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Climate change and tuberculosis: an analytical framework.
No full textClimate change is likely to exacerbate a range of determinants that drive tuberculosis, the world's leading cause of death from a single infectious agent. However, tuberculosis is often neglected in wider climate health discussions. Commissioned by WHO, we developed an analytical framework outlining potential causal relationships between climate change and tuberculosis. We drew on existing knowledge of tuberculosis determinants, identified determinants likely to be sensitive to the effects of climate change, and conceptualised the mechanistic pathways through which these effects might occur. We collated evidence for these pathways, but found no studies directly linking climate change and tuberculosis, warranting research to build evidence for action. Nevertheless, the available indirect evidence supports the existence of plausible causal links between climate change and tuberculosis. This evidence highlights the need to consider tuberculosis as a climate-sensitive disease, and include tuberculosis in climate risk adaptation and mitigation programmes, and climate-resilient funding and response mechanisms. Only through urgent research and comprehensive action can we address this overlooked intersection and ensure that climate change does not become a barrier to ending the global tuberculosis epidemic
Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial.
Get PDFBACKGROUND: The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized with severe pneumonia in Africa.
METHODS AND DESIGN: The EMPIRICAL trial (NCT03915366) is an international multicenter phase II-III, open-label randomized factorial clinical trial conducted in six African countries. The trial has four randomization arms in a 1:1:1:1 fashion with patients allocated to (i) TB-Treatment plus SoC, (ii) valganciclovir plus SoC, (iii) both TB-Treatment and valganciclovir plus SoC, and (iv) SoC only.
DISCUSSION: This paper describes the statistical analysis plan (SAP) for the trial which, per the study publication plan, needs to be published prior to the database lock and final analysis results. The SAP includes details of the analyses to be undertaken and unpopulated tables that will be reported to address primary and secondary endpoints. The database will be locked on 31st January 2025.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT03915366 (registered on April 16, 2019), Universal Trial Number: U111-1231-4736, Pan African Clinical Trial Registry: PACTR201994797961340
Proactive Integrated Consultation-Liaison Psychiatry for older medical inpatients: The HOME Study RCT of its effectiveness and cost-effectiveness.
Get PDFBACKGROUND: Older medical inpatients have complex biopsychosocial problems, which often lead to prolonged hospital stays. Proactive Integrated Consultation-Liaison Psychiatry was designed to help ward teams manage biopsychosocial complexity and thereby reduce the time that older medical inpatients spend in hospital.
OBJECTIVES: To assess the experience, effectiveness and cost-effectiveness of enhancing medical care with Proactive Integrated Consultation-Liaison Psychiatry in The HOME Study.
DESIGN AND SETTING: A parallel-group, multicentre, individually randomised controlled trial with process and economic evaluations in 24 medical wards of three National Health Service hospitals.
PARTICIPANTS: Patients aged ≥ 65 years, admitted in an emergency and expected to remain in hospital for at least 2 days from the time of enrolment.
INTERVENTIONS: Proactive Integrated Consultation-Liaison Psychiatry clinicians (consultation-liaison psychiatrists supported by assisting clinicians) made proactive biopsychosocial assessments of patients' problems, then delivered discharge-focused care as integrated members of ward teams. Usual care was provided by ward teams.
PROCESS EVALUATION: Observations on training Proactive Integrated Consultation-Liaison Psychiatry clinicians and the care they provided; Proactive Integrated Consultation-Liaison Psychiatry clinicians' experiences of working in the new service model; patients' and ward staff members' experiences of Proactive Integrated Consultation-Liaison Psychiatry.
PRIMARY OUTCOME: Time spent as an inpatient (during the index admission and any emergency re-admissions) in the 30 days post randomisation.
SECONDARY OUTCOMES: Rate of discharge for the total length of the index admission; discharge destination; length of the index admission post randomisation truncated at 30 days; number of emergency re-admissions, number of days in hospital and rate of death in the year post randomisation; the patient's experience of the hospital stay and view on its length; anxiety; depression; cognitive function; independent functioning; health-related quality of life; overall quality of life.
ECONOMIC EVALUATION: Cost-effectiveness of Proactive Integrated Consultation-Liaison Psychiatry over 1, 3 and 12 months from a hospital perspective. RESULTS: Two thousand seven hundred and forty-four participants were enrolled (1399 male, 1345 female; mean age 82.3 years; 2565 White; 1373 Proactive Integrated Consultation-Liaison Psychiatry, 1371 usual care). Proactive Integrated Consultation-Liaison Psychiatry was experienced positively by patients (43 interviews) and ward staff (54 interviews). The mean time spent in hospital in the 30 days post randomisation was 11.37 days (standard deviation 8.74) with Proactive Integrated Consultation-Liaison Psychiatry and was 11.85 days (standard deviation 9.00) with usual care; adjusted mean difference -0.45 (95% confidence interval -1.11 to 0.21; p = 0.18). The only statistically and clinically significant difference in secondary outcomes was the rate of discharge, which was 8.5% higher [rate ratio 1.09 (95% confidence interval 1.00 to 1.17); p = 0.042] with Proactive Integrated Consultation-Liaison Psychiatry - a difference most apparent in patients who stayed for > 2 weeks. Compared with usual care, Proactive Integrated Consultation-Liaison Psychiatry was estimated to be modestly cost saving and cost-effective over 1 and 3, but not 12, months.
MAIN LIMITATION: Uncertain generalisability to other populations, hospitals and healthcare systems.
CONCLUSIONS: This is the first randomised controlled trial of Proactive Integrated Consultation-Liaison Psychiatry. Proactive Integrated Consultation-Liaison Psychiatry is experienced by older medical inpatients and ward staff as enhancing medical care. It is also likely to be cost saving in the short term. Although the trial does not provide strong evidence that Proactive Integrated Consultation-Liaison Psychiatry reduces time in hospital, it does support and inform its future development and evaluation.
FUTURE RESEARCH: Effectiveness of different forms of Proactive Integrated Consultation-Liaison Psychiatry; predictors of long hospital stays; barriers to and facilitators of the implementation of biopsychosocial medical care.
STUDY REGISTRATION: This study is registered as Current Controlled Trials ISRCTN86120296.
FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/11/16) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 41. See the NIHR Funding and Awards website for further award information
Factors Associated with Retention in Routine Well-Care Visits Among Children of Adolescent Mothers Living With and Without HIV: A Community-Based Study in the Eastern Cape, South Africa.
Get PDFOBJECTIVE: To describe well-care visit attendance among children of adolescent mothers living with HIV and HIV-negative adolescent mothers and identify factors associated with optimal retention in the well-care visit schedule up to 18 months. DESIGN, SETTING, PARTICIPANTS: Cross-sectional data were used from a community-based observational cohort study of adolescent mothers (10-19 years; n=481) and their children (≥19 months old; n=502) in the Eastern Cape, South Africa. OUTCOME: Optimal well-care visit retention up to 18 months was defined as attending visits within 4 weeks of the recommended child age, attending the 18-month visit and missing no more than one scheduled visit. RESULTS: Attendance was highest at the 6-week visit (88.4%; 95% confidence interval (CI) 85.6% to 91.3%) and lowest at the 18-month visit (58.0%, 95% CI 53.6% to 62.3%). About one-third (36.1%; 95% CI 31.8% to 40.3%) of children were retained to 18 months. Retention was highest among children living in rural vs urban areas (adjusted odds ratio (aOR)=2.01, 95% CI 1.32 to 3.06), those born to mothers whose highest education at pregnancy was secondary versus primary school (aOR=2.73, 95% CI 1.60 to 4.65), born via caesarean section vs vaginal birth (aOR=1.65, 95% CI 1.05 to 2.60) and living closer to the clinic (aOR=0.52, 95% CI 0.28 to 0.96 for long vs short distance). There was weak evidence that retention was lower among children of mothers living with HIV (aOR=0.64, 95% CI 0.40 to 1.02) and higher among food-secure children (aOR=2.18, 95% CI 0.96 to 4.96) and those receiving the child support grant (aOR=1.71, 95% CI 0.92 to 3.16). CONCLUSIONS: Universal interventions are needed for retention beyond the neonatal period for children of adolescent mothers living with HIV and HIV-negative adolescent mothers. Interventions must address structural barriers, especially for adolescent mothers with primary education and in urban areas. Future research should examine the underlying mechanisms linking mode of delivery with well-care retention
The Water Insecurity Experiences (WISE) Scales are suitable for use in high-income settings: findings from cognitive interviews and nationally representative surveys.
Get PDFBACKGROUND: The Water Insecurity Experiences Scales are validated tools for reliably and comparably assessing experiences with water access and use in low- and middle-income countries. Although theoretically applicable in high-income countries, their performance in these settings has not been assessed. This study therefore examined whether the Water Insecurity Experiences Scales function similarly in high-income countries, and if they generated measures comparable to those in low- and middle-income countries.
METHODS: We conducted cognitive interviews with 73 adults from four high-income countries (Bulgaria, the Netherlands, the United Kingdom, and the United States) to assess whether participants understood the items in the Individual Water Insecurity Experiences Scale as intended. We then used nationally representative Gallup World Poll data from two high-income countries (Australia, the United States) and three low- and middle-income countries (Bangladesh, Brazil, and Uganda) to evaluate internal consistency, unidimensionality, and measurement invariance (n = 4,928). Construct validity was assessed by testing hypothesized associations between water insecurity scores and wealth, household size, self-reported stress, and satisfaction with water quality within Australia and the United States.
RESULTS: Items were understood as intended by participants in cognitive interviews. The prevalence of moderate-to-high water insecurity was low in Australia (3.7%) and the United States (1.0%). In both countries, the scale was internally consistent, conformed to the unidimensional structure, and demonstrated good model fit based on criteria established a priori. Configural and scalar measurement invariance were supported across the examined low-, middle-, and high-income countries. Regarding scale validity, water insecurity scores were associated with sociodemographic characteristics (wealth, household size), self-reported stress, and satisfaction with water quality in the directions hypothesized. For example, the percentage of participants with moderate-to-high water insecurity reporting stress during the previous day or water quality dissatisfaction was 1.80 times (95% CI: 1.50, 2.17) and 4.12 times (95% CI: 2.87, 5.93) higher, respectively, than among those with no-to-low water insecurity.
CONCLUSIONS: The Individual Water Insecurity Experiences Scale performs well in high-income countries and yields cross-country comparable measures, supporting its use for global monitoring of water insecurity.
SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12939-025-02686-x
Conflicting perspectives on what constitutes fair compensation and benefits among research stakeholders in Malawi.
No full textBACKGROUND: International ethics guidelines such as the Council for International Organizations of Medical Science (CIOMS) recommend that research participants must be compensated for their time, travel, and inconveniences. However, there is continued debate on what constitutes fair compensation and benefits for research participants. We conducted a qualitative study and sought views of various research stakeholders on what they considered as appropriate compensation and benefits for study participation in Malawi.
METHODS: We employed a qualitative study design and conducted 10 focus group discussions (FGD) with frontline researchers, community leaders, research participants, study decliners and Community Advisory Group (CAG) members from medical research projects conducted in rural and urban Malawi. We also conducted 17 in-depth interviews (IDI) with researchers, ethics committee members and District Health Officers. Thematic and framework analysis was used to interpret the results.
RESULTS: Our findings showed that ethics review committee members, researchers and frontline researchers had a common understanding of compensation, informed by available literature. On the other hand, some community members understood that compensation was given due to harm resulting from study participation while others indicated that intended study benefits were not visible to the community. Our study participants also expressed concerns that offering unequal compensation based on study design, procedures and risks had the potential to make some individuals feel devalued if they received lower payment amounts compared to others.
CONCLUSION: This study revealed conflicting perspectives on compensation and benefits among research stakeholders. While stakeholders involved in conducting research had a shared understanding of compensation as reimbursement for time and costs, some community members viewed it as redress for harm. The disconnect suggests unequal access to information about research ethics among research stakeholders. Varying compensation based on study procedures also raised concerns over perceived inequalities and feelings of being devalued. These results suggest a need for consensus-building through inclusive stakeholder engagement and open dialogue to co-design guidelines that balance individual reimbursement and community benefits to advance ethical research practices centered on respect for participants. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12910-025-01358-3
Pregnant Women and Vaccine Safety in Uganda: Knowledge, Barriers, and Opportunities for Engagement.
Get PDFBackground/Objectives: New vaccines designed to combat infections such as Group B Streptococcus and respiratory syncytial virus will soon be accessible in Africa. While outbreak response vaccines are given to pregnant women, safety data for maternal vaccines in low- and middle-income countries (LMICs) are limited. This study explored Ugandan pregnant women's knowledge, attitudes, and engagement in adverse event reporting and vaccine decision-making.
Methods: This nested qualitative study was part of a national gap analysis of pharmacovigilance systems for maternal vaccines. Five Focus Group Discussions (FGDs), each involving eight participants, were held with pregnant and or breastfeeding women at four healthcare facilities and one research center. The data collected from these discussions were analyzed thematically using a manifest content analysis, conducted in Atlas.ti software version 9 for qualitative data analysis.
Results: Women valued maternal vaccines, particularly tetanus, but reported confusion about schedules and hesitancy when informed of potential side effects. Many adverse events were normalized, therefore not reported, and most participants were unaware of national reporting mechanisms beyond informing healthcare providers. Barriers included inadequate information, dismissive or rushed provider interactions and reliance on family, peers, and informal care networks to manage side effects. Women expressed a strong desire to be informed and actively involved in decisions about pregnancy vaccines, including the introduction of new vaccines.
Conclusions: Strengthening maternal vaccine safety monitoring requires clearer, balanced communication; simplified and well-publicized reporting tools; supportive provider-patient interactions; and integration of community and informal networks. Pregnant women should be engaged as active partners in pharmacovigilance and maternal vaccine introduction to build trust, improve adverse event reporting, and support vaccine uptake
High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury.
Get PDFBACKGROUND: Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals.
OBJECTIVE: To apply tree-based scan statistics in real-world data to identify drugs associated with hospitalization for severe ALI among patients without liver/biliary disease and with chronic liver disease (CLD).
METHODS: We implemented a self-controlled case-crossover design in Veterans Health Administration data (2000-2023) among patients hospitalized for laboratory-confirmed severe ALI. We identified all newly dispensed drugs within 365 days prior to their hospitalization and used conditional Bernoulli tree-based scan statistics to identify potential associations (p < 0.3). We performed analyses separately in patients without liver/biliary disease and with CLD.
RESULTS: Among 12 860 patients without liver/biliary disease and 17 512 with CLD hospitalized for severe ALI, we evaluated associations with 450 and 543 drugs, respectively. Drugs associated with severe ALI among patients without liver/biliary disease included: acid-suppressives (ranitidine [p < 0.001], omeprazole [p = 0.004]), antiemetics (ondansetron [p < 0.001], promethazine [p = 0.06]), antibiotics (amoxicillin/clavulanate [p = 0.008], ciprofloxacin [p = 0.02], mupirocin [p = 0.032], ethambutol [p = 0.275]), anticoagulants (heparin [p = 0.015]), and chemotherapy (pazopanib [p = 0.275]). Drugs associated with severe ALI among CLD patients were: diuretics (spironolactone, furosemide [both p < 0.001]), antiemetics (ondansetron, metoclopramide, promethazine [all p < 0.001]), appetite stimulants (p < 0.001), analgesics (morphine, oxycodone, fentanyl [all p < 0.001]), chemotherapy (sorafenib [p < 0.001]), antibiotics (ciprofloxacin [p = 0.011], metronidazole [p = 0.020]), antipsychotics (prochlorperazine [p = 0.105]), vitamins (p = 0.134), acid-suppressives (omeprazole [p = 0.164]), and gastrointestinal/liver disease treatments (lactulose, senna, docusate, silicones, antiflatulents [all p < 0.001]; sucralfate [p = 0.005], albumin [p = 0.228]).
CONCLUSIONS: High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies
A roadmap to scale up person-centred care in the HIV response: recommendations from a global consensus-building process.
Get PDFINTRODUCTION: World Health Organization global normative guidance recommends person-centred care (PCC) approaches to reduce HIV-related mortality and morbidity and to improve health-related quality of life (HrQoL). However, consensus on the priority PCC elements and guidance on how different stakeholders can realize PCC principles at the health systems, service delivery and individual client-healthcare worker (HCW) levels are lacking. We conducted a global consensus-building process to define core PCC elements and develop recommendations for implementation at scale.
METHODS: We used a multi-phase process to build consensus and prioritize recommendations, consisting of a literature review, five stakeholder consultations (34-43 participants each) between July 2022 and July 2023 and a three-round Delphi survey from March to July 2024 (49 participants). We sought diverse actors (including clients, HCWs, policymakers and researchers) from all world regions. Initial statements were drafted during the final consultation meeting, and adjustments to statements and recommendations were made during the Delphi survey.
RESULTS: All statements achieved over 90% agreement, and recommendations reached at least 95% agreement. At the core of PCC is an effective primary healthcare (PHC) system, which prioritizes individual health, HrQoL and wellbeing and which adapts to evolving needs. Other core elements include: HCW responsibility to create safe, inclusive and stigma-free spaces; prioritizing community leadership, including in care provision by trained and compensated peers and community HCWs; power sharing within client-HCW relationships, reinforced by HCW training and client literacy; use of appropriate digital technology to increase engagement; and cross-disciplinary collaboration to address different health issues in an integrated manner. Recommendations include: policymakers setting national targets for self-reported HrQoL; strengthening integrated PHC; researchers prioritizing community-academic partnerships; and HCWs routinely assessing client-reported outcomes.
CONCLUSIONS: Our findings outline a roadmap with roles and actions for different stakeholders to realize the full potential of PCC. Jointly, there is a need to foster a culture that hears all voices in the care team, including clients and their caregivers, the community and all HCW cadres. At a systems level, it will be crucial to strengthen HIV/PHC integration and align with the universal health coverage agenda for increased investment in inclusive, responsive and sustainable healthcare for all