A post pandemic roadmap toward remote assessment for neuromuscular disorders: limitations and opportunities

Recent advances in technology and expanding therapeutic opportunities in neuromuscular disorders has resulted in greater interest in and development of remote assessments. Over the past year, the rapid and abrupt COVID-19 shutdowns and stay-at-home orders imposed challenges to routine clinical management and clinical trials. As in-person services were severely limited, clinicians turned to remote assessments through telehealth to allow for continued care. Typically, disease-specific clinical outcome assessments (COAs) for neuromuscular disorders (NMD) are developed over many years through rigorous and iterative processes to fully understand their psychometric properties. While efforts were underway towards developing remote assessments for NMD before the pandemic, few if any were fully developed or validated. These included assessments of strength, respiratory function and patient-reported outcomes, as well as wearable technology and other devices to quantify physical activity and function. Without many choices, clinicians modified COAs for a virtual environment recognizing it was not yet known how they compared to standard in-person administration. Despite being able to quickly adapt to the demands of the COVID-19 pandemic, these experiences with remote assessments uncovered limitations and opportunities. It became clear that existing COAs required modifications for use in a virtual environment limiting the interpretation of the information gathered. Still, the opportunity for real-world evaluation and reduced patient burden were clear benefits to remote assessment and may provide a more robust understanding and characterization of disease impact in NMD. Hence, we propose a roadmap navigating an informed post-pandemic path toward development and implementation of safe and successful use of remote assessments for patients with NMD.

Disruption Leads to Methodological and Analytic Innovation in Developmental Sciences: Recommendations for Remote Administration and Dealing With Messy Data

The COVID-19 pandemic has impacted data collection for longitudinal studies in developmental sciences to an immeasurable extent. Restrictions on conducting in-person standardized assessments have led to disruptive innovation, in which novel methods are applied to increase participant engagement. Here, we focus on remote administration of behavioral assessment. We argue that these innovations in remote assessment should become part of the new standard protocol in developmental sciences to facilitate data collection in populations that may be hard to reach or engage due to burdensome requirements (e.g., multiple in-person assessments). We present a series of adaptations to developmental assessments (e.g., Mullen) and a detailed discussion of data analytic approaches to be applied in the less-than-ideal circumstances encountered during the pandemic-related shutdown (i.e., missing or messy data). Ultimately, these remote approaches actually strengthen the ability to gain insight into developmental populations and foster pragmatic innovation that should result in enduring change.

Perspectives on the Emergency Remote Assessment during the COVID-19 Pandemic

The unprecedented health crisis triggered by the COVID-19 pandemic put on hold traditional educational practices. Emergency remote teaching was adopted as a response, with various degrees of success and satisfaction around the globe. This perspective chapter focuses on the remote emergency assessment as a measure to ensure the completion of the educational cycle for students caught in the 2020 crisis, after debates around the relevance and soundness of such activities both for students, and for society at large. Some voices enthusiastically champion the technological innovation and point to the benefits brought by the computer-assisted assessment, while others warn against the ‘one-size-fit-all’ approach and insist that the emergency measures need a careful examination and, although lessons can be taken away from the situation, the traditional patterns should be kept in place.

Remote Assessment Preferences of NIA Alzheimer’s Disease Research Center Participants During COVID-19 Pandemic

Background In a progressively technology-infused world, older adults are becoming accustomed to the digitization of research participation. During the COVID-19 pandemic, it became necessary to conduct remote study visits typically carried out over the telephone or using video calling programs (e.g. Zoom). Methods The National Alzheimer’s Coordinating Center developed a COVID-19 Technology Accessibility Survey to determine preferred types of study visits for study participants and to understand how this older population accesses the internet. Results Seven Alzheimer Disease Research Centers collected 1282 survey responses (mean age: ±71.8 years, mean education: 16.5±2.5 years, race/ethnicity: 86% White/non-Hispanic). In respondents aged 65-80, internet access was endorsed by 73% regarding smartphones, 61% for laptops, and 46% for tablets. Interest in wearable devices was expressed by 21% of respondents and interest in smart homes by 6%. Study visit preference among this age group was 42% in favor of in-person, 25% via phone, and 33% via video. In respondents aged >80 internet access was endorsed by 47% regarding smartphones, 47% for laptops, and 34% for tablets. Interest in wearable devices was expressed by 9% of respondents and interest in smart homes by 3%. Study visit preference among this age group was 38% in favor of in-person, 34% via phone, and 29% via video. Discussion In light of the COVID-19 pandemic, the survey suggests many study participants are interested in remote visits. Significant age group differences are present regarding internet access. Further studies are required to increase the understanding of the efficacy of this research visit format.

Collection of free-living accelerometry data in large clinical studies before and during the COVID-19 pandemic

The recent COVID-19 pandemic had a substantial impact on clinical research, including recruitment and follow-up visits in new and ongoing studies, especially affecting ones focused on older, at-risk adults. As the objective assessment of physical activity with wearables is usually initiated during in-person visits, the collection of these data experienced substantial, unplanned gaps. We report the frequency of data collection (visits-per-month) in studies collaborating with the Accelerometry Resource Core (ARC) at Johns Hopkins Center on Aging and Health. We focus on two, NIH-funded, studies that implemented the ARC accelerometry protocol. The Atherosclerosis Risk in Communities that stopped visit 8 enrollment in early 2020 and reinstated in 2021 for visit 9, and the Peripheral Artery Disease Study of SOL that started the data collection in early 2021, first via the mail-in protocol, then shifting towards in-clinic visits. Through March 2020, ARC processed an average of 125 new accelerometry per month (SD = 54). There was no new data collected for the remainder of 2020. The collection restarted in January 2021 with an average of 55 (SD = 43) files a month in the first and 112 (SD = 53) in the second quarter of 2021. A total of 573 new accelerometry observations were collected across both studies since the first wave of COVID-19 in March 2020 including 282 observations collected exclusively using a mail-in protocol. This recovery of data collection demonstrates that wearable devices allow for safer, remote assessment of physical activity, function, and sleep eliminating the need for in-person visits.

Impact of potential modifications to Alzheimer’s disease clinical trials in response to disruption by COVID-19: a simulation study

Background The COVID-19 pandemic disrupted Alzheimer disease randomized clinical trials (RCTs), forcing investigators to make changes in the conduct of such trials while endeavoring to maintain their validity. Changing ongoing RCTs carries risks for biases and threats to validity. To understand the impact of exigent modifications due to COVID-19, we examined several scenarios in symptomatic and disease modification trials that could be made. Methods We identified both symptomatic and disease modification Alzheimer disease RCTs as exemplars of those that would be affected by the pandemic and considered the types of changes that sponsors could make to each. We modeled three scenarios for each of the types of trials using existing datasets, adjusting enrollment, follow-ups, and dropouts to examine the potential effects COVID-19-related changes. Simulations were performed that accounted for completion and dropout patterns using linear mixed effects models, modeling time as continuous and categorical. The statistical power of the scenarios was determined. Results Truncating both symptomatic and disease modification trials led to underpowered trials. By contrast, adapting the trials by extending the treatment period, temporarily stopping treatment, delaying outcomes assessments, and performing remote assessment allowed for increased statistical power nearly to the level originally planned. Discussion These analyses support the idea that disrupted trials under common scenarios are better continued and extended even in the face of dropouts, treatment disruptions, missing outcomes, and other exigencies and that adaptations can be made that maintain the trials’ validity. We suggest some adaptive methods to do this noting that some changes become under-powered to detect the original effect sizes and expected outcomes. These analyses provide insight to better plan trials that are resilient to unexpected changes to the medical, social, and political milieu.