Objective: To describe parents' motivations for and against participation in neonatal research, including the views of those who declined participation.
Study Design: We performed 44 semi-structured, qualitative interviews of parents approached for neonatal research. Here we describe their motivations for and against participation.
The survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well-conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.
View Article and Find Full Text PDFObservational studies are notoriously susceptible to bias, and parallel-group randomized trials are important to identify the best overall treatment for eligible patients. Yet, such trials can be expected to be a misleading indicator of the best treatment for some subgroups or individual patients. In selected circumstances, patients can be treated in n-of-1 trials to address the inherent heterogeneity of treatment response in clinical populations.
View Article and Find Full Text PDFBackground: The COVID-19 pandemic affected home and work routines, which may exacerbate existing academic professional disparities. Objectives were to describe the impact of the pandemic on pediatric faculty's work productivity, identify groups at risk for widening inequities, and explore mitigation strategies.
Methods: A cross-sectional study of faculty members was conducted at nine U.
Background: Vaccination of pregnant patients with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccine during influenza season can reduce maternal and fetal morbidity and mortality; nevertheless, vaccination rates remain suboptimal in this patient population. To investigate the effect of a brief educational counseling session on maternal Tdap and influenza vaccination and determine factors influencing women's decision in regards to receiving Tdap and or influenza vaccine during their pregnancy.
Methods: A face-to-face semi-structured cross-sectional survey was administered to postpartum patients on their anticipated day of discharge (June 11-August 21, 2018).
Background: The single patient (n-of-1) trial can be used to resolve therapeutic uncertainty for the individual patient. Treatment alternatives are systematically tested against each other, generating patient-specific data used to inform an individualized treatment plan. We hypothesize that clinical decisions informed by n-of-1 trials improve patient outcomes compared to usual care.
View Article and Find Full Text PDFHarv Data Sci Rev
September 2022
The ethical and regulatory oversight of any clinical activity related to human subjects is commonly determined based on its categorization as either clinical practice or research. Prominent bioethicists have criticized the traditional distinctions used to delineate these categories, calling them counterproductive and outmoded, and arguing that learning and clinical practice should be deliberately and appropriately integrated. Personalized trials represent a clinical activity with characteristics that overlap both categories, making ethical and regulatory oversight requirements less straightforward.
View Article and Find Full Text PDFDuring the Coronavirus Disease 2019 (COVID-19) epidemic, many health professionals used social media to promote preventative health behaviors. We conducted a randomized controlled trial of the effect of a Facebook advertising campaign consisting of short videos recorded by doctors and nurses to encourage users to stay at home for the Thanksgiving and Christmas holidays ( NCT04644328 and AEARCTR-0006821 ). We randomly assigned counties to high intensity (n = 410 (386) at Thanksgiving (Christmas)) or low intensity (n = 410 (381)).
View Article and Find Full Text PDFUnlabelled: During the COVID-19 epidemic, many health professionals started using mass communication on social media to relay critical information and persuade individuals to adopt preventative health behaviors. Our group of clinicians and nurses developed and recorded short video messages to encourage viewers to stay home for the Thanksgiving and Christmas Holidays. We then conducted a two-stage clustered randomized controlled trial in 820 counties (covering 13 States) in the United States of a large-scale Facebook ad campaign disseminating these messages.
View Article and Find Full Text PDFDuring the COVID-19 epidemic, many health professionals started using mass communication on social media to relay critical information and persuade individuals to adopt preventative health behaviors. Our group of clinicians and nurses developed and recorded short video messages to encourage viewers to stay home for the Thanksgiving and Christmas Holidays. We then conducted a two-stage clustered randomized controlled trial in 820 counties (covering 13 States) in the United States of a large-scale Facebook ad campaign disseminating these messages.
View Article and Find Full Text PDFMultisystem inflammatory syndrome in children is a severe illness associated with the SARS-CoV-2 pandemic that possesses features overlapping with other pediatric diseases causing systemic inflammation. Significant diagnostic and treatment uncertainty remain, and clinicians should maintain a broad differential when evaluating patients for multisystem inflammatory syndrome in children, as antibiotic-susceptible infections such as murine typhus may present similarly.
View Article and Find Full Text PDFBackground: Acute flaccid myelitis is characterized by acute-onset flaccid limb weakness with predominantly gray matter lesions in the spinal cord spanning one or more segments. Rates of full recovery are poor, and there is no standard treatment or definitive cause.
Methods: This is a retrospective review of children diagnosed with acute flaccid myelitis in Texas during 2016.
We report a 15 year-old Nigerian adolescent male with chronic osteomyelitis caused by an extensively drug-resistant (XDR) strain of sequence type 773 (ST773) carrying and an extended spectrum β-lactamase (ESBL)-producing strain. The patient developed neurological side effects in the form of circumoral paresthesia with polymyxin B and asymptomatic elevation of transaminases with aztreonam (used in combination with ceftazidime-avibactam). Cefiderocol treatment for 14 weeks plus bone implantation resulted in apparent cure and avoided amputation.
View Article and Find Full Text PDFThe impact of antibiotic therapy on the diagnosis of healthcare-associated ventriculitis and meningitis (HCAVM) is unknown. Antibiotics were administered before obtaining cerebrospinal fluid (CSF) in 217 out of 326 (66%) patients with HCAVM, and they impacted the sensitivity of the cerebrospinal fluid Gram stain and culture ( ≤ .004).
View Article and Find Full Text PDFBackground: Large epidemiologic studies evaluating the etiologies, management decisions and outcomes of infants and children with meningitis and encephalitis in the United States are lacking.
Methods: Children 0-17 years of age with meningitis or encephalitis as assessed by International Classification of Diseases, Ninth Revision, codes available in the Premier Healthcare Database during 2011-2014 were analyzed.
Results: Six thousand six hundred sixty-five patients with meningitis or encephalitis were identified; 3030 (45.
Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake.
View Article and Find Full Text PDFWe report voriconazole levels in an infant with disseminated Candida glabrata infection who received combination antifungal therapy and rescue voriconazole treatment. Serum and cerebrospinal fluid voriconazole levels were higher than anticipated and above target. Dose reduction did not lead to a reduction in the blood or cerebrospinal fluid levels.
View Article and Find Full Text PDFBackground: Aseptic meningitis represents a common diagnostic and management dilemma to clinicians.
Objectives: To compare the clinical epidemiology, diagnostic evaluations, management, and outcomes between adults and children with aseptic meningitis.
Study Design: We conducted a retrospective study from January 2005 through September 2010 at 9 Memorial Hermann Hospitals in Houston, TX.
Background: Viral central nervous system (CNS) infections are typically characterized by a cerebrospinal fluid (CSF) lymphocytic pleocytosis. A CSF neutrophilic pleocytosis presentation has been described, but its prognostic and clinical significance is unknown. The objectives of this study were to (1) compare the clinical and laboratory characteristics of viral CNS infections with a CSF neutrophilic pleocytosis to those with a lymphocytic pleocytosis, and (2) evaluate factors associated with an adverse clinical outcome.
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