Waiver informed consent

BACKGROUND: Bladder cancer is the sixth most common malignancy in the United States (US). Despite its high prevalence and the significant potential benefits of early detection, no reliable, cost-effective screening algorithm exists for asymptomatic patients at risk. Nonetheless, reports of incidentally identified early bladder cancer on CT/MRI scans performed for other indications are emerging in the literature. This represents a new opportunity for early detection, with over 80 million CT scans performed in the US yearly, 40% of which are abdominopelvic CTs...

OBJECTIVE: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. METHODS: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres...

INTRODUCTION: Pelvic exenteration (PE) surgery represents the only potentially curative treatment option for patients with locally advanced or recurrent rectal cancer (LARRC). Given the potential morbidity, whether or not PE should be recommended for an individual patient presents a major decisional conflict. This study aims to identify the outcomes of PE for which there is consensus among patients, carers and clinicians regarding their importance in guiding treatment decision-making, and to develop a risk prediction tool which predicts these outcomes...

PURPOSE: The United States' National Institutes of Health (NIH) have long challenged academia to improve clinical trial enrollment, especially in underrepresented populations; inclusive of geography, age, disability status, racial and ethnic minorities. It has been shown that rural and urban residents enrolled in clinical trials have similar outcomes, yet, rural healthcare systems struggle to provide opportunities to rural residents to participate in clinical trials when infrastructure is limited or unsupportive of research programs and/or research staffing levels are insufficient...

Background Tuberculosis (TB) is among the leading causes of infectious death worldwide. Contact investigation is an evidence-based, World Health Organisation-endorsed intervention for timely TB diagnosis, treatment, and prevention but has not been widely and effectively implemented. Methods We are conducting a stepped-wedge, cluster-randomised, hybrid Type III implementation-effectiveness trial comparing a user-centred to a standard strategy for implementing TB contact investigation in 12 healthcare facilities in Uganda...

INTRODUCTION: With progress in the 'diagnose', 'link' and 'retain' stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include 'data to care' (D2C)-using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers...

BACKGROUND: Treatment for stroke is time-dependent, and ambulance services play a vital role in the early recognition, assessment and transportation of stroke patients. Innovations which begin in ambulance services to expedite delivery of treatments for stroke are developing. However, research delivery in ambulance services is novel, developing and not fully understood. AIMS: To synthesise literature encompassing ambulance service-based randomised controlled interventions for acute stroke with consideration to the characteristics of the type of intervention, consent modality, time intervals and issues unique to research delivery in ambulance services...

Tygerberg Hospital (TBH) is a tertiary level hospital in the Western Cape of South Africa that serves a large, low to middle income population with centralised advanced cardiac care. Acute coronary syndrome (ACS) remains an important cause of death in the region, despite a high burden of communicable diseases, including people living with human immunodeficiency virus (PLHIV).   Objectives. We sought to describe the incidence of ST elevation myocardial infarction (STEMI) and high-risk non-ST elevation ACS (HR-NSTEACS) in the TBH referral network, describe the in-hospital and 30-day mortality of these patients and identify important high-risk population characteristics...

Undertaking research involving vulnerable groups, such as those requiring resuscitation involves careful analysis during the ethical review process. When a person lacks the capacity to make an informed choice about their participation in a research study, a waiver of consent offers an alternative. This paper is based on a doctoral research study using ethnography to explore the resuscitative practices and experiences of rural nurses through observation and interviews. This paper aims to explore the ethical issues raised by the Human Research Ethics Committee relating to consent of vulnerable patients requiring resuscitation within a rural context...

Background phase errors in 4D Flow MRI may negatively impact blood flow quantification. In this study, we assessed their impact on cerebrovascular flow volume measurements, evaluated the benefit of manual image-based correction, and assessed the potential of a convolutional neural network (CNN), a form of deep learning, to directly infer the correction vector field. With IRB waiver of informed consent, we retrospectively identified 96 MRI exams from 48 patients who underwent cerebrovascular 4D Flow MRI from October 2015 to 2020...

BACKGROUND: The COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct. METHODS: A systematic scoping review was performed by searching PubMed and Embase...

Emergency research studies are high-stakes studies that are usually performed on the sickest patients, where many patients or guardians have no opportunity to provide full informed consent prior to participation. Many emergency studies self-select healthier patients who can be informed ahead of time about the study process. Unfortunately, results from such participants may not be informative for the future care of sicker patients. This inevitably creates waste and perpetuates uninformed care and continued harm to future patients...

BACKGROUND: Tygerberg Hospital (TBH) is a tertiary-level hospital in Western Cape Province, South Africa, that provides healthcare to a large low- to middle-income population with services including centralised advanced cardiac care. Acute coronary syndrome (ACS) remains an important cause of death in the region despite a high burden of communicable diseases, including HIV. OBJECTIVES: To describe the incidence of ST-elevation myocardial infarction (STEMI) and high-risk non-ST-elevation ACS (HR-NSTEACS) in the TBH referral network, describe the in-hospital and 30-day mortality of these patients, and identify important high-risk population characteristics...

BACKGROUND: Tygerberg Hospital (TBH) is a tertiary-level hospital in Western Cape Province, South Africa, that provides healthcare to a large low- to middle-income population with services including centralised advanced cardiac care. Acute coronary syndrome (ACS) remains an important cause of death in the region despite a high burden of communicable diseases, including HIV. OBJECTIVES: To describe the incidence of ST-elevation myocardial infarction (STEMI) and high-risk non-ST-elevation ACS (HR-NSTEACS) in the TBH referral network, describe the in-hospital and 30-day mortality of these patients, and identify important high-risk population characteristics...

INTRODUCTION: Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically unwell patients. New-onset AF (NOAF) affects 5%-11% of all admissions and up to 46% admitted with septic shock. NOAF is associated with increased morbidity, mortality and healthcare costs. Existing trials into the prevention and management of NOAF suffer from significant heterogeneity making comparisons and inferences limited. Core outcome sets (COS) aim to standardise outcome reporting, reduce inconsistency between trials and reduce outcome reporting bias...

BACKGROUND: The Utrecht Cardiovascular Cohort - CardioVascular Risk Management (UCC-CVRM) was set up as a learning healthcare system (LHS), aiming at guideline based cardiovascular risk factor measurement in all patients in routine clinical care. However, not all patients provided informed consent, which may lead to participation bias. We aimed to study participation bias in a LHS by assessing differences in and completeness of cardiovascular risk management (CVRM) indicators in electronic health records (EHRs) of consenting, non-consenting, and non-responding patients, using the UCC-CVRM as an example...

INTRODUCTION: People who inject drugs (PWID) are at risk of invasive infections such as bloodstream infections, endocarditis, osteomyelitis and septic arthritis. Such infections require prolonged antibiotic therapy, but there is limited evidence about the optimal care model to deliver to this population. The Epidemiology and Management of invasive infections among people who Use drugs (EMU) study aims to (1) describe the current burden, clinical spectrum, management and outcomes of invasive infections in PWID; (2) determine the impact of currently available models of care on completion of planned antimicrobials for PWID admitted to hospital with invasive infections and (3) determine postdischarge outcomes of PWID admitted with invasive infections at 30 and 90 days...

INTRODUCTION: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of oral olanzapine is more effective than a dose of oral diazepam at successfully sedating young people with ASBD...

INTRODUCTION: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of intramuscular olanzapine is more effective than intramuscular droperidol at successfully sedating young people with ASBD requiring intramuscular sedation...

INTRODUCTION: Antibiotics are time-critical in the management of sepsis. When infectious organisms are unknown, patients are treated with empiric antibiotics to include coverage for gram-negative organisms, such as antipseudomonal cephalosporins and penicillins. However, in observational studies, some antipseudomonal cephalosporins (eg, cefepime) are associated with neurologic dysfunction while the most common antipseudomonal penicillin (piperacillin-tazobactam) is associated with acute kidney injury (AKI)...