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Scientific Reports Jul 2024Our objective was to study disparities in access to contraception during the COVID-19 pandemic. We performed a cross-sectional study at the University of Campinas,...
Our objective was to study disparities in access to contraception during the COVID-19 pandemic. We performed a cross-sectional study at the University of Campinas, Brazil using a Google questionnaire applied from December 2021 until February 2022, disseminated via snowball technique. The survey asked about sociodemographic characteristics and contraceptive use, as well as the demand for new methods and difficulties in continuing to use contraceptives during the COVID-19 pandemic. We analyzed 1018 completed questionnaires; in total, 742 (72.9%) were women aged between 20 and 39 years, 746 (73.3%) were White and 602 (59.2%) used contraceptives. During the COVID-19 pandemic, about 23% of respondents changed their method and approximately 20% of respondents looked for new methods. Among the latter, 31.3% reported some difficulty with obtaining guidance on new methods while only 5.3% of the respondents reported some difficulty with continuing their contraceptive. The main difficulty in both cases was the difficulty with getting a healthcare provider appointment. Our results point to a particular epidemiological population, of younger black and biracial women, with lower education and lower income, which suffered health disparities during the COVID-19 pandemic and found difficulties with using contraceptives and accessing family planning services.
Topics: Humans; COVID-19; Brazil; Female; Adult; Cross-Sectional Studies; Young Adult; Contraception; Health Services Accessibility; SARS-CoV-2; Surveys and Questionnaires; Contraception Behavior; Pandemics; Healthcare Disparities
PubMed: 38951554
DOI: 10.1038/s41598-024-65946-w -
Early Intervention in Psychiatry Jul 2024Recent preventative approaches with young people at clinical high risk for psychosis (CHR-P) have focused on the remediation of the cognitive deficits that are readily...
AIM
Recent preventative approaches with young people at clinical high risk for psychosis (CHR-P) have focused on the remediation of the cognitive deficits that are readily apparent and predictive of future illness. However, the small number of trials using cognitive remediation with CHR-P individuals have reported mixed results. The proposed 2-phased study will test an innovative internet-based and remotely-delivered Specific COgnitive REmediation plus Surround (or SCORES) intervention that targets early processing speed deficits in CHR-P adolescents aged 14-20 years old.
METHODS
In the first R61 phase, a single-arm 2-year proof of concept study, 30 CHR-P individuals will receive SCORES for 10 weeks (4 h per week/40 h total) with a midpoint assessment at 20 h (5 weeks) to demonstrate target engagement and identify the optimal dose needed to engage the target. The Go/No-Go criteria to move to the R33 phase will be processing speed scores improving by a medium effect size (Cohen's d ≥ .6). The proposed package includes a set of complimentary support surround procedures to increase enjoyment and ensure that participants will complete the home-based training. In the second R33 phase, a 3-year pilot study, we will replicate target engagement in a new and larger sample of 54 CHR-P individuals randomized to SCORES (optimized dose) or to a video game playing control condition. In addition, the R33 phase will determine if changes in processing speed are associated with improved social functioning and decreasing attenuated positive symptoms. The support surround components of the intervention will remain constant across phases and conditions in the R33 phase to firmly establish the centrality of processing speed training for successful remediation.
CONCLUSIONS
The SCORES study is a completely virtual intervention that targets a core cognitive mechanism, processing speed, which is a rate-limiting factor to higher order behaviours and clinical outcomes in CHR-P adolescents. The virtual nature of this study should increase feasibility as well improve the future scalability of the intervention with considerable potential for future dissemination as a complete treatment package.
PubMed: 38951112
DOI: 10.1111/eip.13587 -
BMJ Open Jul 2024Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain,...
Photobiomodulation therapy for chronic knee pain in obese patients in pre-rehabilitation for bariatric surgery: randomised, placebo-controlled, double-blinded, clinical trial protocol.
INTRODUCTION
Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery.
METHODS AND ANALYSES
This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways.
ETHICS AND DISSEMINATION
This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.
Topics: Humans; Double-Blind Method; Bariatric Surgery; Chronic Pain; Low-Level Light Therapy; Randomized Controlled Trials as Topic; Obesity; Quality of Life; Knee Joint; Pain Measurement; Adult; Arthralgia
PubMed: 38951012
DOI: 10.1136/bmjopen-2023-079864 -
BMJ Open Jul 2024Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource...
Respiratory support with standard low-flow oxygen therapy, high-flow oxygen therapy or continuous positive airway pressure in adults with acute hypoxaemic respiratory failure in a resource-limited setting: protocol for a randomised, open-label, clinical trial - the Acute Respiratory Intervention...
RATIONALE
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.
METHODS
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.
ETHICS AND DISSEMINATION
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04693403.
PROTOCOL VERSION
8 September 2023; version 5.
Topics: Humans; Continuous Positive Airway Pressure; Oxygen Inhalation Therapy; Respiratory Insufficiency; Prospective Studies; Uganda; Adult; Hypoxia; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Acute Disease; Resource-Limited Settings
PubMed: 38951007
DOI: 10.1136/bmjopen-2023-082223 -
BMJ Open Jul 2024The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and... (Randomized Controlled Trial)
Randomized Controlled Trial
Assessing the efficacy of a brief universal family skills programme on child behaviour and family functioning in Gilgit-Baltistan, Pakistan: protocol for a feasibility randomised controlled trial of the Strong Families programme.
PURPOSE
The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and acceptability of the Strong Families programme in enhancing child behaviour and family functioning in low-resource settings in Gilgit-Baltistan, Pakistan.
METHODS AND ANALYSIS
This is a two-arm, multisite feasibility randomised controlled trial with an embedded process evaluation in three districts of Gilgit-Baltistan, namely Gilgit, Hunza and Skardu. 90 families living in these challenged settings, comprising a female primary caregiver aged 18 or above, and at least one child aged 8-15 years, will participate. Participants will be randomly assigned to either receive the Strong Families programme or to the waitlist group. Strong Families is a 7-hour family skills group intervention programme attended by children and their primary caregivers over 3 weeks. The waitlist group will be offered the intervention after their outcome assessment. Three raters will conduct blind assessments at baseline, 2 and 6 weeks postintervention. The primary outcome measures include the feasibility of Strong Families, as determined by families' recruitment and attendance rates, and programme completeness (mean number of sessions attended, attrition rates). The secondary outcomes include assessment of child behaviour, parenting practices, parental adjustment and child resilience. Purposefully selected participants, including up to five caregivers from each site, researchers and facilitators delivering the intervention, will be interviewed. Descriptive statistics will be used to analyse primary and secondary outcomes. The process evaluation will be conducted in terms of programme context, reach, fidelity, dose delivered and received, implementation, and recruitment.
ETHICS AND DISSEMINATION
This study has been approved by the UNODC Drug Prevention and Health Branch in the Headquarters office of Vienna and the National Bioethics Committee of Pakistan. Findings will be disseminated through publication in reputable journals, newsletters and presentations at conferences.
TRIAL REGISTRATION NUMBER
NCT05933850.
Topics: Humans; Pakistan; Child; Feasibility Studies; Adolescent; Female; Child Behavior; Randomized Controlled Trials as Topic; Male; Family Therapy; Program Evaluation; Parenting
PubMed: 38951006
DOI: 10.1136/bmjopen-2023-081557 -
BMJ Open Jul 2024The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population...
INTRODUCTION
The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population of 3.2 million childbearing-age migrant women, most of whom migrated to the city with their husbands for economic reasons. There is a general lack of help-seeking behaviour for mental disorders in China due to the perceived risk of social stigmatisation. In Shanghai, 70% of women did not seek professional help for perinatal mental health problems. We aim to gather information from multiple perspectives, such as the migrant women with PPD and perinatal depression (PND), their caregivers, health service providers and communities, to understand the help-seeking behaviour of postpartum migrant women with PPD or PND in China.
METHODS AND ANALYSIS
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for Scoping Reviews will guide this review. A bilingual research librarian developed a comprehensive search strategy to retrieve published and unpublished English and Chinese studies involving factors influencing women's PPD or PND help-seeking behaviour in China. This literature includes perceptions, views, patterns, acceptance and refusal, tendencies, probability, service accessibility and utilisation, and facts. We will search PubMed, Embase, Web of Science and CINAHL for English literature and CINKI for Chinese literature. Backward and forward snowball approaches will be used to identify additional relevant papers from the reference lists of selected papers. Two independent reviewers will screen the title and abstract and review the full text of selected papers to identify eligible articles for data extraction. We will build a Microsoft Access database to record the extracted data. The results will be presented in tables and a causal map to demonstrate the relationships between extracted variables and help-seeking behaviours for PPD and PND. A conceptual simulation model will be formulated based on the information from the literature to validate the logic of the relationships between variables, identify knowledge gaps and gain insights into potential intervention approaches. Experts and stakeholders will be invited to critique and comment on the results during group model building (GMB) workshops in Shanghai. These comments will be essential to validate the findings, receive feedback and obtain additional insights.
ETHICS AND DISSEMINATION
The literature review component of our study does not require ethical approval because the information and data collected will be obtained from publicly available sources and will not involve human subjects. Our collaborating research partner, International Peach Maternal Child Hospital, obtained the IRB approval (GKLW-A-2023-020-01) for screening and enrolling participants in GMB workshops. Stanford University received IRB approval under protocol number 67 419. The full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report findings.
Topics: Humans; Female; China; Transients and Migrants; Depression, Postpartum; Help-Seeking Behavior; Patient Acceptance of Health Care; Research Design; Pregnancy; Review Literature as Topic
PubMed: 38951005
DOI: 10.1136/bmjopen-2023-082571 -
BMJ Open Jul 2024Critically ill patients are at risk of suboptimal beta-lactam antibiotic (beta-lactam) exposure due to the impact of altered physiology on pharmacokinetics. Suboptimal...
INTRODUCTION
Critically ill patients are at risk of suboptimal beta-lactam antibiotic (beta-lactam) exposure due to the impact of altered physiology on pharmacokinetics. Suboptimal concentrations can lead to treatment failure or toxicity. Therapeutic drug monitoring (TDM) involves adjusting doses based on measured plasma concentrations and individualising dosing to improve the likelihood of improving exposure. Despite its potential benefits, its adoption has been slow, and data on implementation, dose adaptation and safety are sparse. The aim of this trial is to assess the feasibility and fidelity of implementing beta-lactam TDM-guided dosing in the intensive care unit setting.
METHODS AND ANALYSIS
A beta-lactam antibiotic Dose AdaPtation feasibility randomised controlled Trial using Therapeutic Drug Monitoring (ADAPT-TDM) is a single-centre, unblinded, feasibility randomised controlled trial aiming to enroll up to 60 critically ill adult participants (≥18 years). TDM and dose adjustment will be performed daily in the intervention group; the standard of care group will undergo plasma sampling, but no dose adjustment. The main outcomes include: (1) feasibility of recruitment, defined as the number of participants who are recruited from a pool of eligible participants, and (2) fidelity of TDM, defined as the degree to which TDM as a test is delivered as intended, from accurate sample collection, sample processing to result availability. Secondary outcomes include target attainment, uptake of TDM-guided dosing and incidence of neurotoxicity, hepatotoxicity and nephrotoxicity.
ETHICS AND DISSEMINATION
This study has been approved by the Alfred Hospital human research ethics committee, Office of Ethics and Research Governance (reference: Project No. 565/22; date of approval: 22/11/2022). Prospective consent will be obtained and the study will be conducted in accordance with the Declaration of Helsinki. The finalised manuscript, including aggregate data, will be submitted for publication in a peer reviewed journal. ADAPT-TDM will determine whether beta-lactam TDM-guided dose adaptation is reproducible and feasible and provide important information required to implement this intervention in a phase III trial.
TRIAL REGISTRATION NUMBER
Australian New Zealand Clinical Trials Registry, ACTRN12623000032651.
Topics: Humans; Drug Monitoring; Anti-Bacterial Agents; Feasibility Studies; Critical Illness; beta-Lactams; Randomized Controlled Trials as Topic; Intensive Care Units
PubMed: 38951004
DOI: 10.1136/bmjopen-2023-083635 -
BMJ Open Jul 2024Non-small cell lung cancer (NSCLC) has a poor prognosis. Transvascular intervention is an important approach for treating NSCLC. Drug-eluting bead bronchial artery...
BACKGROUND
Non-small cell lung cancer (NSCLC) has a poor prognosis. Transvascular intervention is an important approach for treating NSCLC. Drug-eluting bead bronchial artery chemoembolisation (DEB-BACE) is a technique of using DEBs loaded with chemotherapeutic drugs for BACE. This study aims to conduct a meta-analysis to comprehensively assess the effectiveness and safety of DEB-BACE in treating NSCLC and investigate a novel therapeutic strategy for NSCLC.
METHODS AND ANALYSIS
Wanfang, China National Knowledge Infrastructure, Medline (via PubMed), Cochrane Library, Scopus and Embase databases will be searched in November 2024. A meta-analysis will be conducted to assess the effectiveness and safety of DEB-BACE in the treatment of NSCLC. The following keywords will be applied: "Carcinoma, Non-Small-Cell Lung", "Non-Small Cell Lung Cancer", "Drug-Eluting Bead Bronchial Arterial Chemoembolization" and "drug-eluting beads". Reports in Chinese or English comparing the efficacy of DEB-BACE with other NSCLC treatment options will be included. Case reports, single-arm studies, conference papers, abstracts without full text and reports published in languages other than English and Chinese will not be considered. The Cochrane Handbook for Systematic Reviews of Interventions will be used to independently assess the risk of bias for each included study. In case of significant heterogeneity between studies, possible sources of heterogeneity will be explored through subgroup and sensitivity analysis. For the statistical analysis of the data, RevMan V.5.3 will be used.
ETHICS AND DISSEMINATION
This meta-analysis will seek publication in a peer-reviewed journal on completion. Ethical approval is not required for this study as it is a database-based study.
PROSPERO REGISTRATION NUMBER
CRD42023411392.
Topics: Humans; Antineoplastic Agents; Bronchial Arteries; Carcinoma, Non-Small-Cell Lung; Chemoembolization, Therapeutic; Lung Neoplasms; Meta-Analysis as Topic; Research Design
PubMed: 38951003
DOI: 10.1136/bmjopen-2023-079038 -
BMJ Open Jul 2024Milk fat globule membrane (MFGM) is a complex lipid-protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective... (Randomized Controlled Trial)
Randomized Controlled Trial
Infant formula supplemented with milk fat globule membrane compared with standard infant formula for the cognitive development of healthy term-born formula-fed infants: protocol for a randomised controlled trial.
INTRODUCTION
Milk fat globule membrane (MFGM) is a complex lipid-protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formula-fed full-term infants.
METHODS AND ANALYSIS
This is a randomised, controlled, clinician-blinded, researcher-blinded and participant-blinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group.
ETHICS AND DISSEMINATION
The Women's and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/19/WCHN/140). Caregivers gave written informed consent prior to enrolling in the trial. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
ACTRN12620000552987; Australian and New Zealand Clinical Trial Registry: anzctr.org.au.
Topics: Humans; Glycolipids; Infant Formula; Lipid Droplets; Glycoproteins; Cognition; Infant; Child Development; Female; Infant, Newborn; Male; Randomized Controlled Trials as Topic; Dietary Supplements; Breast Feeding; Milk, Human
PubMed: 38951000
DOI: 10.1136/bmjopen-2023-083399 -
BMJ Open Jul 2024Children and adolescents with recent-onset type 1 diabetes (T1D) commonly maintain a certain level of insulin production during the remission phase, which can last...
INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes.
INTRODUCTION
Children and adolescents with recent-onset type 1 diabetes (T1D) commonly maintain a certain level of insulin production during the remission phase, which can last months to years. Preserving β-cell function can reduce T1D complications and improve glycaemic control. Influenza vaccination has pleiotropic effects and administration of the vaccine during the early phases of T1D may offer β-cell protection. This study aims to assess the effect of influenza vaccination on preserving β-cell function in children and adolescents with recent-onset T1D.
METHODS AND ANALYSIS
The INfluenza VaccInation To mitigate typE 1 Diabetes trial is a randomised, double-blind, placebo-controlled, multicentre trial in paediatric patients with recent-onset T1D aged 7-17 years. 100 participants will be randomised in a 1:1 ratio to receive either a standard inactivated quadrivalent influenza vaccine or a placebo within 14 days of diagnosis. The primary outcome is a difference in mean change (from baseline to 12 months) in C-peptide level between groups during a 2-hour mixed-meal tolerance test. Secondary outcomes include mean change (from baseline to 6 months) in C-peptide levels, haemoglobin A1c, ambulatory glucose profiles and insulin requirements. Exploratory outcomes are diabetes-related autoantibodies, inflammatory markers and serum haemagglutinin inhibition antibody titres against the influenza viruses. The current treatment for T1D is largely symptomatic, relying on insulin administration. There is a pressing need for novel pharmacological approaches aimed at modulating the immune system to preserve residual β-cell function. Existing immunotherapies are cost-prohibitive and associated with multiple side effects, whereas influenza vaccination is inexpensive and generally well tolerated. A positive outcome of this study holds potential for immediate implementation into standard care for children and adolescents with recent-onset T1D and may guide future research on immune modulation in T1D.
ETHICS AND DISSEMINATION
Ethical approval was obtained from Danish Health Authorities prior to participant enrollment. The trial results will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov NCT05585983 and EudraCT Number 2022-500906-17-01.
Topics: Humans; Diabetes Mellitus, Type 1; Adolescent; Child; Influenza Vaccines; Double-Blind Method; Female; Male; Influenza, Human; Glycated Hemoglobin; C-Peptide; Randomized Controlled Trials as Topic; Blood Glucose; Insulin; Vaccination; Insulin-Secreting Cells
PubMed: 38950997
DOI: 10.1136/bmjopen-2024-084808