Publications by authors named "Elizabeth A Sugar"
Background: Key to the success of any prospective cohort study is the effective recruitment and retention of participants, but the specific factors that influence younger adults of the Millennial generation to participate in research are not well-understood. The objective of this qualitative study was to identify factors that motivated participation and engagement in longitudinal research studies focused on respiratory health among a diverse group of young adults.
Methods: We conducted qualitative, semi-structured interviews with 50 younger adult participants (aged 25-35 years) regarding factors influencing their participation in longitudinal research studies.
Article Synopsis
- The study aimed to explore the relationship between four definitions of bronchodilator response (BDR) and asthma control in a large group of participants with poorly controlled asthma.
- Researchers analyzed data from 931 participants, focusing on changes in lung function after using albuterol and how this related to asthma control and symptoms.
- Findings revealed that while BDR was observed in a significant number of participants, it did not correlate with asthma control or symptom burden, raising doubts about the relevance of BDR in clinical assessments for asthma management.
Purpose: To evaluate the rate of, risk factors for, and outcomes of cataract surgery in patients with intermediate, posterior, and panuveitides treated with systemic corticosteroids and immunosuppression.
Design: Cohort study of participants from a randomized clinical trial.
Methods: A multicenter clinical trial with extended follow-up comprised the study setting.
Background: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention.
Objective: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial.
Purpose: To evaluate the effectiveness of 3 different intravitreal treatments for persistent or recurrent uveitic macular edema (ME): dexamethasone implant, methotrexate, and ranibizumab.
Design: Single-masked, randomized controlled clinical trial.
Participants: Patients with minimally active or inactive uveitis and persistent or recurrent uveitic ME in one or both eyes.
Background: Vitamin D insufficiency is associated with risk of multiple sclerosis (MS) relapse; whether supplementation influences prognosis is unknown. The Vitamin D to Ameliorate MS (VIDAMS) trial aimed to determine if high dose (5000 International Units (IU)/day) versus low dose (600 IU/day) vitamin D added to daily glatiramer acetate (GA), reduced the risk of clinical relapse in people with established relapsing remitting MS (RRMS) over 96 weeks.
Methods: VIDAMS is a randomised, phase 3, double-blind, multi-centre, controlled trial conducted at sixteen neurology clinics in the United States.
Background: Of the only 20% of patients with resectable pancreatic ductal adenocarcinoma (rPDA), cancer recurs in 80% of cases. Epigenetic dysregulation is an early hallmark of cancer cells acquiring metastatic potential, and epigenetic modulators may reactivate tumor suppressor genes, delay recurrence, and sensitize PDA to future chemotherapy.
Methods: This was a randomized phase II study (NCT01845805) of CC-486 (oral DNA methyltransferase inhibitor azacitidine) vs.
Article Synopsis
- Uveitides are over 30 diseases causing inflammation in the eye, often treated with oral corticosteroids and immunosuppressants, complicating clinical trials due to their rarity and diverse characteristics.
- Many trials have faced challenges with efficacy measures, leading to unclear results and difficulties in recruitment due to the need for a specific outcome measure for each disease.
- A promising approach involves using a single outcome focusing on successful corticosteroid sparing (inactive uveitis with low prednisone) to streamline assessment, which is currently being tested in the ADVISE Trial.
Article Synopsis
- A study assessed the feasibility of using neoadjuvant therapy with cabozantinib and nivolumab for patients with hepatocellular carcinoma (HCC) who might not qualify for traditional surgical resection.
- Out of 15 participants, 80% had successful surgeries with negative margins, and 42% exhibited significant tumor response following treatment.
- The analysis of biospecimens revealed that responders had a notable immune profile, including T effector cells and B cell arrangements, suggesting an enhanced immune response against the tumor in those patients.
: We evaluated risk factors and demographic characteristics of associated with mild cognitive impairment (MCI) in patients with COPD. : 220 individuals with COPD enrolled in a cohort study designed to evaluate anxiety conducted at 16 clinical centers. Cognitive impairment was assessed with the Montreal Cognitive Assessment (MoCA), a cutoff score of <26 defined as MCI.
View Article and Find Full Text PDFPurpose: To evaluate the long-term outcomes of uveitic macular edema (ME).
Design: Longitudinal follow-up of a cohort of participants in a randomized clinical trial.
Participants: A total of 248 eyes of 177 participants with uveitic ME enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.
Purpose: To evaluate the responsiveness of quality of life (QoL) metrics to ocular and systemic events in patients with noninfectious uveitis.
Design: Cohort study using randomized controlled trial data.
Participants: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study.
Background: Biomarkers that can predict loss of asthma control among patients being considered for step-down therapy in well-controlled disease are lacking.
Objective: To evaluate whether baseline biomarkers of type 2 airway inflammation and/or serial measurement of fractional exhaled nitric oxide (Feno) predict loss of asthma control as therapy is stepped down.
Methods: In subanalyses of a multicenter randomized, double-blind, parallel 3-arm trial comparing strategies for step-down therapy in well-controlled asthma (Long-Acting Beta-Agonist Step-Down Study), we assessed whether baseline atopy as determined by serum aeroallergen allergy screening test (Phadiatop), baseline serum eosinophil peroxidase, or baseline or serial Feno measurements during follow-up predicted the time to loss of asthma control among participants.
Purpose: To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, "implant") therapy.
Design: Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
Purpose: This phase II study tested granulocyte-macrophage colony-stimulating factor (GM-CSF)-allogeneic pancreatic tumor cells (GVAX) and ipilimumab in metastatic pancreatic ductal adenocarcinoma (PDA) in the maintenance setting.
Patients And Methods: Patients with PDA who were treated with front-line chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible. Patients were randomized 1:1 to treatment with GVAX and ipilimumab given every 3 weeks for four doses then every 8 weeks (Arm A) or to FOLFIRINOX continuation (Arm B).
Purpose: Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated -expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B).
Patients And Methods: Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B.
Background: The Hedgehog (Hh) signalling pathway is overexpressed in pancreatic ductal adenocarcinoma (PDA). Preclinical studies have shown that Hh inhibitors reduce pancreatic cancer stem cells (pCSC), stroma and Hh signalling.
Methods: Patients with previously untreated metastatic PDA were treated with gemcitabine and nab-paclitaxel.
Background And Objective: The reduction of forced expiratory volume in 1 s (FEV ) in response to methacholine challenge in asthma may reflect two components: airway narrowing, assessed by the change in FEV /forced vital capacity (FVC), and airway closure, assessed by the change in FVC. The purpose of this study was to determine the degree and determinants of airway closure in response to methacholine in a large group of asthmatic patients participating in studies conducted by the American Lung Association-Airways Clinical Research Centers (ALA-ACRC).
Methods: We used the methacholine challenge data from participants in five studies of the ALA-ACRC to determine the closing index, defined as the contribution of airway closure to the decrease in FEV , and calculated as %ΔFVC/%ΔFEV .
Background: Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage.
View Article and Find Full Text PDFImportance: Numerous interventions have improved prescription of venous thromboembolism (VTE) prophylaxis; however, many prescribed doses are not administered to hospitalized patients, primarily owing to patient refusal.
Objective: To evaluate a real-time, targeted, patient-centered education bundle intervention to reduce nonadministration of VTE prophylaxis.
Design, Setting, And Participants: This nonrandomized controlled, preintervention-postintervention comparison trial included 19 652 patient visits on 16 units at The Johns Hopkins Hospital, Baltimore, Maryland, from April 1 through December 31, 2015.
Purpose: To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI).
Design: Multicenter, randomized clinical trial.
Participants: Patients with uveitic ME.
Anxiety is a common comorbidity of chronic obstructive pulmonary disease (COPD) that is associated with higher morbidity and mortality. We evaluated three anxiety screening questionnaires: the Generalized Anxiety Disorder 7-Item Scale (GAD-7), the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and the Anxiety Inventory for Respiratory Disease (AIR). To evaluate and compare the test performance characteristics of three anxiety screening questionnaires, using the Mini-International Neuropsychiatric Interview (MINI), version 7.
View Article and Find Full Text PDFRationale: Although national and international guidelines recommend reduction of asthma controller therapy or "step-down" therapy in patients with well-controlled asthma, it is expected that some individuals may experience worsening of asthma symptoms or asthma exacerbations during step-down. Characteristics associated with subsequent exacerbations during step-down therapy have not been well defined. The effect of environmental tobacco smoke exposure on risk of treatment failure during asthma step-down therapy has not been reported.
View Article and Find Full Text PDFBackground: Stepping down therapy when asthma is well controlled on combination inhaled corticosteroids (ICSs) and long-acting beta-agonists (LABAs) is recommended, but it is not known whether lowering the ICS dose or stopping LABA is superior.
Objective: To evaluate whether step-down therapy with LABA is superior to one without; and, secondarily, to evaluate whether reducing the ICS dose while maintaining LABA is noninferior to remaining on stable-ICS/LABA.
Methods: The study was a randomized, double-masked 3-arm parallel group trial in participants aged 12 years or older.