Anthony Sung

Hematopoietic stem cell transplantation (HCT) has the potential to cure malignant and nonmalignant diseases but remains associated with a wide range of complications, necessitating dedicated lifelong follow-up. While patients are monitored closely during the peri-HCT period, leaving the hospital setting after HCT introduces new challenges. This scoping review explores the current use of patient-generated eHealth data in the outpatient setting. A systematic search of the PubMed, Scopus, Cumulative Index to Nursing and Allied Health Literature, American Psychological Association PsycINFO, and International Health Technology Assessment databases in July 2021 identified the 22 studies (13 full text articles and 9 abstracts) included in this review. The large majority were small to medium-sized (n = 15; 68.2%) pilot or feasibility studies (n = 18; 81.8%) that were published between 2016 and 2021 (n = 16; 72.7%). Collection of patient-reported outcomes was the most frequently reported eHealth intervention (n = 14; 63.6%), followed by vital sign monitoring (n = 5; 22.7%) and home-based spirometry (n = 3; 13.6%), mostly in the early post-transplantation setting. eHealth interventions had favorable feasibility and acceptability profiles; however, we found little data on the efficacy, long-term monitoring, data security, and cost-effectiveness of eHealth interventions. Larger randomized studies are warranted to draw formal conclusions about the impact of eHealth on HCT outcomes and the best ways to incorporate eHealth in clinical practice.

PURPOSE OF REVIEW: Recent medical advances have allowed a greater number of older patients to undergo hematopoietic stem cell transplantation (HSCT) and participate in HSCT trials. In this review, we outline recent advances in HSCT that have made this possible, general setbacks, and their effects on the landscape of HSCT trials in older adults. RECENT FINDINGS: Reduced-intensity conditioning regimens and a more physiological approach to transplant candidate selection have given older patients an opportunity to participate in HSCT trials. However, difficulties in allogeneic donor selection, post-transplant complications, and the misalignment of trial goals with patient goals may pose challenges for future trial recruitment and success. While increasing amounts of evidence show that older adults may benefit from participation in HSCT trials, clinicians, investigators, and patients must carefully weigh the benefits with potential repercussions.

INTRODUCTION: The COVID-19 pandemic has proven to be an unprecedented challenge to worldwide health, and strategies to mitigate the spread and severity of COVID-19 infection are urgently needed. Emerging evidence suggests that the composition of the gut microbiome and modification of microbial ecology via probiotics can affect susceptibility to a wide range of infections, including respiratory tract infections. In this study, we aim to evaluate the effects of the probiotic Lactobacillus rhamnosus GG (LGG) versus placebo on COVID-19 infection status and the gut microbiome in subjects with a household contact who has tested positive for COVID-19. METHODS AND ANALYSIS: In this double-blinded, randomised, placebo-controlled trial, we will randomise 1132 subjects having a household contact who has recently (≤7 days) tested positive for COVID-19 to daily oral LGG or placebo for 28 days. We hypothesise that taking LGG as a probiotic will protect against COVID-19 infection and reduce the severity of disease in those who become infected (primary endpoint: decreased symptoms), and will be associated with beneficial changes in the composition of the gut microbiome. Stool samples and nasal swabs will be collected to evaluate the microbiome by 16S rRNA sequencing and the presence of SARS-CoV-2 by PCR, respectively. We will also conduct multivariate analysis of demographic, behavioural, temporal, and other variables that may predict development of symptoms and other outcomes. ETHICS AND DISSEMINATION: This trial is conducted under a Food and Drug Administration Investigational New Drug for LGG, has received ethics approval by the institutional review board of Duke University and enrolment has begun. We plan to disseminate the results in peer-reviewed journals and at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04399252.