Advancing Equitable Participation in Pediatric Clinical Trials Through Cognitive Interviewing

Lena and her 6-year-old daughter with severe persistent asthma enroll in a clinical trial for pediatric asthma management; they are hopeful this study will improve her daily wheezing symptoms that have led to weeks of missed school. Lena reads in Spanish only and sits down to complete the Spanish-language version of the baseline study survey. The first question asks: “En últimas cuatro semanas, cuántos días experimentó su hijo sibilancias?” (professionally back-translated from the English survey question: In the last 4 weeks, how many days did your child have wheezing?). Lena hesitates for a few minutes, unfamiliar with the word “sibilancias” (wheezing); she responds: 0 days. Lena’s confusion with this survey question made her less inclined to continue on in this trial, and she decided not to complete the follow-up surveys.Children and families from low-income and racial and ethnically minoritized backgrounds have low participation rates in clinical trials in part due to inaccessible study materials.1,2 In pediatric clinical trials, over 66% of participants are white, with very low representation from minoritized populations (12% Black and 7% Hispanic).3 This lack of diversity extends beyond social constructs of race and ethnicity. Individuals with low income and low educational attainment are hard-to-reach groups in medical research and do not have equitable access to clinical trials and potentially life-saving approaches.4,5 Pervasive exclusion of low-income and minoritized children and families from research contributes to decreased generalizability of results and reinforces existing inequities.2,6 Contributing factors include systemic barriers like study inclusion criteria limited to English-speaking and English-reading individuals and lack of tailored efforts to ensure materials support recruitment and retention of diverse groups.7,8 Compounding this issue is the fact that low-income and minoritized families are less likely to participate in research due to time commitment, poor understanding or accessibility of study materials, cost, and mistrust in research and/or the medical community stemming from historical mistreatment.7–14 In light of these barriers, the purpose of this commentary is to present cognitive interviewing as a strategy that research teams can use to improve the accessibility of study materials for underrepresented participants and promote more equitable research participation.2,15Integrating cognitive interviewing of study materials into clinical trial preparation is a concrete strategy to improve accuracy and validity of study materials for diverse, multicultural study populations who speak a language other than English and to enhance equitable representation in research. This may be especially useful for materials that undergo professional translation to promote reach to multilingual and multicultural populations. Cognitive interviewing is a qualitative technique that elicits participant input to refine surveys by decreasing response error, limiting response burden on participants, and establishing content validity.16,17 Although it is commonly used to refine large- and small-scale survey instruments,18–21 few clinical trials report using cognitive interviewing to support participant recruitment and accessibility of study materials.22,23 Given that randomized controlled trials are a powerful and pervasive tool for assessing the safety and effectiveness of health interventions,24 cognitive interviewing could serve as a powerful strategy to improve equitable representation. Herein we describe our process and lessons learned from using cognitive interviewing in preparation for a large pediatric asthma clinical trial.Asthma Link is a school-supervised asthma therapy intervention that connects pediatric providers, school nurses, and families to improve daily preventive medication adherence for children with poorly controlled asthma.25–28 In preparation for a large, National Institutes of Health (NIH)-funded clinical trial of Asthma Link, wherein 350 parent–child dyads will be recruited largely from low-income and minoritized families, we conducted cognitive interviewing. We sought to determine appropriateness and comprehension of our trial surveys for both English and Spanish-speaking/reading participants and for those from low-income and low-literacy backgrounds. Although many initial survey questions were derived from validated survey instruments written at a ninth-grade reading level, we learned from our pilot trial that many participants would read at a lower reading level than this, and we therefore aimed to assess comprehension of the initial survey question at a fourth to fifth grade reading level. We initially budgeted for professional translation of study materials; however, we did not budget for cognitive interviewing. Despite this, after reviewing our initial trial survey questions, we thought cognitive interviewing would be a critical step to advance equitable participation in this trial, and we completed the work with minimal staff time and financial resources (18 hours to conduct and take notes on interviews, 6 hours to analyze data, $350 for participant incentives). Over 5-weeks, we conducted 12 cognitive interviews: 6 adult interviews with 4 parents (2 completed interviews in both English and Spanish) and 6 child interviews, all conducted in English (Table 1). We concluded interviews when no new feedback emerged (thematic data saturation).29 Parents were identified from a pool of participants in our asthma pilot trial, and all were parents of children with asthma. Children were identified from our asthma pilot trial or clinical interactions with the principal investigator, and all had asthma. Parent and child participants were recruited through a phone call in which study staff introduced the process of cognitive interviews and asked if they wished to participate. We provided compensation for parent participants ($50 gift card) and child participants ($20 gift card and a small toy valued at under $5).We asked participants to “think out loud” and paraphrase survey questions in their own words while they read and processed each question. We elicited feedback on unknown words, unclear questions, and suggestions for improving wording. Two bilingual (English- and Spanish-speaking) and bicultural (Colombian and Spanish) research staff conducted interviews, one being a native Spanish speaker and the other having a bachelor’s degree in Spanish language and over 15 years of Spanish-speaking experience. During the interviews one research staff led, and one took notes. We used matrix analysis of interview notes to identify themes within participant feedback30 and rationale for modification of survey questions. Primary areas of improvement were (1) poor comprehension related to translation, (2) obstructively long or “wordy” questions, (3) intended meaning of question unclear, and (4) unfamiliar wording (both English and Spanish). We collected feedback on 113 questions, revised 29 questions in the English survey and 44 questions in the Spanish survey, and removed 18 survey questions (from both surveys). Examples of these revisions are shown in Table 2.To advance child health equity, practical strategies are needed to improve sociodemographic diversity in clinical trials.1,3,31 Cognitive interviewing is one such strategy that can improve accessibility and generalizability of clinical trial materials and, in so doing, allow for the recruitment and retention of more diverse multilingual and multicultural pediatric populations within clinical trials. We recommend 3 calls to action based on our experience: (1) Integrate cognitive interviewing into early stages of clinical trial preparation. It is possible to efficiently refine trial materials prior to initiating recruitment to promote inclusivity. We completed cognitive interviewing within 5 weeks. Recruiting participants from previous studies allowed us to efficiently complete interviews with the sociodemographic groups we hope to recruit in our trial. Our experience demonstrates feasibility of this brief, pragmatic process to vet study instruments, particularly for studies aiming to engage underrepresented populations, and, in the future, we will build this brief activity into research proposals.(2) Use cognitive interviewing to ensure professional translations account for reading level, comprehension, health literacy, and cultural/regional linguistic differences in target populations. Growing evidence demonstrates a critical need to advance beyond traditional translation methods (professional translation and back translation)32 for participants who speak a language other than English.15 Asthma literature describes patients who speak a language other than English being unfamiliar with medical terminology, specifically the term “wheezing.”33,34 We found that despite professional translation of surveys, much of the feedback we received from Spanish-speaking participants described inappropriate word choice (ie, sibiliancias [wheezing]) or not understanding intended meaning of questions, leading us to revise many survey questions.(3) Prioritize hiring multilingual and multicultural research team members to conduct cognitive interviewing. Staffing research teams with bilingual individuals who can communicate with participants in their preferred language is an important strategy for recruitment and retention of diverse participants.35,36 Our team’s diversity was essential to these processes; we believe that our bilingual, bicultural research staff facilitated receipt of more honest feedback from participants. As demonstrated with our team, this skillset can come in a variety of forms. Our team included a native Spanish speaker and a long-time speaker who studied the language in college. Other teams may additionally include staff who hold formal training as translators or interpreters. Building diverse, multilingual, and multicultural research teams, especially for cognitive interviewing, is an important priority area to increase diversity in research.Although time, resources, and the process of hiring and retaining multilingual/multicultural research staff can be barriers to conducting additional work to improve diversity, equity, and inclusion in research, we have demonstrated the feasibility of conducting cognitive interviewing within a brief time period before clinical trial deployment using few additional resources.Consider how cognitive interviewing could have improved Lena’s experience in our trial. Lena would have read the question “En las últimas 14 días, ¿cuántos días experimentó su hijo/hija sibilancias (un sonido/silbido alto al respirar)?” and, with the added text to describe “wheezing” (“a sound/ loud whistle when breathing”), she may have been able to answer this question with less difficulty, and more accurately report that her daughter experienced “14 days” of symptoms. Due to experiencing less confusion in completing the baseline survey, she may have been more inclined to continue participating and less likely to be lost to research follow-up. The improved clarity of this question could have allowed Lena to accurately report her daughter’s health and support her full participation in this asthma trial.As research teams seek to dismantle the structures that contribute to pediatric health inequities,2,15 cognitive interviewing serves as a concrete, efficient, and patient-centered strategy to promote more diverse representation in research. Specifically, cognitive interviewing can improve accessibility and comprehension of study materials and reduce time burden on participants, both of which are known barriers to engaging underrepresented populations in research.7–9,12,32 Ultimately, cognitive interviewing can facilitate more equitable representation in pediatric clinical trials and advance child health equity.