Observational studies suggest that acid suppression may worsen outcomes among patients infected with SARS-CoV-2. The objectives of this embedded substudy of a randomised controlled trial evaluating pantoprazole in mechanically ventilated patients were to (1) describe the clinical characteristics of critically ill patients with SARS-CoV-2, (2) compare clinical outcomes with a propensity-matched non-infected cohort and (3) assess whether pantoprazole’s treatment effects differed by SARS-CoV-2 infection status.
A pre-planned substudy of the re-evaluating the inhibition of stress erosions (REVISE) trial, including a propensity-matched analysis of infected and non-infected patients comparing the effect of pantoprazole between patients with and without SARS-CoV-2.
68 intensive care units (ICUs) in eight countries.
From July 2019 to October 2023, 4821 eligible participants were enrolled in REVISE whether or not they had SARS-CoV-2 infection.
Participants enrolled in REVISE with SARS-CoV-2 infection had additional data collection, including biomarkers, venous thromboembolism, SARS-CoV-2 therapies and tracheostomy timing. The primary outcomes were clinically important upper gastrointestinal bleeding and 90-day mortality. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, patient-important upper GI bleeding, renal replacement therapy, ICU and hospital mortality and duration of mechanical ventilation, ICU and hospital stay.
Of the eligible trial cohort, 11.9% (540/4550) had SARS-CoV-2; 532 patients had additional SARS-CoV-2-specific data collection. Of these 532 patients, 87.8% received COVID-19-directed treatments—(dexamethasone 75.2%), 11.7% developed pulmonary embolism and 9.2% developed deep-vein thrombosis. After propensity matching, SARS-CoV-2 infection was not associated with clinically important upper gastrointestinal bleeding (adjusted HR 0.78, 95% CI 0.40 to 1.50) but was associated with significantly higher ICU, hospital and 90-day mortality, as well as longer duration of ventilation and ICU and hospital length of stay. The effect of pantoprazole on clinically important upper GI bleeding and 90-day mortality was consistent regardless of SARS-CoV-2 status.
SARS-CoV-2 infection was associated with higher mortality and longer duration of mechanical ventilation, ICU and hospital stays, without an increased risk of clinically important upper gastrointestinal bleeding. Pantoprazole reduced clinically important upper gastrointestinal bleeding without adversely affecting other outcomes.
REVISE trial (NCT03374800), SARS-CoV-2 cohort study (
With improvements in in vitro culture techniques, there has been a steady shift in practice to transfer in vitro fertilisation (IVF) embryos at the blastocyst-stage to increase pregnancy rates per embryo transfer (ET) and reduce the risk of multiple pregnancy. In patients with fewer embryos (≤5 zygotes), fresh cleavage-stage ET is still commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst-stage in vitro. However, evidence for improved outcomes with cleavage-stage embryo transfer in this subgroup of patients is lacking. We will compare blastocyst-stage to cleavage-stage ET with regard to cumulative live birth rates (CLBR) per oocyte retrieval and other patient-centred cycle outcomes in patients with ≤5 zygotes.
Multicentre, randomised pragmatic comparative effectiveness trial with superiority design comparing blastocyst-stage to cleavage-stage ET in patients with ≤5 zygotes. This trial will enrol and randomise 1126 women aged 18–44 undergoing IVF to either fresh cleavage-stage or blastocyst-stage ET at eleven IVF centres. Surplus embryos will be vitrified at the blastocyst-stage. The primary outcome is the CLBR per oocyte retrieval. Secondary outcomes include: multiple pregnancy, pregnancy loss
The Institutional Review Board at Beth Israel Deaconess Medical Center (BIDMC) provides central regulatory oversight. Results will inform timing of embryo transfer in patients with ≤5 zygotes and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants.
Very preterm infants (
Australasian multicentre, two-arm, parallel-group, prospective, randomised, open, blinded-endpoint superiority trial in 868 infants born less than 32 weeks’ gestation. Infants are randomised to cycled environmental light and noise or routine care in a non-cycled hospital environment from soon after birth until discharge home. The intervention comprises wearing eye-masks and ear plugs from 20:00 to 6:00, followed by removal of these devices and exposure to normal environmental noise and 300-600 lux light from 6:00 to 20:00. The primary outcome is composite cognitive score on Bayley-4 developmental assessment at 2 years corrected postnatal age.
The trial is approved by the Child and Adolescent Health Service Human Research Ethics Committee under the National Mutual Acceptance Scheme in Australia. Infants are randomised to intervention or control group after informed parental consent is obtained. Results of the CIRCA DIEM Study will be disseminated widely via presentations at local, national and international conferences, publication in international peer-reviewed journals and inclusion on the study website. Information about trial findings will also be communicated directly to the parents/guardians of trial participants through the regular study newsletter. The trial investigators will seek opportunities to communicate study results to the lay public through media and social media avenues.
ANZCTRN12618000371291.
Peer support is being integrated into the new maternal mental health services in England to further the development of the recovery approach in relation to loss. Psychological support after miscarriage (pregnancy loss prior to viability) is often overlooked, despite significant psychological morbidity. This systematic review explored the effectiveness of peer support interventions to improve mental health outcomes after miscarriage.
Systematic review
A comprehensive systematic search across nine databases (MEDLINE, CINAHL, APA PsycINFO, Web of Science (all databases), EMBASE, CENTRAL, LENS.org, British Nursing Index and Health Management Information Consortium) was conducted in June 2025. Grey literature was identified through website searching, contact with topic experts and a national call for evidence.
Study designs with a quantitative evaluative component or mixed-methods studies reporting effectiveness were eligible if they involved women and/or partners who had experienced miscarriage and been offered a peer support intervention. Any peer support versus control (no treatment, wait list and usual care) or peer support versus another psychosocial intervention was eligible for inclusion. Studies that report any of the following broad groups of outcomes (whether validated measures or by self-report) were eligible for inclusion: (a) personal recovery, (b) mental health recovery, (c) health service use and (d) social outcomes.
Two independent reviewers used standardised methods to search and screen for eligible studies.
Of the 4342 titles screened, 100 potentially relevant full-text papers were retrieved and screened resulting in seven randomised controlled trials and two controlled trials identified across 10 papers. Of these, seven did not evaluate a peer-led intervention, one reported only on women who had experienced pregnancy loss later than 24 weeks gestation, and one reported a peer support intervention for those who experienced pregnancy loss at any age of gestation but did not disaggregate data for those who experienced miscarriage. Thus, no studies were eligible for inclusion. This indicates a significant gap in the current literature. The inconsistencies and limitations in existing research approaches are explored in detail.
This systematic review has identified an evidence gap as there is currently no robust evidence for the effectiveness of peer support interventions after miscarriage. Given the drive for the inclusion of peer support in new maternal mental health services, there is therefore a need for targeted intervention research to provide reliable evidence to determine effective peer support interventions for this population.
CRD42024518248
Miscarriage, defined in the UK as loss of pregnancy prior to 24 weeks gestation, can have long-term psychological implications. Clinical guidelines for perinatal bereavement care do not provide guidance on how best to support the mental health of women, and their partners, after miscarriage. Peer support (support from those who share common characteristics) is often sought, but there is little understanding of its access and use. We conducted a systematic review to understand the barriers to and facilitators of the implementation of peer support to improve mental health outcomes for parents after miscarriage.
Systematic review and thematic synthesis.
A comprehensive systematic search across nine databases (MEDLINE, CINAHL, APA PsycINFO, Web of Science (all databases), EMBASE, CENTRAL, LENS.org, British Nursing Index and Health Management Information Consortium) was conducted in June 2025. Grey literature was identified through website searching, contact with topic experts and a national Call for Evidence.
Qualitative and mixed-methods studies exploring motivations, experiences and preferences for peer support after miscarriage were included.
Two independent reviewers used standardised methods to search, screen, extract and code included studies. Suitable studies were evaluated using the Critical Appraisal Skills Programme Qualitative Research Checklist. Findings were extracted and subjected to a thematic synthesis.
Across nine studies included in the review, three overarching themes were developed, with seven subthemes, capturing both barriers and facilitators. ‘Engaging in relational recognition’ reflects the validation and connection that arise through experiential resonance, often heightened by the context of exclusion from broader social or clinical support. ‘Mechanisms of Communality’ describe how communality is enacted through dynamic peer interactions, including modelling and facilitating grief, benchmarking physical change and mattering through reciprocity, highlighting mutual support and shared coping. ‘Dynamics of Access’ consider factors which shape engagement, including changing needs of individuals across time and modalities of support and their effects.
These findings form the first synthesis of peer support after miscarriage and bring a nuanced service user perspective of barriers and facilitators by examining evidence from diverse studies. Peer support after miscarriage was seen to be a dynamic, relational process shaped by shared experience, mutual exchange and context-specific factors. Findings underscore key policy and practice considerations, including the use of trauma-informed, loss-sensitive approaches and consideration of intersectionality, that should be reflected when offering peer support services, with and for, those who have experienced miscarriage.
CRD42024518248.
Early detection of infection in superficial skin wounds remains a critical determinant of healing outcomes, particularly in paediatric populations, where developmental and behavioural factors often limit clinical assessment. Traditional diagnostic approaches, including visual inspection and culture-based microbiology, are constrained by subjectivity and diagnostic delay. Over the past decade, several innovative technologies have emerged that enable earlier, more objective identification of pathogenic activity in wounds. This focused mini-review summarizes recent advances in novel imaging, biosensor-enabled smart dressings, and molecular diagnostics, with an emphasis on the mechanisms, clinical evidence, and applicability to superficial wound care. Collectively, these technologies represent a shift toward precision wound diagnostics that may facilitate earlier intervention, reduce unnecessary antimicrobial exposure, and improve healing outcomes.
To systematically map the landscape of central venous access device research from 2014 to 2024, identifying critical gaps in evidence that may impact nursing practice and patient outcomes across the full device lifecycle from selection through to removal.
This review was conducted in accordance with the Guidance for producing a Campbell evidence and gap map and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
PubMed, Cumulative Index to Nursing and Allied Health Literature Complete, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched with additional hand-searching of reference lists from included reviews.
We systematically reviewed literature published between 2014 and 2024, mapping 710 studies on central venous access device interventions and outcomes. Studies were categorised by design, population, setting, device characteristics, intervention types, and outcomes. Evidence was evaluated using the National Health and Medical Research Council levels of evidence framework.
Of 710 included studies, 89 were systematic reviews and 621 primary studies, of which 41.1% (n = 292) were randomised controlled trials. Research was primarily conducted in high-income countries (n = 405, 65.2%) and focused on adults (n = 370, 59.6%) in hospital inpatient settings (n = 588, 94.7%). Catheter insertion and infection prevention dominated the evidence base, while device selection and removal procedures were less studied. Infection outcomes were extensively reported (bloodstream infection: n = 455, 13.6% of 3349 outcomes), while patient-reported outcomes (n = 218, 6.5%) and cost (n = 60, 1.8%) were underrepresented.
This review reveals that central venous access device research is predominantly focused on insertion and infection prevention while other key parts of nursing practice are under-supported.
Future nursing research should address these gaps to improve evidence-based care across diverse populations and healthcare contexts, particularly focusing on understudied device types, settings, and vulnerable populations.
This review was conducted and reported in accordance with the Guidance for producing a Campbell evidence and gap map.
This study did not include patient or public involvement in its design, conduct, or reporting.
Although the positive correlation between self-efficacy and quality of life and the negative correlation between symptom occurrence and self-efficacy are well established in the cancer literature, the underlying mechanism, whether self-efficacy mediates the effect of symptoms on quality of life, remains unclear due to the cross-sectional design of prior studies. Longitudinal investigation is crucial for establishing the causal mechanism of self-efficacy in mitigating the adverse impact of cancer-related symptoms on quality of life.
To examine the longitudinal mediating effect of self-efficacy on the relationship between symptom occurrence and quality of life among 534 cancer patients on treatment with moderate to high symptoms.
This is a secondary data analysis of the longitudinal mediating effect. A sample of patients with moderate to high symptoms on cancer treatments (N = 534) from a randomised controlled trial was used. We adopted a cross-lagged panel model (CLPM) approach to test the longitudinal mediating effect with three waves. The longitudinal invariance of the measurement was previously tested.
The results showed that cancer-coping self-efficacy predicted the following assessment of symptom occurrence, but not vice versa. Also, cancer-coping self-efficacy had an immediate direct impact on quality of life and the influence sustained to the following assessment. Our mediating analysis showed that cancer-coping self-efficacy totally mediated the relationship between symptom occurrence and quality of life (unstandardized β = −0.008, standardised B = −0.036, p = 0.036, CI95 = [−0.001, −0.016]).
Our findings provide initial evidence supporting the causal mechanism of cancer-coping self-efficacy in interventions that aim for symptom management and quality of life improvement.
This study is the first to test the longitudinal mediating mechanism of cancer-coping self-efficacy in the relationship between symptom occurrence and quality of life among the cancer population. Further testing using a randomised controlled trial of a specifically designed self-efficacy-enhancing intervention is needed.
No patient or public contribution.
by Liubov Arbeeva, Virginia B. Kraus, Amanda E. Nelson, Maryalice Nocera, Leigh F. Callahan, Richard F. Loeser, Kenneth L. Cameron, Jesse R. Trump, Stephen W. Marshall, Yvonne M. Golightly
PurposeTo investigate the longitudinal relationships between serum biomarkers of joint metabolism, knee injury, and Knee Injury and Osteoarthritis Outcome Score (KOOS) using novel methodologies.
MethodsData were collected from military officers who enrolled as cadets between 2004–2009, with follow-up conducted between 2015–2017. Analyses included 234 officers who had no history of knee ligament/meniscal injury at the time of military academy matriculation, had serum biomarker measurements at matriculation and graduation, demographic data, and KOOS assessment at follow-up. Biomarkers included Collagen Type II (C2C) and Type I and II (C1,2C) collagenase-generated cleavage epitopes, C-terminal propeptide of Type II collagen (CPII), and C- and N-terminal telopeptides of type I collagen (CTX and NTX). Angle-based Joint and Individual Variation Explained (AJIVE) was used to determine demographic determinants of biomarker levels and individual modes of variation specific to biomarker levels at matriculation and graduation, stratified by sex.
ResultsWe confirmed known associations of joint metabolism biomarkers with age in both sexes and with smoking in males. Matriculation biomarker data in males suggested a protective biomarker profile characterized by high cartilage synthesis and low cleavage of type I and II collagen in association with healthy KOOS scores at follow-up. CPII measured at matriculation was negatively associated with incident injuries after adjustment for smoking status (p = 0.03, logistic regression), confirming results from AJIVE.
ConclusionThese exploratory analyses suggest that CPII alone, or in combination with other joint metabolism biomarkers, may help identify individual risk of knee injury.
The Cancer Behaviour Inventory–Brief Version was designed to assess cancer-coping self-efficacy in clinical and research settings where minimising patient burden is essential. However, there is no evidence of its longitudinal validity. Although widely used in cancer research, the lack of evidence for longitudinal invariance significantly undermines its validity in studies spanning multiple time points. Establishing longitudinal invariance enables valid comparisons over time, enhancing our confidence in applying it in longitudinal research.
To examine the factor structure of the measurement and test its longitudinal invariance across four time points in cancer patients experiencing moderate-to-high symptoms during curative cancer treatment.
A longitudinal psychometric evaluation.
This is a secondary data analysis of a randomised controlled trial in patients with moderate-to-high symptoms undergoing cancer treatment (N = 534). We conducted longitudinal invariance tests for the measurement using four time points. Other psychometric tests included confirmatory factor analysis, reliability analyses and correlations.
Our confirmatory factor analysis supported the four-factor, 12-item structure for the Cancer Behaviour Inventory–Brief Version. Items 1 and 6 were found to be moderately correlated. The resulting 12-item measure demonstrated good internal consistency, with convergent and divergent validity supported by correlations with selected instruments. Finally, longitudinal invariance was tested, which revealed strict measurement invariance across four time points (CFI = 0.930, RMSEA = 0.045, SRMA = 0.056).
We found that the factor structure of the Cancer Behaviour Inventory–Brief Version remained stable over four time points in a sample of patients having moderate to high symptoms under cancer treatment. This supports its accountability for examining the changes in cancer-coping self-efficacy among cancer patients over time in longitudinal studies.
This study confirms that Cancer Behaviour Inventory–Brief Version has adequate internal consistency and demonstrated evidence of construct validity. Our conclusion of strict longitudinal invariance supports its credibility for continuous assessment of cancer-coping self-efficacy to evaluate patient outcomes and intervention processes over time in clinical and research settings.
No patient or public contribution.
by Tyler Marshall, Karin Olson, Adam Abba-Aji, Xin-Min Li, Richard Lewanczuk, Sunita Vohra
BackgroundShared decision-making (SDM) is a process in which healthcare providers (HCPs) and patients make health-related decisions collaboratively, guided by the best available evidence. Previous research suggests that emerging adults (aged 18–29) with mental health concerns might prefer SDM over traditional approaches; however, it remains unclear whether prevalent symptoms of anxiety, depression, or health-related quality of life (HRQL) are associated with the level of SDM that occurs during a clinical encounter.
ObjectiveThis study explored whether prevalent symptoms of anxiety, depression or HRQL among emerging adults were associated with the perceived level of SDM involvement during a single clinic visit at a primary care or community addiction and mental health (AMH) setting.
MethodsA cross-sectional survey was conducted using a subset of data (emerging adults and their HCPs) obtained from an overarching study on SDM in adults (18–64 years) in Alberta, Canada. Sociodemographic data were collected and reported descriptively. SDM was the primary outcome variable and was measured dyadically (i.e., the mean score between HCPs and patients) using the Alberta Shared Decision-Making Instrument (ASK-MI). Symptoms of patient anxiety/depression and HRQL were measured using the Hospital Anxiety and Depression Scale (HADS) and the EQ-5D-5L. Pearson R correlation matrices were conducted to explore relationships between SDM, anxiety/depression, HRQL, and demographic variables.
ResultsForty-two emerging adult patients and 31 HCP dyads were recruited from six community AMH settings and eight primary care settings. The mean SDM dyad rating was 8.69 (SD, ± 2.01), indicating an “excellent” level of SDM. Symptoms of anxiety, depression, and HRQL were not significantly correlated with SDM dyad ratings during the clinic visit. Post hoc analyses showed that patient age was inversely related to SDM dyad ratings; R = −0.34, p = 0.03.
DiscussionIn this study, emerging adults reported high levels of perceived engagement in SDM, regardless of their HRQL or symptoms of anxiety and depression. However, several limitations, such as the risk of performance bias, should be considered when interpreting these findings. To strengthen the evidence base, future research should aim to address these limitations.
To explore the implementation contexts and strategies that influence the uptake and selection of alternative peripherally inserted central catheter (PICC) materials and design.
Qualitative evaluation of end user perspectives within a randomized control trial of different PICC materials and design.
Semi-structured interviews with key stakeholders were undertaken via an adapted, rapid-analytic approach using the Consolidated Framework for Implementation Research. Outcomes were mapped against the Expert Recommendations for Implementing Change (ERIC) tool for strategies to guide innovation in PICC practice.
Participants (n = 23) represented a combination of users and inserters/purchasers, from adult and paediatric settings. Dominant themes included intervention characteristics (intervention source), inner setting (structural characteristics) and individuals involved (self-efficacy). Strategies emerging to support a change from ERIC mapping (n = 16) included promotion of intervention adaptability, inclusion of staff and consumer perspectives and sufficient funding. Implementation contexts such as inner setting and individuals involved equally impacted PICC success and implementation effectiveness and enabled a greater understanding of barriers and facilitators to intervention implementation in this trial.
Trial evidence is important, but healthcare decision-making requires consideration of local contexts especially resourcing. Implementation contexts for Australian healthcare settings include a practical, strategic toolkit for the implementation of alternative PICC materials and designs.
This study adhered to COREQ guidelines.
No patient or public contribution.