -2 and -3. Modification of the effect of azithromycin on mortality by underweight status was examined on the additive and multiplicative scale. Between December 2014 and August 2017, 27,222 children 1-11 months of age from 593 communities had weight measured at their first study visit. Overall, the average age among included children was 4.7 months (interquartile range [IQR] 3-6), 49.5% were female, 23% had a WAZ < -2, and 10% had a WAZ < -3. This analysis included 523 deaths in communities assigned to azithromycin and 661 deaths in communities assigned to placebo. The mortality rate was lower in communities assigned to azithromycin than placebo overall, with larger reductions among children with lower WAZ: -12.6 deaths per 1,000 person-years (95% CI -18.5 to -6.9, P < 0.001) overall, -17.0 (95% CI -28.0 to -7.0, P = 0.001) among children with WAZ < -2, and -25.6 (95% CI -42.6 to -9.6, P = 0.003) among children with WAZ < -3. No statistically significant evidence of effect modification was demonstrated by WAZ subgroup on either the additive or multiplicative scale (WAZ < -2, additive: 95% CI -6.4 to 16.8, P = 0.34; WAZ < -2, multiplicative: 95% CI 0.8 to 1.4, P = 0.50, WAZ < -3, additive: 95% CI -2.2 to 31.1, P = 0.14; WAZ < -3, multiplicative: 95% CI 0.9 to 1.7, P = 0.26). The estimated number of deaths averted with azithromycin was 388 (95% CI 214 to 574) overall, 116 (95% CI 48 to 192) among children with WAZ < -2, and 76 (95% CI 27 to 127) among children with WAZ < -3. Limitations include the availability of a single weight measurement on only the youngest children and the lack of power to detect small effect sizes with this rare outcome. Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level. CONCLUSIONS: Although mortality rates were higher in the underweight subgroups, this study was unable to demonstrate that nutritional status modified the effect of biannual azithromycin distribution on mortality. Even if the effect were greater among underweight children, a nontargeted intervention would result in the greatest absolute number of deaths averted. TRIAL REGISTRATION: The MORDOR trial is registered at clinicaltrials.gov NCT02047981.

Indigenous nurses' practice realities of cultural safety and socioethical nursing.

BACKGROUND: Persistent healthcare emphasis on universal moral philosophy has not advantaged indigenous and marginalised groups. Centralising cultural components of care is vital to provide ethical healthcare services to indigenous people and cultural minorities internationally. Woods' theoretical explication of how nurses can integrate cultural safety into a socioethical approach signposts ethical practice that reflects culturally congruent relational care and systemic critique. AIM: To demonstrate the empirical utility of Woods' ethical elements of cultural safety within a socioethical model, through analysis of indigenous nurses' practice realities in Aotearoa New Zealand. RESEARCH DESIGN: The study used a qualitative indigenous narrative inquiry. PARTICIPANTS AND RESEARCH CONTEXT: Participants were recruited nationally. Twelve Maori registered nurses and nurse practitioners were interviewed. All participants provided direct care in either primary or secondary health services. ETHICAL CONSIDERATIONS: Research approval was gained from the Human Ethics Committee of the lead author's tertiary institution. Participation was voluntary, and written informed consent was obtained. FINDINGS: Analysis highlighted the following: (1) cultural needs, which for Maori were integral to care, were easily subsumed by clinical care being prioritised; (2) ethical care by non-indigenous nurses requires critical reflection about broader equity issues that impact Maori disengagement from healthcare; (3) retention of indigenous nurses was seen as essential because their advocacy and the cultural 'fit' for Maori contributed to positive healthcare outcomes; and (4) committed leadership ensured culturally safe care was not eroded through workplace efficiencies. DISCUSSION: The data provide rich representation of Woods' model. The data indicate that nurses must engage reflexively with a relational ethic of care and social justice dimensions in order to deliver culturally safe care. CONCLUSION: Woods' model provides a critical lens for nurses to examine their relational practice and systemic factors that enhance or detract from culturally safe care when caring for members of any indigenous group.

Biannual mass azithromycin distributions and malaria parasitemia in pre-school children in Niger: A cluster-randomized, placebo-controlled trial.

BACKGROUND: Mass azithromycin distributions have been shown to reduce mortality in preschool children, although the factors mediating this mortality reduction are not clear. This study was performed to determine whether mass distribution of azithromycin, which has modest antimalarial activity, reduces the community burden of malaria. METHODS AND FINDINGS: In a cluster-randomized trial conducted from 23 November 2014 until 31 July 2017, 30 rural communities in Niger were randomized to 2 years of biannual mass distributions of either azithromycin (20 mg/kg oral suspension) or placebo to children aged 1 to 59 months. Participants, field staff, and investigators were masked to treatment allocation. The primary malaria outcome was the community prevalence of parasitemia on thick blood smear, assessed in a random sample of children from each community at study visits 12 and 24 months after randomization. Analyses were performed in an intention-to-treat fashion. At the baseline visit, a total of 1,695 children were enumerated in the 15 azithromycin communities, and 3,029 children were enumerated in the 15 placebo communities. No communities were lost to follow-up. The mean prevalence of malaria parasitemia at baseline was 8.9% (95% CI 5.1%-15.7%; 52 of 552 children across all communities) in the azithromycin-treated group and 6.7% (95% CI 4.0%-12.6%; 36 of 542 children across all communities) in the placebo-treated group. In the prespecified primary analysis, parasitemia was lower in the azithromycin-treated group at month 12 (mean prevalence 8.8%, 95% CI 5.1%-14.3%; 51 of 551 children across all communities) and month 24 (mean 3.5%, 95% CI 1.9%-5.5%; 21 of 567 children across all communities) than it was in the placebo-treated group at month 12 (mean 15.3%, 95% CI 10.8%-20.6%; 81 of 548 children across all communities) and month 24 (mean 4.8%, 95% CI 3.3%-6.4%; 28 of 592 children across all communities) (P = 0.02). Communities treated with azithromycin had approximately half the odds of parasitemia compared to those treated with placebo (odds ratio [OR] 0.54, 95% CI 0.30 to 0.97). Parasite density was lower in the azithromycin group than the placebo group at 12 and 24 months (square root-transformed outcome; density estimates were 7,540 parasites/µl lower [95% CI -350 to -12,550 parasites/µl; P = 0.02] at a mean parasite density of 17,000, as was observed in the placebo arm). No significant difference in hemoglobin was observed between the 2 treatment groups at 12 and 24 months (mean 0.34 g/dL higher in the azithromycin arm, 95% CI -0.06 to 0.75 g/dL; P = 0.10). No serious adverse events were reported in either group, and among children aged 1 to 5 months, the most commonly reported nonserious adverse events (i.e., diarrhea, vomiting, and rash) were less common in the azithromycin-treated communities. Limitations of the trial include the timing of the treatments and monitoring visits, both of which took place before the peak malaria season, as well as the uncertain generalizability to areas with different malaria transmission dynamics. CONCLUSIONS: Mass azithromycin distributions were associated with a reduced prevalence of malaria parasitemia in this trial, suggesting one possible mechanism for the mortality benefit observed with this intervention. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT02048007).

Comparing cancer incidence, stage at diagnosis and outcomes of First Nations and all other Manitobans: a retrospective analysis.

BACKGROUND: Globally, epidemiological evidence suggests cancer incidence and outcomes among Indigenous peoples are a growing concern. Although historically cancer among First Nations (FN) peoples in Canada was relatively unknown, recent epidemiological evidence reveals a widening of cancer related disparities. However evidence at the population level is limited. The aim of this study was to explore cancer incidence, stage at diagnosis, and outcomes among status FN peoples in comparison with all other Manitobans (AOM). METHODS: All cancers diagnosed between April 1, 2004 and March 31, 2011 were linked with the Indian Registry System and five provincial healthcare databases to compare differences in characteristics, cancer incidence, and stage at diagnosis and mortality of the FN and AOM cohorts. Cox proportional hazard regression models were used to examine mortality. RESULTS: The FN cohort was significantly younger, with higher comorbidities than AOM. A higher proportion of FN people were diagnosed with cancer at stages III (18.7% vs. 15.4%) and IV (22.4% vs. 19.9%). Cancer incidence was significantly lower in the FN cohort, however, there were no significant differences between the two cohorts after adjusting for age, sex, income and area of residence. No significant trends in cancer incidence were identified in either cohort over time. Mortality was generally higher in the FN cohort. CONCLUSIONS: Despite similar cancer incidence, FN peoples in Manitoba experience poorer survival. The underlying causes of these disparities are not yet understood, particularly in relation to the impact of colonization and other determinants of health.