Conectar
Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.
Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.
The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.
NCT05575128,
Early sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood culture, broad-spectrum antibiotics, 30 mL/kg crystalloid for hypotension/lactate ≥4 mmol/L and vasopressors for hypotension during/after fluid resuscitation within 1 hour of sepsis recognition) is low across healthcare settings. Delays in sepsis recognition and a lack of high-quality evidence hinder its implementation. We propose a novel sepsis care model (National Early Warning Score, NEWS-1 care), in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS-2 (≥5). This study aims to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation trial on the NEWS-1 care in multiple EDs.
We will conduct a pilot type 1 hybrid trial and prospectively recruit 200 patients from 4 public EDs in Hong Kong cluster randomised in a stepped wedge design over 10 months. All study sites will start with an initial period of standard care and switch in random order at 2-month intervals to the NEWS-1 care unidirectionally. The implementation evaluation will employ mixed methods guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, which includes qualitative and quantitative data from focus group interviews, staff survey and clinical record reviews. We will analyse the 14 feasibility outcomes as progression criteria to a full-scale trial, including trial acceptability to patients and staff, patient and staff recruitment rates, accuracy of sepsis screening, protocol adherence, accessibility to follow-up data, safety and preliminary clinical impacts of the NEWS1 care, using descriptive statistics.
The institutional review boards of all study sites approved this study. This study will establish the feasibility of a full-scale hybrid trial. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities.
Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.
The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.
Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.
Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.
This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.
This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences.
Despite advancement in vaccines and treatments for COVID-19 over the past 2 years, many concerns remain about reinfection and waning immunity against COVID-19 and its variants, especially among people with substance use disorder (SUD). The study assessed the risk of COVID-19 reinfection and severe illness among adults with SUD and their vaccination status to inform management in this vulnerable population as the pandemic continues.
Retrospective cohort study.
Nationwide electronic health records (TriNetX database) in the USA among adults with COVID-19 infection from January 2020 to June 2022.
Adults (age ≥18 years) who were infected by COVID-19, excluding those who had cancer or lived in nursing homes or palliative care facilities.
COVID-19 reinfection was defined as a new diagnosis after 45 days of the initial infection. Logistic regression was applied to assess the OR of COVID-19 reinfection and severe outcomes within 30 day of reinfection for adults with alcohol (AUD), opioid (OUD), cocaine (CUD), stimulant (STUD), cannabis (CAUD) and other use disorders, controlled for demographic and comorbid conditions.
The SUD cohort was 13%–29% more likely to be reinfected by COVID-19 and had significantly higher 30-day mortality. Adults with AUD, STUD and OUD were at greater risks (adjusted ORs, AORs=1.69–1.86) of emergency department, hospital and intensive care admissions after 30 days of reinfection. Individuals with SUD and multiple vaccines doses were associated with decreased risks of worse COVID-19 outcomes. Lower COVID-19 reinfection rates (AORs=0.67–0.84) were only found among individuals with AUD, CUD or CAUD who had COVID-19 vaccination.
Individuals with SUD had greater risks of COVID-19 reinfection and poor outcomes, especially those with OUD, STUD and AUD. Multiple vaccinations are recommended to reduce severe illness after COVID-19 reinfection in the SUD population.
Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.
This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg-1 min-1 and titrated per protocol. The primary outcome is the dose of norepinephrine required to maintain a mean arterial pressure ≥65 mm Hg. Secondary outcomes include vasopressin or epinephrine requirement and duration of hypotension. Safety outcomes include incidence of thromboembolism within 48 hours of the end of surgery and severe hypertension. An intention-to-treat analysis will be performed for all randomised subjects receiving the study drug. The total dose of norepinephrine will be compared between the two arms by a one-tailed Mann-Whitney U test.
The trial protocol was approved by the local Institutional Review Board (#20–30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.
FreshRSS 