Search

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. Methods: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. Results: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33% (26/79) of all adolescents were Black, 57% (45/79) were male, and 61% (48/79) had a household income of

Nonadherence to asthma medications is prevalent among adolescents and young adults (AYAs) with asthma, leading to worsened control of asthma symptoms and more frequent exacerbations. AYAs have unique developmental transitional challenges that may alter medication adherence. We aimed to use a socio-ecological framework to explore the effect of transitional challenges from adolescence to young adulthood on asthma controller medication adherence and to identify possible strategies to promote medication adherence. We conducted qualitative semi-structured interviews by phone with 7 adolescents (14 to 17 years), their respective caregivers, and 7 young adults (18 to 30 years). Participants were recruited from a respiratory clinical trial network and pulmonary clinics in 4 states at 6 different sites through convenience sampling. Interviews were audio recorded, transcribed and coded using thematic analyses. Participants identified personal challenges affecting adherence to asthma medications during the transition from adolescence to young adulthood including responsibility for asthma self-management, understanding of asthma condition and severity, embarrassment, and life demands. Health systems factors including medication cost, challenges with insurance, difficulties obtaining refills, and difficulty with access to medications at school also impacted asthma medication adherence. Participants recommended adherence strategies including improved access to inhalers, incorporating asthma medications into daily routines, and using reminders. Focusing on the transitional challenges of AYAs during the time period from adolescence to young adulthood is necessary for supporting their asthma medication adherence and creating future interventions. Socio-ecological and systems factors should also be targeted for improved asthma medication adherence. Supplemental data for this article can be accessed online at . [ABSTRACT FROM AUTHOR]

The uveitides consist of >30 diseases characterized by intraocular inflammation. Noninfectious intermediate, posterior, and panuveitides typically are treated with oral corticosteroids and immunosuppression, with a similar treatment approach for most diseases. Because these uveitides collectively are considered a rare disease, single-disease trials are difficult to impractical to recruit for, and most trials have included several different diseases for a given protocol treatment. However, measures of uveitis activity are disease specific, resulting in challenges for trial outcome measures. Several trials of investigational immunosuppressive drugs or biologic drugs have not demonstrated efficacy, but design problems with the outcome measures have limited the ability to interpret the results. Successful trials have included diseases for which a single uveitis activity measure suffices or a composite measure of uveitis activity is used. One potential solution to this problem is the use of a single, clinically relevant outcome, successful corticosteroid sparing, defined as inactive uveitis with a prednisone dose ≤7.5 mg/day coupled with disease-specific guidelines for determining inactive disease. The clinical relevance of this outcome is that active uveitis is associated with increased risks of visual impairment and blindness, and that prednisone doses ≤7.5 mg/day have a minimal risk of corticosteroid side effects. The consequence of this approach is that trial visits require a core set of measures for all participants and a disease-specific set of measures, both clinical and imaging, to assess uveitis activity. This approach is being used in the Adalimumab Versus Conventional Immunosuppression (ADVISE) Trial. [ABSTRACT FROM AUTHOR]

Objective: There is a high prevalence of obesity in people with asthma, and obesity is associated with poorly controlled asthma. Significant weight loss might improve asthma control: the purpose of this study was to investigate patient characteristics and factors that might affect implementation of a weight loss and/or roflumilast intervention, to target both obesity and asthma. Methods: A cross‐sectional study of people with obesity and poorly controlled asthma performed at 13 sites across the United States. Results: One hundred and two people participated in this study. Median BMI was 37 (IQR 35–42). The majority, 55%, were African American and 76% were female. Fifty two percent had very poorly controlled asthma. Most participants were quite sedentary (70% reported being inactive or participating only in light‐intensity activities according to the Stanford Brief Activity Survey). Participants reported significant impairments related to physical function on the Impact of Weight on Quality of Life‐Lite questionnaire (median score 67 [IQR 41–84]). Thirty‐five percent of participants reported mild, and 2 % moderate, depressive symptoms as assessed by the Patient Health Questionnaire‐9. Conclusions: Poorly controlled asthma and obesity often affect minority populations and are associated with significant impairments in health related to physical function and low levels of physical activity that might complicate efforts to lose weight. Interventions targeted at poorly controlled asthma associated with obesity in the United States need to address factors complicating health in underserved communities, such as increasing opportunities for physical activity, while also managing activity limitations related to the combination of asthma and obesity. [ABSTRACT FROM AUTHOR]

Introduction: We evaluated visual acuity (VA) over 5 years in a subspecialty noninfectious uveitis population.Methods: Retrospective data from 5,530 noninfectious uveitis patients with anterior, intermediate, posterior or panuveitis were abstracted by expert reviewers. Mean VA was calculated using inverse probability of censoring weighting to account for losses to follow-up.Results: Patients were a median of 41 years old, 65% female, and 73% white. Initial mean VA was worse among panuveitis (20/84) than posterior (20/64), intermediate (20/47), and anterior (20/37) uveitides. On average, mean VA improved by 0.62, 0.51, 0.37, and 0.26 logMAR-equivalent lines over 2 years, respectively (each P < .001), then remained stable, except posterior uveitis mean VA worsened to initial levels.Conclusion: Mean VA of uveitic eyes improved and, typically, improvement was sustained under uveitis subspecialty care. Because VA tends to improve under tertiary care, mean VA change appears a better outcome for clinical studies than time-to-loss of VA. [ABSTRACT FROM AUTHOR]

Background: Social distancing early in the COVID-19 pandemic helped mitigate viral spread and protect vulnerable populations. Broad availability of vaccines allowed social re-integration, but effects on mental health, social determinants of health, and attitudes among individuals with chronic obstructive pulmonary disease (COPD), who are high risk for adverse outcomes following COVID-19 infection, are unknown., Methods: Participants in the Losartan Effects on Emphysema Progression trial were recruited into an ancillary study from May to November 2020. Study coordinators administered telephone questionnaires to evaluate respiratory symptoms (COPD Assessment Test [CAT]), anxiety (Generalized Anxiety Disorder-7 [GAD-7]) and depressive (Patient Health Questionnaire [PHQ-8]) symptoms, social isolation, instrumental support, and attitudes and actions related to the COVID-19 pandemic. Generalized estimating equation models evaluated changes in patient-reported scores from the period before vaccine availability (prevaccine, May to December 2020) to the postvaccine period (May 2021 to September 2022)., Results: Of 157 enrolled participants, 138 were interviewed during both periods. Compared with the prevaccine period, severe respiratory symptoms (CAT>20) were higher in the postvaccine period (odds ratio [OR] 1.36, 95% confidence interval [CI] 95%: 1.00-1.85), as were moderate anxiety symptoms (GAD-7≥10; OR 1.65, 95%CI: 1.11-2.46) and moderate depressive symptoms (PHQ-8≥10; OR 1.77, 95%CI: 1.22-2.55). Social isolation improved, though not significantly, and instrumental support was unchanged. In the postvaccine period compliance with COVID-19 mitigation strategies remained high and governmental health care entities were viewed as trustworthy by fewer respondents., Conclusion: Despite a trend towards less social isolation following broad availability of COVID-19 vaccines, individuals with COPD reported worse symptoms, and greater anxiety and depressive symptoms compared to the prevaccine period., (JCOPDF © 2024.)

The uveitides consist of >30 diseases characterized by intraocular inflammation. Noninfectious intermediate, posterior, and panuveitides typically are treated with oral corticosteroids and immunosuppression, with a similar treatment approach for most diseases. Because these uveitides collectively are considered a rare disease, single-disease trials are difficult to impractical to recruit for, and most trials have included several different diseases for a given protocol treatment. However, measures of uveitis activity are disease specific, resulting in challenges for trial outcome measures. Several trials of investigational immunosuppressive drugs or biologic drugs have not demonstrated efficacy, but design problems with the outcome measures have limited the ability to interpret the results. Successful trials have included diseases for which a single uveitis activity measure suffices or a composite measure of uveitis activity is used. One potential solution to this problem is the use of a single, clinically relevant outcome, successful corticosteroid sparing, defined as inactive uveitis with a prednisone dose ≤7.5 mg/day coupled with disease-specific guidelines for determining inactive disease. The clinical relevance of this outcome is that active uveitis is associated with increased risks of visual impairment and blindness, and that prednisone doses ≤7.5 mg/day have a minimal risk of corticosteroid side effects. The consequence of this approach is that trial visits require a core set of measures for all participants and a disease-specific set of measures, both clinical and imaging, to assess uveitis activity. This approach is being used in the Adalimumab Versus Conventional Immunosuppression (ADVISE) Trial., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The Losartan Effects on Emphysema Progression (LEEP) trial was designed to test the hypothesis that losartan slows progression of emphysema in chronic obstructive pulmonary disease (COPD) patients (NCT00720226). It was conducted by the Pulmonary Trials Cooperative consortium, in collaboration with the American Lung Association Airways Clinical Research Centers network. We describe the design of the trial and challenges for recruitment and follow-up of participants. LEEP is a placebo-controlled, parallel randomized trial, allocation ratio of 1:1, with a planned sample size of 220. Primary eligibility criteria were mild emphysema based on high-resolution computed tomography (HRCT) scans with 5% to 35% voxels <-950 Hounsfield units (HU), airway obstruction based on spirometry, and not taking an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor. Participants received either losartan or placebo for 48 weeks. A total of 2779 individuals were screened to enroll 220 eligible participants at 26 clinical sites, all located in the continental United States. Recruitment took 45% longer than planned (32 months versus 22 months), with an average accrual rate of 6.7 participants per month. Recruitment challenges included identification of eligible participants who were not already taking or who did not have an established clinical indication for an angiotensin receptor blocker or ACE inhibitor drug and recalls of contaminated lots of losartan by the Food and Drug Administration. A number of recruitment initiatives were launched in response. Recruitment was completed in February 2020, just prior to a nationwide shutdown of research activities due to the coronavirus disease 2019 (COVID-19) pandemic., (JCOPDF © 2021.)