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Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Por: Messika · J. · Eloy · P. · Boulate · D. · Charvet · A. · Fessler · J. · Jougon · J. · Lacoste · P. · Mercier · O. · Portran · P. · Roze · H. · Sage · E. · Thes · J. · Tronc · F. · Vourc'h · M. · Montravers · P. · Castier · Y. · Mal · H. · Mordant · P. · Investigators from the ECMOToP Study
Introduction

Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis

We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination

The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number

NCT05664204.

Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerou

Por: Hartman · T. J. · Christie · J. · Wilson · A. · Ziegler · T. R. · Methe · B. · Flanders · W. D. · Rolls · B. J. · Loye Eberhart · B. · Li · J. V. · Huneault · H. · Cousineau · B. · Perez · M. R. · O'Keefe · S. J. D.
Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.

Evaluating the long-term impact of large-scale trainings: an exposure based cross-sectional study on female genital mutilation-related knowledge, attitudes and practices among Sudanese midwives in Khartoum State

Por: Ahmed · W. · Abdelrahim · M. · Gloyd · S. · Farquhar · C. · Puttkammer · N.
Objectives

To examine the long-term impact of large-scale training targeting midwives in a setting where they are the main female genital mutilation (FGM) practitioners. We hypothesised that trained midwives would have significantly higher knowledge, greater opposition to midwives’ involvement in this practice, and improved clinical practice in FGM prevention and care compared with non-trained midwives.

Design

We conducted an exposure based cross-sectional study, using closed-ended and open-ended questions during phone interviews.

Setting

Khartoum State in Sudan has a high prevalence of FGM (88%) mainly performed by midwives.

Participants

Midwives who received (n=127) and did not receive FGM training (n=55).

Primary and secondary outcome measures

We developed primary outcomes aligned to the three levels (reaction, learning and behaviour) of Kirkpatrick’s training evaluation model for descriptive and multivariable analyses in Stata.

Results

All the midwives interviewed were female, mostly village midwives (92%) and worked in health centres (89%). The mean age and midwifery experience was 51 years (SD=10) and 23 years (SD=12), respectively. Overall, most midwives (>90%) reported being supportive of FGM discontinuation. Midwives who had FGM training were more aware that performing FGM violates code of conduct (p=0.001) and reported to always counsel patients to abandon FGM (p

Conclusion

Though past trainings were associated with higher knowledge and greater opposition to midwives’ involvement in FGM, this was not translated into appropriate corrective clinical procedures among affected women during labour. The Sudan Ministry of Health invested heavily in training midwives and it would be important to investigate why trained midwives do not implement recommended FGM-related clinical management.

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

Por: Williams · A. J. · Cleare · S. · Borschmann · R. · Tench · C. R. · Gross · J. · Hollis · C. · Chapman-Nisar · A. · Naeche · N. · Townsend · E. · Slovak · P. · On behalf of Digital Youth · Creswell · Fonagy · Arseneault · Lloyd · Mendes · Holter · Jirotka · Lazar · Patalay · Kelly · Ka
Introduction

Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

Methods and analysis

The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.

Ethics and dissemination

Ethical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

Trial registration number

NCT06025942.

Effects of armed conflict on maternal and infant health: a mixed-methods study of Armenia and the 2020 Nagorno-Karabakh war

Por: Rostomian · L. · Chiloyan · A. · Hentschel · E. · Messerlian · C.
Introduction

Armed conflict worldwide and across history has harmed the health of populations directly and indirectly, including generations beyond those immediately exposed to violence. The 2020 war between Armenia and Azerbaijan over Nagorno-Karabakh, inhabited by an ethnically Armenian population, provides an example of how conflict harmed health during COVID-19. We hypothesised that crises exposure would correspond to decreased healthcare utilisation rates and worse health outcomes for the maternal and infant population in Armenia, compounded during the pandemic.

Methods

Following a mixed-methods approach, we used ecological data from 1980 to 2020 to evaluate health trends in conflict, measured as battle-related deaths (BRDs), COVID-19 cases, and maternal and infant health indicators during periods of conflict and peace in Armenia. We also interviewed 10 key informants about unmet needs, maternal health-seeking behaviours and priorities during the war, collecting recommendations to mitigate the effects of future crisis on maternal and infant health. We followed a deductive coding approach to analyse transcripts and harvest themes.

Results

BRDs totalled more in the 2020 war compared with the previous Nagorno-Karabakh conflicts. Periods of active conflict between 1988–2020 were associated with increased rates of sick newborn mortality, neonatal mortality and pre-eclampsia or eclampsia. Weekly average COVID-19 cases increased sevenfold during the 2020 Nagorno-Karabakh war. Key informants expressed concerns about the effects of stress and grief on maternal health and pregnancy outcomes and recommended investing in healthcare system reform. Participants also stressed the synergistic effects of the war and COVID-19, noting healthcare capacity concerns and the importance of a strong primary care system.

Conclusions

Maternal and infant health measures showed adverse trends during the 2020 Nagorno-Karabakh war, potentially amplified by the concurrent COVID-19 pandemic. To mitigate effects of future crises on population health in Armenia, informants recommended investments in healthcare system reform focused on primary care and health promotion.

Acceptability of aspirin for cancer preventive therapy: a survey and qualitative study exploring the views of the UK general population

Por: Lloyd · K. E. · Hall · L. H. · Ziegler · L. · Foy · R. · Green · S. M. C. · MacKenzie · M. · Taylor · D. G. · Smith · S. G. · Aspirin for Cancer Prevention AsCaP Steering Committee · Cuzick · Balkwill · Bishop · Burn · Chan · Crooks · Hawkey · Langley · McKenzie · Nedjai · Patrign
Objectives

Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy.

Design

We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants’ acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework.

Setting

Online survey and remote interviews.

Participants

We recruited 400 UK respondents aged 50–70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents.

Results

In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals.

Conclusions

Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Cost-effectiveness analysis of probiotic peanut oral immunotherapy (PPOIT) versus placebo in Australian children with peanut allergy alongside a randomised trial

Por: Huang · L. · Dalziel · K. · Lloyd · M. · Loke · P. · Lozinsky · A. C. · Tang · M.
Objective

To compared the cost-effectiveness of coadministration of a probiotic adjuvant with peanut oral immunotherapy (PPOIT) with placebo (no treatment) in children with peanut allergy.

Design

Prospectively planned cost-effectiveness analysis alongside a randomised control trial.

Setting

The Royal Children’s Hospital, Melbourne, Australia.

Participants

56 children with peanut allergy aged 1–10 years at recruitment.

Intervention

A daily dose of probiotic Lactobacillus rhamnosus CGMCC 1.3724 (NCC4007) and peanut oral immunotherapy administered for 1.5 years.

Main outcomes measures

Costs were considered from a healthcare system perspective and included costs of treatment delivery and adverse events. Effectiveness outcomes included rate of sustained unresponsiveness (SU) and quality-adjusted life years (QALYs). The cost-effectiveness of PPOIT versus placebo was analysed using patient-level data. Time horizon was 10 years from commencement of PPOIT treatment, comprising 1.5 years of treatment (actual data), 4 years of post-treatment follow-up (actual data), and 4.5 years of extrapolation thereafter (modelling).

Results

Healthcare cost per patient over 10 years was higher for PPOIT compared with placebo ($A9355 vs $A1031, p

Conclusions

Cost per QALY gained using PPOIT compared with no treatment is approximately $A20 000 (£10 000) and is well below the conventional value judgement threshold of $A50 000 (£25 000) per QALY gained, thus deemed good value for money ($A1= £0.5 approximately).

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12608000594325; Post-results.

Evaluation of laser power stability of repeatedly used SubCyclo probe in micropulse transscleral cyclophotocoagulation for glaucoma: A step towards sustainable ophthalmic surgery

by Pukkapol Suvannachart, Ploysai Rujkorakarn, Thanita Watha, Parinya Srihatrai

Purpose

To evaluate the laser power stability of the SubCyclo probe for micropulse transscleral cyclophotocoagulation after repeated use.

Materials and methods

This experimental study involved 6 new probes. Each probe was connected to the SubCyclo mode (2,000 mW power, 31.3% duty cycle, and 100 seconds duration) of the Vitra 810 laser delivery system (Quantel Medical, France). Laser power measurements were taken using a calibrated laser power meter (Nova, Ophir Optronics Solutions, Israel) every 10 seconds from 10 to 90 seconds during each of the 40 cycles. Intra-rater reliability was assessed using intraclass correlation (ICC). A linear mixed model for repeated measures and pairwise comparisons with Bonferroni adjustment were used for the analysis.

Results

The mean (SD) power outputs of all probes for the first cycle and all cycles were 421.9 (19.7) mW and 436.7 (16.1) mW, respectively. During the first cycle, the mean (SD) laser power gradually decreased from 444.3 (13.4) mW at 10 seconds to 407.3 (17.0) mW at 90 seconds (Fig 3). For all cycles, the power was 446.0 (13.6) mW at 10 seconds and gradually declined to 426.8 (21.0) mW at 90 seconds. Pairwise comparisons revealed significant differences in mean laser power outputs after 16 cycles of repeated use compared to the first cycle. The ICC estimate (95% CI) for intra-rater reliability was 0.96 (0.89, 0.99).

Conclusions

The SubCyclo probe maintains stable laser power outputs throughout repeated use for up to 16 cycles, with a significant increase observed after 16 cycles.

Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

by Petek Eylul Taneri, Jamie J. Kirkham, Eleanor J. Molloy, Linda Biesty, Richard A. Polin, James L. Wynn, Barbara J. Stoll, Niranjan Kissoon, Kondwani Kawaza, Mandy Daly, Aoife Branagan, Lívia Nagy Bonnard, Eric Giannoni, Tobias Strunk, Magdalena Ohaja, Kenneth Mugabe, Denise Suguitani, Fiona Quirke, Declan Devane

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients’ parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.

Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous

Por: Ng · K. · Metcalf · R. · Sacco · J. · Kong · A. · Wheeler · G. · Forsyth · S. · Bhat · R. · Ward · J. · Ensell · L. · Lowe · H. · Spanswick · V. · Hartley · J. · White · L. · Lloyd-Dehler · E. · Forster · M.
Introduction

Head and neck cancer is the eighth most common cancer in the UK. Current standard of care treatment for patients with recurrent/metastatic squamous cell head and neck carcinoma (HNSCC) is platinum-based chemotherapy combined with the anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, cetuximab. However, most patients will have poor median overall survival (OS) of 6–9 months despite treatment. HNSCC tumours exhibit an immune landscape poised to respond to immunotherapeutic approaches, with most tumours expressing the immunosuppressive receptor programmed death-ligand 1 (PD-L1). We undertook the current study to determine the safety and efficacy of avelumab, a monoclonal antibody targeting the interaction between PD-L1 and its receptor on cytotoxic T-cells, in combination with cetuximab.

Methods and analysis

This is a multi-centre, single-arm dose de-escalation phase II safety and efficacy study of avelumab combined with cetuximab; the study was to progress to a randomised phase II trial, however, the study will now complete after the safety run-in component. Up to 16 participants with histologically/cytologically recurrent/metastatic squamous cell carcinoma (including HNSCC) who have not received cetuximab previously will be recruited. All patients will receive 10 mg/kg avelumab and cetuximab (500, 400 or 300 mg/m2 depending on the cohort open at time of registration) on days 1 and 15 of 4-week cycles for up to 1 year, (avelumab not given cycle 1 day 1). A modified continual reassessment method will be used to determine dose de-escalation. The primary objective is to establish the safety of the combination and to determine the optimum dose of cetuximab. Secondary objectives include assessing evidence of antitumour activity by evaluating response rates and disease control rates at 6 and 12 months as well as progression-free and OS.

Ethics and dissemination

Approval granted by City and East REC (18/LO/0021). Findings will be published in peer-reviewed journals and disseminated at conferences.

Trial registration number

NCT03494322.

Supporting adolescents participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens (RT4T) hybrid type III implementation-effectiveness trial

Por: Kelly · H. T. · Smith · J. J. · Verdonschot · A. · Kennedy · S. G. · Scott · J. J. · McKay · H. · Nathan · N. · Sutherland · R. · Morgan · P. J. · Salmon · J. · Penney · D. · Boyer · J. · Lloyd · R. S. · Oldmeadow · C. · Reeves · P. · Pursey · K. · Hua · M. · Longmore · S. · Norman · J. · Vo
Introduction

In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.

Objective

To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.

Methods and analysis

We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p

Ethics and dissemination

Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.

Trial registration number

ACTRN12622000861752.

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