Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen Jennifer Lord-Bessen, Danielle Rodriguez, Karin Coyne, Spencer Schaff, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3921908/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 Jun, 2025 Read the published version in Therapeutic Innovation & Regulatory Science → Version 1 posted 7 You are reading this latest preprint version Abstract Background: In clinical trials, the single-item-per-screen format is commonly used for electronic patient-reported outcomes (ePROs). However, participant preferences for this format over multiple items per screen have not been investigated. This study evaluated participant preferences for single-item-per-screen vs. multiple-items-per-screen ePRO formats, the effect on completion times, and the comparability of scores between formats. Methods: Participation in this randomized, crossover, observational study involved ePRO completion in both single-item-per-screen and multiple-items-per-screen formats on an electronic tablet device during two study visits. A paper-based preference questionnaire was completed at each visit. Results: Thirty-seven adults (mean [SD] age=49.6 [15.4] years; 51.4% female; 54.1% White) enrolled and 36 participants completed both visits. Twelve participants (33.3%) preferred the multiple-item format, 12 (33.3%) preferred the single-item format, 10 (27.8%) had no preference, and 2 (5.6%) did not notice a difference. Seventeen participants (47.2%) preferred the single-item format when participating in a clinical trial, and most (n=20; 55.6%) believed that others would prefer this format in a clinical trial. The ePRO completion time (minutes: seconds) was longer for the single-item format than the multiple-item format (mean [SD], 6:42 [2:24] vs. 6:21 [2:22]; p = 0.1540). The ePRO scores were similar across both formats. Conclusion: This study provided evidence that both single-item and multiple-items-per-screen presented on an electronic tablet device are acceptable to users and that format preference may be specific to each individual. Thus, clinical programs need to consider the targeted study population, the purpose of use, and the overall the trial design when designing ePRO solutions. clinical trials electronic data capture electronic patient-reported outcomes ePRO patient-reported outcomes electronic clinical outcome assessment Figures Figure 1 Introduction A patient-reported outcome (PRO) is a standardized, validated questionnaire often used in clinical trials to capture patient information on symptoms (e.g., pain), daily functioning (e.g., the ability to carry groceries or perform self-care), or health-related quality of life (e.g., the patient’s emotional response to the constraints they experience due to their health condition) [ 1 ]. PRO administration in electronic format has improved the integrity and accuracy of data collected in clinical trials by providing a record of data entries, preventing or identifying retrospective and prospective data entry, decreasing incomplete or missing data entries, and preventing the entry of unusable responses [ 2 ]. The US Food and Drug Administration’s (FDA) PRO Guidance explicitly endorses the use of electronic patient-reported outcomes (ePROs) in clinical trials [ 3 ]. Several ePRO modes of data collection are currently used in clinical trials including handheld devices, desktop or laptop computers, and electronic tablets [ 4 ]. Of these, electronic tablets are primary platform for onsite ePRO data collection due to their ease of use and convenient screen size [ 2 , 5 – 8 ]. Most PROs were developed and validated on paper; therefore, care must be taken when converting (i.e., ‘migrating’) PROs from paper to an electronic mode to preserve their psychometric properties and maintain measurement comparability [ 6 , 9 ]. A ‘faithful’ migration occurs when the new mode does not introduce response biases due to changes in presentation, formatting, or participant interaction [ 4 ]. Ensuring faithful migration with minimal or no effect on the measurement characteristics of the PRO is especially important in clinical trials where PRO data may be used in regulatory submissions. Current practices to ensure faithful migration have largely been shaped by Task Force reports from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on measurement comparability of PROs across modes of data capture [ 4 , 10 ]. According to the ISPOR Task Force reports, comparability is driven by the degree of modification applied to the content and format of the original paper-based PRO, with the magnitude of modification determining the level of equivalence evidence required through cognitive interviews or quantitative testing. However, since the initial report, studies have consistently shown that participants answer comparably across modes of data capture for common response scales [ 11 , 12 ]. The updated ISPOR Task Force report recommends an evidence-based approach to equivalence testing and deems generating further equivalence evidence unnecessary when there is sufficient evidence on measurement comparability and faithful migration has been followed [ 13 ]. A shared recommendation across the several guidance documents outlining PRO migration best practices is to present a single-item (i.e., one question and its response options) per screen when the PRO measure is implemented electronically [ 9 , 14 – 20 ]. The single-item-per-screen format has historically been considered a minor level of modification from the paper-based format [ 10 , 19 , 20 ]. Based on the updated ISPOR Task Force report, the single-item-per-screen format would not require additional equivalence testing as participants provide consistent responses on a paper-based format presenting multiple items together and an electronic device presenting single-item- per-screen [ 11 , 12 ]. An advantage of the single-item-per-screen format is consistency across screen-based migrations of the same PRO on different types of devices [ 19 , 21 , 22 ]. The single-item-per-screen format is also used because multiple-items-per-screen on smaller device screens (e.g., smartphones) may create ‘cluttered’ screens (i.e., reduced space between questions) resulting in readability challenges [ 22 ]. Additionally, multiple-items-per-screen on small devices may require scrolling, which is generally not recommended [ 9 , 15 , 16 , 19 , 20 ]. Despite usability and patient input into PRO measure development being emphasized by regulators, when it comes to formatting and presentation, prior research has focused primarily on measurement comparability [ 23 – 25 ]. Participant format preferences and perceived usability for ePRO have not been investigated for key migration recommendations, such as implementing a single-item-per-screen format. Although the single-item-per-screen format is dominant for ePRO measures, it is not known whether participants prefer a single-item-per-screen format over a multiple-item-per-screen format or which format may be perceived as being easier to use. The main drawback to a single-item-per-screen format is that it increases the number of screens when each ePRO item is presented independently, resulting in increased completion time which could affect participant burden [ 26 ]. This study examined participant preferences for single-item-per-screen vs. multiple-items-per-screen formats and investigated whether presentation formats affected key metrics of ePRO performance, including the time required to complete the questionnaire, with the aim of supporting development of patient-centric solutions in clinical trials. Methods Study design This was a randomized, crossover, observational research study involving participants completing ePROs in two formats (i.e., single-item-per-screen and multiple-items-per-screen) using an electronic tablet device (Lenovo Duet 3 LTE; 1280 x 800 pixels) during two in-person visits. Adult participants were screened and enrolled from three geographic locations in the US (Dallas, TX; Los Angeles, CA; and Baltimore, MD). Data were collected at each location between September and October 2022. Participants had to be aged ≥ 18 years; able to understand, read, and speak English sufficiently to complete all study assessments; and willing and able to attend two in-person visits. Potential participants were contacted, screened, and recruited by a third-party market research vendor. Individuals were contacted by telephone, and a screening script was used to determine eligibility. Participants were recruited to fill target quotas for key demographic characteristics (i.e., age, sex, education, and race/ethnicity) of the general US population. The market research vendor worked with each eligible participant to schedule two in-person visits (visit 1 on day 1 and visit 2 between days 2 and 5). Both visits were scheduled within a 5-day timeframe to ensure general stability of concepts being measured by the assessments. The study protocol and informed consent form were approved by an institutional review board (Advarra). All participants provided written informed consent at visit 1 and verbally reconfirmed consent at visit 2. No investigational drugs, devices, or invasive procedures were administered or evaluated as part of this study. All screening forms and questionnaires were anonymized and tracked by unique participant identifiers. This study was conducted in accordance with the International Society for Pharmacoepidemiology Guidelines for Good Epidemiology Practices and the Declaration of Helsinki. Design and development of electronic clinical outcome assessment The primary objective was to evaluate whether participants preferred completing ePROs using a single-item-per-screen or multiple-items-per-screen format. Participants completed the same set of ePRO questionnaires on the tablet at both visits; the questionnaires were presented once in a single-item format and once in a multiple-item format. Participants were randomized to the presentation format they received first. Participants answered six questions on paper after each visit regarding the presentation of the items, the overall burden of completing the ePROs, and how bothersome it was to navigate through the screens. Additional objectives were to determine the effect of presenting a single-item-per-screen vs. multiple-items-per-screen on the time required to complete each ePRO, the total time required to complete the questionnaires, and the comparability of the ePRO scores. The electronic tablet device was programmed with two versions of the ePROs. One version had a single-item-per-screen, and one version had multiple-items-per-screen (Fig. S1 ) . After the initial set-up of the electronic tablet device, the content and layout of the screens were reviewed for quality and functionality. Two rounds of user acceptance testing were conducted before the start of the study to ensure accuracy and readiness for use. Study conduct A trained facilitator assigned to each study location facilitated both visits at that location. The facilitator ensured that the environment during the two visits was controlled, and the facilitator behaved in the same manner during each visit. Before visit 1, participants were randomly assigned using a 2:4 block randomization to determine which format (i.e., single-item or multiple-item format) they were to complete first. The randomized group assignments were placed in sealed envelopes opened by the facilitators after obtaining the participants’ written informed consent at visit 1. Participants in Group A completed the ePROs using the single-item-per-screen format at visit 1 and the multiple-item-per-screen format at visit 2, whereas participants in Group B completed the ePROs using the multiple-item-per-screen format at visit 1 and the single-item-per-screen format at visit 2 (i.e., each participant completed each ePRO question in the single-item and multiple-item formats). Each participant completed a brief training on the tablet before completing the ePROs. The training led participants through each format (i.e., single-item and multiple-items) and response type that they would encounter when completing the different ePROs. All participants completed the following ePROs at each visit in the following order: the Medical Outcomes Study 36-item Short-form Health Survey (SF-36) Version 1.0, the Patient-Reported Outcomes Measurement Information System Short-form Fatigue (PROMIS-SF) version 1.0, the Single-Item Numerical Rating Scale (NRS) and Visual Analog Scale (VAS), and the Patient Global Impression of Change (PGIC) [ 27 , 28 ]. Details on the ePRO measures are presented in Table S1 . For both presentation formats, participants were required to click a ‘Next’ button on the bottom of the screen to move through the screens and a ‘Back’ button to review or change their answers. No forced response was required for any of the ePROs. When completing the single-item-per-screen format, participants went through each of the ePROs and completed one question at a time ( Fig. S1 ). For the multiple-item format, items were presented in a grid or as multiple questions listed on the screen. Questions in the multiple-item format ranged from 4–10 questions per screen, depending on the PRO and how the questions were formatted on paper (i.e., grid or list of questions). Where applicable, the grouping of items on each screen in the electronic multiple-items-per-screen format matched the grouping of items on the validated paper version. After completing the ePROs, participants completed a paper-based sociodemographic form at visit 1 and paper-based preference questionnaires exploring the perceived burden and preferences associated with completing the ePROs at both visits. In the preference questionnaire, participants answered six questions regarding the presentation of items, overall burden of completing the ePROs, and how bothersome it was to select the ‘Next’ button on each page. At visit 2, the preference questionnaire had additional questions to explore the participants’ preferences for the two formats, the perceived time it took to answer questions in each format, and their choice of format if they were to participate in a clinical trial setting. Details on the study assessments are presented in Table S2 . Study objectives were measured by the participants’ preferences for the presentation; readability of ePRO items; perceived burden of navigating the different formats; the difference in all item responses and ePRO scores between formats; and the time required to complete an ePRO, defined as the difference in time (in minutes and seconds) to complete each ePRO at each visit. All paper-based forms (i.e., visits 1 and 2 patient preference questionnaires and sociodemographic form) were collected and managed using DFdiscover (DFnet, Seattle, WA), a direct PDF-to-computer data management system. Participants who completed all activities received remuneration of $ 100 at each visit. Statistical analysis All data were analyzed using SAS® statistical software version 9.4 (SAS Institute Inc., Cary, NC). Descriptive statistics were used to describe the sample and results. Paired t-tests were used to compare visit 1 and visit 2 data within each group assignment. T-tests, intraclass correlation coefficients, and chi-squares were used for group comparisons. There was no adjustment for multiplicity so all p-values are nominal. Participants who completed both visits were included in the overall response analyses while stable participants, those who completed both visits and responded “about the same/no change” to the PGIC item at visit 2, were used in a sensitivity analysis. Results Study population Block randomization of 37 participants enrolled across three sites created near equal groups (n = 18 in Group A and n = 19 in Group B). All participants (n = 37) completed visit 1; however, one participant in Group A was lost to follow-up. Thus, 36 participants completed visit 2; of these, 29 participants (80.6%; n = 15 in Group A and n = 14 in Group B) were reported to be stable on the PGIC (i.e., responded “about the same/no change” at visit 2). Three participants (8.3%) reported feeling “a little worse”, three participants (8.3%) reported feeling “a little better”, and one participant (2.8%) reported feeling “much better”. The mean (standard deviation [SD]) age of participants was 49.6 (15.4) years, and 56.8% were aged ≥ 50 years (Table 1 ). Slightly more than half of participants were female (n = 19; 51.4%) and White (n = 20; 54.1%). The most frequently reported health conditions were hypertension (n = 10; 27.0%), arthritis (n = 7; 18.9%), and obesity (n = 6; 16.2%); about 37% (n = 14) reported no health conditions. Most participants (n = 25; 67.5%) reported an associate degree-level education or higher (Table 1 ). There were no statistically significant differences by age, sex, race, educational background, employment status, or health conditions between Groups A and B. All participants (n = 37) had previous experience using electronic devices, including electronic tablets (n = 27; 73.0%) and computers (n = 36; 97.3%). Table 1 . Sociodemographic and Clinical Characteristics of Participants Overall (N=37) Group A (N=18) Group B (N=19) p-value Age (years) 0.505 Mean (SD) 49.6 (15.4) 47.9 (15.5) 51.3 (15.4) Median (min–max) 52.0 (19.0–75.0) 51.5 (19.0–70.0) 54.0 (26.0–75.0) IQR (Q1–Q3) 23.0 (39.0–62.0) 27.0 (35.0–62.0) 25.0 (40.0–65.0) 18–49, n (%) 16 (43.2) 8 (44.4) 8 (42.1) 50–64, n (%) 13 (35.1) 7 (38.9) 6 (31.6) ≥65, n (%) 8 (21.6) 3 (16.7) 5 (26.3) Sex, n (%) 0.873 Male 18 (48.6) 9 (50.0) 9 (47.4) Female 19 (51.4) 9 (50.0) 10 (52.6) Racial and Ethnic Background, n (%) 0.326 White 20 (54.1) 9 (50.0) 11 (57.9) Black or African American 6 (16.2) 4 (22.2) 2 (10.5) Asian 2 (5.4) 2 (11.1) 0 (0.0) Hispanic or Latino 5 (13.5) 1 (5.6) 4 (21.1) Mixed Race 4 (10.8) 2 (11.1) 2 (10.5) Employment, n (%) 0.207 Employed, full-time 20 (54.1) 12 (66.7) 8 (42.1) Employed, part-time 4 (10.8) 1 (5.6) 3 (15.8) Homemaker 1 (2.7) 1 (5.6) 0 (0.0) Student 1 (2.7) 1 (5.6) 0 (0.0) Retired 6 (16.2) 1 (5.6) 5 (26.3) Disabled 4 (10.8) 1 (5.6) 3 (15.8) Other 1 1 (2.7) 1 (5.6) 0 (0.0) Education, n (%) 0.850 Secondary/high school 12 (32.4) 5 (27.8) 7 (36.8) Associate degree, technical or trade school 11 (29.7) 5 (27.8) 6 (31.6) College/university 10 (27.0) 6 (33.3) 4 (21.1) Postgraduate school 4 (10.8) 2 (11.1) 2 (10.5) Health Conditions, n (%) 2 Hypertension 10 (27.0) 4 (22.2) 6 (31.6) 0.714 Arthritis 7 (18.9) 2 (11.1) 5 (26.3) 0.405 Obesity 6 (16.2) 2 (11.1) 4 (21.1) 0.660 Anxiety disorders 4 (10.8) 1 (5.6) 3 (15.8) 0.604 Asthma 4 (10.8) 2 (11.1) 2 (10.5) 1.000 Depression 4 (10.8) 2 (11.1) 2 (10.5) 1.000 Diabetes 4 (10.8) 2 (11.1) 2 (10.5) 1.000 Sleep apnea 4 (10.8) 1 (5.6) 3 (15.8) 0.604 Heart disease 3 (8.1) 2 (11.1) 1 (5.3) 0.604 Cancer 1 (2.7) 0 (0.0) 1 (5.3) 1.000 COPD 1 (2.7) 1 (5.6) 0 (0.0) 0.487 Lung disease 1 (2.7) 0 (0.0) 1 (5.3) 1.000 Stroke 1 (2.7) 1 (5.6) 0 (0.0) 0.487 Other 3 9 (24.3) 5 (27.8) 4 (21.1) 0.714 No health conditions 14 (37.8) 9 (50.0) 5 (26.3) 0.138 Don't know 1 (2.7) 0 (0.0) 1 (5.3) 1.000 Abbreviations: ADHD, attention deficit hyperactivity disorder; COPD, chronic obstructive pulmonary disease; HIV, human immunodeficiency virus; IQR, interquartile range; SD, standard deviation 1 Self-employed/part-time. 2 Not mutually exclusive. 3 Other health conditions included ADHD (n = 2), bursitis (n = 1), chronic pain/injury (n = 2), high cholesterol (n = 1), HIV (n = 1), insomnia (n = 1), and traumatic brain injury (n = 1). Participant preferences for single-item-per-screen versus multiple-items-per-screen formats Overall, 12 (33.3%) participants preferred the multiple-item format, 12 (33.3%) participants preferred the single-item format, 10 (27.8%) participants had no preference, and 2 (5.6%) participants did not notice a difference between the two formats (Table 2 ). Some participants (n = 14; 38.9%) reported that it took more time to answer questions in the single-item format, and a similar number of participants (n = 13; 36.1%) did not notice a difference between the two formats. Many participants (n = 17; 47.2%) reported that they would prefer the single-item format if they were to participate in a clinical trial. Only two participants (n = 2; 5.6%) had a difference in response between their preference for the formats in this study and their preference of format for a clinical trial. Table 2 Participant preference questionnaire at visit 2 Questions Overall (N = 36) Group A (N = 17) Group B (N = 19) p-value 1 Which approach (single vs. multiple) did you prefer? n (%) 0.962 Multiple Questions on a Screen 12 (33.3) 6 (35.3) 6 (31.6) Single Question Per Screen 12 (33.3) 6 (35.3) 6 (31.6) No Preference 10 (27.8) 4 (23.5) 6 (31.6) Did not notice a difference 2 (5.6) 1 (5.9) 1 (5.3) Which approach took more time to complete? n (%) 0.707 Multiple Questions on a Screen 9 (25.0) 5 (29.4) 4 (21.1) Single Question Per Screen 14 (38.9) 7 (41.2) 7 (36.8) No difference 13 (36.1) 5 (29.4) 8 (42.1) Did not remember 0 (0.0) 0 (0.0) 0 (0.0) Which format (single vs. multiple) would you prefer to answer questions in clinical trial? n (%) 0.205 Multiple Questions on a Screen 13 (36.1) 6 (35.3) 7 (36.8) Single Question Per Screen 17 (47.2) 10 (58.8) 7 (36.8) No Preference 6 (16.7) 1 (5.9) 5 (26.3) Which format (single vs. multiple) do you think others would prefer to answer questions in clinical trial? n (%) 0.619 Multiple Questions on a Screen 15 (41.7) 7 (41.2) 8 (42.1) Single Question Per Screen 20 (55.6) 10 (58.8) 10 (52.6) Other 1 (2.8) 0 (0.0) 1 (5.3) ePRO electronic patient-reported outcome 1 p-value was calculated using the chi-square test. Group A was presented ePROs in the single-item format at visit 1 and multiple-item format at visit 2. Group B was presented ePROs in the multiple-item format at visit 1 and single-item format at visit 2. Most participants (n = 20; 55.6%) believed that others would prefer the single-item format if participating in a clinical trial. Two participants (5.6%) had a difference in response between their preference of format during a clinical trial and their thoughts on other people’s preference of format during a clinical trial. Participant preferences did not differ based on sex, race, age, or ethnicity. Additionally, there were no statistically significant differences in participant preferences between Groups A and B ( Table 2 ). Participants who preferred the single-item format reported that it was “clearer, less intimidating” and that they “put more effort and thought to a single question” . Participants who preferred a multiple-item format reported that seeing “all questions on the screen provided perspective” and that it was “faster” . Participants who indicated no preference reported that “both formats were easy to understand and answer” ( Table S3 ). Participants who responded that most people would prefer the single-item format if they were participating in a clinical trial noted that this format would provide “more time to reflect and provide accurate and honest results” , that “if you were receiving an experimental treatment you would want to go a bit slower and read the questions fully” , and that the “grid format (multiple-items) can appear overwhelming . Participants who responded that most people would prefer a multiple-item format if they were to participate in a clinical trial noted that this format “would allow people to finish faster” , and that “having multiple questions on one screen minimizes the number of pages to get through” ( Table S3 ). Perceived usability and accessibility of single-item-per-screen versus multiple-items-per-screen formats Overall, participants (n = 36) rated both formats highly and found it easy to select their responses to questions in either format (Table 3 ). Participants rated the single-item format marginally higher than the multiple-item format for ease of reading text (mean [SD], 5.0 [0.2] vs. 4.8 [0.6]; p = 0.019), the presentation of text on the screen (mean [SD], 4.8 [0.5] vs. 4.4 [1.0]; p = 0.035), how easy it was to select the answer to each question (mean [SD], 4.8 [0.4] vs. 4.5 [0.8]; p = 0.021), how much the amount of text on the screen bothered them (mean [SD], 4.8 [0.5] vs. 4.5 [1.1]; p = 0.021), and how difficult it was to complete the questionnaires (mean [SD], 5.0 [0.0] vs. 4.8 [0.4]; p = 0.032) (Table 3 ). Table 3 Comparison of participant preferences by format Overall Single item per Screen (N = 36) Multiple items per Screen (N = 36) p-value 1 How was it to read the text on each screen? 2 0.019 N 36 36 Mean (SD) 5.0 (0.2) 4.8 (0.6) Median (min-max) 5.0 (4.0–5.0) 5.0 (3.0–5.0) How did you like the presentation of the questions on each screen? 3 0.035 N 36 36 Mean (SD) 4.8 (0.5) 4.4 (1.0) Median (min-max) 5.0 (3.0–5.0) 5.0 (1.0–5.0) How easy was it to select your response on each question? 2 0.021 N 36 36 Mean (SD) 4.8 (0.4) 4.5 (0.8) Median (min-max) 5.0 (4.0–5.0) 5.0 (2.0–5.0) How bothersome was it to select the ‘Next’ button on each page? 2 0.183 N 36 36 Mean (SD) 4.9 (0.2) 4.9 (0.5) Median (min-max) 5.0 (4.0–5.0) 5.0 (2.0–5.0) How much did the amount of text on the screen bother you? 4 0.021 N 36 34 Mean (SD) 4.8 (0.5) 4.5 (1.1) Median (min-max) 5.0 (3.0–5.0) 5.0 (1.0–5.0) Overall, how difficult was it to complete the entire questionnaire? 2 0.032 N 36 36 Mean (SD) 5.0 (0.0) 4.8 (0.4) Median (min-max) 5.0 (5.0–5.0) 5.0 (3.0–5.0) SD standard deviation 1 p-value from paired t-test. 2 Numerical rating scales: 0–5 (anchors: 0 = very difficult; 5 = to very easy). 3 Numerical rating scales: 0–5 (anchors: 0 = disliked very much; 5 = liked very much). 4 Numerical rating scales: 0–5 (anchors: 0 = very bothersome; 5 = not at all bothersome). Group A participants (single-item format at visit 1) rated the single-item format more highly than the multiple-item format for ease of reading text ( p = 0.030), how much the amount of text on the screen bothered them ( p = 0.016), and how difficult it was to complete the questionnaires ( p = 0.029) (Fig. 1 ). The differences between the ratings for the two formats by Group B participants (multiple-item format at visit 1) were not statistically significant. Participants who preferred a single-item format commented that “everything was clear and easy to understand” , that it was “very user friendly” , and that “information was easier to parse through quickly and the size/scale of the tablet and size of font combo worked well” ( Table S4 ). Participants who preferred a multiple-item format commented that “the questions were easy to read and respond to” and that “the overall experience felt much faster”. Usability and accessibility characteristics were the only variables that showed differences by age group. Participants aged 18–64 years rated the single-item format more highly than the multiple-item format for ease of reading text ( p = 0.032), ease of selecting a response to each question ( p = 0.039), and how much the amount of text on the screen bothered them ( p = 0.019). Participants aged 18–64 years rated both formats equally on how much they liked the presentation of questions on each screen, how bothersome it was to select to select the ‘Next’ button on each page, and the overall difficulty of completing the entire questionnaire series. No statistically significant differences in participant ratings of perceived usability and accessibility were observed in responses from participants aged ≥ 65 years or based on the participants’ sex, race, or ethnicity. ePRO responses for single-item-per-screen versus multiple-items-per-screen formats For stable participants based on the PGIC (n = 29), there were no statistically significant differences between the total scores or individual items in the SF-36, PROMIS-SF, and NRS questionnaires, suggesting that the format did not alter participants’ responses ( Table S5 , Table S6 , and Table S7 ). There was a statistically significant difference between responses to the VAS questions on “how energized you felt” (single-item format, 72.6 vs. multiple-item format, 68.9; p = 0.042) and “ sleep rating” (single-item format, 60.8 vs. multiple-item format, 55.8; p = 0.031) ( Table S8 ). ePRO completion times Participants (n = 36) took longer (minutes: seconds) on average to complete the questionnaires in the single-item format (mean [SD], 6:42 [2:24] vs. 6:21 [2:22]; p = 0.154). However, the difference in time was not statistically significant, except for the NRS and VAS questionnaires (p = 0.027) (Table 4 ). Group A participants took longer to complete the questionnaires in the single-item format ( p = 0.003, overall; p = 0.001, SF-36; and p = 0.005, NRS and VAS). Group B participants took longer to complete the PROMIS-SF in the multiple-item format ( p = 0.035); all other questionnaires and overall completion time had no significant difference by format for Group B ( Fig. S2 ). Participants (n = 36) in both groups completed the visit 2 questionnaires in a shorter amount of time, regardless of the format, which may have been due to familiarity with the electronic tablet as well as the format and content of the questionnaires from visit 1 ( Fig. S2 ). Participants aged ≥ 65 years took longer to complete ePROs in each format than participants aged 18–64 years. The difference in mean (SD) time (minutes: seconds) taken by participants aged 18–64 years and ≥ 65 years was statistically significant for both the single-item (6:06 [1:34] vs. 8:44 [3:34]; p = 0.009) and multiple-items (5:37 [2:02] vs. 8:55 [2:19]; p = 0.001) formats. Table 4 ePRO completion times Completion time Overall Single item per Screen (N = 36) Multiple items per Screen (N = 36) p-value 1 SF-36 0.094 N 36 36 Mean (SD) 4:20 (1:41) 4:03 (1:31) Median (min-max) 3:58 (2:21–11:26) 3:39 (2:06–8:22) PROMIS-SF 0.781 N 36 36 Mean (SD) 1:18 (0:28) 1:19 (0:36) Median (min-max) 1:11 (0:35–2:35) 1:06 (0:37–-3:01) NRS and VAS 0.027 N 36 36 Mean (SD) 1:04 (0:24) 0:58 (0:20) Median (min-max) 1:00 (0:34–2:42) 0:56 (0:33–2:08) Total time spent 0.154 N 36 36 Mean (SD) 6:42 (2:24) 6:21 (2:22) Median (min-max) 6:26 (3:30–16:43) 5:39 (3:25–13:09) ePRO electronic patient-reported outcome, NRS numerical rating scale, PROMIS-SF Patient-Reported Outcomes Measurement Information System Short-Form, SD standard deviation, SF-36 36-item Short Form health survey, VAS Visual Analog Scale 1 p-value from paired t-test. Mean and median in minutes: seconds. Discussion This study evaluated participant preferences for single-item-per-screen vs. multiple-items-per-screen formats for presenting ePROs and the effect of format on the time required to complete the ePROs. Perceived usability and readability were high for both formats. However, there were marginally statistically significant, differences in the ratings between the single-item vs. multiple-item formats. Participant responses indicated that the single-item format may be slightly easier to read, easier to select responses on, less bothersome, and easier to complete than the multiple-item format. When commenting on the multiple-item format, participants stated that the questions were easy to read and understand and that the grid displayed was fast to complete; however, some participants also noted the grid could feel overwhelming to complete. Participants took less than 6.5 minutes on average to respond to all ePRO questions (58 questions at visit 1, and 59 questions at visit 2) in both presentation formats, which is significantly lower than the completion time of 25 minutes that was shown to be acceptable (i.e., not burdensome to participants) in previous research [ 26 ]. Participants also took more time to complete questions in the single-item format than in the multiple-item format, however, the difference in completion times between formats was less than 20 seconds across all ePROs and not statistically significant. This slight difference is unlikely to increase the perceived participant burden. Participants over 65 years took longer to complete all ePROs. However, participants of all ages took less time to complete questions at visit 2, regardless of the format, which may be because they had responded to the same ePROs at visit 1 and were familiar with the questions. All participants in this study were able to appropriately navigate the electronic tablet devices used in the study; a more technology-naive sample could show a more pronounced format preference. The study used ePROs in English; the readability of multiple items on a screen based on different languages with longer average word character length may influence the ePRO scores. This study used a single electronic device (i.e., a tablet) to collect data, therefore, our findings have limited applicability to ePRO design for devices with smaller screen sizes (e.g., smartphones). For devices such as smartphones, ePRO measures are not usually designed in the multiple-item format due to screen size limitations and the need for scrolling [ 9 , 15 , 16 , 19 , 20 ]. However, smartphones are often used in clinical trials to collect ePRO data and understanding participant preferences on ePRO presentation and design features for smartphones would be useful in designing ePRO solutions for smaller screens. Eremenco et al noted that presenting multiple-items-per-screen for ePROs administered on electronic tablet devices may save time but also carry the risk of missing data or confusion and that a single-item-per-screen approach may provide more consistent results [ 4 ]. In the current study, more participants noted that they believed most people would prefer a single-item format over a multiple-item format in a clinical trial. Participants who preferred the single-item format noted that it allowed more time to reflect on individual questions, that it reduced confusion, and that questions presented in this format were clear and easy to understand. Participants who preferred the multiple-item format noted that it allowed participants to complete the ePRO faster and that the questions were easier to navigate. However, the ePRO scores were largely the same across both formats, except for two VAS items, which showed a small but significant difference between formats. This is likely to be a spurious result given the non-adjustment for multiplicity and the lack of any other significant differences between formats on other VAS items. While this study provides insights on participant preferences and perceived usability of ePRO presentation formats, format preferences as well as other format characteristics may vary depending on the patient population that is participating in a clinical trial (e.g., participants with vision or motor and dexterity limitations with specific accessibility needs, or participants with serious illnesses) [ 29 ]. Therefore, it is important for future studies to consider the specific needs of the study population when designing ePRO solutions that will be used in clinical trials. Conclusions Overall, this study provides evidence that both single-item and multiple-item formats presented on an electronic tablet device are acceptable to users and that format preference may be specific to each individual. Thus, clinical programs need to consider the targeted study population, the purpose of use, and the overall the trial design when designing ePRO solutions. Abbreviations ADHD: Attention deficit hyperactivity disorder CI: Confidence interval COPD: Chronic obstructive pulmonary disease ePRO: Electronic patient-reported outcomes FACIT: Functional Assessment of Chronic Illness Therapy FDA: US Food and Drug Administration HIV: Human immunodeficiency virus HRQoL: Health-related quality of life ICC: Intraclass correlation coefficient IQR: Interquartile range ISPOR: International Society for Pharmacoeconomics and Outcomes Research MCS: Mental Component Summary NRS: Numerical Rating Scale PCS: Physical Component Summary PGIS: Patient Global Impression of Change PRO: Patient-reported outcome PROMIS-SF: Patient-Reported Outcomes Measurement Information System Short-form Fatigue Q: Question SF-36: 36-item Short Form health survey SD: Standard deviation VAS: Visual Analog Scale VRS: Verbal Response Scales Declarations Competing Interests All authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors. Bristol Myers Squibb reviewed the manuscript for scientific accuracy and intellectual property considerations. J.L-B. is an employee and stock/equity holder of Bristol Myers Squibb. D. R., K.S.C., and S. S are employees of Evidera, Inc., which was contracted by Bristol Myers Squibb for this study. A.V.K-S. is an employee of Signant Health, which developed the ePRO solution that was used in this study. Author Contribution D.R., K.S.C., J.L-B., and A.V.K-S. designed the study and main conceptual ideas. D.R., K.S.C., A.V.K-S., and S.S. collected and analyzed the study data. J.L-B. acquired funding for the study. All authors contributed to the development of this manuscript. References FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD): Food and Drug Administration (US); Bethesda (MD): National Institutes of Health; 2016. Ganser A, Raymond S, Pearson J. Data quality and power in clinical trials: A comparison of ePRO and paper in a randomized trial. In: Byrom B, Tiplady B, editors. ePro: Electronic Solutions for Patient-Reported Data: Gower; 2010. p. 49. FDA. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. [accessed 13 March 2023]. Eremenco S, Coons SJ, Paty J, Coyne K, Bennett AV, McEntegart D. PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO mixed modes good research practices task force. Value Health. 2014;17(5):501-16. Miseta E. What Is driving the adoption of EDC applications? : Clinical Leader; 2021. https://www.clinicalleader.com/doc/what-is-driving-the-adoption-of-edc-applications-0001. [ Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value in Health. 2009;12(4):419-29. Shields AL, Shiffman S, Stone A. Patient compliance in an ePRO environment: Methods for consistent compliance management, measurement and reporting. In: Byrom B, Tiplady B, editors. ePRO: Electronic solutions for patient-reported data: Gower; 2010. p. 127-42. Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials. The Patient - Patient-Centered Outcomes Research. 2015;8(4):301-9. Palmblad M, Tiplady B. Electronic diaries and questionnaires: Designing user interfaces that are easy for all patients to use. Quality of Life Research. 2004;13(7):1199-207. Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009;12(4):419-29. Byrom B, Doll H, Muehlhausen W, et al. Measurement equivalence of patient-reported outcome measure response scale types collected using bring your own device compared to paper and a provisioned device: Results of a randomized equivalence trial. Value in Health. 2018;21(5):581-9. Byrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats: A Review of Evidence and Recommendations for Clinical Trials and Bring Your Own Device. Ther Innov Regul Sci. 2019;53(4):426-30. O'Donohoe P, Reasner DS, Kovacs SM, et al. Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force. Value Health. 2023;26(5):623-33. Byrom B, & Muehlhausen, W. Electronic Patient-Reported Outcome Measures: An Implementation Handbook For Clinical Research2018. ePRO Consortium. Best Practices for Electronic Implementation of Response Scales for Patient-Reported Outcome Measures . 2018. https://c-path.org/programs/ecoac/epro-overview/best-practice-documents/. [accessed 11 Apr 2023]. ePRO Consortium. Best Practices for Migrating Existing Patient-Reported Outcome Measures to a New Data Collection Mode. 2018. https://c-path.org/wpcontent/uploads/2022/02/BestPractices3_Migrating.pdf. [accessed 11 Apr 2023]. Innovation OU. Patient Reported Outcomes-From Paper to ePROs Good Practice Guide for Migration .2016. Tiplady B, & Byrom, B. ePro. Electronic Solutions for Patient-Reported Data.: Routledge; 2010. Eremenco S, Coons SJ, Paty J, Coyne K, Bennett AV, McEntegart D. PRO data collection in clinical trials using mixed modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force. Value in Health. 2014;17(5):501-16. Minto C, Vriz GB, Martinato M, Gregori D. Electronic questionnaires design and implementation. The Open Nursing Journal. 2017;11(Suppl-1, M3):157-203. Gwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review. Value in Health. 2008;11(2):322-33. Muehlhausen W, Byrom B, Skerritt B, McCarthy M, McDowell B, Sohn J. Standards for instrument migration when implementing paper patient-reported outcome instruments electronically: Recommendations from a qualitative synthesis of cognitive interview and usability studies. Value in Health. 2018;21(1):41-8. European Medicines Agency. Guideline on computerised systems and electronic data in clinical trials 2021. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-computerised-systems-electronic-data-clinical-trials_en.pdf. [accessed 06 June 2023]. FDA. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments 2022. [accessed 06 June 2023]. FDA. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-collecting-comprehensive-and-representative-input. [accessed 28 July 2023]. Bodart S, Byrom B, Crescioni M, Eremenco S, Flood E. Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study. Ther Innov Regul Sci. 2019;53(3):318-23. Ware JE, Sherbourne CD. The MOS 36-ltem Short-Form Health Survey (SF-36). Medical Care. 1992;30(6):473-83. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. Journal of Pain and Symptom Management. 1997;13(2):63-74. Irvine D, Zemke A, Pusateri G, Gerlach L, Chun R, Jay WM. Tablet and Smartphone Accessibility Features in the Low Vision Rehabilitation. Neuroophthalmology. 2014;38(2):53-9. Additional Declarations Competing interest reported. All authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors. Bristol Myers Squibb reviewed the manuscript for scientific accuracy and intellectual property considerations. J.L-B. is an employee and stock/equity holder of Bristol Myers Squibb. D. R., K.S.C., and S. S are employees of Evidera, Inc., which was contracted by Bristol Myers Squibb for this study. A.V.K-S. is an employee of Signant Health, which developed the ePRO solution that was used in this study. Supplementary Files SupplementalAppendixTIRS.docx Cite Share Download PDF Status: Published Journal Publication published 10 Jun, 2025 Read the published version in Therapeutic Innovation & Regulatory Science → Version 1 posted Editorial decision: Revision requested 10 Sep, 2024 Reviews received at journal 25 Mar, 2024 Reviewers agreed at journal 04 Mar, 2024 Reviewers invited by journal 18 Feb, 2024 Editor assigned by journal 09 Feb, 2024 Submission checks completed at journal 07 Feb, 2024 First submitted to journal 02 Feb, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3921908","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":271524956,"identity":"80ce1ddd-b9c1-4661-aa8e-af50ee7fb81b","order_by":0,"name":"Jennifer Lord-Bessen","email":"data:image/png;base64,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","orcid":"","institution":"Bristol-Myers Squibb (United States)","correspondingAuthor":true,"prefix":"","firstName":"Jennifer","middleName":"","lastName":"Lord-Bessen","suffix":""},{"id":271524957,"identity":"2ca074c5-cf0a-47f1-9ea8-51b00301021a","order_by":1,"name":"Danielle Rodriguez","email":"","orcid":"","institution":"Evidera","correspondingAuthor":false,"prefix":"","firstName":"Danielle","middleName":"","lastName":"Rodriguez","suffix":""},{"id":271524958,"identity":"8c8e4ee9-73b0-4198-9d17-2f8582e23e3d","order_by":2,"name":"Karin Coyne","email":"","orcid":"","institution":"Evidera","correspondingAuthor":false,"prefix":"","firstName":"Karin","middleName":"","lastName":"Coyne","suffix":""},{"id":271524959,"identity":"b629caba-f97a-4d26-862b-1bc2f8ba60cf","order_by":3,"name":"Spencer Schaff","email":"","orcid":"","institution":"Evidera","correspondingAuthor":false,"prefix":"","firstName":"Spencer","middleName":"","lastName":"Schaff","suffix":""},{"id":271524960,"identity":"0e61e95b-93ae-4ece-8512-9851504cf9e0","order_by":4,"name":"Alexandra Kalpadakis-Smith","email":"","orcid":"","institution":"Signant Health","correspondingAuthor":false,"prefix":"","firstName":"Alexandra","middleName":"","lastName":"Kalpadakis-Smith","suffix":""}],"badges":[],"createdAt":"2024-02-02 18:59:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3921908/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3921908/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s43441-025-00811-0","type":"published","date":"2025-06-10T15:57:51+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":50926373,"identity":"05eaf70b-d3c7-4fed-81be-e1b824a9a1da","added_by":"auto","created_at":"2024-02-09 17:10:51","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":444621,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of Participant Preferences by Visit \u003c/strong\u003e\u003csup\u003e\u003cstrong\u003ea\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eePRO \u003c/em\u003eelectronic patient-reported outcome, \u003cem\u003eNE \u003c/em\u003enot estimable, \u003cem\u003eSD\u003c/em\u003e standard deviation\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e p-value from paired t-test.\u003c/p\u003e\n\u003cp\u003eQuestions 1, 3, 4, 6: Numerical rating scale 0–5 (anchors: 0 = very difficult; 5 = to very easy).\u003c/p\u003e\n\u003cp\u003eQuestion 2: Numerical rating scale 0–5 (anchors: 0 = disliked very much; 5 = liked very much).\u003c/p\u003e\n\u003cp\u003eQuestion 5: Numerical rating scale 0–5 (anchors: 0 = very bothersome; 5 = not at all bothersome).\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3921908/v1/c02f53ff8ef721ba06b9c148.jpeg"},{"id":84726530,"identity":"117a4abb-8c59-4e58-92fb-eed044e8b20b","added_by":"auto","created_at":"2025-06-16 16:06:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2019728,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3921908/v1/50d0253e-eeb9-41e3-82bf-bc48ae074db7.pdf"},{"id":50926374,"identity":"91401a2a-c899-4495-bfd9-14cd09302d2f","added_by":"auto","created_at":"2024-02-09 17:10:51","extension":"docx","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":365200,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementalAppendixTIRS.docx","url":"https://assets-eu.researchsquare.com/files/rs-3921908/v1/6270dfc1e55958b483d62450.docx"}],"financialInterests":"Competing interest reported. All authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors. Bristol Myers Squibb reviewed the manuscript for scientific accuracy and intellectual property considerations. J.L-B. is an employee and stock/equity holder of Bristol Myers Squibb. D. R., K.S.C., and S. S are employees of Evidera, Inc., which was contracted by Bristol Myers Squibb for this study. A.V.K-S. is an employee of Signant Health, which developed the ePRO solution that was used in this study.","formattedTitle":"Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen","fulltext":[{"header":"Introduction","content":"\u003cp\u003eA patient-reported outcome (PRO) is a standardized, validated questionnaire often used in clinical trials to capture patient information on symptoms (e.g., pain), daily functioning (e.g., the ability to carry groceries or perform self-care), or health-related quality of life (e.g., the patient\u0026rsquo;s emotional response to the constraints they experience due to their health condition) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. PRO administration in electronic format has improved the integrity and accuracy of data collected in clinical trials by providing a record of data entries, preventing or identifying retrospective and prospective data entry, decreasing incomplete or missing data entries, and preventing the entry of unusable responses [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The US Food and Drug Administration\u0026rsquo;s (FDA) PRO Guidance explicitly endorses the use of electronic patient-reported outcomes (ePROs) in clinical trials [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Several ePRO modes of data collection are currently used in clinical trials including handheld devices, desktop or laptop computers, and electronic tablets [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Of these, electronic tablets are primary platform for onsite ePRO data collection due to their ease of use and convenient screen size [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan additionalcitationids=\"CR6 CR7\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMost PROs were developed and validated on paper; therefore, care must be taken when converting (i.e., \u0026lsquo;migrating\u0026rsquo;) PROs from paper to an electronic mode to preserve their psychometric properties and maintain measurement comparability [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. A \u0026lsquo;faithful\u0026rsquo; migration occurs when the new mode does not introduce response biases due to changes in presentation, formatting, or participant interaction [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Ensuring faithful migration with minimal or no effect on the measurement characteristics of the PRO is especially important in clinical trials where PRO data may be used in regulatory submissions.\u003c/p\u003e \u003cp\u003eCurrent practices to ensure faithful migration have largely been shaped by Task Force reports from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on measurement comparability of PROs across modes of data capture [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. According to the ISPOR Task Force reports, comparability is driven by the degree of modification applied to the content and format of the original paper-based PRO, with the magnitude of modification determining the level of equivalence evidence required through cognitive interviews or quantitative testing. However, since the initial report, studies have consistently shown that participants answer comparably across modes of data capture for common response scales [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. The updated ISPOR Task Force report recommends an evidence-based approach to equivalence testing and deems generating further equivalence evidence unnecessary when there is sufficient evidence on measurement comparability and faithful migration has been followed [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA shared recommendation across the several guidance documents outlining PRO migration best practices is to present a single-item (i.e., one question and its response options) per screen when the PRO measure is implemented electronically [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan additionalcitationids=\"CR15 CR16 CR17 CR18 CR19\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The single-item-per-screen format has historically been considered a minor level of modification from the paper-based format [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Based on the updated ISPOR Task Force report, the single-item-per-screen format would not require additional equivalence testing as participants provide consistent responses on a paper-based format presenting multiple items together and an electronic device presenting single-item- per-screen [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. An advantage of the single-item-per-screen format is consistency across screen-based migrations of the same PRO on different types of devices [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. The single-item-per-screen format is also used because multiple-items-per-screen on smaller device screens (e.g., smartphones) may create \u0026lsquo;cluttered\u0026rsquo; screens (i.e., reduced space between questions) resulting in readability challenges [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Additionally, multiple-items-per-screen on small devices may require scrolling, which is generally not recommended [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite usability and patient input into PRO measure development being emphasized by regulators, when it comes to formatting and presentation, prior research has focused primarily on measurement comparability [\u003cspan additionalcitationids=\"CR24\" citationid=\"CR24\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Participant format preferences and perceived usability for ePRO have not been investigated for key migration recommendations, such as implementing a single-item-per-screen format. Although the single-item-per-screen format is dominant for ePRO measures, it is not known whether participants prefer a single-item-per-screen format over a multiple-item-per-screen format or which format may be perceived as being easier to use. The main drawback to a single-item-per-screen format is that it increases the number of screens when each ePRO item is presented independently, resulting in increased completion time which could affect participant burden [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study examined participant preferences for single-item-per-screen vs. multiple-items-per-screen formats and investigated whether presentation formats affected key metrics of ePRO performance, including the time required to complete the questionnaire, with the aim of supporting development of patient-centric solutions in clinical trials.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis was a randomized, crossover, observational research study involving participants completing ePROs in two formats (i.e., single-item-per-screen and multiple-items-per-screen) using an electronic tablet device (Lenovo Duet 3 LTE; 1280 x 800 pixels) during two in-person visits. Adult participants were screened and enrolled from three geographic locations in the US (Dallas, TX; Los Angeles, CA; and Baltimore, MD). Data were collected at each location between September and October 2022. Participants had to be aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years; able to understand, read, and speak English sufficiently to complete all study assessments; and willing and able to attend two in-person visits.\u003c/p\u003e \u003cp\u003ePotential participants were contacted, screened, and recruited by a third-party market research vendor. Individuals were contacted by telephone, and a screening script was used to determine eligibility. Participants were recruited to fill target quotas for key demographic characteristics (i.e., age, sex, education, and race/ethnicity) of the general US population. The market research vendor worked with each eligible participant to schedule two in-person visits (visit 1 on day 1 and visit 2 between days 2 and 5). Both visits were scheduled within a 5-day timeframe to ensure general stability of concepts being measured by the assessments.\u003c/p\u003e \u003cp\u003e The study protocol and informed consent form were approved by an institutional review board (Advarra). All participants provided written informed consent at visit 1 and verbally reconfirmed consent at visit 2. No investigational drugs, devices, or invasive procedures were administered or evaluated as part of this study. All screening forms and questionnaires were anonymized and tracked by unique participant identifiers. This study was conducted in accordance with the International Society for Pharmacoepidemiology Guidelines for Good Epidemiology Practices and the Declaration of Helsinki.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDesign and development of electronic clinical outcome assessment\u003c/h2\u003e \u003cp\u003eThe primary objective was to evaluate whether participants preferred completing ePROs using a single-item-per-screen or multiple-items-per-screen format. Participants completed the same set of ePRO questionnaires on the tablet at both visits; the questionnaires were presented once in a single-item format and once in a multiple-item format. Participants were randomized to the presentation format they received first. Participants answered six questions on paper after each visit regarding the presentation of the items, the overall burden of completing the ePROs, and how bothersome it was to navigate through the screens. Additional objectives were to determine the effect of presenting a single-item-per-screen vs. multiple-items-per-screen on the time required to complete each ePRO, the total time required to complete the questionnaires, and the comparability of the ePRO scores.\u003c/p\u003e \u003cp\u003eThe electronic tablet device was programmed with two versions of the ePROs. One version had a single-item-per-screen, and one version had multiple-items-per-screen \u003cb\u003e(Fig. \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e)\u003c/b\u003e. After the initial set-up of the electronic tablet device, the content and layout of the screens were reviewed for quality and functionality. Two rounds of user acceptance testing were conducted before the start of the study to ensure accuracy and readiness for use.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy conduct\u003c/h2\u003e \u003cp\u003eA trained facilitator assigned to each study location facilitated both visits at that location. The facilitator ensured that the environment during the two visits was controlled, and the facilitator behaved in the same manner during each visit.\u003c/p\u003e \u003cp\u003eBefore visit 1, participants were randomly assigned using a 2:4 block randomization to determine which format (i.e., single-item or multiple-item format) they were to complete first. The randomized group assignments were placed in sealed envelopes opened by the facilitators after obtaining the participants\u0026rsquo; written informed consent at visit 1. Participants in Group A completed the ePROs using the single-item-per-screen format at visit 1 and the multiple-item-per-screen format at visit 2, whereas participants in Group B completed the ePROs using the multiple-item-per-screen format at visit 1 and the single-item-per-screen format at visit 2 (i.e., each participant completed each ePRO question in the single-item and multiple-item formats). Each participant completed a brief training on the tablet before completing the ePROs. The training led participants through each format (i.e., single-item and multiple-items) and response type that they would encounter when completing the different ePROs.\u003c/p\u003e \u003cp\u003eAll participants completed the following ePROs at each visit in the following order: the Medical Outcomes Study 36-item Short-form Health Survey (SF-36) Version 1.0, the Patient-Reported Outcomes Measurement Information System Short-form Fatigue (PROMIS-SF) version 1.0, the Single-Item Numerical Rating Scale (NRS) and Visual Analog Scale (VAS), and the Patient Global Impression of Change (PGIC) [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Details on the ePRO measures are presented in \u003cb\u003eTable \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e.\u003c/p\u003e \u003cp\u003eFor both presentation formats, participants were required to click a \u0026lsquo;Next\u0026rsquo; button on the bottom of the screen to move through the screens and a \u0026lsquo;Back\u0026rsquo; button to review or change their answers. No forced response was required for any of the ePROs. When completing the single-item-per-screen format, participants went through each of the ePROs and completed one question at a time (\u003cb\u003eFig. \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e). For the multiple-item format, items were presented in a grid or as multiple questions listed on the screen. Questions in the multiple-item format ranged from 4\u0026ndash;10 questions per screen, depending on the PRO and how the questions were formatted on paper (i.e., grid or list of questions). Where applicable, the grouping of items on each screen in the electronic multiple-items-per-screen format matched the grouping of items on the validated paper version.\u003c/p\u003e \u003cp\u003eAfter completing the ePROs, participants completed a paper-based sociodemographic form at visit 1 and paper-based preference questionnaires exploring the perceived burden and preferences associated with completing the ePROs at both visits. In the preference questionnaire, participants answered six questions regarding the presentation of items, overall burden of completing the ePROs, and how bothersome it was to select the \u0026lsquo;Next\u0026rsquo; button on each page. At visit 2, the preference questionnaire had additional questions to explore the participants\u0026rsquo; preferences for the two formats, the perceived time it took to answer questions in each format, and their choice of format if they were to participate in a clinical trial setting. Details on the study assessments are presented in \u003cb\u003eTable S2\u003c/b\u003e.\u003c/p\u003e \u003cp\u003eStudy objectives were measured by the participants\u0026rsquo; preferences for the presentation; readability of ePRO items; perceived burden of navigating the different formats; the difference in all item responses and ePRO scores between formats; and the time required to complete an ePRO, defined as the difference in time (in minutes and seconds) to complete each ePRO at each visit.\u003c/p\u003e \u003cp\u003eAll paper-based forms (i.e., visits 1 and 2 patient preference questionnaires and sociodemographic form) were collected and managed using DFdiscover (DFnet, Seattle, WA), a direct PDF-to-computer data management system. Participants who completed all activities received remuneration of \u003cspan\u003e$\u003c/span\u003e100 at each visit.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll data were analyzed using SAS\u0026reg; statistical software version 9.4 (SAS Institute Inc., Cary, NC). Descriptive statistics were used to describe the sample and results. Paired t-tests were used to compare visit 1 and visit 2 data within each group assignment. T-tests, intraclass correlation coefficients, and chi-squares were used for group comparisons. There was no adjustment for multiplicity so all p-values are nominal. Participants who completed both visits were included in the overall response analyses while stable participants, those who completed both visits and responded \u0026ldquo;about the same/no change\u0026rdquo; to the PGIC item at visit 2, were used in a sensitivity analysis.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eStudy population\u003c/h2\u003e\n \u003cp\u003eBlock randomization of 37 participants enrolled across three sites created near equal groups (n\u0026thinsp;=\u0026thinsp;18 in Group A and n\u0026thinsp;=\u0026thinsp;19 in Group B). All participants (n\u0026thinsp;=\u0026thinsp;37) completed visit 1; however, one participant in Group A was lost to follow-up. Thus, 36 participants completed visit 2; of these, 29 participants (80.6%; n\u0026thinsp;=\u0026thinsp;15 in Group A and n\u0026thinsp;=\u0026thinsp;14 in Group B) were reported to be stable on the PGIC (i.e., responded \u0026ldquo;about the same/no change\u0026rdquo; at visit 2). Three participants (8.3%) reported feeling \u0026ldquo;a little worse\u0026rdquo;, three participants (8.3%) reported feeling \u0026ldquo;a little better\u0026rdquo;, and one participant (2.8%) reported feeling \u0026ldquo;much better\u0026rdquo;.\u003c/p\u003e\n \u003cp\u003eThe mean (standard deviation [SD]) age of participants was 49.6 (15.4) years, and 56.8% were aged\u0026thinsp;\u0026ge;\u0026thinsp;50 years (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). Slightly more than half of participants were female (n\u0026thinsp;=\u0026thinsp;19; 51.4%) and White (n\u0026thinsp;=\u0026thinsp;20; 54.1%). The most frequently reported health conditions were hypertension (n\u0026thinsp;=\u0026thinsp;10; 27.0%), arthritis (n\u0026thinsp;=\u0026thinsp;7; 18.9%), and obesity (n\u0026thinsp;=\u0026thinsp;6; 16.2%); about 37% (n\u0026thinsp;=\u0026thinsp;14) reported no health conditions. Most participants (n\u0026thinsp;=\u0026thinsp;25; 67.5%) reported an associate degree-level education or higher (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). There were no statistically significant differences by age, sex, race, educational background, employment status, or health conditions between Groups A and B. All participants (n\u0026thinsp;=\u0026thinsp;37) had previous experience using electronic devices, including electronic tablets (n\u0026thinsp;=\u0026thinsp;27; 73.0%) and computers (n\u0026thinsp;=\u0026thinsp;36; 97.3%).\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e. Sociodemographic and Clinical Characteristics of Participants\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOverall\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N=37)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup A\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N=18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup B\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N=19)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge (years)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.505\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e49.6 (15.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e47.9 (15.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e51.3 (15.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eMedian (min\u0026ndash;max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e52.0 (19.0\u0026ndash;75.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e51.5 (19.0\u0026ndash;70.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e54.0 (26.0\u0026ndash;75.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eIQR (Q1\u0026ndash;Q3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e23.0 (39.0\u0026ndash;62.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e27.0 (35.0\u0026ndash;62.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e25.0 (40.0\u0026ndash;65.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e18\u0026ndash;49, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e16 (43.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e8 (44.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e8 (42.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e50\u0026ndash;64, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e13 (35.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e7 (38.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026ge;65, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e8 (21.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e3 (16.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e5 (26.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSex, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.873\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e18 (48.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e9 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e9 (47.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e19 (51.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e9 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e10 (52.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eRacial and Ethnic Background, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.326\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eWhite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e20 (54.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e9 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e11 (57.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eBlack or African American\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e6 (16.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (22.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eAsian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (5.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eHispanic or Latino\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e5 (13.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e4 (21.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eMixed Race\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmployment, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.207\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eEmployed, full-time\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e20 (54.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e12 (66.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e8 (42.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eEmployed, part-time\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e3 (15.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eHomemaker\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eStudent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eRetired\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e6 (16.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e5 (26.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eDisabled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e3 (15.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eOther \u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEducation, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.850\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eSecondary/high school\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e12 (32.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e5 (27.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e7 (36.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eAssociate degree, technical or trade school\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e11 (29.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e5 (27.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eCollege/university\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e10 (27.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e6 (33.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e4 (21.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003ePostgraduate school\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHealth Conditions, n (%) \u003csup\u003e2\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e10 (27.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (22.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.714\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eArthritis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e7 (18.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e5 (26.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.405\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.79245283018868%\" valign=\"top\"\u003e\n \u003cp\u003eObesity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e6 (16.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e4 (21.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.14622641509434%\" valign=\"top\"\u003e\n \u003cp\u003e0.660\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eAnxiety disorders\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e3 (15.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.604\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eAsthma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eDepression\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eDiabetes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e2 (10.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eSleep apnea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e4 (10.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e3 (15.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.604\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eHeart disease\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e3 (8.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e2 (11.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.604\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eCancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eCOPD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.487\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eLung disease\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eStroke\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.487\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eOther \u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e9 (24.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e5 (27.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e4 (21.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.714\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eNo health conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e14 (37.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e9 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e5 (26.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e0.138\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"37.617924528301884%\" valign=\"top\"\u003e\n \u003cp\u003eDon\u0026apos;t know\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.9811320754717%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.27358490566038%\" valign=\"top\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.320754716981131%\" valign=\"top\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviations: ADHD, attention deficit hyperactivity disorder; COPD, chronic obstructive pulmonary disease; HIV, human immunodeficiency virus; IQR, interquartile range; SD, standard deviation\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003e Self-employed/part-time.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003e Not mutually exclusive.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e3\u003c/sup\u003e Other health conditions included ADHD (n = 2), bursitis (n = 1), chronic pain/injury (n = 2), high cholesterol (n = 1), HIV (n = 1), insomnia (n = 1), and traumatic brain injury (n = 1).\u003c/p\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eParticipant preferences for single-item-per-screen versus multiple-items-per-screen formats\u003c/h2\u003e\n \u003cp\u003eOverall, 12 (33.3%) participants preferred the multiple-item format, 12 (33.3%) participants preferred the single-item format, 10 (27.8%) participants had no preference, and 2 (5.6%) participants did not notice a difference between the two formats (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Some participants (n\u0026thinsp;=\u0026thinsp;14; 38.9%) reported that it took more time to answer questions in the single-item format, and a similar number of participants (n\u0026thinsp;=\u0026thinsp;13; 36.1%) did not notice a difference between the two formats. Many participants (n\u0026thinsp;=\u0026thinsp;17; 47.2%) reported that they would prefer the single-item format if they were to participate in a clinical trial. Only two participants (n\u0026thinsp;=\u0026thinsp;2; 5.6%) had a difference in response between their preference for the formats in this study and their preference of format for a clinical trial.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eParticipant preference questionnaire at visit 2\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eQuestions\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOverall\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;36)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eGroup A\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eGroup B\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;19)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value \u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eWhich approach (single vs. multiple) did you prefer? n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.962\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMultiple Questions on a Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 (33.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (35.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSingle Question Per Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 (33.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (35.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo Preference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (27.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (23.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (31.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDid not notice a difference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (5.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (5.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eWhich approach took more time to complete? n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.707\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMultiple Questions on a Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (25.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (29.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (21.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSingle Question Per Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e14 (38.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (41.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (36.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo difference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (36.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (29.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8 (42.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDid not remember\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eWhich format (single vs. multiple) would you prefer to answer questions in clinical trial? n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.205\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMultiple Questions on a Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (36.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (35.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (36.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSingle Question Per Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e17 (47.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (58.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (36.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo Preference\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (16.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (5.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (26.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eWhich format (single vs. multiple) do you think others would prefer to answer questions in clinical trial? n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.619\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMultiple Questions on a Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e15 (41.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (41.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8 (42.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSingle Question Per Screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e20 (55.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (58.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (52.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (2.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003cem\u003eePRO\u003c/em\u003e electronic patient-reported outcome\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003csup\u003e1\u003c/sup\u003e p-value was calculated using the chi-square test.\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003eGroup A was presented ePROs in the single-item format at visit 1 and multiple-item format at visit 2. Group B was presented ePROs in the multiple-item format at visit 1 and single-item format at visit 2.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eMost participants (n\u0026thinsp;=\u0026thinsp;20; 55.6%) believed that others would prefer the single-item format if participating in a clinical trial. Two participants (5.6%) had a difference in response between their preference of format during a clinical trial and their thoughts on other people\u0026rsquo;s preference of format during a clinical trial. Participant preferences did not differ based on sex, race, age, or ethnicity. Additionally, there were no statistically significant differences in participant preferences between Groups A and B \u003cstrong\u003e(\u003c/strong\u003eTable \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e\u003cstrong\u003e).\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eParticipants who preferred the single-item format reported that it was \u003cem\u003e\u0026ldquo;clearer, less intimidating\u0026rdquo;\u003c/em\u003e and that they \u003cem\u003e\u0026ldquo;put more effort and thought to a single question\u0026rdquo;\u003c/em\u003e. Participants who preferred a multiple-item format reported that seeing \u003cem\u003e\u0026ldquo;all questions on the screen provided perspective\u0026rdquo;\u003c/em\u003e and that it was \u003cem\u003e\u0026ldquo;faster\u0026rdquo;\u003c/em\u003e. Participants who indicated no preference reported that \u003cem\u003e\u0026ldquo;both formats were easy to understand and answer\u0026rdquo;\u003c/em\u003e (\u003cstrong\u003eTable S3\u003c/strong\u003e).\u003c/p\u003e\n \u003cp\u003eParticipants who responded that most people would prefer the single-item format if they were participating in a clinical trial noted that this format would provide \u003cem\u003e\u0026ldquo;more time to reflect and provide accurate and honest results\u0026rdquo;\u003c/em\u003e, that \u003cem\u003e\u0026ldquo;if you were receiving an experimental treatment you would want to go a bit slower and read the questions fully\u0026rdquo;\u003c/em\u003e, and that the \u003cem\u003e\u0026ldquo;grid format (multiple-items) can appear overwhelming\u003c/em\u003e. Participants who responded that most people would prefer a multiple-item format if they were to participate in a clinical trial noted that this format \u003cem\u003e\u0026ldquo;would allow people to finish faster\u0026rdquo;\u003c/em\u003e, and that \u003cem\u003e\u0026ldquo;having multiple questions on one screen minimizes the number of pages to get through\u0026rdquo;\u003c/em\u003e (\u003cstrong\u003eTable S3\u003c/strong\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003ePerceived usability and accessibility of single-item-per-screen versus multiple-items-per-screen formats\u003c/h2\u003e\n \u003cp\u003eOverall, participants (n\u0026thinsp;=\u0026thinsp;36) rated both formats highly and found it easy to select their responses to questions in either format (Table \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). Participants rated the single-item format marginally higher than the multiple-item format for ease of reading text (mean [SD], 5.0 [0.2] vs. 4.8 [0.6]; \u003cem\u003ep\u0026thinsp;=\u003c/em\u003e\u0026thinsp;0.019), the presentation of text on the screen (mean [SD], 4.8 [0.5] vs. 4.4 [1.0]; \u003cem\u003ep\u0026thinsp;=\u003c/em\u003e\u0026thinsp;0.035), how easy it was to select the answer to each question (mean [SD], 4.8 [0.4] vs. 4.5 [0.8]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.021), how much the amount of text on the screen bothered them (mean [SD], 4.8 [0.5] vs. 4.5 [1.1]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.021), and how difficult it was to complete the questionnaires (mean [SD], 5.0 [0.0] vs. 4.8 [0.4]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.032) (Table \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eComparison of participant preferences by format\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eOverall\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSingle item per Screen\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;36)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMultiple items\u003c/p\u003e\n \u003cp\u003eper Screen\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;36)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value \u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow was it to read the text on each screen?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.019\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (0.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.8 (0.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (4.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (3.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow did you like the presentation of the questions on each screen?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.035\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.8 (0.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.4 (1.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (3.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (1.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow easy was it to select your response on each question?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.8 (0.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.5 (0.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (4.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (2.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow bothersome was it to select the \u0026lsquo;Next\u0026rsquo; button on each page?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.183\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.9 (0.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.9 (0.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (4.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (2.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eHow much did the amount of text on the screen bother you?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e34\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.8 (0.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.5 (1.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (3.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (1.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOverall, how difficult was it to complete the entire questionnaire?\u003c/strong\u003e \u003csup\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.032\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.8 (0.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (5.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.0 (3.0\u0026ndash;5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003e\u003cem\u003eSD\u003c/em\u003e standard deviation\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003e\u003csup\u003e1\u003c/sup\u003e p-value from paired t-test.\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003e\u003csup\u003e2\u003c/sup\u003e Numerical rating scales: 0\u0026ndash;5 (anchors: 0\u0026thinsp;=\u0026thinsp;very difficult; 5\u0026thinsp;=\u0026thinsp;to very easy).\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003e\u003csup\u003e3\u003c/sup\u003e Numerical rating scales: 0\u0026ndash;5 (anchors: 0\u0026thinsp;=\u0026thinsp;disliked very much; 5\u0026thinsp;=\u0026thinsp;liked very much).\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003e\u003csup\u003e4\u003c/sup\u003e Numerical rating scales: 0\u0026ndash;5 (anchors: 0\u0026thinsp;=\u0026thinsp;very bothersome; 5\u0026thinsp;=\u0026thinsp;not at all bothersome).\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eGroup A participants (single-item format at visit 1) rated the single-item format more highly than the multiple-item format for ease of reading text (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.030), how much the amount of text on the screen bothered them (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.016), and how difficult it was to complete the questionnaires (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.029) (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). The differences between the ratings for the two formats by Group B participants (multiple-item format at visit 1) were not statistically significant.\u003c/p\u003e\n \u003cp\u003eParticipants who preferred a single-item format commented that \u003cem\u003e\u0026ldquo;everything was clear and easy to understand\u0026rdquo;\u003c/em\u003e, that it was \u003cem\u003e\u0026ldquo;very user friendly\u0026rdquo;\u003c/em\u003e, and that \u003cem\u003e\u0026ldquo;information was easier to parse through quickly and the size/scale of the tablet and size of font combo worked well\u0026rdquo;\u003c/em\u003e (\u003cstrong\u003eTable S4\u003c/strong\u003e). Participants who preferred a multiple-item format commented that \u003cem\u003e\u0026ldquo;the questions were easy to read and respond to\u0026rdquo;\u003c/em\u003e and that \u003cem\u003e\u0026ldquo;the overall experience felt much faster\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eUsability and accessibility characteristics were the only variables that showed differences by age group. Participants aged 18\u0026ndash;64 years rated the single-item format more highly than the multiple-item format for ease of reading text (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.032), ease of selecting a response to each question (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.039), and how much the amount of text on the screen bothered them (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.019). Participants aged 18\u0026ndash;64 years rated both formats equally on how much they liked the presentation of questions on each screen, how bothersome it was to select to select the \u0026lsquo;Next\u0026rsquo; button on each page, and the overall difficulty of completing the entire questionnaire series. No statistically significant differences in participant ratings of perceived usability and accessibility were observed in responses from participants aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years or based on the participants\u0026rsquo; sex, race, or ethnicity.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eePRO responses for single-item-per-screen versus multiple-items-per-screen formats\u003c/h2\u003e\n \u003cp\u003eFor stable participants based on the PGIC (n\u0026thinsp;=\u0026thinsp;29), there were no statistically significant differences between the total scores or individual items in the SF-36, PROMIS-SF, and NRS questionnaires, suggesting that the format did not alter participants\u0026rsquo; responses (\u003cstrong\u003eTable S5\u003c/strong\u003e, \u003cstrong\u003eTable S6\u003c/strong\u003e, and \u003cstrong\u003eTable S7\u003c/strong\u003e). There was a statistically significant difference between responses to the VAS questions on \u003cem\u003e\u0026ldquo;how energized you felt\u0026rdquo;\u003c/em\u003e (single-item format, 72.6 vs. multiple-item format, 68.9; \u003cem\u003ep\u0026thinsp;=\u003c/em\u003e\u0026thinsp;0.042) and \u0026ldquo;\u003cem\u003esleep rating\u0026rdquo;\u003c/em\u003e (single-item format, 60.8 vs. multiple-item format, 55.8; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.031) (\u003cstrong\u003eTable S8\u003c/strong\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eePRO completion times\u003c/h2\u003e\n \u003cp\u003eParticipants (n\u0026thinsp;=\u0026thinsp;36) took longer (minutes: seconds) on average to complete the questionnaires in the single-item format (mean [SD], 6:42 [2:24] vs. 6:21 [2:22]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.154). However, the difference in time was not statistically significant, except for the NRS and VAS questionnaires (p\u0026thinsp;=\u0026thinsp;0.027) (Table \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e). Group A participants took longer to complete the questionnaires in the single-item format (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.003, overall; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001, SF-36; and \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.005, NRS and VAS). Group B participants took longer to complete the PROMIS-SF in the multiple-item format (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.035); all other questionnaires and overall completion time had no significant difference by format for Group B (\u003cstrong\u003eFig. S2\u003c/strong\u003e). Participants (n\u0026thinsp;=\u0026thinsp;36) in both groups completed the visit 2 questionnaires in a shorter amount of time, regardless of the format, which may have been due to familiarity with the electronic tablet as well as the format and content of the questionnaires from visit 1 (\u003cstrong\u003eFig. S2\u003c/strong\u003e). Participants aged\u0026thinsp;\u0026ge;\u0026thinsp;65 years took longer to complete ePROs in each format than participants aged 18\u0026ndash;64 years. The difference in mean (SD) time (minutes: seconds) taken by participants aged 18\u0026ndash;64 years and \u0026ge;\u0026thinsp;65 years was statistically significant for both the single-item (6:06 [1:34] vs. 8:44 [3:34]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.009) and multiple-items (5:37 [2:02] vs. 8:55 [2:19]; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001) formats.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab4\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eePRO completion times\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCompletion time\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eOverall\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSingle item per Screen\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;36)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMultiple items per Screen\u003c/p\u003e\n \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;36)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value \u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSF-36\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.094\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4:20 (1:41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4:03 (1:31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3:58 (2:21\u0026ndash;11:26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3:39 (2:06\u0026ndash;8:22)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePROMIS-SF\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.781\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:18 (0:28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:19 (0:36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:11 (0:35\u0026ndash;2:35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:06 (0:37\u0026ndash;-3:01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNRS and VAS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.027\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:04 (0:24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0:58 (0:20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1:00 (0:34\u0026ndash;2:42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0:56 (0:33\u0026ndash;2:08)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal time spent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.154\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6:42 (2:24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6:21 (2:22)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (min-max)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6:26 (3:30\u0026ndash;16:43)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5:39 (3:25\u0026ndash;13:09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003cem\u003eePRO\u003c/em\u003e electronic patient-reported outcome, \u003cem\u003eNRS\u003c/em\u003e numerical rating scale, \u003cem\u003ePROMIS-SF\u003c/em\u003e Patient-Reported Outcomes Measurement Information System Short-Form, \u003cem\u003eSD\u003c/em\u003e standard deviation, \u003cem\u003eSF-36\u003c/em\u003e 36-item Short Form health survey, \u003cem\u003eVAS\u003c/em\u003e Visual Analog Scale\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003e\u003csup\u003e1\u003c/sup\u003e p-value from paired t-test.\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\"\u003eMean and median in minutes: seconds.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study evaluated participant preferences for single-item-per-screen vs. multiple-items-per-screen formats for presenting ePROs and the effect of format on the time required to complete the ePROs. Perceived usability and readability were high for both formats. However, there were marginally statistically significant, differences in the ratings between the single-item vs. multiple-item formats. Participant responses indicated that the single-item format may be slightly easier to read, easier to select responses on, less bothersome, and easier to complete than the multiple-item format. When commenting on the multiple-item format, participants stated that the questions were easy to read and understand and that the grid displayed was fast to complete; however, some participants also noted the grid could feel overwhelming to complete.\u003c/p\u003e \u003cp\u003eParticipants took less than 6.5 minutes on average to respond to all ePRO questions (58 questions at visit 1, and 59 questions at visit 2) in both presentation formats, which is significantly lower than the completion time of 25 minutes that was shown to be acceptable (i.e., not burdensome to participants) in previous research [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Participants also took more time to complete questions in the single-item format than in the multiple-item format, however, the difference in completion times between formats was less than 20 seconds across all ePROs and not statistically significant. This slight difference is unlikely to increase the perceived participant burden. Participants over 65 years took longer to complete all ePROs. However, participants of all ages took less time to complete questions at visit 2, regardless of the format, which may be because they had responded to the same ePROs at visit 1 and were familiar with the questions.\u003c/p\u003e \u003cp\u003eAll participants in this study were able to appropriately navigate the electronic tablet devices used in the study; a more technology-naive sample could show a more pronounced format preference. The study used ePROs in English; the readability of multiple items on a screen based on different languages with longer average word character length may influence the ePRO scores. This study used a single electronic device (i.e., a tablet) to collect data, therefore, our findings have limited applicability to ePRO design for devices with smaller screen sizes (e.g., smartphones). For devices such as smartphones, ePRO measures are not usually designed in the multiple-item format due to screen size limitations and the need for scrolling [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. However, smartphones are often used in clinical trials to collect ePRO data and understanding participant preferences on ePRO presentation and design features for smartphones would be useful in designing ePRO solutions for smaller screens.\u003c/p\u003e \u003cp\u003eEremenco et al noted that presenting multiple-items-per-screen for ePROs administered on electronic tablet devices may save time but also carry the risk of missing data or confusion and that a single-item-per-screen approach may provide more consistent results [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In the current study, more participants noted that they believed most people would prefer a single-item format over a multiple-item format in a clinical trial. Participants who preferred the single-item format noted that it allowed more time to reflect on individual questions, that it reduced confusion, and that questions presented in this format were clear and easy to understand. Participants who preferred the multiple-item format noted that it allowed participants to complete the ePRO faster and that the questions were easier to navigate. However, the ePRO scores were largely the same across both formats, except for two VAS items, which showed a small but significant difference between formats. This is likely to be a spurious result given the non-adjustment for multiplicity and the lack of any other significant differences between formats on other VAS items.\u003c/p\u003e \u003cp\u003eWhile this study provides insights on participant preferences and perceived usability of ePRO presentation formats, format preferences as well as other format characteristics may vary depending on the patient population that is participating in a clinical trial (e.g., participants with vision or motor and dexterity limitations with specific accessibility needs, or participants with serious illnesses) [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Therefore, it is important for future studies to consider the specific needs of the study population when designing ePRO solutions that will be used in clinical trials.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eOverall, this study provides evidence that both single-item and multiple-item formats presented on an electronic tablet device are acceptable to users and that format preference may be specific to each individual. Thus, clinical programs need to consider the targeted study population, the purpose of use, and the overall the trial design when designing ePRO solutions.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eADHD:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eAttention deficit hyperactivity disorder\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCI:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eConfidence interval\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCOPD:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eChronic obstructive pulmonary disease\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eePRO:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eElectronic patient-reported outcomes\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eFACIT:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eFunctional Assessment of Chronic Illness Therapy\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eFDA:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eUS Food and Drug Administration\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eHIV:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eHuman immunodeficiency virus\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eHRQoL:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eHealth-related quality of life\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eICC:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eIntraclass correlation coefficient\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eIQR:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eInterquartile range\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eISPOR:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eInternational Society for Pharmacoeconomics and Outcomes Research\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eMCS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eMental Component Summary\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNRS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eNumerical Rating Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePCS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003ePhysical Component Summary\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePGIS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003ePatient Global Impression of Change\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePRO:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003ePatient-reported outcome\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePROMIS-SF:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003ePatient-Reported Outcomes Measurement Information System Short-form Fatigue\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eQ:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eQuestion\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eSF-36:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003e36-item Short Form health survey\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eSD:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eStandard deviation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVAS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eVisual Analog Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.860031104199066%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVRS:\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"70.13996889580093%\" valign=\"top\"\u003e\n \u003cp\u003eVerbal Response Scales\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors. Bristol Myers Squibb reviewed the manuscript for scientific accuracy and intellectual property considerations. J.L-B. is an employee and stock/equity holder of Bristol Myers Squibb. D. R., K.S.C., and S. S are employees of Evidera, Inc., which was contracted by Bristol Myers Squibb for this study. A.V.K-S. is an employee of Signant Health, which developed the ePRO solution that was used in this study.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eD.R., K.S.C., J.L-B., and A.V.K-S. designed the study and main conceptual ideas. D.R., K.S.C., A.V.K-S., and S.S. collected and analyzed the study data. J.L-B. acquired funding for the study. All authors contributed to the development of this manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eFDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD): Food and Drug Administration (US); Bethesda (MD): National Institutes of Health; 2016.\u003c/li\u003e\n\u003cli\u003eGanser A, Raymond S, Pearson J. Data quality and power in clinical trials: A comparison of ePRO and paper in a randomized trial. In: Byrom B, Tiplady B, editors. ePro: Electronic Solutions for Patient-Reported Data: Gower; 2010. p. 49.\u003c/li\u003e\n\u003cli\u003eFDA. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. [accessed 13 March 2023].\u003c/li\u003e\n\u003cli\u003eEremenco S, Coons SJ, Paty J, Coyne K, Bennett AV, McEntegart D. PRO data collection in clinical trials using mixed modes: report of the ISPOR PRO mixed modes good research practices task force. Value Health. 2014;17(5):501-16.\u003c/li\u003e\n\u003cli\u003eMiseta E. What Is driving the adoption of EDC applications? : Clinical Leader; 2021. https://www.clinicalleader.com/doc/what-is-driving-the-adoption-of-edc-applications-0001. [\u003c/li\u003e\n\u003cli\u003eCoons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value in Health. 2009;12(4):419-29.\u003c/li\u003e\n\u003cli\u003eShields AL, Shiffman S, Stone A. Patient compliance in an ePRO environment: Methods for consistent compliance management, measurement and reporting. In: Byrom B, Tiplady B, editors. ePRO: Electronic solutions for patient-reported data: Gower; 2010. p. 127-42.\u003c/li\u003e\n\u003cli\u003eCoons SJ, Eremenco S, Lundy JJ, O\u0026rsquo;Donohoe P, O\u0026rsquo;Gorman H, Malizia W. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials. The Patient - Patient-Centered Outcomes Research. 2015;8(4):301-9.\u003c/li\u003e\n\u003cli\u003ePalmblad M, Tiplady B. Electronic diaries and questionnaires: Designing user interfaces that are easy for all patients to use. Quality of Life Research. 2004;13(7):1199-207.\u003c/li\u003e\n\u003cli\u003eCoons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health. 2009;12(4):419-29.\u003c/li\u003e\n\u003cli\u003eByrom B, Doll H, Muehlhausen W, et al. Measurement equivalence of patient-reported outcome measure response scale types collected using bring your own device compared to paper and a provisioned device: Results of a randomized equivalence trial. Value in Health. 2018;21(5):581-9.\u003c/li\u003e\n\u003cli\u003eByrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats: A Review of Evidence and Recommendations for Clinical Trials and Bring Your Own Device. Ther Innov Regul Sci. 2019;53(4):426-30.\u003c/li\u003e\n\u003cli\u003eO\u0026apos;Donohoe P, Reasner DS, Kovacs SM, et al. Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force. Value Health. 2023;26(5):623-33.\u003c/li\u003e\n\u003cli\u003eByrom B, \u0026amp; Muehlhausen, W. Electronic Patient-Reported Outcome Measures: An Implementation Handbook For Clinical Research2018.\u003c/li\u003e\n\u003cli\u003eePRO Consortium. \u003cem\u003eBest Practices for Electronic Implementation of Response Scales for Patient-Reported Outcome Measures\u003c/em\u003e. 2018. https://c-path.org/programs/ecoac/epro-overview/best-practice-documents/. [accessed 11 Apr 2023].\u003c/li\u003e\n\u003cli\u003eePRO Consortium. Best Practices for Migrating Existing Patient-Reported Outcome Measures to a New Data Collection Mode. 2018. https://c-path.org/wpcontent/uploads/2022/02/BestPractices3_Migrating.pdf. [accessed 11 Apr 2023].\u003c/li\u003e\n\u003cli\u003eInnovation OU. \u003cem\u003ePatient Reported Outcomes-From Paper to ePROs Good Practice Guide for Migration\u003c/em\u003e.2016.\u003c/li\u003e\n\u003cli\u003eTiplady B, \u0026amp; Byrom, B. ePro. Electronic Solutions for Patient-Reported Data.: Routledge; 2010.\u003c/li\u003e\n\u003cli\u003eEremenco S, Coons SJ, Paty J, Coyne K, Bennett AV, McEntegart D. PRO data collection in clinical trials using mixed modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force. Value in Health. 2014;17(5):501-16.\u003c/li\u003e\n\u003cli\u003eMinto C, Vriz GB, Martinato M, Gregori D. Electronic questionnaires design and implementation. The Open Nursing Journal. 2017;11(Suppl-1, M3):157-203.\u003c/li\u003e\n\u003cli\u003eGwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review. Value in Health. 2008;11(2):322-33.\u003c/li\u003e\n\u003cli\u003eMuehlhausen W, Byrom B, Skerritt B, McCarthy M, McDowell B, Sohn J. Standards for instrument migration when implementing paper patient-reported outcome instruments electronically: Recommendations from a qualitative synthesis of cognitive interview and usability studies. Value in Health. 2018;21(1):41-8.\u003c/li\u003e\n\u003cli\u003eEuropean Medicines Agency. Guideline on computerised systems and electronic data in clinical trials 2021. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-computerised-systems-electronic-data-clinical-trials_en.pdf. [accessed 06 June 2023].\u003c/li\u003e\n\u003cli\u003eFDA. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments 2022. [accessed 06 June 2023].\u003c/li\u003e\n\u003cli\u003eFDA. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-collecting-comprehensive-and-representative-input. [accessed 28 July 2023].\u003c/li\u003e\n\u003cli\u003eBodart S, Byrom B, Crescioni M, Eremenco S, Flood E. Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study. Ther Innov Regul Sci. 2019;53(3):318-23.\u003c/li\u003e\n\u003cli\u003eWare JE, Sherbourne CD. The MOS 36-ltem Short-Form Health Survey (SF-36). Medical Care. 1992;30(6):473-83.\u003c/li\u003e\n\u003cli\u003eYellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. Journal of Pain and Symptom Management. 1997;13(2):63-74.\u003c/li\u003e\n\u003cli\u003eIrvine D, Zemke A, Pusateri G, Gerlach L, Chun R, Jay WM. Tablet and Smartphone Accessibility Features in the Low Vision Rehabilitation. Neuroophthalmology. 2014;38(2):53-9.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"therapeutic-innovation-and-regulatory-science","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"tirs","sideBox":"Learn more about [Therapeutic Innovation \u0026 Regulatory Science](https://link.springer.com/journal/43441)","snPcode":"43441","submissionUrl":"https://www.editorialmanager.com/tirs/default.aspx","title":"Therapeutic Innovation \u0026 Regulatory Science","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"clinical trials, electronic data capture, electronic patient-reported outcomes, ePRO, patient-reported outcomes, electronic clinical outcome assessment","lastPublishedDoi":"10.21203/rs.3.rs-3921908/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3921908/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e In clinical trials, the single-item-per-screen format is commonly used for electronic patient-reported outcomes (ePROs). However, participant preferences for this format over multiple items per screen have not been investigated. This study evaluated participant preferences for single-item-per-screen vs. multiple-items-per-screen ePRO formats, the effect on completion times, and the comparability of scores between formats.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Participation in this randomized, crossover, observational study involved ePRO completion in both single-item-per-screen and multiple-items-per-screen formats on an electronic tablet device during two study visits. A paper-based preference questionnaire was completed at each visit.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Thirty-seven adults (mean [SD] age=49.6 [15.4] years; 51.4% female; 54.1% White) enrolled and 36 participants completed both visits. Twelve participants (33.3%) preferred the multiple-item format, 12 (33.3%) preferred the single-item format, 10 (27.8%) had no preference, and 2 (5.6%) did not notice a difference. Seventeen participants (47.2%) preferred the single-item format when participating in a clinical trial, and most (n=20; 55.6%) believed that others would prefer this format in a clinical trial. The ePRO completion time (minutes: seconds) was longer for the single-item format than the multiple-item format (mean [SD], 6:42 [2:24] vs. 6:21 [2:22]; \u003cem\u003ep \u003c/em\u003e= 0.1540). The ePRO scores were similar across both formats.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e This study provided evidence that both single-item and multiple-items-per-screen presented on an electronic tablet device are acceptable to users and that format preference may be specific to each individual. Thus, clinical programs need to consider the targeted study population, the purpose of use, and the overall the trial design when designing ePRO solutions.\u003c/p\u003e","manuscriptTitle":"Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-09 17:10:42","doi":"10.21203/rs.3.rs-3921908/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-09-10T18:44:55+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-03-25T21:18:10+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"5474da81-9f82-4749-ae41-50e7388cb619","date":"2024-03-04T11:24:39+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-02-19T02:52:59+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-02-09T19:09:25+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-02-07T09:52:31+00:00","index":"","fulltext":""},{"type":"submitted","content":"Therapeutic Innovation \u0026 Regulatory Science","date":"2024-02-02T18:45:23+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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