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Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients

Por: Monet · C. · Piron · L. · Pressac · M. · Molinari · N. · De Jong · A. · Guiu · B. · Jaber · S.
Introduction

In non-intubated patients, symptomatic treatment of hypoxaemic respiratory failure is still debated, with different options: (1) standard oxygen therapy (SOT), (2) high-flow nasal cannula oxygen therapy (HFNC) and (3) non-invasive ventilation (NIV). The objective of this study is to compare the effects of HFNC and NIV on lung volumes assessed by CT scan to allow a better understanding of their effectiveness.

Methods and analysis

The HONIVAH study (High-flow Oxygen therapy and Non-Invasive ventilation on lung Volumes and on upper Airway in Hypoxemic critically ill patients) is an investigator-initiated, prospective, single-centre, physiological, randomised, parallel-group, unblinded trial with an electronic system-based randomisation. Patients with hypoxaemic respiratory failure, defined as the need for SOT flow ≥3 L/min to maintain a pulsed oxygen saturation ≥95%, and a CT scan prescribed by the physician in charge of the patient, will be randomly assigned to the HFNC group or the NIV group. Two inspiratory thoracic CT scans will be performed, one with SOT as part of the routine patient management and a second thoracic CT scan with HFNC or NIV, depending on the allocation group. The primary outcome is the comparison of the relative variation in ‘poorly aerated’ and ‘non-aerated’ lung volumes before and after the intervention between the HFNC group and NIV group, assessed by thoracic CT scan. Secondary outcomes included the variation in tracheal cross-sectional upper airway area, lung volumes, gas exchange and patient comfort.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-mer 1, France, 2022-A02458-35). Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration

ClinicalTrials.gov identifier: NCT05643911.

Surgical Nurses' Perspectives on Low‐Value Care and Non‐Nursing Tasks: A Cross‐Sectional Study

ABSTRACT

Background

Low-value care provides little or no benefit to patients, or its risk of harm outweighs the potential benefits. Non-nursing tasks refer to tasks performed by nurses below their scope of practice. With increasing pressure on the global nursing workforce, it is necessary to identify these concepts to deliver fundamental care.

Aim(s)

To assess the prevalence, influencing factors and associations of low-value nursing care, and to identify non-nursing tasks and potential solutions in surgical hospital care settings.

Design

The study followed a cross-sectional study design using a self-developed questionnaire.

Methods

A questionnaire on low-value care and non-nursing tasks was distributed to surgical wards in four hospitals in The Netherlands.

Results

A total of 302 nurses responded to the survey. Five most prevalent low-value care practices were identified, including routine preoperative fasting (84.8%), taking over blood glucose monitoring (59.3%) and leaving in place any type of venous catheter (42.1%). These practices were mainly performed due to habitual practice, in accordance with an established protocol, or upon physicians' request. Most reported non-nursing tasks were administrative duties and cleaning patient rooms and equipment. Provided solutions included clearly defining responsibilities and taking personal responsibility.

Conclusion

Low-value care, provided by surgical nurses, is common in daily practice. This requires targeted de-implementation of each low-value care practice, based on influencing factors. Additionally, 85.8% of nurses perform non-nursing tasks daily or several times a day, underlining the need to re-organise nursing tasks.

Implications for the Profession and/or Patient Care

De-implementing low-value care and reducing non-nursing tasks is necessary to ease pressure on the global nursing workforce and to improve fundamental care.

Impact

Low-value nursing care and non-nursing tasks persist when nurses lack leadership responsibility.

Reporting Method

STROBE checklist.

Patient or Public Contribution

No patient contribution.

Is the Active Involvement of Family Caregivers in Adult Hospital Care Effective to Improve Patient Outcomes? A Systematic Review

ABSTRACT

Aim

To investigate the effects of active involvement of family caregivers in adult in-hospital care on patients' readmissions, complications, mortality, length of hospital stay, quality of life, psychological distress and activities of daily living, as well as on the satisfaction of patients, HCPs and family caregivers.

Design

Systematic review.

Data Sources

Ovid Medline, Ovid Embase, EBSCO CINAHL, Cochrane Library (from inception to February 2024).

Methods

The PRISMA 2020 statement was followed. Prospective controlled studies focusing on active involvement of family caregivers in adult in-hospital care were included. Two independent teams of authors conducted study selection, quality assessment and data extraction.

Results

Thirteen studies were included, comprising 11 randomised controlled trials. The clinical and methodological heterogeneity precluded a meta-analysis. Six of these studies were performed in stroke patients. Some studies reported statistically significant benefits of active family involvement on readmission rates, hospital LOS, ADL, psychological distress for patients and family members, QoL and satisfaction of family caregivers. However, others did not observe differences in these outcomes. For complication rates, mortality and satisfaction of patients and HCPs, no studies demonstrated significant differences between groups.

Conclusion

Further research is needed to provide a conclusive answer as to whether active family caregiver involvement improves outcomes of adult hospitalised patients.

Implications for Patient Care

Despite the inconclusive findings of this review, advocating for active involvement of family caregivers in adult in-hospital care fits the perspective of patient- and family-centred care.

Impact

As the care of hospitalised adults is shifting to a more family-centric approach, investigating the effects of an active role of family caregivers in adult in-hospital care is necessary. However, the small number of studies available and heterogeneity between studies included in this review hamper firm conclusions. Further evaluations through well-designed studies are required.

Prevention of extubation failure in neurocritical care patients with residual disorder of consciousness: the Brain-Injured Patients Extubation Readiness (BIPER) study protocol for a stepped-wedge cluster-randomised controlled trial

Por: Chabanne · R. · Godet · T. · Andanson · B. · Borrel · P. · Astier · L. · Caumon · E. · Bourguignon · N. · Laclautre · L. · Morand · D. · De Jong · A. · Futier · E. · Constantin · J.-M. · Pereira · B. · Jabaudon · M.
Introduction

In the intensive care unit (ICU), brain-injured patients are frequently exposed to mechanical ventilation to protect the brain and preserve physiology. After intracranial pressure control and sedation withdrawal, this population is prone to residual disorder of consciousness and altered neurological control of respiratory drive, cough and airway protection. Consequently, extubation failure is more frequent than in general ICU patients, and there is no clear evidence-based clinical trigger for extubation. Different risk factors for extubation failure were described in observational trials, and clinical scores were constructed to detect patients at higher risk of extubation failure. Nevertheless, none of these scores were prospectively tested as interventional tools to prevent extubation failure. The Brain-Injured Patients Extubation Readiness (BIPER) study is an ongoing multicentre stepped-wedge cluster-randomised controlled trial aiming to test one of these scores as an intervention protocol to decrease extubation failure in neurocritical care patients with residual disorder of consciousness.

Methods and analysis

Trial design: Stepped-wedge cluster-randomised controlled trial with five groups of three to six clusters (20 ICUs). Groups of clusters are randomised to five possible sequences of nine periods with crossing from a control condition period (usual care for extubation) to an intervention condition period (BIPER-guided extubation protocol), separated by a 3-month transition period.

Participants: Participants are clinically stable brain-injured patients (18–75 years old), requiring more than 48 hours of invasive mechanical ventilation with residual disorder of consciousness after sedation withdrawal, and who achieved a spontaneous breathing trial.

Interventions: The control condition consists of extubation based on usual care and local practice. The intervention condition consists of extubation triggered by a clinical score evaluating deglutition, gag reflex, cough and visual tracking (Coma Recovery Scale-Revised Visual Scale).

Objective: To determine whether adoption of an extubation protocol based on a clinical score can lessen extubation failure compared with usual care in brain-injured patients with residual disorder of consciousness.

Outcome: The primary outcome measure is extubation failure, defined within 5 days following extubation. The key secondary outcome measure is time to effective extubation.

Randomisation: Clusters are allocated to sequence of treatments using random blocks randomisation. The constitution of groups of clusters was stratified according to planned recruitment of each centre.

Blinding: Investigators and outcome assessors are not blinded to condition allocation.

Number of participants: 660 patients (220 in the control condition and 440 in the intervention condition).

Ethics and dissemination

The BIPER trial was approved by an independent ethics committee. The study began on 9 February 2020, and 571 participants are now included. Results will be published in an international peer-reviewed medical journal. 

Trial registration number

NCT04080440.

ProVag: the effect of oral probiotics on the vaginal microbiota composition in women receiving medical assisted reproduction in a Dutch fertility clinic - protocol of a randomised, placebo-controlled, double-blind study

Por: van Haren · A. · Morre · S. A. · Stolaki · M. · de Jonge · J. · Stevens Brentjens · L. · van Golde · R.
Introduction

Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

Methods and analysis

This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethics and dissemination

Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Trial registration number

CCMO NL81210.068.22, registered 25 September 2023.

Testing learning as alternative to the blank slate hypothesis in the honey bee, <i>Apis mellifera</i>

by Olav Rueppell, Kayla De Jong, Jacob J. Herman, Cleo Randall

Reliable recognition of nestmates and discrimination against non-nestmates is key to the integrity of social insect colonies. Cuticular hydrocarbon profiles play a key role in this recognition process in many species, including honey bees. Newly emerged worker bees are largely devoid of cuticular hydrocarbons and therefore believed to represent a “blank slate” that is not discriminated against and instead accepted into other colonies regardless of colony origin. However, instead of being unrecognizable, the absence of cuticular hydrocarbons may also represent a recognizable “Gestalt”. Thus, an alternative hypothesis for the universal acceptance of newly emerged workers may be that older workers in every colony learn the absence of cuticular hydrocarbons as a familiar stimulus that belongs to their colony because other such workers are constantly emerging under normal circumstances. Here, we tested this hypothesis by comparing the response to newly emerged workers between bees that matured in colonies with and without newly emerging bees. Contrary to our prediction, we found no significant difference between these two experimental groups in an aggression bioassay towards newly emerged workers. We thus failed to provide empirical evidence against the blank slate hypothesis. However, the groups displayed significant differences in aggression towards foragers from their own respective colonies, indicating that the emergence of new workers in a colony can affect group discriminatory behavior in honey bees. Furthermore, we identified a negative effect of temperature on aggressive behavior toward newly emerged workers.

Cohort profile: the Dutch oral cavity cancer cohort

Purpose

The Dutch Head and Neck Audit–Oral Cavity (DHNA-OC) cohort was collected to study the quality of care, current treatment and survival for oral cavity cancer (OCC) across all hospitals treating head and neck cancer (HNC) in the Netherlands.

Patients

The DHNA-OC is a registry-based national cohort of 2545 first primary OCC patients treated with curative intent between 2018 and 2021. All 14 HNC hospitals in the Netherlands contributed, guaranteeing national coverage. The DHNA-OC cohort is an elaborate dataset including variables on patient and tumour characteristics, treatment, complications, recurrence rates and survival.

Findings to date

The median age at diagnosis was 67 years and most tumours were early stage (cT1 in 32% and cT2 in 31%). Tongue tumours were most common, and surgery was performed in 91.3% of the patients. The number of included patients per hospital varied from 82 to 367. The proportion of advanced tumour stage varied significantly between hospitals. Substantial data completeness was acquired with only two variables exceeding 10% missing (comorbidities and performance score).

Future plans

The DHNA-OC cohort will be used to study benchmarking of and current knowledge gaps in OCC care. Collaboration with other institutions or national/regional databases is highly encouraged. Some examples of planned studies are the assessment of hospital variation in outcome indicators for surgery and population-based treatment effects. The results of these studies will be used to identify best practices and continue improving the quality of care. Longitudinal cohort follow-up and enrolment will continue prospectively.

Lung cancer screening with volume computed tomography is cost-effective in Greece

by Xuanqi Pan, Katerina Togka, Hilde ten Berge, Lisa de Jong, Harry Groen, Maarten J. Postma, Eleftherios Zervas, Ioannis Gkiozos, Christoforos Foroulis, Kyriaki Tavernaraki, Sofia Lampaki, Georgia Kourlaba, Antonios Moraris, Sofia Agelaki, Konstantinos Syrigos

Objective

This study aimed to assess the cost-effectiveness of lung cancer screening (LCS) employing volume-based low-dose computed tomography (LDCT) in contrast to the absence of screening, targeting an asymptomatic high-risk population in Greece, leveraging the outcomes derived from the NELSON study, the largest European randomized control trial dedicated to LCS.

Methods

A validated model incorporating a decision tree and an integrated state-transition Markov model was used to simulate the identification, diagnosis, and treatments for a population at high risk of developing lung cancer, from a healthcare payer perspective. Screen-detected lung cancers, costs, life years (LYs), quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER) were predicted. Sensitivity and scenario analyses were conducted to assess the robustness and reliability of the model’s outcomes under varying parameters and hypothetical situations.

Results

Annual LCS with volume-based LDCT detected 17,104 more lung cancer patients at early-stage among 207,885 screening population, leading to 8,761 premature lung cancer deaths averted. In addition, in contrast to no screening, LCS yielded 86,207 LYs gained and 50,207 incremental QALYs at an additional cost of €278,971,940, resulting in an ICER of €3,236 per LY and €5,505 per QALY, over a lifetime horizon. These estimates were robust in sensitivity analyses.

Conclusions

LCS with volume-based LDCT, targeting an asymptomatic high-risk population, is highly cost-effective in Greece. Implementing LCS ensures efficient allocation of public healthcare resources while delivering substantial clinical benefits to lung cancer patients.

The initiation of Dutch newly qualified hospital-based midwives in practice, a qualitative study

In the Netherlands, a percentage of newly qualified midwives start work in maternity care as a hospital-based midwife, although prepared particularly for working autonomously in the community.
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