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A minimal common outcome measure set for COVID-19 clinical research
Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.
Journal Article
Oral GS-5806 Activity in a Respiratory Syncytial Virus Challenge Study
Respiratory syncytial virus is a common cause of illness and hospitalization, especially among infants and immunocompromised persons, but there are no accepted antiviral therapies. In this RSV challenge study, GS-5806, a new compound, showed activity against RSV.
Respiratory syncytial virus (RSV) infection accounts for substantial morbidity and mortality among infants
1
–
7
and is the most common reason for hospitalization of infants in the United States,
8
with an even greater outpatient burden of disease. Estimates indicate that among children younger than 2 years of age, the annual rate of RSV-related hospitalization is 5.2 per 1000, the rate of emergency department encounters is 32 to 57 per 1000, and the rate of outpatient visits is 66 to 177 per 1000.
2
Among infants younger than 1 year of age, the risk of death from respiratory causes is increased by a . . .
Journal Article
Impact of a smartphone app on prescriber adherence to antibiotic guidelines in adult patients with community acquired pneumonia or urinary tract infections
Mobile phone apps have been shown to enhance guideline adherence by prescribers, but have not been widely evaluated for their impact on guideline adherence by prescribers caring for inpatients with infections.
To determine whether providing the Auckland City Hospital (ACH) antibiotic guidelines in a mobile phone app increased guideline adherence by prescribers caring for inpatients with community acquired pneumonia (CAP) or urinary tract infections (UTIs).
We audited antibiotic prescribing during the first 24 hours after hospital admission in adults admitted during a baseline and an intervention period to determine whether provision of the app increased the level of guideline adherence. To control for changes in prescriber adherence arising from other factors, we performed similar audits of adherence to antibiotic guidelines in two adjacent hospitals.
The app was downloaded by 145 healthcare workers and accessed a total of 3985 times during the three month intervention period. There was an increase in adherence to the ACH antibiotic guidelines by prescribers caring for patients with CAP from 19% (37/199) to 27% (64/237) in the intervention period (p = 0.04); but no change in guideline adherence at an adjacent hospital. There was no change in adherence to the antibiotic guidelines by prescribers caring for patients with UTI at ACH or at the two adjacent hospitals.
Provision of antibiotic guidelines in a mobile phone app can significantly increase guideline adherence by prescribers. However, providing an app which allows easy access to antibiotic guidelines is not sufficient to achieve high levels of prescriber adherence.
Journal Article
Fetal Loss and Preterm Birth Caused by Intraamniotic Haemophilus influenzae Infection, New Zealand
Invasive Haemophilus influenzae infection during pregnancy can cause preterm birth and fetal loss, but the mechanism is unclear. We investigated 54 cases of pregnancy-associated invasive H. influenzae disease in 52 unique pregnancies in the Auckland region of New Zealand during October 1, 2008‒September 30, 2018. Intraamniotic infection was identified in 36 (66.7%) of 54 cases. Outcome data were available for 48 pregnancies. Adverse pregnancy outcomes, defined as fetal loss, preterm birth, or the birth of an infant requiring intensive/special care unit admission, occurred in 45 (93.8%) of 48 (pregnancies. Fetal loss occurred in 17 (35.4%) of 48 pregnancies, before 24 weeks’ gestation in 13 cases, and at >24 weeks’ gestation in 4 cases. The overall incidence of pregnancy-associated invasive H. influenzae disease was 19.9 cases/100,000 births, which exceeded the reported incidence of pregnancy-associated listeriosis in New Zealand. We also observed higher rates in younger women and women of Māori ethnicity.
Journal Article
Occult Suicidality and Psychiatric Disease Among Emergency Department Patients with Low-acuity Chief Complaints
Patients presenting to emergency departments (ED) are often screened for suicidality, even when their chief complaint does not involve mental health concerns. Patient receptiveness to ED-based mental health screening and intervention is unknown, particularly among patients with low-acuity chief complaints, who often prioritize rapid evaluation and discharge.
This cross-sectional study included adults with low-acuity chief complaints presenting to an urban, academic ED in the Northeastern United States during daytime and evening hours, from 2015 to 2016. Participants completed validated mental health screening instruments, including the Suicide Behaviors Questionnaire-Revised and the Patient Health Questionnaire-4. Participants were also asked to rate the importance of addressing mental health concerns during their ED visit.
We approached 1,688 patients, and 816 (48.4%) consented to participate in the study. Of these, 27% screened positive for anxiety and 25% screened positive for depression. Even among patients with no prior depression history, 17% were at high risk of depression. Eleven percent of participants were at high risk for suicidal behavior, including 5% of those with no reported history of depression or bipolar disorder. Thirty-five percent of patients at risk for suicide and 53% of those at high risk of depression thought it was important or very important to address these issues during the ED visit.
Symptoms of mental health disorders were common among this group of ED patients presenting with low-acuity chief complaints. Patients often desired to address these mental health concerns as part of their ED visit.
Journal Article
The OECD and transnational governance
A timely and insightful volume, The OECD and Transnational Governance fills an important gap in the literature on global governance.
eBook
Community-Onset Genitourinary Tract Infection due to CTX-M-15–Producing Escherichia coli among Travelers to the Indian Subcontinent in New Zealand
A series of patients are described who presented to a New Zealand hospital with genitourinary tract infection due to CTX-M-15-producing Escherichia coli. All had a history of travel to the Indian subcontinent and lacked traditional risk factors for urinary tract infection due to a multidrug-resistant organism.
Journal Article
Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter?
ObjectivesPrevious studies have shown that a majority of patients cite altruistic motives, such as contributing to generalisable medical knowledge, as factors motivating clinical trial participation. We sought to examine the impact of making trial results publicly available on patients' willingness to participate in clinical research.DesignCross-sectional analysis using a questionnaire developed by a panel with expertise in publication bias, informed consent and survey design.SettingA single urban, academic emergency department (ED) in the Northeastern USA.Participants799 ED patients.Outcome MeasuresWe assessed (1) participants' attitudes towards clinical trial participation, and (2) the impact of whether study results would eventually be made publicly available or not on willingness to participate in a trial.ResultsOf 799 patients surveyed, 36% (95% CI 32% to 39%) reported that they would generally like to participate in a trial, and another 50% (95% CI 47% to 54%) reported that they would consider participation depending on study details. For the majority of participants, the publication of trial results was either important (36%; 95% CI 33% to 40%) or very important (48%; 95% CI 44% to 51%). Most (63%; 95% CI 59% to 66%) reported they would be less likely to participate in a trial if investigators had not publicly released results from a prior study. Additionally, 85% (95% CI 82% to 87%) felt that it was important or very important to receive information about the publication track record of sponsors and investigators during the informed consent process.ConclusionsThe majority of patients in this sample would consider participation in a clinical trial. Patients value the public release of trial results, and believe that the informed consent process should address the possibility of non-publication.
Journal Article
The effects of advanced factor analysis approaches on outcomes in randomised trials for depression: protocol for secondary analysis of individual participant data
Modern psychometric methods make it possible to eliminate nonperforming items and reduce measurement error. Application of these methods to existing outcome measures can reduce variability in scores, and may increase treatment effect sizes in depression treatment trials.
We aim to determine whether using confirmatory factor analysis techniques can provide better estimates of the true effects of treatments, by conducting secondary analyses of individual patient data from randomised trials of antidepressant therapies.
We will access individual patient data from antidepressant treatment trials through Clinicalstudydatarequest.com and Vivli.org, specifically targeting studies that used the Hamilton Rating Scale for Depression (HRSD) as the outcome measure. Exploratory and confirmatory factor analytic approaches will be used to determine pre-treatment (baseline) and post-treatment models of depression, in terms of the number of factors and weighted scores of each item. Differences in the derived factor scores between baseline and outcome measurements will yield an effect size for factor-informed depression change. The difference between the factor-informed effect size and each original trial effect size, calculated with total HRSD-17 scores, will be determined, and the differences modelled with meta-analytic approaches. Risk differences for proportions of patients who achieved remission will also be evaluated. Furthermore, measurement invariance methods will be used to assess potential gender differences.
Our approach will determine whether adopting advanced psychometric analyses can improve precision and better estimate effect sizes in antidepressant treatment trials. The proposed methods could have implications for future trials and other types of studies that use patient-reported outcome measures.
Journal Article