ABSTRACT
Coronavirus (COVID-19) laid bare the disproportionate effects of infectious agents on vulnerable communities. however, historically, infectious diseases have long been known to affect certain communities to a greater extent than others. The mechanisms behind these differences are multifactorial, and lie less in biological susceptibility and instead more on socioeconomic factors and other social determinants of health. This article highlights health disparities in common infections such as respiratory syncytial virus, tuberculosis, HIV, syphilis, and influenza and will use lessons learned from previous pathogens and infectious disease disparities in vulnerable populations to provide context to the COVID-19 pandemic.
ABSTRACT
Background: Autologous hematopoietic stem cell transplantation (aHSCT) is an effective and safe treatment resulting in suppression of disease activity and delay of disease progression in patients with highly active relapsing remitting multiple sclerosis (RRMS) who failed first line disease modifying treatments (DMT) (Burt et al. 2019). However, its safety and effectiveness compared to high efficacy DMTs remains undetermined. Around 4-14% RRMS patients present with an aggressive clinical course (Lacobaeus et al. 2020). There is no unanimous definition of aggressive MS but rapidly evolving severe MS (RES-MS) is defined as patients with >=2 disabling relapses in 1 year, and >=1 gadoliniumenhancing lesions or a significant increase in T2 lesion load on brain magnetic resonance imaging (MRI). High efficacy DMTs are usually a first line treatment to prevent long term disability (Laffaldano et al. 2021). In a retrospective study Das et al. (2021) demonstrated no evidence of disease activity in 100% of patients with treatment naive aggressive RRMS treated with aHSCT. Method(s): Star-MS, ISRCTN88667898, is a multicentre parallelgroup rater-blinded randomised controlled trial of aHSCT versus high efficacy DMT (alemtuzumab, cladribine, ocrelizumab and ofatumumab) of 198 RRMS patients in the United Kingdom. aHSCT is delivered using non-myeloablative conditioning with a cyclophosphamide/anti-thymocyte globulin regimen followed by an unselected autologous graft. Eligibility was based on clinical practice at the time the trial was conceived in 2019 and included patients with >=2 relapses, or 1 relapse and evidence of MRI disease activity >3 months before or after its onset, in the last 12 months despite use of a DMT (but not a comparator DMT). Star-MS opened recruitment in September 2021 following an 18 month delay due to COVID. Changes to clinical practice, namely early use of high efficacy treatment, no longer aligned with trial design, reducing the pool of eligible patients, resulting in slower than expected recruitment. Trial protocol was revised to include active RRMS, defined as >=1 relapse or evidence of MRI disease activity in last 12 months use of a DMT, or RES-MS in treatment naive patients. Here we describe the positive impact of utilising adaptations to study design to keep clinical trials aligned with clinical practice. Conclusion(s): Clinical trials must be responsive to changing clinical practice to ensure success and relevance to the target patient population.
ABSTRACT
Purpose of Study Prior to the COVID-19 pandemic, we initiated a randomized clinical trial for childhood obesity. The trial consented 131 and randomized 104;6-12 year old patients who reside in rural regions in 4 member states (DE, NE, SC, and WV) of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) Approximately 6 weeks into the 10-week recruitment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment and study methods to using virtual procedures. This descriptive paper outlines ways to recruit and manage clinical trial participants using technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods Used We reviewed multiple data sources to describe the transition to virtual study procedures. These include research electronic data capture (REDCap) surveys conducted both during the pause and at the completion of the study to identify readiness for each site to conduct virtual recruitment and other study procedures as well as at the end of the study to identify issues that each site encountered during the virtual phase of the project. We also reviewed meeting notes and study enrollment figures. Summary of Results The IRB approved study changes allowed for variability between clinical sites in terms of virtual communication platforms and methods for participant consent and height/weight assessment. Identified advantages of the study included ability to conduct visits during all times of the day or evening, and reduced travel requirements. Challenges included poor Internet reliability in some rural areas;additional participant contacts for consent and eligibility screening;shipping delays of materials;reliance on family to perform height and weight measures;increased costs for materials and shipping. Despite the added challenges, all sites were able to meet the study enrollment objectives. Flexibility was key in implementation of virtual procedures given the variations in site resources. Conclusions While each study site had certain challenges unique to their location during the pandemic, we also identified several common issues with the transition to remote procedures. Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with a difficult to reach rural and underserved populations or during challenging events like the pandemic.
ABSTRACT
Background: Pediatric obesity interventions of 26 or more contact hours may be more effective than those with fewer contact hours, but research is inconclusive. Disagreement may be due to the lack of uniformity in reporting dose. To remedy this issue experts recommend reporting dose intended, dose delivered, and dose received. Also, very little is known about the accumulation of dose in rural populations, and no information has been published regarding the accumulation of dose in the time of COVID 19. The purpose of the current is to describe the accumulation of dose in a four-state pediatric obesity intervention trial that was conducted in the IDeA States Pediatric Clinical Trials Network. Methods: Rural medical clinics located in four states participated. Each clinic targeted recruitment of 28 children from rural areas who were 6-11 years of age with a BMI%ile≥85th and their primary caregivers who (after consent/assent) were randomly assigned to a monthly newsletter only condition or to the iAmHealthy mHealth intervention, which was composed of 12 weekly and 3 monthly one hour group sessions and 11 hours of individual family health coaching. The 6-month intervention period began on August 24, 2020 and completed on February 7, 2021 when the impact of the COVID 19 pandemic was high in participating sites. Results: 52 of the 104 randomized participants were assigned to iAmHealthy;87% (n = 45) of these participants were retained through the final measurement. Dose intended was 26 contact hours (15 hours of group sessions and 11 hours of health coaching sessions), with a goal for families to receive 80% of these hours (20.8 hours). Dose delivered by the intervention team included 15 hours of group sessions and up to 17 hours for health coaching sessions. Dose received varied widely for both group (0.73-16.78;X = 10.65) and health coaching sessions (0.45-16.85;X = 8.21). Therefore, total accumulated contact hours varied as well (2.45-31.13;X = 18.86). Two thirds of the retained participants met the a priori dose goal of 20.8 contact hours. Conclusions: Dose intended and dose received were highly concordant, but dose received varied widely by participant. Future research should continue to explore these measures of dose, especially in underserved populations, and whether these factors are related to health behavior outcomes and body mass changes.