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The COVID-19 pandemic has necessitated a rapid shift to web-based or blended design models for both ongoing and future clinical research activities. Research conducted virtually not only has the potential to increase the patient-centeredness of clinical research but may also further widen existing disparities in research participation among underrepresented individuals. In this viewpoint, we discuss practical strategies for quantitative and qualitative remote research data collection based on previous literature and our own ongoing clinical research to overcome challenges presented by the shift to remote data collection. We aim to contribute to and catalyze the dissemination of best practices related to remote data collection methodologies to address the opportunities presented by this shift and develop strategies for inclusive research.
The COVID-19 pandemic is transforming the landscape of clinical research. The pandemic has necessitated the unexpected adaptation of ongoing clinical research activities to web-based or blended design (ie, part web-based, part in-person) models [
Many health care providers and clinical researchers have marveled at the way the COVID-19 pandemic catalyzed the widespread adoption and expansion of telemedicine, seemingly overnight [
This shift toward virtually conducted clinical research creates many
At the same time, the transition to virtually conducted clinical research also presents many
To thoughtfully respond to the challenges associated with remote data collection and ensure that disparities in access to clinical research do not widen, there is a critical need for practical strategies for researchers. By integrating recommendations from previous literature with examples from the ongoing clinical research projects of this authorship team with extensive patient and provider populations (ie, adults and adolescents with neurofibromatosis, older adults with chronic pain and cognitive decline, adults with cancer and serious mental illness, adults with young-onset dementia, and orthopedic medical providers), we present a discussion of practical strategies for researchers to support the rigorous, efficient, and patient-centered collection of quantitative and qualitative data remotely. Summary tables present a list of strategies related to the remote collection of quantitative (
Challenges in remote quantitative data collection and associated strategies.
Challenges | Strategy | Example approach |
Study staff do not have sufficient technological experience or access to technology. | Equip study staff with technology as necessary and instruct them on foundational technological skills. | Ensure that all study staff have access to necessary technology to carry out study responsibilities (eg, laptops with webcams, phones, and software programs) and have been thoroughly trained in their use. |
Validating participant credentials and ensuring data quality. | Incorporate eligibility, attention, and manipulation checks throughout surveys. | Attention check: for quality assurance, please select |
Study staff lack experience remotely communicating with study participants. | Train study staff on good clinical practices and foundations of verbal and nonverbal communication that are appropriate for web-based setting. | Study staff collecting measures should be educated on best practices for protecting participant privacy and confidentiality through remote methods (ie, use of secure software and calling from private locations). Study staff should be trained on verbal and nonverbal communication appropriate for web-based settings (eg, eye contact through webcams and body language from shoulders up) and be mentored with peer or hierarchical supervision. |
Managing the secure electronic distribution of measures to study participants. | Use a secure web platform to distribute measures. | Study staff can use secure electronic platforms (eg, REDCapa and Qualtricsb) to distribute measures and use functionalities (eg, scheduling surveys and automatic reminders) to maximize efficiency and organization for study team. |
Assisting study participants in using technology to complete remote study measures. | Proactively identify participants’ comfort with technology and then tailor individualized supportive approaches. | Study staff should first engage in |
Engaging participants who lack access to technology or lack technological literacy to independently complete remote study measures. | Allow flexible and multimodal alternatives for measurement completion, along with offering relevant instructions on using these modalities. | Study participants can be mailed letter copies of the self-report measures or give their answer to survey questions via phone calls with study staff. Study staff should communicate with study participants about their preferred modality and support with associated burden. |
Adapting study protocol to determine new ways to gather non–self-report data that previously required in-person assessment. | Conduct a literature search to identify and implement innovative, creative, and flexible alternatives. | Study teams can use previously adapted and validated measures for remote delivery, such as a mobile app to measure distance walked in 6 minutes (ie, 6-minute walk test). |
Burden on participants of completing remote electronic study measures. | Asynchronous distribution of study measures. | Study staff can send participants a link from a secure web platform so that participants can complete the measurement independently at a time and place most convenient for them. |
Participants who require or prefer assistance in measure completion. | Provide live assistance to participants during measure completion (ie, synchronous completion) via phone or live video. | Pay attention to participants’ focus, engagement, and comprehension during synchronous measure completion (eg, ask participants if they have any questions about the phrasing of measures and offer participants the option to take pauses during the assessment). |
Participants who require or prefer visual aid during synchronous measure completion. | Use |
Using secure and institutionally approved videoconferencing technology (eg, Zoom and WebEx), study staff can |
Protecting participant privacy and confidentiality during remote calls. | Proactively promote actions in coordination with the study participant to uphold good clinical practice and protect privacy and confidentiality. | Confirm with study participants if they are in a safe space to openly answer questions, advising them of the sensitive nature of questions before administering measures, and assisting participants with strategies to maximize their privacy (eg, scheduling calls at a participant’s preferred time and wearing headphones). |
Building rapport with study participants while communicating virtually. | Focus on body language, tone of voice, and language appropriate for web-based settings. | Use verbal strategies appropriate for web-based settings (eg, establish a conversational tone, use participants’ names, speak clearly and directly into microphone, and provide technological support so that participants feel comfortable) and nonverbal strategies appropriate for web-based settings (eg, smile at participants, make direct eye contact with webcam, and sit upright). |
Promoting completion of unfinished surveys. | Schedule reminders at predetermined intervals for participants who have not completed measures. | Participants who do not complete the survey in a scheduled time can be prompted to do so via automated electronic reminders within the distribution platform or individual outreach (eg, calling, texting, reminding in person). Study staff should flexibly use different outreach methods and communicate in advance to the participant how often they will send reminders through each method. |
Reaching participants who are difficult to reach via technological means or who are no longer responding to outreach. | Determine standardized study procedures about who will contact the participant, how many times, and through what method. | Decide on a number of times to call a participant before transferring the matter via an established chain of command. Use creative approaches such as considering the individual’s circumstances and best ways and times to reach them, involving family members, and involving incentives as appropriate. |
aREDCap: Research Electronic Data Capture (Vanderbilt University).
bQualtrics Survey Distribution (Qualtrics XM Platform).
cHIPAA: Health Insurance Portability and Accountability Act.
Challenges in remote qualitative data collection and associated strategies.
Challenges | Strategies | Example approach |
Inclusive outreach to participants. | Multimodal outreach strategies. | Send physical letters with focus group information and offer both telephone only and videoconferencing modalities. |
Coordinating a meeting time for web-based interviews or focus groups. | Provide flexible hours and focus on participants’ schedule preferences. | Study staff can offer multiple times for web-based focus groups to assess times that would maximize attendance. |
Securely conducting web-based interviews or focus groups. | Select HIPAAa-compliant videoconferencing platforms. | Platforms that are HIPAA-compliant have security features such as password-protected meetings and waiting rooms that study staff can use to protect participants’ privacy and confidentiality. |
Encouraging active participation in web-based interviews or focus groups. | Proactively plan the focus group structure to optimize participation. | Consider the target size of the focus group to promote participation. Study staff can also give an introduction at the start of focus sessions to set a tone of welcome and inclusivity (eg, build rapport and give overview of study topics) and be intentional about the use of verbal and nonverbal communication throughout the focus group to encourage participation. |
Solving technological issues with participants. | Review technological features and any problems at the start of the session and then address emerging issues as needed. | Expend a portion of the focus group, ensuring that all technological components are functioning (eg, microphones and videos turned on as appropriate) and review features of the platform. Have a study staff member on call to assist with technological problems as needed. |
Conducting interviews or focus groups in a timely fashion. | Coordinate the team approach to adhering to a predetermined schedule. | Determine allotted time for aspects of the focus group’s discussion in advance and divide labor among the study staff during focus groups to maximize efficiency. |
aHIPAA: Health Insurance Portability and Accountability Act.
Asynchronous distribution and measure completion (eg, electronic distribution of surveys) maximize efficiency for the study team and flexibility for study participants but necessitates additional consideration for participants with varying levels of familiarity with and access to technology. Secure web platforms (eg, REDCap [Research Electronic Data Capture], Vanderbilt University and Qualtrics, Qualtrics XM Platform) are ideal for asynchronous distribution because they have functionalities that promote study team efficiency and organization (eg, scheduling survey distribution in advance and automatic reminders to participants to complete surveys) while enabling participants to complete measures independently and at a time most convenient for them [
Many of these platforms also offer participant screening, consenting functionality, and mobile device compatibility, which maximize the utility for study teams [
Validating participant credentials in studies where research staff have no personal interaction with participants (ie, web-based survey studies) is another challenge with web-based research. Data quality checks, such as eligibility, attention, and manipulation checks (see
We use REDCap and rely on predominantly asynchronous measure completion to collect quantitative data in an ongoing randomized controlled trial of a mind-body intervention to promote quality of life in adults with a genetic condition called neurofibromatosis [
For quantitative measures other than self-report surveys, study teams may need to use innovative methods to adapt data collection methods for remote delivery. Although not all measures can be adapted for remote delivery (eg, imaging data collection), many can through a combination of creative and flexible strategies, including using mobile device data collection, mailing materials and devices to participants, and conducting assessments over live videoconferencing. Even the collection of biomarker data, common in quantitative research clinical trials, can sometimes be adapted for remote conduct through mailing of devices and use of smartphone technology, such as mailing saliva or nicotine strips for the verification of tobacco abstinence or the provision of personal devices to measure expired carbon monoxide that are compatible with smartphones [
In our randomized controlled trial with patients with chronic pain and cognitive decline, we conducted a literature search to identify remote methods for assessing cognitive functioning as well as performance-based physical function. The Montreal Cognitive Assessment [
In the process of adapting quantitative measures for remote completion, the safety of the participants must be considered. For example, in our randomized controlled trial with adults with neurofibromatosis, we used the Patient Health Questionnaire-9, which contains an item assessing suicidal ideation, to measure depression. We developed a standardized protocol to respond to cases in which participants endorse suicidality, including collecting the name and number of an emergency contact for each study participant during enrollment, having the study clinician and principal investigator receive immediate notification from REDCap, and having the study clinician or principal investigator follow up over phone with the participant within 24 hours to complete a safety assessment [
Depending on the study protocol and population, the best practice may be the synchronous completion of measures (ie, in which a study team member administers the assessment to the participant in real time). The synchronous completion of self-report measures enables study staff to directly support participants in completing measures, including ensuring participants’ best effort, attention, focus, and comprehension during measure completion. Assisting participants synchronously in completing self-report measures also allows study staff to ensure that data are supplied directly from intended participants and eliminate the possibility that participants are being influenced by others such as spouses or parents. The factors to consider when making this decision include participants’ age, cognitive ability, previous experience with technology, and preference. When assisting participants with assessment completion remotely, multiple modalities that can be used. First, calling participants by phone requires minimal technology access and familiarity for participants and enables study staff to
For some participants, the visual component was beneficial for enhancing their comprehension of measure items. Video calling a participant with HIPAA-compliant, secure platforms [
We use this novel
For group-based interventional studies and situations in which study staff want to be available to answer potential questions related to measure completion (about either technology use or specific items) but do not want to walk participants through every item, a group support procedure could be used using videoconferencing. In this strategy, a member of study staff can email participants the links to complete surveys on their own devices and schedule a time in which the group of participants joins a videoconferencing call to complete the measures at the same time. We use this strategy in our randomized controlled trial for older adults with chronic pain and cognitive decline [
As with the shift to remote clinical care, the privacy and confidentiality of patients is not as easy to ensure as it is in person. Research staff have an obligation to ensure participant privacy and confidentiality to adhere to the principles of good clinical practice [
Building relationships with study participants is central to engaging participants in study procedures and ensuring thorough and thoughtful data collection. Survey fatigue and general fatigue related to research participation pose real challenges to data collection as well as study retention [
Building rapport.
Study teams face additional challenges in prompting participants to complete measures when participants are difficult to reach or are unresponsive. Persisting in using creative outreach methods for calling and texting participants using HIPAA-compliant technologies (eg, Cisco Jabber and Twilio) [
As the COVID-19 pandemic continues to lay bare the existing health disparities in racially, ethnically, and socioeconomically minoritized groups, concerns that the increased reliance on digital technologies for clinical care and research will exacerbate the digital divide rather than mitigate systemic health inequities are prevalent [
Building capacity for person-centered, equitable research can be facilitated by providing smartphones or internet plans to participants if access to these technologies is an inclusion requirement [
Providing adequate technology support is also of utmost importance. Study teams must provide training to participants for all forms of technology used, through manual documentation, prerecorded videos, or live assistance (eg, over the phone) [
Focus groups, or interviews, are conducted synchronously; therefore, time (and time zone) coordination is required. For individual interviews, offering flexible hours that prioritize participants’ preferences may assist in study enrollment because participants will be able to schedule and mark their calendars for a
HIPAA-compliant videoconferencing software (eg, Zoom and WebEx) is necessary for the conduct of remote qualitative interviews or focus groups (as opposed to phone calls) to facilitate rapport building between study staff and participants to ensure that participants feel at ease. Many types of videoconferencing software contain features, such as waiting rooms and passcodes, that maximize participants’ security and confidentiality. Still, participants should be informed of the privacy risks associated with participation in remote focus groups (eg, the unsanctioned audiotaping or videotaping of groups) and the rules for participation (eg, use of headphones and being against recording of groups) should be clearly articulated at the start of every group. Features such as
Having study staff on call during interviews and focus groups is essential to provide technological support to participants in case of issues. Study staff can provide individual support to participants and troubleshoot issues related to remote participation, including poor connectivity with the internet, audio or camera issues, the use of videoconferencing software, and environmental disruptions [
We used these strategies at the beginning of the pandemic to transition from an in-person focus group study investigating barriers to smoking cessation clinical trials for Hispanic, Latino, or Latina individuals to remote procedures. Before the pandemic, we recruited Hispanic, Latino, or Latina individuals for focus groups conducted in both English and Spanish. After transitioning to remote research, we ran the web-based focus groups with smaller numbers than intended in person (3-4 people) to ease the burden on the study team while we navigated the new technology and ensured that each participant was able to receive one-on-one assistance. We faced challenges with technology, including finding solutions for individuals who did not have email or webcam access, a noted disparity among older Hispanic individuals [
Although remotely conducted interviews and focus groups may pose some challenges to interviewers in engaging participants, connecting with participants, and encouraging open and active dialogue among participants, there are many verbal and nonverbal strategies that interviewers can adopt. Before the interview, study staff should begin building rapport with participants (
Assuming that they are visible to participants, interviewers should also pay attention to their nonverbal communication. If interviewers must take notes during qualitative data collection and are therefore unable to maintain eye contact throughout the interview or focus group, participants should be informed to avoid potential nonverbal miscommunication. Reactive facial expressions are critical in remote qualitative data collection, as body language cannot be observed as it typically would be in person, although some aspects such as posture may be observed. Nonverbally reacting appropriately to what participants share is vital to encourage participants to be open and honest during an interview. The key aspects of nonverbal communication include eye contact (toward the participant or the camera), using facial expressions to demonstrate understanding and listening, and body language, including nodding [
For structured and semistructured interviews and focus groups, keeping track of the timing during the interview is also necessary to ensure that all questions are answered, with appropriate time allocated to each section or question. This is particularly important for remotely conducted interviews, in which participants may only reserve the exact expected amount of time for the call (eg, 60 minutes) and when adequate attention and focus might be more difficult to maintain than in person. To support interviewers in managing time, we commonly include time stamps in interview guides and denote the questions to be prioritized. In focus groups, it is recommended to have 2 interviewers on the call if possible. That way, at least one interviewer can be primarily concerned with active listening and engagement with the participants, whereas another interviewer can focus on note-taking and timekeeping.
In our recent qualitative study with patients with young-onset dementia and their caregivers (dyadic interviews), we found it critical to consider the specific cognitive challenges of persons with dementia in facilitation as well as the sensitive nature of dyadic interviews. All questions were piloted with experts in young-onset dementia before the interviews to ensure clarity. Interviewers were prepared to repeat questions several times as well as define or explain keywords as needed. Because couples were asked to share their perspectives regarding the person with dementia’s symptoms and illness progression as well as relationship satisfaction in front of each other, we prefaced the interview by validating the difficulty of openly sharing and encouraging participants to be as open as possible. When participants were hesitant in sharing, we found that
At the forefront of training competencies to conduct remote data collection is ensuring study staff have familiarity with practices to promote participant privacy and security, including encrypting computer devices; using secure, encrypted video and audio software; and conducting qualitative data collection in private, quiet locations. Equipping the study team with institutionally encrypted equipment (laptops with webcams and phones) and software programs facilitates standardized and HIPAA-protected data collection [
Given the unique challenges to rapport building and participant engagement through remote encounters, it is also important to provide study staff with adequate training in verbal and nonverbal communication. For study staff with less experience with participant interaction and without clinical training, providing some level of peer or hierarchical supervision may be helpful in supporting them in developing effective communication skills.
In this paper, we integrated recommendations from previous literature with examples from our ongoing clinical research to identify and respond to specific challenges to remote data collection (
Future research is needed to evaluate whether data collected through web-based study designs are of the same nature and quality as data collected through traditional in-person approaches and to continue to identify strategies to maximize the validity of data collected remotely. The shift toward more web-based designs prompted by the COVID-19 pandemic brings with it the opportunity to remove many barriers of access to clinical research and engage more diverse participant populations while minimizing the burden on participants. However, without proper capacity building for web-based research, we risk widening the digital divide perpetuating existing disparities. We discussed our experiences with conducting web-based research with different populations, including individuals underrepresented in research such as Hispanic, Latino, or Latina individuals, those with serious mental illness, and those who face increased barriers to research participation, such as older adults with dementia and adolescents with learning disabilities. The strategies presented (eg, device provision, increasing technological support, and using multiple modalities to conduct research) are examples of mechanisms to promote equity in research participation. We acknowledge the significant participant burden in using technology for research and that the same digital health solutions do not work for all individuals. Therefore, it is imperative that researchers assess barriers specific to their study designs and populations of interest to mitigate the threat of increasing existing disparities. Additional research is needed to further characterize strategies that can be used to ensure accessibility of virtually conducted research to marginalized and underrepresented populations.
6-minute walk test
Health Insurance Portability and Accountability Act
Research Electronic Data Capture
None declared.