Abstract
Objective
Obtaining ecologically valid biological samples is critical for understanding respiratory effects of tobacco use, but can be burdensome. In two diverse samples, we examined feasibility and acceptability of studying pulmonary function and respiratory health entirely remotely.
Design
Observational feasibility and acceptability study.
Setting and participants
Adults age 18–25 (Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes [BREATHE] Study) and 21–65 (Adult IQOS Respiratory [AIRS] Study) recruited from previous research studies and advertisements in Southern California, USA (BREATHE (AIRS): N=77 (N=31) completed baseline, n=64 (n=20) completed feasibility and acceptability measures). Shared inclusion criteria for the two studies were ownership of a smartphone, willingness to download applications and English fluency. In addition, BREATHE participants reported one of three tobacco use patterns. AIRS participants smoked daily and were willing to use a heated tobacco product. Exclusion criteria were medical contraindications.
Interventions
A 4-week study consisted of five virtual study visits, twice daily ecological momentary assessment diaries and spirometry assessments, and weekly Nasal Epithelial Lining Fluid and saliva collection. All study visits were conducted via video conference; study materials and biospecimens were exchanged via mail. Participants reported feasibility and acceptability of daily diaries, breath tests, biospecimen collection and shipments.
Measures
Surveys assessed perceptions of timing and overall experience of daily diaries and breath tests, difficulty of and overall experience with biospecimen collection, and experience sending and receiving shipments.
Results
Most participants evaluated daily diaries and breath tests as manageable (62.5%–95.0%) and likeable (54.7%–70.0%). Breath tests were frequently described as ‘interesting’ (55.0%–57.8%) and ‘easy’ (25.0%–48.4%). Most participants reported that biospecimen collection was easy (50.0%–85.0%), and that shipments were easy to send (87.5%–95.0%), receive (95.3%–95.0%) and schedule (56.3%–60.0%). No participants received shipments in poor condition.
Conclusions
Remote research procedures may be feasible and acceptable to facilitate tobacco research studies, potentially resulting in more diverse samples of participants and more generalisable research results.
Keywords: Telemedicine, Substance misuse, RESPIRATORY MEDICINE (see Thoracic Medicine)
STRENGTHS AND LIMITATIONS OF THIS STUDY.
Participant samples were sociodemographically diverse.
Results may not generalise to older adults (age 66+).
Attrition bias may have affected results.
Introduction
Use of non-cigarette nicotine/tobacco products among US adults has become increasingly prevalent. E-cigarettes are the most commonly used nicotine/tobacco product among young adults, with approximately 23% of young adults age 21–22 reporting past-month e-cigarette use in 2021.1 E-cigarette use may have adverse effects on young adults’ respiratory health, including acute symptoms of respiratory disease2–6 and detrimental effects on lung cellular and organ physiology and immune function.7–10 IQOS, another non-cigarette product, is a heated tobacco product, which was authorised by the US Food and Drug Administration (FDA) in 2020 to be marketed as a modified risk tobacco product.11 The manufacturer’s application for the modified risk designation contained limited data on the respiratory outcomes associated with switching from combustible tobacco to IQOS under real-world conditions.12 Objectively assessing the respiratory effects of nicotine/tobacco products such as e-cigarettes and IQOS can be enhanced with the use of biological data such as spirometry and collection of biospecimens such as saliva (eg, cotinine as a biomarker of nicotine use) and nasal epithelial lining fluid (NELF; eg, to detect biomarkers of respiratory inflammation or immune changes).
Participating in studies with intensive biological data collection has traditionally required in-person study visits. During the COVID-19 pandemic, remotely administered study procedures became necessary to keep both participants and study staff safe. Beyond the pandemic, remotely administered procedures are needed to increase sociodemographic diversity in participant pools, improve generalisability and ecological validity of results, and promote equitable opportunities to contribute to scientific research. In-person visits can create barriers to study participation, as they can be burdensome or inaccessible for participants who do not live near the study site or do not have reliable transportation.13 Studies requiring in-person visits may exclude populations who face accessibility challenges, such as socioeconomically disadvantaged individuals, people living in rural areas and those with disabilities. These populations, along with racial/ethnic minorities and sexual/gender minorities, are under-represented in biomedical research, detrimentally affecting the benefit of science to broader society.14 Fully remote self-report data and biological data collection may address some barriers to research participation, such as travel time, cost and accessibility needs. Although higher-income Americans are more likely than lower-income Americans to have reliable Internet access, the ‘digital divide’ is closing as more people obtain Internet and smartphone access.15
Mobile spirometry devices and procedures have been validated for home use, with demonstrated feasibility and acceptability in patient populations.16–18 While past research studies have collected salivary cotinine and carbon monoxide measurements remotely,19 little is known about the feasibility and acceptability of intensive remote procedures (eg, daily spirometry measurements, weekly biospecimen collection and video meetings). To address this gap, we examined feasibility and acceptability of studying adults’ pulmonary function and respiratory health entirely remotely. Over a 4-week study period, adult participants in two diverse samples completed five sessions with study staff via video conference, twice daily diaries and spirometry measurements, and weekly collection of saliva and nasal epithelial fluid, with study materials and biospecimens sent via mail. Participants reported their experience with study procedures in feasibility and acceptability surveys throughout the study. This study described participants’ experience with study procedures.
Methods
Participants
Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes Study
The Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes (BREATHE) Study examined changes in pulmonary functioning and respiratory health by tobacco product use status. Participants were young adults recruited in ninth grade in 2013 from 10 Southern California high schools to participate in a prospective cohort study of health and well-being (IRB protocol #HS-12–00180).20 Cohort members who had agreed to be contacted about future studies were invited to complete an online eligibility screener for the BREATHE Study. Inclusion criteria were: (A) ownership of a smartphone and willingness to download applications; (B) past 3-month exclusive e-cigarette use, past 3-month couse of e-cigarettes and other tobacco products, or no past 6-month tobacco product use; (C) age 18–25; and (D) English fluency. Exclusion criteria were: (A) self-reported lung disease (eg, cystic fibrosis); (B) unstable or significant psychiatric conditions; (C) past 3-month cardiac event or distress; (D) current COVID-19 illness or past 3-month hospitalisation for COVID-19 and (E) current pregnancy, plans to become pregnant or breast feeding. Recruitment spanned April–October 2021; feasibility and acceptability data collection occurred May–December 2021.
Adult IQOS Respiratory Study
The Adult IQOS Respiratory Study (AIRS) examined perceptions and use of IQOS, a heated tobacco product. Participants were adults who smoked cigarettes daily, recruited from previous studies and from social media and other advertisements in the greater Los Angeles area. Inclusion criteria were: (A) ownership of a smartphone and willingness to download applications; (B) current daily smoking (ie, more than five cigarettes/day for the past 6 months); (C) age 21–65; (D) English fluency; (E) never having used IQOS previously and (F) willingness to try IQOS for the next 30 days. Exclusion criteria were the same as those in BREATHE, except that participants could not have used other tobacco products or marijuana more than 5 days of the past 30. Recruitment spanned January–December 2021; feasibility and acceptability data collection occurred February–December 2021.
Procedures
Overview
After recruitment, the BREATHE and AIRS studies followed the same procedure. The 4-week study period consisted of a baseline visit, twice daily ecological momentary assessment (EMA) diaries and spirometry assessments, and weekly NELF and saliva collection. All study visits were conducted over a university-approved video conferencing platform. At the baseline visit, study staff obtained informed consent and participant contact information and explained the study procedures and compensation schedule. After the baseline visit, staff emailed a baseline survey and mailed a study materials kit to the participant. The study kit contained a spirometer kit, disposable mouthpieces for the spirometer, a saliva cotinine collection kit, an NELF nasal swab kit, disposable gloves, cotton balls, alcohol wipes, ice packs and three prelabelled return packages. Additional 30 min study visits were conducted via video conference on days 1, 8, 15 and 22, during which participants collected NELF and saliva. Participants stored biospecimens in their own freezers while awaiting return shipments. Biospecimens were picked up from the participant’s home and sent back to the study team on days 8 and 22. After the day 22 visit, study staff coordinated a shipment pick-up time with participants. Feasibility and acceptability questionnaires were administered after the day 1 visit (device and biological data collection experience) and at the completion of the study (study engagement and remote sampling mailing experience). Participants were compensated US$50 for the baseline visit, US$20 weekly for completed saliva and NELF collection (up to US$60 total), US$2 for completed daily diaries and spirometry measurements (up to US$44 total) and an additional US$76 for completing 75% or more of the daily diaries, for a total possible compensation of US$230.
Daily diaries and spirometry tests
Daily diaries were administered twice daily via the LifeData app. Daily diary morning prompts were pushed between awakening and the start of any school or work commitments, and evening prompts were pushed before the participant’s bedtime. Spirometry was conducted with a Spirobank21 handheld spirometer and smartphone app immediately after each daily diary. Because participants were not monitored every time they used the spirometer, we could not confirm whether all American Thoracic Society standards of acceptability and reproducibility22 were met each time. However, staff provided all necessary training and equipment. Participants completed a study staff-led directed training via video conference and viewed an instructional video on spirometer use during the day 1 visit. To use the spirometer, participants placed the device in their mouths, took a deep breath and exhaled as quickly as possible. Measurements were repeated at least three times, and spirometric indices were automatically recorded for the best test.23 The training video was easily accessible in the spirometry app for reviewing instructions at any time.
NELF and saliva collection
Saliva and NELF were collected once weekly during each study check-in visit conducted via video conference. Participants viewed instructional videos during the day 1 visit. Participants collected saliva using standardised methods by providing passive drool into a collection tube. Nasal epithelial fluid was collected using validated procedures.10 24 25 Specifically, participants sprayed their nostrils with a sterile, normal saline irrigation solution, inserted test strips into their nostrils and clamped their nostrils shut for 2 min, then removed the test strips and placed them into marked tubes. Biospecimens were stored in participants’ freezers until scheduled return shipment pickup times.
Self-reported measures of feasibility
Daily diaries and breath tests
Participants rated the timing (forced choice: very manageable, somewhat manageable, neutral, somewhat disruptive, very disruptive), number (too little, just right, too many) and overall experience (liked a great deal, liked a moderate amount, neither liked nor disliked, disliked a moderate amount, disliked a great deal) of the daily diaries and breath tests. In addition, participants described breath tests selecting all that apply from a menu of options (easy, interesting, enjoyable, challenging, very challenging, uncomfortable).
Nasal swabs (NELF) and saliva collection
Participants rated the difficulty (easy, somewhat challenging, very challenging) and frequency (too frequent, just right, too sparse) of the nasal swabs and saliva collection, and selected all applicable descriptors for the nasal swab and saliva collection (difficult to find a place to do the swab/collection, easy to find a place to do the swab/collection, gross, uncomfortable, frustrating, manageable, uncomplicated and time-consuming).
Shipments
Using two items, participants rated their experience receiving (arrived on time, arrived late, easy to receive, easy to schedule, difficult to receive, difficult to schedule, received in good condition, received in poor condition) and sending (easy to schedule, easy to ship, difficult to schedule, difficult to ship) shipments, selecting all applicable descriptors for each item.
Sociodemographic characteristics
Participants reported their age, gender identity (male, female, transgender, gender variant/non-binary, other), sexual identity (asexual, bisexual, gay, straight, lesbian, pansexual, queer, questioning/unsure, other), race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, white, another race), Hispanic/Latinx ethnicity (yes/no), yearly income (less than US$10 000, US$10 000–US$99 999 (in increments of US$10 000), over US$100 000, student, unknown), perceived financial status compared with others (much better, better, same, worse, much worse, unknown), educational attainment (less than high school, some high school, high school graduate, some college, associate degree, bachelor’s degree, master’s degree, doctorate degree, professional school degree) and current employment status (unemployed, employed part time, employed full time, student).
Statistical analysis
Descriptive statistics were examined to characterise the sample’s sociodemographic characteristics and reported feasibility and acceptability of the daily diaries, breath tests, NELF, saliva collection and shipments. Missing data were handled using listwise deletion. Analyses were conducted with SPSS V.27. Of the 77 participants who completed the BREATHE baseline questionnaire, 83.1% (n=64) completed the feasibility and acceptability questionnaires (n=13 did not). Of the 31 participants who completed the AIRS baseline questionnaire, 64.5% (n=20) completed the feasibility and acceptability questionnaires (n=11 did not). Reported percentages for the feasibility and acceptability items reflect the participants (n=64 in BREATHE, n=20 in AIRS) who completed the questionnaires.
Patient and public involvement
None.
Results
Participant characteristics
Participant demographic characteristics for BREATHE (N=77) and AIRS (N=31) are presented in table 1. Taken together, the two samples comprise a diverse group of adults. The BREATHE sample contained a notably high proportion of sexual and gender minority participants. A plurality of participants in BREATHE were Hispanic; a plurality in AIRS were non-Hispanic Black. Both samples were diverse in indicators of socioeconomic status, such as educational attainment and perceived financial status relative to others. In BREATHE, 10 participants completed the baseline survey but withdrew from the study or were lost to follow-up, an attrition rate of 13.0%. Five were lost to follow-up. The remaining five withdrew, or were withdrawn, from the study due to the perceived time burden, loss of interest in participating, non-compliance with study procedures, safety concerns or undisclosed reasons. An additional three participants did not complete the feasibility and acceptability questionnaires. In AIRS, seven participants withdrew or were withdrawn (attrition rate=22.6%). Three had technical difficulties with biospecimen storage, downloading study apps or using IQOS. One stopped attending study sessions. The remaining three expressed that the procedure was too burdensome or that they were no longer interested. An additional four participants did not complete the feasibility and acceptability questionnaires.
Table 1.
Participant characteristics in two samples of adults
| BREATHE Study (N=77) | AIRS Study (N=31) | |
| % (n) | ||
| Age (M/SD) | 21.5 (0.6) | 49.6 (8.1) |
| Gender | ||
| Cisgender man | 33.8 (26) | 54.8 (17) |
| Cisgender woman | 58.4 (45) | 45.2 (14) |
| Transgender or another gender* | 5.2 (4) | 0.0 (0) |
| Unreported | 2.6 (2) | 0.0 (0) |
| Sexual identity | ||
| Straight | 70.1 (54) | 83.9 (26) |
| Gay/lesbian | 5.2 (4) | 6.5 (2) |
| Bisexual or pansexual | 11.7 (9) | 6.5 (2) |
| Asexual | 3.4 (3) | 3.2 (1) |
| Another sexual identity† | 5.2 (4) | 0.0 (0) |
| Unreported | 3.9 (3) | 0.0 (0) |
| Race/ethnicity | ||
| Hispanic | 41.6 (32) | 12.9 (4) |
| Non-Hispanic white | 10.4 (8) | 25.8 (8) |
| Black | 5.2 (4) | 45.2 (14) |
| Asian | 23.4 (18) | 12.9 (4) |
| American Indian/Alaska Native | 0.0 (0) | 3.2 (1) |
| Native Hawaiian/Pacific Islander | 1.3 (1) | 0.0 (0) |
| Multiple races/ethnicities | 13.0 (10) | 0.0 (0) |
| Another race/ethnicity | 2.6 (2) | 0.0 (0) |
| Unreported | 2.6 (2) | 0.0 (0) |
| Yearly income | ||
| Less than US$10 000 | 28.6 (22) | 19.4 (6) |
| US$10 000–US$29 999 | 31.2 (24) | 38.7 (12) |
| US$30 000 or more | 11.7 (9) | 41.9 (13) |
| Student | 14.3 (11) | 0.0 (0) |
| Unknown or unreported | 14.3 (11) | 0.0 (0) |
| Financial status | ||
| Better or much better than others | 22.1 (17) | 6.5 (2) |
| Same as others | 45.5 (35) | 22.6 (7) |
| Worse or much worse than others | 22.1 (17) | 54.8 (17) |
| Unknown or unreported | 10.4 (8) | 16.1 (5) |
| Educational attainment | ||
| High school or less | 11.7 (9) | 25.8 (8) |
| Some college | 48.1 (37) | 48.4 (15) |
| Associate’s degree or more | 37.7 (29) | 25.8 (8) |
| Unreported | 2.6 (2) | 0.0 (0) |
| Current employment | ||
| Unemployed | 18.2 (14) | 51.6 (16) |
| Employed part time | 29.9 (23) | 29.0 (9) |
| Employed full time | 23.4 (18) | 16.1 (5) |
| Student | 22.1 (17) | 0.0 (0) |
| Unreported | 6.5 (5) | 3.2 (1) |
*Includes transgender (n=1) and gender variant/non-binary (n=3)
†Includes queer (n=1) and questioning/unsure (n=3).
AIRS, Adult IQOS Respiratory Study; BREATHE, Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes.
Feasibility and acceptability
Daily diaries and breath tests
Perceptions of the daily diaries and breath tests are reported in table 2. Across both studies, most participants rated the daily diaries as somewhat to very manageable (BREATHE: 73.4%; AIRS: 95.0%; see figure 1). Most rated the number of daily diaries (ie, every morning and night) as ‘just right’ (BREATHE: 89.1%; AIRS: 85.0%). Over half of participants liked the daily diary app a great deal or a moderate amount (BREATHE: 57.8%; AIRS: 70.0%). Breath tests were similarly rated manageable by most participants (BREATHE: 62.5%; AIRS: 75.0%; see figure 1), and most (BREATHE: 82.8%; AIRS: 90.0%) perceived the number of breath tests as ‘just right’. Over half of participants liked the breath device (spirometer) a great deal or a moderate amount (BREATHE: 54.7%; AIRS: 55.0%). The most commonly selected adjectives to describe the breath tests were ‘interesting’ (BREATHE: 57.8%; AIRS: 55.0%), ‘easy’ (BREATHE: 48.4%; AIRS: 25.0%) and ‘challenging’ (BREATHE: 31.3%; AIRS: 30.0%). Notably, ‘challenging’ may have referred to the physical challenge of forced exhalation, not necessarily to the remotely administered aspects of the procedure.
Table 2.
Feasibility and acceptability of daily diaries and breath tests
| BREATHE Study (N=64) | AIRS Study (N=20) | |
| % (n) | ||
| What did you think about the timing of the daily diaries? | ||
| Very manageable | 37.5 (24) | 85.0 (17) |
| Somewhat manageable | 35.9 (23) | 10.0 (2) |
| Neutral | 12.5 (8) | 5.0 (1) |
| Somewhat disruptive | 12.5 (8) | 0.0 (0) |
| Very disruptive | 1.6 (1) | 0.0 (0) |
| What did you think of the amount of daily diaries? | ||
| Just right | 89.1 (57) | 85.0 (17) |
| Too many | 10.9 (7) | 15.0 (3) |
| What did you think about the timing of the breath tests? | ||
| Very manageable | 29.7 (19) | 50.0 (10) |
| Somewhat manageable | 32.8 (21) | 25.0 (5) |
| Neutral | 15.6 (10) | 5.0 (1) |
| Somewhat disruptive | 18.8 (12) | 10.0 (2) |
| Very disruptive | 3.1 (2) | 10.0 (2) |
| What did you think about the number of breath tests we asked you to complete? | ||
| Just right | 82.8 (53) | 90.0 (18) |
| Too many | 17.2 (11) | 10.0 (2) |
| I found the breath tests to be… | ||
| Easy | 48.4 (31) | 25.0 (5) |
| Interesting | 57.8 (37) | 55.0 (11) |
| Enjoyable | 10.9 (7) | 5.0 (1) |
| Challenging | 31.3 (20) | 30.0 (6) |
| Very challenging | 3.1 (2) | 5.0 (1) |
| Uncomfortable | 6.3 (4) | 15.0 (3) |
| Overall, how was your experience using the breath device? | ||
| Liked a great deal | 28.1 (18) | 25.0 (5) |
| Liked a moderate amount | 26.6 (17) | 30.0 (6) |
| Neither liked nor disliked | 32.8 (21) | 30.0 (6) |
| Disliked a moderate amount | 12.5 (8) | 0.0 (0) |
| Overall, how was your experience using the daily diary app? | ||
| Liked a great deal | 31.3 (20) | 25.0 (5) |
| Liked a moderate amount | 26.6 (17) | 45.0 (9) |
| Neither liked nor disliked | 39.1 (25) | 30.0 (6) |
| Disliked a moderate amount | 1.6 (1) | 15.0 (3) |
| Disliked a great deal | 1.6 (1) | 0.0 (0) |
AIRS, Adult IQOS Respiratory Study; BREATHE, Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes.
Figure 1.
Perceived manageability of completing daily diaries and spirometry in the Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes (BREATHE) (A) and Adult Respiratory IQOS Study (AIRS) (B) studies.
NELF and saliva collection
Feasibility and acceptability of biospecimen collection are reported in table 3. Most participants (BREATHE: 79.7%; AIRS: 85.0%) reported NELF collection was easy. Nearly all (BREATHE: 93.8%; AIRS: 100.0%) described frequency as ‘just right’. The most commonly selected adjectives to describe NELF were ‘manageable’ (BREATHE: 67.2%; AIRS: 65.0%), ‘easy to find a place to do the swabs’ (BREATHE: 50.0%; AIRS: 55.0%) and ‘uncomplicated’ (BREATHE: 42.2%; AIRS: 35.0%). Giving enough spit for saliva collection was generally described as ‘easy’ (BREATHE: 50.0%; AIRS: 60.0%) or ‘somewhat challenging’ (BREATHE: 46.9%; AIRS: 40.0%), with frequency of collection most often described as ‘just right’ (BREATHE: 95.3%; AIRS: 100.0%). The most commonly selected descriptors for saliva collection were ‘manageable’ (BREATHE: 57.8%; AIRS: 60.0%), ‘easy to find a place to collect the saliva’ (BREATHE: 54.7%; AIRS: 60.0%) and ‘uncomplicated’ (BREATHE: 29.7%; AIRS: 25.0%).
Table 3.
Feasibility and acceptability of biospecimen collection and shipment
| BREATHE (N=64) | AIRS (N=20) | |
| % (n) | ||
| What was the difficulty level of doing the nasal swabs? | ||
| Easy | 79.7 (51) | 85.0 (17) |
| Somewhat challenging | 20.3 (13) | 15.0 (3) |
| How was the frequency of the nasal swabs? | ||
| Too frequent | 4.7 (3) | 0.0 (0) |
| Just right | 93.8 (60) | 100.0 (20) |
| Too sparse | 1.6 (1) | 0.0 (0) |
| The nasal swabs were… | ||
| Easy to find a place to do the swab | 50.0 (32) | 55.0 (11) |
| Difficult to find a place to do the swab | 4.7 (3) | 0.0 (0) |
| Gross | 12.5 (8) | 5.0 (1) |
| Uncomfortable | 17.2 (11) | 5.0 (1) |
| Frustrating | 4.7 (3) | 0.0 (0) |
| Manageable | 67.2 (43) | 65.0 (13) |
| Uncomplicated | 42.2 (27) | 35.0 (7) |
| Time-consuming | 1.6 (1) | 0.0 (0) |
| Giving enough spit for the saliva collection tubes was… | ||
| Easy | 50.0 (32) | 60.0 (12) |
| Somewhat challenging | 46.9 (30) | 40.0 (8) |
| Very challenging | 3.1 (2) | 0.0 (0) |
| How did you find the frequency of the saliva tests? | ||
| Too frequent | 3.1 (2) | 0.0 (0) |
| Just right | 95.3 (61) | 100.0 (20) |
| Too sparse | 1.6 (1) | 0.0 (0) |
| The saliva tubes were… | ||
| Difficult to find a place to collect the saliva | 7.8 (5) | 15.0 (3) |
| Easy to find a place to collect the saliva | 54.7 (35) | 60.0 (12) |
| Gross | 10.9 (7) | 5.0 (1) |
| Uncomfortable | 10.9 (7) | 5.0 (1) |
| Frustrating | 6.3 (4) | 5.0 (1) |
| Manageable | 57.8 (37) | 60.0 (12) |
| Uncomplicated | 29.7 (19) | 25.0 (5) |
| Time-consuming | 15.6 (10) | 5.0 (1) |
| My experience receiving the shipments was… | ||
| Easy to receive | 95.3 (61) | 95.0 (19) |
| Easy to schedule | 56.3 (36) | 60.0 (12) |
| Received in a good condition | 50.0 (32) | 65.0 (13) |
| Difficult to receive | 3.1 (2) | 0.0 (0) |
| Difficult to schedule | 3.1 (2) | 0.0 (0) |
| My experience sending the shipments was… | ||
| Easy to send | 87.5 (56) | 95.0 (19) |
| Easy to schedule | 56.3 (36) | 60.0 (12) |
| Difficult to send | 4.7 (3) | 0.0 (0) |
| Difficult to schedule | 7.8 (5) | 0.0 (0) |
AIRS, Adult IQOS Respiratory Study; BREATHE, Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes.
Shipments
Participants’ experience with sending and receiving shipments is reported in table 3. The most commonly selected descriptors for receiving shipments were ‘easy to receive’ (BREATHE: 95.3%; AIRS: 95.0%), ‘easy to schedule’ (BREATHE: 56.3%; AIRS: 60.0%) and ‘received in good condition’ (BREATHE: 50.0%; AIRS: 65.0%). No participants reported receiving shipments in poor condition. The most commonly selected descriptors for sending shipments were ‘easy to send’ (BREATHE: 87.5%; AIRS: 95.0%), ‘easy to schedule’ (BREATHE: 56.3%; AIRS: 60.0%) and ‘difficult to schedule’ (in BREATHE only, 7.8%). A few participants (4.7%) in BREATHE reported that shipments were ‘difficult to send’, due to their living situation (eg, living on a military base, moving) or difficulties with FedEx pick-ups (eg, late pick-up, lack of communication with FedEx).
Discussion
Adults across the age spectrum, participating in two 4-week studies of the respiratory effects of non-cigarette tobacco products, found remote study procedures to be feasible and acceptable. Participants engaged in twice daily diaries and spirometry measurements and weekly collection of saliva and nasal epithelial fluid during video calls with study staff. Most participants considered the study procedures to be manageable and not excessively frequent. Receiving and scheduling shipments of study materials and biospecimens was typically considered easy, with shipments arriving in good condition. Protocols were entirely remote in order to maintain social distancing and to avoid aerosol-generating procedures during the COVID-19 pandemic. Feasibility and acceptability data suggest that remote administration of an observational study involving spirometry, biospecimen collection and EMA (ie, daily diaries) is a viable alternative to in-person data collection. Beyond the COVID-19 pandemic, remote protocols can still be used to expand access to research participation and to increase the geographical diversity of participant pools. Prior research on young adults’ tobacco use has found remote monitoring of carbon monoxide26 and salivary cotinine27 to be feasible and acceptable. This study further suggests that repeated collection of multiple forms of biodata, plus EMA, can be done entirely remotely.
Young adults may be more familiar and comfortable with using smartphone apps and video conferencing than older adults, and older adults are less likely than young adults to own a smartphone.28 However, the increased use of video conferencing for socialising, working and receiving healthcare during the COVID-19 pandemic likely increased many older adults’ familiarity with and comfort with using these technologies. Indeed, participants across the age spectrum eligible for these studies (age 18–65) found the study procedures to be feasible and acceptable. Importantly, smartphone ownership was an eligibility criterion for participating in this study. Although smartphone ownership has increased for lower-income Americans, 24% of adults with annual household incomes below US$30 000 reported not owning a smartphone in 2021.15 However, smartphone ownership is similar across racial/ethnic groups.28 Despite the requirement of smartphone ownership, this study recruited diverse samples of adults. Only 10.4% of the BREATHE sample was non-Hispanic white (25.8% of the AIRS sample). The majority of the AIRS sample (54.8%) perceived their financial status as worse than other peoples’, and only 11.7% of the BREATHE sample reported annual income of US$30 000 or more.
Physical access to a study site is only one barrier to participating in biomedical research. Other barriers include limited exposure to research participation opportunities, information being presented in language that is difficult to understand, receiving information from unfamiliar sources and unaddressed privacy concerns.13 Many participants in these studies were already familiar with participating in research and received an invitation to participate from a familiar source (ie, the study team), which may have increased participants’ willingness to participate in the study. Achieving equity in research participation opportunities will require addressing additional barriers, beyond physical access to study sites.
Limitations and future directions
This study had several limitations in addition to those included above. First, generalisability of results beyond adults in Southern California may be limited. This participant pool was diverse in characteristics such as race/ethnicity, socioeconomic status and sexual identity; however, replication in a national sample would additionally be informative. Second, results may have been affected by attrition bias. Participants who found study procedures to be feasible and acceptable may have been more likely to complete follow-up surveys. In both samples, some participants who encountered barriers to participating in the study were not included in our data due to attrition. For example, several participants stated that they withdrew because the study was too time-consuming or burdensome, or because they were no longer interested in participating. One participant encountered technical difficulty downloading the study apps. Other participants may have had similar or different concerns. Future research could examine participant retention strategies in a remotely delivered study involving biological data collection.
Conclusions
The COVID-19 pandemic has highlighted the ongoing need for the remote conduct of research studies involving biological data collection. Remote research procedures may improve the diversity of samples and generalisability of research results. Overall, this study demonstrates that mobile apps and devices may be feasible and acceptable in facilitating tobacco research studies involving biological data collection.
Supplementary Material
Footnotes
Contributors: EAV wrote the original draft and conducted data analysis. MER and JM reviewed and edited the manuscript for important intellectual content. MW conducted data analysis and reviewed and edited the manuscript for important intellectual content. AL acquired funding for the study and reviewed and edited the manuscript for important intellectual content. APT conceptualised the study, provided supervision and project oversight, acquired funding and edited the manuscript for important intellectual content. APT is guarantor.
Funding: This work was supported by the National Heart, Lung, and Blood Institute (NHLBI) under Award Number K01-HL148907 and the National Cancer Institute and the FDA Center for Tobacco Products (CTP) under Award Number U54CA180905.
Competing interests: None declared.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review: Not commissioned; externally peer reviewed.
Data availability statement
Data are available on reasonable request. Relevant data are available from the corresponding author on reasonable request.
Ethics statements
Patient consent for publication
Not applicable.
Ethics approval
The BREATHE Study (IRB# UP-20-00992) and AIRS Study (IRB# UP-20-01209) were approved by the University of Southern California Institutional Review Board. Participants gave informed consent to participate in the study before taking part.
References
- 1.Patrick ME, Schulenberg JE, Miech RA. Monitoring the future panel study annual report: national data on substance use among adults age 19 to 60, 1976-2021. Ann Arbor, MI: University of Michigan Institute for Social Research, 2022. [Google Scholar]
- 2.Braymiller JL, Barrington-Trimis JL, Leventhal AM, et al. Assessment of nicotine and cannabis vaping and respiratory symptoms in young adults. JAMA Netw Open 2020;3:e2030189. 10.1001/jamanetworkopen.2020.30189 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Chaffee BW, Barrington-Trimis J, Liu F, et al. E-cigarette use and adverse respiratory symptoms among adolescents and young adults in the United States. Prev Med 2021;153:106766. 10.1016/j.ypmed.2021.106766 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Gotts JE, Jordt S-E, McConnell R, et al. What are the respiratory effects of e-cigarettes? BMJ 2019;366:l5275. 10.1136/bmj.l5275 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Kechter A, Schiff SJ, Simpson KA, et al. Young adult perspectives on their respiratory health symptoms since vaping. Subst Abus 2021;42:1–13. 10.1080/08897077.2020.1856290 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.McConnell R, Barrington-Trimis JL, Wang K, et al. Electronic cigarette use and respiratory symptoms in adolescents. Am J Respir Crit Care Med 2017;195:1043–9. 10.1164/rccm.201604-0804OC [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Hickman E, Hinton A, Zorn B. E-Cigarette use, cigarette use, and sex modify the nasal microbiome and nasal Host-Microbiota interactions; 2021.
- 8.Martin EM, Clapp PW, Rebuli ME, et al. E-cigarette use results in suppression of immune and inflammatory-response genes in nasal epithelial cells similar to cigarette smoke. Am J Physiol Lung Cell Mol Physiol 2016;311:L135–44. 10.1152/ajplung.00170.2016 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Reidel B, Radicioni G, Clapp PW, et al. E-cigarette use causes a unique innate immune response in the lung, involving increased neutrophilic activation and altered mucin secretion. Am J Respir Crit Care Med 2018;197:492–501. 10.1164/rccm.201708-1590OC [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Rebuli ME, Glista-Baker E, Hoffman JR, et al. Electronic-cigarette use alters nasal mucosal immune response to live-attenuated influenza virus. A clinical trial. Am J Respir Cell Mol Biol 2021;64:126–37. 10.1165/rcmb.2020-0164OC [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.FDA authorizes marketing of IQOS tobacco heating system with ‘reduced exposure’ information [press release], 2020
- 12.Moazed F, Chun L, Matthay MA, et al. Assessment of industry data on pulmonary and immunosuppressive effects of IQOS. Tob Control 2018;27:s20–5. 10.1136/tobaccocontrol-2018-054296 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Davis TC, Arnold CL, Mills G, et al. A qualitative study exploring barriers and facilitators of enrolling underrepresented populations in clinical trials and biobanking. Front Cell Dev Biol 2019;7:74. 10.3389/fcell.2019.00074 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Mapes BM, Foster CS, Kusnoor SV, et al. Diversity and inclusion for the all of US research program: a scoping review. PLoS One 2020;15:e0234962. 10.1371/journal.pone.0234962 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Vogels EA. Digital divide persists even as Americans with lower incomes make gains in tech adoption, 2021. Available: https://www.pewresearch.org/fact-tank/2021/06/22/digital-divide-persists-even-as-americans-with-lower-incomes-make-gains-in-tech-adoption/ [Accessed 09 Mar 2022].
- 16.Degryse J, Buffels J, Van Dijck Y, et al. Accuracy of office spirometry performed by trained primary-care physicians using the miR spirobank hand-held spirometer. Respiration 2012;83:543–52. 10.1159/000334907 [DOI] [PubMed] [Google Scholar]
- 17.Fox L, McLeod L, Russell A, et al. An observational study of self-monitoring of spirometry and symptoms via a mobile electronic health journal in usual care of patients with idopathic pulmonary fibrosis. Am J Respir Crit Care Med 2020;201:A3394. [Google Scholar]
- 18.Ramsey RR, Plevinsky JM, Milgrim L, et al. Feasibility and preliminary validity of mobile spirometry in pediatric asthma. J Allergy Clin Immunol Pract 2021;9:3821–3. 10.1016/j.jaip.2021.06.005 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Dahne J, Tomko RL, McClure EA, et al. Remote methods for conducting tobacco-focused clinical trials. Nicotine Tob Res 2020;22:2134–40. 10.1093/ntr/ntaa105 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Leventhal AM, Strong DR, Kirkpatrick MG, et al. Association of electronic cigarette use with initiation of combustible tobacco product smoking in early adolescence. JAMA 2015;314:700–7. 10.1001/jama.2015.8950 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Lin C-H, Cheng S-L, Wang H-C, et al. Novel app-based portable spirometer for the early detection of COPD. Diagnostics 2021;11:785. 10.3390/diagnostics11050785 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Graham BL, Steenbruggen I, Miller MR, et al. Standardization of spirometry 2019 update. An official American thoracic society and European respiratory society technical statement. Am J Respir Crit Care Med 2019;200:e70–88. 10.1164/rccm.201908-1590ST [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Barreiro TJ, Perillo I. An approach to interpreting spirometry. Am Fam Physician 2004;69:1107–15. [PubMed] [Google Scholar]
- 24.Rebuli ME, Speen AM, Martin EM, et al. Wood smoke exposure alters human inflammatory responses to viral infection in a sex-specific manner. A randomized, placebo-controlled study. Am J Respir Crit Care Med 2019;199:996–1007. 10.1164/rccm.201807-1287OC [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Rebuli ME, Speen AM, Clapp PW, et al. Novel applications for a noninvasive sampling method of the nasal mucosa. Am J Physiol Lung Cell Mol Physiol 2017;312:L288–96. 10.1152/ajplung.00476.2016 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.McClure EA, Tomko RL, Carpenter MJ, et al. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse 2018;44:561–70. 10.1080/00952990.2018.1467431 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Palmer AM, Tomko RL, Squeglia LM, et al. A pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth. Drug Alcohol Depend 2022;232:109311. 10.1016/j.drugalcdep.2022.109311 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Pew Research Center . Mobile fact sheet. Pew research center, 2021. Available: https://www.pewresearch.org/internet/fact-sheet/mobile/ [Accessed 09 Mar 2022].
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Data are available on reasonable request. Relevant data are available from the corresponding author on reasonable request.