-
BMJ Open Jul 2024Complex trauma can have serious impacts on the health and well-being of Aboriginal and Torres Strait Islander families. The perinatal period represents a 'critical...
Healing the Past by Nurturing the Future: trauma-aware, healing-informed care to improve support for Aboriginal and Torres Strait Islander families - implementation and evaluation study protocol.
INTRODUCTION
Complex trauma can have serious impacts on the health and well-being of Aboriginal and Torres Strait Islander families. The perinatal period represents a 'critical window' for recovery and transforming cycles of trauma into cycles of healing. The Healing the Past by Nurturing the Future (HPNF) project aims to implement and evaluate a programme of strategies to improve support for Aboriginal and Torres Strait islander families experiencing complex trauma.
METHOD
The HPNF programme was codesigned over 4 years to improve awareness, support, recognition and assessment of trauma. Components include (1) a trauma-aware, healing-informed training and resource package for service providers; (2) trauma-awareness resources for parents; (3) organisational readiness assessment; (4) a database for parents and service providers to identify accessible and appropriate additional support and (5) piloting safe recognition and assessment processes. The programme will be implemented in a large rural health service in Victoria, Australia, over 12 months. Evaluation using a mixed-methods approach will assess feasibility, acceptability, cost, effectiveness and sustainability. This will include service user and provider interviews; service usage and cost auditing; and an administrative linked data study of parent and infant outcomes.
ANALYSIS
Qualitative data will be analysed using reflexive thematic analysis. Quantitative and service usage outcomes will be described as counts and proportions. Evaluation of health outcomes will use interrupted time series analyses. Triangulation of data will be conducted and mapped to the Consolidated Framework for Implementation Research and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks to understand factors influencing feasibility, acceptability, effectiveness, cost and sustainability.
ETHICS AND DISSEMINATION
Approval granted from St Vincent's Melbourne Ethics Committee (approval no. 239/22). Data will be disseminated according to the strategy outlined in the codesign study protocol, in-line with the National Health and Medical Research Council Aboriginal and Torres Strait Islander Research Excellence criteria.
Topics: Humans; Native Hawaiian or Other Pacific Islander; Health Services, Indigenous; Victoria; Female; Program Evaluation; Wounds and Injuries; Australian Aboriginal and Torres Strait Islander Peoples
PubMed: 38960467
DOI: 10.1136/bmjopen-2024-085555 -
BMJ Open Jul 2024Despite universal access to government-funded direct-acting antivirals (DAAs) in 2016, the rate of hepatitis C treatment uptake in Australia has declined substantially....
INTRODUCTION
Despite universal access to government-funded direct-acting antivirals (DAAs) in 2016, the rate of hepatitis C treatment uptake in Australia has declined substantially. Most hepatitis C is related to injecting drug use; reducing the hepatitis C burden among people who inject drugs (PWID) is, therefore, paramount to reach hepatitis C elimination targets. Increasing DAA uptake by PWID is important for interrupting transmission and reducing incidence, as well as reducing morbidity and mortality and improving quality of life of PWID and meeting Australia's hepatitis C elimination targets.
METHODS AND ANALYSIS
A cluster randomised cross-over trial will be conducted with three intervention arms and a control arm. Arm A will receive rapid hepatitis C virus (HCV) antibody testing; arm B will receive rapid HCV antibody and rapid RNA testing; arm C will receive rapid HCV antibody testing and same-day treatment initiation for HCV antibody-positive participants; the control arm will receive standard of care. The primary outcomes will be (a) the proportion of participants with HCV commencing treatment and (b) the proportion of participants with HCV achieving cure. Analyses will be conducted on an intention-to-treat basis with mixed-effects logistic regression models.
ETHICS AND DISSEMINATION
The study has been approved by the Alfred Ethics Committee (number HREC/64731/Alfred-2020-217547). Each participant will provide written informed consent. Reportable adverse events will be reported to the reviewing ethics committee. The findings will be presented at scientific conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT05016609.
TRIAL PROGRESSION
The study commenced recruitment on 9 March 2022 and is expected to complete recruitment in December 2024.
Topics: Humans; Antiviral Agents; Cross-Over Studies; Substance Abuse, Intravenous; Hepatitis C; Australia; Randomized Controlled Trials as Topic; Hepatitis C Antibodies; Hepacivirus
PubMed: 38960465
DOI: 10.1136/bmjopen-2023-083502 -
BMJ Open Jul 2024Previous studies demonstrated that wedge resection is sufficient for ground glass-dominant lung adenocarcinoma (LUAD) with tumour diameter ≤2 cm, however, the optimal...
INTRODUCTION
Previous studies demonstrated that wedge resection is sufficient for ground glass-dominant lung adenocarcinoma (LUAD) with tumour diameter ≤2 cm, however, the optimal surgical type for ground glass-dominant LUAD with tumour diameter of 2-3 cm remains unclear. The purpose of this trial is to investigate the safety and efficacy of segmentectomy for ground glass-dominant invasive LUAD with tumour size of 2-3 cm.
METHODS AND ANALYSIS
We initiated a phase III trial to investigate whether segmentectomy is suitable for ground glass-dominant invasive LUAD with tumour size of 2-3 cm. This trial plans to enrol 307 patients from multiple institutions including four general hospitals and two specialty cancer hospitals over a period of 5 years. The primary endpoint is 5 year disease-free survival. Secondary endpoints are lung function, 5 year overall survival, the site of tumour recurrence and metastasis, segmentectomy completion rate, radical segmentectomy (R0 resection) completion rate and surgery-related complications.
ETHICS AND DISSEMINATION
This trial has been approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (reference 2212267-18) and by the institutional review boards of each participating centre. Written informed consent is required from all participants. The study results will be published in a peer-reviewed international journal.
TRIAL REGISTRATION NUMBER
NCT05717803.
Topics: Humans; Lung Neoplasms; Pneumonectomy; Adenocarcinoma of Lung; Female; Male; Clinical Trials, Phase III as Topic; Disease-Free Survival; Multicenter Studies as Topic; Middle Aged; Adult; Neoplasm Recurrence, Local; China; Aged; Tumor Burden
PubMed: 38960464
DOI: 10.1136/bmjopen-2024-087088 -
BMJ Open Jul 2024Post-traumatic stress disorder (PTSD) is a prevalent and severe psychiatric disorder. Repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Post-traumatic stress disorder (PTSD) is a prevalent and severe psychiatric disorder. Repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex provides limited relief for symptoms of PTSD. This study will be conducted to validate the efficacy of MRI-guided rTMS in targeting the sites most closely associated with the amygdala for patients with PTSD. We hypothesise that the intervention will improve clinical symptoms by decreasing amygdala activity in patients.
METHODS AND ANALYSIS
A randomised, double-blind, sham-controlled trial will be conducted. Forty-eight eligible patients with PTSD will be randomly assigned to receive either active or sham MRI-guided rTMS for 10 consecutive days after the initial MRI scans. MRI scans will be recollected at the end of the intervention. Clinical assessments will be performed at baseline, treatment day 5, treatment day 10, and 2 weeks, 4 weeks, 8 weeks after completion of the intervention to monitor changes in clinical symptoms. The primary assessment outcome is the change in PTSD symptoms between baseline and treatment day 10, as measured by the PTSD Checklist for DSM-5. Repeated measures analysis of variance will be performed using statistical software SPSS V.26.0. The significance level will be set at 0.05.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the Ethics Committee of Xijing Hospital in Xi'an, China (KY20222176-X-1), and the trial has been registered on ClinicalTrials.gov. The findings of this trial will be disseminated at academic conferences or published in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER
NCT05544110.
Topics: Humans; Stress Disorders, Post-Traumatic; Transcranial Magnetic Stimulation; Magnetic Resonance Imaging; Double-Blind Method; Amygdala; Adult; Male; Randomized Controlled Trials as Topic; Middle Aged; Female; Treatment Outcome; Young Adult
PubMed: 38960463
DOI: 10.1136/bmjopen-2023-081751 -
BMJ Open Jul 2024This study compares rectal administration with vaginal administration of progesterone as luteal phase support in hormone replacement therapy frozen embryo transfer...
Rectal versus vaginal progesterone administration for luteal phase support in the hormone replacement therapy frozen embryo transfer (HRT-FET) cycle: protocol for a non-inferiority randomised controlled trial.
INTRODUCTION
This study compares rectal administration with vaginal administration of progesterone as luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycles. The reason for comparing the two routes of administration is that rectal administration has been suggested to be more patient friendly.
METHODS AND ANALYSIS
This study is a randomised controlled trial comparing the ongoing pregnancy rate (OPR) at week 12 in HRT-FET cycles after rectal administered progesterone as the only administered progesterone compared with a vaginal luteal phase support regimen. All patients are enrolled from a Danish public fertility clinic and randomised to one of two groups, with 305 patients receiving embryo transfer assigned to each group. Endometrial preparation includes 6 mg oestradiol daily. The intervention group receives rectally administered progesterone (400 mg/12 hours) and the control group receives vaginally administered progesterone (400 mg/12 hours). If P4 is <35 nmol/L on blastocyst transfer day an additional rectal luteal phase rescue regimen is started (control group). Thawing and transferring of a single autologous vitrified blastocyst is scheduled on the sixth day of progesterone administration in both groups. The power calculation is based on a non-inferiority analysis with an expected OPR in both groups of 44% and the upper limit of a one-sided 95% CI will exclude a difference in favour of the control group of more than 10.0%. An interim analysis will be conducted once half of the study population has been enrolled.
ETHICS AND DISSEMINATION
The trial was approved on 21 November 2023 by the Danish National Ethical Committee and the Danish Medicines Agency and is authorised by the Clinical Trials Information System (EUCT number 2023-504616-15-02). All patients will provide informed consent before being enrolled in the study. The results will be published in an international journal.
TRIAL REGISTRATION NUMBER
EUCT number: 2023-504616-15-02.
Topics: Humans; Female; Progesterone; Embryo Transfer; Administration, Intravaginal; Luteal Phase; Pregnancy; Pregnancy Rate; Cryopreservation; Administration, Rectal; Hormone Replacement Therapy; Progestins; Adult; Denmark; Equivalence Trials as Topic
PubMed: 38960462
DOI: 10.1136/bmjopen-2023-082879 -
BMJ Open Jul 2024Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management,...
Development of the DONOR prediction model on the risk of hypertensive complications in oocyte donation pregnancy: study protocol for a multicentre cohort study in the Netherlands.
INTRODUCTION
Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this. The current project aims to establish the first prediction model on the risk of hypertensive complications in OD pregnancy.
METHODS AND ANALYSIS
The present study is conducted within the DONation of Oocytes in Reproduction project. For this multicentre cohort study, at least 541 OD pregnancies will be recruited. Baseline characteristics and obstetric data will be collected. Additionally, one sample of maternal peripheral blood and umbilical cord blood after delivery or a saliva sample from the child will be obtained, in order to determine the number of fetal-maternal human leucocyte antigen mismatches. Following data collection, a multivariate logistic regression model will be developed for the binary outcome hypertensive complication 'yes' and 'no'. The Prediction model Risk Of Bias ASsessment Tool will be used as guide to minimise the risk of bias. The study will be reported in line with the 'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis' guideline. Discrimination and calibration will be determined to assess model performance. Internal validation will be performed using the bootstrapping method. External validation will be performed with the 'DONation of Oocytes in Reproduction individual participant data' dataset.
ETHICS AND DISSEMINATION
This study is approved by the Medical Ethics Committee LDD (Leiden, Den Haag, Delft), with protocol number P16.048 and general assessment registration (ABR) number NL56308.058.16. Further results will be shared through peer-reviewed journals and international conferences.
Topics: Humans; Female; Oocyte Donation; Pregnancy; Netherlands; Hypertension, Pregnancy-Induced; Risk Factors; Risk Assessment; Adult; Multicenter Studies as Topic; Cohort Studies; Logistic Models; Research Design
PubMed: 38960461
DOI: 10.1136/bmjopen-2023-079394 -
European Journal of Hospital Pharmacy :... Jul 2024Invasive fungal infections (IFI) can contribute to increased mortality and morbidity rates after heart transplant in adults. The most common causes are and species....
INTRODUCTION
Invasive fungal infections (IFI) can contribute to increased mortality and morbidity rates after heart transplant in adults. The most common causes are and species. There is uncertainty on how effective antifungal prophylaxis is against spp infections and limited guidance on the prevention of spp infections. This systematic review and meta-analysis will assess the literature to see if antifungal prophylaxis reduces the incidence of IFI after heart transplant in adults.
METHODS AND ANALYSIS
This systematic review protocol follows the Preferred Reporting Items for Systematic reviews and Meta Analysis guidelines. A systematic search of the Cochrane Library, Web of Science, Scopus, Embase, MEDLINE, and Proquest databases will be undertaken. Reference lists of retrieved publications and conference abstracts will also be searched. Title, abstract and full-text screening will be undertaken by two reviewers. Discrepancies will be resolved by a third reviewer. Studies with paediatric patients, multi-organ transplants, or patients with a second heart transplant will be excluded, along with those who do not have clear definitions and diagnostic criteria for IFI. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool and the Risk of Bias in Non-randomised Studies of Interventions tool. A meta-analysis will be carried out, but if studies are not deemed to be sufficiently similar, only a narrative synthesis will be undertaken.
ETHICS AND DISSEMINATION
Ethical approval is not required for this systematic review as primary data will not be collected. The results of the review will be disseminated through publication in an academic journal and scientific conferences.
PROSPERO REGISTRATION NUMBER
CRD42024516588.
PubMed: 38960452
DOI: 10.1136/ejhpharm-2024-004266 -
Journal of Substance Use and Addiction... Jul 2024Government agencies have identified evidence-based practice (EBP) dissemination as a pathway to high-quality behavioral health care for youth. However, gaps remain about...
INTRODUCTION
Government agencies have identified evidence-based practice (EBP) dissemination as a pathway to high-quality behavioral health care for youth. However, gaps remain about how to best sustain EBPs in treatment organizations in the U.S., especially in resource-constrained settings like publicly-funded youth substance use services. One important, but understudied, determinant of EBP sustainment is alignment: the extent to which multi-level factors that influence sustainment processes and outcomes are congruent, consistent, and/or coordinated. This study examined the role of alignment in U.S. states' efforts to sustain the Adolescent Community Reinforcement Approach (A-CRA), an EBP for youth substance use disorders, during the COVID-19 pandemic.
METHODS
In this mixed methods study, the qualitative investigation preceded and informed the quantitative investigation. We interviewed state administrators and providers (i.e., supervisors and clinicians) from 15 states that had completed a federal A-CRA implementation grant; providers also completed surveys. The sample included 50 providers from 35 treatment organizations that reported sustaining A-CRA when the COVID-19 pandemic began, and 20 state administrators. In qualitative thematic analyses, we applied the EPIS (Exploration, Preparation, Implementation, Sustainment) framework to characterize alignment processes that interviewees described as influential on sustainment. We then used survey items to quantitatively explore the associations described in qualitative themes, using bivariate linear regressions.
RESULTS
At the time of interview, staff from 80 % of the treatment organizations (n = 28), reported sustaining A-CRA. Providers from both sustainer and non-sustainer organizations, as well as state administrators, described major sources of misalignment when state agencies ceased technical assistance post-grant, and because limited staff capacity conflicted with A-CRA's training model, which was perceived as time-intensive. Participants described the pandemic as exacerbating preexisting challenges, including capacity issues. Sustainer organizations reported seeking new funding to help sustain A-CRA. Quantitative associations between self-rated extent of sustainment and other survey items largely followed the pattern predicted from the qualitative findings.
CONCLUSIONS
The COVID-19 pandemic amplified longstanding A-CRA sustainment challenges, but treatment organizations already successfully sustaining A-CRA pre-pandemic largely continued. There are missed opportunities for state-level actors to coordinate with providers on the shared goal of EBP sustainment. A greater focus on alignment processes in research and practice could help states and providers strengthen sustainability planning.
PubMed: 38960147
DOI: 10.1016/j.josat.2024.209445 -
Environmental Pollution (Barking, Essex... Jul 2024Pharmaceutical plant sites play a significant role in the dissemination of antibiotic resistance genes (ARGs) into the environment. It is imperative to comprehensively...
Pharmaceutical plant sites play a significant role in the dissemination of antibiotic resistance genes (ARGs) into the environment. It is imperative to comprehensively monitor of ARGs across various environmental media at these sites. This study focused on three pharmaceutical plants, two located in North China and one in South China. Through metagenomic approaches, we examined the composition, mobility potential, and bacterial hosts of ARGs in diverse media such as process water, groundwater, topsoil, soil cores, and pharmaceutical fermentation residues across diverse environmental matrices, including topsoil, soil cores, process water, groundwater, and pharmaceutical fermentation residues. We identified a wide array of ARGs, comprising 21 types and 740 subtypes, with process water exhibiting the highest abundance and diversity. Treatment processes varied in their efficacy in eliminating ARGs, and the clinically relevant ARGs should also be considered when evaluating wastewater treatment plant efficiency. Geographical distinctions in groundwater ARG distribution between northern and southern regions were observed. Soil samples from the three sites showed minimal impact from pharmaceutical activity, with vancomycin-resistance genes being the most prevalent. High levels of ARGs in pharmaceutical fermentation residues underscore the necessity for improved waste management practices. Metagenomic assembly revealed that plasmid-mediated ARGs were more abundant than chromosome-mediated ARGs. Metagenome-assembled genomes (MAGs) analysis identified 166 MAGs, with 62 harboring multiple ARGs. Certain bacteria tended to carry specific types of ARGs, revealing distinct host-resistance associations. This study enhances our understanding of ARG dissemination across different environmental media within pharmaceutical plants and underscores the importance of implementing strict regulations for effluent and residue discharge to control ARG spread.
PubMed: 38960118
DOI: 10.1016/j.envpol.2024.124482 -
American Journal of Obstetrics and... Jul 2024There is an increasing burden of hepatitis C virus (HCV) among persons of reproductive age, including pregnant and breastfeeding women, in many regions worldwide....
There is an increasing burden of hepatitis C virus (HCV) among persons of reproductive age, including pregnant and breastfeeding women, in many regions worldwide. Routine health services during pregnancy present a critical window of opportunity to diagnose and link women with HCV infection for care and treatment to decrease HCV-related morbidity and early mortality. Effective treatment of HCV infection in women diagnosed during pregnancy also prevents HCV-related adverse events in pregnancy and HCV vertical transmission in future pregnancies. However, linkage to care and treatment for women diagnosed in pregnancy remains insufficient. Currently, there are no best practice recommendations from professional societies to ensure appropriate peripartum linkage to HCV care and treatment. We convened a virtual Community of Practice (CoP) to understand key challenges to the HCV care cascade for women diagnosed with HCV in pregnancy, highlight published models of integrated HCV services for pregnant and postpartum women, and preview upcoming research and programmatic initiatives to improve linkage to HCV care for this population. Four-hundred seventy-three participants from 43 countries participated in the CoP, including a diverse range of practitioners from public health, primary care, and clinical specialties. The CoP included panel sessions with representatives from major professional societies in obstetrics/gynecology, maternal fetal medicine, addiction medicine, hepatology, and infectious diseases. From this CoP, we provide a series of best practices to improve linkage to HCV treatment for pregnant and postpartum women, including specific interventions to enhance co-location of services, treatment by non-specialist providers, active engagement and patient navigation, and decreasing time to HCV treatment initiation. The CoP aims to further support antenatal providers in improving linkage to care by producing and disseminating detailed operational guidance and recommendations and supporting operational research on models for linkage and treatment. Additionally, the CoP may be leveraged to build training materials and toolkits for antenatal providers, convene experts to formalize operational recommendations, and conduct surveys to understand needs of antenatal providers. Such actions are required to ensure equitable access to HCV treatment for women diagnosed with HCV in pregnancy and urgently needed to achieve the ambitious targets for HCV elimination by 2030.
PubMed: 38960017
DOI: 10.1016/j.ajog.2024.06.028