Circulation, Ahead of Print. BACKGROUND:Fontan circulatory failure (FCF) is a chronic state in palliated single ventricle heart disease with high morbidity and mortality rates, including heart failure, multisystem end-organ disease, and need for heart transplant. Specific FCF morbidities have not been rigorously defined, limiting study of how FCF morbidities affect pre–heart transplant and post–heart transplant outcomes. We hypothesized that FCF-related morbidities affect survival from heart transplant waitlisting through 1 year after heart transplant.METHODS:This 20-center, retrospective cohort study collected demographic, medical/surgical history, waitlist, and peri- and post–heart transplant data, and a priori defined FCF-specific morbidities, in Fontan patients who were listed for heart transplant from 2008 through 2022. Univariate 2-group statistics compared surviving individuals with those who died anytime from waitlisting to 1 year after heart transplant, died on the waitlist, or underwent transplant and died within 1 year after transplant. Using covariates from both univariate analyses, multivariable logistic regression determined the primary study outcome of independent FCF risk factors for death between waitlist and 1 year after heart transplant.RESULTS:Of 409 waitlisted patients, 24 (5.9%) died on the waitlist. Of the 341 (83.4%) who underwent transplant, 27 (8.5%) did not survive to 1 year. Univariate risk factors for waitlist death included higher aortopulmonary collateral burden, >1 hospitalization in the previous year, younger age, sleep apnea, higher New York Heart Association class, nonenrollment in school or work, and single-parent home. Risk factors for 1-year post–heart transplant mortality included hypoplastic left heart syndrome diagnosis, patent fenestration, anatomic Fontan obstruction, clinical cyanosis (pulse oximetry 1 hospitalization in the year before waitlisting (adjusted odds ratio, 2.0 [95% CI, 1.0–4.1];P=0.05) and clinical cyanosis (adjusted odds ratio, 5.0 [95% CI, 1.8–13.4];P=0.002).CONCLUSIONS:Patients with Fontan palliation selected for heart transplant have substantial mortality rates from waitlisting through transplant. Among FCF-specific morbidities, cyanosis is associated with worsened survival and necessitates further study. Clinical morbidity of any type requiring repeated hospital admission also should prompt consideration of heart transplant.
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Understanding Predictors of Lifelong Initiation and Follow-up Treatment for adolescents and youth living with HIV (UPLIFT): an integrated prospective cohort in Eastern Cape, South Africa
Purpose
Adolescents living with HIV (ALHIV) are a priority population for achieving global HIV prevention and treatment targets but experience poorer outcomes than adults. Long-term follow-up is essential to understand their transition into adulthood. By linking self-reported survey data with routine laboratory records, we established a social science clinical cohort of ALHIV South Africa’s Eastern Cape to explore factors shaping their long-term health and well-being.
Participants
Eligible participants were adolescents who were part of a three-wave quantitative cohort of ALHIV and not living with HIV (2014–2018) and had consented (adolescent and caregiver) to having their self-reported interviews linked with routine health records (n=1563). Adolescents were recruited into the existing three-wave cohort through clinic and community-based methods (97% enrolment, >90% retention over three waves). Between 2019 and 2022, we abstracted laboratory test records from the National Health Laboratory Services database for all eligible participants, with matching based on demographic variables. Individuals with at least one HIV-related record form our ‘lifelong social science cohort’, a total of 956 ALHIV (852 of 1107 ALHIV and 104 of 456 HIV-uninfected).
Findings to date
A total of 32 886 laboratory test records from 2004 to 2023 were matched through three rounds of data extraction, using iteratively refined record-linking searches. Most records were viral load (8864) and CD4 count (6801) results, with a median of 10 (IQR: 7–14) and 8 (IQR: 5–11) tests per matched adolescent, respectively. Overall, 956 of 1563 adolescents (61%) were successfully linked to laboratory data, including 852 of 1107 (77%) ALHIV. Analysis of the matched cohort survey-laboratory data provided several insights. Self-reported antiretroviral therapy adherence was strongly associated with viral suppression, even after adjusting for covariates. The strongest predictors of suppression were not reporting missed doses in the past 3 days, past week and not missing clinic appointments in the past year. Among adolescent girls and young women living with HIV, access to safe and affordable facilities, and kind and respectful staff were associated with a higher likelihood of multiple improved HIV-related outcomes, including viral suppression. Exposure to sexual and intimate partner violence predicted worse viral load outcomes among adolescents.
Future plans
This integrated prospective cohort provides an opportunity to characterise long-term HIV treatment outcomes among ALHIV in Africa. We will investigate how individual, familial, community and healthcare experiences in childhood, and adolescence shape these outcomes. Since the COVID-19 pandemic happened during the period of matched data, we will also investigate the potential effect of the COVID-19 pandemic on adolescent HIV treatment outcomes, with potential subgroup analyses for individuals with available COVID-19-related results.
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Association of triglyceride-glucose index with in-hospital outcomes in patients with acute myocardial infarction: a retrospective, single-centre, cohort study in China
Objectives
To investigate the association between triglyceride-glucose (TyG) index levels at hospital admission and the risk of in-hospital adverse events, including all-cause mortality, in patients with acute myocardial infarction (AMI). The primary hypothesis was that higher TyG index levels are associated with greater risk of adverse in-hospital outcomes.
Design
Retrospective cohort study.
Setting
Tertiary hospital inpatient care in China. The study included consecutively hospitalised patients with AMI between 1 August 2011 and 10 January 2022.
Participants
A total of 3458 patients with AMI were included. The mean age was 60.8 years, and 78.4% were men. Patients were excluded if they had incomplete data for TyG index calculation or outcome ascertainment.
Interventions
No therapeutic intervention was assigned; the study was observational. TyG index was calculated using fasting triglycerides and fasting plasma glucose levels at admission.
Primary and secondary outcome measures
The primary outcome was all-cause in-hospital mortality. Secondary outcomes included cardiogenic shock and fatal rapid arrhythmia. Outcomes were identified through standardised clinical records.
Results
Among 3458 patients, 375 (10.84%) died during hospitalisation, 236 (6.84%) developed cardiogenic shock and 147 (4.25%) experienced fatal rapid arrhythmia. After multivariable adjustment, higher TyG index levels were significantly associated with increased odds of all-cause mortality (OR, 1.27; 95% CI, 1.02 to 1.57; p
Patient and caregiver perspectives on treatment strategies and care priorities of childhood steroid-sensitive nephrotic syndrome: a qualitative study
Objectives
We explored the experiences of treatment strategies for steroid-sensitive nephrotic syndrome (SSNS) and care priorities among children living with the condition and their caregivers.
Design
A qualitative study using semistructured interviews. Data were analysed using reflexive thematic analysis. We coded transcripts in duplicate and developed themes that integrate key concepts across roles.
Setting
Southern Alberta, Canada.
Participants
A purposive sample of children aged 8–18 years, with SSNS and their caregivers from a paediatric nephrotic syndrome cohort.
Results
28 individuals (10 children and 18 caregivers) participated in this study. All had experienced a relapse after initial diagnosis and steroid treatment. Participants identified how their experiences with SSNS treatments influenced their willingness to accept further steroids and other second-line agents. Findings are elaborated across the following four themes: (1) reluctant acceptance of steroids (steroid aversion, lack of personalised steroid dosing, altered self-regulation and acknowledging steroid effectiveness); (2) coping with unexpected relapses (repeating the cycle, restricted life participation and tempered optimism); (3) uncertainty about second-line therapies (striving for stability, cumulative burden of adverse effects and exploring alternatives) and (4) directing attention to unmet treatment needs and priorities (mechanistic approaches to therapy, steroid minimisation, child and family involvement and enhanced social supports).
Conclusions
Children with SSNS and their caregivers expressed a dislike of steroids and a desire for individualised treatment protocols. Investigation into therapeutic alternatives for SSNS should integrate patients’ preferences, values and care priorities.
Evaluating an intervention to promote access to mental healthcare for low language proficient migrants and refugees across Europe (MentalHealth4All): study protocol for a pretest-post-test cross-national survey study
Background
Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.
Methods and analysis
We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).
Ethics and dissemination
For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.
Registration details
The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.
Platinum and etoposide chemotherapy, durvalumab with thoracic radiotherapy in the first-line treatment of patients with extensive-stage small-cell lung cancer: CHEST-RT (TROG 20.01) Trial – protocol for a phase II study
Background
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.
Methods
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).
Ethics and dissemination
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.
Trial registration numbers
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
Use of an electronic medication management application to support Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC): a study protocol for a parallel cluster randomised controlled trial
Introduction
Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.
Methods and analysis
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.
Ethics and dissemination
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.
Trial registration number
ACTRN12624001409561.
Fertility treatments and stroke: a scoping review
Objectives
Fertility therapies are becoming an increasingly common option for conception, but there is little knowledge on the interactions of assisted reproductive technology (ARTs) and stroke in women, and its use among women with a history of stroke. This scoping review aims to examine the current state of knowledge and identify the knowledge gaps regarding: (1) the stroke risk with use of fertility therapy and (2) the safety of fertility therapy among stroke survivors, to help guide future research and clinical practice.
Design
The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist for scoping reviews was followed.
Data sources
MEDLINE (Ovid), Cochrane Central Registry of Controlled Trials (Ovid), EMBASE (Ovid), Medline, ClinicalTrials.gov and International Clinical Trials Registry Platform were searched through 20 June 2023.
Eligibility criteria for selecting studies
All observational studies pertaining to use of fertility and stroke in humans over the age of 18 were included in this review.
Data extraction and synthesis
Title and abstract and subsequent full-text review were performed by two independent reviewers in duplicate. A narrative synthesis of final articles for data abstraction is presented.
Results
10 studies met inclusion criteria. The only meta-analysis that was included could not estimate the risk of stroke among all individuals undergoing fertility therapy due to lack of high-quality prospective cohort studies. There was only one prospective cohort that examined pregnancy among stroke survivors. Among the 32 pregnancies, one was conceived through in vitro fertilisation (IVF), although the details regarding stroke type, time since stroke, medications and IVF protocol were not specified. Therefore, the safety and effectiveness of ART among stroke survivors is currently unknown.
Conclusion
In this comprehensive review of existing fertility therapy science and stroke risk, we identify a large knowledge gap and a major scientific need for a systematic approach and prospective studies to better inform the risk of stroke during fertility therapy, especially among stroke survivors. Understanding this risk and developing treatment strategies serves to better inform women and healthcare providers as more women with a history of stroke seek and contemplate fertility therapy.
Trial registration number
DOI 10.17605/OSF.IO/PHQ4X
Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study
Background
Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.
Objective
This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.
Design
A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p
Human Germline Genome Editing, 10 Years On
This Viewpoint discusses human germline genome editing (GGE) in light of changes in the landscape around biomedical technology over the last 10 years, considering ethical, legal, and social issues and in particular whether GGE holds future therapeutic value.
Study Models Costs of Ending Water Fluoridation
Removing fluoride from US public water systems could lead to 25.4 million additional cases of tooth decay after 5 years, with associated costs approaching $10 billion, according to a modeling study published in JAMA Health Forum.
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