Harnessing the power of telemedicine to accomplish international pediatric outcome research during the COVID-19 pandemic

Abstract

The COVID-19 pandemic occurred during planned neurodevelopmental follow-up of Colombian children with antenatal Zika-virus exposure. The objective of the study was to leverage the institution’s telemedicine infrastructure to support international clinical child outcome research. In a prospective cohort study of child neurodevelopment (NCT04398901), we used synchronous telemedicine to remotely train a research team and perform live observational assessments of children in Sabanalarga, Colombia. An observational motor and conceptional standardized tool kit was mailed to Colombia; other materials were translated and emailed; team training was done virtually. Children were recruited by team on the ground. Synchronous activities were video-recorded directly to two laptops, each with a telehealth Zoom link to allow simultaneous evaluation of “table” and “standing” activities and back-up recordings were captured directly on the device in Colombia. The U.S. team attended live over Zoom from four states and five distinct locations, made observational notes, and provided real-time feedback. Fifty-seven, 3-4-year-old children with Zika-virus exposure and 70 non-exposed controls were studied during 10 daytrips. Direct laptop recording ensured complete record of child activities due to internet outages. Telemedicine can be used to successfully perform international neurodevelopmental outcome research in children during the COVID-19 pandemic. Telemedicine can benefit global health studies.

Introduction

In February 2016 the World Health Organization declared Zika-virus (ZIKV) a public health emergency of international concern due to recognition that ZIKV causes a congenital infection that can result in Congenital Zika Syndrome with infant microcephaly.(1) Central and South America were heavily impacted by the ZIKV epidemic and devastating rate of infants born with microcephaly and other birth defects caused by antenatal ZIKV infection.(1) Fortunately, many infants born to mothers with ZIKV infection in pregnancy did not have Congenital Zika Syndrome nor severe birth defects.(2, 3) However, we showed in our longitudinal cohort established during pregnancy that normocephalic infants with antenatal ZIKV exposure can have lower neurodevelopmental scores to 18 months of age.(3, 4) Thus, longitudinal neurodevelopmental assessments to older ages are essential in order to understand the full effects of the ZIKV epidemic to child health, even in the absence of ZIKV-related birth defects.(5)

The COVID-19 pandemic occurred at an important time when children with antenatal ZIKV exposure were of age for scheduled neurodevelopmental evaluations in early childhood. Multiple international cohorts of pregnant women, infants, and children with antenatal ZIKV infection were established between 2016-2018; however, those with planned follow-up after two years of age are few.(6) Cohort studies with longitudinal follow-up planned to older ages are essential in order to provide key outcome data on child outcomes since many measures of child neurodevelopment can only be assessed at older ages.(7) The intersection of the current pandemic on a Colombian community still recovering from a major health epidemic and effects to their children presents enormous challenges. Like many countries, Colombia placed a quarantine limiting travel into the country and between regions, which prompted a need to develop alternative strategies to follow child outcomes for an international research team.

Almost overnight with the spread of SARS-CoV-2, telemedicine use expanded rapidly in an effort to protect patients and care providers, but as a way to provide clinical care during the COVID-19 pandemic.(8-10) Previously, telemedicine was mostly used for clinical patient visits and it is only beginning to be utilized in clinical research.(11-13) Telemedicine can also support medical care in resource limited international settings.(14) We previously used recorded videos to score infant motor development for our cohort of infants in Colombia with antenatal ZIKV exposure, so had experience with remote video-based scoring methods.(4) However, the current pandemic forced a shift in our research methods to fully utilize telemedicine to train our international research team and perform live observational assessments of child developmental activities. The objective of this study is to describe the use of telemedicine for international evaluations of children with antenatal ZIKV exposure using a synchronous telemedicine approach.

Methods

Participants

We performed a prospective cohort study of child neurodevelopment in Sabanalarga, a rural town, in Colombia using synchronous telemedicine from September 2020 to February 2021. Children born between August 1, 2016 and November 30, 2017 with antenatal ZIKV exposure previously studied to 18-months of age who did not have CZS were eligible.(4) The COVID-19 pandemic occurred during planned in-person neurodevelopmental follow-up of this cohort when the children were 3-4 years of age. Children age 4-5 years, born before March 31, 2016 without antenatal ZIKV exposure were recruited in the same town to serve as non-exposed controls. Due to the rural location of the study, children were scheduled by both in-person and phone contact. The study was approved by the Children’s National Institutional Review Board (IRB, Pro00012759), Washington, DC, by the CIRCIE IRB, Barranquilla, Colombia, and has trial registration NCT04398901 (https://clinicaltrials.gov/ct2/show/NCT04398901).

Team Training by Telemedicine

The neurodevelopmental assessments were selected due to being culturally appropriate, available in English and Spanish languages, and for their ability to lend themselves to virtual training. An observational motor and conceptional standardized tool kit (Movement-ABC-2 and Bracken School Readiness Assessment- 3^rd Edition [Pearson]) and questionnaires were mailed to Colombia; other materials were translated into Spanish and emailed. Remote team training was performed virtually over three days using HIPAA compliant Zoom telehealth accounts. Each assessment was demonstrated by the U.S. team and real-time Spanish interpretation was provided. The Colombian team had the developmental testing kits and questionnaires available during the trainings. They then practiced and demonstrated learned skills to the U.S. team virtually over two days using non-research children of similar age.

Child Evaluations

Evaluations of the children in Colombia were performed by the team in-person with the children with synchronous telemedicine connection to the U.S. team via two Zoom telehealth connected devices (Figure 1). Children were brought for their in-person assessments to either a community center or public school, both with space to perform the activities, where the team connected using a portable WIF antenna. Children were evaluated by the Movement-ABC-2 which includes measures of manual dexterity, aiming and catching, and balance and by the Bracken School-Readiness Assessment. The later includes developmental concepts of colors, letters, numbers, shapes, and comparisons. The children rotated between performing the standing activities and the table activities to maintain child engagement and efficiency for the research team. Written portions of the test including the children’s drawings, were scanned, and scored remotely. The team in Colombia wore masks, handwashed, and cleaned items between children.

Figure 1: Schematic Representation of Telemedicine Approach for Child Neurodevelopmental Evaluations.

Schematic figure showing synchronous telemedicine connection of the U.S. team from four states using laptops and tablets with Zoom telemedicine recording ability and real-time connection to children in Sabanalarga, Colombia performing standing and table activities to assess neurodevelopment.

The child activities were synchronously video recorded directly to two laptops, each with a telehealth Zoom link to allow simultaneous evaluation of “table” and “standing” activities (Figure 1). Back-up recordings were captured by the research team in Colombia. The U.S. team attended live over Zoom from four states and five distinct locations, made live qualitative observational notes of the child’s movements and performance on the different measures, and provided real-time feedback in Spanish and English to the Colombian team. The teams communicated using WhatsApp to clarify questions or provide feedback when necessary and to keep track of the order of participants. Video recordings will be used for qualitative assessment and scoring.

Data Analysis

Child age is reported as mean and standard deviation. The cost of the team training and evaluations done using telemedicine was compared to the original budget that did not include telemedicine.

Results

Fifty-seven of 70 (81%) eligible children with antenatal ZIKV-exposure with a mean (SD) age of evaluation of 4.0 (0.4) years were evaluated during five daytrips in Sabanalarga, Colombia. Day 1 did not have a working internet connection. Day 2 (community center) and days 3-5 (school) had an internet connection for live telemedicine Zoom but had multiple brief outages despite conducting prior connectivity testing. Following the evaluation days of the children with ZIKV-exposure, 70 non-exposed control children (100% of goal enrollment) with mean age of 5.4 (0.2) years were evaluated over five days with synchronous telemedicine connection to the U.S. team. These visits occurred at the school and had internet connection with brief disruptions. For all study days, direct laptop recording of the children was necessary to ensure complete video record of child activities. Recorded videos by the laptop were saved and utilized for evaluation and scoring during internet outages that affected the Zoom telemedicine recordings. The telemedicine approach enabled the U.S. team to provide important feedback based on live assessment observations of the children and make real-time adjustments to performance of the neurodevelopmental tests.

The original study budget included $6,240 for travel from the U.S. to Colombia for four team members to accomplish training of the Colombian research team and to see initial participants together to verify skills. During the travel, the neurodevelopmental testing kits and record forms would be brought by the team as luggage to avoid additional costs. Using the telehealth approach, neurodevelopmental testing kits and forms were air-mailed in two boxes, for a total cost of $1,440: 77% less than the budget for travel using the non-telehealth approach. The cost of telehealth Zoom at our institution is $16 per month per user.

Discussion

Telemedicine infrastructure enabled synchronous international research collaboration to train a research team, evaluate child outcomes in a rural international setting and enroll study controls during the COVID-19 pandemic. By utilizing telemedicine to train the study team, enrollment goals and timepoints of assessment were able to be maintained at the appropriate child age for the original study objective, without significant delay from the travel restrictions imposed by the COVID-19 pandemic. The careful choice of testing materials combined with live telemedicine observation allowed multidisciplinary child assessments by trained rehabilitational, neurological, and psychological professionals to observe both gross motor, fine motor, and verbal and nonverbal conceptual skills. The children were able to perform in their community environment and there was minimal difficulty in establishing rapport with assessors. Most importantly, this approach-maintained collaboration of the international team at a time when international travel was not possible.

Virtual training using a Zoom telemedicine platform was found to be effective with excellent acquisition of skills by the research team. Telemedicine has been successfully used for international clinical neurodevelopmental evaluations and team training.(15) The choice of culturally appropriate assessments available in Spanish likely contributed to successful use of the toolkit by the Colombian research team.(16) The use of telemedicine to provide international expertise for training and child assessment was also less expensive than having an international team travel to be on-site. This method may be a more efficient way to sustain international research collaborations during the pandemic and beyond.(17)

Evaluation of child motor neurodevelopment can be done by observation and thus lend itself to work well in a telemedicine setting. Building upon our prior study that used video scoring of the observational motor assessment, the Alberta Infant Motor Scale, we utilized the Movement-ABC-2 (Pearson) to assess child motor development and function.(4) For telemedicine child neurodevelopmental evaluations, it is important to choose assessments that allow observation of child skills as a main measure. Much can be learned by keen observation of a child and this can be readily utilized by telemedicine. Even in a clinical setting, home videos of infant and child movements can help evaluate for neurodevelopmental disabilities and abnormalities of movement.(18)

One of the great potentials of telemedicine is that it can bring health resources to remote, isolated areas of the world, areas often with significant disparities in the opportunity for specialty medical care.(19) The telemedicine tool is reliant on available technology and internet connectivity which in some remote places may be a barrier to this method of care. An additional benefit for telemedicine is cost savings, and reduced travel time expense for patients and providers. To our knowledge the cost savings benefit to clinical child outcome research has not been previously reported. By utilizing telemedicine to accomplish evaluations of child neurodevelopmental outcome, our study saved in travel costs and had the additional major benefit of enabling the U.S. research team to attend all of the child visit days live and provide direct feedback to the research team on the ground. By this method, the children benefitted by having a child neurologist, developmental pediatrician, and physical therapist virtually observe child evaluations. This team of three pediatric specialists are not available in the community where these children live, so participation in the research was a benefit to them and their families. In turn, the research team benefitted by live presence enabling quality observational assessments for the research study and the ability of the U.S. and Colombian research team members to train and work together to accomplish the child evaluations.

One limitation encountered of a telemedicine approach for our study was difficulty maintaining internet connection through all child assessments in a rural setting. Internet outages triggered breaks in recordings on Zoom telehealth devices and they were overcome by having direct recording to the laptop at the site as a backup to the telemedicine recordings. Adequate internet connection should be tested prior to research activities and direct video recording should be available as a backup. Future studies may benefit from having satellite internet capabilities, especially in rural research sites, which could potentially improve the quality and experience. Our institution did not have a preexisting telemedicine research policy and procedure. Based on our experience and the growing experience of others, the use of telemedicine for accomplishing outcome research is likely to dramatically expand and will require policies for use in research settings.

While our study was not originally designed to use telemedicine in such a significant way, through this process, we found that synchronous telemedicine connected the research team and enabled international child outcome research during the pandemic which would not have otherwise been possible. The use of this technology for international research will likely continue past the pandemic due to enhanced efficiency, lower cost, and ability to maintain collaborations between multiple study sites.